European Union | Draft Commission Regulation amending Annex II to Regulation (EC) No 1107/2009 as regards specific criteria for the approval of active substances that are micro-organisms

Title of document
Draft Commission Regulation amending Annex II to Regulation (EC) No 1107/2009 as regards specific criteria for the approval of active substances that are micro-organisms (5 page(s), in English; 3 page(s), in English)

Description
This draft Commission Regulation includes the amendments of the approval criteria of microbial active substances set in Annex II to Regulation (EC) No 1107/2009 which needed to be complemented in order to appropriately reflect the particularities of micro-organisms.

Notifying member: European Union

Notification: G/TBT/N/EU/849

Objective tag
Protection of human health or safety; Protection of animal or plant life or health; Protection of the environment

Objective
The Farm to Fork Strategy aims, among others, at reducing dependency on chemical pesticides, also by facilitating the placing on the market of biological active substances, including micro-organisms. To support this objective, this Regulation aims at specifying approval criteria for microbial active substances in Annex II to Regulation (EC) No 1107/2009, in order to appropriately reflect the particularities of microbial active substances, which are different from chemical substances. This initiative is complemented by others concerning: the Commission Regulation (EU) No 283/2013 setting out the data requirements for active substances which are micro-organisms (submitted in parallel for TBT), the Commission Regulation (EU) No 284/2013 setting out the data requirements for plant protection products including active substances which are micro-organisms (submitted in parallel for TBT), the Commission Regulation (EU) No 546/2011 setting out the uniform principles for evaluation and authorisation of plant protection products (submitted in parallel for TBT), two Commission Communications in the framework of the implementation of Commission Regulation (EU) No 283/2013 and Commission Regulation (EU) No 284/2013 (will be submitted for TBT).

Documents

• 21_6923_00_e.pdf
• 21_6923_01_e.pdf

Agency responsible
European Commission

Timing:

• Submission: 29/10/2021
• Reception: 01/11/2021
• Distribution: 01/11/2021
• Final date for comments: 31/12/2021
• Proposed date of adoption: N/A