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1 REACH Registration, Evaluation, Authorisation and Restriction of Chemicals

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Page 1: REACH - ArçelikREACH is a new European Union regulation concerning the Registration, Evaluation, Authorisation and restriction of CHemicals. REACH has several aims: •Protection

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REACH

Registration, Evaluation, Authorisation and Restriction of Chemicals

Page 2: REACH - ArçelikREACH is a new European Union regulation concerning the Registration, Evaluation, Authorisation and restriction of CHemicals. REACH has several aims: •Protection

GENERAL INFORMATION

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Page 3: REACH - ArçelikREACH is a new European Union regulation concerning the Registration, Evaluation, Authorisation and restriction of CHemicals. REACH has several aims: •Protection

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Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) is a

European Union Regulation of 18 December 2006. It came into force on 1st June 2007

and replaces a number of European Directives and Regulations with a single system.

For technical, scientific and administrative management of the Regulation, the

European Chemicals Agency (ECHA), built in Helsinki, was established.

: http://www.echa.europa.eu/

REACH(Registration, Evaluation, Authorisation and Restriction of Chemicals)

Page 4: REACH - ArçelikREACH is a new European Union regulation concerning the Registration, Evaluation, Authorisation and restriction of CHemicals. REACH has several aims: •Protection

REACH(Registration, Evaluation, Authorisation and Restriction of Chemicals)

REACH is a new European Union regulation concerning the Registration, Evaluation,

Authorisation and restriction of CHemicals.

REACH has several aims:

• Protection of human health and the environment from the use of chemicals

• To make the people who place chemicals on the market (manufacturers and importers responsible for understanding and managing the risks associated with their use.)

• To allow the free movement of substances on the EU market.

• To enhance innovation in and the competitiveness of the EU chemicals industry.

• To promote the use of alternative methods for the assessment of the hazardous properties of substances e.g. quantitative structure-activity relationships (QSAR) and read across.

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Page 5: REACH - ArçelikREACH is a new European Union regulation concerning the Registration, Evaluation, Authorisation and restriction of CHemicals. REACH has several aims: •Protection

A major part of REACH is the requirement for manufacturers or importers of

substances to register them with a central European Chemicals Agency (ECHA). A

registration package will be supported by a standard set of data on that substance.

The amount of data required is proportionate to the amount of substance

manufactured or supplied.

If you do not register your substances, then the data on them will not be available

and as a result, you will no longer be able to manufacture or supply them legally,

i.e. no data, no market!

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REACH(Registration, Evaluation, Authorisation and Restriction of Chemicals)

NO DATA NO MARKET!

Page 6: REACH - ArçelikREACH is a new European Union regulation concerning the Registration, Evaluation, Authorisation and restriction of CHemicals. REACH has several aims: •Protection

REACH applies to substances manufactured or imported into the EU in quantities

of 1 tonne per year or more.

Generally, it applies to all individual chemical substances on their own, in

preparations or in articles (if the substance is intended to be released during

normal and reasonably foreseeable conditions of use from an article). 6

SCOPE

Product

Substance

Article

Mixture

Page 7: REACH - ArçelikREACH is a new European Union regulation concerning the Registration, Evaluation, Authorisation and restriction of CHemicals. REACH has several aims: •Protection

REACH OBLIGATIONS

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REGISTRATION

COMMUNICATION IN THE SUPPLY CHAIN

NOTIFICATION

AUTHORIZATION

RESTRICTIONS

Page 8: REACH - ArçelikREACH is a new European Union regulation concerning the Registration, Evaluation, Authorisation and restriction of CHemicals. REACH has several aims: •Protection

REGISTRATION

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Registration is a requirement on industry (manufacturers/importers) to collect and collate specified sets of information on the properties of those substances they manufacture or supply at or above 1 tonne per year. This information is used to perform an assessment of the hazards and risks that a substance may pose and how those risks can be controlled. This information and its assessment is submitted to the European Chemicals Agency in Helsinki.

