REACH- EU New Chemicals Policy

Presentation to the European Aerosol Federation28 September 2005Athens GreeceDeborah Hotchkiss, SC Johnson

REACH – 5 key points

1. Biggest piece of chemical legislation ever to hit the EU

2. Will impact all of our products

3. Will impact all chemicals we use

4. Will impact all of our suppliers /distributors

5. Failure to respond adequately puts the chemical industry at risk in the EU

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

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

Significant increase in chemicals in the EU

• Volume of chemicals in the EU has increased by 400 times during last 70 years

Many more obligations on new chemicals

Than onexisting chemicals

0.01% 99.99%Volume on market

The current legislation on chemicals puts

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

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

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)

Registration

GeneralRequirement8 information

elements

>1 Tonnes(includes transportedisolated intermediatesabove 1000 TPY)24 data elements(2)

>10 Tonnes+Chemical Safety Rpt.37 data elements (2),6 assessments; 16evaluations

>100 Tonnes+Chemical Safety Rpt.56 data elements (2),6 assessments, 16evaluations

>1000 Tonnes+Chemical Safety Rpt.62 data elements (2),6 assessments16 evaluations

Special Requirements

Deferrals- PPORD(5 informationelements)

- Phase-inSubstances

PeriodicObligations(7 informationelements)

Downstream Users(6 information elements)

Animal Test Plans(1 assessment)

Articles- Intended Release:(8 information elements)-Unintended Release:Notification - (6 informationelements)

SDS (16 data elements)

Intermediates-Site limited (4 informationelements)-Transported (4 informationelements)

Preregistration of Phase-inSubstances(5 information elements)

Info Down Supply Chain if noSDS (4 information elements& 4 update requirements)

Evaluation

DossierEvaluation

Examine Test

Proposals

ComplianceCheck

SubstanceEvaluation

Rolling Plan

Additional Info from

ProducersAddt’l. Data

Restrictions

DraftDecisionsto Agency

Authorization

Agency orMember

StateInitiates

PrepareDossier

AgencyRisk

Assessment

Socio-economicAnalysis

8 elements

Agency orMember

StateRecomm.

Commission

Decision onRestriction

Listed & CriteriaSubstances

ProducersApplication

3 informationrequirements

RiskAssessment

1 analysis + CSR

AlternativeAnalysis

6 elements

SocioeconomicAnalysis

8 elements

AgencyAssessment

List onAnnex VIII

OR

OR

OR

OR

1 Major processes with requirements for industry (does not include all REACH provisions)

2 Maximum number; actual requirements are substance dependent

3 Exemptions 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

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

Registration deadlines*

• 2010: All chemicals sold in quantities>1000 tpa & Carcinogenic,Mutagenic or Reprotoxic (CMR)

• 2013: All chemicals sold in quantities100-1000 tpa

• 2017: All chemicals sold in quantities1-100 tpa

* If legislation not finalised in 2007, then these dates will alter

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

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

Status

2001

2003 2004 2005 2006 2007

White paper

InternetConsultation

CommissionProposalOct 29, 2003

First ParliamentReading

Starts

Second ParliamentReading (?)

FinalLegislation(??)

WE ARE HERENew

ParliamentSummer '04

New CommissionJanuary '05

UKPresidency

Deadline forAmendmentsvia Parliament

2006 2005 F M A M J J A S O N D

First Council

Position (?)

Plenary Voting

AmendmentsParliament

SecondCouncil

Position (?)

CommissionOpinion (?)

End 1st reading Amendments Compromise

End U.K.Presidency

EU Political Scene - Council

Jan ‘04 – Jun ‘04 Jul ’04 – Dec ’04 Jan ‘05 – Jun ‘05 Jul ’05 – Dec ‘05

Ireland Netherlands Luxembourg UK

High Level Reading Scope & Registration EvaluationAuthorization

Agency Enforcement

UK Presidency: • REACH = high priority• good cooperation with Parliament• goal: 1st position by Council before end 2005• main concerns: 1) Competitive Industry

2) Workable REACH3) Minimize Animal

Testing

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

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

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

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

2. Cost of chemicals will increase

1. Need for administration & expert resources

Probable impact on consumer product industry

3. More substances Classified as “dangerous” • Less choice….

Potential impact on consumer product industry

• Adverse labelling on products

• Potential PR issue• Stricter packaging

requirements• More administration in the

factories• etc…

• Less flexibility to innovate• Re-formulation of brands

Questions?

Thank you for your time

Deborah Hotchkissdhotchki@scj.com

+44(0) 1784 484 4250