In September 2010, the European Parliament adopted a binding directive for the protection of laboratory animals. Its aim is the implementation of the principle “Reduce, refine, replace”. The directive is exclusively concerned with experiments related to testing medicaments and research on diseases. Some important points of the directive are:

- Apes may only be used for research purposes in exceptional cases (Art. 8).

- The authorization requirement for animal experiments has been expanded to include experiments for educational purposes (Art. 23, para. 2).

- Every proposal for carrying out an experiment on animals must be summarized and anonymously published (Art. 43).

- The maintenance of laboratory animals must be done by qualified personnel.

- There are specific load levels for the tests, so that animals, which have already been heavily burdened, are to be excluded from further tests (Art. 15).

- Experiments must be divided into different load levels which must be prospectively published with the statistics on the numbers of laboratory animals (Art. 54, para. 2).

- Fatal experiments on animals and all experiments on primates must be retrospectively evaluated. Also less severe experiments can be retrospectively evaluated by the responsible authorities (Art. 38).

- Possible alternatives to experiments on animals must be officially allowed (Art. 4, para. 1 and art. 47).

 On 3 June 2010 the cabinet formally accepted the directives and put them into effect. The member states have two years to implement the law.

The following EU-Regulations represent a selection of the documents relevant to the present legal development:

Annex 5 of Directive 67/548/EEC of the European Parliament and of the Council of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances,
Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products,
Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market,
Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market,
Regulation (EC) No. 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents.
The European Pharmacopeia also requires tests that include animal experiments.

Recently, the so-called REACH-Regulation (No. 1907/2006) has triggered controversies among the population.

With this regulation, the European Union creates a system for the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishes a European Chemicals Agency (ECHA). The REACH-system aims at ensuring a higher level of protection for human health and the environment concerning chemical products.

Not only does the REACH-Regulation bind producers and importers to make subject to an evaluation process all such products that exceed a yearly amount of one ton per producer and per importer; they also have to arrange for the re-evaluation of  chemicals that had already been on the market prior to the regulation.

Although the regulation explicitly declares the advancement of alternative test procedures to be the primary concern and issues a duty to inform concerning animal experiments that have already been conducted (Article 27, paragraph 1) in order to obviate unnecessary multi-experiments, the number of test animals is expected to rise significantly until 2020.

There is, however, deep disagreement concerning exact numbers. While the EU acts on the assumption of nine millione animals  needed for the REACH-system, researchers of the Johns Hopkins Center for Alternatives to Animal Testing by means of extrapolation have arrived at the result of 54 million animals. Until the first registration deadline on 30 November 2010, 24,675 dossiers were submitted to ECHA, most of them by large enterprises, small and medium-sized enterprises accounting for 10 % of the dossiers.

Through the disclosure and conjunction of information, a higher protection level shall be obtained for human health and the environment in relation to chemical products. Further registration deadlines are scheduled for 2013 and 2018.