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REACH- EU New Chemicals Policy

REACH- EU New Chemicals Policy. Presentation to the European Aerosol Federation 28 September 2005 Athens Greece Deborah Hotchkiss, SC Johnson. REACH – 5 key points. Biggest piece of chemical legislation ever to hit the EU Will impact all of our products Will impact all chemicals we use

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REACH- EU New Chemicals Policy

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  1. REACH- EU New Chemicals Policy Presentation to the European Aerosol Federation 28 September 2005 Athens Greece Deborah Hotchkiss, SC Johnson

  2. REACH – 5 key points • Biggest piece of chemical legislation ever to hit the EU • Will impact all of our products • Will impact all chemicals we use • Will impact all of our suppliers /distributors • Failure to respond adequately puts the chemical industry at risk in the EU

  3. REACH – History • 1998 – informal meeting of Environment ministers • 2001 – Commission White Paper • May 2003 – draft Commission proposal for consultation • October 2003 – Commission proposal • 2004 onwards – over to Council of Ministers and European Parliament

  4. REACH-Registration, Evaluation and Authorisation of CHemicals • Overall goal is to address concerns over the potential effects of chemicals on human health and environment • Also aims to eliminate the data differences between new and existing chemicals • “New chemicals” are those put on the market post 1981

  5. Significant increase in chemicals in the EU • Volume of chemicals in the EU has increased by 400 times during last 70 years The current legislation on chemicals puts Than on existing chemicals Many more obligations on new chemicals 99.99% 0.01% Volume on market

  6. REACH principles • Make industry responsible for safe use of chemicals • Extend the responsibility along the manufacturing chain (downstream users will be involved) • Encourage consortia to share data, costs and avoid animal testing • Promote substitution of hazardous chemicals • Make information publicly available

  7. Scope • Each manufacturer (located in the EU) or importer (from outside EU) of a substance in a volume of one ton or more per annum (tpa) must submit a registration (includes natural substances) • Downstream users can register for a specific use • Responsibility shifts to Industry

  8. Exemptions • No obligation to register: • Medical products for humans and veterinary use • A food additive • A flavoring substance • Substances used for animal nutrition • Preparations (must register substances manufactured or imported greater than 1 ton that are in the preparation) • Exemption for cosmetic use (consumer safety covered by Cosmetics Directive)

  9. Downstream Users(6 information elements) Registration Evaluation Restrictions Authorization GeneralRequirement8 informationelements Animal Test Plans(1 assessment) Special Requirements Agency orMemberStateInitiates Listed & CriteriaSubstances Articles- Intended Release:(8 information elements)-Unintended Release:Notification - (6 informationelements) DossierEvaluation SubstanceEvaluation Deferrals- PPORD(5 informationelements) - Phase-inSubstances ProducersApplication3 informationrequirements OR >1 Tonnes(includes transportedisolated intermediatesabove 1000 TPY)24 data elements(2) Examine TestProposals Rolling Plan PrepareDossier Additional Info fromProducersAddt’l. Data RiskAssessment1 analysis + CSR ComplianceCheck AgencyRiskAssessment SDS(16 data elements) OR PeriodicObligations(7 informationelements) >10 Tonnes+Chemical Safety Rpt.37 data elements (2),6 assessments; 16evaluations Intermediates-Site limited(4 informationelements)-Transported(4 informationelements) AlternativeAnalysis6 elements Socio-economicAnalysis8 elements DraftDecisionsto Agency OR SocioeconomicAnalysis8 elements Preregistration of Phase-inSubstances(5 information elements) >100 Tonnes+Chemical Safety Rpt.56 data elements (2),6 assessments, 16evaluations Agency orMemberStateRecomm. AgencyAssessment Info Down Supply Chain if noSDS(4 information elements& 4 update requirements) OR CommissionDecision onRestriction List onAnnex VIII >1000 Tonnes+Chemical Safety Rpt.62 data elements (2),6 assessments16 evaluations 1 Major processes with requirements for industry (does not include all REACH provisions)2 Maximum number; actual requirements are substance dependent 3Exemptions from Registration - Medicinal Products - Food Additives - Food Stuffs & Feeding Stuffs - Animal Nutrition - Annexes II & III- substances in Plant Protection Products- Active Substances in Biocidal Products- Polymers A complex process

  10. Registration • Affects all chemicals manufactured or imported into the EU greater than 1 tpa • Manufacturer or importer is responsible • Requires dossier stating: • End uses of the material • Physio-chemical, toxicological and ecotoxicological data specific to the risk associated with the end use

  11. Registration deadlines* • 2010: All chemicals sold in quantities >1000 tpa & Carcinogenic, Mutagenic or Reprotoxic (CMR) • 2013: All chemicals sold in quantities 100-1000 tpa • 2017: All chemicals sold in quantities 1-100 tpa * If legislation not finalised in 2007, then these dates will alter

  12. Evaluation • Performed by the member states • Two types of evaluation: • Dossier Evaluation • Alternatives to animal testing and literature reviews • Substance Evaluation • Performed if the substance poses a risk to human health or environment

  13. Authorisation • If substance, when evaluated, is found to be of high concern it cannot be used without Authorisation • Risk must be “adequately controlled” • Socio-economic benefit must be shown • Supplier/user must be actively researching a substitute

  14. Status WE ARE HERE New Parliament Summer '04 New Commission January '05 Commission Opinion (?) 2001 2003 2004 2005 2006 2007 Commission Proposal Oct 29, 2003 Internet Consultation White paper Second Parliament Reading (?) Final Legislation (??) Plenary Voting Amendments Parliament First Parliament Reading Starts First Council Position (?) Second Council Position (?) UK Presidency Deadline for Amendments via Parliament End 1st reading Amendments Compromise End U.K.Presidency 2005 F M A M J J A S O N D 2006

  15. EU Political Scene - Council UK Presidency: • REACH = high priority • good cooperation with Parliament • goal: 1st position by Council before end 2005 • main concerns: 1) Competitive Industry 2) Workable REACH 3) Minimize Animal Testing

  16. Overview • 100,000 existing chemicals on EINECS • 30,000 require Registration • Estimated 1 in 5 of the chemicals Registered will need to be Evaluated • 1,500 will require Authorisation

  17. Definition of “Downstream User” • Any legal person, other than the manufacturer or the importer, who uses a substance (either on its own or in a preparation) in the course of his industrial or professional activities • A distributor or a consumer is not a downstream user

  18. Responsibilities of the Downstream User • Downstream Users need to • Communicate identified uses to suppliers • Implement suppliers RRM for identified uses • Perform chemical safety assessments for unidentified uses • Inform agency of unidentified uses >1 tonne/year

  19. Cost implications for Downstream Users • Estimated cost to all Downstream users of chemicals is €2.8 - 5.2 billion • EU estimate 1-2% of chemicals could be withdrawn as production would not be profitable • Chemical Industry estimate up to 40% of chemicals on the EU market could be withdrawn

  20. 2. Cost of chemicals will increase Probable impact on consumer product industry 1. Need for administration & expert resources

  21. Adverse labelling on products Potential PR issue Stricter packaging requirements More administration in the factories etc… Potential impact on consumer product industry • 3. More substances Classified as “dangerous” • Less choice…. • Less flexibility to innovate • Re-formulation of brands

  22. Questions? Thank you for your time Deborah Hotchkiss dhotchki@scj.com +44(0) 1784 484 4250

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