final report - march 2012

Implementation and Enforcement of Restrictions under Title VIII and Annex XVII

to REACH in the Member States

Final Report

Submitted to

European Commission

Directorate General Enterprise and Industry

7 March 2012

This Final Report has been prepared by Milieu Ltd., under contract to the European

Commission, DG Enterprise and Industry (Study Contract No ENTR/G1/2007/062/2 30-

CE-0404726/00-58). The report was written by Josephine Armstrong and Claire Dupont.

The views expressed herein are those of the consultants alone and do not represent the

official views of the European Commission.

Milieu Ltd (Belgium), 15 rue Blanche, B-1050 Brussels, tel: +32 2 506 1000; fax +32 2

514 3603; e-mail: [email protected]

mailto:[email protected]

Table of contents

Executive Summary .................................................................................................................. 4

1 Introduction ..................................................................................................................... 10

1.1 Background to the study ........................................................................................... 10

1.2 Objectives of the study.............................................................................................. 11

1.3 Restrictions covered by the study ............................................................................. 12

1.4 Coordination with the FORUM ................................................................................ 13

1.5 Methodology of the study ......................................................................................... 14

2 Implementation and Enforcement of specific restrictions .......................................... 18

2.1 Introduction ............................................................................................................... 18

2.2 Enforcement campaigns and other actions ............................................................... 18

2.3 Asbestos Fibres (Entry 6).......................................................................................... 23

2.4 Mercury (Entry 18a) ................................................................................................. 27

2.5 Nickel (Entry 27) ...................................................................................................... 30

2.6 Creosote (Entry 31) ................................................................................................... 38

2.7 Nonylphenol and Nonylphenol ethoxylates (Entry 46) ............................................ 42

2.8 Chromium VI compounds (Entry 47) ....................................................................... 47

2.9 Toluene (Entry 48) .................................................................................................... 52

2.10 Trichlorobenzene (Entry 49) ..................................................................................... 55

2.11 PAH (Entry 50) ......................................................................................................... 57

2.12 Phthalates (Entries 51 and 52) .................................................................................. 65

2.13 CMR Substances (Entries 28 to 30) .......................................................................... 70

2.14 Information on campaigns covering other restrictions ............................................. 75

3 Implementation and enforcement of restrictions - general information .................. 76

3.1 Introduction ............................................................................................................... 76

3.2 Market surveillance in the Member States................................................................ 77

3.3 Measures taken by different actors in supply chain to ensure compliance ............... 85

3.4 Analytical methods used and costs relating to testing .............................................. 90

3.5 Resources .................................................................................................................. 92

3.6 Consumer products and professional use .................................................................. 93

3.7 Imports ...................................................................................................................... 94

3.8 Sanctions and Penalties ........................................................................................... 102

3.9 Consistency in application across Member States .................................................. 104

3.10 Suggestions for improvement for implementation and enforcement ...................... 105

4 Communication and cooperation ................................................................................ 108

4.1 Cooperation within Member States ........................................................................ 108

4.2 Cooperation between Member States ..................................................................... 110

4.3 RAPEX notifications .............................................................................................. 112

5 Main Findings................................................................................................................ 124

6 Recommendations ......................................................................................................... 130

Tables

Table 1.1 Overview of the respondents to the questionnaire .................................................... 16

Table 2.1 – Member State National Campaigns ....................................................................... 19 Table 2.2 Overview of national campaigns according to the number of Member States ......... 20 Table 2.3 Overall coverage of restrictions by enforcement Campaigns and other actions ....... 21 Table 2.4 Coverage of specific restrictions by enforcement campaigns and other actions ...... 22 Table 2.5 Substances covered by Entry 6 ................................................................................. 23

Table 2.6 Substances covered by Entry 18a ............................................................................. 27 Table 2.7 Substances covered by Entry 27 ............................................................................... 30

Table 2.8 Substances covered by Entry 31 ............................................................................... 38

Table 2.9 Substances covered by Entry 46 ............................................................................... 42 Table 2.10 Substances covered by Entry 47 ............................................................................. 47 Table 2.11 Substances covered by Entry 48 ............................................................................. 52 Table 2.12 Substances covered by Entry 49 ............................................................................. 55

Table 2.13 Substances covered by Entry 50 ............................................................................. 57 Table 2.14 Substances covered by Entries 51 and 52 ............................................................... 65

Table 2.15 Substances covered by Entries 28 to 30 .................................................................. 70 Table 3.1 Inspections covering REACH Restrictions............................................................... 82 Table 3.2 Inventory of analytical methods ............................................................................... 91

Table 3.3 Restrictions and examples of potential corresponding TARIC Chapter/Codes ...... 95

Table 3.4 Overview of penalties ............................................................................................. 103

Annexes

Annex I – Documentation Review

Annex II – Questionnaires

Annex III – RAPEX notifications – asbestos

Annex IV – RAPEX notifications – nickel

Annex V – RAPEX notifications – toluene

Annex VI – RAPEX notifications – phthalates

Annex VII – Analytical methods

Annex VIII – Country fiches

Milieu Ltd Implementation and enforcement of restrictions

under REACH Annex XVII / 5

Executive Summary

Annex XVII of REACH replaces Directive 76/769/EEC on the approximation of the laws,

regulations and administrative provisions of the Member States, relating to restrictions on the

marketing and use of certain dangerous substances and mixtures. It thus introduced a new

restriction process aimed at regulating the manufacture, placing on the market or use of certain

substances on their own, in preparations and in articles if they pose an unacceptable risk to health

or the environment, which forms a key component of REACH, as it acts as a "safety net" in order

to manage risks that are not addressed by other provisions of REACH. The socio-economic

aspects as well as the availability of alternatives are also taken into account when action at

Community-level is addressed.

The aim of this study is to provide information on the level of implementation and enforcement

of the restrictions under Annex XVII of REACH as well as to generate possible suggestions on

how to improve implementation and enforcement of restrictions.

Whilst there are approximately 60 existing restrictions under REACH (until 1 September 2011),

the study focuses on 10 selected restrictions, being those covered by Entries 6 (asbestos fibres),

18a (mercury in measuring devices), Entry 27 (nickel articles in contact with the skin), Entry 31

(creosote in treated wood), Entry 46 (nonylphenol and nonylphenol ethoxylates), Entry 47

(chromium VI in cement), Entry 48 (toluene in adhesives and spray paints), Entry 49

(trichlorobenzene), Entry 50 (PAH in extender oils for tyres), and Entries 51 and 52 (phthalates

in toys and childcare articles). Restrictions were selected which presented a good sample

covering both environmental protection, consumer protection and worker protection. The aim

was also to have a good diversity in the selection of restrictions: restrictions concerning articles

that last longer and are placed in the second hand market (creosote/asbestos); mixtures that are

banned only for the general public (toluene); and a diversity in the types of substances selected

such as metal, inorganic materials and organic materials.

The study involved stakeholder consultation and follow-up interviews with Member State

competent authorities, companies and industry associations, retailers and NGO’s in order to

obtain information on the level of implementation and enforcement of the 10 selected restrictions

following an initial desk-top study.

Based on the responses received from Member States and stakeholders, the report draws together

information on the implementation and enforcement of the 10 restrictions covered by the study,

providing details of their application and use, specific enforcement campaigns carried out in

Member States, any products notified under RAPEX, information received from the

questionnaire responses, and any difficulties in the implementation and enforcement of the

specific restriction. From this it can be concluded that the degree of implementation and

enforcement varies according to each of the 10 selected restrictions, which reflects the overall

need for Member State authorities to prioritise the enforcement of certain restrictions over others.

For example, in relation to the specific restrictions covered by the study, Entries 27, 48, 50 and

51 and 52, more than half of the Member States have taken measures to enforce the restriction,

and in the cases of Entries 27, and 51 and 52, those measures have focused largely on one or

more targeted campaigns being carried out. At the other end of the scale only five Member



States have taken measures to enforce Entry 49, with only one of those Member States having

carried out a targeted campaign in relation to this entry.

Overall however, 82% of Member States were found to be carrying out one or more targeted

enforcement campaigns in relation to at least some of the restrictions covered by this study, with

the majority of Member States having taken some sort of action, such as reactive enforcement,

non-official product checks, checks on products notified under RAPEX, preliminary

investigations or information campaigns, rather than actual enforcement campaigns, to enforce at

least half of the 10 selected restrictions.

The report also provides a horizontal analysis of the implementation and enforcement of

restrictions generally under Annex XVII, without focusing on the 10 restrictions covered by the

study. This overview is based on responses received from Member States, companies and

industry associations, retailers and NGO’s. Finally, cooperation within Member States and

between Member States on the implementation and enforcement of restrictions is also

considered, and whether products posing a serious risk are notified by the authorities under the

Community Rapid Information System for non-food dangerous products (known as “RAPEX”),

as required under Regulation (EC) 765/2008. Through an analysis of the notifications under

RAPEX concerning preparations and articles containing substances subject to the 10 selected

restrictions, again it can be seen that certain products/restrictions occur more regularly than

others, in particular those of phthalates, nickel and toluene.

A number of recommendations are made in order to improve the overall implementation and

enforcement of restrictions. These feature actions in order to improve prioritisation of

enforcement actions, exchange of information among enforcement authorities, market

surveillance, including RAPEX, testing and availability of laboratories, and cooperation with

customs. These are summarized below, according to each of the overall findings set out in

Chapter 5.

Resources - Overall, there is a lack of resources in the Member States for the

implementation and enforcement of restrictions. It is recommended that substances

should continue to be selected for enforcement by the FORUM, information campaigns

should be used to increase awareness & improve compliance with restrictions, target

companies and relevant products should be identified for further investigation through

desktop/market research, information on the supply chain should be obtained, focusing

on the source in order to target manufacturers and importers and other actors, and

prioritisation tools should be used by national enforcement authorities.

Market Surveillance - Despite significant practical issues in covering all 60 restrictions,

certain Member States show that market surveillance can be better targeted and improved

using a number of methods. It is therefore recommended that in addition to continuing

with the current variety of measures carried out, national enforcement authorities should

conduct awareness raising campaigns, carry out desktop/market research during the early

stages of an enforcement campaign, and possibly use incentives, such as reduced

frequency of inspections where a good track-record of compliance is evident, as

incentives to comply with REACH, where these measures are not already being used.



Testing – As some Member States experience difficulties in the enforcement of particular

restrictions due to a lack of in-country facilities and testing equipment for analysis of

samples, it is recommended that the Commission with the assistance of the FORUM,

draw up an EU list of analytical methods suitable for enforcement, compile an EU

database of existing laboratory capacities across all 27 Member States, and to develop

guidance on restrictions. It is also recommended that industry could be involved in a

voluntary scheme used to compile a database/summary of products tested and % of

failures found in order to help national enforcement authorities and industry to focus

testing on high risk areas. In addition, it is recommended that the Commission to ensure

that the analytical standard applicable to each restriction reflects current industry practice

and the most recent testing standards developed technical progress when adapting Annex

XVII to technical progress.

Exchange of information – As the exchange of information amongst national authorities

helps considerably in the implementation and enforcement of restrictions, it is

recommended that the FORUM should facilitate further exchange of information, which

could cover Member States experience in the enforcement of specific restrictions, that the

FORUM and national authorities facilitate exchange programmes for inspectors, training

workshops etc, that authorities other than the REACH Competent Authority could assist

in the exchange of information between different national authorities and that there is

improved access to information (e.g. registration dossiers) via ECHA.

Cooperations with customs - The majority of non-compliant products are imported

products from outside EU. As a result cooperation with customs is extremely important

in the implementation and enforcement of restrictions. In this regard, it is recommended

that the FORUM should proceed with REACH EN-FORCE 3, that Member States should

look at putting in place formal cooperation and/or data-sharing agreements between

customs and REACH Competent Authorities regarding REACH (including restrictions),

and that the Commission should investigate the possibility of streamlining customs and

chemicals rules.

Abbreviations

CA Competent authority

CARACAL Competent Authorities for REACH and CLP

ECHA European Chemicals Agency

EU European Union

FORUM Forum for Exchange of Information on Enforcement

MS Member-State(s)

SDS Safety Data Sheet

REACH Regulation (EC) No 1907/2006 of the European Parliament and of the Council of

18 December 2006 concerning the Registration, Evaluation, Authorisation and

Restriction of Chemicals



1 Introduction

1.1 Background to the study

Regulation (EC) No. 1907/2006 (“REACH”) encompasses every chemical substance, mixture or

article manufactured or placed on the market in the EU, except for those specifically exempted.

A significant innovation of REACH is its shifting of the burden of proof to industrial actors, to

demonstrate that the substances, mixtures and articles they produce or place on the market are

safe,. Under REACH, industry must register the substances they produce or use. This

requirement extends to downstream users, if they use a substance in a mixture, or if they employ

it in a use not included in the upstream usage scenarios.

REACH also restricts the use of certain substances, through Annex XVII, which replaces

Directive 76/769/EEC on the approximation of the laws, regulations and administrative

provisions of the Member States, relating to restrictions on the marketing and use of certain

dangerous substances and mixtures. The REACH Regulation therefore introduces a new

restriction process aimed at regulating the manufacture, placing on the market or use of certain

substances if they pose an unacceptable risk to human health or the environment which need to

be addressed at Community level. Restrictions are a key component of REACH, since they are

designed to act as a "safety net" in order to manage risks that are not addressed by other

provisions of REACH. It is therefore possible for any substance on its own, in a preparation or

in an article to be subject to a restriction if it is shown that the risks identified need to be

addressed on a Community-wide basis. Proposals for restrictions can be prepared by Member

States or by the ECHA at the request of the Commission or on its own.

The harmonisation of enforcement amongst Member States was a key issue during the

development of REACH and led to the development of the European Chemicals Agency Forum

for Exchange of Information on Enforcement (the FORUM). The FORUM, according to

Regulation (EC) 1907/2006, coordinates a network of enforcement authorities responsible for the

following tasks:

Spread good practice and highlight problems at Community level

Propose, coordinate and evaluate harmonised enforcement projects and joint inspections

Coordinate exchange of inspectors

Identify enforcement strategies, as well as best practice in enforcement

Develop working methods and tools of use to local inspectors

Develop an electronic information exchange procedure

Liaise with industry, taking particular account of the specific needs of SMEs, and other

stakeholders, including relevant international organisations, as necessary



Examine proposals for restrictions with a view to advising on enforceability (Art.77(4))

Agree common issues to be covered in the annual reports from the Member States in

relation to enforcement (Art. 127).

The Forum has adopted a set of minimum inspection criteria,1 which should be utilised primarily

in the context of the Market Surveillance Regulation.2 The REACH Minimum Criteria propose

an inspection regime based on coordinating the work of the various enforcement and customs

authorities whose mandates include REACH; advance planning of inspection activities;

recording and reporting results; and communicating clearly with REACH dutyholders.3 The

inspections themselves should consider risks to and impact on health and the environment, and

should respond promptly to complaints or incidents. They should also “promote dutyholders’

knowledge and understanding of their duties under REACH,” and “preserve confidentiality

where necessary.”4

These criteria “operate alongside” the Forum’s “Strategies for enforcement of [REACH] of

March 2009,”5 and do so “on an equal footing” with that document.

6 The document provides a

framework and general recommendations for developing national REACH and CLP enforcement

strategies within the Member States, who may develop their national enforcement strategies and

establish their enforcement priorities according to the national circumstances within the

framework developed in the document. The document includes at Annex I, the essential

requirements for REACH, which includes Article 67(1) within the list of supply chain related

duties and use related duties, which should be considered when setting priorities for enforcement

activities. Article 67(1) of REACH states that substances subject to restriction, shall not be

manufactured or placed on the market unless they comply with the condition of that restriction.

1.2 Objectives of the study

The aim of this study is to provide information on the level of implementation and enforcement

of the restrictions under REACH. Whilst there are approximately 60 existing restrictions under

REACH, the study focuses on 10 selected restrictions. Information has therefore been sought on

any difficulties encountered by Authorities and companies in implementing the restrictions and

enforcement for these 10 restrictions in particular. This will then be used to analyse current

levels of implementation and enforcement and suggest possible ways of improving the situation,

such as the publication of a ‘best practice’ note or guidance document by ECHA.

1 Minimum Criteria for REACH Inspections, ECHA Forum for Exchange of Information on Enforcement,

December 2009 (REACH Minimum Criteria). 2 Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the

requirements for accreditation and market surveillance Official Journal L 218, 13/08/2008 P. 0030 – 0046. See

REACH Minimum Criteria, recitals viii, ix. 3 REACH Minimum Criteria, sections 5, 6, 8.

4 REACH Minimum Criteria, section 7.

5 Strategies for enforcement of Regulation (EC) No 1907/2006 concerning the Registration, Evaluation,

Authorisation and Restriction of Chemicals (REACH), ECHA Forum for Exchange of Information on Enforcement,

March 2009 (REACH Enforcement Strategies). 6 REACH Minimum Criteria, recital vii.



The study has three main objectives:

i) To obtain information on the level of implementation and enforcement of restrictions

across all 27 Member States. At the moment the information held by the Commission is

based on the information provided by the FORUM, RAPEX notifications and particular

issues/queries raised by the FORUM members. As a result, the knowledge surrounding

implementation and enforcement is somewhat removed from the market level and

therefore does not necessarily cover how implementation and enforcement of restrictions

works in practice and the problems associated with the implementation and enforcement

of restrictions.

ii) The Study has also been commissioned in order to generate suggestions on how to

improve implementation and enforcement of existing restrictions.

iii) The results of the Study will feed into the general report on the experience acquired with

the operation of REACH, which is to be published by the Commission by 1 June 2012, in

accordance with Article 117(4) of REACH.

1.3 Restrictions covered by the study

In line with the Terms of Reference, the study was to focus on ten restrictions from Annex XVII

REACH. The ten restrictions were selected following internal consultation within the

Commission, consultation with the FORUM and discussion between the Commission and

Milieu.

The aim was to select restrictions which presented a good sample covering both environmental

protection, consumer protection and worker protection. Moreover, the aim was to have a good

diversity in the selection of restrictions: restrictions concerning articles that have a long life and

are placed in the second hand market (creosote/asbestos); mixtures that are banned only for the

general public (entry 28 on CMR and toluene); and a diversity in the types of substances selected

such as metals, inorganic and organic compounds.

The final list of restrictions to be covered by the study therefore comprised the following:

Risks to Consumers

Entry 27 – Nickel in articles with contact with the skin

Entry 48 – Toluene in adhesives and spray paints

Entries 51 and 52 – Phthalates in toys and childcare articles



Risks to Workers

Entry 6 – Asbestos

Entry 47 – Chromium VI in cement

Entry 49 - Trichlorobenzene

Risks to Environment

Entry 18a – Mercury in measuring devices

Entry 31 – Creosote and creosote treated wood

Entry 46 - Nonylphenol and Nonylphenol ethoxylates

Entry 50 – PAH in extender oils for tyres

It was also agreed that a general question should be included in the questionnaire in relation to

Entry 28-30 on CMR substances, asking the Member State to provide information on how they

prevent the sale of CMR substances and mixtures to the general public, difficulties encountered

in enforcing this restriction and any suggestions as to ways to improve its implementation and

enforcement, and an indication of the general level of awareness surrounding the CMR

restriction.

1.4 Coordination with the FORUM

From the start, it was emphasised that the FORUM should be closely involved in the project,

particularly with regard to helping to approach Forum Members. In particular, it was agreed that

in the first instances, all contact with the Member State competent authorities should be

channelled via the FORUM members, for them to contact the relevant personnel direct, or to

advise Milieu whom they should contact. Therefore any reference to Member States Competent

Authorities must be considered as Enforcement Authorities or FORUM Members

The Commission had already made the FORUM aware of the study prior to the terms of

reference being issued, and asked in advance for the collaboration of the FORUM, who indicated

that they were willing to assist on this project. The Commission also drew the FORUM’s

attention to this project at a meeting that they had with FORUM representatives on 7 April 2011,

and CARACAL were also advised of the study.

In addition, the following letters were issued:

A letter from the Commission to the FORUM, dated 15 April 2011, drawing attention to

the study and what is expected of them, providing the overall framework and timescales

and also setting out the period within which FORUM members will be required to assist

Milieu on this project; and



A letter from Milieu to the FORUM members for Bulgaria, Germany and Sweden, dated

26 April 2011, asking if they would be willing to participate in the pilot exercise to be

carried out on the questionnaire, and advising them of the specific timings of this.

1.5 Methodology of the study

The methodology of this study relied on five main steps.

1.5.1 Step 1: Desk-top study

During the Inception period, Milieu immediately commenced a review of all existing available

literature. For example, all RAPEX notifications made since 2005 were reviewed. The full list

of documentation reviewed is attached at Annex I.

The results of this desk-top study were used in the next step 2, in developing the questionnaire.

1.5.2 Step 2: Questionnaire survey and stakeholder identification

The next step in the methodology was to develop the questionnaires, and identify stakeholders.

Initially, three separate questionnaires were developed, tailored to each of the different groups of

stakeholders:

Member State authorities,

companies, including SMEs , manufacturers and importers

NGO’s.

The draft questionnaires were based primarily on the issues listed in the Terms of Reference and

on the initial conclusions reached during our desk-top review outlined above. It also took into

account issues that were discussed at the Inception meeting, such as the inclusion of a general

question regarding the enforcement of Entry 28-30 on CMR substances.

The questionnaires were in English. However, to account for any language difficulties it was

indicated on the questionnaire that where difficulties are faced in completing the questionnaire in

English, it may be completed in other languages. As a result of this, a number of completed

questionnaires were provided in French, German, Hungarian, Portuguese and Spanish, which the

consultant’s pool of national experts assisted in translating.

In order to refine the questionnaire that was drafted for Member State competent authorities, a

pilot study was carried out with three FORUM Members, Bulgaria, Germany and Sweden. The

relevant FORUM member from each of these Member States, was asked to fill-in the draft

questionnaire and provide feed-back on any inconsistency or lack of clarity in our questions as

well as any difficulties they encountered in answering the questions. The draft Member State

questionnaire was thereafter revised in order to reflect this input from the pilot phase.

Meanwhile, it was decided that a fourth separate questionnaire should be developed for retailers,



who face slightly different issues than companies manufacturing or placing on the market

products. Copies of each questionnaire are provided at Annex 2.

A list of stakeholders was then drawn up, according to the categories of stakeholders for which

the questionnaires were developed: Member State authorities; companies, manufacturers,

importers and SME’s, retailers and selected NGO’s.

With regard to the first category, the first point of contact was to be the relevant FORUM

member for each Member State, who in most cases worked for the national competent authority

for REACH and was therefore best placed to identify other authorities who held responsibilities

for the enforcement of REACH in their country. The members of the FORUM were therefore

asked to distribute the questionnaire to all relevant competent authorities in their country which

have responsibility for enforcement of restrictions. The selection of stakeholders in the

remaining three categories was done of the basis of the restrictions covered by the study.

The questionnaires for industry, retailers and NGO’s were issued to stakeholders on 7 June 2011.

Stakeholders were asked to reply by 6 July 2011. Approximately 280 companies, retailers and

industry associations were contacted by email and asked to complete the questionnaire.

However, the relevant industry associations were asked to distribute the questionnaire to their

member associations or companies, who in turn were asked to distribute the questionnaire to the

appropriate companies. Stakeholders were also encouraged to forward the questionnaire on to other stakeholders who would have an interest in the study. As a result, the exact number of

recipients of the questionnaires cannot be established.

In order to allow time to receive feedback from the pilot study, the questionnaire for Member

State competent authorities was issued to members of the FORUM on 15 June 2011. FORUM

Members were asked to reply by 15 July 2011.

1.5.3 Step 3: Collection and analysis of questionnaire responses

In each case a period of a month was provided for stakeholders to respond to the questionnaire.

Throughout this period it was necessary to send multiple email reminders to the relevant

stakeholders before the filled-out questionnaires were returned and in certain cases, it was

necessary to make reminder phone calls as well. This was particularly important during the first

week after distribution of the questionnaire, in order to ensure that industry organisations had

passed the questionnaire on to their members or to offer again that Milieu contacts their members

direct. In some cases, an extension to the deadline for responses was requested. Following

receipt of responses these were collated and analysed.

Overall 93 responses were received to the questionnaires issued to companies and industry

associations, retailers/distributors and non-governmental organisations (NGO’s). Of these 93

responses, 36 responded simply to confirm that the questionnaire was not relevant to their

operations, or that they did not produce, place on the market or import any product or product

types that are subject to any of the restrictions covered by the study, and therefore did not include

any information other than their name and contact details. The remaining 57 responses are made

up of 32 responses from companies, 10 responses from industry associations, 8 responses from

NGO’s, 6 responses from retailers/distributors, and 1 response from an academic institution. In



some cases, where a response was received from an industry association, it was stated that the

organisation had consulted all their members and that the response was provided on behalf of all

their members. In another case, a joint response was provided by the relevant industry body

along with a number of its members.

All FORUM Members provided a response to the questionnaire.

Table 1.1 Overview of the respondents to the questionnaire

Respondents Number of responses received

Companies 32

Industry associations 10

NGO’s 8

Retailers/distributors 6

Academic institution 1

Questionnaire not relevant 36

TOTAL 93

1.5.4 Step 4: Follow-up interviews

Following receipt of all Member State responses and completion of the analysis of responses

during September, follow-up interviews were arranged and carried out during October and early

November. These aimed to clarify a particular response or to obtain further information on a

particular point/issue raised in the response. Proposed interviewees were therefore primarily

selected from those companies, retailers, NGOs and Member State competent authorities who

responded to the questionnaire. However, in addition, since there had been a poor response rate

from NGO’s and only limited information had been received for certain sectors or in relation to

certain restrictions, a number of NGO’s and industry associations/companies were contacted

again in order to try and seek their agreement to participate in a phone interview or alternatively

to provide a written response during this phase of the study. An initial list of 30 proposed

interviewees was drawn up, subject to their acceptance to take part in an interview. Of these, 22

phone interviews were carried out. All interviews were recorded in writing by the interviewee

and the results from these follow-up interviews were collated and analysed along with the initial

questionnaire responses.



1.5.5 Step 5: Compilation of results

A number of findings emerged from the initial responses received from stakeholders and the

results of follow-up interviews, which formed the basis of the conclusions and recommendations

to this report. These are structured around the key aspects identified in the Terms of Reference

(market surveillance in terms of institutional settings, human and financial resources,

prioritisation, types and efficiency of various market surveillance measures, including those

applied to imported products, as well as for consumers versus professional use and industrial use.

Section 5 below therefore sets out the key problems encountered by stakeholders, and areas for

improvement and outlines possible options to address the problems identified, identifying areas

for improvement and making recommendations as to best practice/guidance documentation that

may be developed by ECHA.



2 Implementation and Enforcement of specific restrictions

2.1 Introduction

This section provides information on the implementation and enforcement of the 10 restrictions

covered by the study. This section is based on responses received from Member States,

companies and industry associations, retailers and NGO’s, follow-up interviews conducted with

Member States and stakeholders, as well as RAPEX information. In each case details of their

application and use, specific enforcement campaigns carried out in Member States, any products

notified under RAPEX, information received from the questionnaire respondents, and any

difficulties in the implementation and enforcement of the specific restriction is provided.

2.2 Enforcement campaigns and other actions

A summary of the national campaigns and other actions carried out by Member States in relation

to the 10 selected restrictions is provided in Table 2.1 below. This shows the campaigns that

were carried out by 24 of the 27 Member States, 3 Member States having indicated that they

have not carried out any campaigns in relation to the 10 selected restrictions.

The information is categorised as follows:

A - Several enforcement campaigns have been carried out

B - At least 1 enforcement campaign has been carried out

C - Other action taken, e.g. reactive enforcement, non-official product checks, or checks on

products notified under RAPEX

D - Preliminary investigations on relevant market players or to locate products on the market

E - Information campaign only

F – Future enforcement campaign planned



Table 2.1 – Member State National Campaigns

1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 21. 23. 24.

Entry 6 B C C C B C B B C B C C B

Entry18

a B D C C B B B C B C B B B

Entry

27 A B A A A C B C B C C B C B B B B

Entry

31 A A C C B B C B B

Entry

46 A C B C B B B B B B C F D B

Entry

47 A B C C B C B B B B A C B B B

Entry

48 B B B B C C B C B B B C C B C B C D B A

Entry

49 C

B F C C

Entry

50 D

B E B C E D B F B B C B B B B

Entry

51+52 A A A A C A B B C B B C A B B A



Table 2.2 summarises this information according to the number of Member States that have

carried out a particular type of action in relation to enforcing a restriction, as in some cases

Member States have carried out repeat campaigns for certain restrictions or are only at the

stage of carrying out preliminary investigations to locate products on the market. Section 3.2

below provides details of the number of inspections carried out by Member States in 2009,

covering REACH generally and those that addressed restrictions specifically.

Table 2.2 Overview of national campaigns according to the number of Member States

A B C D E F Total

number

of

Member

States

Entry 6

Asbestos

6 7 13

Entry 18a

Mercury

8 4 1 13

Entry 27

Nickel

4 8 5 17

Entry 31

Creosote

2 4 3 9

Entry 46

Nonylphenol

1 8 3 1 1 14

Entry 47

Chromium

2 9 4 15

Entry 48

Toluene

1 10 8 1 20

Entry 49

Trichlorobenzene

1 3 1 5

Entry 50

PAH

9 2 2 2 1 16

Entry 51+52

Phthalates

7 6 3 16

TOTAL 17 69 42 5 2 3

As can be seen, in the most right-hand column in the case of some restrictions covered by the

study, for example Entries 27, 48, 50 and 51 and 52, more than half of the Member States

have taken measures to enforce the restriction, and in the cases of Entries 27, and 51 and 52,



those measures have focused largely on targeted campaigns on the basis of categories A and

B. At the other end of the scale only 5 Member States have taken measures to enforce Entry

49, within only one of those Member States having carried out a targeted campaign in relation

to this entry. It should be borne in mind however that this only covers information on the 10

selected restrictions, and it may be that Member States are focusing their efforts in

enforcement on some of the other 50 restrictions.

It is also possible to break the information down according to the number of restrictions

covered by this study that each Member State has taken action in relation to, by any of the

means outlined above.

Table 2.3 Overall coverage of restrictions by enforcement Campaigns and other actions

Restrictions (of the 10

selected) covered by MS

enforcement campaigns

Number of Member States

carrying out 1 of more


(Categories A and B)


taking action under

Categories A to F

0 restrictions 5 3

1-3 restrictions 10 6



The second column above shows that 82% of Member States (22 countries) are carrying out

enforcement campaigns (Categories A and B above) to enforce at least some of the

restrictions covered by this study, i.e. are either carrying out 1 or several campaigns in

relation to the 10 selected restrictions. The third column shows that the majority of Member

States have taken some sort of action, albeit not in all cases an enforcement campaign, to

enforce at least half of the 10 selected restrictions



In terms of how this is broken down per restriction, the following table shows these figures

according to each of the 10 restrictions:

Table 2.4 Coverage of specific restrictions by enforcement campaigns and other actions

Restriction Number of Member States

carrying out one or more


(Categories A and B)


taking action under

Categories A to F

Entry 6

Asbestos

6 13

Entry 18a

Mercury

8 13

Entry 27

Nickel

12 17

Entry 31

Creosote

6 9

Entry 46

Nonylphenol

9 14

Entry 47

Chromium

11 15

Entry 48

Toluene

12 20

Entry 49

Trichlorobenzene

1 5

Entry 50

PAH

9 16

Entry 51+52

Phthalates

13 16

As can be seen, the degree of enforcement varies according to each of the 10 selected

restrictions, which reflects the overall need for Member State authorities to prioritise the

enforcement of certain restrictions over others. While the study only covers 10 of the overall

60 restrictions, it is expected that this represents the overall position regarding the

implementation and enforcement of all 60 restrictions due to the practical difficulties that

would be involved in enforcing all 60 restrictions.



