Subject: Future EU rules on the import and use of equine chorionic gonadotropin
Equine chorionic gonadotropin (eCG) is a hormone extracted from the blood of pregnant mares and used to synchronise oestrus and increase fertility in farmed animals. Investigations by non- governmental organisations have raised serious concerns about the welfare of mares kept in ‘blood farms’ in Iceland, Uruguay and Argentina, as well as of farmed animals that are administered the hormone throughout the EU.
Alternatives to eCG, which is also known as pregnant mare serum gonadotropin, are already available. This means that it is dispensable and in breach of Directive 2010/63/EU1and the principle of the Three Rs (replacement, reduction and refinement) in relation to the use of animals.
1. Does the Commission intend to clarify that the production of eCG is in breach of Directive 2010/63/EU on the protection of animals used for scientific purposes?
2. Will it propose a ban on imports of eCG from outside the EU, on animal welfare grounds?
3. Can it clarify the timeline for the revision of the guidelines on good manufacturing practice and ascertain whether eCG production can be listed as a prohibited practice in view of the standards that will be included?
Submitted: 22.5.2023
1 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).
Answer given by Ms Kyriakides on behalf of the European Commission
(7 July 2023)
1. Directive 2010/63/EU (2) on the use of animals for scientific purposes has been transposed by Member States into their national legislation and its correct application and enforcement is the responsibility of the Member State authorities. Competent authorities must carry out a case by case project evaluation to ensure that all authorised projects comply with the Three Rs principle (3).
2. The options currently being assessed by the Commission for the revision of the EU animal welfare legislation, including Council Directive 98/58/EC (4), do not include the option of a ban on the production or use of Pregnant Mare Serum Gonadotropin (PMSG). However, one option being considered is the inclusion in the EU animal welfare rules of specific provisions on the welfare of horses, which could include empowerments to adopt delegated acts based on future opinions of the European Food Safety Authority. Those specific requirements on the welfare of horses might have an impact on the conditions of extraction of blood serum from pregnant mares for the production of PMSG.
3. The implementing act on Good Manufacturing Practice (GMP) referred to in Article 93(2) of Regulation (EU) 2019/6 (5) is to be adopted by 29 January 2025. Preparatory work is ongoing and scientific advice from the European Medicines Agency on its content is expected by the end of December 2023.
With regard to the production of Equine chorionic gonadotropin (eCG), Recital 68 of Regulation (EU) 2019/6 refers to the fact that GMP should take account of international animal welfare standards. Should Union or international standards be developed in the future, in particular as a result of the above-mentioned revision, the Commission would take these into account and amend the implementing act on GMP.
1 ∙ ⸱ 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).
2 ∙ ⸱ https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32010L0063
3 ∙ ⸱ To Replace, Reduce and Refine the use of animals in scientific procedures.
4 ∙ ⸱ Article 38(2)(b) of Directive 2010/63/EU, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A31998L0058
5 ∙ ⸱ Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC.
OJ L 4, 7.1.2019, p. 43.