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Appendix 4: Methods Adopted by the EU for Testing Chemicals

In the EU, legally recognised and standardised testing methods for determining the hazardous properties of chemical substances are contained in Annex V of Directive 67/548/EEC on the Classification, Packaging and Labelling of Dangerous Substances. Once included in Annex V, the results obtained with these methods are recognised by the regulators. They play a central role in chemicals control, and they are referred to in many other pieces of EU legislation (for example, those related to dangerous preparations, pesticides, cosmetics and biocides also refer to these methods). The standardised Annex V Testing Methods, on the one hand, are the basic tools for generating the data needed for the hazard prediction and risk assessment of chemicals. These constitute the basis for attaining a high degree of protection for human health and the environment in the EU. On the other hand, they are also important for ensuring the Single Market in the EU, by allowing the free movement of goods between EU Member States. The Annex V methods are either original or are adaptations of internationally recognised standards (for example, those of the International Standards Organisation [ISO], the United Nations [UN] or the OECD). When they are adaptations of internationally recognised methods, they also contribute to the free movement of goods at the global level. For this reason, their development is closely linked and coordinated, in particular, with the parallel OECD Test Guidelines programme. DG Environment of the European Commission (EC) proposes to the Member States the methods which should be introduced into Annex V. This is done by an Adaptation to Technical Progress (ATP) of the “mother” Directive, Directive 67/548/EEC. For such an Adaptation, the EC prepares a proposal for a Directive that would amend Directive 67/548/EEC by introducing new or updated existing methods into Annex V, and presents it to the relevant Regulatory Committee. In this Committee, the delegates from Member States can discuss the fine-tuning of the proposal and then vote on it by qualified majority. In case of a favourable vote, the Directive is subsequently adopted by the EC, and soon afterwards, it is published in the Official Journal of the European Union. All the technical work needed for preparing an EC proposal for Annex V methods is carried out by the European Chemicals Bureau (ECB) of the EC Joint Research Centre, in consultation with the Group of the National Coordinators for Testing Methods, who are experts from the Member States, supported, as necessary, by further experts in their respective countries. The National Coordinators represent the Competent Authorities (CAs) of the Member States and advise the ECB on any issues related to Testing Methods. Whenever a need for a new or updated method is identified, either by the EC Services or by the CAs of the Member States, it is discussed by the National Coordinators, who advise, either in a meeting or by a written procedure, on the proposed testing protocol, work plan, priorities and preferred approach.