Zonal plant protection product approval: binding nature of risk assessment by the evaluating Member State

The Higher Regional Court of Lüneburg (OVG Lüneburg) decided by order dated 19.05.2025 (10 ME 33/25) on the scope of the risk assessment by the evaluating Member State for a zonal plant protection product approval.

1. Legal background: European plant protection product law and the zonal approval procedure for plant protection product approvals

Regulation (EC) No. 1107/2009 Verordnung (EG) Nr. 1107/2009 provides the Union legal framework for the approval of plant protection products. The objective of this Regulation is a high level of protection for human health, animals and the environment (Art. 1 Abs. 3 VO (EG) Nr. 1107/2009). At the same time, it pursues harmonization of the internal market through the so-called zonal approval procedure (Art. 33 ff. VO), whereby a product approved in one geographical zone is to be approved in principle also in the other Member States of that zone.

A central aspect in this respect is Art. 36 VO (EG) Nr. 1107/2009. According to this, a "Member State concerned" (i.e. one in which the product is to be put on the market) is in principle bound by the risk assessment of the "evaluating Member State" in plant protection product approval. An independent refusal of approval is only permissible under the narrow conditions of Art. 36 Abs. 3 Unterabs. 2 VO – for example in the case of specific national environmental or health risks.

2. What was the case about? – Dispute over approval of a flufenatec-containing plant protection product

At the centre of the proceedings was the approval of the plant protection product "G.", which contains the active substance Flufenacet. The Czech Republic, as the evaluating Member State, had granted a reference approval. The respondent (the Federal Office of Consumer Protection and Food Safety) adopted this assessment and granted the national plant protection product approval for Germany on 22 December 2022, later extended by amended order dated 14 October 2024.

An environmental association applied to the Administrative Court of Braunschweig (VG Braunschweig) for the restoration of the suspensory effect of its objection to the approval. The Administrative Court granted the application – on the grounds that in view of new scientific findings the product posed an unacceptable risk to human health and the environment and that the applicant respondent had not provided proof of its harmlessness.

3. Legal considerations of the Higher Regional Court of Lüneburg (OVG Lüneburg)

a) Binding effect of risk assessment in plant protection product approval in the zonal procedure

The OVG Lüneburg sets aside the order of the Administrative Court (VG) and points to the clear binding of the Member State concerned by the risk assessment of the evaluating Member State. The court follows in this respect the current case-law of the Court of Justice of the European Union (C-308/22, C-309/22, C-310/22 of 25.04.2024):

A Member State may only deviate from the risk assessment and refuse approval if specific ecological or agricultural conditions constitute an unacceptable risk – and these were not taken into account by the evaluating Member State.

This limitation is intended to serve the harmonization and simplification of approval procedures (Recitals 9 and 29 VO).

b) No comprehensive review competence of the Member State concerned

The OVG Lüneburg makes clear: Even if new scientific findings exist, the Member State concerned is not free to independently repeat or correct the entire risk assessment – unless the narrow conditions mentioned in Art. 36 Abs. 3 Unterabs. 2 VO are met.

c) No continuous obligation to provide proof on the part of the approval holder

Contrary to the view of the Administrative Court of Braunschweig (VG Braunschweig), the OVG Lüneburg denies a "continuing obligation to provide proof" on the part of the approval holder. No such obligation arises from Art. 29 Abs. 2 VO, but may at most ex-post apply within the framework of revocation pursuant to Art. 44 VO – not, however, in the framework of ongoing opposition proceedings.

d) Role of the precautionary principle

The OVG Lüneburg confirms the importance of the precautionary principle, but emphasizes that this must not lead to a hollowing out of the binding effect under Union law. An approval may only be refused if specific national risks exist in the individual case, not on the grounds of general uncertainty about the toxicity of the active substance.

4. Conclusion: significance of the decision for authorities, manufacturers and environmental associations

a) For national authorities

The decision underscores the strict binding effect of the assessment conducted by the evaluating Member State in plant protection product approval. The authority's own discretion is limited to exceptional cases. A blanket reference to new findings is not sufficient to refuse approval.

b) For plant protection product manufacturers

Manufacturers can rely on a largely reliable legal framework within the scope of the zonal approval procedure for plant protection products. The binding effect protects against national unilateral action and repeated reassessment. At the same time, the obligation to continuous monitoring and notification pursuant to Art. 56 VO continues to exist if new risks become known.

c) For environmental associations and claimants

Actions against national approval are subject to high hurdles. Successful challenge requires that specific national risks be demonstrated that were not captured by the evaluating Member State. General doubts about active substance safety are not sufficient.

5. Recommended actions

• Marketing authorization holder should carefully document that no new risks exist pursuant to Art. 56 of Regulation (EC) No 1107/2009, and communicate proactively.
• Competent authorities are well advised to align their decision-making grounds strictly with Art. 36 (3) of the Regulation in order to issue authorizations that are capable of withstanding judicial review.
• Environmental associations should gather scientifically substantiated evidence for specific national risk scenarios at an early stage – ideally before the assessment procedure in the reference Member State.

For further questions regarding plant protection product authorization under European law, judicial challenge or risk assessmentjudicial challenge or risk assessment pursuant to Art. 29 and 36 of Regulation (EC) No 1107/2009, the attorneys of AVANTCORE Rechtsanwälte in Stuttgart are available with in-depth expertise in administrative law and European law.