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  • 1. REACH – European Regulation“BUREAU VERITAS PROPRIETARY Copyright Bureau Veritas [2005] Bureau Veritas – CHEMICAL COMPLIANCE REGISTER-REACH 1 DO NOT DISCLOSE OUTSIDE YOUR ORGANIZATION WITHOUT BUREAU VERITAS PRIOR WRITTEN CONSENT”
  • 2. What is REACH REACH is about controlling risks to human health and the environment that result from the use of chemicals REACH is about knowing what is in your products REACH is about information communication REACH is about controlling chemical ‘substances’, not products that contain them. “BUREAU VERITAS PROPRIETARY Copyright Bureau Veritas [2005] Bureau Veritas – CHEMICAL COMPLIANCE REGISTER-REACH 2 DO NOT DISCLOSE OUTSIDE YOUR ORGANIZATION WITHOUT BUREAU VERITAS PRIOR WRITTEN CONSENT”
  • 3. What is REACH REACH Regulation (EC) No 1907/2006 Effective Date: 1 June 2007 (Progressive schedule) + Pre-registration Registration + Notification Evaluation Authorisation & restriction of CHemicals “BUREAU VERITAS PROPRIETARY Copyright Bureau Veritas [2005] Bureau Veritas – CHEMICAL COMPLIANCE REGISTER-REACH 3 DO NOT DISCLOSE OUTSIDE YOUR ORGANIZATION WITHOUT BUREAU VERITAS PRIOR WRITTEN CONSENT”
  • 4. Overview of EU REACH Regulation R egistration, E valuation, A uthorisation,What does it stand for? and restriction of CH emicals Designed to protect human health and Purpose the environment Staggered process over 11 years which involves the Timeline Registration, Evaluation, Notification, Authorizations and Restriction of Chemicals (REACH) REACH is about knowing what substances are In Essence in products and their impact on human health and the environment “BUREAU VERITAS PROPRIETARY Copyright Bureau Veritas [2005] Bureau Veritas – CHEMICAL COMPLIANCE REGISTER-REACH 4 DO NOT DISCLOSE OUTSIDE YOUR ORGANIZATION WITHOUT BUREAU VERITAS PRIOR WRITTEN CONSENT”
  • 5. WHAT IS REACH?DEFINITION SUBSTANCES versus PREPARATIONS versus ARTICLES Individual pigments or single substanceSUBSTANCES(Single Chemical with CAS/EC #) CAS # : Chemical Abstracts Service Number EC # : European Chemical NumberPREPARATIONS(Mixture or solution of twoor more substances) Mixture pigments, solvents, ink, concrete, etcARTICLESSpecific shape, surface ordesign, which determinesits function to a largerdegree than its chemical Different components in an article.composition Packaging is a separate Article “BUREAU VERITAS PROPRIETARY Copyright Bureau Veritas [2005] Bureau Veritas – CHEMICAL COMPLIANCE REGISTER-REACH 5 DO NOT DISCLOSE OUTSIDE YOUR ORGANIZATION WITHOUT BUREAU VERITAS PRIOR WRITTEN CONSENT”
  • 6. Examples of substance They are single Ethanol substances with EC# EC#: 200-578-6 and CAS# CAS#: 64-17-5 Sodium cyanide EC#: 205-599-4 CAS#: 143-33-9 Copper sulphate EC#: 231-847-6 CAS#: 7758-98-7 “BUREAU VERITAS PROPRIETARY Copyright Bureau Veritas [2005] Bureau Veritas – CHEMICAL COMPLIANCE REGISTER-REACH 6 DO NOT DISCLOSE OUTSIDE YOUR ORGANIZATION WITHOUT BUREAU VERITAS PRIOR WRITTEN CONSENT”
  • 7. Examples of preparation Glues Mixture of two or more substances Bleach Dyes “BUREAU VERITAS PROPRIETARY Copyright Bureau Veritas [2005] Bureau Veritas – CHEMICAL COMPLIANCE REGISTER-REACH 7 DO NOT DISCLOSE OUTSIDE YOUR ORGANIZATION WITHOUT BUREAU VERITAS PRIOR WRITTEN CONSENT”