Substance

Mixture (Substance A, Substance B…)

Article (with intended release substance )

≥ 1 tonne/year Registration

Page 9: REACH - ArçelikREACH is a new European Union regulation concerning the Registration, Evaluation, Authorisation and restriction of CHemicals. REACH has several aims: •Protection

Substances exempted from Registration

Food or feedingstuffs

Medicinal products

Substances included in Annex IV and covered by Annex V of the REACH Regulation

Recycled or recovered substance already registered

Re-imported substance

Polymer

Substances use for purpose of product and process oriented research and development (PPORD)

Active substance for use in biocides

Active substance for use in plant protection products

Notified substances according to Directive 67/548/EEC

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Page 10: REACH - ArçelikREACH is a new European Union regulation concerning the Registration, Evaluation, Authorisation and restriction of CHemicals. REACH has several aims: •Protection

Registration for Non-EU Companies

As a non-EU company , you can not use REACH-IT directly and register by

yourself. You either should:

Register through an EU importer

By your only representative (OR)

Register through an EU subsidiary

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Page 11: REACH - ArçelikREACH is a new European Union regulation concerning the Registration, Evaluation, Authorisation and restriction of CHemicals. REACH has several aims: •Protection

Guidance on Registration

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http://www.echa.europa.eu/A8ED95BE-2F8F-48FD-B6CD-FA39E894F7C8/FinalDownload/DownloadId-80E7EB703818E0AE0736017F38D67F41/A8ED95BE-2F8F-48FD-B6CD-FA39E894F7C8/documents/10162/13632/registration_en.pdf

http://reach.immib.org.tr/web/dokumanlar/Guidance_on_registration-tr.pdf?phpMyAdmin=2p8bZQKjlFaVmOGyAMzUX6coO69

Page 12: REACH - ArçelikREACH is a new European Union regulation concerning the Registration, Evaluation, Authorisation and restriction of CHemicals. REACH has several aims: •Protection

Registration Timeline

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Page 13: REACH - ArçelikREACH is a new European Union regulation concerning the Registration, Evaluation, Authorisation and restriction of CHemicals. REACH has several aims: •Protection

ARTICLE AND REACH

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Page 14: REACH - ArçelikREACH is a new European Union regulation concerning the Registration, Evaluation, Authorisation and restriction of CHemicals. REACH has several aims: •Protection

ARTICLE AND REACH

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Article means an object which during production is given a specific shape, surface or design which determines its function to a greater degree than does its chemical composition. (REACH Regulation Article 3.3)

Plastic products

Electronic products

Home appliances

Automobile

Textile products

Packaging products etc.

Page 15: REACH - ArçelikREACH is a new European Union regulation concerning the Registration, Evaluation, Authorisation and restriction of CHemicals. REACH has several aims: •Protection

• Article • Substance/mixture in a container

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“Article” / “Chemical”

Page 16: REACH - ArçelikREACH is a new European Union regulation concerning the Registration, Evaluation, Authorisation and restriction of CHemicals. REACH has several aims: •Protection

OBLIGATIONS OF ARTICLE PRODUCERS/IMPORTERS

1. Registration of substances that are intended to be

released (Article 7(1))

2. SVHC notification (Article 7(2))

3. Communicate information (Article 33)

4. Authorization List (ANNEX-XIV)

5. Restriction List (ANNEX-XVII)

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Page 17: REACH - ArçelikREACH is a new European Union regulation concerning the Registration, Evaluation, Authorisation and restriction of CHemicals. REACH has several aims: •Protection

INTENDED RELEASE

Article 7(1):

Substance is needed to be registered to ECHA if both of these conditions

are met:

• The substances are intended to be released from the produced or imported article(s) during normal and reasonable foreseeable conditions of use

• The total amount of the substance present in the articles with intended releases produced and/or imported by that actor exceeds 1 tonne per year per producer or importer.

Article 7(6)

• Registration is not required for substances that have already been registered for that use.

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Intended release: Intended releases are deliberately planned and have a specific function for the article, which is frequently not the main but an accessory function of the object. Exp: scented eraser.