2.3 Asbestos Fibres (Entry 6)

2.3.1 Application of restriction and uses

The substances covered by Entry 6 (Asbestos fibres) and the conditions of restrictions are set

out in Table 2.5 below:

Table 2.5 Substances covered by Entry 6

Substance Conditions of restriction

6. Asbestos fibres

(a) Crocidolite

CAS No 12001-28-4

(b) Amosite

CAS No 12172-73-5

(c) Anthophyllite

CAS No 77536-67-5

(d) Actinolite

CAS No 77536-66-4

(e) Tremolite

CAS No 77536-68-6

(f) Chrysotile

CAS No 12001-29-5

CAS No 132207-32-

0

1. The manufacture, placing on the market and use of these fibres and of articles

containing these fibres added intentionally is prohibited.

However, Member States may exempt the placing on the market and use of

diaphragms containing chrysotile (point (f)) for existing electrolysis installations

until they reach the end of their service life, or until suitable asbestos-free

substitutes become available, whichever is the sooner.

By 1 June 2011 Member States making use of this exemption shall provide a

report to the Commission on the availability of asbestos free substitutes for

electrolysis installations and the efforts undertaken to develop such alternatives,

on the protection of the health of workers in the installations, on the source and

quantities of chrysotile, on the source and quantities of diaphragms containing

chrysotile, and the envisaged date of the end of the exemption. The Commission

shall make this information publicly available.

Following receipt of those reports, the Commission shall request the Agency to

prepare a dossier in accordance with Article 69 with a view to prohibit the placing

on the market and use of diaphragms containing chrysotile.

2. The use of articles containing asbestos fibres referred to in paragraph 1 which

were already installed and/or in service before 1 January 2005 shall continue to be

permitted until they are disposed of or reach the end of their service life. However,

Member States may, for reasons of protection of human health, restrict, prohibit or

make subject to specific conditions, the use of such articles before they are

disposed of or reach the end of their service life.

Member States may allow placing on the market of articles in their entirety

containing asbestos fibres referred to in paragraph 1 which were already installed

and/or in service before 1 January 2005, under specific conditions ensuring a high

level of protection of human health. Member States shall communicate these

national measures to the Commission by 1 June 2011. The Commission shall

make this information publicly available.

3. Without prejudice to the application of other Community provisions on the

classification, packaging and labelling of substances and mixtures, the placing on

the market and use of articles containing these fibres, as permitted according to the

preceding derogations, shall be permitted only if suppliers ensure before the

placing on the market that articles bear a label in accordance with Appendix 7 to

this Annex.

Uses: Fibres or articles containing intentionally added fibres



2.3.2 Specific enforcement campaigns in Member States

48% of Member States (13 countries) have carried out some sort of action on asbestos. Of

these, almost half, i.e. 6 countries referred to specific enforcement campaigns targeting the

restriction under Entry 6 having been carried out, whereas the other 7 countries, referred to

other action having been taken, either through reactive enforcement, non-official product

checks, or check on products notified under RAPEX. The enforcement campaigns carried out

by Member States have involved on-site controls and targeting of particular sectors and

products.

Of the countries that are carrying out specific targeted campaigns, one Member State stated

that enforcement authorities are executing on-site controls, checking documentation and

information made available by operators in order to control this restriction.

Another country commented that during the last two years there has been an enforcement

campaign on asbestos fibres, concerning the removal of asbestos fibres from buildings and the

use of asbestos fibres in products. Previously, the Member State had tried to have a more

proactive campaign, but since asbestos is now prohibited in the market, this should be less of

an issue. However as cases of non-compliance were still found, asbestos was selected for

enforcement action. In total 30 companies were inspected in that Member State and 11 cases

of non-compliances were found, which resulted in administrative measures being taken in

nine cases and criminal law measures being taken in two cases. Examples of non-compliance

that have been found in articles containing intentionally added fibres include asbestos in

roofing materials and asbestos in heaters. This campaign is ongoing as the Member State

intends to continue with follow-up to this campaign next year.

A third Member State ran a proactive campaign looking at the presence of asbestos in Sky

Lanterns following evidence obtained by Local Authority Trading Standards Officers that

asbestos was present in such products. This involved identifying and writing to the major

suppliers of sky lanterns in that country and asking them to provide evidence that their

products did not contain asbestos. This project is ongoing and other than the original lantern

no further non-compliance has been identified. This non compliance was publicised on

RAPEX, and as a result of which other Member States have checked the same product in their

country.

Actions taken by those Member States that indicated that they have taken steps to enforce the

restriction on asbestos, albeit not through specific targeted campaign, included the following:

Announcements and controls carried out in relation to products notified under

RAPEX, for example regarding the thermos flasks and sky lanterns that were found to

contain asbestos;

Controls in response to any complaints received from industry, NGOs or consumers,

or when non-compliance issues are detected during inspections;

Refusing entry of goods containing asbestos to the EU market following information

provided by customs to the REACH enforcement authority;

Control of asbestos fibres used in construction through checks made on labels at the

point of import, since imported products that bear labels declaring that there are no



asbestos fibres present in the product, have been found to contain asbestos fibres

following testing;

Documentation checks and investigation of products following notification of articles

containing asbestos fibres, as a result of which the product withdrawn was from the

market and the case reported to the prosecutor; and

The introduction of the requirement to hold a certificate for the transport, use etc. of

asbestos-containing articles

In terms of controls on the placing on the market of articles containing asbestos fibres which

were already installed and/or in service before 1 January 2005, one Member State referred

specifically to having introduced legislation, which requires an ‘asbestos article exemption

certificate’ to be applied for before asbestos-containing articles may be placed on the market.

In that country it is an offence to place such articles on the market, without holding such an

exemption certificate, and asbestos containing articles which were originally installed or in

service before 1 January 2005 can only be placed on the market in accordance with the

conditions and time limits specified in the exemption certificate. The Guidance

accompanying the legislation stated that examples of such articles would include second-hand

acetylene cylinders, articles of historical value and classic/vintage cars. However, the

Guidance also makes clear that an exemption certificate will not be issued where it is

reasonably practicable for the asbestos-containing component of the article to be substituted

and also in the case of articles containing asbestos which were are used in construction

applications since safer alternatives are available.

2.3.3 Products notified under RAPEX

A total of 34 notifications have been made to date in relation to the restriction on asbestos

fibres. This covers all RAPEX notifications made since 2005. Figures on the total number of

cases notified per Member State, per year, and according to the country of origin of the

product are provided in Section 5.3.3 below. A summary table, providing details of all these

notifications is provided in Annex 3.

Example of good practice:

The example of where one Member State identified a product in which asbestos

was present, investigated this and publicised the non-compliance on RAPEX, can

be cited as an example of best practice. This allowed other Member States to

target a specific product in order to enforce the restriction, without having to

invest huge resources and time in carrying out a full-blown enforcement

campaign, as already had the benefit of market intelligence from another country.

This has also been the approach particularly in the campaign on Entry 50 (PAH)

as outlined in Section 2.10 below.



The following types of products have been notified under RAPEX as containing asbestos7:

Product Notifications

Thermos/vacuum flask 24

Garden oil lamp/torch 4

Brake disks/linings 4

Heating radiator 1

Sky lantern 1

TOTAL 34

2.3.4 Information received from questionnaire respondents

Very few respondents commented specifically in relation to this restriction. Only one

company indicated that the restriction regarding asbestos fibres was applicable to the products

they produced, placed on the market or imported. The main responses came from NGO’s,

who had carried out awareness raising campaigns at the local and national level. One NGO

stated that its aim and principle area of concern was to secure a complete ban on asbestos, due

to the risks associated with asbestos in the workplace. It had concerns regarding the practices

of particular companies, which are believed to still be importing asbestos and devices

containing asbestos, though these may relate to products which were already installed and/or

in service before 1 January 2005 and shall continue to be permitted until they are disposed of

or reach the end of their service life.

2.3.5 Difficulties in implementation and enforcement of restriction

No specific difficulties in the implementation and enforcement of this restriction were

identified. However, difficulties in the implementation and enforcement of restrictions in

general, are outlined in Section 3.2 below.

7 As far as we are aware, none of the notified products fell within paragraph 2 of Entry 6 and thus were permitted

to be placed on the market until they were disposed of, or reached the end of their service life in the respective

notifying countries.



2.4 Mercury (Entry 18a)


The substances covered by Entry 18a (Mercury) and the conditions of restrictions are set out

in Table 2.6 below.

Table 2.6 Substances covered by Entry 18a


18a. Mercury

CAS No 7439-97-6

EC No 231-106-7

1. Shall not be placed on the market:

(a) in fever thermometers;

(b) in other measuring devices intended for sale to the general public (such as

manometers, barometers, sphygmomanometers, thermometers other than fever

thermometers).

2. The restriction in paragraph 1 shall not apply to measuring devices that were in

use in the Community before 3 April 2009. However Member States may restrict

or prohibit the placing on the market of such measuring devices.

3. The restriction in paragraph 1(b) shall not apply to:

(a) measuring devices more than 50 years old on 3 October 2007;

(b) barometers (except barometers within point (a)) until 3 October 2009.

4. By 3 October 2009 the Commission shall carry out a review of the availability

of reliable safer alternatives that are technically and economically feasible for

mercury containing sphygmomanometers and other measuring devices in

healthcare and in other professional and industrial uses. On the basis of this review

or as soon as new information on reliable safer alternatives for

sphygmomanometers and other measuring devices containing mercury becomes

available, the Commission shall, if appropriate, present a legislative proposal to

extend the restrictions in paragraph 1 to sphygmomanometers and other measuring

devices in healthcare and in other professional and industrial uses, so that mercury

in measuring devices is phased out whenever technically and economically

feasible.

Uses: fever thermometers and other measuring devices


48% of Member States (13 countries) have carried out some sort of action on mercury. Of

these, 8 countries referred to specific enforcement campaigns targeting the restriction under

Entry 18a having been carried out, whereas 4 countries, referred to other action having been

taken, either through reactive enforcement, non-official product checks, or check on products

notified under RAPEX, and 1 country referred to preliminary investigations regarding

relevant market players or in order to locate products on the market, having only been carried

out.

The following key aspects of national campaigns on mercury have been identified, based on

information provided by Member States:



1) Awareness raising of the restriction – As with other restrictions, the enforcement

authorities in some countries announces the restriction on their website and uploads a

copy of the relevant legislation whenever there is a new addition or amendment to

Annex XVII. In one country, the authorities also issue a letter by email or fax to all

associations (asking them to inform their members), ministries, and other parties who

may have an interest or be affected by the restriction, in order to notify them of the

terms of the restriction.

2) Pre-information - In the case of mercury, the relevant products are normally sold in

pharmacies, and therefore recipients were specifically informed that they could not

sell thermometers containing mercury and other measuring devices any more.

3) Selection of target product - Entry 18a restricts a specific use of mercury. This has

been reflected in the selection of products for targeted campaigns, as Member State

campaigns have specifically targeted thermometers containing mercury placed on the

market, focusing in particular on the healthcare sector. In one Member State, fever

thermometers, and other measuring devices, were selected for enforcement on the

basis of target analysis carried out in that country, where the authorities had looked at

what the market was for components containing mercury and researched which

companies were placing these on the market.

4) Preliminary investigations - to locate the product placed on the market

5) Market controls – In a number of Member States the national campaign involves

checking the documentation and information provided by importers or distributors of

thermometers and other measuring devices, following which any products presenting a

serious risk are withdrawn from the market. In other Member States, market controls

also involve taking samples from the market in cooperation with other national

authorities. One Member State indicated that while the information part of the

campaign has been completed, they have not yet started taking samples from the

market, though the number of samples and products from which they should be taken

are agreed in advance each year.

6) Results and follow-up - As a result of the campaigns, several product lines have been

withdrawn from the market. In one Member State, the national campaign was based

on checking the companies identified during the target analysis and in total 57

companies were inspected and 35 samples were analysed. Non-compliance was found

in three importing companies in relation to thermometers, and these offences were

reported.

As regards, actions taken by those Member States that indicated that they have taken steps to

enforce the restriction on mercury, albeit not through specific targeted campaign, one Member

State referred to controls being carried out in response to any complaints received from

industry, NGOs or consumers, or when non-compliance issues are detected during

inspections.

No information was received regarding implementation and enforcement of paragraph 2 of

Entry 18a, which states that the restriction shall not apply to measuring devices that were in

use in the Community before 3 April 2009.




All RAPEX notifications made since 2005 were reviewed. There have been no notifications

under RAPEX of fever thermometers or other measuring devices containing mercury.

2.4.4 Information received from questionnaire responses

Only two respondents commented specifically in relation to the restriction on mercury. One

trade association within the healthcare sector responded, commenting that while REACH can

have implications for their membership, they have had no reports to date of any issues with

Annex XVII restrictions. During the follow-up interviews, a further response was also

received from an NGO, which was mainly involved in awareness raising activities, such as

the publication of a study on the neurotoxicity of mercury on children.


Only one Member State referred to specific difficulties in the implementation and

enforcement of Entry 18a (mercury). The Member State had carried out an enforcement

campaign on mercury in measuring devices during 2009 and found that the restriction was not

straight forward to enforce as there are a number of scenarios covered by the restriction which

determine how it is applied. As placing on the market of fever thermometers is completely

restricted, this is straightforward to enforce. However, other measuring devices are only

restricted from being placed on the market where they are intended for sale to the general

public. In this respect the application of the restriction was a challenge. Many mercury

measuring devices were found on sale to the general public during the campaign. However,

difficulties arose with regard to establishing when these devices were first placed on the

market (and therefore if they were within the scope of the restriction) as this required detailed

information from companies. It should be noted also that the majority of the companies that

were identified as marketing potentially restricted products were small companies with a

small number of products, which do not necessarily represent the greatest environmental risk.

The approach of the authorities however was to identify the companies that represent the

greatest environmental risk, which therefore was not always clear in this campaign, though in

most cases would not include such companies.

Examples of good practice:As with other restrictions, efficient communication

and the use of pre-information in order to raise awareness can be cited as an

example of best practice. As with other campaigns, the enforcement authorities in

some countries announced the restriction on their website, issued letters by email

or fax to all associations, ministries and other parties who may have an interest or

be affected by the restriction, and also specifically notified pharmacies that they

could no longer sell thermometers containing mercury and other measuring

devices.

As this restriction relates to a very specific article, that of fever thermometers and

other measuring devices, the examples of where in-depth market research has

been carried out by a number of Member States, in the initial stages of their

campaign, can also be cited as another example of best practice. This appears to

be crucial to completing an effective enforcement campaign as by investing time

in carrying out desk-top research prior to going out to the market, this will lead to

a more targeted campaign and therefore efficient use of resources.



2.5 Nickel (Entry 27)


The substances covered by Entry 27 (Nickel) and the conditions of restrictions are set out in

Table 2.7.



27. Nickel

CAS No 7440-02-0

EC No 231-111-4

and its compounds

1. Shall not be used:

(a) in any post assemblies which are inserted into pierced ears and other pierced

parts of the human body unless the rate of nickel release from such post

assemblies is less than 0,2 μg/cm 2 /week (migration limit);

(b) in articles intended to come into direct and prolonged contact with the skin

such as: — earrings,

— necklaces, bracelets and chains, anklets, finger rings,

— wrist-watch cases, watch straps and tighteners,

— rivet buttons, tighteners, rivets, zippers and metal marks, when these are used

in garments,

if the rate of nickel release from the parts of these articles coming into direct and

prolonged contact with the skin is greater than 0,5 μg/cm 2 / week.

(c) in articles referred to in point (b) where these have a non-nickel coating unless

such coating is sufficient to ensure that the rate of nickel release from those parts

of such articles coming into direct and prolonged contact with the skin will not

exceed 0,5 μg/cm 2 / week for a period of at least two years of normal use of the

article.

2. Articles which are the subject of paragraph 1 shall not be placed on the market

unless they conform to the requirements set out in that paragraph.

3. The standards adopted by the European Committee for Standardisation (CEN)

shall be used as the test methods for demonstrating the conformity of articles to

paragraphs 1 and 2.

Ues: articles intended to come into direct and prolonged contact with the skin



In relation to this restriction, certain particular points should be noted:

Studies have shown that nickel contact dermatitis is now largely an “imported

allergy”, due to the overwhelming majority of consumer articles that can cause nickel

contact dermatitis

Nickel is now imported predominantly from non EU Countries

The consumer articles regulated by this restriction are used by almost every individual

in the EU during some stage of their life therefore the corresponding number of

articles in circulation is very high.

In certain countries, there is evidence of a large variation and a large number of

articles which do not comply with the nickel restriction.


63% of Member States (17 countries) have carried out enforcement action on nickel. Of


Entry 27 having been carried out, 4 countries referred to several enforcement campaigns

having been carried out, and 5 countries referred to other action having been taken, either

through reactive enforcement, non-official product checks, or check on products notified

under RAPEX. In addition, one of these countries has planned a campaign on mercury for

next year.

The following examples of national campaigns on nickel have been identified, based on

information provided by Member States:

1) Obtaining information from the market - In one Member State, the restriction was

selected due to the number of notifications made through RAPEX concerning these

products and also since there was provision made in the national budget that year to

carry out an analysis of products for public use. In undertaking the campaign,

enforcement officers obtained information from the market on importers of the

products themselves, by going to shops and getting information on the origin, types of

products etc, and then made a plan of which companies and domestic producers to

inspect. Thereafter, in order to find a laboratory that was capable of doing the

analysis, they sought proposals from a number of laboratories that used the appropriate

CEN standards in order to choose which one was the most appropriate. During the

operational phase, samples were taken on site, which are signed by the responsible

person in the company and placed in a sealed bag and sent to the laboratory. The

laboratory then prepared an analysis report and recommendations. If the results are

within the conditions of the restriction, the national competent authorities inform the

company and provide the company with a copy of the results. Where non-compliance

is found, further steps are taken, for example removal of the remaining stock from the

market, and in certain cases, imposition of a fine.

2) Annual monitoring programme - In one country, the necessity to launch a targeted

campaign on nickel in jewellery emerged following systematic controls carried out on

the market. An annual monitoring programme has been established in order to control



a representative number of samples from the market. For this campaign, 5 samples

which were taken were found to contain nickel above the permitted level. All of these

samples were taken from imported products at customs.

3) Targeting products prior to production - One Member State also targeted products at

the research level. Following the reported use of recycled raw materials for the

fabrication of jewellery, a research protocol was established for tracing nickel in

jewellery. As in other cases, where evidence of non-compliance is found, a specific

campaign is launched and jewellery is also targeted for controls during importation,

for example covering false jewellery being imported from non-EU countries.

4) Testing of products on the market - One Member State carried out a national campaign

in which a total of 85 different products were tested. The products were mainly

watches, jewellery at the lower end of the market, toy jewellery, charms, metal buttons

and metal fabric accessories that may come into contact with the skin. 9% of the

samples tested were found not to comply with the restriction. Similarly, in another

Member State the campaign involved enforcement officers going out to normal stores

and purchasing pieces of jewellery, which they then had analysed in accordance with

the nickel test. Following testing, companies were informed of the results and in cases

of exceedances, the company in most cases would voluntarily withdraw the product

from the market without the need for any further action. The operational phase of the

campaign outlined at 1) above, also involved testing.

As stated above, a number of Member States indicated that they have carried out multiple

campaigns concerning the nickel restriction. One Member State indicated that during the last

three years it has undertaken special campaigns for the collection of samples and for their

subsequent analysis of nickel content, and as a result there has been a significant reduction in

the number of non-compliant products observed over this period. In another Member State,

laboratory testing of samples of jewellery for nickel has been carried out in 2008, 2010 and

2011. Other items that may contain nickel and may come into contact with the skin, such as

phones, hairclips and belt buckles were also tested, and reactive controls taken in response to

any complaints received from industry, NGOs or consumers each year. Another Member

State carried out annual enforcement campaigns concerning nickel in jewellery between 2002

and 2007 and also in 2008 during the CLEEN “EUNICK” project,8 where a single non-

compliance was observed. During these 6 years only a few jewellery products were detected,

which were not in compliance with the restriction and in each case a RAPEX notification was

made. Low levels of non-compliance were also found in another Member State, which

indicated that in 2010, there was only one sample which exceeded the limit value.

One Member State referred to a campaign on nickel that it has planned for the future, which

will involve evaluating the nickel migration from body contact materials (except jewellery,

textiles) through testing 150 samples and evaluating the levels of nickel and other heavy

metals.

8 The EUNICK project was carried out within the CLEEN network (Chemical Legislation European

Enforcement Network), in relation to the control of the limits of nickel released from jewellery and other

products which have a direct and prolonged contact with skin under Directive 76/769/EEC. The project

commenced in 2007 and involved 10 countries including Austria, Belgium, Cyprus, Denmark, Estonia, Sweden,

Switzerland and the United Kingdom – see http://www.cleen-europe.eu/projects.

http://www.cleen-europe.eu/projects



Finally, while not referred to as one of the measures taken above, it should be noted that the

authorities in one Member State initiated a comprehensive nationwide campaign at the time of

the introduction of the Nickel Directive in order to provide information to importers,

manufactures, consumers and enforcement authorities about the restrictions on the use of

nickel. It has been stated that this campaign was one of the major contributing factors for the

subsequent decrease in nickel allergy in that Member State.9


A total of 49 notifications have been made to date in relation to the restriction on nickel. This

covers all RAPEX notifications made since 2005. Figures on the total number of cases

notified per Member State, per year, and according to the country of origin of the product are

provided in Section 5.3.3 below. A summary table, providing details of all these notifications

is provided in Annex 3.

The following types of products have been notified under RAPEX as containing asbestos:


Jewellery 29

Clothing 13

Watch 5

Earphones 1

Hairslide 1


Eight respondents commented specifically in relation to the nickel restriction. Six of those

respondents listed nickel as being applicable to the products they produced, placed on the

market or imported. The respondents included one employers’ association (jewellery), a

national federation for the jewellery industry within one of the Member States, as well as a

number of companies.

9 Jacqueline Biesterbos, Kerem Yazar and Carola Liden. Nickel on the Swedish market:follow-up10 years after

entry into force of the EU Nickel Directive. Contact Dermatitis 2010: 63: 333-339

Examples of good practice: The campaign referred to above, where one Member

State carried out a nationwide information campaign at the time of the

introduction of the Nickel Directive, which was found to be a major contributing

factor in reducing non-compliance, can be cited as an example of good practice.

The restriction on nickel also covers a large number of products, primarily

jewellery products, and therefore the examples of where Member States have

carried out a number of repeat campaigns over consecutive years, is another

example of good practice.



The responses revealed that 3 main types of action are taken to ensure compliance with the

restriction:

Using some sort of documentary checks to ensure that their products comply with the

restriction. These included checks made using the Safety Data Sheet (SDS), written

confirmation from the supplier, and certification letters from their sub-contractors.

Communicating with downstream users on uses advised against in the SDS for the

substance, and by imposing restrictions on their suppliers.

Carrying out testing to ensure that their products comply with the restriction. This was

either carried out internally or involved external testing in certified laboratories on a

product by product basis.

Among the few respondents that had been subject to market surveillance, one company

referred to controls being carried out on a regular basis to check the source of the material, the

manufacturing process and the analysis reports. Industry bodies highlighted that in many

cases companies do not usually realise that they do not comply with the restriction.

In respect of the prioritisation of market surveillance, one academic department also

responded to the questionnaire in relation to the nickel restriction, due to its involvement in

scientific analysis of the frequency of nickel contact allergy in terms of time trends and

specifically affected subgroups and co-operation in the analysis of exposure surveillance

results. According to surveys and exposure studies by different groups, the proportion of non-

compliant (i.e., nickel releasing) items differs depending on (i) country, (ii) setting (e.g., street

markets vs. department stores) and (iii) types of items.10

It stated that such information

should be used in identifying targets for intensified surveillance by national authorities and

therefore is of relevance in the prioritisation of market surveillance for this restriction.

Regarding the effectiveness of enforcement, continuous surveillance both of the exposure and

exposure-related morbidity is necessary to identify the effective success of intervention

(encompassing the successive steps of regulation, implementation and enforcement), or, even

more importantly, a possible lack of success, and thus, the necessity for in-depth research,

intensified enforcement, or other appropriate measures.

Studies on the enforcement of the nickel restriction

One questionnaire respondent provided information on various studies on the enforcement of

the REACH regulations that had been carried out for nickel in Germany and Switzerland and

also referred to the European project carried out by the Chemical Legislation European

Enforcement Network (EUNICK project) in 2008 involving 10 Member States studying the

nickel release from consumer articles. Preliminary results from that study have shown a large

variation and a large number of articles not complying with the nickel regulations.11 For the

other studies, the following information and results of testing were provided:

10

Thyssen, J. P., T. Menne, et al. (2011). "Excessive nickel release from earrings purchased from independent

shops and street markets - a field study from Warsaw and London." J Eur Acad Dermatol Venereol 25(9): 1021-

1026. 11

Press release 10th

CLEEN Conference Solothurn Switzerland 2009



In Germany, in 2008, a government surveillance study was undertaken for nickel

release from earrings and piercing articles. The results of this study were compared

with actual dermatological information for nickel supplied by a contact allergy

surveillance network gathering information (IVDK) from dermatological departments

in hospitals in Germany, Switzerland, and Austria.12

The results of the surveillance

study demonstrated that 14% of piercing articles, 5.6% of decorative attachments and

9% of clasps were not compliant with the limit values for nickel release.13

The nickel

release values found in some of the tested articles were found to probably be sufficient

enough to cause sensitization to nickel in non-sensitized individuals and almost

certainly in many instances to cause nickel contact dermatitis in individuals already

sensitized to nickel.14

The significance of market surveillance results is clearly visible

in the nickel allergy trend data from the IVDK. The most important age group to

consider is 0-17 years, as the majority of these individuals were born after the

introduction of the Nickel Directive and furthermore, started to wear or come into

contact with nickel releasing consumer articles, for the first time when the current

nickel restrictions were already in force. However, the nickel allergy trend in this age

group has not shown any significant decrease between 2001 and 2009, which would

have been expected if the present restrictions were being properly enforced.

In Switzerland, a national government market surveillance study was undertaken in

200715

, looking at nickel release from fashion jewellery and belts. From the 496

articles tested, 21 % (96 articles) were found not to conform to the nickel regulations.

A number of laboratories in Switzerland have also noted non-compliance with the

nickel restriction. The Kanton Laboratory Zurich has observed over the last decade a

decrease in the number of articles not conforming to the nickel regulations. The latest

results indicate that 9% of the tested articles didn’t conform to the nickel regulations.16

It is reported however, that the smaller the company selling the article the greater the

probability that the article would not conform to the nickel regulations. In this context

there has been intensified cooperation with the local environment and health

authorities and the custom authorities in order to improve the control over such

companies. The Urkantone Laboratory has reported that in 2010 imported fashion

jewellery articles were tested for nickel release, of which 68% were found to be non

compliant,17 while the Kanton Laboratory Aargau has reported that in 2010, 20% of

fashion jewellery and belts that were tested for nickel release, were found to be non

compliant.18

12

Schnuch A, Uter W, Lessmann H, Arnold R, Geier J. Klinische Epidemiologie der Kontaktallergien: Das

Register und das Überwachungssystem des IVDK. Eine Übersicht. Allergo J 2008: 17: 611–624. 13

Axel Schnuch, Jörg Wolter and Wolfgang Uter. Nickel allergy is still frequent in young German females-

probably because of insufficient protection from nickel-releasing objects. Contact Dermatitis 2011: 64: 142–150 14

Louise Arup Fischer, Torkil Menne, Aage Voelund, Jeanne Duus Johansen. Can exposure limitations for well-

known contact allergens be simplified? An analysis of dose-response patch test data. Contact Dermatitis 2010:

64: 337 -342 15

Laboratorium der Urkantone Kantonschemiker Kantonstierarzt Jahresbericht 2007 16

Kantonales Labor Zürich Jahresbericht 2010 17

Laboratorium der Urkantone Kantonschemiker Kantonstierarzt Jahresbericht 2010 18

Amt für Verbraucherschutz AARGAU Jahresbericht 2010



Testing for compliance with the restriction

The respondent went on to comment on the different stages of the product chain and the need

for testing at the stage of import, commenting that the testing undertaken for nickel by the

market surveillance authorities on a national level plays a vital part in protecting the consumer

from developing nickel contact dermatitis. The company therefore recommended that

appropriate steps to improve compliance control at the point of entries into Europe are

incorporated into the revision of the General Product Safety Directive.

The respondent went on to refer to a proposal to improve surveillance and border controls has

recently been made by the Netherlands and supported by Germany,19

part of which would

involve the levying of fees on the importer in order to pay for the increased import control

measures. For importers that showed a high degree of compliance an exemption from paying

such fees has been suggested.

In addition, the company recommended two screening methods that could be used for nickel

during the import control period, which are currently used to screen for the presence of nickel

in consumer articles. Both of these methods are quick to apply and are currently used by the

market surveillance authorities in Switzerland, though not foreseen by EU legislation.

i) DMG Test - This involves using dimethylgloxime (DMG) which gives a pink to red

coloration in the presence of nickel. DMG testing kits are available commercially, are

inexpensive and are simple and quick to apply. A standard describing the procedure for DMG

testing of consumer articles is available.

ii) XRF - The second method recommend is the use of portable x-ray fluorescence

spectrometers.

The use of these two test methods in combination is advocated by the company since both

methods are screening tests and a certain percentage of the DMG tests can give uncertain

results. They recommend that where the screening test indicates that the article could be non-

compliant, an import ban should be placed on the complete batch of articles, which should

then be sent to the responsible testing laboratory for nickel release analysis and tested

according to the appropriate CEN reference standards. Although the two screening methods

are recommended for import control testing purposes, the European standard reference

methods developed by CEN must however be used in order to prove legal compliance with

the REACH regulations. The company also recommended that the sampling plans, which are

an essential element of the import control process, take into account the size and homogeneity

of the batch sizes.

Guidance

Finally, a company also recommended that in order to ensure consistent application of the

nickel restriction by all European market surveillance authorities, and avoid differences of

opinion as to what articles come into direct and prolonged contact with the skin, the European

Commission should provide guidance about what articles are covered by the restriction. In

response to this stakeholder comment, it should be noted that the Commission has already

provided such guidance, for example when the question of whether mobile phones were

19

Summary record of the meeting of the consumer safety network (CSN) Brussels 27 May 2011



regarded as items that were intended to come into direct and prolonged contact with the skin,

and thus covered by Entry 27.


Several Member States mentioned specific difficulties in the implementation and enforcement

of the restriction on nickel. Issues have arisen regarding the following aspects:

the wording of the restriction, which refers to “articles intended to come into direct

and prolonged contact with skin”. The use of the word “intended” could be given a

narrow interpretation which would therefore limit the application of the restriction and

therefore only cover for example, a button on a pair of jeans for which there is an

explicit intention that the item comes into contact with skin. The use of the word

“prolonged” could also be open to interpretation and is difficult to proof in

enforcement cases.

the analytical method as the nickel release test is not always reliable or accurate and

thus careful consideration should be applied when interpreting results from analysis

made using this test method. One Member State has experienced false positive results

because of insufficient sample preparation performed by the laboratories (the back of

the sample and edges have not been covered or protected from the test according to the

standard). It is therefore very important that laboratories document their sample

preparation in the test report according to the standard. For example, during the

enforcement campaign on mobiles, the authorities encountered problems with the

nickel test, as it is only the surface that requires to be tested, since this is the only part

than comes into contact with skin. However, in order to test these parts the authorities

had to break the phone into parts and test each part. Some parts however do not come

into contact with the skin though and therefore these would be covered with epoxy in

order to avoid cross-contamination of the areas that have to be tested. Problems with

testing meant that initially they found lots of violations but then these decreased.