  • 8. Examples of preparation Silica gel pack All of above are PREPARATION in ARTICLE “BUREAU VERITAS PROPRIETARY Copyright Bureau Veritas [2005] Bureau Veritas – CHEMICAL COMPLIANCE REGISTER-REACH 8 DO NOT DISCLOSE OUTSIDE YOUR ORGANIZATION WITHOUT BUREAU VERITAS PRIOR WRITTEN CONSENT”
  • 9. Examples of article Handbag Object with specific shape, surface or design Physical properties determines its Sandal function to a greater degree than its chemical composition T-shirt “BUREAU VERITAS PROPRIETARY Copyright Bureau Veritas [2005] Bureau Veritas – CHEMICAL COMPLIANCE REGISTER-REACH 9 DO NOT DISCLOSE OUTSIDE YOUR ORGANIZATION WITHOUT BUREAU VERITAS PRIOR WRITTEN CONSENT”
  • 10. Definitions Intended release The release is essential for the end use function of the article, andwithout the release of the substances, the article would not worksufficientlyTypical examples are : Joss sticks The release contributes to a quality or minor function of the article,or, in other words, the release contributes to an ‘added value’ of thearticle, which is not directly connected to the end use functionTypical examples are : scented T-shirt and eraser “BUREAU VERITAS PROPRIETARY Copyright Bureau Veritas [2005] Bureau Veritas – CHEMICAL COMPLIANCE REGISTER-REACH 10 DO NOT DISCLOSE OUTSIDE YOUR ORGANIZATION WITHOUT BUREAU VERITAS PRIOR WRITTEN CONSENT”
  • 11. Examples of ADDED VALUE The smell from the T-shirt is for adding value, not the end use function of it Scented T-shirt Peach smell Grape smell “BUREAU VERITAS PROPRIETARY Copyright Bureau Veritas [2005] Bureau Veritas – CHEMICAL COMPLIANCE REGISTER-REACH 11 DO NOT DISCLOSE OUTSIDE YOUR ORGANIZATION WITHOUT BUREAU VERITAS PRIOR WRITTEN CONSENT”
  • 12. Definitions SUBSTANCES OF VERY HIGH CONCERN (SVHC)Generally effect the Environmental and or HumanHealth Persistent, Bio accumulative & Toxic (PBT’s) Very Persistent & Very Bio accumulative (vPvB’s) Carcinogenic, Mutagenic or toxic to ReproductionThere are 46 SVHC presently TOXIC / VERY TOXIC / Dangerous to Environment HARMFUL / IRRITANT / “BUREAU VERITAS PROPRIETARY Copyright Bureau Veritas [2005] Bureau Veritas – CHEMICAL COMPLIANCE REGISTER-REACH 12 DO NOT DISCLOSE OUTSIDE YOUR ORGANIZATION WITHOUT BUREAU VERITAS PRIOR WRITTEN CONSENT”
  • 13. “BUREAU VERITAS PROPRIETARY Copyright Bureau Veritas [2005] Bureau Veritas – CHEMICAL COMPLIANCE REGISTER-REACH 13 DO NOT DISCLOSE OUTSIDE YOUR ORGANIZATION WITHOUT BUREAU VERITAS PRIOR WRITTEN CONSENT”
  • 14. “BUREAU VERITAS PROPRIETARY Copyright Bureau Veritas [2005] Bureau Veritas – CHEMICAL COMPLIANCE REGISTER-REACH 14 DO NOT DISCLOSE OUTSIDE YOUR ORGANIZATION WITHOUT BUREAU VERITAS PRIOR WRITTEN CONSENT”
  • 15. “BUREAU VERITAS PROPRIETARY Copyright Bureau Veritas [2005] Bureau Veritas – CHEMICAL COMPLIANCE REGISTER-REACH 15 DO NOT DISCLOSE OUTSIDE YOUR ORGANIZATION WITHOUT BUREAU VERITAS PRIOR WRITTEN CONSENT”
  • 16. “BUREAU VERITAS PROPRIETARY Copyright Bureau Veritas [2005] Bureau Veritas – CHEMICAL COMPLIANCE REGISTER-REACH 16 DO NOT DISCLOSE OUTSIDE YOUR ORGANIZATION WITHOUT BUREAU VERITAS PRIOR WRITTEN CONSENT”
  • 17. Definitions Only representative With mutual agreementNon-EU Manufacturer/ Producerappoint a natural or legal person Have sufficient backgroundestablished in the Community to in the practical handling offulfil, as his only representative, the substancethe obligations on importers Have information related to the substance Shall keep the latest safety data sheet Non-EU EU Manufacturer/ Only ECHA Producer representative “BUREAU VERITAS PROPRIETARY Copyright Bureau Veritas [2005] Bureau Veritas – CHEMICAL COMPLIANCE REGISTER-REACH 17 DO NOT DISCLOSE OUTSIDE YOUR ORGANIZATION WITHOUT BUREAU VERITAS PRIOR WRITTEN CONSENT”