Page 18: REACH - ArçelikREACH is a new European Union regulation concerning the Registration, Evaluation, Authorisation and restriction of CHemicals. REACH has several aims: •Protection

SUBSTANCES OF VERY HIGH CONCERN(SVHC)

The criteria are given in article 57 of the REACH Regulation. A substance

may be proposed as an SVHC if it meets one or more of the following

criteria:

it is carcinogenic;

it is mutagenic;

it is toxic for reproduction;

it is persistent, bioaccumulative and toxic according to the criteria set out in Annex XIII to the REACH Regulation(PBT substances);

it is very persistent and very bioaccumulative according to the criteria set out in Annex XIII to the REACH Regulation (vPvB substances);

there is "scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern"; such substances are identified on a case-by-case basis.

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Page 19: REACH - ArçelikREACH is a new European Union regulation concerning the Registration, Evaluation, Authorisation and restriction of CHemicals. REACH has several aims: •Protection

SVHC LIST

First list 20.10.2008 15 substances

13.01.2010 14 substances

30.03.2010 1 substance

18.06.2010 8 substances

15.12.2010 8 substances

20.06.2011 7 substances

19.12.2011 20 substances

June 2012 13 substances*

* Proposed 19

73 SVHC

It is a living list

Page 21: REACH - ArçelikREACH is a new European Union regulation concerning the Registration, Evaluation, Authorisation and restriction of CHemicals. REACH has several aims: •Protection

NOTIFICATION

Article 7(2) :

Any producer or importer of articles shall notify the Agency, if both the

following conditions are met:

• the substance is present in those articles in quantities totalling over one tonne per producer or importer per year;

• the substance is present in those articles above a concentration of 0,1 % weight by weight (w/w).

Article7(6) :

Notification is not required for substances that have already been registered for

that use.

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Page 22: REACH - ArçelikREACH is a new European Union regulation concerning the Registration, Evaluation, Authorisation and restriction of CHemicals. REACH has several aims: •Protection

WHEN?

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Companies will have to notify ECHA of the presence of such a substance in their articles not later than 6 months after the inclusion of such a substance in the Candidate List. For those substances included in the Candidate List by 1 December 2010, the relevant notifications have to be submitted not later than 1 June 2011.

Page 23: REACH - ArçelikREACH is a new European Union regulation concerning the Registration, Evaluation, Authorisation and restriction of CHemicals. REACH has several aims: •Protection

DUTY TO COMMUNICATE INFORMATION ON

SUBSTANCES IN ARTICLES

Article 33

Any supplier of an article containing a SVHC in a concentration above 0,1

% weight by weight (w/w) shall provide the recipient of the article with

sufficient information, available to the supplier, to allow safe use of the

article including, as a minimum, the name of that substance.

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Page 24: REACH - ArçelikREACH is a new European Union regulation concerning the Registration, Evaluation, Authorisation and restriction of CHemicals. REACH has several aims: •Protection

ARÇELİK

Arçelik fulfil this obligation of REACH Regulation with:

• Communicate with suppliers,

• Give informations to the costumer in line with informations of suppliers

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Page 25: REACH - ArçelikREACH is a new European Union regulation concerning the Registration, Evaluation, Authorisation and restriction of CHemicals. REACH has several aims: •Protection

ARÇELİK

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ARÇELİK

BANNED/RESTRICTED SUBTANCES PROCEDURE

GCP-16329

REACH

RoHS

PAH

Other Local Regulations

Page 26: REACH - ArçelikREACH is a new European Union regulation concerning the Registration, Evaluation, Authorisation and restriction of CHemicals. REACH has several aims: •Protection

ARÇELİK’S SVHC INFORMATION REQUEST FORM

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Page 27: REACH - ArçelikREACH is a new European Union regulation concerning the Registration, Evaluation, Authorisation and restriction of CHemicals. REACH has several aims: •Protection

ECHA’S EXAMPLE OF SVHC INFORMATION

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Page 28: REACH - ArçelikREACH is a new European Union regulation concerning the Registration, Evaluation, Authorisation and restriction of CHemicals. REACH has several aims: •Protection

GUIDANCE ON ARTICLES

http://www.echa.europa.eu/A8ED95BE-2F8F-48FD-B6CD-FA39E894F7C8/FinalDownload/DownloadId-11E5D7984513CE7CC01EB1F16CE6DCBD/A8ED95BE-2F8F-48FD-B6CD-FA39E894F7C8/documents/10162/13632/articles_en.pdf

