Micro-organisms or microbes (e.g. bacteria, fungi or protozoa) are invisible to us but play a significant ecological role as they help to break down organic matter and produce oxygen. Some of them protect crops from pests and diseases, making them a suitable alternative to chemical-based plant protection. Given its ambition to reduce the overall use of chemical pesticides by 50% and to have at least 25% of EU agricultural land dedicated to organic farming by 2030, the European Commission has adopted four Implementing Regulations amending the legal framework applicable to micro-organisms, which will start applying from 21 November 2022.
General regulatory framework
Regulation (EC) No 1107/2009 (‘the PPP Regulation’) is the key legal instrument that regulates the placing of plant protection products (PPPs) on the EU market. It establishes a two-tier system in which active substances (i.e. the component that neutralises pests or plant diseases) are approved at EU-level while the products containing them are authorised for marketing by the Member States. Approval of an active substance depends on a positive evaluation by the Member States, the European Food Safety Authority (EFSA) and the Commission regarding its safety for human and animal health, possible residues in food and the effects on the environment. It is up to the applicant seeking the approval of an active substance to provide scientific data to prove the safety of the substance in question. Both chemicals and micro-organisms are eligible as active substances and are assessed on the basis of very similar criteria. This will change in the near future.
Specific changes for micro-organisms
Scientific knowledge about micro-organisms has evolved since the PPP Regulation’s entry into force, which allows for a more accurate approach to their assessment. The European Commission has tried to accommodate this development by taking into account the biological differences between chemical substances and micro-organisms. This has resulted in four Implementing Regulations that each treat a different part of the approval process. The most important changes for each one are highlighted below.
Commission Regulation (EU) 2022/1438 amends Annex II of the PPP Regulation, which sets out the criteria for the approval of active substances. An important change concerns the information that applicants must provide to reliably predict residues in food and feed. While the principle remains that toxic residues have to be avoided, the Regulation now clarifies that the presence of micro-organisms in itself is not an obstacle to approval. This is only so where the micro-organism in question has a toxic output. Also, micro-organisms are now assessed against more specific criteria for approval as ‘low-risk’ active substances with a focus on the number of antimicrobial agents against which the micro-organism is demonstrated to be susceptible. This is commercially relevant as those substances benefit from a first approval that lasts fifteen years instead of the standard ten years after which the rules on renewal of approval in Article 14 of the PPP Regulation will apply. The approval of viruses as active substances, on the other hand, is subject to different criteria, essentially due to their usual narrow host range (i.e. the variety of host cells that a virus can infect). Viruses that are infectious for humans are excluded from approval altogether. Finally, several other changes are introduced as well, such as setting out the appropriate information required to define the composition of a micro-organism (for example, the taxonomical identification), more specific methods for analysing micro-organisms and a clarification that pathogenicity to humans excludes micro-organisms from receiving approval as an active substance.
Commission Regulation (EU) 2022/1439 amends Part B of the Annex to Regulation (EU) No 283/2013, which sets out the data requirements for active substances. The common thread throughout these changes is that the data requirements for micro-organisms should fit their specificity. For example, certain micro-organisms might produce metabolites that require a thorough assessment, while the inherent harmlessness of others towards non-plants reduces the need for animal testing. The Regulation also addresses the problem of antimicrobial resistance (AMR), which occurs when mutated micro-organisms gain resistance against the effects of a medicine. It does so by integrating into the data requirements the capacity of micro-organisms to transfer antimicrobial resistance genes to pathogenic (i.e. harmful) micro-organisms, potentially hindering the effectiveness of antimicrobials used in human or veterinary medicine. This facilitates an evaluation of the health risks for humans and animals linked to a possible transfer of antimicrobial resistance genes.
Logically-speaking, changes in the data requirements for active substances that are micro-organisms should also lead to a change in the specific data requirements for plant protection products containing micro-organisms. Commission Regulation (EU) 2022/1440 has done that by amending Part B of the Annex to Regulation (EU) No 284/2013, which sets out the data requirements for plant protection products and follows the same logic as above.
The last changes to be discussed come from Commission Regulation (EU) 2022/1441, which amends Commission Regulation (EU) No 546/2011 on the uniform principles for evaluation and authorisation of PPPs. These uniform principles ensure that national evaluations and decisions for PPP authorisations respect the high level of protection of human and animal health and the environment as prescribed by the PPP Regulation. They also give guidance to the Member States on how they should assess data submitted by applicants in accordance with the applicable data requirements. As explained above, the data requirements for PPPs containing micro-organisms have been updated by Commission Regulation (EU) 2022/1440. Therefore, the guidance on data assessment will be aligned with these new requirements so that Member States can correctly and uniformly assess applications that are submitted according to the new rules.
The new regulatory framework will apply from 21 November 2022 onwards. However, each Implementing Regulation foresees transitional measures, which means that the old regime for micro-organisms can still apply after this date depending on when applicants file for (renewal of) approval or submit the relevant data.
With this specific regulatory framework for micro-organisms, the European Commission is hoping to enable a turnaround for sustainable crop protection. Although only time will tell whether the new criteria indeed sufficiently promote the use of micro-organisms in pesticides, the general sentiment appears to be that progress has been made and that a fair assessment will follow once the new rules are applied in practice. If you would like any further information, please contact Philippe de Jong (philippe.deJong@altius.com) or Bart Junior Bollen (email@example.com).