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European Chemicals Bureau
Croatia-JRC-ECB InfoDays, 11-13 December 2006
The Testing Methods Process:From Current Legislation to REACH
Juan Riego Sintes Steven Eisenreich
Croatia – JRC-ECB InfoDays
11-13 December 2006
Zagreb, Croatia
European Chemicals Bureau
Croatia-JRC-ECB InfoDays, 11-13 December 2006
Objectives of this talk
Give general information on:
General on TMs
- Why do we need standardized Testing Methods?
- Which methods do we have, where are them?
- How and by whom are they developed?
Extract on Regulatory Acceptance
Activities in the Interim period
Testing Methods in REACH / RIP 3.3
European Chemicals Bureau
Croatia-JRC-ECB InfoDays, 11-13 December 2006
Protecting People andthe Environment
fromDangerous Chemicals
RISK ASSESSMENTRISK ASSESSMENT
DETERMINATION OF HAZARDOUSPROPERTIES OF CHEMICALS
DETERMINATION OF HAZARDOUSPROPERTIES OF CHEMICALS
RISK MANAGEMENT FOR HUMANSAND THE ENVIRONMENT
RISK MANAGEMENT FOR HUMANSAND THE ENVIRONMENT
HAZARD IDENTIFICATIONAND ASSESSMENT
HAZARD IDENTIFICATIONAND ASSESSMENT
CLASSIFICATION AND LABELINGCLASSIFICATION AND LABELING
TESTING METHODSTESTING METHODS
Why
European Chemicals Bureau
Croatia-JRC-ECB InfoDays, 11-13 December 2006
Single Market andFree Trade
FREE MOVEMENT OF GOODSFREE MOVEMENT OF GOODS
MUTUAL ACCEPTANCE OF DATAMUTUAL ACCEPTANCE OF DATA
HARMONISATIONOF
TESTING METHODSfor
HAZARDOUS OR DANGEROUS CHEMICALS
HARMONISATIONOF
TESTING METHODSfor
HAZARDOUS OR DANGEROUS CHEMICALS
basedon
relieson
Both at EU and global levele.g. OECD
Both at EU and global levele.g. OECD
Why
MADagreement
European Chemicals Bureau
Croatia-JRC-ECB InfoDays, 11-13 December 2006
Testing MethodsAnnex V structure
Current:
ANNEX V
Dir. 67/548/EEC*
Current:
ANNEX V
Dir. 67/548/EEC*
Contains standardised Testing Methods to determine the properties of chemicals
Part A.
Methods for thedetermination of
PHYSICO-CHEMICALPROPERTIES
Part A.
Methods for thedetermination of
PHYSICO-CHEMICALPROPERTIES
Part C.
Methods for thedetermination of
ECOTOXICITY
Part C.
Methods for thedetermination of
ECOTOXICITY
Part B.
Methods for thedetermination of
TOXICITY
Part B.
Methods for thedetermination of
TOXICITY
88/302/EEC92/69/EEC93/21/EEC
96/54/EC98/73/EC
2000/32/EC2000/33/EC2001/59/EC2004/73/EC
88/302/EEC92/69/EEC93/21/EEC
96/54/EC98/73/EC
2000/32/EC2000/33/EC2001/59/EC2004/73/EC
Where
Future: Testing Methods regulation
*These methods are legally binding
European Chemicals Bureau
Croatia-JRC-ECB InfoDays, 11-13 December 2006
EUROPEAN CHEMICALS BUREAU
WA 1
Classificationand labelling
WA 2
NewSubstances
WA 3
TestingMethods
WA 4
ExistingSubstances
WA 5
Import/Export
WA 6
Biocides
Carries out and co-ordinates scientific/technical work neededfor the implementation of EU legislation in the area of chemicals control
Current 67/548/EEC
Draft REACH proposal
Overlapping regulations and actions
Who
European Chemicals Bureau
Croatia-JRC-ECB InfoDays, 11-13 December 2006
CO-ORDINATECO-ORDINATE the
DEVELOPMENT
INTRODUCTION of
ADAPTATION TO TECHNICALPROGRESS (ATP)
DEVELOPMENT
INTRODUCTION of
ADAPTATION TO TECHNICALPROGRESS (ATP)
TESTING METHODS
(Annex V to Dir. 67/548/EEC
TESTING METHODS
(Annex V to Dir. 67/548/EEC
Duties of Testing Methods Work Area
Who
European Chemicals Bureau
Croatia-JRC-ECB InfoDays, 11-13 December 2006
Testing MethodsTasks
- Co-ordinate COM and EU needs and input into OECD Test Guidelines Programme (National Co-ordinators Meeting).
