New requirements for animal testing

The amendments to the Animal Welfare Act (TierSchG) and the Animal Welfare and Experimental Animal Ordinance (TierSchVersV) came into force on January 1, 2022. The press has only heard a little about them because they also affected dog ownership. However, the amendments also addressed animal transport, the killing of day-old chicks, commercial breeding, the ban on tethering in livestock farming, and, of course, animal testing.

What is relevant for research-based university institutions is, among other things, that for animal experiments conducted for the purpose of education, training, and continuing education (Section 7a, Paragraph 1, No. 7 of the Animal Welfare Act), notification is no longer sufficient, as was previously the case; instead, a permit is required under Section 34 of the Animal Welfare Ordinance. For non-university institutions, this now also applies to animal experiments for the approval of pharmaceuticals (Section 7a, Paragraph 1, No. 4 of the Animal Welfare Act).

In addition, the review processes for the authorities have been expanded, which means that facility operators must meet additional requirements. Due to the new definition of the term "animal experiment" in Section 7 of the Animal Welfare Act (TierSchG), since the beginning of the year, interventions or treatments that do not serve experimental purposes are also considered animal experiments. Before animal experiments can be conducted, proof of necessity must always be provided (Section 7a Paragraph 1 Sentence 1 of the Animal Welfare Act). Furthermore, on the authorities' side, Section 15 of the Animal Welfare Act requires the establishment of an animal experiment commission that does not consist exclusively of scientists.

Since the Animal Welfare Act and the Animal Welfare Ordinance are also environmental regulations, the new requirements can also be imposed on experimental projects that have previously obtained approval through notification. There is therefore no protection against grandfathering. This applies, for example, if the facility or the purpose of the research is changed.