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Registration, Evaluation, Authorisation and Restriction

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Presentation on theme: "Registration, Evaluation, Authorisation and Restriction"— Presentation transcript:

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

2 REACH Implementation Timeline
Pre-Registration period Registration deadline for importing/ manufacturing 1,000 tonnes SVHC per year Registration deadline for importing/ manufacturing ,000 tonnes SVHC per year REACH entered into force Registration deadline for importing/manufacturing tonnes SVHC per year 1 June 2007 1 Dec. 2008 30 Nov. 2010 31 May 2013 31 May 2018 1 June 2008

3 REACH and Textile Industry
REACH Regulation requires information on substances contained in/ used in the manufacturing of articles. When supplying/ exporting apparel to EU, the article from REACH point of view would include the product itself and the packaging. The main suppliers to the EU are in Asia (with India and China being one of the major suppliers) Turkey and Switzerland. In case the exporter exports jeans having buttons, buckles, Zips, etc. then each of these parts when placed in EU market will individually be treated as articles within REACH. REACH and Textile Industry

4 What is an article? An object which during production is given a special shape, surface or design which determines its function to a greater degree than its chemical composition (REACH Article 3) An article is composed of one or more substances or preparations Specific substances may be added to give the article special properties Examples  furniture, clothes, vehicles, toys

5 A Scenario A Swedish retailer buys ladies top with a plastic belt from an Indian based garment company with an own production site in India. The retailer asks the garment manufacturer to sign a declaration that his products are REACH compliant. The garment manufacturer is sure that he is not using any chemicals in his factory and signs the declaration. Neither the retailer nor the garment manufacturer have any idea if this product might be affected by the REACH directive The quality department makes a chemical analysis on Phthalates (Phthalates are additives which give to resins and plastics elasticity and softness) within regular quality checks on samples taken from the stores.

6 Result: •Nothing was detected in the Top
• High concentration of 4.5 % (w/w) of Phthalates in the belt restricted by the REACH directive.

7 Borderline cases Car battery Perfumed eraser Thermo- meter
Paint in pot Fire cracker Spray can

8 The risk factors Phthalates are giving increasing concern as potential endocrine modulators, toxic for reproduction and carcinogenic. Three phthalates are on the REACH Candidate List identified as Substances of Very High Concern. Actions taken by the retailer The retailer recalls the products from the POS, belts are removed in the Swedish warehouse and goods are re-distributed to the stores. The retailer claims the total costs including sales loss from the supplier. The retailer gives a warning to the supplier because he considers him responsible based on signed declaration. The belts will be dumped

9 REACH - Workflow for the registration of substances in articles
Check if Artical 6 or Article 30(4) may apply Producer or importer of articals SVHC defination Annex 1 Identify in article Chapter 5.4 Defination of intended release Annex 1 Is there an intended release from the article ? Dose the article contain SVHC No Yes Yes No further action needed Check if registration is required Check if Art 30(4) applies and if notification is required Workflow 2 Workflow 3

10 Packaging of Articles Substances, mixtures and articles can be contained inside of packaging, such as a carton, a plastic wrapping or a tin can. The packaging does not belong to the substance, mixture or article being packaged and is therefore to be considered as a separate article under REACH. The obligation to notify substances in articles also applies to packaging materials, which may be produced or exported separately as packaging of exported goods. The obligations to communicate information on substances in articles also apply to packaging materials. Packaging with different functions needs to be considered separately Examples of the materials and substance used in packaging include: paper, metal, inks, adhesives, glass, coatings, plastics, board, foil, drums etc.

11 Legal Background 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 in our Annex XIII to the REACH Regulation (PBT substances) it is very persistent and very bioaccumulative according to the criteria set our 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

12 SVHC Chemicals In October 2008 the first version of the candidate list containing 15 Substances of Very High Concern were published. Since then more substances have been included, and today the list has 46 items. A substance of very high concern (SVHC) is a chemical substance (or part of a group of chemical substances) for which it has been proposed that the use within the European Union be subject to authorisation under the REACH Regulation. The listing of a substance as an SVHC by the European Chemicals Agency (ECHA) is the first step in the procedure for authorisation and restriction of use of a chemical.

13 ECHA Updates the REACH Candidate List
Seven new substances have been added to the Candidate List of Substances of Very High Concern (SVHC) for authorisation. Companies manufacturing or importing these substances, or articles containing the substances, need to check their potential obligations that result from the listing. The List now contain 53 substances in total. Visit the below web-site to see the updated candidate list

14 Following SVHC are added to the candidate list by ECHA.
S.NO. Substance Name EC No./CAS No. Application Areas 1 Dibutyl phthalate / Clothes of coated textile, dresses, jerseys, pullovers, vests etc., overcoats & jackets, ski suits, socks & stockings of knitwear, track suits, t-shirts 7 singlets, work & protection clothes for Men. 2 Bis (2-ethyl (hexyl) phthalate) (DEHP) / Softener in Polymers and Synthetical resin 3 Hexabromocyclododecane (HBCDD) / Clothes of coated textile, dresses, jerseys, pullovers, vests etc., overcoats & jackets, ski suits, socks & stockings of knitwear, track suits, t-shirts & singlets, work & protection clothes for men 4 Alkanes, C10-13, chloro (short chain chlorinated Paraffins) 5 Bis(tributyltin)oxide / Biocide in anti-mould coulours 6 Benzyl butyl phthalate / Softner in polymers and synthetic resin 7 Sodium dichromate, dehydrated (CMR) / 8 Anthracene / Textile mordant 9 Cobalt dichloride / Mordant dye 10 Diars pentaoxide / Colouring industry, preserver. 11 Potassium dichromate / Clothes of coaed textile, dresses, pullover, vests etc., overcoats & jackets, ski suits, socks & stockings of knitwear, track suits, t-shirts & singlets, work & protection clothes for men 12 Tris(2-chloroethyl) phosphate / Clothes of coated textile, dresses, jerseys, pullovers, vests etc., overcoats & jackets, ski suits, socks & stockings of knitwear, track suits, t-shirts & singlets 13 Lead Sulfochromate yellow (C.I. Pigment Red 104) / 14 Lead chromate molybdate sulphate red (C.I. Pigment Red 104) / Clothes of coated textile, dresses, jerseys, pullovers, vests etc., overcoats & jackets, ski suits, socks & stockings of knitwear, track suits, t-shirts & singlets, work & protection clothes for men 15 4,4’- Diaminodiphenylmethane / Raw Material for the production of “ Methylendiphenyldiisocyanat” for PUR (main application) Epoxi resin, adhesives