  • 18. REACH: Registration, Evaluation and Authorisation The most important dates, from 1st Jun to 1st Dec 2008Pre-Registration To benefit from staggered registration deadlines depending on the substances and tonnage bands (2010, 2013, 2018) Pre-register through a EU legal entityRegistration Registration applies to: Substance in its own or in preparation • Annual import to EU 1 tonne Substance in articles • Annual import to EU > 1 tonne • Intended to be released under normal or foreseeable conditions of use One Substance, One Registration (OSOR)Evaluation Carried out by ECHA & member states based on risk – provides basis for authorisation or restrictionAuthorization Manufacturers, Importers and/or user of substances classified as SVHC need Authorization - based on Annex XIV issued by ECHA in 2009 “BUREAU VERITAS PROPRIETARY Copyright Bureau Veritas [2005] Bureau Veritas – CHEMICAL COMPLIANCE REGISTER-REACH 18 DO NOT DISCLOSE OUTSIDE YOUR ORGANIZATION WITHOUT BUREAU VERITAS PRIOR WRITTEN CONSENT”
  • 19. REACH: Restriction and Notification Restriction REACH adopts restriction approach based on existing directives & systems A restricted substance shall not be manufactured, placed on the market or used unless it complies with the conditions of that restriction. Notification If articles contain substances classified as SVHC, its manufacturers, importers & or downstream users must notify ECHA regarding its use if: 1. The substance is present > 1 tpa per producer or importer 2. The substance is present > 0.1 % weight by weight 3. The substance is classified as SVHC Exemption can apply where exposure to humans or the environment can be demonstrated “BUREAU VERITAS PROPRIETARY Copyright Bureau Veritas [2005] Bureau Veritas – CHEMICAL COMPLIANCE REGISTER-REACH 19 DO NOT DISCLOSE OUTSIDE YOUR ORGANIZATION WITHOUT BUREAU VERITAS PRIOR WRITTEN CONSENT”
  • 20. WHAT IS REACH? REACH applies to many consumer product related industries such as: Chemicals Dyeing Printing Soft lines Softlines - textile and apparel Footwear Footwear Toys Consumer electronics Hard lines Household products Other Consumer Products… Toys Electrical “BUREAU VERITAS PROPRIETARY Copyright Bureau Veritas [2005] Bureau Veritas – CHEMICAL COMPLIANCE REGISTER-REACH 20 DO NOT DISCLOSE OUTSIDE YOUR ORGANIZATION WITHOUT BUREAU VERITAS PRIOR WRITTEN CONSENT”
  • 21. REACH EXEMPTIONSProduct categories exempt and covered under other regulations Food, Feeding products, additives, flavourings and animal nutrition Human and Veterinary Medicine and Pharmaceutical Plant Protection and Biocides including fumigants, pesticides, herbicides Radioactive substances Waste (as defined in Directive 2006/12/EC) Non-isolated intermediates of chemical production Polymers excluded but monomers to be registered, if > 2% and 1 tonne p/a Annex IV, water, carbon dioxide, carbon, glucose, etc. Annex V, natural substances – ores, crude oil, minerals, coal, etc. “BUREAU VERITAS PROPRIETARY Copyright Bureau Veritas [2005] Bureau Veritas – CHEMICAL COMPLIANCE REGISTER-REACH 21 DO NOT DISCLOSE OUTSIDE YOUR ORGANIZATION WITHOUT BUREAU VERITAS PRIOR WRITTEN CONSENT”