- Promote Testing Methods development for EU legislation (co-ordinated with OECD as far as possible).
- Organise transfer of OECD accepted Test Guidelines into Annex V.
- Co-operate with the European Centre for validation of Alternative Methods (ECVAM) to promote development and to accompany adoption of alternative Testing Methods within EU legislation and OECD TG programme.
- Participate in relevant UN activities for global harmonisation.
- Organise, support and evaluate ring tests or validation studies.
- Organise and host expert meetings.
- Develop review documents.
Who and how
European Chemicals Bureau
Croatia-JRC-ECB InfoDays, 11-13 December 2006
Testing MethodsDevelopment (II)
Member StatesCompetent Authorities
Scientific Community
National Co-ordinators Meeting or written procedureadvice on work plan
prioritiespreferred approach
European Chemicals Bureau
OECD TG Programme
National Co-ordinator
Development by ECB Development by MS
Working GroupsTask Forces
Experts’ MeetingsWorkshops
NC’s Meeting or written procedure
Decide to introduce in Annex V
TMC&L
New SubstancesExisting Substances
BiocidesOther Commission Services
Commission ServicesConsultants
Experts
Who and how
European Chemicals Bureau
Croatia-JRC-ECB InfoDays, 11-13 December 2006
Preparation of proposal for ATPInterservice ConsultationsProposal to Member StatesATP CommitteePublication in OJ
Draft Method
Meeting of NC’s or written procedureApproval to introduce into Annex V
Formatting
Commenting Round(s)
Final version of Testing Method
Meeting(s) of NC’sor Experts
Meeting or written procedureApproval by NC’s
Translation in all official languages
Checking by NCs Correction of translated versions
Final translated versions of TM
DG ENV
Introduce Correctionsand/or Guidance
Testing MethodsDevelopment (III)
Draft Testing Method in Annex V format
Who and how
European Chemicals Bureau
Croatia-JRC-ECB InfoDays, 11-13 December 2006
REGULATORY ACCEPTANCEof TMs (extract)
European Chemicals Bureau
Croatia-JRC-ECB InfoDays, 11-13 December 2006
ROLES IN THE EU (current)* (regarding to TMs acceptance)
EUROPEAN COMMISSION:Coordinates and prepares proposals
Has legislative initiativeReview, endorse, implement
MEMBER STATES:Give opinion and advice
Vote Commission’s proposalReview, endorse, implement, enforce
DG Environment: “Chef de file”
Policy responsible
Competent Authorities: Policy responsible
ECB:Technical matters and delegated duties
National Coordinators:Technical matters and delegated duties
*In future similar for TMs, where Agency?
European Chemicals Bureau
Croatia-JRC-ECB InfoDays, 11-13 December 2006
Ensure acceptance of data at OECD level(among authorities, 30+3)
Harmonized guidelines at OECD level
MAD* agreement:If you use these, I will accept
Ensure acceptance at EU level(within and among authorities, 25+2+1)
Harmonized methods at EU level
Legally binding: You must use these
EU Annex V OECD TG
*MAD: Mutual Acceptance of data
HARMONISATION Aims to allow Single market, free trade, free movement of goods at EU and global level
Important to keep harmonization between both sets
European Chemicals Bureau
Croatia-JRC-ECB InfoDays, 11-13 December 2006
INTERIMfrom Annex V to the new Testing Methods
Regulation and REACH
European Chemicals Bureau
Croatia-JRC-ECB InfoDays, 11-13 December 2006
Testing Methods (Interim)Objective: Coordinate the development, introduction and adaptation to technical progress of
Testing Methods of Annex V to Dir 67/548 and contribute to relevant REACH Implementation Projects (RIP).
