Statistics for 2018 on the use of animals for scientific purposes, which were released on 15 July 2021 by the Directorate-General for the Environment, show that dogs were used a total of 25 722 times in 2018, up by 20 % since 2017. 108 tests were conducted on dogs to satisfy requirements for plant protection product legislation and 36 tests on dogs were carried out to satisfy requirements for industrial chemicals legislation.
1. Can the Commission explain why dogs were used in relation to chemicals legislation?
2. What is it doing about the use of dogs (or any another species, as animals were used a total of 69 424 times for satisfying non-EU legislative requirements only) for non-EU purposes where their use is not required in the EU?
3. What is it recommending to reduce and replace the use of dogs for satisfying requirements for plant protection and chemicals legislation and will it review the need for dogs across all areas?
1. The EU Chemicals Regulation(1) does not require the use of dogs to obtain safety data. Following the contacts with respective Member States, it was confirmed that in one case the entries had been erroneously recorded under chemicals legislation. The correct reference should have been ‘legislation on medicinal products for human use’. In the second case, the investigation is still ongoing.
2. The directive on the protection of animals used for scientific purposes(2) does not allow the use of animals in cases where an alternative non-animal method is recognised by the legislation of the Union. However, when there is no equivalent testing requirement in the EU, animals can be used to satisfy legislation in third countries. The Commission is continuously working to improve harmonisation of safety and efficacy data requirements through collaboration with international organisations(3).
3. A 90-day study on dogs is currently required(4) to provide information on potential health effects on humans of active substances used in plant protection products‐ including possible neurotoxic, immunotoxic, genotoxic and endocrine disruptive effects. However, in general to fulfil the data requirements under Regulation (EC) 1107/2009(5), unnecessary animal testing must be avoided(6) and other methods (e.g. in vitro testing, in silico methods) need to be taken into account where possible.
The Commission is at present not reviewing the use of dogs across all areas but does not exclude such a possibility in the future. Currently, no clear trend in dog use can be identified. Since 2015, the use of dogs has fluctuated, with the highest use in 2018 (25 717 uses) and the lowest use just a year before 2017 (21 359 uses)(7).
(1) REACH: 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, establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, OJ L 396, 30.12.2006.
(2) Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes, OJ L 276, 20.10.2010, p. 33.
(3) such as the Organisation for Economic Cooperation and Development , the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and the Veterinary International Conference on Harmonisation.
(4) Data requirement set out in point 5.3.2 of Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, OJ L 93, 3.4.2013, p. 1.
(5) Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC, OJ L 309, 24.11.2009, p. 1‐50.
(6) In accordance with Directive 2010/63/EU, Regulation (EC) No 1107/2009 (Recitals 11 and 40, Articles 8.1(d), 18(b), 33.3(c) and 62.1)