It can be very difficult to track and recall articles of the same batch already present on

the market when a non-compliant article is found, due to the lack of a bar code or any

other identification number on the non-compliant product.



2.6 Creosote (Entry 31)


The substances covered by Entry 31 (Creosote) and the conditions of restrictions are set out in

the table below:



31. (a) Creosote;

wash oil

CAS No 8001-58-9

EC No 232-287-5

(b) Creosote oil;

wash oil

CAS No 61789-28-4

EC No 263-047-8

(c) Distillates (coal

tar), naphthalene

oils; naphthalene oil

CAS No 84650-04-4

EC No 283-484-8

(d) Creosote oil,

acenaphthene

fraction; wash oil

CAS No 90640-84-9

EC No 283-484-8EC

No 292-605-3

(e) Distillates (coal

tar), upper; heavy

anthracene oil

CAS No 65996-91-0

EC No 266-026-1

(f) Anthracene oil

CAS No 90640-80-5

EC No 292-602-7

(g) Tar acids, coal,

crude; crude phenols

CAS No 65996-85-2

EC No 266-019-3

(h) Creosote, wood

CAS No 8021-39-4

EC No 232-419-1

(i) Low temperature

tar oil, alkaline;

extract residues

(coal), low

temperature coal tar

alkaline

CAS No 122384-78-

5

1. Shall not be placed on the market, or used, as substances or in mixtures where

the substance or mixture is intended for the treatment of wood. Furthermore, wood

so treated shall not be placed on the market.

2. By way of derogation from paragraph 1:

(a) The substances and mixtures may be used for wood treatment in industrial

installations or by professionals covered by Community legislation on the

protection of workers for in situ retreatment only if they contain:

(i) benzo[a]pyrene at a concentration of less than 50 mg/kg (0,005 % by weight),

and

(ii) water extractable phenols at a concentration of less than 3 % by weight.

Such substances and mixtures for use in wood treatment in industrial installations

or by professionals:

— may be placed on the market only in packaging of a capacity equal to or greater

than 20 litres,

— shall not be sold to consumers.

Without prejudice to the application of other Community provisions on the

classification, packaging and labelling of substances and mixtures, suppliers shall

ensure before the placing on the market that the packaging of such substances and

mixtures is visibly, legibly and indelibly marked as follows:

“For use in industrial installations or professional treatment only”.

(b) Wood treated in industrial installations or by professionals according to

subparagraph (a) which is placed on the market for the first time or retreated in

situ may be used for professional and industrial use only, for example on railways,

in electric power transmission and telecommunications, for fencing, for

agricultural purposes (for example stakes for tree support) and in harbours and

waterways.

(c) The prohibition in paragraph 1 on the placing on the market shall not apply to

wood which has been treated with substances listed in entry 31 (a) to (i) before 31

December 2002 and is placed on the second-hand market for re-use.

3. Treated wood referred to under paragraph 2(b) and (c) shall not be used:



EC No 310-191-5 — inside buildings, whatever their purpose,

— in toys,

— in playgrounds,

— in parks, gardens, and outdoor recreational and leisure facilities where there is

a risk of frequent skin contact,

— in the manufacture of garden furniture such as picnic tables,

— for the manufacture and use and any re-treatment of:

— containers intended for growing purposes,

— packaging that may come into contact with raw materials, intermediate or

finished products destined for human and/or animal consumption, — other

materials which may contaminate the articles mentioned above.

Uses: Wood treatment


33% of Member States (9 countries) have carried out enforcement action on creosote. Of


Entry 31 having been carried out, 2 countries referred to several enforcement campaigns

having been carried out, and 3 countries referred to other action having been taken, either


under RAPEX.

The following examples of national campaigns on creosote have been identified, based on

information provided by Member States, which highlights two different approaches:

1) Targeting the sales of creosote products placed on the market - Targeted inspections

of DIY/hardware stores were carried out in order to ascertain whether creosote

products were being sold for amateur use, since only creosote products for

professional use were registered with the relevant authority.

2) Targeting the application/use of creosote specifically in railway sleepers - In this case

the substance was selected for enforcement since the authorities expected non-

compliance as had received signals of non-compliance in imports, exports and

regarding railway sleepers. The campaign involved inspecting 40 distributors and

users of railway sleepers, therefore targeting different stages of the supply chain of

railway sleepers. 12 of these distributors and users were found not to comply with the

restriction, resulting in administrative and/or criminal law measures being taken. The

campaign involved cooperation between three different national authorities as customs

played an important role in providing information on imports and exports, and waste

inspection colleagues were also involved.

With regard the countries that referred to other action having been taken, either through

reactive enforcement, non-official product checks, or check on products notified under

RAPEX, one Member State referred to reactive measures having been taken in relation to

creosote as well as information brochures were having been distributed and seminars held at

the time of the introduction of the restriction.





under RAPEX in relation to Entry 31.


Four respondents indicated that creosote was applicable to the products they produced, placed

on the market or imported, their activities covering toys, the other manufacturing of organic

substances, the production of base chemicals and polymers and the distillation of coal tar.

Regarding measures taken to ensure compliance with this restriction, one company referred to

regularly checking Annex XVII of REACH and also the ECHA website for new/current

restrictions, whilst also having in place a tool to ensure that their products comply with the

restrictions. This is an internal tool, which essentially checks all legislative requirements, not

just REACH, enabling you to see what the specific requirements are by entering a product

code. The other company referred to having policies in place to deal with all restrictions. In

some cases they find it necessary to perform testing on a product by product basis, while in

other cases, they impose restrictions on their suppliers.

Among the few respondents, one commented that they are infrequently subject to market

surveillance controls, while another stated that the restrictions are controlled by the local and

state authorities as local authorities visit their facilities on an annual basis in order to check

compliance with the law, and with the requirements of the registry of biocides which the

company registered its creosote with.

The final company, which manufacturers European Grade B and C creosote according to

EN13991, stated that its customers are wood treatment plants which are aware of the

marketing and use restriction regarding creosote. As a result it is expected that surveillance

should focus on the treated wood which is the final product placed on the market. However,

the company did comment that it did receive wood samples treated with creosote, which did

not fulfill the European requirements, which were stated to be of European origin.


The following specific difficulties in the implementation and enforcement of the restriction on

creosote were identified:

One Member State identified that difficulties arose in some enforcement actions, in

certifying by analytical methods that wood was treated with creosote, though did not

provide further details;

Example of good practice: The example of where one Member States campaign

focused on the particular application/use of creosote in railway sleepers, targeting

different stages of the supply chain by inspecting distributors and users, can be

cited as an example of good practice. Over 20% of those inspected were found

not to comply, which was followed up by criminal and/or administrative measures

being taken.



the application of the derogation for wood which has been treated with substances

listed in Entry 31 (a) to (i) before 31 December 2002 and is placed on the second-hand

market for re-use; and

concerns as to whether the derogation waste wood treated prior to 31 December 2002

adequately addressed the potential threat posed by those woods since wood containing

a large amount of one of the substances in letters a-i, can be reused, even in the private

sector, while wood that has been treated recently with creosote-enriched protection

products may only be used for the industrial sector.



2.7 Nonylphenol and Nonylphenol ethoxylates (Entry 46)


The substances covered by Entry 46 (Nonylphenol and Nonylphenol ethoxylates) and the

conditions of restrictions are set out in Table 2.9.



46. (a) Nonylphenol

C 6 H4(OH)C 9 H

19

CAS 25154-52-3

EC 246-672-0

(b) Nonylphenol

ethoxylates

(C 2 H 4 O) n C 15

H 24 O

Shall not be placed on the market, or used, as substances or in mixtures in

concentrations equal to or greater than 0,1 % by weight for the following

purposes:

(1) industrial and institutional cleaning except:

— controlled closed dry cleaning systems where the washing liquid is recycled or

incinerated,

— cleaning systems with special treatment where the washing liquid is recycled or

incinerated.

(2) domestic cleaning;

(3) textiles and leather processing except:

— processing with no release into waste water,

— systems with special treatment where the process water is pre-treated to remove

the organic fraction completely prior to biological waste water treatment

(degreasing of sheepskin);

(4) emulsifier in agricultural teat dips;

(5) metal working except: uses in controlled closed systems where the washing

liquid is recycled or incinerated;

(6) manufacturing of pulp and paper;

(7) cosmetic products;

(8) other personal care products except: spermicides;

(9) co-formulants in pesticides and biocides. However national authorisations for

pesticides or biocidal products containing nonylphenol ethoxylates as co-

formulant, granted before 17 July 2003, shall not be affected by this restriction

until their date of expiry.

Uses: Cleaning products and other various uses


52% of Member States (14 countries) have carried out enforcement action on nonylphenol

and nonylphenol ethoxylates. Of these, 8 countries referred to specific enforcement

campaigns targeting the restriction under Entry 46 having been carried out, 1 country referred

to several enforcement campaigns having been carried out, 3 countries referred to other action

having been taken, either through reactive enforcement, non-official product checks, or check

on products notified under RAPEX, 1 country referred to preliminary investigations having

been carried out in order to locate relevant market players or locate products on the market

and 1 country referred to there being plans for a future campaign.



The following examples of national campaigns on nonylphenol and nonylphenol ethoxylates

have been identified, based on information provided by Member States:

Desktop research – A bottom up approach is used whereby the authorities invest a lot

of time upfront in carrying out desktop based research, where they review the products

and try and target where the chemical is most likely to end up.

Checking the information on labels, information contained documentation and

information provided by formulators, importers or distributors of mixtures intended

for cleaning, as well as checking the persons responsible for the placing on the market

of cosmetic products. Products presenting a serious risk were withdrawn from the

market. No information was provided however regarding the costs of such a

campaign.

Carrying out a specific campaign on the control of detergents for their nonylphenol

content;

Carrying out an annual monitoring programme of cleaning and detergent products on

the market, which involved checking a representative number of samples each year.

Checking the registration of plant protection products containing NPE’s and minor

formulation changes made in order to remove the NPE components from plant

protection products.

Regarding the reasons for selection of this restriction for enforcement action, it is worth

noting that one Member State targeted this restriction since NGO’s were focusing heavily on

the enforcement of Entry 46 at the time and asking for action to be taken by the authorities.

With regard to the countries that referred to other action having been taken, either through


RAPEX, one Member State referred to controls being carried out in response to any

complaints received from industry, NGOs or consumers, or when non-compliance issues are

detected during inspections.

Finally, one Member State planned an enforcement campaign for 2011 based on information

it has received from the pre-registration of this substance as about 50 companies in that

Member State have pre-registered these substances.




In relation to the restriction on nonylphenol and nonylphenol ethoxylates, two RAPEX

notifications have been made, both of which were notified by the same Member State. This

covers all RAPEX notifications made since 2005. One product notified was a bathroom

cleaner, which contained approximately 0.9% of nonylphenol ethoxylate, which originated

from a non-EU country, while the other was a lime scale remover spray, which originated

from a European but non-EU country. In both cases a ban on sales in the European country

was imposed.

The following types of products have been notified under RAPEX as containing nonylphenol

and nonylphenol ethoxylates:


Bathroom cleaner 1

Lime scale remover spray 1


Four respondents listed this restriction as being applicable to the products they produced,

placed on the market or imported, whose activities covered toys, textiles used as

reinforcements for tyres and MRG applications, the manufacture of chemical intermediates

and the production of nonylphenols and nonylphenol ethoxylates. In addition, one NGO has

carried out a campaign regarding the presence of NPE in textiles and clothing.


In this case desk top research involved internet based research, checking trade

databases, waste transfer data, information from environmental monitoring etc. In

some cases this provides the authorities with sufficient evidence of non-

compliance, on the basis of which the authorities can inform the company, who

will in most cases voluntarily stop using the substance. On occasion the company

was simply unaware that what their use was restricted, which highlights the

importance of communication. However, there are also cases where people

reformulate, e.g. supplier of dispersing agent reformulates their product but does

not tell those they are supplying that they have done so, the recipient therefore

simply continuing to sell the product. However, generally the desktop research

allows the authorities to take lots of products off the market without having to

take further action. Generally the authorities try and obtain as much information

on the supply chain in order to try and target non-compliance in this way as

otherwise it takes a huge resource to build a case file for prosecution. This

approach has been successful to date in terms of the number of chemicals

removed from the market



The responses reveal that 3 main types of action are taken to ensure compliance with the

restriction:

Informing customers about the restrictions placed on the use of the substance – One

company manufacturing chemical intermediates stated that they inform all their EU

customers about the prevailing market and use restrictions for the substance concerned

and request a signed confirmation of acknowledgement before first supply. The

REACH SDS informs their customers about uses advised against in accordance with

Annex XVII listings. Similarly, another company producing nonylphenol and

nonylphenol ethoxylates, stated that their customers have been informed and

information is provided as part of the MSDS. Since nonylphenol has been registered,

the restricted uses are advised against in the MSDS.

Declaration of substances used in products - In order to ensure that their product

complies with the relevant restriction, another company stated that they ask their

suppliers to fill in a REACH declaration, where they declare what substances they use

in their products and the registration number if it exists.

Imposing requirements on suppliers and carrying out testing – Another company

referred to having policies in place to deal with all restrictions. In some cases they

find it necessary to perform testing on a product by product basis, while in other cases,

they impose restrictions on their suppliers.

Only one of the four respondents referred to being subject to market surveillance in relation to

restrictions.

Finally, as stated above, information was received from an NGO, regarding its campaign

concerning the presence of NPE in textiles and clothing. Linking its global campaign on

name brand companies (e.g., Nike, Puma, Adidas, H&M, C&A that have committed to

phase out all hazardous substances throughout their supply chain) to the policy work in non-

EU countries and the EU, has highlighted specific chemicals of concern such as

nonylphenol (NP). Even though NP is virtually banned in the EU pursuant to the

restriction, it continues to contaminate European waters. Under the Water Framework

Directive (Directive 2000/60/EC), NP is included as a ‘priority hazardous substance’. This

is most probably the result of imported articles (mostly textiles) that are contaminated with

NP which end up in the water via water treatment facilities (washing out effect).

Consequently, the NGO is calling for the need to prohibit imports of contaminated articles

in order to stop this pathway of pollution.

The campaign, “Dirty Laundry 2: Hung out to Dry”, revealed that clothing and certain

fabric-based shoes sold internationally by major clothing brands are manufactured using

nonylphenol ethoxylates, which are subject to restriction under Entry 46 of Annex XVII of

REACH. As a result, the NGO believes that there is a need to end this entry pathway by

placing a restriction on contaminated imports, which would have the effect of removing

NPE pollution in Europe, and require non-EU manufacturers using the EU market to

substitute NPE with non-hazardous chemicals.

As a result of the campaign, 6 name brand companies are now committed to phasing out

NPE and other hazardous substances throughout their supply chain. The NGO will



therefore now work with these companies on their phase out action plans and substitution

research, development and implementation. The list of companies involved from the private

sector is expected to grow, and to include company associations. It is anticipated that the

work will stop chemical pollution from an important private sector, as well as provide an

example to other companies and policy makers that substitution works. Consequently the

work is linked to moving the substitution dynamic at policy level, in non-EU countries, as

well as in relation to the REACH Regulation.


Only one Member State referred to there being difficulties in the implementation and

enforcement of Entry 46. The Member State commented that it has carried out several

enforcement campaigns on this restriction since 2008 which have focussed on cleaning

products and personal care products. In each case, analysis is required in order to determine

the compliance of a product with the restriction, which has financial implications. However,

the Member State regarded the main issue with the enforcement of this restriction as being in

how to establish if an ingredient is covered by the restriction in the first place as there are

numerous CAS numbers and synonyms for nonylphenol and nonylphenol ethoxylates.



2.8 Chromium VI compounds (Entry 47)


The substances covered by Entry 47 (Chromium VI compounds) and the conditions of

restrictions are set out in Table 2.10.



47. Chromium VI

compounds

1. Cement and cement-containing mixtures shall not be placed on the market, or

used, if they contain, when hydrated, more than 2 mg/kg (0,0002 %) soluble

chromium VI of the total dry weight of the cement.

2. If reducing agents are used, then without prejudice to the application of other

Community provisions on the classification, packaging and labelling of substances

and mixtures, suppliers shall ensure before the placing on the market that the

packaging of cement or cement-containing mixtures is visibly, legibly and

indelibly marked with information on the packing date, as well as on the storage

conditions and the storage period appropriate to maintaining the activity of the

reducing agent and to keeping the content of soluble chromium VI below the limit

indicated in paragraph 1.

3. By way of derogation, paragraphs 1 and 2 shall not apply to the placing on the

market for, and use in, controlled closed and totally automated processes in which

cement and cement-containing mixtures are handled solely by machines and in

which there is no possibility of contact with the skin.

Uses: Cement and cement mixtures


56% of Member States (15 countries) have carried out enforcement campaigns on chromium

VI in cement. Of these, 9 countries referred to specific enforcement campaigns targeting the

restriction under Entry 47 having been carried out, 2 countries referred to several enforcement

campaigns having been carried out, and 4 countries referred to other action having been taken,

either through reactive enforcement, non-official product checks, or check on products

notified under RAPEX.

In one Member State, inspectors carried out controls on cement during 2007 to 2009 and

found two cases of cement containing Chromium VI content (RAPEX notification 1567/09

and information A110006/08). In another Member State, cooperation between the customs

authorities and certain ministries has been established in order to control both cement imports

and relevant products placed on the market.

Another country which has carried out a specific campaign in relation to chromium in cement

explained that this restriction was selected for enforcement due to there being large quantities

of cement imported from a non-EU country. The national authorities therefore cooperated

specifically with customs and agreed a procedure with customs, whereby customs provided

the REACH enforcement authorities with information on cement imported every 3 months.

Following this, the information was collated and communicated to the local authorities in

order to ensure that there was a flow of information from customs to the central authorities,

and in turn to the local authorities. The local authorities were then responsible for taking



samples and having these analysed, using local laboratories. The results of compliance or

non-compliance found through testing were then compiled in a report and provided to

customs. Customs then used this information to apply a risk profile (red light v green light

procedure). Where the product is considered to be a red light, it will be stopped at the border

and customs will call the central authorities to come and test the product. However, this

procedure has not become fully operational yet due to difficulties involved in one step of the

procedure, that of setting up a test method to test chromium VI. The local authorities have

only recently established the competency to test for chromium VI so have not yet got any test

results. This campaign is therefore ongoing. As part of this campaign therefore the

authorities are already trying to put in place greater cooperation with customs, which will be

encouraged under the REACH EN-FORCE-3 project.

In respect of those countries that referred to having carried out several enforcement

campaigns on chromium VI in cement, enforcement authorities in one Member State have

carried out inspections relating to this restriction which included checking the information on

labels, information contained documentation and information provided by producers,

importers or distributors of cement and cement-containing mixtures, and laboratory checks of

cement and cement containing mixtures. Products placed on the market for general public are

withdrawn from the market.

Of those countries that referred to other action having been taken, either through reactive

enforcement, non-official product checks, or check on products notified under RAPEX,

reference was also made to cooperation with customs having now been established, whereby

information on cement imports is provided by Customs to REACH enforcement authorities.

The imported products are subsequently controlled for their Cr (VI) content.

Finally, one Member State adopted additional implementing measures in relation to the

restriction for Chromium VI compounds content in cement and cement-containing mixtures in

Annex XVII of REACH. The enforcement of this restriction is monitored and controlled by

regional competent authorities, who have put in place effective monitoring and control

measures, including inspections on site. Furthermore, the national association for

standardisation and certification has developed a voluntary labelling scheme, in order to

ensure compliance with the requirements set out in standards applicable to each type of

product, which guarantees that the manufacturer, among other things, can demonstrate

compliance with the requirements demanded by its clients and, for those products where it is

applicable, the current regulations. In the case of cement, these include the following

measures:-

Initial certification is based on laboratory inspection and production control visits, as

well as on audits of the quality system according to ISO 9001. Verification of

statistical compliance and contrast correction using the contrast samples over a three

month period under intensive control are also carried out.

Verification of compliance via three annual visits (two inspection visits and one audit)

to factories as well as dispatch points.

Taking of contrast samples, in factory and/or at dispatch points, monthly.

Complete contrast testing in accredited laboratories, with the corresponding samples.



Half-yearly statistical evaluations of compliance according to the plan stated in the

compliance evaluation as well as extra statistical criteria.

Taking of samples on the market where verification of compliance of all the certified

cements is given. Performance of the corresponding tests and contrast with the

relevant evaluation period both of the external control and the in-house control.

Individual requirements superior to those established in the standard, for certain

cements.

Quarterly evaluation of compliance.

Monthly verification of the in-house control.

Follow-up and control of breakage devices of the testing equipment of the contrast

laboratories and the Secretariat.

Inter-laboratory programmes of each one of the types of cement as well as clinker and

the content characteristics of Cr VI dissolved in water in the cement.

Follow-up schedule of the activities in the case of one-off and statistical non-

compliances.

Outline of certification developed for distribution centres.


In relation to the restriction on chromium VI compounds, three notifications have been made

relating to cement originating from one Member State and from a neighbouring country,

where the content of chromium VI found within the cement was found to exceed 0.0002%.

The notifications were made by three different Member States. This covers all RAPEX

notifications made since 2005. In each case the product was withdrawn from the market.


Ten respondents listed this restriction as being applicable to the products they produced,

placed on the market or imported. Of these, six respondents are producers of cement (one

company said that they place eight different cements on the market while another listed the


In this case, two examples of good practice have been identified. First, carrying

out compliance checks at a specific point in the supply chain, which seek to verify

compliance at cement plants and other points of dispatch, can be cited as an

example of good practice. Such action ensures that steps are taken to check

compliance prior to the product being placed on the market. Second, a number of

Member States have cooperated with customs specifically in relation to this

restriction, requesting that customs provide information on cement imports to the

REACH enforcement authorities, allowing for follow-up action to be taken at the

stage of import.



specific types of cement they produce as being CEM I 52.5N; CEM II/ A-LL 42.5N; CEM II/

B-LL 32.5 R and CEM II/ B-M (S-P-L) 32.5 R). Of the other four respondents, two

respondents were Member State cement industry associations, one company produces

chemicals for the construction sector, while the final respondent was involved in the

production of intumescent coatings, fire retardant paints and varnishes and spray

plasters/mortars designed for passive fire protection of construction products.

The responses reveal that in most cases, analysis is carried out by companies regarding its Cr

(VI) content in order to ensure compliance with the restriction. A number of companies also

referred to the use of reduction agents in order to ensure that they are within the limits of the

restriction.

1) Analysis - Quality control of the production of the cement is carried out using EN 196-

10, in some cases during both production and storage. One company stated that

quality control was carried out through regular Cr VI determination and occasionally

shelf life testing.

2) Use of reduction agents - According to REACH, the levels of Cr (VI) in cement

products shall not be more than 2ppm. A number of companies therefore referred to

the use of reduction agents during production, in order to ensure that the level of 2ppm

of chromium in the cement, was adhered to. In one case the use of diverse Cr (VI)

reduction agents, e.g. ferrous-sulphate, was specifically referred to. One of the

companies went on to state that they ensure that all cement bags contain the relevant

packaging data and the appropriate period for use of the product, during which time

the reducing agent is effective and the Cr 6+ content is therefore under the limit values

indicated in Annex XVII to REACH. The packaging shall also indicate that where the

reducing agents action period is expired the cement can only be used in controlled

closed and totally automated processes, where it will not come into contact with the

skin.

Of the two companies that did not specifically refer to producing cement, but stated that this

restriction was relevant to their products, one company stated that they have procedures,

which are properly designed to comply with REACH, which involved listing all raw materials

involved in the manufacturing process and all the products that they place on the market and

controlling compliance with the restriction/s by checking the information obtained from

updated MSDS documents. The other company referred to the constant information flow

with suppliers on the basis of technical and safety datasheets, using dedicated and constantly

updated software. They also referred to the addition of suitable reagents to cement-containing

mixtures in order to reduce chromium VI contents below requested limits.

The majority of companies indicated that they had been subject to market surveillance.

Regarding the frequency of such checks, one company stating that samples are taken monthly,

while another company stated that the national authority carries our checks every second

month. Other companies referred to the frequency with which they themselves sampled their

own product. In one case the company measures the Cr(VI) in both the cement and the

clinker twice a week, based on which they can adjust the quantity of the reduction agent.

Another company stated that they had been audited by the national competent authority, after

having only been given three hours’ notice prior to the authorities visiting the plant. Cement

samples were taken from bags and sampled for Cr VI determination. Relevant documentation

was also checked, such as the SDS of cement constituents including eventual Registrations



(iron sulphate among them), the SDS of the companies own products, and the companies

clinker notification to the ECHA.

In some cases, the company provides samples of cement to the national research institute or

industry association for testing. In one case this is done six times a year for soluble chromium

VI analysis in accordance with the requirements of the national legislation. In another case,

annual audit samples are provided on a voluntary basis in order to check the content of

soluble Cr(VI).

Of those companies that stated that they had not been subject to market surveillance, one

company indicated that this was because the company itself measures the content at the plant,

provides the results of testing to the national authority, and these are accepted by the national

authority.

Finally, with regard to evidence of non-compliant products, four of the respondents, answered

specifically in relation to the restriction of chromium VI compounds in cement. One

respondent stated that they were aware of some cases related to non-compliance with the

restriction concerning cement imported from a neighbouring country, however provided no

further details of this. Another respondent stated that they were aware that not all operators

who place cement on the market comply with the restriction, and therefore have a competitive

advantage since they do not have to meet the costs of compliance. Another respondent stated

that despite the actions of the national competent authority to date, multiple cases of non-

compliance by some cement importers still occur. Finally, one national cement association

commented in relation to one Member State that since no specific role in enforcement was

ascribed to the customs authorities under REACH, the customs authorities in that country do

not supervise compliance with REACH restrictions, and therefore there is no evidence that

cement imported from non-EU countries complies with the prohibitions and restrictions

referred to in Article 67 and Annex XVII of REACH. However, in a number of Member

States, the customs authorities have been tasked with checking imports of cement.


Only two Member States referred to there being difficulties in the implementation and

enforcement of Entry 47. One Member State commented that the analytical method is not

applicable for mixtures containing cement, but only for pure cement. The other Member State

stated that the scope of the derogation within Entry 47 (use in controlled closed and totally

automated processes in which cement and cement-containing mixtures are handled solely by

machines and in which there is no possibility of contact with the skin) is unclear and therefore

represents a significant challenge to enforcement authorities, though no further information on

the precise challenges was provided.



2.9 Toluene (Entry 48)


The substances covered by Entry 48 (Toluene) and the conditions of restrictions are set out in

Table 2.11.



48. Toluene

CAS No 108-88-3

EC No 203-625-9

Shall not be placed on the market, or used, as a substance or in mixtures in a

concentration equal to or greater than 0,1 % by weight where the substance or

mixture is used in adhesives or spray paints intended for supply to the general

public.

Uses: Adhesives or spray paints


74% of Member States (20 countries) have carried out enforcement action on toluene. Of


Entry 48 having been carried out, 1 country referred to several enforcement campaigns having

been carried out, 8 countries referred to other action having been taken, either through


RAPEX, and 1 country referred to preliminary investigations only having been carried out at

this stage.

The following examples of actions carried out as part of national campaigns on toluene have

been identified, based on information provided by Member States:

Checking information on labels;

Checking information provided by importers or distributors of adhesives, following

which products placed on the market for the general public and presenting a serious

risk are withdrawn from the market.

Inspections and laboratory checks of adhesives;

Targeting of specific products such as glue in bicycle repair kits;

Specific cooperation with customs and the authorities responsible for consumer

products, in order to control the imports of adhesive materials, superglues and other

products placed on the market.

In one Member State, the restriction on toluene was selected due to the number of

notifications made through RAPEX concerning these products and also since there was

provision made in the national budget that year to carry out an analysis of products for public

use. In undertaking the campaign, enforcement officers obtained information from the market

on importers of the products themselves, by going to shops and getting information on the

origin, types of products etc, and then made a plan of which companies and domestic



producers to inspect. If the results are within the conditions of the restriction, they inform the

company and provide the company with a copy of the results. Where non-compliance is

found, further steps are taken, for example removal of the remaining stock from the market,

and in certain cases, imposition of a fine.

One Member State provided more specific details on the extent of sampling carried out as part

of the campaign, stating that a total of 31 products, adhesives and spray paints were sampled

and analysed in 2007, 5 of which were found to contain toluene at levels of between 2% and

10%. For 5 of these products an official report was issued. Within this study five samples of

thinner were also taken, three of which were found to contain toluene, the highest level being

23%.

Another country carried out a campaign this year on toluene which involved testing samples

taken from 32 different glues, which were analysed for benzene, toluene and chloroform. In

order to select the glues for sampling, they were to retailers and shops of different sizes to

find different glue products both from their own country, the EU and outside the EU. The

specific glues that were selected were glues for bicycle kits and glue for toys, in particular

modelling kit glues (war hammer figures). Information from RAPEX suggested that there

was a problem with these glues therefore the authorities thought it would be interesting to see

if there is a problem in their country. Results from testing have only recently been received

and therefore the authorities are now preparing to carry out further investigations based on

these by contacting the companies involved.

Of those countries that referred to other action having been taken, either through reactive

enforcement, non-official product checks, or check on products notified under RAPEX, one

Member State commented that it has carried out regular testing of toluene since 2006, on the

basis of those products notified using the RAPEX system. A few glues containing toluene

were also stopped on the border following receipt of information from customs.

In another Member State, reference was made to reactive controls as in several cases

adhesives containing toluene were found on the market. From a review of RAPEX

notifications there also appeared to be a large number of cases arising regarding toluene found

in adhesives, therefore the environmental authorities decided to check whether this was also

the case on their own market. They therefore carried out testing of a number of products

found in their stores and took action in relation to any found containing toluene. These were

notified to RAPEX. The presence of toluene in glues was proved by laboratory tests and all

adhesives containing toluene were recalled from the market, with fines being imposed in two

cases, though these were stated only to be of a small amount.

Examples of good practice:

The example of where a Member State campaign targets specific products such as

glue in bicycle repair kits and glue for toys, can be cited as an example of good

practice. As with other restrictions, evidence of specific cooperation being carried

out with customs in order to control the imports of adhesives, superglues and

other products, can also be cited as an example of good practice in relation to the

controls taken regarding toluene.




A total of 39 notifications have been made to date in relation to the restriction on toluene.

This covers all RAPEX notifications made since 2005. Figures on the total number of cases

notified per Member State, per year, and according to the country of origin of the product are

provided in Section 5.3.3 below. A summary table, providing details of all 39 notifications is

provided in Annex 3.

The following types of products have been notified under RAPEX as containing toluene:


Bicycle tyre repair glue 20

Other glues20

8

Spray paint 7

Rubber solution 3

Artificial nail glue 1


Only two respondents indicated that this restriction was applicable to the products they

produced, placed on the market or imported, one of whom dealt with toys, while the other

manufactures organic substances.

In one case the company regularly checks Annex XVII of REACH and also the ECHA

website for new/current restrictions, and also has in place a tool to ensure that products

comply with the restrictions, which essentially checks all legislative requirements, not just

REACH, enabling you to see what the specific requirements are by entering a product code.

The other company referred to having policies in place to deal with all restrictions, though in

some cases they find it necessary to perform testing on a product by product basis, while in

other cases, they impose restrictions on their suppliers.

One company, which operates in five Member States, commented that the levels for a number

of restrictions vary across the Member States, though couldn’t refer to specific examples. In

addition, it also commented that in glue, there is great variance in the results as if you cannot

vapourise the product prior to shipping then it will be a higher level, whereas if the product is

vapourised before shipment, the level can come down.



identified. However, difficulties in the implementation and enforcement of restrictions

generally, are outlined in Section 3.2 below.

