The EU’s Green Deal Farm to Fork Strategy is moving us towards a sustainable food system.

The European Union has announced, amended, and adopted the regulations regarding biopesticides on (EU) Nos. 546/2011 and 1107/2009 (Annex II). They lay out standardized principles and criteria for assessing and authorizing plant protection products and microorganism active substances. Regulation (EU) No. 283/2013 gives the information to be submitted for active substances and the specific data requirements for micro-organisms.  Regulation (EU) No 284/2013 gives the information to be submitted for plant protection products and the specific data requirements for plant protection products containing micro-organism origin.

The draft was proposed on 26 October 2021. From 26 October to 23rd November 2021 was the feedback period. Now, it has been adopted on 31August 2022.

Major points were segregated in those amendments.

The term microbial active substance has been replaced by ‘Microbial Pest Control Agent (MPCA)’.

The number of requirement of studies has been reduced. In this case mostly ‘the weight of evidence’-approach with justification shall be followed.

The amended version focuses on identifying, taxonomizing, and phylogeny of the microorganism, as well as its origin, occurrence, and history of use.

It also gives clarity about dossier submission which shall be done in accordance with Part A if the active substance is a chemical substance (including both semiochemicals and extracts from biological material), or a metabolite produced by a micro-organism.

To provide information on development of resistance, in case of provision of data is required, such data may be generated in experimental studies (either in laboratories or under field conditions) or retrieved from available scientific literature. Otherwise, information already submitted for the active substance under point 3.4 of Part B of the Annex to Regulation (EU) No 283/2013 are sufficient to permit an assessment to be performed.

The goal is to reflect the specificities and use of biological substances as compared to chemical substances.

The European Food Safety Authority (EFSA) is currently evaluating its 2013 document on the risk assessment of plant protection products and bees (Apis mellifera, Bombus spp., and solitary bees).

What is the content of the guidance document published in 2013?

The objective of this Guidance Document (GD) is to outline a process by which plant protection products (PPPs) can be evaluated for their potential risk in causing unacceptable harm to groups of non-target organisms (bees). The guidance document has taken care of the potential risk in causing unacceptable harm to a group of non-target organisms (bees), maximum exposure level given by the specific protection goals (SPGs), the use of a tiered risk assessment scheme with a simple and cost-effective first tier to more complex higher tier studies under semi-field and field conditions.

Updates

In a meeting held on 17 February 2022, the Commission initiated discussions with Member States on setting specific protection goals for bumblebees and solitary bees.

The EFSA has prepared a revised draft guidance document based on the mandate, which has been submitted for public comment along with the respective data, analysis, and background data.

The EFSA launched a public consultation on 18 July 2022 on its draft guidance document on risk assessment of plant protection products and bees, covering honeybees, bumble bees, and solitary bees.

The consultation was open for 12 weeks and closed on 3 October 2022.

In addition, the Commission has asked the EFSA to ensure that all opinions and viewpoints are taken into consideration in the process.

Following the completion of the workshop with stakeholders and member states, the EFSA can finalize the revision of the guidance document.