european chemicals bureau croatia-jrc-ecb infodays, 11-13 december 2006 the testing methods process:...

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



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



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



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



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.


PHYSICO-CHEMICALPROPERTIES

Part C.


ECOTOXICITY

Part C.


ECOTOXICITY

Part B.


TOXICITY

Part B.


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



Where



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



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



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



Testing MethodsDevelopment (II)

Member StatesCompetent Authorities

Scientific Community

National Co-ordinators Meeting or written procedureadvice on work plan

prioritiespreferred approach


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



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



REGULATORY ACCEPTANCEof TMs (extract)



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?



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



INTERIMfrom Annex V to the new Testing Methods

Regulation and REACH



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:



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



(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



• 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)



• 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)



• 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)



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



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



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)



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)



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)



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



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



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.



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)



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



Task 1: General structure / cross-cutting issues



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



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



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



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



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



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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