20

These include glue, textile glues, artificial nail adhesive, glue for plastic material and boot glue.



2.10 Trichlorobenzene (Entry 49)


The substances covered by Entry 49 (Trichlorobenzene) and the conditions of restrictions are

set out in Table 2.12.



49.

Trichlorobenzene

CAS No 120-82-1

EC No 204-428-0

Shall not be placed on the market, or used, as a substance or in mixtures in a

concentration equal to or greater than 0,1 % by weight for any use except:

— as an intermediate of synthesis, or,

— as a process solvent in closed chemical applications for chlorination reactions,

or,

— in the manufacture of 1,3,5-triamino — 2,4,6-trinitrobenzene (TATB).

Uses: General use in substances or mixtures


19% of Member States (5 countries) have carried out enforcement action on trichlorobenzene.

Of these, 1country referred to having carried out a specific enforcement campaign targeting

the restriction under Entry 49, 3 countries referred to other action having been taken, either


under RAPEX, and 1 country referred to a future campaign being planned.

A campaign and monitoring programme on trichlorobenzene is currently being discussed in

one Member State as an analytical method and infrastructure is available to enable them to

enforce this restriction. For this campaign, the authorities will follow a number of steps.

First, as with all campaigns on restrictions, they will announce the restriction on their website

and upload a copy of the relevant legislation whenever there is a new addition or amendment

to Annex XVII. They then issue a letter by email of fax to all associations (asking them to

inform their members), ministries, and other parties who may have an interest or be affected

by the restriction, in order to notify them of the terms of the restriction. Thereafter, they will

carry out controls on the market in cooperation with other authorities in order to take samples

from the market, which are then passed to the state laboratory for testing.


The use of pre-information in order to raise awareness can again be cited as an

example of best practice, this time in relation to trichlorobenzene. As with other

campaigns, the enforcement authorities in some countries announced the

restriction on their website, issued letters by email or fax to all associations,

ministries and other parties who may have an interest or be affected by the

restriction.







Two respondents indicated that this restriction applied to the products that they produced,

placed on the market or imported, one of whom dealt with toys, while the other referred

specifically to the manufacture of 1,2,4-Trichlorobenzene.

In order to ensure that their product complies with this restriction, the company stated that

manufacturing and use take place under strictly controlled conditions. 1,2,4-Trichlorobenzene

is already registered under REACH but only as an intermediate according to Article 18 of

REACH. The compound is therefore only delivered to known customers as a REACH Article

18 intermediate. Confirmation from downstream users of the substance, that the intermediate

uses take place under strictly controlled conditions according to Article 18 of REACH, are

collected worldwide.

The company manufacturing trichlorobenzene stated that to date, the national authorities have

not controlled the restriction, though the company itself however applies internal control

mechanisms.



identified. However, difficulties in the implementation and enforcement of restrictions

generally, are outlined in Section 3.2 below.



2.11 PAH (Entry 50)


The substances covered by Entry 50 (PAH) and the conditions of restrictions are set out in the

table below:



50. Polycyclic-aromatic

hydrocarbons (PAH)

(a) Benzo[a]pyrene (BaP)

CAS No 50-32-8

(b) Benzo[e]pyrene (BeP)

CAS No 192-97-2

(c) Benzo[a]anthracene

(BaA)

CAS No 56-55-3

(d) Chrysen (CHR)

CAS No 218-01-9

(e) Benzo[b]fluoranthene

(BbFA)

CAS No 205-99-2

(f) Benzo[j]fluoranthene

(BjFA)

CAS No 205-82-3

(g) Benzo[k]fluoranthene

(BkFA)

CAS No 207-08-9

(h)

Dibenzo[a,h]anthracene

(DBAhA)

CAS No 53-70-3

1. From 1 January 2010, extender oils shall not be placed on the market, or

used for the production of tyres or parts of tyres if they contain:

— more than 1 mg/kg (0,0001 % by weight) BaP, or,

— more than 10 mg/kg (0,001 % by weight) of the sum of all listed PAHs.

These limits shall be regarded as kept, if the polycyclic aromatics (PCA)

extract is less than 3 % by weight as measured by the Institute of Petroleum

standard IP346: 1998 (Determination of PCA in unused lubricating base oils

and asphaltene free petroleum fractions — Dimethyl sulphoxide extraction

refractive index method), provided that compliance with the limit values of

BaP and of the listed PAHs, as well as the correlation of the measured values

with the PCA extract, is controlled by the manufacturer or importer every six

months or after each major operational change, whichever is earlier.

2. Furthermore, tyres and treads for retreading manufactured after 1 January

2010 shall not be placed on the market if they contain extender oils exceeding

the limits indicated in paragraph 1.

These limits shall be regarded as kept, if the vulcanised rubber compounds do

not exceed the limit of 0,35 % Bay protons as measured and calculated by

ISO 21461 (Rubber vulcanised — Determination of aromaticity of oil in

vulcanised rubber compounds).

3. By way of derogation, paragraph 2 shall not apply to retreaded tyres if their

tread does not contain extender oils exceeding the limits referred to in

paragraph 1.

4. For the purpose of this entry “tyres” shall mean tyres for vehicles covered

by:

— Directive 2007/46/EC of the European Parliament and of the Council of 5

September 2007 establishing a framework for the approval of motor vehicles

and their trailers,

— Directive 2003/37/EC of the European Parliament and of the Council of

26 May 2003 on type-approval of agricultural or forestry tractors, their

trailers and interchangeable towed machinery, together with their systems,

components and separate technical units, and

— Directive 2002/24/EC of the European Parliament and of the Council of

18 March 2002 relating to the type-approval of two or three-wheel motor

vehicles and repealing Council Directive 92/61/EEC.

Uses: Tyres



Regarding the scope of the restriction, which is very specific in its coverage of extender oils

and tyres, one company suggested that the restriction should be extended so as to cover PAH

in toys as well, due to these having rubber tyres. Currently, tyres in toys would not meet the

definition of tyres under the restriction.


59% of Member States (16 countries) have carried out enforcement campaigns on PAH. Of

these, 9 countries referred to having carried out a specific enforcement campaign targeting the

restriction under Entry 50, 2 countries referred to other action having been taken, either

through reactive enforcement, non-official product checks, 2 countries referred to preliminary

investigations having been carried out, 1 country referred to a future campaign being planned,

and 2 countries referred to information campaigns on this restriction having been carried out.

Enforcement campaign led by one Member State

Entry 50 (PAH) was identified for action by the FORUM. This enforcement campaign on

PAH has primarily been led by one Member State, with other Member States enforcing the

restriction on the basis of the results found in that Member State. The lead Member State

produced an enforcement manual that provided background information about the restriction,

target markets and suggested ways of enforcing the restrictions. Documentary checks were

carried out, which have led to the withdrawal of certain product lines in that Member State.

As the authorities progressed through the enforcement campaign, information and intelligence

has been shared with other Member States via Interpol (for secure intelligence transfer).

Using this intelligence, other Member States have then been able to determine whether those

tyres that were found to be in non-compliance in the lead Member State are also sold on their

market. Specific Member States have been able to focus on PAH in tyres since it is those

countries that are the main producers and importers in Europe. Despite this being a FORUM

initiative, it has not been necessary for each individual Member State to carry out the same

work as has been done in the lead Member State as this would duplicate a lot of the work

carried out in that country and therefore be a waste of resources.

Targeted campaigns based on FORUM Enforcement Project

In a number of other countries, the PAH content of tyres is also being examined as part of the

FORUM project. In one country, the PAH content of tyres has been examined by taking

samples from tyres and analysing these according to ISO 21461, as a result of which 15 tyres

have been removed from the market due to the non-compliances found. In another country, a

campaign commenced in 2010, based on the FORUM project, and will run until 2012, during

which time producers and importers of tyres will be inspected. In another country, a targeted

enforcement campaign has been carried out, which took the form of desktop research in

relation to the tyre industry in that country, and the checking of documentation provided by

the industry on request. Based on this, no extender oil manufacturers or importers or rubber

mixing plants or tyre manufacturers were found to be located in that country, so the

documentary checks were thus limited to what was made available by tyre importers and

suppliers. A report outlining findings and learning from the study is being prepared for

submission to the lead Member State, and will also be used to plan future work in this area.



Inspection of plants

In other Member States that have carried out specific campaigns, one country stated that it has

inspected whether all rubber mixing plants using extender oils are compliant with REACH

provisions. A specific inspection manual was prepared for inspectors, with inspections being

carried out in the second half of 2010. All rubber mixing plants that use proper extender oils

were found to comply with the PAH content set out in the restriction. However, importers of

tyres from third countries could not be inspected since this would have required testing of

tyres according to ISO 21461, for which there was no accredited laboratory for that analytical

method in the country. To transport the tyres to the nearest available laboratory would have

been very costly. A laboratory that can test according to ISO 21461 is however currently

being set up.

Preliminary investigations

One Member State indicated that it is only at the stage of carrying out preliminary

investigations into the issue of PAH in tyres. At present the authorities in that country are

looking at the results from the lead Member State and carrying out desktop studies using the

internet based on looking at whether they can expect to have tyres on their own market that

are not in compliance with the restriction, for which none have been found to date. The

investigations are therefore focused on the use of the results from the main campaign.

In another country, although a monitoring programme has not been established to date, the

launch of a new campaign regarding this restriction is being discussed. As with other

restrictions, once the campaign is launched the authorities will carry out controls on the

market by taking samples from the market.

Information campaigns

Two countries indicated that they have only carried out information campaigns on this

restriction to date. In one of those countries an announcement has been made regarding the

issue and relevant information has been prepared and published in the press. In the other

country, letters were sent to 112 tyre retail companies in 2010.

Import controls

Finally, one country referred to controls being carried out at the point of import. When

declared for import, new and used tyres and treads for retreading must indicate in the

administrative documentation that the weight of the levels of benzo[a]pyrene or the Σ8

indicated PAH, used in their manufacture does not exceed the values established in Entry 50

of Annex XVII of REACH. Alternatively, a statement that the tyres are not covered by Entry

50 either because chemical alternatives to PAH have been used in the process of manufacture

or refurbishment or because the tyres were manufactured before 1 January 2010, can be

provided. Measures taken by Member States to control imports are discussed further in

Section 3.7.







Six respondents listed this restriction as being applicable to the products they produced,

placed on the market or imported. Of these, four respondents were tyre/rubber manufacturing

associations. The remaining two respondents were a company producing textiles used as

reinforcements for Tyre and MRG application, and a company manufacturing organic

substances.

Members of each of the associations that responded produce tyres and general rubber goods.

The restriction on PAH’s, which restricts the use of PAHs in tyres is limited to new tyres and

treads of re-treaded tyres. In order to comply with the restriction, the tyre companies have

simply phased out the use of the restricted oils from production for all tyres produced after 1

January 2010. As outlined above, tyre plants and products from these plants have been

controlled by national authorities in several EU Member States,. Actions carried out included

information campaigns, desktop research, and documentary checks, but also inspections of

rubber mixing plants using extender oils and testing of the PAH content of finished tyres

using test method ISO 21461.

One Industry Association at the European level has been running a voluntary testing

programme of tyres since October 2010 due to concerns that tyres are being placed on the EU

market that are not being tested for compliance with the restriction. The first initial results

from the high-PAH Oil Testing Programme were published in March 201121

and the technical

reports were communicated to national authorities, as well as the public and industry (tyre

dealers, importers and consumer organisations).

21 http://www.etrma.org/pdf/20110301%20-%20EN%20_ETRMA_Press%20release.pdf and

http://www.etrma.org/pdf/20110301%20-%20ETRMA%20Q-A.pdf


In this case, the example of good practice is where one Member State acted as

lead in relation to an EU-wide enforcement campaign, targeted for enforcement

by the FORUM. The lead Member State produced an enforcement manual

specifically for the restriction, carried out documentary checks which led to the

withdrawal of certain product lines, and undertook testing in accordance with the

specified test methods. The results of the lead campaign were then shared with

other Member States, which mean that the main producers and importers across

Europe could be targeted without a full campaign having to be carried out in each

Member State. This therefore resulted in more targeted campaigns and effective

use of resources.

http://www.etrma.org/pdf/20110301%20-%20EN%20_ETRMA_Press%20release.pdf



The results of the first testing programme carried out between the end of 2010 and February

2011 are summarised below:

The results of the second testing programme were published in October 2011 following a

further testing campaign being carried out between April and September 201122

and are

summarised below:

Overall, the results of the campaign give cause for concern regarding the enforcement of

REACH. As a result, the European association is urging all EU and national authorities to

intensify and broaden testing and enforcement activities and requesting that there be a

coordinated market surveillance programme.

The other associations that commented on this restriction are active at the national level. One

commented that tyre manufacturing is the most important part of the entire rubber processing

industry. It is aware of inspections being organised at the national level, where samples are

taken from the market and tested by the competent authorities. Another stated that

mainstream importers of tyres have taken active steps to ensure that their overseas producing

plants understand and comply with REACH. From time to time, some importers may

undertake secondary verification testing. Producing factories (where PAH & PAH-free are

being run) also take steps to physically separate production runs. It also referred to the

campaign being carried out in the UK. A third association, which is primarily involved with

end-of-life tyres and tyre derived recyclates, which therefore does not cover the production

stage is not aware of any market surveillance carried out by the national authorities to check

compliance with the restriction.

22

http://www.etrma.org/pdf/PAH%202nd%20round_Press%20release_2011%2010%2017.pdf

Findings of first phase tyre testing programme:

- Samples were taken from passenger cars, light truck, motorcycle and

industrial tyres produced in 16 countries (9 EU and 7 non-EU);

- 110 tyres produced under 45 brand names were tested;

- All tyres sampled were produced after 1 January 2010;

- 12 tyres produced under 9 different brand names were non-compliant;

- 12 non-compliant tyres were all imported, produced in non-EU

countries;

- 11% of all tyres were found not to comply with the restriction;

Findings of second phase tyre testing programme:

- April to September 2011;

- Samples were taken from truck, passenger summer and winter,

motorcycle and agricultural tyre types produced in 11 countries;

- 94 tyres produced under 51 brand names were tested;

- All tyres sampled were produced in late 2010 and 2011;

- 10% of tyres, all of which were imported, were non-compliant;



The company producing textiles used as reinforcements for Tyre and MRG applications,

stated that in order to check compliance with the restriction, they ask their suppliers to fill in a

REACH declaration, in which they declare the substances that they use in their products and

provide the registration number, if it exists. While they have not been subject to market

surveillance by the competent authorities to check compliance with REACH, they have had

audits carried out in order to check water and air emissions.

Three respondents commented that there had been tyre imports from non-EU countries which

did not comply with the restriction, though in the meantime the tyre manufacturers from non-

EU countries showed evidence of meeting the restriction requirements. As outlined above,

the high-PAH Oil Testing Programme has shown that there are instances of non-compliance

with tyres manufactured in non-EU countries. Another respondent however, commented that

that they were not aware of any products entering the market though the legitimate supply

chain being non-compliant with REACH.

Finally, one NGO commented that it has been involved in awareness raising activities

regarding this restriction.


33% of Member States (9 countries) stated that the main difficulty in the implementation and

enforcement of this restriction was with the application of the analytical method specified in

the restriction, which refers to the use of IP 346 for testing extender oils, and ISO 21461 for

testing tyres.

Costs of testing

In each case reference was made to the high costs of using the test method ISO 21461, which

if followed rigidly required 5 rubber samples to be taken for each tyre, making it too time

consuming and expensive for use in broad market surveillance. Problems arise with the

restriction since it uses an expensive and complicated test method, which requires specific

equipment (NMR). As a result, analysis using this test method has only been carried out by

certain Member States, due to a lack of financial resources and as a consequence there are

potentially a great number of tyres being placed on the market illegally since they are not

detected. However, analysis is required in all cases in order to establish the compliance of a

tyre with this restriction. One Member State commented that it has been suggested numerous

times from industry that a ‘tyre labelling’ system would be very beneficial, which could

provide an immediate visual confirmation of whether a tyre complies with the restriction or

not.

Availability of facilities

A number of Member States also indicated that currently they do not have the facilities to

carry out analysis for this restriction since there are no accredited laboratories for ISO 21461

within their country and even the costs of transportation of samples to the nearest countries

that do have laboratories that use this analytical method, are too high. Member States would

have to start from scratch to get existing laboratories accredited. At least two Member States

indicated that they are currently looking into the possibility of establishing an accredited

laboratory for ISO 21461 within their country.



Conflicting results

Another Member State, which currently does not have the facilities to test for PAH in tyres,

commented also that the two test methods specified in Entry 50 can produce conflicting

results in some cases, with the extender oil found to be compliant using IP 346, while the

overall tyre can be found not to comply using test method ISO 21461 (these concerns were

also raised by other Member States). The method also does not relate to the exact content of

PAH but instead measures the degree of aromatics and there is no correlation table provided.

The authorities in that country are therefore trialling a project, in which they are looking to

develop a new method, which they will seek to validate and present to the Commission.

Another Member State suggested that in order to avoid conflicting results, the references to

the compliance of extender oils could be removed so that only tyres are required to comply

with the PAH limits. However, given the high costs of testing the overall tyre using the test

method ISO 21461, identified above, it may not be wise to remove the option of using the

analytical method for extender oils, IP 346, which is understood to be more reasonably priced.

Suitability of test method

A number of other Member States also referred to the suitability of the test method specified

in the restriction. The issue with the test methods for PAH in tyres was raised by a number of

authorities, who explained that as the PAH restriction was developed and agreed upon years

ago, at which stage it was decided to use the industry standard, which was used to test the

majority of extender oils at that time. However, due to technical developments, there is now a

new test method used by industry. IP 346 is now only appropriate for some oils and not for

others, as there are now a lot more oils on the market, which can’t be tested using IP 346.

Overall, it was stated that this restriction is too complicated and too specific and is not fully

understood by those in industry. The current specified test method can also produce

erroneous results. As a result of the test method being regarded as unreliable, certain Member

States have not carried out further enforcement of the PAH restriction in tyres and are

recommending that the restriction should not specify a test method. The inclusion of specific

methods within a restriction creates issues regarding sourcing local, accredited, reasonably

priced laboratories that can carry out the analysis.

However, the test methods are enshrined in law and it would take some time to change the

Annex to reflect the current situation. Some Member States argue that there should not be

any test methods enshrined in law. However, other Member States are in favour of specifying

the test method in the restriction as otherwise different test methods could be used which may

cause difficulties in terms of enforcement if the results from one could be dismissed on the

basis of this being the incorrect test method.

Information

One Member State commented that it is difficult to get analytical test reports from importers.

A few companies were very reluctant to share what they consider to be confidential trade

information such as the ingredients used in their tyres. Member States also experienced

problems in establishing target companies and products due to the complicated tyre supply

chain and the global, multi-level companies involved. Many companies manufacturing tyres

were non-EU which meant the EU Member States had very little influence or power to gather

information. In this regard, parallel importing is a concern, whereby non-EU companies



produce tyres for the EU market in compliance with the REACH restriction, but at the same

time makes tyres for the US market in compliance with the relevant standard in the US which

has a less stringent level for compliance. Someone could buy tyres for the US market but

then ship them to an EU country and sell them on the EU market which would be in breach of

the restriction, which raises concerns of parallel importing.

Also, in relation to the exchange of information between Member States problems arose

regarding the use of secure intelligence transfer between Member States as the success

depends heavily on the receiving countries operating systems and whether they are set-up to

receive intelligence in this way.



2.12 Phthalates (Entries 51 and 52)


The substances covered by Entries 51 and 52 (Phthalates) and the conditions of restrictions

are set out Table 2.14.

Table 2.14 Substances covered by Entries 51 and 52


51. The following

phthalates (or other

CAS and EC

numbers covering

the substance):

(a) Bis (2-

ethylhexyl) phthalate

(DEHP)

CAS No 117-81-7

EC No 204-211-0

(b) Dibutyl phthalate

(DBP)

CAS No 84-74-2

EC No 201-557-4

(c) Benzyl butyl

phthalate (BBP)

CAS No 85-68-7

EC No 201-622-7

52. The following

phthalates (or other

CAS- and EC

numbers covering

the substance):

(a) Di-“isononyl”

phthalate (DINP)

CAS No 28553-12-0

and 68515-48-0

EC No 249-079-5

and 271-090-9

(b) Di-“isodecyl”

phthalate (DIDP)

CAS No 26761-40-0

and 68515-49-1

EC No 247-977-1

and 271-091-4

(c) Di-n-octyl

phthalate (DNOP)

CAS No 117-84-0

EC No 204-214-7

1. Shall not be used as substances or in mixtures, in concentrations greater than

0,1 % by weight of the plasticised material, in toys and childcare articles.

2. Toys and childcare articles containing these phthalates in a concentration

greater than 0,1 % by weight of the plasticised material shall not be placed on the

market.

3. The Commission shall re-evaluate, by 16 January 2010, the measures provided

for in relation to this entry in the light of new scientific information on such

substances and their substitutes, and if justified, these measures shall be modified

accordingly.

4. For the purpose of this entry “childcare article” shall mean any product intended

to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the

part of children.

1. Shall not be used as substances or in mixtures, in concentrations greater than

0,1 % by weight of the plasticised material, in toys and childcare articles which

can be placed in the mouth by children.

2. Such toys and childcare articles containing these phthalates in a concentration

greater than 0,1 % by weight of the plasticised material shall not be placed on the

market.

3. The Commission shall re-evaluate, by 16 January 2010, the measures provided

for in relation to this entry in the light of new scientific information on such

substances and their substitutes, and if justified, these measures shall be modified

accordingly.

4. For the purpose of this entry “childcare article” shall mean any product intended

to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the

part of children.

Uses: Toys and childcare articles




59% of Member States (16 countries) have carried out enforcement actions on phthalates. Of

these, 6 countries referred to having carried out a specific enforcement campaign targeting the

restrictions under Entries 51 and 52, 7 countries referred to having carried out several

campaigns, and 3 countries referred to other action having been taken, either through reactive

enforcement, non-official product checks, or checks on products notified under RAPEX.

In the case of those countries that have carried out campaigns, in some cases these campaigns

related to very specific items such as children’s strollers, carnival masks, bathing toys and

“slime”, while in other cases more general campaigns are carried out for example sampling

plastic toys.

One country targeted plastic toys and childcare articles for controls during importation and

therefore focused on a specific stage of the supply chain. In some countries, campaigns on

phthalates are repeated annually, so for example, one country performs market surveillance

activities concerning childcare articles each year, taking approximately 10 to 20 samples per

year. If the restriction level is exceeded in any case, depending on the level of risk, the

enforcement authority will ask the responsible economic operator to take action such as

withdrawal, recall and/or destruction of the product posing a serious risk. Another country

stated that it carried out annual campaigns between 2001 and 2007 as well as reactive controls

following complaints from industry, NGO’s and consumer each year.

One Member State commented that the restriction on phthalates was chosen for enforcement

due to the number of notifications that were made concerning phthalates found in toys.

Another Member State selected phthalates for enforcement since there was an expected risk,

low level of compliance and it had been specifically requested by the policy department of

that authority. In each case samples were taken in the market and from retail companies, and

tested in the authorities own laboratories. If non-compliance was detected, the authorities

would inspect the company that distributed the product to the supply chain, therefore focusing

on suppliers. This was a national campaign. If non-compliance, a fine and prohibition from

selling the product could be imposed.

- During 2007 a total of 200 different kinds of soft plastic toys and 12 different kinds of

soft plastic childcare articles were sampled from the consumer market. These included

bath toys, bouncy balls and inflatable aquatic toys, as well as bibs, changing table

pillows and seats of high chairs. At least 96 brands were represented. Most examined

samples (67%) were made of PVC. Of the examined samples of toys as well as

childcare articles, 41% exceeded the legislative limit for the six phthalates. A total of

48 fines and 2 warnings were given. During this survey the plasticizers DINCH,

nonylphenol cluster and DEHTP were often identified in the samples. It is not clear

whether these plasticizers are a safe alternative for the six phthalates.

- In 2008 148 different kind of soft plastic toys and 22 soft plastic childcare articles

were sampled. Samples were taken from mainstream commercial channels where

consumers usually buy toys. Special attention was given to soft plastic articles

intended for very young children during sampling. At least 87 different brands were

represented. In 43 of the 148 soft plastic toys the sum of phthalates exceeded the

legislative limit for the six phthalates. In 4 of the soft plastic childcare article the sum



of phthalates exceeded the legislative limit for the six phthalates. A total of 34 retailers

were fined.

- In 2009 159 different soft plastic toys and 11 different soft plastic childcare articles

were sampled. A total of at least 84 different brands were represented. In 3 of the 11

child care articles (= 27%) the legal limit for phthalates was exceeded: the sum of

DEHP, DBP and BBP and / or the amount of DINP, DIDP and DNOP was exceeded.

A total of 39 fines and 3 warnings were given.

In each case the Member State made a RAPEX notification. By way of follow-up to the

above campaigns, the Member State is now changing its approach from more product based

inspections to more company based inspections, therefore including phthalates in general

inspections.

Finally, one Member State commented that during the 3 years that it has undertaken special

campaigns for the collection of samples and for their analysis for phthalate content, a

significant reduction in the number of non-compliant products has been observed.


A total of 652 notifications have been made to date in relation to the restriction on phthalates.

This covers all RAPEX notifications made since 2005. Figures on the total number of cases

notified per Member State, and according to the country of origin of the product are provided

in Section 5.3.3 below. A summary table, providing details of all 652 notifications is

provided in Annex 6.

Almost all of the products that have been notified under RAPEX as containing phthalates are

toys.


Five responses listed these restrictions as being applicable to the products they produced,

placed on the market or imported, which included companies whose activities covered toys,

paints, the manufacture of organic substances, the production of phthalate plasticiser (DEHP),

and the production of DINP and DIDP (this was provided by way of a joint response from a

number of companies involved in this activity as well as their industry organisation, the

ECPI).

Examples of good practice:

For this restriction, awareness raising can be cited as an example of good practice,

which includes action taken by NGO’s, referred to below. This is also an

example of where targeted campaigns have proven successful, focusing on

specific stages of the supply chain such as importation and distribution, and

specific products, in this case toy and childcare articles. Finally, the example

from Member States also show the importance of carrying out repeat annual

campaigns, given the large number of products covered by the restriction.



The responses reveal that 5 main types of action are taken to ensure compliance with the

restriction:

1) Knowledge of supply chain – One company stated that it refuses to sell products to

downstream users who intend to use it in a restricted application, and keeps full

records of each product line, which are available for any market surveillance or

inspection.

2) Imposing restrictions on suppliers

3) Use of internal control procedures such as ISO 9001 and 14001

4) Provision of information such as Safety Data Sheets to customers – One company also

stated that it supports a website which included full details of the restrictions and links

to the actual legislation in order to improve the flow of information and general

awareness. Another company stated that they regularly check Annex XVII of REACH

and also the ECHA website for new/current restrictions, and also had in place a tool to

ensure that their products comply with the restrictions.

5) Perform testing on a product by product basis

With regard to market surveillance, one company stated that it was infrequently subject to

market surveillance controls. Another company commented that inspections by authorities

under REACH are more likely to concern general compliance under REACH rather than a

specific restriction.

One NGO indicated that it has been campaigning indirectly on phthalates for a number of

years. For example, in 2008, it ran a campaign concerning chemicals of concern in toys,

during the revision of the Toys Safety Directive. This involved testing of toys for the general

public in Germany and France, and the adoption of a position paper, submission of proposed

amendments, and letters to national and European public authorities, in relation to the

proposed Toys Safety Directive. This resulted in a lot of media attention, and made the

general public more aware of the hazards related to chemicals of concern in toys. During

2009, 2010 and 2011, it also released various pocket guides to inform the general public on

products such as toys, cleaning products, baby cosmetics and cosmetics for pregnant women.

These pocket guides were edited in several languages to inform the general public, and

especially future and young parents on the presence of chemicals of (very high) concern in

consumer products, covering some of the substances already restricted for some uses

according to the restrictions under Annex XVII, but still used in other products categories

(e.g. nickel can still be found in some make-up products, etc.). The guide was distributed not

only to the general public, but also health, children professionals and other potentially

interested professionals, in German, English, French and other languages.

The NGO also participated in a right to know campaign during 2010, which concerned

consumer’s right to information regarding the presence of phthalates, especially DEHP, in

children articles. The campaign involved testing of products, letters to retailers, and the

release of a final report. The outcome of the campaign was increased media attention, and

awareness raising of the presence of phthalates (among them the above restricted ones) in toys

and children articles.



Another NGO stated that it is currently running a project on phthalate contamination in day-

care centres. Within this project, dust samples from more than 200 German Kindergartens

were analysed for phathalates, showing that the contamination was on average three times

higher compared to households.



identified by Member States. However, difficulties in the implementation and enforcement of

restrictions generally, are outlined in Section 3.2 below.

One retailer however commented that misinterpretations have arisen regarding REACH, for

example the removal of jelly shoes from sale due to phthalate content, as notified through

RAPEX, yet which were not childcare articles. Another retailer commented that the

interaction between the legislation on toys covering phthalates and the cross over with the

phthalates on the Candidate list is hard for suppliers to understand.



2.13 CMR Substances (Entries 28 to 30)

In addition to covering the 10 selected restrictions, information was also sought generally on

the implementation and enforcement of Entries 28 to 30, which cover substances which are

carcinogenic, mutagenic and toxic to reproduction (CMR substances).


The substances covered by Entries 28 to 30 (CMR substances) and the conditions of

restrictions are set out in Table 2.15.

Table 2.15 Substances covered by Entries 28 to 30


28. Substances which appear in Part 3 of Annex VI

to Regulation (EC) No 1272/2008 classified as

carcinogen category 1A or 1B (Table 3.1) or

carcinogen category 1 or 2 (Table 3.2) and listed as

follows:

— Carcinogen category 1A (Table 3.1)/carcinogen

category 1 (Table 3.2) listed in Appendix 1

— Carcinogen category 1B (Table 3.1)/carcinogen




germ cell mutagen category 1A or 1B (Table 3.1)

or mutagen category 1 or 2 (Table 3.2) and listed as

follows:

— Mutagen category 1A (Table 3.1)/mutagen


— Mutagen category 1B (Table 3.1)/mutagen




toxic to reproduction category 1A or 1B (Table 3.1)

or toxic to reproduction category 1 or 2 (Table 3.2)

and listed as follows:

— Reproductive toxicant category 1A adverse

effects on sexual function and fertility or on

development (Table 3.1) or reproductive toxicant

category 1 with R60 (May impair fertility) or R61

(May cause harm to the unborn child) (Table 3.2)

listed in Appendix 5

— Reproductive toxicant category 1B adverse

effects on sexual function and fertility or on

development (Table 3.1) or reproductive toxicant

category 2 with R60 (May impair fertility) or R61

(May cause harm to the unborn child) (Table 3.2)

listed in Appendix 6

Without prejudice to the other parts of this Annex

the following shall apply to entries 28 to 30:

1. Shall not be placed on the market, or used,

— as substances,

— as constituents of other substances, or,

— in mixtures,

for supply to the general public when the individual

concentration in the substance or mixture is equal

to or greater than:

— either the relevant specific concentration limit

specified in Part 3 of Annex VI to Regulation (EC)

No 1272/2008, or,

— the relevant concentration specified in Directive

1999/45/EC.

Without prejudice to the implementation of other

Community provisions relating to the classification,

packaging and labelling of substances and

mixtures, suppliers shall ensure before the placing

on the market that the packaging of such substances

and mixtures is marked visibly, legibly and

indelibly as follows: “Restricted to professional

users”.