  • 22. Scope of REACH Who shall follow REACH Regulation? • EU manufacturers and importers of substances on their own or in preparations. • EU producers and importers of articles. • EU-based “only representatives” appointed by a manufacturer, formulator or article producer outside the EU. Failure to register a substance will mean it can not be used in manufactured goods or placed on the market “BUREAU VERITAS PROPRIETARY Copyright Bureau Veritas [2005] Bureau Veritas – CHEMICAL COMPLIANCE REGISTER-REACH 22 DO NOT DISCLOSE OUTSIDE YOUR ORGANIZATION WITHOUT BUREAU VERITAS PRIOR WRITTEN CONSENT”
  • 23. Example of supply-chain obligation (registration) Outside EU EU Manufacturer A Manufacturer A Manufacturer B registers substance X Substance Substance Manufacturer B X Y registers substance YPreparation VZ Formulator C Formulators C & D with no obligation Formulator D Preparation XY Importer E Preparation Importer E registers XYVZ substances V&Z Preparation XYVZ “BUREAU VERITAS PROPRIETARY Copyright Bureau Veritas [2005] Bureau Veritas – CHEMICAL COMPLIANCE REGISTER-REACH 23 DO NOT DISCLOSE OUTSIDE YOUR ORGANIZATION WITHOUT BUREAU VERITAS PRIOR WRITTEN CONSENT”
  • 24. Registration Obligations“BUREAU VERITAS PROPRIETARY Copyright Bureau Veritas [2005] Bureau Veritas – CHEMICAL COMPLIANCE REGISTER-REACH 24 DO NOT DISCLOSE OUTSIDE YOUR ORGANIZATION WITHOUT BUREAU VERITAS PRIOR WRITTEN CONSENT”
  • 25. CONSUMER GROUPS ARE ALSO ACTING RAPIDLY European Women Group promoting the New REACH legislation and shoppers’ right to know what’s in their products “BUREAU VERITAS PROPRIETARY Copyright Bureau Veritas [2005] Bureau Veritas – CHEMICAL COMPLIANCE REGISTER-REACH 25 DO NOT DISCLOSE OUTSIDE YOUR ORGANIZATION WITHOUT BUREAU VERITAS PRIOR WRITTEN CONSENT”
  • 26. NGOs are also advising consumers what to write… … will you be able to respond within 45 days? “BUREAU VERITAS PROPRIETARY Copyright Bureau Veritas [2005] Bureau Veritas – CHEMICAL COMPLIANCE REGISTER-REACH 26 DO NOT DISCLOSE OUTSIDE YOUR ORGANIZATION WITHOUT BUREAU VERITAS PRIOR WRITTEN CONSENT”
  • 27. REACH ENFORCEMENT WHAT HAPPENS IF YOU GET IT WRONG? Improvement notice Legal action • Fines • Imprisonment HOW DO YOU PROTECT YOURSELF? Always consider the ‘spirit’ of REACH not just the words Document every decision and reasoning Be able to demonstrate that your know what substances are in your products and that you are working with your supply chain“BUREAU VERITAS PROPRIETARY Copyright Bureau Veritas [2005] Bureau Veritas – CHEMICAL COMPLIANCE REGISTER-REACH 27 DO NOT DISCLOSE OUTSIDE YOUR ORGANIZATION WITHOUT BUREAU VERITAS PRIOR WRITTEN CONSENT”
  • 28. WHAT NEEDS TO BE DONE ?“BUREAU VERITAS PROPRIETARY Copyright Bureau Veritas [2005] Bureau Veritas – CHEMICAL COMPLIANCE REGISTER-REACH 28 DO NOT DISCLOSE OUTSIDE YOUR ORGANIZATION WITHOUT BUREAU VERITAS PRIOR WRITTEN CONSENT”
  • 29. REACH Key Dates … Pre-registration (Legally recommended): • Individual substances than 1 tonne/annum • Substances in preparations than 1 tonne/annum • Substances in articles than 1 tonne/annum and intentionally released Pre-registration (Bureau Veritas recommended): • For SVHC’s >0.1%w/w (1,000 mg/kg) in articles (Likely & Intended release) • Monomers >2% w/w in polymers and than 1 tonne/annumRegistration Registration of (if pre-registered): “Usage Specific” 1 tonne/year CMR’s (1+2) For R50 & 53 classified substances than 100 tonne/annum (Toxic to aquatic) 1000 tonnes/year Registration of (if pre-registered): “Usage Specific” 100 tonnes/year Registration of (if pre-registered): “Usage Specific” 1 tonne/year Registration of new substances (Non-phase in) 1 tonne/year Annex XIV will be Notification for SVHC in pub- article: >1 tpa, and >0.1% (w/w) lished Authorisation for the “use” of SVHC in EU “BUREAU VERITAS PROPRIETARY Copyright Bureau Veritas [2005] Bureau Veritas – CHEMICAL COMPLIANCE REGISTER-REACH 29 DO NOT DISCLOSE OUTSIDE YOUR ORGANIZATION WITHOUT BUREAU VERITAS PRIOR WRITTEN CONSENT”
  • 30. Decision for standalone SUBSTANCE or in a PREPARATION Substance Classified as SVHC > 1 tpa Authorization Registration “BUREAU VERITAS PROPRIETARY Copyright Bureau Veritas [2005] Bureau Veritas – CHEMICAL COMPLIANCE REGISTER-REACH 30 DO NOT DISCLOSE OUTSIDE YOUR ORGANIZATION WITHOUT BUREAU VERITAS PRIOR WRITTEN CONSENT”
  • 31. Decision for substances in an ARTICLE Substance Classified as SVHC? YES > 0.1% (w/w)? > 1 tpa? YES YES Intentional > 1 tpa? release? YES YES Not registered? Registration YES Notification “BUREAU VERITAS PROPRIETARY Copyright Bureau Veritas [2005] Bureau Veritas – CHEMICAL COMPLIANCE REGISTER-REACH 31 DO NOT DISCLOSE OUTSIDE YOUR ORGANIZATION WITHOUT BUREAU VERITAS PRIOR WRITTEN CONSENT”
  • 32. Registration according to Article 7(1) (and 7(5)) A registration (Article 7.1) of substances in articles is obligatory for an article producer or importer only if the following 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 ton per year per producer or importer. “BUREAU VERITAS PROPRIETARY Copyright Bureau Veritas [2005] Bureau Veritas – CHEMICAL COMPLIANCE REGISTER-REACH 32 DO NOT DISCLOSE OUTSIDE YOUR ORGANIZATION WITHOUT BUREAU VERITAS PRIOR WRITTEN CONSENT”
  • 33. Notification according to Article 7(2)4 Notification of substances in articles is required when all conditions of Article 7(2) are met: The substance is included in the candidate list (SVHC) for authorization (Article 59(1)) and The substance is present in all articles produced or imported by one actor in an amount totaling over 1 tonne per year (per producer or importer) The substance is present in articles above a concentration of 0.1% weight by weight (w/w) “BUREAU VERITAS PROPRIETARY Copyright Bureau Veritas [2005] Bureau Veritas – CHEMICAL COMPLIANCE REGISTER-REACH 33 DO NOT DISCLOSE OUTSIDE YOUR ORGANIZATION WITHOUT BUREAU VERITAS PRIOR WRITTEN CONSENT”
  • 34. Obligations According to Article 33 The aim of Article 33 is to ensure that sufficient information is communicated with articles to allow their safe use. Producers, importers and other suppliers of articles containing substances of very high concern (SVHC) included on the candidate list for authorization in a concentration above 0.1% (w/w) have to provide respective information available to them to the recipients of the articles and as a minimum the name of the substance. There is no tonnage trigger for this obligation (i.e. it also applies below 1 tonne/a) and the obligation cannot be exempted neither via Article 7(3) (exclusion of exposure) nor via Article 7(6) (already registered for that use). “BUREAU VERITAS PROPRIETARY Copyright Bureau Veritas [2005] Bureau Veritas – CHEMICAL COMPLIANCE REGISTER-REACH 34 DO NOT DISCLOSE OUTSIDE YOUR ORGANIZATION WITHOUT BUREAU VERITAS PRIOR WRITTEN CONSENT”
