{"id":27572,"date":"2025-05-30T11:26:35","date_gmt":"2025-05-30T09:26:35","guid":{"rendered":"https:\/\/avantcore.de\/?p=27572"},"modified":"2025-10-07T14:57:02","modified_gmt":"2025-10-07T12:57:02","slug":"zonal-pesticide-authorization-risk-assessment","status":"publish","type":"post","link":"https:\/\/avantcore.de\/en\/zonal-pesticide-authorization-risk-assessment\/","title":{"rendered":"Zonal plant protection product authorization: Link to the risk assessment of the Member State conducting the assessment"},"content":{"rendered":"

The OVG L\u00fcneburg has ruled Decision of 19.05.2025 (10 ME 33\/25)<\/a> decided on the scope of the risk assessment of the reviewing Member State for a zonal plant protection product authorization.<\/strong><\/p>\r\n

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    Legal background: European plant protection product legislation and the zonal authorization procedure for plant protection product authorization<\/strong><\/h4>\r\n<\/li>\r\n<\/ol>\r\n

    The Regulation (EC) No. 1107\/2009<\/a> forms the EU legal framework for the authorization of plant protection products. The aim of this regulation is to ensure a high level of protection for humans, animals and the environment (Art. 1 para. 3 Regulation (EC) No. 1107\/2009). At the same time, it aims to harmonize the internal market through the so-called zonal approval procedures<\/strong> (Art. 33 ff. of the Regulation), according to which a product once authorized in a geographical zone should in principle also be authorized in the other member states of this zone.<\/p>\r\n

    A central aspect of this is Art. 36 Regulation (EC) No. 1107\/2009<\/strong>. Accordingly, a \"Member State concerned\" (i.e. a Member State in which the product is to be placed on the market) is generally bound by the risk assessment of the \"reviewing Member State\" when authorizing a plant protection product. An independent rejection of the authorization is only possible under the strict conditions of the Art. 36 para. 3 subpara. 2 VO<\/strong> permissible - for example in the case of specific national environmental or health risks.<\/p>\r\n

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      What was the issue here? - Dispute over the approval of a plant protection product containing flufenacet<\/strong><\/h4>\r\n<\/li>\r\n<\/ol>\r\n

      \"Plant<\/p>\r\n

      The proceedings centered on the approval of the plant protection product \"G.\", which contains the active ingredient Flufenacet<\/strong> contains. The Czech Republic, as Member State under review<\/strong> granted a reference authorization. The defendant (the Federal Office of Consumer Protection and Food Safety) adopted this assessment and granted the national plant protection product authorization for Germany on December 22, 2022, later extended by an amendment notice dated October 14, 2024.<\/p>\r\n

      An environmental association applied to the Braunschweig Administrative Court to restore the suspensive effect of its objection to the approval. The VG granted the application on the grounds that the product posed an unacceptable risk to humans and the environment in light of new scientific findings and that the defendant had not provided proof of its harmlessness.<\/p>\r\n

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        Legal considerations of the OVG L\u00fcneburg<\/strong><\/h4>\r\n<\/li>\r\n<\/ol>\r\n

        a) Binding effect of the risk assessment for the authorization of plant protection products in the zonal procedure<\/strong><\/p>\r\n

        The OVG overturns the decision of the VG and refers to the clear obligation of the Member State concerned to the risk assessment of the Member State conducting the assessment. In doing so, the court follows the current ECJ case law (C-308\/22, C-309\/22, C-310\/22 of 25.04.2024)<\/strong>:<\/p>\r\n

        A Member State may only deviate from the risk assessment and refuse authorization if specific ecological or agricultural conditions justify an unacceptable risk - and these were not taken into account by the Member State carrying out the assessment.<\/strong><\/p>\r\n

        This restriction is intended to Harmonization and simplification<\/strong> of the approval procedures (recitals 9 and 29 of the Regulation).<\/p>\r\n

        b) No comprehensive review competence of the Member State concerned<\/strong><\/p>\r\n

        The OVG clarifies: Even if new scientific findings are available, the Member State concerned is not free to repeat or correct the entire risk assessment independently - unless the narrow conditions of Art. 36 (3) subparagraph 2 of the Regulation are met.<\/p>\r\n

        c) No uninterrupted obligation of the marketing authorization holder to provide evidence<\/strong><\/p>\r\n

        Contrary to the opinion of the VG Braunschweig, the OVG denies a \"continuing obligation to provide evidence\" on the part of the licensee. Such an obligation does not arise from Art. 29 (2) of the Regulation, but can at most be ex-post<\/strong> in the context of revocation pursuant to Art. 44 of the Regulation - but not in the context of an ongoing objection review.<\/p>\r\n

        d) Role of the precautionary principle<\/strong><\/p>\r\n

        Although the OVG confirms the importance of the precautionary principle, it emphasizes that this must not lead to an undermining of the binding effect under EU law. A Authorization may only be refused if there are specific national risks in individual cases<\/strong>but not due to a general uncertainty about the toxicity of the active substance.<\/p>\r\n

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          Conclusion: Significance of the decision for authorities, manufacturers and environmental associations<\/strong><\/h4>\r\n<\/li>\r\n<\/ol>\r\n

          a) For national authorities<\/strong><\/p>\r\n

          The decision underlines the close link to the assessment made by the reviewing Member State when authorizing plant protection products. Its own decision-making competence is limited to Exceptional cases limited<\/strong>. A general reference to new findings is sufficient not<\/strong> to the refusal of admission.<\/p>\r\n

          b) For plant protection product manufacturers<\/strong><\/p>\r\n

          As part of the zonal procedure for plant protection product authorization, manufacturers can rely on a largely reliable legal framework<\/strong> support. The commitment protects against individual national approaches and repeated reassessment. At the same time, there is still an obligation to continuous monitoring and communication<\/strong> in accordance with Art. 56 of the Regulation if new risks become known.<\/p>\r\n

          c) For environmental associations and plaintiffs<\/strong><\/p>\r\n

          Legal action against national approval is associated with high hurdles. A successful challenge requires that Specific national risks<\/strong> that were not recorded by the Member State conducting the review. General doubts about the safety of the active substance are not sufficient.<\/p>\r\n

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            Recommendations for action<\/strong><\/h4>\r\n<\/li>\r\n<\/ol>\r\n