EU Biopesticides Update
EU Biopesticides Update – Comments to European Commission’s Proposals published
During the feedback period on the amendments of the EU regulation of micro-organisms used in plant protection products in the context of the implementation of the Farm-to-Fork Strategy, several comments were submitted by industry, authorities, NGOs and EU citizens in response to the European Commission’s proposals for the new data requirements for approving active substances, new data requirements for authorising products, approval criteria for microbial active substances, and new uniform principles for evaluating and authorising products.
While acknowledging the need for safety testing and risk assessments for microbial products comparable to those applied to chemical products, industry representatives highlighted the issue that authorities lack resources for the evaluation of micro-organisms used in plant protection products. To provide sufficient resources to enable different Member States to increase their knowledge in micro-organism assessment, CropLife proposed to set up EU funded training programs and the “creation of a European expert network”. Moreover, several comments submitted calls for tailored guidance for a harmonised evaluation.
The International Biocontrol Manufacturers Association (IBMA) took note that changes in the data requirements mainly concern the implementation of the secondary metabolite guidance, driving the requirements and “create some technically unrealistic studies for microbial metabolites that are not of safety concern”. Conditional data requirements leave room for interpretation, which may depend on the experience of the evaluators. Overall, this may be a challenge to reach consistent assessments of similar micro-organisms, and timely completion of evaluations.
Comments from the wider industry highlighted that, due to the data requirements and approval timelines being amongst the longest and most resource intensive of any market, the approval of innovative biocontrol technologies and their availability to EU farmers and consumers are already hampered, an increase in complexity and extended timelines of the approval process are critical issues.
In order to reach the ambitious targets set out by the Farm-to-Fork initiative to reduce conventional plant protection products, companies require predictability based on clear data requirements and their interpretation.
IBMA also proposed clarification on transitional measures based on the practicalities of dossier preparation for approval and authorisation, recommending that active substance and products should be addressed under the same set of data requirements. A transition period of at least 2 years is considered appropriate.
From EU Member State authorities side, German Environment Agency (UBA) raised the point that indirect/trophic chain effects of plant protection products need to be addressed for the transparent description of the overall risk, irrespectively whether it is a chemical or biological product. UBA proposed an amendment to the draft act and the development of corresponding scientific methods and guidance.
Some NGOs support the new data requirements but emphasize that maintaining some flexibility for discussion, as well as the assumption in the area of low-risk active substances that micro-organisms are safe, is important. Concerns raised also related to harmonisation in interpretation and capacities for evaluation.
Comments from EU citizens support the concept of a detailed testing and safety assessment of micro-organisms, which may be indicative of a critical perception of micro-organisms used in biocontrol by parts of the society within the EU.
For further details, please refer to the links provided above.
Our team of biopesticides experts will continue to follow the latest developments to anticipate issues during data generation and dossier preparation for EU approvals accordingly. Please contact Joachim Rumbolz if you require regulatory support for your microbial active substances.