2. By way of derogation, paragraph 1 shall not

apply to: (a) medicinal or veterinary products as

defined by Directive 2001/82/EC and Directive

2001/83/EC;

(b) cosmetic products as defined by Directive

76/768/EEC;

(c) the following fuels and oil products:

— motor fuels which are covered by Directive

98/70/EC,

— mineral oil products intended for use as fuel in

mobile or fixed combustion plants,

— fuels sold in closed systems (e.g. liquid gas

bottles); (d) artists’ paints covered by Directive

1999/45/EC.



Uses: General use in substances or mixtures

2.13.2 Enforcement in Member States

A number of methods are used to prevent the sale of carcinogenic, mutagenic and reprotoxic

(CMR) substances, or substances in mixtures to the general public. These include general

market surveillance activities, inspections, specific prohibition of the sale of toxic or

poisonous substances and information campaigns and awareness raising activities. The

majority of Member States however focused on the use of inspections to control this

restriction.

Inspections

52% of Member States (14 countries) referred to inspections being carried out to check the

sale of CMR substances. These appear however to vary a great deal, with some Member

States simply asking companies whether they sell CMR substances to the public, while other

Member States carry out annual enforcement campaigns targeting a specific group of CMR

substances each year.

One Member State commented that CMR substances are subject to continuous surveillance

activities, and areas where the sale of relevant products to the general public may occur are

visited on a regular basis. Where products which are not destined for the general public are

found, these are ordered to be removed from such stores. Another Member State stated that

the Regional Inspectorates for health perform on-site inspections at the premises of wholesale

distributors and in shops and specialised markets in order to verify compliance with the

requirements of Entries 28, 29 and 30 and where there is suspicion of a violation, samples can

be taken and analysed. One Member State commented that where inspectors find CMR

substances during general inspections of manufacturers, importers, and downstream users,

they ask for details of the destination of the substances and verify that such substances are not

destined for sale to the general public. In another Member State, inspectors check whether

retailers are restricting the sale of CMR substances in any way, for example by only selling it

to registered users in which case it should not be on display for sale to the general public or at

least kept within a locked cabinet or other secure location. The remaining countries referred

to inspections being carried out (generally at the point of sale) where the authorities have

found mixtures containing CMR substances are being sold to the public, in which case the

usual provisions regarding withdrawal of the product from the market and imposition of a fine

will apply.

Specific prohibition of the sale of toxic or poisonous substances

15% of Member States (4 countries) stated that their national legislation prohibits the sale of

toxic or poisonous substances unless a specific licence or authorisation is held. In one

Member State, the sale of toxic substances to private persons is only permitted where you

obtain a police certificate, which is only granted in very few circumstances. The police are

aware that selling CMR substances is forbidden and therefore in most cases permission will

be refused on the basis that you should go to a professional who is qualified in the use of toxic

substances. In another Member State the legislation places high demands on individuals

regarding the sale of substances that contain CMR substances, and these requirements are

reviewed regularly. Another Member State has had in place a national law since 2002, which

regulates the delivery, sale, use, and storage of certain substances and preparations which



pose a serious risk, i.e. those that are toxic, very toxic, carcinogenic, mutagenic or toxic for

reproduction, and which states that the retail sale of such toxic substances is forbidden.

Information campaigns

A number of Member States also referred to information campaigns having been carried out

in order to prevent the sale of CMR substances to the public. In one Member State

information is provided to consumers on the restrictions related to specific CMR substances,

while in another joint campaigns are carried out between the Health Board and the authorities

in order to produce publications, leaflets and other information for companies and the general

public, as well as to provide specific information dangerous products containing CMR

substances that have been removed from the market.

Awareness raising activities

One Member State considered that the relevant market players have already had knowledge of

the prohibition on the supply of CMR substances to the general public for a number of years

now, due to information campaigns carried out by industry associations and authorities.

Another Member States commented that due to pro-active measures taken in the previous

years by the competent authority for chemicals legislation, the general level of awareness

regarding the restriction of CMR substances is quite good, and the number of non-

conformities with this restriction found over the last few years has been very low.

However, other Member States commented that the awareness of the restriction could be

improved since awareness of these restrictions vary and is less further down the supply chain.

For those consumers who are aware of the restriction, the knowledge is in general limited to

knowledge of carcinogenic substances. There is therefore a need to raise public awareness

through various channels, including informing the public through the media of

hazardous/dangerous substances/products which are subject to restriction. The demand for

dangerous substances and products containing dangerous substances could be reduced

through raising public awareness of the restriction and the reasons behind the restriction.

Another Member State felt that chemical inspectors play a key role in raising awareness of the

restriction by providing advice on all aspects of chemicals including the restriction of CMR

substances. Finally, one Member State commented that greater awareness raising and

increasing the knowledge base would help in the enforcement of the restrictions on CMR

substances as if stores and retailers understood the restriction, they would then seek

information from their suppliers.


A number of respondents stated that they were aware or were partially aware of what was

done to prevent the sale of CMR substances to the general public. The responses reveal that 4

main types of action are taken to ensure compliance with the restriction.

1) Reliance on suppliers to inform them of where these substances are present in the

products they supply – One company commented that by implementing a robust

quality and management system in companies, hazard information and risk

management measures should be more controlled throughout the entire supply chain,

from the manufacturer, distributor and retailer to the consumer;

2) Checking the Safety Data Sheet for CMR substances;



3) Identification of products through the RAPEX notification system;

4) Compliance with other sectoral legislation – A number of companies commented on

the interaction with the sectoral Directives such as the Toys Directive (2009/48/EC)

that would place restrictions on toys that are CMRs or contain CMRs.

A number of other methods were also referred to, which included the registration of the

substances used in mixtures under REACH, the use of a tool which allows the company only

to sell such substances to industrial/professional customers, the substitution of carcinogenic

and mutagenic substances with less dangerous ones, the communication of substances of

concern to downstream professional users via the MSDS and labelling, documentary studies,

mainly on raw material SDS, and testing and monitoring.

One NGO stated that it is not aware of concrete steps implemented to prevent the sale of

CMR substances to the general public. Since RAPEX reports regularly concern product recall

from the retailer itself, and due to the huge amount of articles placed on the market, there is a

discrepancy between the available means of actions by public authorities to cope with the

potential presence of hazardous products on the market and the quantities of goods placed on

the market. It also commented that the general level of awareness amongst the general public

regarding restrictions is rather poor, as is the knowledge of the general public regarding

REACH.


Member States were asked to outline any difficulties encountered in enforcing the restrictions

on CMR substances. 37% of Member States (10 countries) referred to their being difficulties

in the prevention of the sale of CMR substances to the general public and enforcement of the

restriction. The following 5 main difficulties were identified:

1) Large number of substances and uses caught by the restriction - A number of Member

States commented that the restriction is difficult to enforce because it can apply to a

large number of different situations and targets since the substances mentioned in the

restriction can form part of many different type of mixtures. There are therefore

specific difficulties related to the controls for each specific product, which requires an

individual approach to be taken to the investigation and laboratory analysis of each

substance in order for enforcement to be effective.

2) Analytical methods - Testing capabilities are a big problem as the restrictions on CMR

substances are not supported by any specific test method and many laboratories are too

small to test these substances, unless there are a significant number of samples taken.

In addition, the cost of necessary laboratory tests is seen as difficult.

3) Resources - With there being such a large number of duty holders there is insufficient

manpower and budgetary resources in a number of Member States in order to enforce

the restriction. Personnel are insufficient in many countries to carry out

comprehensive market surveillance as tasks are increasing while staff is diminishing.



4) Evidence of non-compliance - A number of Member States also referred to the

difficulties that are faced in proving that CMR substances are being sold to consumers,

while another Member State stated that one of the main difficulties is with the correct

identification of a CMR substance. One Member State commented that they find

CMR substances on the market in superstores and as a result require measures to be

taken by the stores to remove the product from general sale to the public. However,

enforcement is difficult since stores do not understand why such measures require to

be taken. Compliance with the labelling requirements set out in the restriction, that

requires suppliers to ensure that the packaging of CMR substances and mixtures

placed on the market are marked visibly, legibly and indelibly with the wording

“restricted to professional users”, is therefore key to ensuring compliance of those

further down the supply chain and enforcement of the restriction.

5) Lack of information - One Member State commented that one of the main difficulties

encountered in enforcing the restriction on CMR substances is the lack of information

as inspectors, who do not have direct access to data of ECHA such as REACH

dossiers, are unable to check companies’ statements. Files of companies from other

Member States (imports) could also provide valuable information.



2.14 Information on campaigns covering other restrictions

As there are 60 restrictions under Annex XVII, it is clear that Member States can only select a

number of these for targeted enforcement at any one time. In some cases therefore,

enforcement action may at present be focused on restriction other than those covered by the

study.

As indicated in the table at Section 2.1, a number of Member States made reference to other

specific campaigns that are being carried out, which included the following:

- Entry 3 – use of liquid substances or mixtures which are regarded as dangerous in

decorative lamp oils

- Entry 7 – Tris(aziridinyl)phosphinoxide

- Entry 9 – use of soap bark powder, benzidine, o-Nitrobenzaldehyde and other powders

in jokes and hoaxes

- Entry 10 - use of ammonium sulphide, ammonium hydrogen sulphide and ammonium

polysulphide in jokes and hoaxes

- Entry 23 – cadmium

- Entry 54 – placing on the market of DEGME in paints, paint strippers, cleaning agents

etc

- Entry 55 – placing on the market of DEGBE in spray paints or cleaners

- Entry 56 – placing on the market of MDI as a constituent of mixtures

- Entry 57 – placing on the market of cyclohexane as a constituent of neoprene-based

contact adhesives.

In some cases, a range of substances in particular products are also being targeted in the

context of REACH, for example, preservatives in children’s products, and metals (chromium,

nickel and cobalt) in detergents. In other cases certain sectors are being targeted for the

enforcement of restrictions. For example, in one Member State enforcement is focused on

three industrial sectors - producers of paints and varnishes, producers of cleaning and

disinfectants products and formulators of chemical products for the building sector.



3 Implementation and enforcement of restrictions - general information

In this section, an overview of the implementation and enforcement of restrictions generally

under Annex XVII is provided, without focusing on the 10 restrictions covered by the study.

This overview is based on responses received from Member States, companies and industry

associations, retailers and NGO’s, and follow-up interviews conducted with Member States

and stakeholders.

3.1 Introduction

From 1 June 2009, Annex XVII of the REACH Regulation replaced Directive 76/769/EEC on

the approximation of the laws, regulations and administrative provisions of the Member

States, relating to restrictions on the marketing and use of certain dangerous substance and

preparations. In considering how restrictions are implemented and enforces, it is therefore

worth considering first whether this change from regulation under Directive 76/769/EEC to

the direct application of Title VIII and Annex XVII of REACH resulted in a change of

approach to the implementation and enforcement of restrictions. Overall the majority of

respondents had not noticed changes in the approach to the implementation and enforcement

of restrictions, and where there were changes these were of a positive nature.

59% of Member (16 countries) States indicated that the change in legislation had not changed

their approach to the implementation and enforcement of restrictions, while 26% of Member

States (7 countries) indicated that it had changed their approach. In each case, the following

points regarding regulation under REACH were made:

- Legislative changes have occurred as the restrictions and the wordings are now more

precise, making it easier to enforce restrictions since they are the same in all EU

countries;

- As all restrictions are now compiled in one legislative act, this enables a more uniform

approach to be taken to the question of restrictions. REACH has centralised and

simplified chemical legislation across the whole of the EU, and at a national level

there has been consolidation of legislation. In a number of cases, prior to the

introduction of REACH the entries for restrictions were spread over different national

laws, covering consumer products and professional and institutional products

separately.

- Changes in the competent authority as authorities that did not have competence before

are now being given direct powers to control compliance of downstream users

concerning restrictions on production, marketing and use of chemical substances and

their mixtures.

- Changes in approach to enforcement as previously national legislation implementing

Directive 76/769/EEC was enforced on a reactive basis, whereas a proactive targeted

approach is now underway and being further developed for the enforcement of

REACH restrictions. More market surveillance is taking place as a number of

Member States are now carrying out campaigns on the enforcement of a REACH

restriction for the first time.



With regard to any changes noticed by industry, 25 respondents answered that they had not

noticed any change, while 10 responded that they had noticed changes.

Of those that had noticed changes in the enforcement of restrictions, most comments received

related to the information which now requires to be provided through the supply chain. One

stakeholder commented that retailers are now requesting more and more documentation prior

to committing to a purchase order, and similarly another company commented that more and

more of their customers want to be informed about the content of certain substances in a

product as a results of the restrictions in place, for example the chromium content in cement.

At the same time, one company commented that it has noticed that the number of inspections

has increased since 2009, and as a result of this producers and especially downstream users

are more aware of the importance of complying with the law.

The enforcement of REACH restrictions places great responsibility on companies to manage

and control the risk from dangerous chemicals. Prior to adopting REACH a large number of

chemical substances were manufactured and placed on the market with insufficient

information on the hazards they caused. Through the introduction of the restriction and

authorisation processes, one stakeholder said that it had noticed that companies are paying

more attention to the choice and use of chemicals, and showing a greater interest in the

research and development of “green” new raw materials and products to reduce the overall

impact to the human health and environment.

Finally, one company commented that companies now have to comply with the new

restrictions, introduced since Directive 76/769/EEC. As a result, sometimes the product they

used before cannot be found and therefore they have had to change product/supplier.

However, rarely have they had to modify the production process.

3.2 Market surveillance in the Member States

The market surveillance measures taken in order to enforce restrictions under REACH vary

across the 27 Member States. In general, in each Member State at least some form of market

surveillance is carried out, covering either physical and laboratory checks on the basis of

samples, checking documentation and information made available by operators, entering

premises of economic operators, inspecting and/or taking samples of products and withdrawal

or destruction of products presenting a serious risk, or a number of these measures.

Where specific market surveillance measures have been taken in regard to one of the

restrictions covered by the study these are set out in the relevant section of Chapter 2 above.

3.2.1 Brief summary of the market surveillance activities

The following market surveillance activities are carried out:

Prioritisation of restrictions – A number of Member States use specific tools, such as a pilot

chemical market surveillance programme which is used in one Member State, or a computer

based prioritisation tool which is used in another Member State, to determine which

restrictions should be prioritised for enforcement action. Recommendations of the FORUM



and RAPEX information is also used more widely to prioritise enforcement action. Further

information is provided in Section 3.2.2 below.

Information campaigns – A number of different information campaigns are used by Member

States to raise awareness of restrictions and assist in enforcement, which include circulating

information on any new restriction at the time of its introduction, specific products notified

under RAPEX, and providing information directly to companies. Further information is

provided in Section 3.2.3 below.

Desktop activities and document checks – Desktop research and documentary checks can be

carried out regarding products or companies as a first step in an enforcement campaign, in

order to identify companies that may be dealing with the products or substances subject to

restriction and any evidence of non-compliance. Further information is provided in Sections

3.2.3 and 3.2.4 below.

Inspections – Inspections are carried out either as part of a particular enforcement campaign

targeting a specific restriction or more generally under REACH, though focused on

restrictions. Further information is provided in Section 3.2.5 below.

Sampling and analysis of market products – Sampling is carried out either as part of a

particular enforcement campaign targeting a specific restriction, more generally under

REACH, though focused on restrictions, or in response to individual cases of non-compliance

found. Further information is provided in Section 3.2.5 below.

3.2.2 Prioritisation of enforcement in Member States

Ahead of carrying out market surveillance measures in order to enforce restrictions, a number

of Member States have referred to the use of specific tools in order to prioritise their work.

The following examples were provided:

Recommendations of the FORUM - One country stated that market surveillance measures to

check compliance with the restriction under REACH are decided each year taking into

account a number of criteria, including the recommendations of the FORUM. Reference to

the recommendations of the FORUM was also made by a number of other Member States, a

number of whom stated that action on the national level was strongly influenced by the

FORUM’s recommendations.

RAPEX notifications and other information - Another Member State commented that

inspections are either planned (based on the enforcement authorities priorities, often campaign

based) or non-routine, based on complaints, RAPEX notifications or monitoring results. The

majority of Member States refer to prioritisation of enforcement action, in some cases based

on information received from RAPEX, and in other cases using their own tools in order to

categorise substances and products (mixtures and articles) for enforcement action. Only one

country stated that market surveillance was done on a reactive basis when a complaint is

received or when a sample is forwarded to the authority because it is suspected to contain any

of the mentioned restricted substances.



Specific prioritisation tools – Two Member States referred to the use of the following specific

tools to prioritise enforcement of restrictions:

(i) A pilot chemical market surveillance programme - the programme uses a

market surveillance form covering all products on the market, in order to set

out an overarching plan to enforce restrictions, as well as other aspects of

REACH. Based on the information received from the market surveillance

forms, the authorities select specific product lines for enforcement. The

authorities in this country are currently carrying out a number of pilot projects

in order to test how effective this approach to prioritisation is and will add

further products each year, focusing on those items notified under RAPEX

(where these relate to human health) and those with a risk to the environment.

(ii) A computer based prioritisation tool – This incorporates usage/hazard and

monitoring data to assess a range of restricted chemicals and others of interest.

Exposure information and hazard information is inputted into the prioritisation

tool, which then multiplies it and comes up with a rating of between 1 and 6. It

is used for substances restricted under Annex XVII, as well as other

substances. The Member State has identified shortcomings with using the tool

however, which can only be used to a limited extent and should only be treated

as a first step. There may be other things such as industry/ NGO/ political

considerations which require action irrespective of the rating given. There can

be issues with the information that is used to populate the tool as well and

therefore the authorities try to use information gathered by them rather than

that provided on Safety Data Sheets, which can be limited and particularly in

the case of exposure data may not cover all the uses of that substance.

Strategy for enforcement - Finally, a number of Member States referred to a strategy for

enforcement action having been drawn up on the basis of the Market Surveillance Directive.

For example, one Member State has in place a Market Surveillance Council, in which the

heads of all Market surveillance Authorities are represented. They meet to discuss any market

surveillance problems and to establish priorities and further market surveillance actions.

3.2.3 Information campaigns

Several options were given by different Member States:

Information campaigns only and based on RAPEX - One Member State referred to having

only carried out information campaigns to date, having informed national suppliers about

products which have features in RAPEX notifications in order for those suppliers to take the

necessary action recommended in the notification.

Information campaign as first step for enforcement actions - The majority of Member States

use information campaigns as a first step in their overall enforcement of a restriction.

Selection of companies to be inspected - A number of Member States will collect information

about the companies potentially concerned by a particular restriction, from which they will

then chose the companies that are to be inspected. Company visits then take place where

compliance with restrictions is checked, and if necessary legal action against offenders is

initiated.



Communication tools for information campaigns - Another country stated that they announce

the restriction on their website and upload a copy of the relevant legislation whenever there is

a new addition or amendment to Annex XVII. They then issue a letter by email or fax to all

associations (asking them to inform their members), ministries, and other parties who may

have an interest or be affected by the restriction, in order to notify them of the terms of the

restriction.

Market controls (sampling and analysis) – Another county carries out controls on the market

in cooperation with the Ministry of Commerce, which has a special body, which takes

samples from the market, which are then passed to the State Laboratory for testing. The State

Laboratory has its own laboratories, where the testing is carried out. The State Laboratory has

a contract of collaboration with the Ministry of Commerce, which specifies that they should

take a certain number of samples each year from specific products. The Ministry of

Commerce is then responsible for taking samples in accordance with that agreement, while

the State Laboratory is responsible for testing the samples taken.

Information directly to companies - In another case, the Member State informs industry and

companies of restrictions through information campaigns whereby information is sent to

companies directly and information is also put on the website of the helpdesk. This is always

the first step in any campaign.

Desktop research in enforcement - Following this, they may carry out desktop research in

order to identify companies that may be dealing with the products or substances subject to

restriction and will then ask the regional and local inspectorates at the municipal level to

enforce specific restrictions.

Involvement of local authorities - This involves checking local shops, wholesalers and

downstream users and thereafter carrying out sampling in the market.

3.2.4 Documentation checks

Checks made on documentation are a common means of market surveillance used by almost

all Member States. Again, in some cases this is the only means of market surveillance carried

out, but in most cases, further measures are taken following on from this. In one Member

State, it was stated that the only way to verify the compliance with the restrictions under

REACH is to check the Safety Data Sheets and the labels of products containing restricted

substances, since it is not possible at present to take samples of products to perform laboratory

analysis.

In one Member State, the current approach is a top down approach, whereby they target

importers and manufacturers, who are placing the products on the market, rather than going to

distributors, who then have to go back to their supplier etc to obtain the information.

Problems arise though regarding internet sales, which are difficult to control and carry out

checks on.

3.2.5 Inspections and sampling

Information from Member State questionnaires

Based on the information received from Member State questionnaires, the following examples

of inspection and sampling practice are provided in different Member States:



- Overall number of product checks per annum - The competent authority for REACH

in one Member State checks around 5000 products per annum, with controls on

chemicals forming 30% of all product checks per year. Inspectors check restrictions

through documentary checks and if needed take samples for laboratory testing.

Inspections are divided according to planned activities and reactive activities,

following complaints and control of information.

- Targeted sampling under individual restriction campaigns - One country investigates

an average of 20 to 30 samples for each national campaign that it carries out for a

specific restriction. A specific administrative procedure exists in one Member State,

whereby the authorities communicate to the duty-holders that they are starting an

investigation, the product is then purchased, and documentary and analytical checks

are then carried out. Where the product does not comply with the restriction,

administrative penalties and other measures such as withdrawal from the market,

destruction and the requirement to inform consumers may be imposed. The Ministry

of Health will also inform consumers promptly though publication of any product

recalls on its website.

- Sampling required for customs clearance - In one country, customs carries out an

initial documentary check on the documents and information declared by the importer,

based on the information provided by the exporter / supplier. If irregularities are

found in the customs declaration, customs does not allow the clearance of the

chemical in question, and samples are taken for analysis to assess the degree of risk to

human health and the environment, determining, as appropriate, re-export, removal or

destruction of that product.

- Preventative inspections and sampling - In another Member State, preventive checks

on business entities are carried out as well as targeted product safety programmes. The

relevant authority has the power to enter the premises of economic operators in order

to perform documentary and physical checks on products and to take samples of the

products. Thereafter, the authority has the power to prohibit the supply of dangerous

non-food products to the market, to withdraw, recall and destroy such products, and

make a RAPEX notification.

- Sampling following inspections - The authorities in another Member State check

compliance with the restrictions under REACH through laboratory tests of samples

taken by inspectors. In case of discrepancies the marketing of the substance,

preparation or article contrary to the prohibition or restriction specified in the

provisions of Annex XVII of REACH, the further transfer of the substance, the

mixture or product is prohibited. In addition, inspectors convey information about the

irregularities to any other appropriate authority, which supervises compliance with the

restriction. In another Member State, the monitoring of compliance with restrictions is

primarily done in the context of on-site inspections and review of relevant documents.

Depending on the circumstances, the monitoring might also include sampling and

laboratory testing. In case of any non-compliance found, monitoring is followed by

state administrative actions, which can vary from a requirement to rectify the problem

to prohibition of sale.



Information on inspections reported by Member States under Article 117(1) of REACH

Under Article 117(1) of REACH, Member States are required to submit to the Commission by

1 June 2010 a report on the operation of REACH, including sections on evaluation and

enforcement. Within the reporting questionnaires submitted, each country has provided

details of inspections carried out for the years 2007, 2008 and 2009, covering the total number

of inspections and investigations carried out by enforcing authorities in which REACH was

discussed and/or enforced for those years, and also the number of inspections that addressed

restriction. From this data, it is useful to compare the most recent figures provided for 2009.

For three Member States, no data was provided. Of the remaining 24 Member States, 8

Member States gave details of the total number of inspections and investigations carried out

by enforcing authorities in which REACH was discussed and/or enforced for those years, but

stated that none of these address restrictions. 16 Member States provided the total number of

inspections carried out in relation to REACH generally, as well as the total number of those

that related to restrictions. From this it is possible to calculate the percentage of REACH

inspections that addressed restriction, which is presented in Table 3.1 in ascending order.

Table 3.1 Inspections covering REACH Restrictions

Member

State

Number of

inspections

in REACH

generally

Number of

inspections

devoted to

restrictions

% of

inspections

devoted to

restrictions

1 25700 117 0,005

2 21502 1981 0,09

3 2637 63 2

4 726 30 4

5 349 18 5

6 243 19 8

7 2089 213 10

8 44 10 23

9 9436 2886 31

10 350 120 34

11 333 131 39

12 168 70 42

13 109 70 64

14 2828 1884 67

15 153 116 76

16 1472 1185 81

From this it can be seen that in four Member States, more than 50% of the inspections carried

out in 2009, related specifically to restrictions.

It can also be seen that there is great variance between the numbers of inspections that

addressed restriction in 2009, which range from 10 in one Member State, to 2,886 in another

Member State. However, this reflects the variance between the overall number of inspections



carried out in relation to REACH, which range from 2 in one Member State (this Member

State had not carried out any inspections relating to restrictions and is therefore not shown in

the table above), to 25,700 inspections in relation to REACH in general in another Member

State.

In addition, information was received for one Member State regarding inspections planned for

2012. In that country, a list of national actions has been prepared for 2012. The programme

of priorities sets out the priority action with regard to chemicals, which includes control of

compliance with restrictions in order to reinforce pilot actions carried out in that country in

2011. Controls will be carried out in 2012 by way of joint action between customs and the

Ministry of Economy, Finance and Industry, with analysis being undertaken by the common

laboratory services under a common service framework agreement. The restrictions that are

to be controlled are to be selected jointly by customs and the Ministry of Economy, Finance

and Industry, and shall target establishments that are producers, importers of chemical

substances and users in classified installations, irrespective of what their field of activity is.

30 inspections are planned in certain regions, to be identified by the regional representatives

of the state. Indicators that are to be used are the number of inspections done, the number of

substances controlled and the number of cases of non-conformity recorded. This shows that

inspections devoted to restrictions are clearly part of priority enforcement action in that

country, and also that customs will have a large role both in the selection and implementation

of this action plan.

3.2.6 General difficulties

Member State authorities identified a number of difficulties faced by them in carrying out

market surveillance and enforcement of restrictions in Annex XVII of REACH. Where these

relate specifically to one of the 10 restrictions these are outlined in Chapter 2 above.

The remaining issues identified by Member States covered the following aspects:

1) Testing and availability of laboratories - 44% of Member States (12 countries) referred to

difficulties regarding the analytical methods or the availability of laboratories within their

Member State, which is dealt with in Section 3.5 below.

2) Resources - A number of Member States also referred to a lack of resources as being the

main difficulty, which is covered in Section 3.6 below.

3) Prioritisation - 4 Member States commented that difficulties arise due to the specificity of

the restrictions, that therefore require detailed investigation and sophisticated laboratory

analysis. As a result, efficient enforcement is largely only possible through organising a

targeted campaign as individual restrictions are almost impossible to cover without such a

campaign. The setting of priorities for surveillance based on RAPEX alerts or other means is

therefore necessary, as authorities cannot focus on all 60 restrictions.

4) Obtaining information on the market/supply chain – Inspection campaigns are often

hindered due to lack of information of the market of the supply chain. In particular, there are

problems in obtaining information on the supply chain, which are often very complex, in

order to select those companies that supply products which contain substances subject to

restriction. Information on the market/supply chain is important as if enforcement activities

can target the highest point within a supply chain this can stop the manufacturer from making

a non-compliant product and therefore stop it entering the market entirely. However, as a



large majority of modern day products are manufactured outside Europe, Member States

authorities are unable to target the manufacturing stage and therefore the next best route is to

identify companies importing restricted products, which can be a challenge.

One Member State explained that many of its campaigns start with internet research to find

products being sold on the internet. This approach relies heavily on manufacturers and

retailers providing sufficiently detailed information about their products through safety data

sheets, ingredient lists and product specifications. However, as industry becomes more aware

of how the authorities gather their initial intelligence it is likely that they will provide as little

information as possible. Identifying a product’s ingredients or components to determine

compliance with a restriction is time consuming and not always possible. Some products such

as personal care products list all ingredients on the product (as required by other legislation

governing cosmetic products) which makes it relatively easy to determine compliance.

However, many products do not have such detailed information. Many products have safety

data sheets which can be useful but these contain vague or limited information about

ingredients. Also, many safety data sheets are out of date and incorrect and many companies

use obscure synonyms or generic chemical names. All these issues make it difficult to identify

non-compliant products.

5) Exchange of information - A number of other Member States also referred to the problems

with obtaining information generally, one example being provided of inspectors who do not

have direct access to data from the ECHA such as all of the information contained within

REACH registration dossiers, which makes it difficult to verify company information. It is

also essential for the dossiers of companies from other Member States to be made available,

so that the legality of these substances can be checked. Another Member State referred to the

lack of documentation relevant for RAPEX alerts available in their national language.

Another Member State commented that datasheets for chemical preparations can be out of

date and/or internet websites are not updated, leading to delays in finding relevant information

and wasted time.

The declarations of manufacturers purchased and presented by the distributors are often very

general, not available in the national language and do not concern the product being

distributed, but instead the products of the manufacturer in general. It is often the case that

even upon the distributors’ explicit request, the manufactures refuse to provide the necessary

documentation. In these cases, the only solution is to identify all actors of the supply chain,

and checking their liability, which is particulary difficult in cross-border cases.

Finally, in respect of difficulties identified regarding the specific supply chains, one Member

State commented on difficulties in tracing similar non-compliant products, such as jewellery

and clothing, since these products do not usually bear lot numbers or other characteristics that

can differentiate the non-compliant products tested from others placed on the market.

6) Wording of restrictions – A number of Member States commented on difficulties with the

wording of the restrictions, for example with regard to the terms “placing on the market” and

“supplier”, which can be open to differing interpretations. One Member State commented

that these terms are problematic for inspectors who have to understand the role of the

operator. There is an overall risk that Member States interpret a restriction differently and

thus create discrepancies across Europe. Member States commented also that there was a lack

of clarity in the scope of some of the entries in Annex XVII, for instances as to whether the

second hand market is included or not. Complicated exemptions also represent challenges.



One Member State suggested that it would be helpful if guidance was issued on each

restriction at the time a restriction enters into force, which could include definitions for terms

included within the restriction that may be ambiguous. Another Member State commented

that more guidance documents are needed generally on how to control and enforce

restrictions.

7) Cooperation with customs and Market surveillance authorities – One Member State

referred to difficulties in making agreements with customs in order to prevent products being

placed on the market at the stage of import. Another Member State referred to the lack of

guidelines with regard to the role and task of customs. There are numerous guidelines on

REACH-related issues for operators, competent authorities etc, which however, do not refer

to the specific tasks of customs authorities. Another Member State referred to the lack of

cooperation between the two authorities dealing with market surveillance and REACH

restrictions.

8) Industry knowledge - Reference was also made to problems associated with companies’

lack of knowledge of the products and the applicable legislation, which raises practical

problem during the surveillance/administrative control. Moreover, companies are not always

willing to provide the authorities with the documentation necessary within the administrative

control processes. Market safeguards would be substantially enhanced if companies were

obliged to perform self-control of the goods they use and of the goods they place on the

market. Not only then would enforcement agencies only have to inspect the self-control

carried by the companies, but the net extent of the market surveillance and thus the net

beneficial effect would attain another range. Today the burden of self-control is still

considered by many companies as unacceptable.

3.3 Measures taken by different actors in supply chain to ensure compliance

With the introduction of REACH, the responsibility for compliance, in terms of registration

and authorisation requirements as well as compliance with restrictions, is now placed squarely

on those placing chemicals on the market, i.e. manufacturers, importers and other private

economic actors. Information was therefore sought from companies and retailers regarding

the steps they take to ensure that their products comply with the restrictions set out in Annex

XVII of REACH.

