Official Journal of the European Union

C series

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C/2025/2632

19.5.2025

(Case C-809/23,

Sumitomo Chemical Agro Europe)

(Reference for a preliminary ruling - Biocidal products - Directive 98/8/EC - Regulation (EU) No 528/2012 - Applicability ratione temporis - Transitional rules - Access to information - Articles 66 and 67 - Request for access to a report on the technical equivalence of active substances in biocidal products drawn up by the competent authority of a Member State - Protection of commercial interests - Directive 2003/4/EC - Applicability ratione materiae - Article 4(2) - Concept of ‘information on emissions into the environment’)

(C/2025/2632)

Language of the case: French

Referring court

Parties to the main proceedings

Applicant: Sumitomo Chemical Agro Europe SAS

Defendants: Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail (ANSES), Compagnie européenne de réalisations antiparasitaires SAS France (CERA)

Operative part of the judgment

1.Articles 96 and 97 of 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, as amended by Regulation (EU) No 334/2014 of the European Parliament and of the Council of 11 March 2014,

must be interpreted as meaning that a request for access to information on an active substance contained in an authorised biocidal product and, in particular, on its technical equivalence with an approved active substance, which was submitted after the date on which that regulation became applicable, must be assessed in the light of the provisions of that regulation, even if such a request concerns a biocidal product authorised in accordance with 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 or, as the case may be, under that regulation on the basis of technical equivalence established by a competent authority designated in accordance with Article 26 of that directive.

2.Article 66(3)(j) of Regulation No 528/2012, as amended by Regulation No 334/2014,

must be interpreted as meaning that after an authorisation to place a biocidal product on the market has been granted, the competent authority cannot refuse the requested access to the information on the methods of analysis which have made it possible to establish the technical equivalence of the active substances contained in that product. That information must be precise and complete, but does not extend to the results or conclusions obtained as a result of applying those methods.

3.Article 67(1)(h), Article 67(3)(e) and Article 67(4)(b) of Regulation No 528/2012, as amended by Regulation No 334/2014,

must be interpreted as meaning that the communication of a report establishing the technical equivalence of an active substance contained in an authorised biocidal product with an approved active substance, drawn up by the competent authority of a Member State when examining an application for an authorisation to place that product on the market falls outside the scope of those provisions.

4.Article 66 of Regulation No 528/2012, as amended by Regulation No 334/2014,

must be interpreted as not defining a specific and comprehensive regime for access to information held by the competent authorities of a Member State relating to biocidal products and, in particular, to the technical equivalence of the active substance contained therein with an approved active substance, such as to preclude the application, by those authorities, of the national provisions transposing the second subparagraph of Article 4(2) of Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information and repealing Council Directive 90/313/EEC.

5.The second subparagraph of Article 4(2) of Directive 2003/4

must be interpreted as meaning that the concept of ‘information on emissions into the environment’, within the meaning of that provision, is not, in principle, applicable to information contained in a report drawn up by the competent authority of a Member State following the assessment of the technical equivalence of an active substance, contained in an authorised biocidal product, with an approved active substance.

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(1) OJ C C/2024/2140.

ELI: http://data.europa.eu/eli/C/2025/2632/oj

ISSN 1977-091X (electronic edition)

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