• Maintain functioning current system and prepare for new (at COM, EU and OECD levels):• Methods needed for the base set.• Alternative or in vitro methods.• Methods for EU specific needs.
•Contribute to RIP projects, in particular developing new “Intelligent” Testing Strategies (ITS) (e.g. RIP 3.3)•Identify and prioritize new or updated methods needed for REACH implementation.•Cooperate with the leading DG(s) in order to finalise the new Regulation on Testing Methods
• Collaboration with EU MS National Coordinators and other stakeholders.• Collaboration with OECD• Collaboration with ECVAM and other COM Units
How:
Current priorities:
European Chemicals Bureau
Croatia-JRC-ECB InfoDays, 11-13 December 2006
REACH and Test Methods
General political objectives of REACH
RIPs
RP 3.3 motivation
Information integration: ITS
Testing requirements
Adaptations and waiving
Overview of RIP 3.3
Objectives
Deliverables
Management
Status
European Chemicals Bureau
Croatia-JRC-ECB InfoDays, 11-13 December 2006
(some) REACH Political objectivesHow are they reflected in the Testing Strategies?
• Protection of human health and the environment• Maintenance and enhancement of the competitiveness• Prevent fragmentation of internal market• Increased transparency• Integration with international efforts• Promotion of non-animal testing (= avoid testing in animals)• Conformity with EU obligations under WTO
European Chemicals Bureau
Croatia-JRC-ECB InfoDays, 11-13 December 2006
• Protecting health and environment
– Gathering and generating the information required to prepare a Chemical Safety Report and eventually manage the risks.
– Priority evaluation of substances of particular concern (CMR, PBT, vPvB,…) or when an aggregate tonnage trigger has been reached. This may involve generating new data
REACH objectives (II)
European Chemicals Bureau
Croatia-JRC-ECB InfoDays, 11-13 December 2006
• Maintaining and enhancing competitiveness
– Exhaustive use of existing information (existing test results, human evidence, in vitro,…)
– Use of non-test based information (QSAR, grouping,…)
– No testing for very low production volumes (below 1 T) (and limited between 1-10 T)
– No requirements for polymers and intermediates (with limited exposure potential)
– Exposure driven tailored testing (exposure scenarios)
– R&D exemption (up to 10 y)
– Sharing of data
REACH objectives (III)
European Chemicals Bureau
Croatia-JRC-ECB InfoDays, 11-13 December 2006
• Promoting non-animal testing
Same as previous and, in addition:
– Allow non (not yet)-validated in vitro methods in some circumstances
– Evaluation of proposals for substance-tailored testing involving animals (in particular required under annexes IX and X)
– Limited testing in animals below 10 Tonnes
REACH objectives (III)
European Chemicals Bureau
Croatia-JRC-ECB InfoDays, 11-13 December 2006
REACH Implementation Projects (RIPs)
• RIP 1: REACH Process Description;• RIP 2: REACH – IT;• RIP 3: Technical Guidance and Tools for Industry;• RIP 4: Technical Guidance and Tools for Authorities;• RIP 5: Setting up the Pre-Agency• RIP 6: Setting up the Agency• RIP 7: Commission preparations for REACH
Preparing for REACH: RIPs
European Chemicals Bureau
Croatia-JRC-ECB InfoDays, 11-13 December 2006
Guidance for Industry on how to fulfil Information Requirements (RIP 3.3)
Information Integration before Testing
Endpointinformation
(Q)SARs
Read Across
In-vitro
ExposureScenarios(Annex IX/X)
Existinginformation
TESTING
?
RIP 3.3Intelligently Integrating Information
The 3 I’s
European Chemicals Bureau
Croatia-JRC-ECB InfoDays, 11-13 December 2006
Testing Annexes (Info requirements)
• Annex VI: Guidance on testing annexes plus basic information requirements
• Annex VII: Information requirements for >1T
• Annex VIII: Additional Information requirements for >10T
• Annex IX: Additional Information requirements for >100T
• Annex X: Additional Information requirements for >1000T
• Annex XI: General Guidance and rules for Adaptation of the standard test regime
Testing Methods Regulation
But always hand in hand with Annex I (CSR)!!
