Presentation on theme: "Registration, Evaluation, Authorisation and Restriction"— Presentation transcript:
1Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
2REACH Implementation Timeline Pre-Registration periodRegistration deadline for importing/manufacturing 1,000 tonnes SVHC per yearRegistration deadline for importing/manufacturing ,000 tonnesSVHC per yearREACHenteredinto forceRegistration deadline forimporting/manufacturingtonnes SVHC peryear1 June20071 Dec.200830 Nov.201031 May201331 May20181 June2008
3REACH 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
4What 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 preparationsSpecific substances may be added to give the article special propertiesExamples furniture, clothes, vehicles, toys
5A ScenarioA 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 directiveThe 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.
6Result: •Nothing was detected in the Top • High concentration of 4.5 % (w/w) of Phthalates in the belt restricted by the REACH directive.
7Borderline cases Car battery Perfumed eraser Thermo- meter Paint in potFire crackerSpray can
8The risk factorsPhthalates 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 retailerThe 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
9REACH - Workflow for the registration of substances in articles Check if Artical 6 or Article 30(4) may applyProducer or importer of articalsSVHC defination Annex 1 Identify in article Chapter 5.4Defination of intended release Annex 1Is there an intended release from the article ?Dose the article contain SVHCNoYesYesNo further action neededCheck if registration is requiredCheck if Art 30(4) applies and if notification is requiredWorkflow 2Workflow 3
10Packaging of ArticlesSubstances, 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 separatelyExamples of the materials and substance used in packaging include: paper, metal, inks, adhesives, glass, coatings, plastics, board, foil, drums etc.
11Legal BackgroundA substance may be proposed as an SVHC if it meets one or more ofthe following criteria:it is carcinogenicit is mutagenicit is toxic for reproductionit is persistent, bioaccumulative and toxic according to the criteria setin our Annex XIII to the REACH Regulation (PBT substances)it is very persistent and very bioaccumulative according to the criteriaset 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
12SVHC ChemicalsIn 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.
13ECHA 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
14Following SVHC are added to the candidate list by ECHA. S.NO.Substance NameEC No./CAS No.Application Areas1Dibutyl 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.2Bis (2-ethyl (hexyl) phthalate) (DEHP)/Softener in Polymers and Synthetical resin3Hexabromocyclododecane (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 men4Alkanes, C10-13, chloro (short chain chlorinated Paraffins)5Bis(tributyltin)oxide/Biocide in anti-mould coulours6Benzyl butyl phthalate/Softner in polymers and synthetic resin7Sodium dichromate, dehydrated (CMR)/8Anthracene/Textile mordant9Cobalt dichloride/Mordant dye10Diars pentaoxide/Colouring industry, preserver.11Potassium 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 men12Tris(2-chloroethyl) phosphate/Clothes of coated textile, dresses, jerseys, pullovers, vests etc., overcoats & jackets, ski suits, socks & stockings of knitwear, track suits, t-shirts & singlets13Lead Sulfochromate yellow (C.I. Pigment Red 104)/14Lead 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 men154,4’- Diaminodiphenylmethane/Raw Material for the production of “ Methylendiphenyldiisocyanat” for PUR (main application) Epoxi resin, adhesives
15Authorization 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 NameEC No.14,4’- Diaminodiphenylmethane2Dibutyl phthalate3Bis (2-ethyl(hexyl)phthalate) (DEHP)4Hexabromocyclododecane (HBCDD)5Benzyl butyl phthalate
17PENALTYThe 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 MemberStateMax. PenaltyAustria€ 38,000Bulgaria€ 51,129Cyprus€ 80,000 and 4 years of prisonFrance€ 75,000 and 2 years of prisonGermanySentenced to a fineGreece€ 35,000Hungary€ 70,427Ireland€ 3,000,000 or/and 2 years or prisonItaly€ 150,000 or 3 months of prisonLiechtenstein€ 131,863 or/and 6 months of prisonLithuania€ 4,350Luxembourg€ 50,000 or/and 3 years of prisonNetherlands€ 740,000 or/and6 years of prisonPoland€ 4,761,905 or/and 2 years of prisonPortugal€ 2,500,000Romania€ 11,889Slovakia€ 99,581Slovenia€ 60,000Spain€ 1,200,000UKUnlimited fine or/and 2 years of prison
18Consequences for the Indian suppliers have to bear all related costsdoes not know which products can contain regulated chemical ingredients or componentscannot 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.
19REACH RegistrationREACH 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 chemicalsubstances, 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
20SHOULD GARMENTS BE REGISTERED 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
22Beneficial 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 themIdentify the components and materials to be checkedControl critical components and substances
23Beneficial 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 availableAchieve knowledge on quality and all-over performance (Environment, H&S, Product Safety etc.) through transparency on suppliers and componentsProvide quick response to customers on REACH complianceAttain overall cost reductions & improvement of qualityaspects and product safety through supply chain transparency and lean supply chain management
24AEPC HELPDESK The AEPC website carries a manual on REACH The FAQ section also carries common queries on REACHYou can post your queries or know more about the forthcoming seminars on REACH at or call atSend us your queries with your name and contact details and do visit-