Case C-809/23, Sumitomo Chemical Agro Europe: Request for a preliminary ruling from the Conseil d’État (France) of 22 December 2023 — Sumitomo Chemical Agro Europe SAS v Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail (ANSES), Compagnie européenne de réalisations antiparasitaires SAS France (CERA)
Date: 2023-12-22
Institutions: Court of Justice
Subjects: biocide, chemical product, confidentiality, environmental protection, market approval, national competent authority, trade information








C_202402140EN.000101.fmx.xml












Official Journal of the European Union


EN
Series C













C/2024/2140


25.3.2024





Request for a preliminary ruling from the Conseil d’État (France) of 22 December 2023 — Sumitomo Chemical Agro Europe SAS v Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail (ANSES), Compagnie européenne de réalisations antiparasitaires SAS France (CERA)
(Case C-809/23, Sumitomo Chemical Agro Europe)
(C/2024/2140)
Language of the case: French

Referring court

Conseil d’État

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)

Other party involved: Ministre de la transition écologique et de la cohésion des territoires

Questions referred







1.


Where the competent national authority, having received an application for marketing authorisation for a biocidal product before 1 September 2013 and, pursuant to Article 91 of Regulation No 528/2012, (1) having examined that application on the basis of the national provisions transposing Directive 98/8/EC (2) receives, after granting that authorisation, a request from a third party for access to information on the biocidal product it has authorised and the active substance it contains, including its technical equivalence with an authorised active substance, must that authority examine that request for access in the light of the rules on confidentiality provided for by the national provisions transposing Article 19 of Directive 98/8/EC, or those provided for by Articles 66 and 67 of Regulation No 528/2012?










2.


If such a request for access is governed by Directive 98/8/EC, Article 19 of which applies without prejudice to Directive 2003/4 (3) of the European Parliament and of the Council of 28 January 2003:






—


Does paragraph 3(k) of that article, which provides that after the marketing authorisation for the biocidal product has been granted, confidentiality does not in any case apply to the ‘methods of analysis referred to in Article 5(1)(c)’, allow the applicant to obtain any detailed information on those methods, even if its disclosure could endanger trade secrets, or only general information on the nature of those methods and any conclusions that may be drawn from them?










—


Do the ‘physical and chemical data concerning the active substance and biocidal product’, which cannot be kept confidential after the authorisation has been granted under Article 19(3)(f), allow the applicant to request the disclosure of detailed data on the composition of the active substance or biocidal product, even if they may directly or indirectly reveal the manufacturing processes?














3.


If, on the other hand, such a request for access is governed by Regulation No 528/2012:






—


Did the EU legislature, by Articles 66 and 67 of that regulation, which do not refer to Directive 2003/4, intend to define a specific and comprehensive regime for the communication to the public of information on biocidal products and their active substances, and thus disapply the provisions of Directive 2003/4 in so far as they provide, on the one hand, that a trade secret may not prevent the communication of information on emissions into the environment and, on the other hand, that if the disclosure of other environmental information could harm the commercial interests of an undertaking, the competent administrative authority must, prior to any refusal of communication, weigh the interest of that undertaking against the public interest?










—


Is the communication of an assessment report on the technical equivalence between an approved active substance and the active substance contained in a biocidal product, prepared in the context of an application for marketing authorisation for that product, governed by Article 67(3)(e) of Regulation No 528/2012, which provides for the publication of the assessment report on approved active substances unless confidential treatment is requested by the applicant, by Article 67(4)(b), which provides for the publication of the assessment report on an authorised biocidal product unless confidential treatment is requested by the applicant, or by other rules?










—


Does Article 66(3)(j) of Regulation No 528/2012, which provides that after the authorisation to place a biocidal product on the market has been granted, access to the ‘methods of analysis referred to in Article 19(1)(c)’ shall not ‘in any case be refused’, allow any detailed information on those methods to be obtained, even if its disclosure could endanger trade secrets, or only general information on the nature of those methods and any conclusions that may be drawn from them?










—


Is Article 67(1)(h) of the same regulation, which provides that from the date of approval of an active substance, the ‘analytical methods referred to under … Section 4.2 of Title 2 of Annex II’ are to be made publicly available free of charge, to be interpreted as actually referring to the provisions of Section 4.3 of Title 2 of Annex II, to which it referred before the intervention of Commission Delegated Regulation of 19 October 2020 amending Annexes II and III to Regulation No 528/2012 (4)? If those provisions are to be interpreted as referring to the provisions currently in force of Section 4.2 of Title 2 of Annex II, and assuming those provisions apply to an active substance which has not been approved but is recognised as technically equivalent to an approved active substance, does the communicability in principle of the ‘analytical methods for the analysis of the micro-organism as manufactured’ mentioned in Section 4.2 allow the applicant to obtain any detailed information on those methods, even if its disclosure could endanger trade secrets, or only general information on the nature of those methods and any conclusions that may be drawn from them?














4.


Lastly, if the provisions of Directive 2003/4 do apply to the present dispute, could the description ‘information on emissions into the environment’ within the meaning of Article 4(2) of that directive, which includes information on the nature, composition, quantity, date and place of those emissions, and data concerning the medium- to long-term consequences of those emissions on the environment, apply to information produced or received by the competent authority when examining the technical equivalence of an active substance with an approved active substance, or can it only apply to information on the biocidal product containing that substance, since it is that product, with all its components, which is emitted into the environment, and not the active substance alone?






(1)  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 (OJ 2012 L 167, p. 1).

(2)  Directive 98/6/EC of the European Parliament and of the Council of 16 February 1998 on consumer protection in the indication of the prices of products offered to consumers (OJ 1998 L 123, p. 21).

(3)  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 (OJ 2003 L 41, p. 26).

(4)  Commission Delegated Regulation (EU) 2021/525 of 19 October 2020 amending Annexes II and III to Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products (OJ 2021 L 106, p. 3).


ELI: http://data.europa.eu/eli/C/2024/2140/oj
ISSN 1977-091X (electronic edition)