Summary: The 2023 Annual Biocontrol Industry Meeting addressed developments in the global biologicals market. One of the objectives of the new requirements for approving microorganisms and PPPs containing them is to accelerate the approval of microorganisms at the EU level. The new data requirements aim to facilitate the use of biological active substances and reduce dependency on chemical PPPs. However, these changes do not provide an easier route for quicker registration of microorganisms and there are still challenges facing registrants.
In this monthly series, Dr. Kalumbu Malekani, Chief Scientific Officer, Environmental Risk Sciences, explores trends and salient topics in environmental and regulatory science. This month, he shares highlights from the 2023 Annual Biocontrol Industry Meeting (ABIM) held in Basel, Switzerland.
Happy New Year! Upon reflection, I found 2023 to be filled with exciting developments in the area of biological crop protection. Of particular note, the Annual Biocontrol Industry Meeting (ABIM)
brought industry professionals together to discuss innovation, digital solutions, and policy.
During the conference in Switzerland, EU regulators provided regulatory updates on biocontrols, and representatives from the Directorate-General for Health and Food Safety of the European Commission and the Dutch Board for the Authorization of Plant Protection Products and Biocides provided advice on registration best practices.
Below is my summary of highlights from the “implementation of the data requirements on microorganisms and plant protection products containing them in the framework of Regulation (EC) 1107/2009” (published on 12 October 2023):
• The regulatory framework for Plant Protection Products (PPP) containing an active substance that is a microorganism is set by Regulation (EC) 1107/2009. Based on this regulation, a PPP is authorized only when the active substance has been approved, the product is sufficiently effective, its use presents no immediate or delayed harmful effects on human or animal health, and it has no unacceptable effects on the environment. These conditions apply to all PPP, regardless of whether the active substance is derived from a synthetic or biological process.
• New requirements for approval of microorganisms and PPP containing them were recently adopted and promulgated as amendments to four existing legal frameworks applicable to PPPs: Regulations (EU) 2022/1438, 2022/1439, 2022/1440, and 2022/1441.
• One of the objectives of the new Regulation (EU) 2022/1439 is to better delimit the differences between microorganisms and chemical substances, focusing on metabolites produced by the microorganism. The main purpose is to improve and accelerate the approval of microorganisms at the EU level. However, there is still the need to meet the standard data requirements in introducing these biological alternatives on the market.
• Another change introduced in the new Regulation (EU) 2022/1438 establishes more specific criteria for classifying microorganisms as low-risk active substances. Low-risk active substances are encouraged by several regulatory incentives, including approval for 15 years instead of the typical ten years. A fast-track authorization procedure with reduced timelines of 120 days instead of one year ensures that low-risk products can be placed on the market quickly. The low-risk status of a PPP can be used in advertising. A microorganism may be considered a low-risk active substance if it can be demonstrated that it is susceptible to at least two classes of antimicrobial agents. However, it is worth noting that viruses that are variants of a pathogen with adverse effects on non-target plants are ineligible for low-risk status. The main purpose of these new requirements was to offer more clarity and certainty on which elements to consider during the evaluation for low-risk approval. However, there is currently no consistent approach to deciding whether a microorganism shall be granted a low-risk status.
• In addition to meeting the above low-risk status criteria of showing sensitivity to two or more antimicrobial classes, the evaluators would still consider other aspects, such as possible production of metabolites of concern or whether risk mitigation measures are necessary.
As stated in Regulation (EU) 2022/1439, these new data requirements aim at facilitating the use of biological active substances such as microorganisms and introducing more tools to combat pest destruction. However, these new changes do not provide an easier route to quicker registration of microorganisms. Microorganisms must still meet more data requirements for their approval. The new regulations do not provide reduced timelines for evaluating microorganisms or PPPs containing these microbial substances. The regulations do not provide harmonized criteria to be used by all member states during their evaluation, which may result in different timelines and standards. As a result, registrants will continue to face difficulties in efforts to make biological alternatives to conventional chemicals.
We look forward to the continuing efforts by the IBMA
in bringing together stakeholders annually through the ABIM meeting and affording the opportunity for collaboration between manufacturers and regulators that will result in the improvement of legislation appropriate for biological crop protection products.
Interested in learning more about the topic of biologicals? Smithers conducts both conventional and biological testing for agrochemical registrations in all regions. Contact Dr. Malekani to discuss your questions about environmental testing of biological products.