New regulation on the approval of safeners and synergists in the EU Important aspects to consider

The long-waited EU Regulation on the approval of safeners and synergists used in plant protection products is expected to be adopted in the first quarter of 2024 (hereinafter, the "Regulation).

This new Regulation aims to fulfil the mandate set out in articles 25 and 26 of Regulation (EC) No 1107/2009 to develop in more detail the process for approval of safeners and synergist in the EU.

In particular, the draft Regulation develops in more detail the following points:

1. Defines data requirements for the approval of safeners and synergists similar to those applicable for the approval of active substances, including supplementary data related to the demonstration of efficacy.
2. Regulates a pre-submission process with EFSA to discuss and advise on necessary test and studies, and possible notifications of studies or data sharing of studies already conducted by other applicants.
3. Set out a work programme for the gradual review of safeners and synergists already on the market. To this end, it foresees the publication of a list of those safeners and synergists, and establishes procedures for potential applicants to notify their interest in submitting applications, deadline for submission and procedures for the evaluation of the admissibility of applications.

However, there are a number of practical and procedural aspects that are not fully covered by the current draft Regulation, although they are key for applicants for approval in the EU or holders of authorisations of plant protection products already on the market.

Some of the most critical issues that are not fully covered or clarified in the draft Regulation are the following:

• Data protection. As part of the process laid down in this new Regulation, applicants will have to submit scientific data to support the approval of the safener or synergist in the EU. In principle, data protection rules set out in Article 59 of Regulation (EC) No 1107/2009 will also apply to data on safeners and synergist. However, it remains to be seen what problems may arise in practice.

Possible issues: when will this data protection period start? What happens to old data on safeners, and synergist already submitted in the past to support product authorisations at national level? Can these old submitted data acquire data protection if it is used in the future to support the approval of a safener and synergist under this new Regulation?

• Overlaps with REACH. Some safeners and synergists are currently regulated under the REACH Regulation (EC) No 1907/2006. In the absence of a clear exemption similar to that provided for pesticide active substances under Article 15(1) of REACH, companies may face a double regulatory burden, as they might have to comply with the approval procedures and requirements laid down in both REACH and the Plant Protection Product Regulation (EC) No 1107/2009.

Possible issues: the exemption in Article 15(1) of REACH  only refer to active substances and co-formulants. Will the REACH be amended to exclude from its scope also safeners and synergists approved under the new forthcoming Regulation and Regulation (EC) No 1107/2009?

• Transitional period. According to Article 81(1) Regulation (EC) No 1107/2009, companies will still be allowed to place on the market plant protection products, containing a safener or synergist that is under evaluation or approval, for a period of 5 years after the adoption of the work programme set out in the draft Regulation for review of safener and synergist already on the market.

Possible issues: what will happen if the approval process for some safeners and synergists last longer than 5 years? Will the Commission adopt an implementing regulation to extend this transitional period for the safeners and synergists under review, as it is usually done for pesticide active substances undergoing renewal under Regulation (EC) No 1107/2009?

• Existing national authorisations. The draft Regulation does not specify whether holders of authorisations of plant protection products must take any action once the safener or synergist contained in the product has been approved at EU level under the new Regulation.

Possible issues: will authorisation holders have to submit a complementary notification or application to the national authority after safeners and synergists are approved at EU level? Will national authorities initiate review and/or withdrawal procedures for existing authorisations if safeners and synergists contained are not yet approved in the EU after the 5-year transition period?

• Regulatory requirements. Article 9 of the draft Regulation seems to put safeners and synergists on an equal position with pesticide active substances in terms of data requirements. However, safeners and synergists may not have the inherent harmful effects of pesticide active substances.

Possible issues: will data requirements for safeners and synergists be further defined or interpreted to adapt them to the risk profile of these particular substances to ensure that they are assessed under realistic conditions?

• One substance-One assessment approach. Article 6(2) of the draft Regulation requires applicants to make all reasonable efforts to submit a joint application or to share relevant scientific data.

Possible issues: does this mean that only a single application will be allowed and that the use of consortia will be mandatory? How will the term "reasonable efforts" be interpreted?

• Administrative burden and competent authorities lack of resources: based on past experience with the approval of pesticide active substances and authorisation of products, a number of issues have arisen in terms of dossier compliance and data requirements. While safeners and synergists may not have the same risk profile of pesticide active substances, the resources of competent authorities to assess application dossiers are usually limited.

Possible issues: will competent authorities be able to cope with the workload triggered by the new system in terms of evaluation and approval of substances and products as well as new guidance that may be adopted along the way to address scientific developments?

A clear regulation or guidance on the above points may be critical to offer applicants and authorisation holders a process with full legal certainty and guarantees that can ensure a smooth transition and adaptation by the industry to this new requirements. In view of the existing wording of the draft Regulation, manufacturers and distributors of plant protection products may face difficulties during the review process and approval of safeners and synergists in the EU, which in turn may also directly affect authorisations of plant protection products currently on market and make a difficult transition into the new legal system.

Until the above issues are fully addressed, companies may in the meantime have to resort to practical legal solutions and tools on a case-by-case basis by applying by analogy basic procedural principles and legal provisions already laid down in Regulation (EC) No 1107/2009.

Fieldfisher's EU regulatory team is experienced in providing our clients with the necessary legal tools to navigate through these transitional periods and adapt to new regulations with the least possible impact on their business activity. We have particular experience with review programs for active substances helping our clients in the various issues that arise in this type of processes, such as data sharing between different companies, creating and managing consortia, delays in the process by the authorities, or changes in criteria and guidelines applied during the process.

Do not hesitate to contact us for advice (Claudio.Mereu@fieldfisher.com and Adrian.ParraGarcia@fieldfisher.com)