The types of actions taken by companies and retailers to ensure that their products comply

with the restrictions generally falls into three categories:

no action (i.e. trusting that suppliers comply with REACH),

seeking confirmation/documentation of compliance with REACH from suppliers, or

carrying out their own documentary checks and testing to ensure compliance with

REACH,

or a combination or one or other or all three of these measures.



No action

The following examples of where no action is taken were provided by stakeholders:

- One retailer indicated that where they buy products from European suppliers, they

simply trust that these suppliers comply with the legal requirements. It is only where

their suppliers are from outside Europe that they ask the supplier for the information

referred to in Article 33 of REACH, and where this is not forthcoming or suggests

non-compliance with REACH, they do not go ahead with the purchase of those

products.

- One company stated that it relies on its suppliers complying with the restrictions and

updates its supplier manual regularly by checking legislative requirements in order

that the supplier manual reflects all current restrictions and other requirements. The

company’s various branch organisations then keep abreast of the manual.

- Another company stated that compliance is ensured by monitoring raw materials, in

respect of the majority of products purchased in the EU, it is assumed that producers

are in compliance with REACH, though this is monitored more closely if greater

volumes are involved.

- Finally, another company stated that they check the Safety Data Sheet and the label of

the product, which contains information on the restriction.

In most cases however, while the retailer or company relies on the conformity of their

suppliers with REACH in order to ensure that the product sold complies with the relevant

restriction, they will require further proof of this, either through documentary evidence or

testing.

Seeking confirmation/documentation from suppliers

Five out of the six responses received from retailers referred to the requirement for

documentation or testing to evidence compliance with the relevant restriction, through the

following methods:

- Framework supplier agreements - One retailer has put in place framework agreements

with suppliers, obliging them to remove products containing hazardous substances

from their product lines;

- Contractual obligations - Another retailer stated that all of their suppliers were

contractually obliged to comply with current legislation, and that prohibited

substances are set out in the appropriate purchasing policies, based on the purchase

contract. In addition, the relevant certificates are required and some tests are carried

out on materials.

- Use of technical data and documentation - Another retailer stated that they used

technical data and documentation provided by their suppliers in order to ensure that

the products complied with the relevant restrictions.Written declarations and other

means of supplier confirmation - One company stated that in order to ensure that their

products comply with REACH restrictions, the company usually establishes regular

on-going contacts with the manufacturers and suppliers, and seeks written declarations



or other documentation, which specifically states that the raw materials they purchase

don’t contain dangerous chemicals subject to REACH restrictions. Another company

referred to the use of Product Regulatory Datasheets. Another company described

themselves as mainly a downstream user, and therefore in order to ensure compliance

with restrictions, they have to rely on their suppliers for the information they need,

seeking confirmation from their suppliers of REACH registration and the content of

SVHC’s in their products.

As an example of good practice, one retailer has in place detailed Restricted Substance

Standards (RSS), which are issued for suppliers to follow, to ensure that all products are

tested to these standards, unless the supplier can demonstrate that they have bought compliant

components from a reputable sources or that they have test reports from other customers.

Restriction Substance Standards (RSS)

One retailer uses information received from RAPEX and testing houses as well as information from the media,

American standards, and NGO campaigns, in order to get a picture of what are the high risk substances that are

likely to fail, and also what substances are in the political spotlight, although their impacts may not yet be

proven. Based on this information they draw up a list of substances. This initial list of substances is then

broken down into substrates, such as those found in plastic, wood, leather etc, and also according to product.

Following this, the list is broken down further, setting out why the substance is particularly hazardous, whether

it is part of a product or the whole product, and setting out if it is hazardous only when disposed of etc.

Substances are then categorised as high risk if they know that they get a lot of failures (e.g. azodyes) and those

covered by legislation (e.g. cadmium), and also things such as NPE.

For those substances that are categorised as high risk, the retailer asks to see testing from suppliers. The testing

is carried out by the external supplier. For all other substances listed, they ask for self-certification. This is

difficult as it varies between suppliers as to how they self-certify. However, the retailer encourages the

suppliers to speak to their own suppliers, so that information is passed up the supply chain, and that they carry

out random checks and screen for certain substances each season. The retailer will also provide feedback to

suppliers based on any failures found and ask that suppliers pass this information on to their own suppliers in

order to increase awareness.

Generally, suppliers are willing to carry out the testing as without it, they are unable to supply to the retailer.

There is of course a cost attached to doing this, but since there is also a cost if there is a product recall further

down the line, most suppliers understand that investing in testing at this stage should avoid costs at a later stage.

The retailer also encourages their suppliers to source their own products from reputable suppliers, who are

known to the retailer, in which case they only request testing of occasional products rather than every product.

The retailer also carries out a monthly audit in order to test that the products are compliant. Two external

laboratories are used by the retailer in order to carry out the testing of products during the monthly audit. As not

all of the substances tested for have set test methods under the relevant restriction, the retailer will consult with

the laboratory as to what they think is the best test method to use.

Given that suppliers are to show compliance with the RSS before being accepted as a supplier, there should not

be high numbers of non-compliant products found at this stage. For example, in 2011, only two failures have

been found (azodyes and phthalates), which were found in very small parts of the product such as the pocket

lining or print on jean rather than the main fabric. Where a non-compliant product is found, in most cases there

is no option but to do a public recall of the product. In addition, the retailer specifies in its supply contracts that

there shall be a £5000 imposed on the supplier in such cases, which is generally used however to cover the costs

of getting all the stock. Thereafter, the retailer will work with the supplier to see what went wrong and what

they can do to avoid it happening again.



Testing

Based on the information received from retailers and companies, a number of approaches to

testing were identified:

Counter testing - In addition to the retailer that uses the RSS outlined above, one other retailer

referred specifically to carrying out counter testing on new product lines, alongside updating

their supplier manual regularly and informing their suppliers accordingly. Regarding testing,

another company stated that it does not ask for specific test results on paper but now and

again will test specific articles, by selecting approximately 5% of articles for counter testing

in order to prove compliance in-house. However, they are currently in the process of

changing their procedure to one where they ask suppliers to provide documentary evidence of

the test results, for articles which they have selected for counter testing, rather than doing it

themselves.

Spot checks/periodic testing - Three companies also referred specifically to carrying out

testing, one commenting that testing is carried out periodically in order to ensure compliance

with restrictions, while another referred to the use of testing (nickel, AZO free, etc) both

internally and externally, and constant monitoring.

Testing of imports – One company stated that goods are also tested prior to shipping, and their

own customers check the products again upon arrival in Europe.

Testing according to product type - Another company explained that its approach to testing

differs according to whether the products are textile or non-textile products. For non-textile

products they require 100% of products to be tested before accepting the product from the

supplier. For textiles, a lot of testing is carried out on products that are randomly selected, but

not all products are tested like in the case of non-textile products. In each case, the testing is

carried out on the product material before the supplier can ship the material and the results of

testing are provided by the supplier. In addition, now and again, the company carries out

random testing on the product once it reaches them and check whether this produces the same

results as those provided by the supplier.

Market Surveillance

Retailers - When asked whether their company had been subject to market surveillance (such

as on-site inspections, documentary checks etc.) carried out by the national competent

authorities to control compliance with restrictions, three of the six retailers indicated that they

had been subject to some sort of checks. Of the three retailers that indicated that checks were

carried out, generally these involve the authorities taking product samples are taken from the

market, which are then analysed in a laboratory. Where these show no evidence of the

relevant chemicals, the company will receive a message confirming this. However, where the

samples test positive, the retailer or their supplier is required to follow-up on this. In such

cases, further action is carried out in consultation with the authorities, such as a ban on sales,

returns to suppliers, or product recall. The remaining three retailers had not been subject to

any market surveillance, although one indicated that they did get checked on occasion for

other issues such as pull tests on children’s clothing, though this was not related to the

restrictions under REACH.

Companies - Based on the responses received from companies, most companies stated that

they have never had a site inspection or other checks by the national authorities in relation to



restrictions. Only one company referred to annual checks carried out by government

authorities, especially in relation to toys. However, a number of factors such as notification

of non-compliance by the company or its past record of compliance also determines the

likelihood and frequency of inspections carried out.

1) Notification of authorities in cases of non-compliance - One company commented that

as soon as they have an issue they contact the authorities, and therefore for this reason

the authorities know that they will be alerted regarding any non-compliance and

therefore do not carry out site visits/spot checks. For example, in one case an article

was notified by them to the authorities, following which the company had discussions

with the authorities, who agreed with their approach and follow-up actions, which

included destroying the article and providing the authorities with proof of destruction.

Recall was not required since there were only low levels of stock, which could be

replaced. Following this, two other Member States required notices to be placed in

shops asking for recall.

2) Inspections based on company compliance - Another company stated that the national

authorities check items by grouping retailers into 3 separate groups (high, middle and

low). Currently the company is in the middle group, which means that annual checks

are carried out on their products by the authorities. The authorities go round and take

samples from groups of products, such as wood products or plastic products, and then

test these samples. However, the company is currently working on being moved into

the highest group, for which no testing is required, since there have been no failures in

compliance found by the authorities.

Finally, two NGO’s also commented in relation to market surveillance activities carried out

by Member States. One NGO was aware of the authorities in one Member State having tested

approximately 1400 samples for substances like the phthalate DEHP during 2010, in order to

check compliance with REACH, though was not aware of the results. However, it stated that

the authorities have relatively limited means of action due to budget constraints. The other

NGO commented that while REACH has numerous entries for certain substances, for

example in relation to phthalates, which means that these requirements are checked, when you

take into account the low number of controls carried out, given the overall number of

restrictions, it is unlikely that the restrictions are properly enforced. As a result, substances

are often found in consumer products when testing them, which are supposed to be banned in

consumer products.

Non-compliance

A number of instances of non-compliance were noted in the responses received from retailers

and companies:

- One retailer indicated that they were aware of products which were not compliant with

the restrictions, having discovered one instance of non-compliance in the past, as a

result of which they returned the product to the supplier. The product was not recalled

though since it was produced in 2005 and the retailer only had a few items left in their

stores.

- Another company stated that it was aware of non-compliant products placed on the

market, most of which were imported products.



While not related to a specific instance of where a product has been found to be non-

compliant with the restriction, four of the retailers set out the steps that they would take and

procedure they have in place, should a product be found to be non-compliant with the

restriction. These covered the following actions:

- One retailer requires immediate disposal by the supplier.

- Two retailers stated that non-compliant products would be immediately withdrawn

from sale and a ban on sales is announced.

- Another retailer explained that following any product recall, there would then be

dialogue between the supplier and a series of tests would be carried out in order to see

if the issue remained, prior to selling any further of these products. If the issue could

not be resolved, an alternative supplier would be sought.

Finally, as indicated above, one retailer uses Restricted Substances Standards, as a result of

which they are aware of the vast majority of non-compliant products through testing carried

out pre-production, in accordance with these standards. Unless they have RSS test approval,

products cannot proceed to the production stage, and therefore if non-compliant components

are found, the supplier must resource alternative components. To back this up, the retailer

also has in place a monthly audit procedure, which randomly tests products again their RSS

standards, which they issue to suppliers. Products are taken from the warehouse, pre-sale, in

order that if any non-compliance is found, the product is rejected and does not go on sale.

3.4 Analytical methods used and costs relating to testing

An Inventory of Analytical Methods for entries in Annex XVII of the REACH Regulation

used by the National Enforcement Authorities in the Member States (version May 2010) was

provided by the FORUM. This has been updated to reflect the information provided by

Member State authorities regarding the standards and test methods used specifically for the 10

restrictions covered by this study. An update table covering the 10 restrictions is provided in

Annex 7. This also included details of the costs of testing and comments regarding the

availability and suitability of the test methods and whether or not the costs are reasonable or

constitute a limiting factor when considering enforcement measures. This information is

summarised in Table 3.2 below.



Table 3.2 Inventory of analytical methods

Restriction

entry Additional

test methods

identified

Availability/suitability Most common

costs range

(full range)

Is the cost of analysis

reasonable or a limiting factor?

6

(Asbestos)

Yes

(see Annex

7)

Methods are available

and suitable.

Ranged from €80-

€100.

(€10-€600)

All respondents stated that the

costs were reasonable and not a

limiting factor.

18a

(Mercury)

Yes

(see Annex

7)

Generally available and

suitable.

Ranged from €9 -

€235 per sample.



limiting factor.

27

(Nickel)

Yes

(see Annex

7)

Available and suitable

even in small

laboratories.

Ranged from €10

- €235 per

sample.



limiting factor.

31

(Creosote)

No No comment received Ranged from €25

- €265.



limiting factor.

46

(Nonylphe

nol)

No Generally available and

suitable, though one MS

commented that there is

limited availability.

Ranged from €45-

€265.


costs were reasonable.

47

(Chromiu

m)

Yes

(see Annex

7)

One Member State

commented that the tests

were laborious.

Ranged from €11

- €235 per

sample.

Most respondents stated that the

costs were reasonable. One MS

was of the view that costs are a

limiting factor.

48

(Toluene)

No Generally available and

suitable although one

MS commented that

there is no standard

method available.

Ranged from €10

- €265.

Costs are reasonable All

respondents stated that the costs

were reasonable.

49

(Trichloro

benzene)

Yes

(see Annex

7)


suitable.

Range from €25 -

€296.

Costs are reasonable Only one

MS commented here, stating that

costs are reasonable and not a

limiting factor.

50 (PAH) Yes

(see Annex

7)

Lack of accredited

laboratories and limited

availability of test

method.

Up to €3,500 for

tyre analysis

using ISO21461 if

transport

included.

The costs are excessive in

comparison to the resources

available. The high cost of testing

is the biggest limiting factor for

the enforcement of this restriction.

51+52

(Phthalates

)

Yes

(see Annex

7)


suitable.

Ranged from €70-

€286.

Costs are reasonable, The

majority of respondents felt that

the costs were reasonable and

not a limiting factor.

2 MS’s however commented

that the costs are excessive in

comparison to the resources

available and are a limiting

factor.



It should be noted that the above comments regarding availability and suitability are based on

the responses of those Member States who provided details of the test methods used, i.e. those

that use the analytical methods available. At least one third of Member States did not

complete the table, in most cases due to the fact that laboratory analysis of restricted

substances is not carried out since facilities are not available and/or budgetary resources are

limited.

For those Member States that do have access to laboratory resources however, it can be seen

that in most cases there are available analytical methods and the costs of testing using these

are regarded as reasonable and suitable. The clear exception to this is the use of the test

methods specified for Entry 50, the costs of which are regarded as being a limiting factor in

the enforcement of this restriction. This is discussed at Section 2.11 above, which covers

Entry 50.

3.5 Resources

Very little information was obtained regarding the level of resources received by enforcement

authorities for the implementation and enforcement of restrictions. With the exception of one

Member State, the majority of Member States indicated that resources are not allocated

specifically for restrictions and therefore that details of the level of resources could not be

provided since these relate to REACH generally.

For the majority of Member States therefore, information on the allocation of resources for

the enforcement of REACH generally was provided. However, in some cases this related to

the percentage of overall resource, monetary budget or number of staff/inspectors, and

therefore does not aide comparison.

For the Member State that did allocate resources for restrictions, these are allocated for the

enforcement of Annex XVII generally and therefore are not specific to the 10 restrictions

covered by the study. The authority responsible for the enforcement of restrictions in that

Member State however allocated 455 man days in one calendar year in order to enforce

Annex XVII.

Member States were also asked whether there is any qualitative or quantitative evidence that

resources for the enforcement of restrictions are inadequate. Of those that responded, 73%

stated that there was such evidence, while 27% responded that there was not any such

evidence. Generally, a lack of resources is apparent for the following reasons:

- Extent of Annex XVII - Resources are limited given the number of Annex XVII entries

and the increasing volume of chemicals on the market. One Member State referred to

the fact that the annual plan for inspections estimates that there are between 15,000

and 30,000 companies to enforce and therefore more resources are needed. Another

Member State commented that the number of inspections is small compared to the

targets for inspection.

- Financial resources – In one Member State financial resources for implementation

and enforcement have been halved each year since REACH entered into force, making

it difficult to carry out the annual activities plan of the competent authority. Another

Member State commented that there is no specific budget to work on restrictions and

therefore that they are only able to enforce restrictions through checking the SDS and



labels of chemicals containing restricted substances, and therefore the present

resources are not enough.

- Lack of personnel - A recent study in one Member State showed that there was a lack

of personnel as the authority needed a minimum of 9 persons where currently it only

had 4 persons. In another Member State, resources were stated to be inadequate and

the hiring of additional staff was being considered due to the volume of work. In

another Member State, human resources allocated to fulfil the obligations of the

REACH competent authority and to maintain an enforcement system are very limited.

- Costs of testing and the availability of dedicated laboratories for analytical control

and associated costs – One Member State referred to the lack of administrative

resources in particular funds for laboratory research. Another Member State

commented that there were limited resources to take an adequate number of samples

and to enforce the full scope of restrictions.

3.6 Consumer products and professional use

Differences may exist between the market surveillance activities carried out in relation to

consumer products and those carried out in relation to professional and industrial products,

where for example there is an overall restriction in place but professional or industrial use is

permitted by way of derogation from restriction. For example, in the case of creosote, certain

industrial and professional use is permitted by way of derogation.

While more than half the Member States (17 countries) consider that there is no difference,

others have identified differences, the most important of them laying in the authority

responsible for enforcing the restrictions. The differences can be simply linked to the fact that

the competent authorities for consumer products and for professional and industrial products

are distinct. However, differences also depend on the focus of the enforcement activities –

health and safety, retail sale or environment. For example, in one Member State, in terms of

human health, if the restriction relates to worker protection or to trade, the authority

responsible for health and safety would enforce it, whereas retail sale would be enforced by

local authorities. For environmental issues, the relevant environment agency would enforce

the restriction. A similar situation also arose in another Member State where the

environmental inspection exercises supervision over users of the environment, but not

consumers, while the labour inspection supervises employers where the use of professional

and industrial chemicals is involved. The trade inspectorates are responsible only in respect

of consumer wholesale and retail trade.

Two potential issues were identified:

- Enforcement is seen by one Member State as more difficult for products only

permitted for professional and industrial use but which are sold in stores and therefore

available for purchase by the public generally, e.g. products containing CMR

substances.

- The fact that only consumer products can be recalled from the market and not also

industrial products can prove to be a problem. However, in case of industrial

products, the authorities can use administrative sanctions as a means of getting the

company to recall the product from the market.



3.7 Imports

The measures carried out by Member States in order to control imports range from 1) no

specific measures being taken, as market surveillance or specific enforcement campaigns

covered imported products along with other products, 2) informal cooperation with customs

authorities in order to receive information on imports or specific products, 3) testing of

imported products by customs, to 4) specific cooperation agreement in place between customs

and the authorities responsible for the enforcement of REACH.

3.7.1 No specific measures

In 45% of Member States (12 countries), the general measures undertaken in order to enforce

the restrictions are also applicable to imported products with no specific measures other than

these are in place. Restrictions are therefore not specifically controlled at the stage of import.

Of these 12 Member States, four referred to the use of the TARIC system in their response.

Using the TARIC system, it is easy for customs to identify certain products where these relate

to a specific customs code. However, while all of the substances subject to the restrictions

covered by the study are covered by a TARIC code, these do not necessarily relate to the

product or use of the substance covered by the restriction. For example, in the case of Entry

47 (chromium) there are various TARIC codes which cover chromium and various ones

which cover cement, but none that relate specifically to the restriction of chromium in cement.

In the case of Entry 27 (nickel), in most cases the TARIC codes cover the base materials

which shall be used in the manufacture of the products, which are ultimately subject to the

restriction, being articles intended to come into direct and prolonged contact with the skin

such as earrings and other jewellery, rather than the finished product itself. In most cases the

TARIC code covers a range of products, or the materials for their manufacture, making it very

The TARIC system (Integrated Tariff of the European Communities) is a multilingual

database in which are integrated all measures relating to tariff, commercial and

agricultural legislation. In other words, it is an online tariff database, containing the

various rules which apply to the import of specific products into the EU. By integrating

and coding these measures, the TARIC system secures their uniform application by all

Member States and provides all economic operators with a clear and coherent view of all

measures to be undertaken when importing or exporting goods. Moreover, the TARIC

system also enables the collection of EU-wide statistics for the measures concerned. The

transmission of TARIC data through the electronic network ensures a smooth and correct

flow of information to the national administrators of the Member States, who accordingly

transmit and use this data to adjust their national systems for customs clearance and

compliance with TARIC obligations. The main categories of measures which are

included in the TARIC are tariff, agricultural and commercial measures, as well as

measures relating to restrictions of movements and measures for gathering of statistical

data.1 In its operation, the TARIC system uses a 8-digit number for exports outside the

EU or goods moving within the EU, and a 10-digit code for imports from outside the EU,

which builds upon the international harmonized system and the combined nomenclature.

In addition, it also adopts a unique 2-digit TARIC component, but in some cases further

four digits may be incorporated into the code in order to differentiate more accurately

between the products. Once the commodity code is known, this is used to complete the

relevant customs documentation and can be used to check other important information

such as the relevant duty rates and any import or export restrictions. In trade relations

with third countries, the TARIC code must be used in customs and statistical declarations.



difficult to find a particular product. For example, it is not possible to find specific codes for

articles such as toys, and it would be impossible to stop all non-compliant toys at customs.

At the same time, while there are TARIC codes for the finished product, such as jewellery

(for example TARIC Code 7113, which covers articles of jewellery), the conditions attached

to these do not relate to the conditions of restriction under Annex XVII of REACH. Even

where there is a specific TARIC code which is relevant to the product, customs will only

inspect the labeling of these products and check what the safety data sheet says, as the

purpose is not to control compliance with the relevant restriction under REACH. Therefore

while the substances listed below, may be covered by a TARIC code, these are primarily

aimed at setting out the relevant rates of duty that will apply to the product as well as other

conditions of import or export, rather than controlling the particular use of that substance that

is subject to restriction.

Table 3.3 Restrictions and examples of potential corresponding TARIC Chapter/Codes

that may contain articles, mixtures or substances covered by restrictions

Restriction TARIC

Chapter/

Code

TARIC Description Member State

procedures

Entry 6

(Asbestos fibres)

Chapter 25 Salt, sulphur, earths and stone,

plastering materials, lime and

cement.

1 MS requires the

importer to present a

declaration confirming

that imported goods are

not asbestos fibres or that

asbestos fibres have not

been intentionally added

to the goods.

2524 Asbestos

25241000 Crocidolite

25249000 Other (would include amosite,

anthophyllite, actinolite,

tremolite and chrysotile)

Entry 18a

(Mercury)

Chapter 28 Inorganic chemicals, organic or

inorganic compounds of

precious metals, of rare-earth

metals, of radioactive elements

or of isotopes

1 MS is preparing

procedures and

information for inclusion

in the customs tariff,

which shall refer to

thermometers and other

instruments, which

contain mercury.

2805 Alkali or alkaline-earth, metals;

rare-earth metals; scandium and

yttrium, whether or not

intermixed or interalloyed;

mercury.

280540 Mercury

2852 Compounds, inorganic or

organic, or mercury, excluding

amalgams.

Entry 27

(Nickel)

Chapter 75 Nickel and articles thereof 1 MS is preparing

procedures and




articles intended to come

into direct and prolonged

contact with skin, such as

7501 Nickel mattes, nickel oxide

sinters and other intermediate

products of nickel metallurgy

7502 Unwrought nickel

7504 Nickel powder and flakes



7505 Nickel bars, rods, profiles and

wire

earrings, necklaces,

bracelets and wire it rings

and rings ankle, wrist

watch cases, watch straps

and buckles, press studs,

buckles, rivets, zippers

and metal parts are used

in garments containing

nickel.

7506 Nickel plates, sheets, strip and

foil

7507 Nickel tubes, pipes and tube or

pipe fittings (for example

couplings, elbows, sleeves)

7508 Other articles of nickel

Entry 31

(Creosote)

Chapter 27 Mineral fuels, mineral oils and

products of their distillation;

bituminous substances; mineral

waxes

2707 Oils and other products of the

distillation of high temperature

coal tar; similar products in

which the weight of the

aromatic constituents exceeds

that of the non-aromatic

constituents

27079100 Creosote oils

Chapter 38 Miscellaneous chemical

products

38070010 Wood tar; wood tar oils; wood

creosote; wood naphtha;

vegetable pitch; brewers' pitch

and similar preparations based

on rosin, resin acids or on

vegetable pitch

Chapter 44 Wood and articles of wood;

wood charcoal

4403 Wood in the rough, whether or

not stripped of bark or sapwood,

or roughly squared

44031000 Treated with paint, stains,

creosote or other preservatives

Entry 46

(Nonylphenol)

Chapter 29 Organic Chemicals

III. Phenols, phenol-alcohols,

and their halogenated,

sulphonated, nitrated or

nitrosated derivatives

2907 Phenols, phenol-alcohols

29071300 Octylphenol, nonylphenol and

their isomers; salts thereof

Entry 47

(Chromium)

No data 1 MS is preparing

procedures and






mixtures containing

cement and cement,

which may contain

compounds of chromium

VI.

Entry 48

(Toluene)

2902 Cyclic hydrocarbons 1 MS is preparing

procedures and




adhesives and spray

paints intended for the

general public that

contain toluene.

29023000 Toluene

Entry 49

(Trichlorobenzene)

2903 Halogenated derivates of

hydrocarbons

29039990 Other

Entry 50

(PAH)

2902 Cyclic hydrocarbons Importer must present a

statement confirming that

the weight of the levels of

BAP or the Σ8 indicated

PAH, used in the

manufacture of new and

used tyres do not exceed

the values or that the tyres

are not covered by Entry

50.

29029000 Other

Entry 51 & 52

(Phthalates)

2917 Polycarboxylic acids, their

anhydrides, halides, peroxides

and peroxyacids; their

halogenated, sulphonated,

nitrated or nitrosated derivates

29173200 Dioctyl orthophthalates

29173400 Other esters of orthophthalic

acid

It has been suggested by one Member State therefore that attempts should be made to

streamline the customs system with the restrictions under REACH in order to check imported

products before they go on the market. For example, there was an issue with asbestos in sky

lanterns which are used at New Year, yet are imported during Autumn. As testing currently

takes 1 to 2 months, these were only recalled in March, by which time they would already all

have been sold and used. As the procedure is too slow, the focus needs to be on suppliers and

stopping products before they are placed on the market, in this case at the stage of import.

While it is unlikely that a complete streamlining of the customs TARIC codes and the

requirements of specific restrictions could be achieved, there may be measures that go at least

some way towards ensuring that the requirements of REACH restrictions are checked at the

stage of import.



For example, as set out in the fourth column of Table 3.3 above, in one Member State

information identifying the procedure for the importation of asbestos fibres and tyres with

PAH has been incorporated into the customs tariff:

1) In order to enable Customs to control the import ban of asbestos fibres and articles

containing these fibres which are added intentionally, the importer must present, along with

the import customs declaration, a declaration of the exporter/producer confirming that the

imported goods are not asbestos fibres or that has not been asbestos fibres intentionally added

to those goods. A separate document must also be filled in, in which a code from the

Declaration of the Exporter/Producer that there were no intentionally added asbestos fibres in

the goods, and that those goods are not forbidden asbestos fibres, has to be declared.

2) Regarding PAH in tyres, a statement by the importer of new and used tyres and treads for

retreading (based on written confirmation from the manufacturer and/or the respective

analysis report), that the weight of the levels of benzo[a]pyrene or the Σ8 indicated PAH, used

in their manufacture do not exceed the values established in Entry 50 of Annex XVII of

REACH has to be provided or alternatively a statement that the tyres are not covered by Entry

50, either because chemical alternatives to PAH have been used in the process of manufacture

or refurbishment, or because the tyres were manufactured before 1 January 2010.

3) Other specific procedures and information dealing with Entries 18a, 27, 47 and 48 are

currently being prepared for inclusion in the customs tariff, which shall refer to:

a) temperature measuring instruments (thermometers) and other instruments such as

manometers, barometers and sphygmomanometers (for measuring blood pressure), which

contain mercury;

b) Articles intended to come into direct and prolonged contact with skin, such as earrings,

necklaces, bracelets and wire it rings and rings ankle, wrist watch cases, watch straps and

buckles, press studs, buckles, rivets, zippers and metal parts are used in garments containing

nickel;

c) Mixtures containing cement and cement, which may contain compounds of chromium VI

and

d) Products adhesives and spray paints intended for the general public that sometimes contain

toluene.

3.7.2 Informal cooperation with customs / provision of data

Regarding the second means of controlling imported products, 45% of Member States (12

countries) stated that the authorities responsible for the enforcement of REACH receive

information from customs on imports of specific products on an informal basis as in most

cases there is no formal agreement in place with customs. However, various types of

arrangements exist between customs and the REACH competent authorities, which can be

categorised as follows:

Reactive cooperation - One Member State commented that cooperation with customs occurs

in a reactive manner, as if customs suspect that a product might contain a restricted substance,

they will forward this information to the REACH competent authorities for them to

investigate. As the relevant restriction relates to placing on the market and there is no import



prohibition on such products, customs can only inform the relevant authorities under REACH

of these products.

Provision of information on an informal basis - Another Member State referred to cooperation

taking place between the competent authority for REACH and the national Customs authority

on an informal basis, whereby the customs authority provides information when required

about imports of goods that are within the scope of Annex XVII of REACH. The information

is processed and disseminated to the relevant enforcement authorities in order to enable them

to fulfil their duties under REACH. To date, information has been exchanged with the

customs authorities specifically in relation to Entry 47 (chromium VI in cement) in order to

guarantee that no non-compliant cement is imported into the country. The provision of

information in this manner also occurred in another Member State, where information on

imports had been provided by customs specifically in relation to asbestos fibres, mercury and

creosote.

Use of information from customs database - In other cases, customs informs the REACH

enforcement authorities about products that are coming into the country, based on information

from the customs database. However, as noted above, this is based on TARIC codes and

therefore in most cases is too general.

Cooperation regarding specific products or importers - Another Member State referred to

there being two ways in which they coordinate work with the customs authorities. First, they

can say that they want information on companies that import a certain product, for example

tyres. The REACH Competent Authorities in one country have cooperated with customs in

this manner in order to enforce specific products such as imported necklaces containing

cadmium. In another country, products containing asbestos and consumer products of non-

EU origin, such as adhesives were subject to special attention by customs and there was

cooperation with customs in order to examine certain chemical characteristics of imported

Under Regulation (EC) No.765/2008 setting out the requirements for accreditation and market

surveillance relating to the marketing of products, customs authorities are obliged to monitor

and to carry out appropriate checks of non-Community goods before their release for free

circulation in close co-operation with other authorities and in line with responsibilities

assigned at national level, which concerns the safety of products released for free circulation.

Customs authorities have the competences under Articles 27 & 28 of Regulation (EC)

No.765/2008 to suspend the release of products when there is a suspicion that the products do

not comply with product safety requirements (also concerning their chemical characteristics).

When there are indications during the checks that the goods might not comply with the product

safety requirements in place, Market Surveillance Authorities are given three days to

investigate the products, to decide if they can be released, if they must be detained or if further

investigations or actions are necessary. According to Article 27(3) of Regulation 765/2008,

customs authorities apply measures when, among others, the product displays characteristics

suspected to present a serious risk to health, safety, the environment or any other public

interest. Customs authorities perform their tasks following risk analysis, though, there are also

undertaken reactive measures following specific circumstances raising customs authorities

suspicion as to fulfilling safety requirements by products to be released for free circulation.

