The Environmental Management Activities Regulation has been abolished with effect from 1 January 2024 due to the entry into force of the Environmental Act. As a result, there is no longer a pathogenicity class classification as shown in Appendix 3 of the regulation. However, animal pathogens have been designated for which biosafety and biosecurity measures apply, and for which there is a reporting obligation for laboratory managers.

Containment measures

The EU Implementing Regulation 2018/1882 ([ignore]https://eur-lex.europa.eu/eli/reg_impl/2018/1882/oj[/ignore]) includes a list of animal pathogens, including a classification into categories for listed diseases and susceptible species. This concerns five categories (A to E) of diseases for which the EU Regulation (EU) 2016/429 (European Animal Health Regulation, [ignore]https://eur-lex.europa.eu/eli/reg/2016/429/oj[/ignore]) rules have been established for the prevention and control of these diseases.

Article 16 of the European Animal Health Regulation (2016/429/EU) contains obligations for laboratories and other institutions that work with pathogens, vaccines and other biological products. Such institutions should take appropriate biosecurity, biosafety and biocontainment measures to prevent the pathogens (as listed in 2018/1882/EU) from being released into the environment from the laboratory and then come into contact with animals outside the laboratory. An explanation (in Dutch) of the requirements imposed on laboratory managers can be found in the explanatory memorandum to the Veterinary Medicines Decree 2022 under Article 4.4.3. “Werken met ziekteverwekkers” ([ignore]https://zoek.officielekennismakingen.nl/stb-2021-169.html[/ignore]).

Notification and Reporting

In addition to the European Animal Health Regulation (2016/429/EU), the Veterinary Medicines Decree 2022 ([ignore]https://wetten.overheid.nl/BWBR0046416/2022-03-11[/ignore]) includes a reporting obligation for working with pathogens ( Article 6.1). This states, among other things, that the person responsible for a laboratory, facility or other space where a pathogen designated by ministerial regulation is located must report this if the pathogen:

- is present in the laboratory, facility or space for a period of at least 30 consecutive days; or
- is grown there.

The Veterinary Medicines Regulations 2022 ([ignore]https://wetten.overheid.nl/BWBR0046239/2024-01-01[/ignore]) includes an appendix with pathogens that must be reported. A further explanation (in Dutch) of the Veterinary Medicines Decree 2022 is included in the explanatory memorandum to the Decree under Article 4.4.3. “Werken met ziekteverwekkers” ([ignore]https://zoek.officielekennismakingen.nl/stb-2021-169.html[/ignore]). The notification must be made to the Netherlands Food and Consumer Product Safety Authority (NVWA) .