EUROPE: New rules for micro-organisms

The European Commission adopted 4 implementing Regulations which amend the current rules applicable to micro-organisms. While, so far, the requirements for micro-organisms have been based on principles very similar to those relating to chemical active substances, these new rules follow a different approach. This new approach takes into account the most recent scientific knowledge and the specificity of micro-organisms, compared to “classical” chemical substances, e.g. the biology and ecology of each micro-organism.

These new requirements are expected to lead to easier and faster approval of micro-organism active substances, and authorization of products containing these substances.

These texts also propose useful definitions for their understanding and their implementation (in particular manufactured microbial pest control agent, metabolite of concern, etc).

The four implementing Regulations will enter into applicability as of November 2022 (with transitory measures up to 2024). 

To download: 

• Commission Regulation (EU) 2022/1438, amending Annex II to Regulation (EC) No 1107/2009: specific criteria for the approval of active substances that are micro-organisms
• Commission Regulation (EU) 2022/1439, amending Regulation (EU) No 283/2013: information to be submitted for micro-organisms active substances 
• Commission Regulation (EU) 2022/1440, amending Regulation (EU) No 284/2013:  information to be submitted for plant protection products containing micro-organisms
• Commission Regulation(EU) 2022/1441, amending Regulation (EU) No 546/2011: new specific uniform principles for evaluation and authorisation 

See also our previous articles: 

EUROPE: New draft rules for the use of microorganisms in PPP

Lynxee consulting’s team is at your disposal to answer your questions.

Contact us! http://lynxee.consulting/en/contact/

Photo credit : nadya_il /pixabay