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SubscribeThe Judgement of the Court of Justice of the EU, of March 20, 2025 (Case C-809/23) – the "Judgement"- addresses a request for access to a report on the technical equivalence of active substances contained in biocides, in the context of the EU legislation on biocides (Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products –"Regulation (EU) 528/2012"–) and on access to environmental information (Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information).
The Judgement analyzes the case in which a company (the claimant) has obtained authorization to market three biocidal products based on a report prepared by Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail ("ANSES") that established the technical equivalence of two active substances. The claimant requested ANSES to provide said report. ANSES made available certain pages of the report but refused to disclose the remaining pages, arguing that they included information protected by commercial secrecy.
Due to their relevance, we must highlight the following conclusions reached by the Court of Justice of the EU:
- Requests for access to information submitted after September 1, 2013, must be evaluated under Regulation (EU) 528/2012, even if they refer to biocides authorized under the former regulation (Directive 98/8 EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market).
- Once the marketing authorization for a biocide has been granted, access to information on the analytical methods used to establish the technical equivalence of the active substances contained in that biocide cannot be denied. Such information must be accurate and complete, but it should not extend to the results or conclusions obtained from the application of those methods.
- The communication of a report that establishes the technical equivalence between an active substance contained in an authorized biocide and an approved active substance, prepared by the competent authority of a Member State during the processing of a marketing authorization application for the said biocidal product, is not covered by the scope of Article 67 of Regulation No. 528/2012 –that is, it is not information that must be made available to the public–.
- he concept of "information on emissions into the environment" is not applicable, in principle, to the information contained in an evaluation report on the technical equivalence of an active substance contained in an authorized biocide.
The conclusions reached by the Court of Justice of the EU undoubtedly constitute very valuable information for operators in the biocidal sector.
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