As a sub-group of plant protection products, biopesticides have the same authorisation procedure as 'conventional' plant protection products. The information regarding the procedure therefore also applies to biopesticides.

However, the authorisation of biopesticides also has specific aspects which result in modified data requirements, assessment or template to submit a dossier. the following points provide additional information for biopesticides.

Plant extracts

The European Commission has drafted a document with adapted requirements for active substances in plant protection products, and in products based on plant extracts:

• Guidance document on botanical substances used in plant protection products (Sanco/11470/2012 – rev.8).

The OECD has drafted a guidance document specifically for plant extracts. This document helps in preparing an application dossier and its assessment:

• OECD Series on pesticides number 90 (ENV/JM/MONO(2017)6 – Guidance document on botanical active substances used in Plant Protection Products

Micro-organisms

The specific criteria for the approval of active substances that are micro-organisms are listed in Commission Regulation (EU) 2022/1438 of 31 August 2022 amending Annex II to Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards specific criteria for the approval of active substances that are micro-organisms.

The requirements for micro-organisms active substance are listed in Corrigendum to Commission Regulation (EU) 2022/1439 of 31 August 2022 amending Regulation(EU) No 283/2013 as regards the information to be submitted for active substances and the specific data requirements for micro-organisms.

The requirements for plant protection products which contain micro-organisms are listed in Corrigendum to Commission Regulation (EU) 2022/1440 of 31 August 2022 amending Regulation (EU) No 284/2013 as regards the information to be submitted for plant protection products and the specific data requirements for plant protection products containing micro-organisms

The specific uniform principles for micro-organisms are listed in Corrigendum to Commission Regulation (EU) 2022/1441 of 31 August 2022 amending Regulation (EU) No 546/2011 as regards specific uniform principles for evaluation and authorisation of plant protection products containing micro-organisms.

The template for the dRR which must be used for submitting an application is adapted for these products.

The OECD has drafted a guidance document specifically for micro-organisms. This document helps in preparing an application dossier and its assessment:

• OECD Series on pesticides number 18 (ENV/JM/MONO(2003)5 – Guidance for registration requirements for microbial pesticides.

Pheromones

The European Commission has drafted a guidance document specifically for pheromones. This document helps in preparing an application dossier and its assessment:

• Guidance document on semiochemical active substances and Plant Protection Products – SANTE/12815/2014 rev. 5.2

Other biopesticides

For other biocides, the following document of the European Commission can be used:

• Draft working document (SANCO/10473/2003 – rev.5) concerning the data requirements for certain chemical active substances and plant protection products containing such substances