UPDATE – New Biological Agents Ordinance (BioStoffV) comes into force

On 5 December 2024, the BioStoffV was amended (see Federal Law Gazette . The footnote to protective measure No. 22 of Annex II of the BioStoffV was amended, which now refers to the new [EU Regulation 2021/821] Annex II of the BioStoffV itself deals with the additional Protective measures during activities in laboratories and similar facilities, as well as in laboratory animal husbandry. According to protective measure No. 22, biological substances must be stored under lock and key. This concerns the so-called dual use (“Dual Use”) of biological substances. AGCT Genetic Engineering. Report from 31.08.2022 “What are dual-use organisms?” and from December 1, 2020 We have already discussed such biological agents in more detail in the section “Storage and access regulations for dual-use organisms”.

The corresponding new footnote refers to the new version of EU Regulation 2021/821 with current amendments from January 2023. For the lists to be applied from it, not only the human, but also the animal pathogens mentioned in the footnote (1C351). Furthermore, toxins Mention in the new footnote. Genetically modified organisms can still be found in list 1C353. A detailed comparison of the old and new footnote text can be found, among other places, here .

The amendment to the Ordinance on Biological Substances (BioStoffV) can be used as an opportunity to review biological substances used in laboratories or animal husbandry for possible dual use. This is applicable for activities involving biological substances from the Risk group 2 Corresponding current lists of pathogens can be found in Part III of EU Regulation 2021/821 under 1C351 and 1C353.