15 Authorization list of SVHC chemicals (REACH Annex 15 inclusion) used
REACH has selected a few substances which are considered to be highly hazardous as compared to the other SVHC substances from the candidate list. These are hazardous substances listed as substances or Authorization. In case a substance present in a textile product is a member of the authorization list then a suitable alternative has to be found within the period provided by the agency. The list of chemicals that needs authorization and are currently used in the textile sector are given below: S.No. Substance Name EC No. 1 4,4’- Diaminodiphenylmethane 2 Dibutyl phthalate 3 Bis (2-ethyl(hexyl)phthalate) (DEHP) 4 Hexabromocyclododecane (HBCDD) 5 Benzyl butyl phthalate

16 Restricted substances list
Asbestos compounds (asbestos) Pesticide compounds (biocides) Dioxins and Furans (dioxins and furans) Azo dyes (dyes) Disperse dyes (dyes) Flame retardants compounds (flame retardants) Formaldehyde (formaldehyde) F-gases (greenhouse gases) Arsenic compounds (Metals) Cadmium compounds (Metals) Chromium compounds (Metals) Lead compounds (Metals) Mercury compounds (Metals) Nickel compounds (Metals) Organostannic compounds (organo tin) Ozone depleting BCMs (ozone depleting substances) Ozone depleting CFCs (ozone depleting substances) Ozone depleting halons (ozone depleting substances) Ozone depleting HBFCs (ozone depleting substances) Ozone depleting HCFCs (ozone depleting substances) Ozone depleting methyl bromide (ozone depleting Ozone depleting solvents (ozone depleting substances)

17 PENALTY The importers or suppliers are considered to be non-compliant and has infringed the REACH provisions, if they fail to register; fail to notify ECHA in advance; not be able to provide sufficient information to their customers or cannot disclose the presence of SVHC in products within 45 days upon request from consumers. The importer or supplier is subject to the following penalty: EU Member State Max. Penalty Austria € 38,000 Bulgaria € 51,129 Cyprus € 80,000 and 4 years of prison France € 75,000 and 2 years of prison Germany Sentenced to a fine Greece € 35,000 Hungary € 70,427 Ireland € 3,000,000 or/and 2 years or prison Italy € 150,000 or 3 months of prison Liechtenstein € 131,863 or/and 6 months of prison Lithuania € 4,350 Luxembourg € 50,000 or/and 3 years of prison Netherlands € 740,000 or/and 6 years of prison Poland € 4,761,905 or/and 2 years of prison Portugal € 2,500,000 Romania € 11,889 Slovakia € 99,581 Slovenia € 60,000 Spain € 1,200,000 UK Unlimited fine or/and 2 years of prison

18 Consequences for the Indian suppliers
have to bear all related costs does not know which products can contain regulated chemical ingredients or components cannot afford neither financially nor time wise to have all products tested continuously and repeatedly on substances of the REACH candidate list. does not know which information and when he has to provide to his customer. risks future orders from the customer.

19 REACH Registration REACH requires a registration of chemical substances produced or imported in quantities from 1 ton per year (t/a) in a central database. Technical dossiers containing the basic attributes of chemical substances, their classification and labelling as well as their purpose of use and guidelines for safe handling have to be provided for registration. The main focus of REACH is to accompany and to assure the complete way of a substance through all production processes e.g. - from the raw material to the final product

UNDER REACH? The regulation does not require registration and testing of preparations (e.g. dye stuffs, textile auxiliaries etc.) or products (e.g. textiles, garments, shoes etc.) However, garment exporters are liable to give information on the article being exported from June 2011

21 Information flow in the supply chain

22 Beneficial steps for industry -I
THINK! If substances of very high concern are used in production, then how to control them or find substitutes. Be Informed! Control their use if they are part of the preparations used in production. Get Aware! If components or packaging material contain these substances , then find a way out to control them Identify the components and materials to be checked Control critical components and substances

23 Beneficial steps for industry -II
Share the liability with all responsible partners in the supply chain. Achieve safety Precautionary Principles. Attain information on risks and hazards available Achieve knowledge on quality and all-over performance (Environment, H&S, Product Safety etc.) through transparency on suppliers and components Provide quick response to customers on REACH compliance Attain overall cost reductions & improvement of quality aspects and product safety through supply chain transparency and lean supply chain management

24 AEPC HELPDESK The AEPC website carries a manual on REACH
The FAQ section also carries common queries on REACH You can post your queries or know more about the forthcoming seminars on REACH at or call at Send us your queries with your name and contact details and do visit-

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