RIP 3.3 background (I)
European Chemicals Bureau
Croatia-JRC-ECB InfoDays, 11-13 December 2006
1 Gather + share existing information on– Properties: test results, QSAR estimates, human
data,…– Uses: current and foreseen– Exposure– Risk Management Measures: implemented or
proposed
2 Identify precise information needs on the basis of– Tonnage – Use– Exposure – Risk Management Measures
General guidance in Annexes VI and XI of draft REACH (1)
RIP 3.3 background (II)
European Chemicals Bureau
Croatia-JRC-ECB InfoDays, 11-13 December 2006
General guidance in Annexes IV and IX of draft REACH (2)
3 Identify information gaps and consider how missing information can be generatedConsider (Annex IX):
– Testing not scientifically necessary• Quality GLP and Annex X quality data exists• Adequate non-GLP or non-Annex X data exists• human data • weight of evidence• QSAR• grouping or read across• in vitro data
– Testing is technically not possible– Substance-tailored exposure-driven testing (consider exposure scenarios)
4 Generate new information or propose testing strategyAccording to Annexes VII to X and using the Testing Methods of the New Regulation
RIP 3.3 background (III)
European Chemicals Bureau
Croatia-JRC-ECB InfoDays, 11-13 December 2006
Development of Guidance for Industry on how to fulfil Information requirements
(RIP 3.3) Overview
• Introduction (Objectives, Deliverables, Organisation)
• Tasks (specific deliverables, status)
RIP 3.3
European Chemicals Bureau
Croatia-JRC-ECB InfoDays, 11-13 December 2006
Objectives of RIP 3.3
• Guidance for industry on how to fulfill the information requirements on intrinsic properties
(Annex VI to XI) andhow to use all information and testing in an optimal way for
decision-making under REACH
This should allow for:
• Carrying out Chemical Safety Assessment (CSA)– includes whether substance is PBT or vPvB
• Classification and labelling (C&L)– includes assessment whether a substances is CMR
European Chemicals Bureau
Croatia-JRC-ECB InfoDays, 11-13 December 2006
RIP 3.3 Deliverables
• Guidance on strategies for generation of information on relevant inherent properties; should explain and illustrate:
• How to find and use existing information (including human data, non GLP studies and other information obtained with non-standard test methods);
• How to implement the rules for adaptation as provided in the different annexes, especially for substances manufactured/imported in higher tonnages;
• The guidance shall provide the rationale for adaptation (waiving) from the test requirements specified in column 2 of Annexes VIII-X.
European Chemicals Bureau
Croatia-JRC-ECB InfoDays, 11-13 December 2006
RIP 3.3 Partners and Organisation (I)
•RIP 3.3. Consortium:– CEFIC (lead)– Concawe– ECETOC– Environment Agency (UK)– DK EPA– Eurométaux– INERIS (F)– KEMI (S)– OECD– RIVM (NL)– TNO (NL)
All are members of Project Management Group (PMG) plus DG ENTR and DG JRC ECVAM/ECB
– Ad hoc working groups – Endpoint Working Groups (EWG)
European Chemicals Bureau
Croatia-JRC-ECB InfoDays, 11-13 December 2006
RIP 3.3 Tasks
• Task 1 : General structure / cross-cutting issues
• Task 2 : Specific Endpoint Guidance
• Task 3 : Chemical Categories / Read Across guidance
• Task 4 : Preparation of draft TGD
European Chemicals Bureau
Croatia-JRC-ECB InfoDays, 11-13 December 2006
Task 1: General structure / cross-cutting issues
European Chemicals Bureau
Croatia-JRC-ECB InfoDays, 11-13 December 2006
Task 1
•ToRs ,Templates (HH and Env) and source documents for EWGs•Harmonisation of horizontal issues and
1 General introduction to REACH2 General Decision Making Framework2.1 Introduction2.2 General Decision Making Framework
3. Information requirements3.1 Information sources/searching3.2 REACH Annexes VI-X interpretation
4 Evaluation of available data4.1 Adequacy4.2 Reliability4.3 Relevance4.4 Fit for purpose