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Page 29: REACH - ArçelikREACH is a new European Union regulation concerning the Registration, Evaluation, Authorisation and restriction of CHemicals. REACH has several aims: •Protection

SINLIST

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www.sinlist.org

Page 30: REACH - ArçelikREACH is a new European Union regulation concerning the Registration, Evaluation, Authorisation and restriction of CHemicals. REACH has several aims: •Protection

Priority

Substances List

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AUTHORIZATION LIST

SVHC List

(Candidate List)

(73 Substances)

Authorization List

(ANNEX-XIV)

First list is

published on

17.02.2011

Second list:

14.02.2012

Page 31: REACH - ArçelikREACH is a new European Union regulation concerning the Registration, Evaluation, Authorisation and restriction of CHemicals. REACH has several aims: •Protection

AUTHORIZATION LIST

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Substance Name EC No. CAS No Dates

Latest Application Date Sunset Date

1 5-tert-butyl-2,4,6-trinitro-m-xylene (Musk xylene)

201-329-4 81-15-2 21.02.2013 21.08.2014

2 4,4’-Diaminodiphenylmethane (MDA) 202-974-4 101-77-4 21.02.2013 21.08.2014

3 Hexabromocyclododecane (HBCDD), alpha-hexabromocyclododecane, beta-hexabromocyclododecane, gamma-hexabromocyclododecane

247-148-4 25637-99-4 21.02.2014 21.08.2015

4 Bis(2-ethylhexyl) phthalate (DEHP) 204-211-0 117-81-7 21.08.2013 21.02.2015

5 Benzyl butyl phthalate (BBP) 201-622-7 85-68-7 21.08.2013 21.02.2015

6 Dibutyl phthalate (DBP) 201-557-4 84-74-2 21.08.2013 21.02.2015

7 Diisobutyl phthalate (DIBP) 201-553-2 84-69-5 21.08.2013 21.02.2015

Page 32: REACH - ArçelikREACH is a new European Union regulation concerning the Registration, Evaluation, Authorisation and restriction of CHemicals. REACH has several aims: •Protection

AUTHORIZATION LIST

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Substance Name EC No. CAS No

Dates

Latest Application Date

Sunset Date

8 Diarsenic trioxide 215-481-4 1327-53-3 21.11.2013 21.05.2015

9 Diarsenic pentaoxide 215-116-9 1303-28-2 21.11.2013 21.05.2015

10 Lead chromate 231-846-0 7758-97-6 21.11.2013 21.05.2015

11 Lead sulfochromate yellow 215-693-7 1344-37-2 21.11.2013 21.05.2015

12 Lead chromate molybdate sulphate red 235-759-9 12656-85-8 21.11.2013 21.05.2015

13 Tris (2-chloroethyl) phosphate (TCEP) 204-118-5 115-96-8 21.02.2014 21.08.2015

14 2,4-Dinitrotoluene (2,4-DNT) 204-450-0 121-14-2 21.02.2014 21.08.2015

Page 33: REACH - ArçelikREACH is a new European Union regulation concerning the Registration, Evaluation, Authorisation and restriction of CHemicals. REACH has several aims: •Protection

RESTRICTION LIST (ANNEX-XVII)

The Restriction List consist of substance names as well as the condition of

restriction. A substance may be limited or banned for a use in an article, so

the article suppliers too need to check the Restriction List which is recently

updated under REACH.

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Page 34: REACH - ArçelikREACH is a new European Union regulation concerning the Registration, Evaluation, Authorisation and restriction of CHemicals. REACH has several aims: •Protection

FOR DETAILED INFORMATION

• http://ec.europa.eu/echa/home_en.html

• http://reach.jrc.it/

• http://ec.europa.eu/enterprise/reach/index_en.htm

• http://ecb.jrc.it/

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Page 35: REACH - ArçelikREACH is a new European Union regulation concerning the Registration, Evaluation, Authorisation and restriction of CHemicals. REACH has several aims: •Protection

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Thank you...