Customs measures may involve documentary checks, physical checks and laboratory checks

on the basis of samples of products. In reference to laboratory checks market surveillance

authorities may request samples of the products questioned by customs authorities and perform

laboratory checks.



goods at one airport using XRF analysis. In another Member State, the market surveillance

authorities may request samples of products questioned by custom authorities and perform

laboratory checks, and customs cooperates on aspects concerning product safety.

Second, they can ask for information on a specific company and receive details of all of the

products that that company imports. In some Member States they can also ask customs to

stop a specific product, for example fireworks, and then go and test these. However, one

Member State commented that this second method of cooperation has not been used yet and

therefore at present the extent of cooperation relates to the provision of data by customs,

which can then be used by the REACH Competent Authorities to determine the products they

select for analysis.

Memorandum of Understanding, data exchange agreement or other formal agreement with

customs - In one Member State there is a Memorandum of Understanding (MoU) in place

between customs (imports/exports), the Department of Agriculture (biocide/plant protection

registrations) and the health and safety authority. There is also a MoU between those bodies

with enforcement responsibilities for the enforcement of REACH, biocides, CLP etc.

However, as this does not include customs a specific date exchange agreement was draw up

between customs and the health and safety authority in relation to the restriction on the

placing on the market or use of PAHs in the extender oils of tyres, which enabled the secure

transfer of information from customs to the health and safety authority in relation to imports

of tyres from third countries. This type of agreement will be used in future market

surveillance activities since customs is not designated as an enforcement authority for

REACH. It should be noted however, that under the chemicals legislation in that country, an

officer of customs and excise may detain any chemical being exported or imported for so long

as is reasonably necessary for an inspector to examine it.

Finally, a number of Member States commented that customs is currently not involved in the

overall enforcement of REACH. In one Member State, the only means of control is the

customs declaration which requires the importer to indicate if they have registered the

substance or not. However, greater cooperation between the enforcement Authorities for

REACH and CLP and customs is currently being tested through a specific project on

chromium VI in imported cement.

3.7.3 Testing of imports by customs

Two Member States stated that customs authorities carry out testing of imports. In one

Member State, in the case of relevant restrictions, the sample taking might be focused on

imported products that pose a higher risk, such as Asian products in the case of Entries 51 and

52 (phthalates), Entry 48 (toluene) and Entry 6 (asbestos fibres).

In the other Member State, the customs authorities decide on the extent and frequency of

sampling of imported products without there being in place an official agreement regarding

the relevant provisions of REACH and CLP. Instead there is an unofficial policy, where over

20% of the imported chemical products are targeted by customs, with specific priority given

to toys, adhesive materials, cement products, jewellery and textiles. Sampling includes

representative parts of the whole taking into consideration both the quantity and lot numbers.

These samples are then analysed for compliance with Annex XVII, either on the basis of an

appropriate certificate of analysis from an accredited testing laboratory provided by the

importer as a proof of compliance, or in the majority of cases based on analytical results



obtained from the samples taken by customs. In case of non-compliance, sanctions and

penalties are imposed in accordance with the national legislation.

3.7.4 Cooperation agreement with customs

Five Member States referred to there being a formal cooperation agreement in place with

customs, or plans to introduce such an agreement in the near future. One Member State

already has a cooperation agreement in place between the REACH CA and customs. The

other four Member States had previously cooperated with customs in an informal manner, but

following the success of specific agreements entered into regarding the provision of

information/data from customs on particular products, have recently decided to extend this to

a comprehensive agreement covering cooperation with customs on REACH. The following

examples of cooperation with customs were provided:

- In one Member State, following specific cooperation on chromium VI in imported

cement, there are plans to put in place an official agreement in future which covers

cooperation with customs on REACH and CLP. At the moment a working group is

being set up to see how the procedure would work, with a view to starting the

procedure in January 2012.

- In another Member State, a Memorandum of Cooperation has been in place with

Customs for several years, which includes REACH, but also covers waste, ODS and

some Annex XVII restrictions such as cadmium, where they take a proactive

approach. For other items, information on imports and exports is provided on request.

However, since this approach has worked well for cadmium, the Member State now

plans to extend the proactive approach to other restrictions, rather than their only

being an information exchange when requested.

- In the third Member State, the environmental protection authority and customs are

party to an agreement concerning pesticides, poisons, ODS etc, which requires

customs to alert the environmental protection authority if any of these enter the

country from non-EU countries. However, they are currently in discussions regarding

extending this agreement to cover REACH and market surveillance more generally.

In the meantime, the environmental protection authority is sometimes contacted by

customs regarding products such as toys to see if certain substances are banned or not.

- Finally, the fourth Member State referred to customs having taken specific monitoring

actions in relation to products subject to the restriction under Entries 51 and 52

(phthalates) since there was evidence of these products exceeding the limits set by the

restriction. Based on this, they were planning similar monitoring actions by customs

on other products as well as participation in REACH-EN-FORCE-3, which shall focus

on imports.



3.8 Sanctions and Penalties

Overall, Member States referred to a variety of sanctions that can be applied in cases of non-

compliance with the restrictions under Annex XVII. These included the following measures:

- Measures requiring the economic actor to cease manufacturing, placing on the market

use and/or the export of chemical substances and/or mixtures for a certain period of

time, or making such activities subject to condition;

- Withdrawal of a product from the market where the breach of the restriction is causing

a severe risk for human health and the environment, and subsequent disposal of the

product;

- Recall from consumer or informing consumer of the risks;

- Sales prohibition;

- Take all necessary measures to remedy the damage caused through violation of the

legal obligations, e.g. tracing route of non-compliance through the supply chain;

- Provision of information through press releases, information on websites of competent

authority and RAPEX notifications;

- Enforcement notices requiring specific action, e.g. disposal by a specific method, be

taken in relation to non-compliances;

- Prosecution resulting in a fine and or/ imprisonment

In relation to the second of these measures, withdrawal of the product from the market, one

Member State commented that this has proved to be a very effective measure as it results in

greater losses for a company than through imposing an administrative penalty.

The publication of the details of successful prosecutions has also proven to be very successful

in one Member State, albeit in relation to other legislation at this stage. In that country,

following a successful prosecution or where a formal caution has been issued, a press release

is issued that names the company and provides details of the case and its outcome, and is

published on the authority’s external website. While not related to the enforcement of

restrictions, a press release was issued following a successful prosecution under the POPs

regulations, which was picked up by other publications and resulted in news of the case

spreading quickly throughout the affected industry. This was therefore a very powerful tool

in highlighting the regulations and the authority’s ability to enforce them and it is anticipated

that similar results would be achieved if a case was brought in relation to restrictions under

REACH.

Where the gravity of the infringement justifies it, prosecution may be taken for breach of the

restrictions. These may result in the imposition of a fine and/or imprisonment. The range of

penalties that can be imposed in each Member State is shown in Table 3.4.



Table 3.4 Overview of penalties

Member State Fine

1. Fine of €360 - €19,000

2. Fine of €52 - €120,000 or imprisonment of 8 days -1 year (non-severe violations)

Fine of €160 - €4,000,000 or imprisonment of 8 days – 3 years (severe violation)

3. 2 years imprisonment and/or fine of up to €80,000

4. Fine of up to €195,000

5. Fine. A penalty of up to 2 years imprisonment can be imposed if done deliberately

or by gross negligence.

6. Fine of up to €1,146 (300 fine units) under the Chemicals Act.

Up to 3 years imprisonment under the Penal Code.

7. Fine

8. 2 years imprisonment and a fine of up to €75,000

9. Imprisonment of up to 3 years and/or a fine

10. Fine of €1500 - €15,000

11. Fine of €6,847 - €68,470

12. Imprisonment of up to 3 months or a fine of €40,000 - €150,000

13. Fine of up to €5,000 or imprisonment for up to 12 months, or both, or

Fine of up to €3,000,000 or imprisonment of up to 2 years, or both

14. Fine of €29 - €430 for violation of the chemical substances and mixtures

regulations

Fine of up to €717 for exceeding the permitted amount of dangerous substances in

goods

15 Administrative fines

16. 1 to 3 years imprisonment and a fine of €251 - €50,000

17. €1,164.69 to €11,646.87 or up to 3 years prison, or to both.

18. 6 years imprisonment and a fine of up to €74,000 (where committed intentionally)

1 year imprisonment and a fine of up to €18,500 (where not committed

intentionally)

19. Fine, restriction of liberty or imprisonment of up to 2 years

20. Fine of €2,000 - €20,000 in case of serious offence

Fine of €20,000 - €37,500 in case of very serious offence

21. Fine of €7,100 - €118,000

22. Fine of €2,000 - €60,000

23. Fine €50,001 - €99,500

24. 2 years imprisonment

25. Fine of up to £5,000 or to imprisonment not exceeding 3 months, or both, or

Fine or imprisonment of up to 2 years, or both.

For two Member States no information was provided. From the 25 Member States

represented above, it can be seen that the maximum levels of fine range from €430 to

€4,000,000, while the term of imprisonment that can be imposed can range from a maximum

of 3 months to a maximum of 6 years, showing that differences exist in the penalties that can

be applied. However, please note that in some countries multiple fines are possible.

Only seven Member States referred to cases covering breach of the restrictions. Of these, two

Member States stated that the cases are currently ongoing, and therefore further details could

not be provided at this stage. In another two countries, one of which related to cases

concerning asbestos and toluene, fines have been issued for breach of restrictions but the level

of fine was unknown. For the remaining three Member State in which specific reference was



made to fines having been imposed, one country stated that several companies had received

fines of up to €6,500 per violation, while in the other two countries there had only been a

single case in which fines of €2,000 and €1,500 had been imposed respectively.

3.9 Consistency in application across Member States

Member States were asked whether they were aware of any cases in which their country had

already adopted more stringent requirements or was considering introducing more stringent

national measures in the future, in relation to the 10 restrictions covered by the study. 78% of

Member States (21 countries) confirmed that they were not aware of more stringent

requirements in their country, while two countries did not respond to this question. Only four

countries therefore provided details of where there were more stringent requirements in place.

One Member State referred to having more stringent requirements in place regarding asbestos

fibres, mercury, creosote and phthalates. In certain cases the national legislative measure is

stricter on the basis that it covers more products than the EU restriction or that a stricter limit

is imposed, but in most cases it is due to it having a wider scope to cover more products.

These regulations have been in place for many years prior to the introduction of EU

restrictions, following which the Member State chose to retain in place the stricter restriction.

In certain case the EU legislation has since caught up with the approach adopted under

national legislation, for example in relation to restrictions that apply to toys. In the meantime,

when enforcing restrictions in each case, the national authorities enforce both the national

requirement and the requirement under REACH Annex XVII.

Another Member State has in place a more stringent requirement for Entry 50. It may also

maintain until 1 June 2013 the following restrictions, which relate to creosote oil and wood

treated with creosote under Entry 31:23

- Prohibition of the placing on the market and use of creosote-treated wood for

applications involving contact with surface water or groundwater (irrespective of the

composition of the coal tar distillate).

- Prohibition of the placing on the market for reuse or the reuse of old treated wood in

applications involving contact with surface water or groundwater if it is removed from

the existing place of application (irrespective of the composition of the coal tar

distillate).

- Prohibition of the placing on the second-hand market for reuse of old wood treated

with substances and mixtures which contain: — Benzo[a]pyrene at a concentration of

0,005 % or more by weight, and — Water-extractable phenols at a concentration of 3

% or more by weight

Finally, two Member States referred to having in place stricter requirements regarding

asbestos. These are set out in legislation, which bans “asbestos-containing products”.

In terms of the wording of the legislation therefore, there does not appear to be a large number

of cases in which more stringent national measures have been adopted.

23

These are in accordance with Commission Decisions 1999/832/EC, 2002/59/EC and 2002/884/EC.



3.10 Suggestions for improvement of implementation and enforcement

A number of suggestions for improvement for implementation and enforcement of restrictions

were put forward by Member States, industry, retailers and NGO’s. These focused mainly on

enforcement by national authorities, inspection activities, and testing/detection of substances

subject to restriction as well as a number of other suggestions.

First, it is worth noting that almost all Member States referred to the involvement of the

FORUM and continuing improvements that could be made in the implementation and

enforcement of restrictions through the coordinated actions of the FORUM. It was suggested

that the FORUM can therefore continue to help in a number of ways:

- Through communication and exchange of information from other Member States on

issues related to the implementation and enforcement of restrictions, such as details of

laboratory capacities across all 27 Member States and the use of analytical methods;

- Seeking better implementation and enforcement of restrictions through cooperation

with customs;

- Through the exchange of information specifically regarding how to find and reach

small companies (big companies are generally aware of their responsibilities) in order

to get information to them in order to help them understand the restriction and get the

overall level of knowledge raised;

- By providing guidance and training for the enforcement authorities;

- By promoting exchange programmes of REACH inspectors;

- By ensuring that further joint REACH enforcement projects are carried out; and

- Providing input into the wording of future restrictions and analytical methods

specified therein, in order to ensure that they are enforceable.

In addition, Member States referred to two other areas in which improvements could be made,

as being overall coordination with customs, the provision of guidance and the exchange of

information, in particular regarding the use of test methods. For this it was suggested that a

list of analytical methods (including extraction methods) suitable for enforcement could be

drawn up, which could be updated on a regular basis. One Member State commented that

following this study it would be useful to have an overview of the testing opportunities and

prices for the 10 restrictions in different EU countries. Another Member State commented

that specific test methods should not be made part of the restriction, since this prevents better

test methods being used, and therefore at most the restriction should recommend but not

require specific test methods.

Enforcement by national authorities

Regarding the role of EU and Member State authorities in the enforcement of restrictions, a

number of respondents felt that imports into the EU should be improved/more strictly

controlled. Greater enforcement through the supply chain as well as effective testing and

control by Member State authorities was suggested as being necessary, also in order to raise

awareness among importers/distributors regarding their responsibilities. National authorities

should increase their activities to raise the awareness of the existing restrictions, to control if



companies actually comply with restrictions, and to identify and propose further substances

for restriction. EU wide enforcement campaigns for some problematic entries of Annex XVII

could also raise awareness and improve the compliance of dutyholders.

Inspection activities

Several companies made suggestions regarding inspections, suggesting that there should be

more training arranged for national inspectorates about what they have to check and how this

should be done in order that both companies and inspectors are fully informed of the

requirements of REACH, especially regarding exemptions and restrictions.

As it is impossible to cover all aspects of REACH within enforcement, it was suggested that

during the first years, enforcement should focus on the basic and main principles of REACH

(health and safety, safe work, registration, communication) and set yearly objectives, one of

which should cover high risk substances and restrictions, since these are directly related to

health and safety.

Testing/detection of substances

In respect of the testing of products, one retailer suggested that the laboratories that detect

substances in articles for consumers should be obliged to notify. Where laboratories detect a

non-compliance in a sample sent for testing by a company, they should be required to notify

the authorities of this in order that the issue is followed up. However, consideration would

have to be given to what information is provided and when, as usually when a non-

compliance is detected in a sample, the company itself will ensure that the product is not

placed on the market or will otherwise deal with the issue, therefore it is important not to

compromise the relationship between industry and the authorities, particularly in the case of

those companies that do contact the authorities as soon as they detect an issue. Such a

notification obligation however, should not extend to making this information publicly

available. In most cases where an issue is detected, this will be resolved prior to placing a

product on the market. If information of this type was made available to the public however,

it may look like the company has not dealt with an issue and that there is a problem with a

product where there is not.

On similar lines, another retailer referred to the screening programmes used by laboratories,

suggesting that this information should be made publicly available. Laboratories generally

have a screening programme, by which they can pick out substances that are found in

particular products and let retailers know what substances they are looking for in the first

place in order to focus on what substances they need to test for. It was therefore suggested

that in order to improve knowledge/awareness, there should be some sort of system of making

this screening information received from laboratories, available to everyone.

A database / summary of products tested against failures found along with the % of failures

found against products tested would be useful. Any specific details of which substrates

contained the restricted substance would be very useful i.e phthalates in PVC, rubber, PU etc

plus the country of origin of the failed components, not just where the failure was found. This

would help focus testing on high risk areas.



Incentives to secure compliance

Several respondents referred to the use of incentives in order to secure compliance with

restrictions. One NGO stated that a key measure for improvement would be to dedicate

appropriate human and financial resources to ensure that the majority of products placed on

the European market are safe and do respect REACH restriction provisions. It was therefore

suggested that incentives should be provided to manufacturers who choose safer alternatives

and thereby protect the consumer should be implemented in order to encourage rapidly the

emergence of a new market. Another NGO stated that a reward system for identifying non-

compliance is also a useful tool.

Another tool that was recommended, similar to the incentive approach, was to utilise an

enforcement department that would be financed directly via the polluter pays principle based

on non-compliance, i.e. the enforcement department would be funded directly from the money

received in payment of fines by those who do not comply with REACH. This would entail no

new or additional funding requirements. As the entries on the Annexes of bans and

restrictions grow there would be more need for such a system to monitor the compliance.

Other comments

A number of companies generally requested clarity or simplification, stating that the

regulations are really not clear, guidance and monitoring, querying whether checks were

carried out.

The remaining companies made the following suggestions:

1. REACH compliance certificates should accompany all product shipments;

2. It could be useful to mark “specific restriction” on the label of the package containing

the dangerous substance, when it is placed on the market;

3. Define subjective terms like “direct and prolonged skin contact”;

4. Develop guidance on the restrictions, for example providing information on sampling

and testing techniques, and collate in one place, where it is publically available; and

5. The introduction of a self audit tool that had been endorsed by the authorities would be

useful.



4 Communication and cooperation

This section of the report considers the level of cooperation within Member States and

between Member States on the implementation and enforcement of restrictions, and whether

products posing a serious risk are notified by the authorities under the Community Rapid

Information System for non-food dangerous products (known as “RAPEX”), as required

under Regulation 765/2008/EC. This is done through making an analysis of the notifications

under RAPEX concerning products containing substances subject to the 10 selected

restrictions.

4.1 Cooperation within Member States

Information was sought on the extent of communication and cooperation that exists between

each of the authorities within a Member State, particularly where there is no central

enforcement authority. 55% of Member States referred to cooperation carried out internally

within their Member State, though in some cases further information is also provided

specifically in relation to cooperation with customs authorities in the section on imports above

(see Section 3.7). The country fiches provided at Annex 2 also provide information on the

cooperation carried out between the specific national authorities in each case.

Examples of the various means of cooperation referred to include where:

Cooperation is carried out at the national level through bi-annual high level meetings.

Cooperation is carried out through the involvement of working groups or other

cooperation groups (for example in one Member State this was called the national

Inter-institutional Coordination Group, while in another they have in place a national

Cooperation Forum on chemicals) that meet regularly to discuss enforcement as well

as to inform each of the authorities of FORUM activities. In one case, a Member State

has in place a specific market surveillance forum where national authorities and bodies

with responsibility for different aspects of market surveillance (including REACH

restrictions) meet and exchange information on an ongoing basis.

Means of cooperation is specified in the national chemicals legislation, which sets out

the duties of all of the enforcement authorities and how they should cooperate, as well

as how they should take part in FORUM activities. In some cases, this also specifies

that annual reports on the performance of their functions must be prepared by each

authority.

Formal cooperation agreements are drawn up between the national authorities in

which it is agreed to exchange information between authorities on specific products or

substances subject to restriction.

Informal exchange of surveillance and enforcement information takes place on a need

to know basis between regional, national and international enforcement agencies.

Common training of personnel is carried out within the various enforcement

authorities.



The member of the FORUM and the relevant person within each of the national

authorities coordinate cooperation, supported by the overall CA for REACH.

Efforts are made to ensure good coordination between the enforcement projects on

specific enforcement programmes. Where the duties of the different enforcement

authorities overlap, one will be assigned the lead role for the specific campaign by

mutual agreement.

Cooperation is carried out with customs regarding specific controls on imported

products on the basis of specific agreements entered into with customs. In some cases

a more general agreement is in place with customs, or is in the process of being setting

up, which covers REACH (see further Section 3.7).

Federal states in one Member State communicate with each other using ICSMS, unless

a RAPEX notification is required, allowing information exchange to take place

quickly and with minimum disruption. Those that don’t use the ICSMS system are

informed in writing, though this process is correspondingly slow.

From the various means of cooperation listed by Member States, certain procedures in place

stand out as examples of good practice.

In one Member State, the competent controlling authorities and other authorities may address requests

to each other, and transfer cases to other authorities within the country if further action is needed.

There is also a central management authority in place, which holds regular consultations and

briefings for the country based chief medical officers and organises training together with the

authorities dealing with REACH for inspectors. These occasions also provide an opportunity for

personnel across the country to discuss potential problems in enforcement.

In another Member State, there is a number of Memorandums of Understanding (MoU) in place,

which are three-way agreements between customs (imports/exports), the Department of Agriculture

(biocide/plant protection registrations) and the health and safety authority. There is also a specific

Memorandum of Understanding between those bodies with enforcement responsibilities under the

national chemicals legislation for the enforcement of REACH, biocides, CLP etc. While such an

agreement does not include customs since they do not have enforcement responsibilities under the

national chemicals legislation, a data sharing/exchange agreement between the authorities and customs

for the purposes of REACH, and more specifically for the exchange of data in relation to specific

campaigns, exists alongside the overall Memorandum of Understanding.

Finally, in a third Member State, the REACH CA organises and runs an Enforcement Liaison Group

(ELG), a body set up with the remit to coordinate enforcement activity across the Member State. The

ELG meets bi-annually to discuss enforcement issues and activities of all of the national authorities,

such as campaign launches and co-operation is sought as necessary both for research, targeting and

follow-up purposes. Information, guidance and intelligence are frequently shared. The ELG also has a

dedicated email account from which it can provide advice and assistance to the other enforcement

authorities. There is also a Memorandum of Understanding in place between the national authorities to

ensure co-operation and agreement in carrying out enforcement activities. Communication with other

Member States is made through the forum of the ELG.



4.2 Cooperation between Member States

Member States were asked to outline the extent of communication and cooperation they have

with other Member States specifically on the issue of implementation and enforcement of the

10 restrictions covered by the study and to what extent the cooperation between Member

States, as required under the Market Surveillance Regulation, assists in the enforcement of

restrictions under Annex XVII of REACH, in particular those covered by this study.

Of the 27 Member States, 11% (3 countries) did not provide any information in response to

this question. 33% (nine) of Member States referred to exchange of information through the

use of the RAPEX system, and 30% (eight) Member States referred to the involvement of the

FORUM. The remaining 26% (seven) of Member States as well as a number of those which

had referred to the use of the RAPEX system or the involvement of the FORUM, referred to a

number of other means of cooperation or specific measures taken in order to enforce

restrictions under Annex XVII of REACH. The following means of cooperation between

Member States were referred to:

- RAPEX notifications - One Member State commented that the exchange of

information through the RAPEX system is the most commonly used method of

cooperation. In order to highlight this means of cooperation, one Member State cited

an example of a recent case in which the market surveillance authority for that country

notified a case of a toy containing phthalates, using the RAPEX system, and the

actions taken following this of withdrawal of the toy from the market, recall and

destruction. The system is explained in greater detail in Section 4.3 below.

- Involvement of the FORUM - A number of Member States also referred to the

involvement of the FORUM in the enforcement of restrictions. In two cases this was

cited as the only means of cooperation between Member States, one Member State

commenting that national inspectors report any discrepancies encountered during the

inspection activities to the national member of the FORUM, who then contacts the

other members of the FORUM by email and pursues the matter as necessary with the

appropriate FORUM representative of another Member State. In another Member

State the involvement of the FORUM was referred to as the main means of

cooperation, leaving little need for any other form of cooperation under the Market

Surveillance Regulation. One Member State commented that the FORUM had been

used to raise specific issues concerning products with the other Members of the

Article 24(1) of the Market Surveillance Regulation requires that Member States shall ensure efficient

cooperation and exchange of information between their market surveillance authorities and those of the

other Member States and between their own authorities and the Commission and the relevant Community

agencies regarding their market surveillance programmes and all issues relating to products presenting

risks. Article 24(2) further specifies that the market surveillance authorities of one Member State shall

give the market surveillance authorities of other Member States assistance on an adequate scale by

supplying information or documentation, by carrying out appropriate investigations or any other

appropriate measure and by participating in investigations initiated in other Member States, while Article

25 makes provision for the setting up by the Commission or Member States of market surveillance

initiatives designed to share resources and expertise between the competent authorities of the Member

States.



FORUM. Another Member State stated that communication with other Member

States on specific cases is mainly done by e-mail, phone or personal meetings, with

representatives from the national enforcing authorities for REACH meeting regularly

in order to coordinate and exchange information on specific enforcement cases and

develop principles and strategies for better co-operation between authorities.

- FORUM common enforcement projects - Another Member State referred specifically

to the FORUM common enforcement project on Entry 50 regarding PAH in tyres.

Information provided by one Member State in relation to research already completed

as part of this project proved to be an invaluable resource for market surveillance work

carried out in other Member States as the lead Member State kept participating

Member States well informed of lessons learned in the process of gathering

information, to ensure that all member states would benefit from the experience

gained. That Member State shared information about the tyres tested and the findings

which assisted other member states in selecting targets for enforcement without

duplicating effort or resources. Regular updates and progress reports were exchanged

throughout 2010 and 2011. A number of issues arose for the authorities in the lead

Member State with regard to this campaign which were highlighted to other Member

States in order to help them avoid the same issues with suggested ways of addressing

them (see Section 2.9).

- Cooperation using EIES and ICSMS systems - Two Member States also referred to the

new Electronic Information Exchange System (EIES), which has been developed by

ECHA, which will improve communication between inspectors in each country and

other Member State authorities. One Member State also referred to the exchange of

messages using the internet-supported information and communication system for the

pan-European market surveillance (ICSMS), which is used by market surveillance

authorities in 11 Member States and one non-Member State.

- Exchange of information between Member State authorities - One Member State

commented that in cases of severe incompliance, in addition to channelling

information through RAPEX, information is provided to other Member State

authorities, particularly in cases where the person introducing the product into the

European market is located in another EEA country. Another Member State also

referred to there being an exchange of surveillance and enforcement information on a

need to know basis between regional, national and international enforcement agencies,

and therefore where cases of non-compliance involve companies established in

another Member States, those Member States are notified.

- Cooperation amongst neighbouring countries - A number of Member States also

referred to having close cooperation with neighbouring Member States. For example,

one Member State referred to maintaining close contacts with two Member States

through the use of email, requests sent and exchanges regarding specific questions and

answers, and also with Member States further afield with which specific questions

were raised and advice received. The Member State also made use of the opportunity

to test samples in laboratories in other Member States. Another Member State

referred to having a more than average cooperation with the neighbouring Member

States, with which it is easy to cooperate regarding specific companies. For instance,

even where they find signals which are not serious enough to be notified under

RAPEX, they still provide the relevant information to each other, investigate it further



and provide feedback. Two Nordic countries, also referred to the cooperation carried

out through the Nordic Council of Ministers working group on enforcement, which

meets once a year and carries out joint projects between the Nordic countries.

- Cooperation with ECHA - Reference was also made to the importance of cooperation

with ECHA regarding enforcement issues, with coordinated enforcement projects

being very important. Positive examples cited included cooperation projects under the

REACH-EN-FORCE project, and CLEEN projects, where there was strong

cooperation between Member States. One Member State also referred to have

participated in a common enforcement project regarding joint market surveillance of

toys in which they received funding for screening testing devices in order to analyse

the metal elements in toys.

- Cooperation between other national authorities - Enforcement authorities with a

specific remit, for example labour inspectorates, also work with labour inspectorates in

other countries, in particular with regard to the exchange of experience of supervision

of the implementation of REACH. In some cases experience is shared though the

participated of employees on training programmes and also through the exchange of

national officials. Another Member State stated that it was very active with contacts

in all of the Member States, especially the smaller ones, through which they

exchanged details of individual experience of enforcement. This flow of information

will naturally improve once more experience is gained amongst the Member States.

4.3 RAPEX notifications

4.3.1 Background to the RAPEX system

The Community Rapid Information System for non-food dangerous products (known as

“RAPEX”) was established under Article 12 of the General Product Safety Directive

(Directive 2001/95/EC).

The General Product Safety Directive therefore established rules to ensure the safety of

consumer products. However, in order to achieve a higher level of safety for consumer

products, the market surveillance mechanisms provided for in the General Product Safety

Directive were reinforced as regards products presenting a serious risk, following the

introduction of Regulation (EC) No 765/2008 setting out the requirements for accreditation

and market surveillance relating to the marketing of products (the Market Surveillance

Regulation).

Article 12 requires that where a Member State adopts or decides to adopt, recommend or agree with

producers and distributors, whether on a compulsory or voluntary basis, measures or actions to prevent,

restrict or impose specific conditions on the possible marketing or use, within its own territory, of products

by reason of a serious risk, it shall immediately notify the Commission thereof through RAPEX. If the

notifying Member State considers that the effects of the risk do not or cannot go beyond its territory, it

shall follow the procedure laid down in Article 11.



Following the entry into force of the Market Surveillance Regulation in January 2010, the

scope of the RAPEX system was extended to risks other than those affecting the health and

safety of consumers (i.e. risks to health and safety in the workplace, the environment and

security) and also to some products for professional use. The RAPEX system therefore

covers all dangerous consumer products, with the exception of food, pharmaceutical and

medical devices.

Where such products are found to be dangerous, the competent national authority will take

appropriate action to eliminate the risk, either through withdrawal of the product from the

market, recall of the product from consumers or by issuing warnings. Following this, the

RAPEX system allows for the rapid exchange of information between Member States, as

central National Contact Points notify the European Commission about the product, the risks

it poses to consumers and the measures taken to prevent or restrict the marketing or use of the

product. Both measures ordered by national authorities and measures taken voluntarily by

producers and distributors are covered by the RAPEX system. Thereafter, the European

Commission circulates the information notified to it, to all other National Contact Points, who

have their own authorities check whether the notified product is present on the market or not.

In certain cases therefore, following notification by one National Contact Point, similar

measures (withdrawal, recall or the issue of warnings) will be taken in another Member State.

The European Commission publishes weekly overviews of the RAPEX notifications on its

website, which also contains details of measures taken in other countries. It should be noted

that currently all 27 Member States as well as the EFTA/EEA countries of Iceland,

Liechtenstein and Norway participate in the RAPEX system.

4.3.2 Consultation responses

Companies, industry associations, retailers and NGO’s were asked if they were aware of the

notification system RAPEX and if so, in their opinion, whether this system works well. Of

the 57 respondents, 58% (33) answered that they were aware of RAPEX, 33% (19) answered

that they were not aware of RAPEX, while 9% (5) respondents did not provide any

information. This information is represented in the following figure:

Article 20 of the Market Surveillance Regulation makes provision for products presenting a serious risk,

which states that Member States shall ensure that products which present a serious risk requiring rapid

intervention, including a serious risk the effects of which are not immediate, are recalled, withdrawn or that

their being made available on their market is prohibited, and that the Commission is informed without delay

thereof, in accordance with Article 22.

Article 22 of the Market Surveillance Regulation makes provision for the exchange of information under

RAPEX. Where a Member State takes or intends to take a measure in accordance with Article 20 and

considers that the reasons which prompted the measure or the effects of the measure go beyond its territory,

it shall immediately notify the Commission of that measure, in accordance with paragraph 4 of this Article.

It shall also inform the Commission without delay of the modification or withdrawal of any such measure.

Article 22(2) also requires that if a product presenting a serious risk has been made available on the market,

Member States shall notify the Commission of any voluntary measures taken and communicated by an

economic operator. The information provided in accordance with Article 22(1) and (2) shall include all

available details, in particular the data necessary for the identification of the product, the origin and the

supply chain of the product, the related risk, the nature and the duration of the national measure taken and

any voluntary measures taken by economic operators. Finally, Article 22(4) specifically refers to the use of

the market surveillance and information exchange system provided for in Article 12 of the General Product

Safety Directive.



