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REACH
Registration, Evaluation, Authorisation and Restriction of Chemicals
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GENERAL INFORMATION
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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)
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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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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!
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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
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REACH OBLIGATIONS
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REGISTRATION
COMMUNICATION IN THE SUPPLY CHAIN
NOTIFICATION
AUTHORIZATION
RESTRICTIONS
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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
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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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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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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
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Registration Timeline
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ARTICLE AND REACH
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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.
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• Article • Substance/mixture in a container
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“Article” / “Chemical”
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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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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.
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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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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
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SVHC LIST
http://echa.europa.eu/web/guest/candidate-list-table
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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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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.
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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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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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ARÇELİK
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ARÇELİK
BANNED/RESTRICTED SUBTANCES PROCEDURE
GCP-16329
REACH
RoHS
PAH
Other Local Regulations
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ARÇELİK’S SVHC INFORMATION REQUEST FORM
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ECHA’S EXAMPLE OF SVHC INFORMATION
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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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SINLIST
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www.sinlist.org
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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
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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
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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
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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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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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Thank you...