reach - enforceability of new restrictions

Enforceability ofnew restrictions:

tools and challenges

Maria Letizia Polci

DG Health PreventionMinistry of Health

Italy

Outline

• Enforceability of a new restriction

• Challenges for enforcers

• Analytical methods

• Other supporting tools under development

2CIR Day 2 - REACH- 8 Sep 2016, Nice

Enforceability of new restrictions:basic principles

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The practicality of the proposed restriction involves :

• Implementability

• Enforceability

• Manageability

Enforceability:• The enforcement authorities and companies are able

to check the compliance.• The enforcement authorities are able to set up an

efficient supervision mechanism.• The resources needed for the enforcement are

proportional to the avoided risks.

CIR Day 2 - REACH- 8 Sep 2016, Nice

Enforceability of new restrictions:key elements

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•Intention

•Exemptions

•DefinitionsScope

•Sampling method

•ArticlesSampling

Analytical methodavailabilityLimit value

Analysis

•Clarity

•ConsistencyWording

•Items not coveredMiscellaneous


Assessment of restrictions currently in force:

• Broad scope and complex approach required toimplement the restrictions (e.g. PAH in consumerproducts, Lead in consumer products);

• The analytical method to be used for checkingcompliance with the restrictions is seldom includedin the legal text;

• A company’s product assessed by one method canbe assessed differently if another method is used;

• Lack of specific guidelines.

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Challenges for enforcers


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Challenges for enforcers:examples (1)

Restriction on Nickel in jewelry

Official analytical method:

The standards adopted by CEN shall be used as the testmethods for demonstrating the conformity of articles to therestriction.

From 31 March 2013

EN 1811:2011 is the reference test method for release ofnickel from all post assemblies which are inserted into piercedparts of the human body and articles intended to come intodirect and prolonged contact with the skin

Criticalities:• Expanded measurement uncertainty and

compliance assessment• Decision rules and acceptance zones


Assessment of Compliance with an Upper Limit

Restriction on Nickel in jewelry:

handling of the expanded measurement uncertainty anddecision rules


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New restriction on lead and its compounds in articlessupplied to the general public

(Reg (EU) 2015/628 of 22 Apr 2015 amending Annex XVII to REACH)

Recital (11) declaring need for guidelines to clarify the scope ofrestriction

The legal text includes:

• Limit value for content of lead

• Limit value for the release rate

• Exemptions

Criticalities:• No reference to a standard method• No reference to the development of a

standard

CIR Day 2 - REACH- 8 Sep 2016, Nice9

ECHA Forum Compendium of Analytical methods


Background

2009- ECHA Forum compiled a firstinventory of analytical methodsaccepted in EU Member States (hugenumber and wide variety of methods);

2010- ECHA Forum concluded on theneed to produce a guidance forsuitable analytical methods for theenforcement of restrictions.

Recommended to check compliance with REACH Annex XVIIrestrictions

Methodology

• A set of functional qualities have been selected todescribe the performance of an analytical method;

• Performance requirements for the selectedcharacteristics have been proposed according togenerally accepted criteria.



CHARACTERISTICS:Applicability, Limit of detection, Recovery, Reproducibility, Measurement uncertainty

PERFORMANCE REQUIREMENTS


Implementation of the methodology

• Request for information on available analyticalmethods to Member State authorities and ECHAAccredited stakeholders – ASOs;

• Assess the performances of gathered availablemethods according to the proposed requirements(and with slight deviations);

• Selected methods are listed in the 1st

Compendium.


DATA ANALYSIS AND DRAFTING 1st COMPENDIUM

DATA GATHERING


• 1st ECHA Forum Compendiumof Analytical methodspublished (March 2016, ECHAwebsite:

https://echa.europa.eu/documents/10162/13577/compendium_of_analytical_methods_en.pdf)

• ECHA Forum invites interestedparties to submit additionalinformation to be incorporatedin future Compendiumupdates.


https://echa.europa.eu/documents/10162/13577/compendium_of_analytical_methods_en.pdf

Other supporting tools:sampling and analysis

• ECHA Forum to elaborate a guidance document oninterpretation of analysis results;

• ECHA Forum harmonised project REF-4 on restrictions-lesson learnt (available in 2017);

And• Inclusion of standardisation initiatives related to

restrictions on chemicals in the Union Annual WorkProgramme for European standardisation (Regulation EC1025/2012 on European standardisation).


Contributions to harmonised enforcement of restrictions on chemicals


EU CommissionUnion Annual Work Programme 2015

• Chemicals

European Standardisation Organisations to developanalytical methods for determining

• the lead content in consumer articles in differentmatrices,

• the migration of lead compounds from consumerarticles,

• the content of 8 polycyclic-aromatic hydrocarbons-PAHs (BaP, BeP, BaA, CHR, BbFA, BjFA, BkFA, DBAhA) inconsumer articles,

• the migration from consumer articles of the abovesubstances (eight PAHs) under reasonably foreseeableconditions of use,

• Cr (VI) compounds in leather articles.

Other supporting tools:sampling and analysis

Other supporting tools:Q&A and Guidelines


• Interpretations made on restriction entries (Q&As: REACH Restrictions @ http://www.echa.europa.eu/qa-display/-/qadisplay/5s1R/view/reach/restrictions;

• ECHA guideline on the interpretation of the concept«which can be placed in the mouth» as laid down in theentry 52-phthalates in toys and childcare articles;

• ECHA work in progress• Guideline on the scope of Entry 63 - Lead and its

compounds in articles supplied to the general publicthat can be mouthed by children.

• Guideline on Nickel in jewellery

http://www.echa.europa.eu/qa-display/-/qadisplay/5s1R/view/reach/restrictions


Message for Industry

• Follow the substance story @ ECHA web PACT (public activities coordination tool)

• Interact with authorities with regard to regulatory risk management measures

• Participate in the call for evidences

• Participate in the public consultations

• Share experiences with sampling and analysis

Thank you!

Maria Letizia [email protected]

mailto:[email protected]

reach - enforceability of new restrictions

Law