19.11.2009   

EN

Official Journal of the European Union

CE 279/85

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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,

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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),

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

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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),

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

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

A.

whereas the draft Commission Regulation aims at

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:

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.