5 Considerations affecting information requirements and testing strategies5.1 Use of existing data5.2 WoE5.3 QSAR5.4 In vitro5.5 Grouping & Read across5.6 Testing is technically not possible5.7 Substance tailored exposure driven testing5.8 Toxicokinetics5.9 Non standard Substances
8 Conclusions on Hazard assessment8.1 Concluding C&L8.2 Concluding DNEL8.3 Info not adequate either for C&L and/or DNEL8.4 Remaining uncertainties
9 Glossary STATUS: 2nd draft available in December
European Chemicals Bureau
Croatia-JRC-ECB InfoDays, 11-13 December 2006
6 Dose response relationship6.1 Derivation of NOAEL, starting point, assessment factors6.2 Modification of NOAEL or LOAEL6.3 Different routes of exposure and bioavailability6.4 Deriving adequate starting point
7 ITS7.1 Phys-chem &adsoption desorption7.2 Skin&Eye Irritation/corrosion & respiratory irritation7.3 Skin & respiratory sensitisation7.4 Acute toxicity7.5 Repeated dose7.6 Reproductive & Developm. Toxicity7.7 Muta and Carcinogenicity7.8 Aquatic Toxicity; long term tox to sediment7.9 Degradation/Biodegradation7.10 Bioconcentration & Bioaccumulation/ long term birds7.11 Effects on Terrestrial Organisms
RIP 3.2
Task 2
European Chemicals Bureau
Croatia-JRC-ECB InfoDays, 11-13 December 2006
Task 2: Development of Guidance & ITS for Specific Endpoints (general)
• PURPOSE OF REACH Balance between ensuring high level of Human Health and Environmental protection - limitation of EU industry administrative burdens/costs in order to maintain competitiveness and innovative capacity (Council document 7524/06 AD1)
• MEANSProviding adequate information for C&L and for carrying out CSA
• HOW- Providing integrated testing strategies.- Minimizing animal testing
• THEREFORE- Integrated testing strategy: move from old to new strategy; tiered approach- Guidance which is accessible and understandable for non-expert- Scientifically robust but practical
European Chemicals Bureau
Croatia-JRC-ECB InfoDays, 11-13 December 2006
Task 2: Development of Guidance & ITS for Specific Endpoints
DELIVERABLES:
• Guidance on identifying information sources and how to ensure the reliability of the used information (generic aspects part of Task 1);
• A testing strategy to help registrants provide adequate and relevant information for registration sufficient for
– Carry out Chemical Safety Assessment (CSA)– Classification and labelling
• Guidance on when and how to use alternative information (instead of (animal) testing) including guidance on what is “adequate and reliable documentation”;
HOW: by specific Endpoint Working Groups (EWG)
STATUS: variable depending on EWG, drafts to be sent to SEG in December
European Chemicals Bureau
Croatia-JRC-ECB InfoDays, 11-13 December 2006
Develop non-prescriptive guidance:
1. explanation of key concepts: SARs, read-across and categories (including sub-categories)
2. how to perform qualitative and quantitative read-across
3. how to build a category (including special cases)
4. how to justify and report the “adequacy” of a read-across or category proposal appropriate reporting formats
Task 3: Guidance on Chemical Categories / Grouping of Substances
STATUS: 6 consensus chapters + >10 individual appendices Submission to SEG on December. Being integrated in Task 1
Results being Merged in Task 1
European Chemicals Bureau
Croatia-JRC-ECB InfoDays, 11-13 December 2006
Task 4 – Preparation of draft TGD
• Specific objective: To combine all the input from the Working Groups into the overall Technical Guidance Document
• Deliverables:– final draft of the Technical Guidance for RIP 3.3
• Status: Task 1 Drafting Group is already engaged in defining the structure and generic content of the overall TGD Information Requirements, liaising with RIP 3.2 to ensure compatibility. To be developed mainly in 2007.
All package expected to be delivered by April 2007
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