David Owen Shell Chemicals Ltd ISRTP Workshop, Baltimore November 2005

Transcription

1 REACH: alternatives and tiered strategies David Owen Shell Chemicals Ltd ISRTP Workshop, Baltimore November 2005

2 Contents Background and scope Components of REACH Information requirements Implementation Projects Comments and Observations

3 Background, Regulatory background Registration, Evaluation and Authorisation of Chemicals Not all new, covers many (but not all) key pieces of chemicals legislation such as: Classification and Labelling Notification of New Substances (NONS) Existing Substances Regulation SDS Industrial chemicals lacked common regulatory infrastructure for many years. NONS provided framework for an approval process; REACH underpinned by tonnage triggers REACH will happen-- introduced mid 2007 to start 2008?

4 Background: Scope All chemicals Manufactured/Imported > 1tpa covered Involves around chemicals Chemicals >10 tpa require a Chemical Safety Report, CSR Register chemicals for specified uses Centred around H & E risk assessments and classification status Industry does the assessments Global Harmonisation Scheme,GHS, will probably be implemented in EU to parallel REACH.

5 White Paper Feb 2001 Council & Parliament Stakeholder Consultation April 2001 Commission (Envir& Ent) Internet Consultation May-July 2003 Legislative Proposals October 2003 In Force, 2007 Council Common Position Parliament 1 st Reading NOW Final Legislative Acts Commission Opinion Parliament 2 nd Reading

6 The REACH Process Pre-Registration Registration Evaluation Consortia/partner build up Inform European Chemical Agency SIEF (data exchange ) Chemical Safety Report to ECA Testing proposals Allocation of Competent Authority Pay Registration Fees Dossier audit and/or evaluation Agree testing plans Authorisation Socio-economic analysis Risk management checks Replacement plans Time limited Authorisation

7 Chemical Assessment and Risk Management Chemical Safety Report Hazard IUCLID 5 CSA Risk Management recommendations SDS Exposure Exposure Scenarios

8 Health Effects data within Annex bands Annex V Annex VI Annex VII Annex VIII All available data information Skin irritation or corrosion (in vitro) Eye irritation (in vitro) S/sensitisation (LLNA) Gene mutation (Ames) Annex V plus: Skin/eye irritation Acute toxicity(2) 28 day repeat dose Screening reprotox Cytogenicity and mammalian cell mutation(in vitro) Toxicokinetic assessment Reinforce Annex VI with: 90 day repeat dose study Developmental tox (1 species) 2 Generation reprotox Reinforce Annex VII with: Chronic tox study Carcinogenicity

9 Testing for Hazard Physical/chemical Environmental Health effects Annex IX voting voting Tons >1000 Annex V V and VI V-VII V-VIII CSR No Yes Yes Yes Timing, years CMRs (1&2), PBTs

10 Data needs: phys/chem, tox, environmental No. of chemicals 1-10 tpa Limited + in vitro data P/C tpa Annex VI (~Base Set) 5000 E tpa Annex VII tpa Annex V H

11 Annex IX considerations The use of existing information (including human data and non-glp studies) The application of a weight of evidence approach Appropriate use (when and how) of and (Q)SARs When and how to use in-vitro methods The application of grouping (categories) and readacross When testing is technically impossible When testing can be omitted based on exposure considerations

12 REACH Implementation Projects, RIPs RIP1: process definition (finalised June 2004) RIP2: IT infrastructure (ongoing) RIP 3 Guidance to Industry (10 subprojects) RIP 4 Guidance to Authorities RIP 5 pre-agency RIP 6 Agency RIP 7 Commission preparation

13 RIP 3 projects 3.1. Guidance on Technical dossier for Registration 3.2. TGD on preparing CSR (04) 3.3. TGD Information requirements (04) 3.4. Guidance on data sharing (pre-registration) 3.5. Guidance downstream user requirements (04) 3.6. Guidance on C&L under GHS 3.7 Guidance on application for Authorisation 3.8. Guidance requirements for articles 3.9. Guidance on SEA 3.10.Guidance on Substance ID checks (04)

14 RIP 3.3- A Scoping Study on the Development of a Technical Guidance Document on Information Requirements on Intrinsic Properties of Substances Critical to Cost basis for industry (2.4+ billion Euro) Use of animals (3.9 million?) Promote alternatives, QSAR, read across, categories, exposure driven testing (Annex IX considerations) Commission drew up details, February 2004, Issued for tender, July Contract signed December 2004 Project completed within scope and on time July 2005 Main project will NOT be tendered and will start 2006

15 RIP 3.3. Consortium DK EPA (OECD) T xicology Advice & Consulting Ltd

16 Project components Reviewing the science: Exposure considerations Testing methodologies Non testing approaches General Decision Making Framework Test with 4 end-points: 1. Degradation 2. Aquatic toxicity 3. Irritation 4. Reproductive toxicity

17 Comments RIP 3.3. Is heavily reliant on tonnage triggers following traditional mindset. ITS ( incl.iterative testing) will be used The need for prioritisation and for a tiered approach for risk assessment is not within remit of RIP 3.3. BUT RIP 3.2. Scoping study does raise the possibility to undertake a tiered risk assessment AND ECETOC has produced a tool and report on TRA to take the concept forward Cefic have advocated a prioritisation stage but not much political support within current legislative changes

18 Diagram A Overall Framework for Information Strategies Available information -main use category -Phys.-chem. data -SAR, QSAR, -read-across -in vitro/in vivo data Further data requirements PBT criteria fulfilled? Yes PBT vpvb? Yes Assess sources and exposure routes Weight of Evidence Required Information Annex V: 1-10 tpa Annex VI: tpa Annex VII: tpa Annex VIII: > 1000 tpa Annex IX exposure based waiving Hazard Assessment Information Adequate? No Yes Yes Yes Classification C&L Criteria Derivation of PNEC/DNEL Yes Refine No Risk Characterisation Concerns? No Risk Management Measures Yes Safe use adequate control See Diagram B Exposure Assessment ** Yes Refine Refine ** 1-10 tpa C&L path only RIP 3.3 RIP 3.2 Exposure information for identified uses ** For classified substances or other purposes if required

19 Some Observations QSAR has value but is far from robust for in vivo replacement In vitro studies are limited, not sufficient for Classification triggers or DNEL in all fields. Reproductive data will be the challenge for M/H volume chemicals. A generic decision making framework has been developed under RIP 3.3. End-point specific guidance is needed to complement this GDMF Exposure considerations must be brought into a testing strategy including risk management conditions as an iterative process. Category /family approaches are the most efficient way to reduce testing, especially in high volumes chemicals

20 Summary 2006 for RIP 3.3. and 3.2 work to develop Technical Guidance Intelligent Testing Strategies now being taken up as a key feature (with ECVAM partnership) Tiered Risk Assessment strategies may be developed in parallel to ITS ITS covers risk assessment as well as classification EU Commission willingness to take the alternative agenda forward: ITS development, end-2006 start: 10 million Euro A-Cute-Tox, ReProTect and Sens-it-iv projects: million Euro. New Partnership for 3Rs Thank you!!