# EUR-Lex - 52008IP0234 - EN

Important legal notice

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# 52008IP0234

**REACH (Draft Test Methods Regulation) European Parliament resolution of 22 May 2008 on the draft Commission Regulation laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) **

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Official Journal C 279 E , 19/11/2009 P. 0085 - 0089 *

REACH (Draft Test Methods Regulation)

P6_TA(2008)0234

European Parliament resolution of 22 May 2008 on the draft Commission Regulation laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)

(2009/C 279 E/19)

The European Parliament,

- having regard to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency [1], and particularly Article 13 thereof,

- having regard to the draft Commission Regulation laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (CMT(2007)1792/7) (hereinafter the draft Commission Regulation),

- having regard to the opinion delivered by the committee referred to in Article 133 of the REACH Regulation,

- having regard to Article 5a(3)(b) of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission [2],

- having regard to Oral Question B6-0158/2008 by its Committee on the Environment, Public Health and Food Safety,

- having regard to Rule 108(5) of its Rules of Procedure,

A. whereas the draft Commission Regulation aims at

- transferring test methods currently contained in Annex V of Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances [3] to a new Commission Regulation, and

- including new or revised test methods which are currently not incorporated in Annex V of Directive 67/548/EEC but were to be included in Annex V as part of the 30th Adaptation to Technical Progress, by 1 June 2008,

B. whereas the draft Commission Regulation is of particular importance also for legislation on other sectors, such as cosmetics [4] and pesticides [5], since the acts relating to them refer to test methods included in chemicals legislation,

C. whereas the total number of animals used for experimental and other scientific purposes in 2005 in the Member States was approximately 12 million [6] and a significant percentage of these animals were used for regulatory testing,

D. whereas the protocol on protection and welfare of animals annexed to the Treaty of Amsterdam provides that in formulating and implementing the Community's agriculture, transport, internal market and research policies, the Community and the Member States shall pay full regard to the welfare requirements of animals, while respecting the legislative or administrative provisions and customs of the Member States relating in particular to religious rites, cultural traditions and regional heritage,

E. whereas the REACH Regulation lays down that, in order to avoid animal testing, testing on vertebrate animals for the purposes of the Regulation shall be undertaken only as a last resort, and that, in particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, through the use of alternative methods, for example in vitro methods or qualitative or quantitative structure-activity relationship models or from information from structurally related substances (grouping or read-across),

F. whereas Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes [7] stipulates that an experiment on animals shall not be performed if another scientifically satisfactory method of obtaining the result sought, not entailing the use of an animal, is reasonably and practicably available and that, in a choice between experiments, those which use the minimum number of animals, involve animals with the lowest degree of neurophysiological sensitivity, cause the least pain, suffering, distress or lasting harm and are most likely to provide satisfactory results shall be selected,

G. whereas the European Centre for the Validation of Alternative Methods (ECVAM) validated a number of alternative methods in 2006/2007 [8] which are, however, not included in the draft Commission Regulation,

H. whereas the draft Commission Regulation furthermore contains one animal testing method which is obsolete, as the same draft Regulation also contains an alternative method for the same endpoint,

I. whereas the Commission justifies the non-inclusion of the validated alternative tests by stating that they have not yet been approved for regulatory purposes,

J. whereas the Commission defers to the OECD with regard to the regulatory acceptance procedure for three of the five tests,

K. whereas the development and publication of an OECD Test Guideline (TG) generally takes a minimum of 3 years, as the relevant institutional bodies meet only once a year, and OECD TGs are not always implemented in the same manner by all OECD Member States,

L. whereas the Commission has made it clear that it always tries to proceed first within the OECD framework; whereas this is contrary to EU legislation and the spirit of the cosmetics Directive 76/768/EEC, which gives priority to the EU process,

M. whereas the predetermined priority for the OECD process of regulatory approval entails at best lengthy delays, and may even prevent an alternative method from being put into practice,

N. whereas there do not seem to be sufficient rules for an efficient preliminary analysis of regulatory relevance before ECVAM scientifically validates an alternative test,

O. whereas the basic concepts of validation and legal acceptance are not used in a uniform manner at national, Community and international level and EU legislation does not provide any definition of "validation" (or criteria for validators) or "regulatory (or legal) acceptance" [9],

P. whereas Commission Communication SEC(1991)1794 provides ECVAM only with a relatively weak mandate to validate alternative methods, although ECVAM has delivered highly appreciated and valuable output in recent years,

Q. whereas validation is also carried out by other national and international bodies and, therefore, the need for formal validation and a type of validation/assessment appropriate for each sector/purpose should be assessed and clarified [10],

R. whereas the internal regulatory acceptance procedure in the European Chemicals Bureau (ECB) after validation by ECVAM and before launching the procedure for possible inclusion of a test method in legislation seems to be inappropriate,

S. whereas the conditions by which potentially far-reaching decisions under this procedure, such as questioning scientific validation by ECVAM or transferring validation and regulatory acceptance to the OECD level, are taken should be decided case by case in a transparent and accountable manner at political level,

T. whereas it is not acceptable that timely inclusion of new alternative methods validated by ECVAM in the draft Commission Regulation is not yet possible due to delays brought about by the opaque, slow, cumbersome and partly inappropriate procedures for the regulatory acceptance of validated alternative methods to animal testing,

U. whereas the problems identified in the area of chemicals legislation concerning validation and regulatory acceptance of alternative test methods might have an even larger dimension when other industrial sectors are taken into account,