Figure 1 Overview of RAPEX awareness

Of the respondents that had heard of RAPEX, the majority thought that it worked well.

However, one respondent thought that it did not work well for a number of reasons. There

was limited information available to manufacturers from which they would benefit from

knowing, far too many notifications that do not qualify as having a serious and immediate

risk, a lack of risk assessment by the authorities, and that enforcement authorities can be too

busy following up on inappropriate notifications that they do not get time to perform some

more important duties. Another respondent stated that while the RAPEX system has a

number of values, it has not been formally examined regarding its effectiveness, completeness

and impact on primary prevention of adverse health effects on European citizens.

One respondent thought that the system worked well for those who have knowledge of it and

where the particular product is promoted in the media, such as in the case of phthalates.

However, where it concerns substances unknown to the general public, it is of little use.

Another respondent stated that it worked well despite not being widely known by the general

public, or their main customers.

One industry association commented that RAPEX is an important information exchange tool

when properly and timely used, particular for rapid and targeted communication between

Member States. Any attempt to make it more effective has to be encouraged. The industry

association was therefore of the strong view that the information source can only come from

national authorities in order to retain the credibility and authority of the system. However, it

commented that there is an urgent need to improve awareness of RAPEX and the EU recall

systems outside the EU. This would have a strong effect on the companies importing to the

EU as well as on the countries where the products originate.

Regarding the information available, one company commented that RAPEX is a valid system

for enterprises to check if their range of products contains those that have been found to be

dangerous in an EU Member State. The system helps enterprises avoid procuring dangerous

products and consequently helps avoid the considerable costs arising from product recalls.

Monitoring RAPEX notifications published weekly on the website of the European

Commission is therefore important for companies and operational reliability. Another



company stated that RAPEX is a relevant sources for their monthly Product Surveillance

Review and is a valuable and efficient tool to prevent the public from chemical risks.

Finally, one respondent commented that they would like to receive weekly emails with all

alerts, rather than having to check the RAPEX website.

All six retailers were aware of the RAPEX notification system and provided the following

information:

- Four retailers indicated that they use the RAPEX system to check the products listed,

one of whom commented that the information it contains is usually very helpful, while

another retailer commented that it is very useful to see where the high risk areas are

and to tailor their own checks accordingly.

- One retailer suggested that it would be useful to receive a direct email, in order to see

all of the new products listed, rather than having to look this up on the internet.

- Another retailer suggested that it would be desirable for not only the person placing

the product on the market or the brand to be listed, but also for the origin of the

supplier to be listed. It should be noted that at present the country of origin is

indicated in the information provided via the RAPEX notification, although details of

the supplier are not provided.

With regard to whether national authorities provided companies with information concerning

non-compliant products or products presenting a serious risk, which were found in their

territory, two retailers referred to information available on the Internet from the German

Federal Environment Ministry (BMU), the Federal Association of the German DIY, Building

and Garden Specialist Stores (BHB), where information is provided to it by the authorities,

and the German Federal Institute for Occupational Health and Safety (BAUA) product recalls.

Another retailer received bulletins from the Member State Competent Authority, as and when

cases arise. Each of these retailers also referred to information obtained from the RAPEX

system of notifications.

One NGO commented that itself and its network of partners in the EECCA region (Eastern

Europe, Caucasian and Central Asia) use the RAPEX system extensively in order to raise

awareness of consumers regarding products safety and especially chemicals aspects. Another

NGO commented that it uses RAPEX as the main source of information regarding recall of

products at the EU level, though are not aware whether the products notified under RAPEX

are also notified by the Member State to the Commission.

Finally, one NGO commented that it was aware that Member States are notifying products

under the RAPEX system, citing the recent example of the notifications made by Germany of

Tattoo inks containing high levels of PAH. However, the NGO commented that there is a

need for the authorities to test products much more frequently since product tests undertaken

by independent bodies, such as NGOs or consumer magazines like Ökotest and Stiftung

Warentest, regularly reveal products which contain restricted substances. This suggests that

the notified products form only the tip of the iceberg of a much larger number of products that

do not comply with the legal requirements, as a result of which the NGO commented that

there needs to be much tighter market controls.



4.3.3 Notified products

Before setting out those notification that relate specifically to the restrictions covered by the

study, it is worth noting that the European Commission has published the 2010 Annual Report

on the operation of the rapid alert system for non-food dangerous products on….24

It reports a

13% increase in the total number of measures taken against dangerous products from 1,993 in

2009 to 2,244 in 2010. By way of a breakdown of this figure, 1,963 of these notifications

related to preventative or restrictive measures on products presenting a serious risk to the

health and safety of consumers (notified under Article 12 of the GPSD and Article 22 of the

MSR), 38 notifications related to measures taken by national authorities with regard to

products posing risks classified as less than serious (notified under Article 11 of the GPSD

and Article 23 of the MSR), and 243 notifications were distributed to Member States for

information purposes only, as did not fall within either of the above categories.

The most notified product category in 2010 was clothing, textiles and fashion items, while

injuries, chemical risks and strangulation was the most commonly notified risk. It was also

reported that the number of products of Chinese origin that were notified under RAPEX

remains high, at 58% in 2010, which reflects the market share held by Chinese manufactured

products. Such trends are reflected also in the notifications listed below relating to the

products covered by the 10 restrictions which are the subject of this study.

All RAPEX notifications from 2005 until the beginning of December 201125

have been

reviewed and are summarised below. These are publicly available of the website of the

European Commission and therefore the notifying country and country of origin is referred to

specifically in each case. RAPEX notifications over the last six years for each of the 10

restrictions covered by this study are summarised below, in terms of the total number of

notifications and broken down in terms of notifying country and country of origin, and

according to the general product categories, where there has been a significant number of

notifications.

Entry 46 (Nonylphenol and nonylphenol ethoxylates)

In relation to the restriction on nonylphenol and nonylphenol ethoxylates, two notifications

have been made, both of which were notified by Germany. One product, a bathroom cleaner,

which contained approximately 0.9% of nonylphenol ethoxylate, which originated from

China, while the other was a lime scale remover spray, which originated from Turkey. In

both cases a ban on sales was imposed.

Entry 47 (Chromium VI compounds)

In relation to the restriction on chromium VI compounds, three notifications have been made

relating to cement, originating from Latvia and the Ukraine, where the content of chromium

VI found within the cement was found to exceed 0.0002%. The notifications were made by

Estonia, Lithuania and Hungary. In each case the product was withdrawn from the market.

24

http://ec.europa.eu/consumers/safety/rapex/docs/2010_rapex_report_en.pdf 25

All reports up until Report 48 (02-12-2011) have been reviewed for the purposes of this analysis.

http://ec.europa.eu/consumers/safety/rapex/docs/2010_rapex_report_en.pdf



Entry 6 (Asbestos fibres)

In total 34 notifications were made in relation to the restriction on asbestos fibres, which

restricts the manufacture, placing on the market and use of asbestos fibres and of articles

containing asbestos fibres added intentionally. Of these cases, 25 of the products originated

from China, two from the Czech Republic, one each from Germany, Malaysia, Turkey and the

United States, and six were of unknown origin.

The total number of cases notified per Member State, are represented in the following figure:

0

2

4

6

8

10

12

14

Bulgaria Germany Italy Lithuania Spain UK

Figure 2 Asbestos – total number of cases notified per Member State

The total number of cases notified each year since 2006 are represented in the following

figure:

Figure 3 Asbestos – number of cases notified per year



The country of origin of the notified product is represented in the following figure:

0

5

10

15

20

25

China Czech Republic

Germany Malaysia Turkey United States

Unknown

Figure 4 Asbestos – country of origin of notified product

A summary table of the restriction and the relevant notifications is set out in Annex 3.

Entry 27 (Nickel)

The restriction on nickel prohibits the use of nickel or nickel compounds in articles intended

to come into contact with the skin, such as jewellery and buttons and other items on clothing.

In total, 49 notifications have been made covering nickel, of which 31 of the products

originated from China, four from India, two each from Thailand, Italy, and Turkey, one each

from Taiwan, the Czech Republic, Poland and the United States, and four of unknown origin.


0

2

4

6

8

10

12

14

16

Figure 5 - Nickel – total number of cases notified per Member State




figure:

0

5

10

15

20

25

30

35

Figure 6 Nickel – number of cases notified per year


0

2

4

6

8

10

12

14

16

2006 2007 2008 2009 2010 2011

Figure 7 Nickel – country of origin of notified product




Entry 48 (Toluene)

The use of toluene is restricted in adhesives or spray paints intended for supply to the general

public. In total, 39 notifications have been made covering toluene, of which 15 of the

products originated from China, six from Taiwan, six from the United States, five from

Germany, three from Poland, and one each from France, Italy, Monaco and Sweden.


0

2

4

6

8

10

12

Figure 8 - Toluene – total number of cases notified per Member State


figure:

0

2

4

6

8

10

12

14

16

Figure 9 Toluene – number of cases notified per year




0

2

4

6

8

10

12

14

16

18

2006 2007 2008 2009 2010 2011

Figure 10 Toluene – country of origin of notified product




Phthalates (Entries 51 and 52)

The use of phthalates as substances or mixtures is restricted in toys and childcare articles. In

total 652 notifications have been made concerning the phthalates subject to this restriction. In

terms of country of origin, 551 cases (85%) were notified by non-EU countries, 62 cases (9%)

were notified by EU countries, and 39 cases (6%) were of unknown origin. The notifying

countries, according to the number of cases notified, are represented in the following figure:

Figure 11 - Phthalates – notifying country



The country of origin of the notified product, according to whether it originates from an EU

country, a non-EU country or unknown, is represented in the following figure:

Figure 12 Phthalates – country of origin of notified product




5 Main Findings

As mentioned in the introduction, this study had three main objectives, to obtain information on

the level of implementation and enforcement of restrictions across all 27 Member States, to

generate suggestions on how to improve implementation and enforcement of restrictions, and to

feed into the Commission’s report on the operation of REACH, required under Article 117(4) of

REACH.

This section therefore provides several main findings from the study, while Chapter 6 presents a

number of recommendations suggesting possibilities for improving the implementation and

enforcement of restrictions.

Information gathering

As set out in Section 1.5, the methodology for the study involved a number of steps – a desk-top

study, questionnaire survey and stakeholder identification, follow-up interviews and compilation

of results. Those consulted as part of the study included Member States, industry associations,

companies, retailers and NGO’s.

The receipt of information from the Member States relied heavily on the assistance of the

FORUM members for each country, since all contact with the Member State competent

authorities was channelled via the FORUM member. Responses were received from all Member

States and therefore this aspect of the information gathering process has proven successful. In

some cases, Member States indicated that the information requested was not available, for

example relating to resources allocated to the enforcement of restrictions, or in relation to the

analytical methods, where testing and laboratory analysis was not carried out in that Member

State. However, overall detailed responses were received from Member States, and where there

were gaps in information or further information was required, this was requested during follow-

up interviews.

In terms of the information received from industry associations, companies, retailers/distributors

and NGO’s, 57 responses to the questionnaire were received, comprising 32 from companies, 10

from industry associations, 8 from NGO’s, 6 from retailers/distributors, and 1 from an academic

institution. Where possible, for example in relation to chromium (Entry 47), which is specific to

cement manufacturers, and in relation to PAH (Entry 50), which is specific to tyre

manufacturers, every attempt was made to reach all companies affected by the restriction by

identifying and contacting the main companies across the Member States. However, in relation

to some of the other restrictions, which cover a number of industries, for example, nonylphenol

and nonylphenol ethoxylates (Entry 46), which covers the textiles, cosmetics, paper and pulp

manufacturing and metal working industries, amongst others, the relevant industry bodies were

identified and asked to distribute the questionnaire to their member bodies, who in turn were

asked to distribute the questionnaire to the appropriate national companies. Inevitably, all

relevant stakeholders may not have been reached, and thus there may be information regarding

the implementation and enforcement of the 10 specific restrictions that is not reflected in this



study. However, where gaps in information were identified following receipt of responses to the

questionnaires, attempts were made to fill these during follow-up interviews.

Based on the information received, an overall picture of the implementation and enforcement of

REACH restrictions generally is provided, along with corresponding information specific to the

10 restrictions covered. From this, a number of main findings can be drawn regarding the

implementation and enforcement of restrictions, which relate to resources, market surveillance,

testing and availability of laboratories, exchange of information and cooperation with customs.

These are dealt with in turn below.

Lack of resources requires more prioritisation

As with other areas of legislation, one of the main issues facing the relevant authorities in the

implementation and enforcement of restrictions is a lack of resources. Given the current

economic climate, this is not likely to improve in the near future, and therefore it will be more

important than ever for authorities to set priorities for enforcement action.

The information obtained from the study has shown that the FORUM has played a key role in

helping Member States to set such priorities. Their strategies for enforcement are for the most

part based on the recommendations of the FORUM. Moreover, some Member States have

already carried out targeted campaigns in order to enforce specific restrictions based on RAPEX

alerts or other indications of non-compliance, while others have developed specific prioritization

tools aimed at more effective allocation of enforcement resources. Examples of these included a

pilot chemical market surveillance programme carried out one country in order to select specific

product lines for enforcement, and a computer based prioritization tool used in another country.

The setting of priorities is necessary, as authorities cannot focus on all 60 restrictions. There are

however a number of steps which can be recommended in order for all Member States to achieve

more efficient enforcement of restrictions (see recommendations in Chapter 6).

Market Surveillance, including RAPEX

The study shows that each Member State currently carries out at least some market surveillance

activities, covering the following main actions:

Information campaigns – A number of different information campaigns are used by

Member States to raise awareness of restrictions and assist in enforcement, which include

circulating information on any new restriction at the time of its introduction and on

specific products notified under RAPEX, as well as providing information directly to

companies.

Desktop activities and document checks – Desktop research and documentary checks can

be carried out regarding products or companies as a first step in an enforcement

campaign, in order to identify companies that may be dealing with the products or

substances subject to restriction and any evidence of non-compliance.



Inspections – Inspections are carried out either as part of a particular enforcement

campaign targeting a specific restriction or more generally under REACH, though

focused on restrictions.

Sampling and analysis of market products – Sampling is carried out either as part of a

particular enforcement campaign targeting a specific restriction, more generally under

REACH, though focused on restrictions, or in response to individual cases of non-

compliance found.

The study also shows that most Member States are carrying out at least one, or in some cases

several enforcement campaigns in relation to the 10 selected restrictions, and that majority of

Member States have taken some sort of action, albeit not in all cases an enforcement campaign,

to enforce at least half of the 10 selected restrictions. In addition to information campaigns and

desktop activities, actions other than targeted enforcement campaigns include reactive

enforcement, non-official product checks, and checks on products notified under RAPEX. In

addition, some Member States indicated that future enforcement campaigns are already planned.

However, despite these positive steps, authorities can only seek to enforce a number of these at

any one time, given the number of restrictions in Annex XVII of REACH. The comments above

concerning setting of priorities can help to target and improve market surveillance activities. In

addition, further recommendations specific to market surveillance are made in Chapter 6.

Testing and availability of laboratories

Some Member States have described difficulties in enforcing specific restrictions because of the

lack of in-country facilities and testing equipment for analysis of samples. The option of sending

samples for testing to facilities in other Member States can also be too costly. At least one third

of Member States stated that laboratory analysis of restricted substances is not carried out since

facilities are not available and/or budgetary resources are limited.

For those Member States that do have access to laboratory resources however, it can be

concluded that for the restrictions covered by the study, there are available analytical methods

and the costs of testing using these are regarded as reasonable and suitable. However, even

where access to laboratories is available, there are a number of exceptions to this general

conclusion as issues have arisen in relation to certain restrictions regarding the reliability of the

test method and specifically in relation to the cost of carrying out testing of the PAH content of

finished tyres, using test method ISO 21461. As these issues do not arise in relation to all of

restrictions covered by the study, these are summarised below for each relevant restriction.

Entry 27 (Nickel) – Information received suggests that the nickel release test is

not always reliable or accurate and thus careful consideration should be applied when

interpreting results from analysis made using the nickel release test. Some Member

States noted a reluctance to invest in testing facilities for test methods specified in the

restrictions, where they were of the opinion that the methods had proven to be inaccurate.

One Member State noted that problems with testing can provide an inaccurate picture of

compliance as they initially found lots of violations, which then decreased once more

accurate results were received.



Entry 50 (PAH) – A third of Member States found that the main difficulty in the

implementation and enforcement of this restriction was with the application of the

analytical method specified in the restriction, which refers to the use of ISO 21461 for

testing tyres. This test method was described as too time consuming and expensive for

use in broad market surveillance. As a result, analysis using this test method has only

been carried out by certain Member States. However, analysis is required using this

method in all cases in order to establish the compliance of a tyre with this restriction.

Information received also suggested that the two test methods specified in Entry 50 can

produce conflicting results in some cases, with the extender oil found to be compliant

using IP 346, while the overall tyre can be found not to comply using test method ISO

21461. Finally, the test methods specified in Entry 50 is regarded as unreliable and not in

keeping with current industry standards since there is now a new test method used by

industry. As a result, certain Member States have not carried out further enforcement of

the PAH restriction in tyres, using the specified test methods.

CMR substances (Entries 28 to 30) – Information received suggests that testing

capabilities are a big problem for the restrictions on CMR substances (Entries 28 to 30)

as these are not supported by any specific test method and many laboratories are too

small to test these substances, unless there are a significant number of samples taken. In

addition, the cost of necessary laboratory tests is seen as problematic.

In order to address these issues, a number of recommendations are outlined in Chapter 6.

Exchange of information among enforcement authorities

The exchange of information among authorities on areas such as the supply chain for a certain

substance or product, or the activities of particular target companies is key to improving the

implementation and enforcement of restrictions. While much information is currently exchanged

through the FORUM, there is room for improvement, both amongst the REACH enforcement

authorities and other national authorities.

A number of positive actions are being taken by Member States to improve the exchange of

information among enforcement authorities. Examples include a central management authority,

which holds regular consultations, briefings and organises training together, Memorandums of

Understandings between a number of national authorities and the REACH enforcement

authorities, and a specific Enforcement Liaison Group in place to coordinate enforcement

activity across the Member State.

However, the information received shows that there are still problems which arise regarding the

exchange of information among enforcement authorities both at the national and EU level. One

example provided was the lack of direct access for inspectors to data from the ECHA such as all

of the information contained within REACH registration dossiers or dossiers of companies from

other Member States, which would assist them in verifying company information and substance

information. Other problems identified included the lack of documentation relevant for RAPEX

alerts being available in all national languages, and datasheets for chemical preparations in some

cases being out of date and/or internet websites not being updated, which can lead to delays in

finding relevant information. The declarations of manufacturers presented by the distributors are



often very general, not available in the national language and do not concern the product being

distributed, but instead the products of the manufacturer in general. Inspection campaigns are

often hindered due to lack of information of the market of the supply chain. In particular, there

are problems in obtaining information on the supply chain, which are often very complex, in

order to select those companies that supply products which contain substances subject to

restriction. Finally, regarding specific supply chains, difficulties were also identified in tracing

similar non-compliant products, such as jewellery and clothing, since these products do not

usually bear lot numbers or other characteristics that can differentiate the non-compliant products

tested from others placed on the market.

Exchange of information amongst EU and national authorities has proven extremely important in

the implementation and enforcement of restrictions and therefore a number of recommendations

as to how to further facilitate such exchanges, are made in Chapter 6.

Cooperation with customs

Information received from Member States as well as details of RAPEX notifications show that

the majority of non-compliant products are imported products. The measures carried out by

Member States in order to control imports range from 1) no specific measures being taken, as

market surveillance or specific enforcement campaigns covered imported products along with

other products, 2) informal cooperation with customs authorities in order to receive information

on imports or specific products, 3) testing of imported products by customs, to 4) specific

cooperation agreement in place between customs and the authorities responsible for the

enforcement of REACH.

The degree to which customs authorities are involved in the implementation and enforcement of

restrictions in each Member State therefore varies from country to country. In some Member

States, customs are specifically designated as an enforcement authority under REACH, while in

other countries there is no legislative basis or guidelines available regarding the role of customs

in the implementation and enforcement of restrictions.

Almost half of the Member States stated that the general market surveillance measures

undertaken in order to enforce restrictions are also applicable to imported products with no

specific measures other than these being in place. In many cases therefore, restrictions are not

specifically controlled at the stage of import. However, almost half of all Member States also

stated that the authorities responsible for the enforcement of REACH receive information from

customs on imports of specific products on an informal basis, and in some cases formal

agreements are put in place with customs. Therefore steps are already being taken to improve

communication and cooperation between customs and the REACH Competent Authorities.

A number of Member States referred to the use of the TARIC system for controlling imports.

However, while a number of TARIC codes are relevant to the substances or products covered by

the restrictions, the conditions attached to these do not relate to the conditions of restriction

under Annex XVII of REACH, as the aim is to set out the relevant rates of duty that will apply to

the product as well as other conditions of import or export, rather than controlling the particular

use of that substance that is subject to restriction.



It is clear therefore that further action would ensure greater cooperation with customs. As has

been highlighted in relation to market surveillance overall, action taken higher up the supply

chain can lead to more efficient and effective enforcement action, and therefore it is important to

control the entrance of imported goods to the EU market. A number of recommendations aimed

at increasing the role of customs in the implementation and enforcement of restrictions are

therefore made in Chapter 6.



6 Recommendations

This section summarises the main findings set out in Chapter 5, and provides a number of

recommendations suggesting possibilities for improving the implementation and enforcement of

restrictions.

Lack of resources requires more prioritisation

As with other areas of legislation, one of the main issues facing the relevant authorities at this

stage is a lack of resources. Given the current economic climate, this is not likely to improve in

the near future, and therefore it will be more important than ever for authorities to set priorities

for enforcement action. Member States can take a number of steps towards achieving more

efficient enforcement of restrictions through the following recommended actions:

1. National enforcement authorities should continue to target substances that are selected for

enforcement by the FORUM;

2. Information campaigns should be carried out prior to any enforcement campaign in order

to increase awareness and improve compliance. If carried out at the time of introduction

of a restriction on a specific substances, they have proven to be effective in increasing the

awareness of economic operators and thereby improving dutyholders’ compliance with

restrictions.

3. Desktop/market research should feature heavily in the initial stages of any enforcement

campaign in order to identify target companies and relevant products for further

investigation.

4. It can be useful to invest time in obtaining information on the supply chain of a restricted

substance/article, so that the enforcement action targets the sources, i.e., the

manufacturers and importers as well as distributors in the market place.

5. Some Member States have developed specific prioritization tools in order to better target

enforcement actions. These tools are examples of best practices which could be shared

across all Member States.

In each of the above cases, the recommendation relates to actions that can be taken by the

national enforcement authorities. However, in the case of recommendations 1 and 5, there is also

room for involvement of the FORUM, in selecting further restrictions that are to be prioritised

for enforcement, and in exchanging examples of best practices regarding prioritisation amongst

the Member States.

Market Surveillance, including RAPEX

Each Member State currently carries out at least some market surveillance activities. However,

given the number of restrictions in Annex XVII, authorities can only seek to enforce a number of

these at any one time. Despite significant practical issues which arise in covering all 60

restrictions, certain Member States have shown that market surveillance can be better targeted



and improved. The recommendations above concerning setting of priorities and exchange of

information can help to target and improve market surveillance activities. In addition, the

following recommendations are made specifically in relation market surveillance:

1. The current variety of measures carried out by national enforcement authorities, namely

prioritisation, information campaigns, desktop activities and document checks,

inspections, sampling of market products and analysis, should all be continued.

2. As noted above, desktop/market research during the initial stages of a campaign can help

to target relevant companies and products up front, even before going out to the

marketplace. In some cases non-compliant products can be found using this information

alone, alleviating the need to carry out further, more costly market surveillance activities,

such as testing of products. Desktop/market research should therefore be carried out

during the early stages of an enforcement campaign in order to increase the effectiveness

of a campaign and reduce costs at later stages in the campaign.

3. The RAPEX system whereby notifications are published weekly on the Commission’s

website is recognised as a very valuable source of information by those who use it.

However, a large number of other stakeholders consulted, including companies, industry

associations, and retailers, were not aware of RAPEX. There thus seems considerable

room for awareness campaigns to inform various dutyholders about RAPEX and how to

use its system of notifications.

4. Incentives for complying with REACH restrictions could include reduced controls of

companies with a proven track record of full compliance.

Again, in each of the above cases, the recommendation primarily relates to actions that can be

taken by the national enforcement authorities. However, in the case of recommendation 3, there

is room for involvement of both the Commission at the EU level and industry at both the EU and

the national level, in conducting awareness raising campaigns concerning RAPEX. Such

campaigns could be organised at EU or Member State level, or even by industry associations,

including for distributors and retailers.

Testing and availability of laboratories

Some Member States have described difficulties in enforcing specific restrictions because of a

lack of in-country facilities and testing equipment for analysis of samples. At least one third of

Member States stated that laboratory analysis of restricted substances is not carried out since

facilities are not available and/or budgetary resources are limited. Where access to laboratories is

available, in most cases there are available analytical methods and the costs of testing using these

are regarded as reasonable and suitable. However, there are a number of exceptions to this

general conclusion as issues have arisen in relation to certain restrictions, such as Entries 27, 28

to 30 and 50, regarding the reliability of the test method and the cost of carrying out testing. In

order to assist in addressing these issues, the following recommendations are made:

1. As not all restrictions specify what analytical method is to be used, it would be useful to

draw up an EU list of analytical methods suitable for enforcement for each restriction;



2. It would be useful to draw up an EU-level database of existing laboratory capacities for

testing according to existing standards that covers all 27 Member States. Such a database

could provide details of the costs of testing in each case. This would enable Member

States to have concrete information about possibilities to have laboratory analyses carried

out in other countries and the associated costs. As this should ideally include not only

governmental laboratories, but also individual companies providing laboratory services in

each country, this would require the involvement of industry and laboratory services in

identifying all available resources in each country.

3. A database / summary of products tested and failures found would be useful. Any

specific details of which products contained the restricted substance would be very useful

for both national enforcement authorities and industry. Such a database could include

details of product tested including the country of origin, the substances tested for, and the

failures found, covering products which are not notified under RAPEX. This would

therefore complement RAPEX, though would be based on a voluntary scheme involving

industry, in order that information could be shared to help focus testing on high risk

areas.

4. As was noted in relation to the analytical methods specified under Entry 50 (PAH), the

methods specified in each particular restriction are sometime no longer in use as have

been replaced by newer standards. The recommendation here is to pay particular

attention when Annex XVII is adapted to technical progress, to ensure that the analytical

standard applicable to each restriction reflects current industry practice and the most

recent testing standards developed. This was identified as an issue with Entry 50 (PAH),

though there may be further restrictions, not subject to the study, for which the analytical

methods specified require to be updated.

5. Develop guidance on the restrictions, for example providing information on sampling and

testing techniques, and collate in one place, where it is publically available. It is

understood that guidance will be developed regarding new restrictions. However, it

would be useful for both enforcement authorities and industry to receive guidance on

existing restrictions.

In the cases of recommendations 1, 2 and 3, the recommendation primarily relates to actions that

can be taken by the Commission, though with the assistance of the FORUM, the national

enforcement authorities and also industry in order to obtain the information required in order to

compile such databases. However, ultimately in order for these databases to be maintained at the

EU level, there requires to be coordination at the EU level. Recommendations 3 and 4 would

require to be implemented by the Commission, though again in the case of Recommendation 4,

development of guidance, the involvement of the FORUM would also be useful.

Exchange of information among enforcement authorities

Key to a number of the above recommendations is the exchange of information among

authorities on areas such as the supply chain for a certain substance or product, or the activities

of particular target companies. While a lot of information is currently exchanged through the

FORUM, there is room for improvement, both amongst the REACH enforcement authorities and

other national authorities. Although a number of positive actions are being taken by Member



States to improve the exchange of information among enforcement authorities, problems still

arise regarding the exchange of information among enforcement authorities both at the national

and EU level. A number of recommendations as to how to further facilitate exchange of

information are therefore outlined below:

1. The FORUM could usefully explore how it might further facilitate exchange of

information across Member State enforcement authorities, particularly regarding

experience in the enforcement of specific restrictions and information on how to reach

the market effectively.

2. Other useful ways to share experiences across Member State inspectorates that could be

further investigated for implementation through the FORUM and also ECHA include

organisation of exchange programmes to enable inspectors to build stronger links with

their peers in other Member States, and training workshops for inspectors on a regional

scale to inter alia explore ways to improve cross-border communication and cooperation.

3. Information on implementation and enforcement of restrictions can assist in enforcing

other EU requirements, e.g., on worker health and safety, and vice versa. Structured

exchanges of information between the various national enforcement authorities can

enable the cross-checking of data as well as the identification of potential instances of

non-compliance, and could be usefully introduced or expanded in a number of Member

States. For example, one Member State referred to a specific campaign in which they

involved not only the REACH enforcement authorities and customs, but also waste

inspection colleagues.

4. Several Member States reported difficulties in having access to data held by ECHA, such

as REACH dossiers, which was needed to cross-check companies’ statements. This is a

clear area where ECHA could play an important role in exploring how to improve such

access.

Recommendations 1 and 2 primarily relate to actions that can be taken by the FORUM and also

ECHA, though with the assistance of the national enforcement authorities. Recommendation 3 is

directed towards national enforcement authorities as concerns exchange of information between

different national authorities, not only the REACH Competent Authority. The final

recommendation 4 is primarily addressed to ECHA, though there may also be areas where the

data is held by other EU or national authorities, in which case this recommendation would also

apply to them.

Cooperation with customs

Information received from Member States as well as details of RAPEX notifications show that

the majority of non-compliant products are imported products. The degree to which customs

authorities are involved in the implementation and enforcement of restrictions in each Member

State however varies from country to country. It is clear therefore that further action needs to be

taken in order to ensure greater cooperation with customs in order to improve the implementation

and enforcement of restrictions. As has been highlighted in relation to market surveillance

overall, action taken higher up the supply chain can lead to more efficient and effective

enforcement action, and therefore it is important to control the entrance of imported goods to the



EU market. The following actions, aimed at increasing the role of customs in the

implementation and enforcement of restrictions are therefore recommended:

1. The FORUM should proceed with the REACH EN-FORCE 3 project, which is a

coordinated enforcement project with customs planned for 2012, which will assist in

improving cooperation with customs.

2. Member State REACH enforcement authorities should look to putting in place formal

cooperation agreements with customs regarding REACH, covering also the

implementation and enforcement of restrictions under REACH. Where such agreements

are already in place regarding other areas of regulation such as biocides, these should be

extended to cover REACH in general, and include restrictions under REACH.

3. In addition, Member State REACH enforcement authorities should put in place

agreements with customs to provide data on a regular basis regarding specific

substances/products entering the market or in regard to the market activities of specific

companies. Such agreements could either be put in place for the duration of a specific

campaign on a product subject to restriction, or could concern a particular substance

found in multiple products.

4. The Commission should investigate the possibility of streamlining TARIC codes with

measures under chemicals legislation, in particular the restrictions under REACH, to

assist customs authorities in each of the Member States to identify products to which

restrictions apply, and thus ensure uniform application of restrictions by all Member

States at the point of import.

The first recommendation is directed to the FORUM which is already taking steps in this regard

to implement REACH EN-FORCE 3. Recommendations 2 and 3 relate to actions to be carried

out by national enforcement authorities, though actions identified above relating to exchange of

best practice amongst Member States will assist in this regard, as will the REACH EN-FORCE 3

project. Finally, recommendation 4 is directed at the Commission, who have already indicated

that it is looking into ways in which to overcome differences between customs and chemical

rules.

final report - march 2012

Documents