  • 35. Registration documentation Registration documentation Technical Dossier - Identity of manufacturer/ importer Substance - Identity of substance to be - Info. on manufacture & use registered - Classification & Labeling - Guidance on safe use - Substance properties (study summaries) - Test proposal (if relevant) - Exposure information > 10 tpa Chemical Safety Report (CSR) also - Hazard and PBT/vPvB assessment Dangerous Chemical Safety Report (CSR) / - Hazard and PBT/vPvB assessment PBT/vPvB also - Exposure assessment Substance - Risk characterization “BUREAU VERITAS PROPRIETARY Copyright Bureau Veritas [2005] Bureau Veritas – CHEMICAL COMPLIANCE REGISTER-REACH 35 DO NOT DISCLOSE OUTSIDE YOUR ORGANIZATION WITHOUT BUREAU VERITAS PRIOR WRITTEN CONSENT”
  • 36. Authorization information Substance(s) identity Name & contact detail of applicant A request, specifying the use(s) of the substance(s) needed authorization Chemical Safety Report if not registered An analysis of substitution A substitution plan if alternatives are available “BUREAU VERITAS PROPRIETARY Copyright Bureau Veritas [2005] Bureau Veritas – CHEMICAL COMPLIANCE REGISTER-REACH 36 DO NOT DISCLOSE OUTSIDE YOUR ORGANIZATION WITHOUT BUREAU VERITAS PRIOR WRITTEN CONSENT”
  • 37. Notification If an article contains SVHC, its manufacturers, importers and/or downstream users needs to notify the ECHA regarding of the use of the substance, if both the following conditions are met: • The SVHC is present > 1 tpa per producer/ importer;AND • The SVHC is present > 0.1 % weight by weight;AND • The SVHC has not been registered After notification, ECHA may request registration, if > 1tpa per producer/ importer Release from article Release of substance presents a risk to human health or the environment “BUREAU VERITAS PROPRIETARY Copyright Bureau Veritas [2005] Bureau Veritas – CHEMICAL COMPLIANCE REGISTER-REACH 37 DO NOT DISCLOSE OUTSIDE YOUR ORGANIZATION WITHOUT BUREAU VERITAS PRIOR WRITTEN CONSENT”
  • 38. Notification information Identity and contact detail of producer/ importer Registration number if available Substance identity Substance classification Description of the use(s) of SVHC in article Tonnage range “BUREAU VERITAS PROPRIETARY Copyright Bureau Veritas [2005] Bureau Veritas – CHEMICAL COMPLIANCE REGISTER-REACH 38 DO NOT DISCLOSE OUTSIDE YOUR ORGANIZATION WITHOUT BUREAU VERITAS PRIOR WRITTEN CONSENT”
  • 39. YOUR OBLIGATIONS IN A NUTSHELL Your obligations require you to identify What substances are in your products Intended release Substances classified into categories – CMR, R50 & 53, Monomers >2% w/w in polymers, SVHC > 0.1%ww Volumes of substances placed on the EU market The precautionary principal and 45 day obligation require you to Demonstrate that you have done the exercise to know what is in your product Be able to respond in 45 days to consumer questions asking what substances are in products and if SVHC are present, then provide information on this. (Article & Substance Safety Data Sheets) “BUREAU VERITAS PROPRIETARY Copyright Bureau Veritas [2005] Bureau Veritas – CHEMICAL COMPLIANCE REGISTER-REACH 39 DO NOT DISCLOSE OUTSIDE YOUR ORGANIZATION WITHOUT BUREAU VERITAS PRIOR WRITTEN CONSENT”
  • 40. “BUREAU VERITAS PROPRIETARY Copyright Bureau Veritas [2005] Bureau Veritas – CHEMICAL COMPLIANCE REGISTER-REACH 40 DO NOT DISCLOSE OUTSIDE YOUR ORGANIZATION WITHOUT BUREAU VERITAS PRIOR WRITTEN CONSENT”