1. Refrains from opposing the adoption of the draft Commission Regulation in the light of the formal commitment received from the Commission in its letter of 5 May 2008 to make the following arrangements to streamline and speed up the Commission's internal procedures for the validation and regulatory acceptance of new alternative test methods:

- the Commission will introduce a "preliminary analysis of regulatory relevance" in all cases to ensure that subsequent scientific validation focuses on test methods that have the best potential to be considered suitable for clearly identified regulatory purposes;

- the Commission will reduce the number of steps and establish new and clear deadlines to streamline and accelerate the current process, insofar as the role of advisory committees and consultation with Member States is concerned;

- all important procedural decisions to be taken by the Commission will be taken at Director-General level;

- the current reorganisation of the JRC Institute for Health and Consumer Protection (IHCP) will make an important contribution to accelerating the on-going efforts to advance alternative methods, including their validation, via ECVAM. This will involve reinforcement of ECVAM's work through support by other IHCP teams. The IHCP is also developing an integrated testing strategy which will leverage the synergies of many complementary activities within the IHCP and allow a more holistic and effective approach to the question of risk assessment, which is central to the regulatory process, thus avoiding unnecessary internal transmission delays. The integrated testing team will, in 2009, consist of about 85 staff members (including the present 62 ECVAM staff members). As part of its contribution to streamlining the process from scientific validation to regulatory acceptance, IHCP will ensure close and consistent follow-up of the regulatory acceptance process both within the Commission and at the level of the OECD;

- the revised process will be more transparent. The procedures for regulatory acceptance of new test methods will be published on the Commission's website once the current review is formalised. The current status of proposed alternative methods will be posted on a specific website to be set up by the JRC allowing interested parties to track progress; the information will be regularly updated. This will happen from the moment any proposed new alternative method undergoes a preliminary regulatory analysis. The website will also include an indication of decisions not to proceed with a particular test method and the reasons why such decisions are taken;

- the Commission will ensure that stakeholders have the opportunity to intervene, as observers, in Competent Authorities' meetings and in Committees of the European Chemicals Agency (for industrial chemicals) when matters relating to validation of non-animal tests are concerned;

- in line with Article 13(2) of the REACH Regulation, the Commission will provide for a more transparent process involving consultation of stakeholders in the run-up to any proposal for an Adaptation to Technical Progress of the Test Methods Regulation;

- the Commission will make the necessary resources available to ensure that real improvements are achieved, in particular by inviting applications from qualified staff with the relevant expertise to be seconded to the OECD Test Guidelines Programme (TGP) in the near future. It will look into possibilities of providing financial support to the OECD TGP Secretariat, concentrating specifically on regulatory acceptance of alternative test methods;

- the Commission will monitor the OECD process closely in each individual case to make sure that following this route does not entail undue delays. This will include systematic stocktaking of the progress of each alternative method at regular intervals. Any unreasonable delays in relation to a particular method will result in the Commission launching the EU process for regulatory approval for the method in question;

2. Understands that the streamlining and acceleration of the internal procedures apply to the entire process from validation to regulatory acceptance with no gaps;

3. Calls on the Commission to ensure full stakeholder participation throughout the process from validation to regulatory approval;

4. Urges the Commission to come forward with a proposal for the first adaptation to technical progress of the Regulation by the end of 2008 as the litmus test for the implementation of the commitments indicated in paragraph 1;

5. Calls on the Commission to report to Parliament by the end of 2008 on the implementation of those commitments;

6. Instructs its President to forward this resolution to the Council, the Commission and the governments and parliaments of the Member States.

[1] OJ L 396, 30.12.2006, p. 1. Corrected in OJ L 136, 29.5.2007, p. 3. Regulation as amended by Council Regulation (EC) No 1354/2007 (OJ L 304, 22.11.2007, p. 1).

[2] OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, p. 11).

[3] (OJ 196, 16.8.1967, p. 1). Directive as last amended by Directive 2006/121/EC of the European Parliament and of the Council (OJ L 396, 30.12.2006, p. 850).

[4] Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (OJ L 262, 27.9.1976, p. 169). Directive as last amended by Commission Directive 2008/42/EC (OJ L 93, 4.4.2008, p. 13).

[5] Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1). Directive as last amended by Commission Directive 2008/45/EC (OJ L 94, 5.4.2008, p. 21).

[6] Commission's fifth Report on the Statistics on the Number of Animals used for Experimental and other Scientific Purposes in the Member States of the European Union, COM(2007)0675.

[7] OJ L 358, 18.12.1986, p. 1. Directive as amended by Directive 2003/65/EC of the European Parliament and of the Council (OJ L 230, 16.9.2003, p. 32).

[8] EpiDERM and EPISKIN (ECVAM/ESAC statement on 27 April 2007), Reduced Local Lymph Node Assay (ECVAM/ESAC statement of 27 April 2007), Bovine Corneal Opacity and Permeability (BCOP) and Isolated Chicken Eye (ICE) Tests (ECVAM/ESAC statement of 27 April 2007), Acute Toxicity for Fish (ECVAM/ESAC statement of 21 March 2006).

[9] European Partnership for Alternative Approaches to Animal Testing, First Annual Progress Report, December 2006, p. 19, http://ec.europa.eu/enterprise/epaa/conf_2006.htm

[10] European Partnership for Alternative Approaches to Animal Testing, First Annual Progress Report, December 2006, p. 19, http://ec.europa.eu/enterprise/epaa/conf_2006.htm

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