1 This request for a preliminary ruling concerns the interpretation of Article 19 of 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 (OJ 1998 L 123, p. 1), of Articles 66 and 67 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 (OJ 2012 L 167, p. 1), as amended by Regulation (EU) No 334/2014 of the European Parliament and of the Council of 11 March 2014 (OJ 2014 L 103, p. 22) (‘Regulation No 528/2012’), and 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 (OJ 2003 L 41, p. 26).
2 The request has been made in proceedings between Sumitomo Chemical Agro Europe SAS, on the one hand, and the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail (ANSES) (National Agency for Food, Environmental and Occupational Health and Safety, France) and the Compagnie européenne de réalisations antiparasitaires SAS France (CERA), on the other hand, concerning the refusal to give access, in full, to a report from that agency concluding that two active substances contained in biocidal products marketed by Sumitomo Chemical Agro Europe and by CERA are technically equivalent.
3 The Convention on access to information, public participation in decision-making and access to justice in environmental matters, signed in Aarhus on 25 June 1998 and approved on behalf of the European Community by Council Decision 2005/370/EC of 17 February 2005 (OJ 2005 L 124, p. 1; ‘the Aarhus Convention’), states, in Article 4, entitled ‘Access to environmental information’: ‘1. Each Party shall ensure that, subject to the following paragraphs of this Article, public authorities, in response to a request for environmental information, make such information available to the public, within the framework of national legislation … … 4. A request for environmental information may be refused if the disclosure would adversely affect: … (d) the confidentiality of commercial and industrial information, where such confidentiality is protected by law in order to protect a legitimate economic interest. Within this framework, information on emissions which is relevant for the protection of the environment shall be disclosed; … The aforementioned grounds for refusal shall be interpreted in a restrictive way, taking into account the public interest served by disclosure and taking into account whether the information requested relates to emissions into the environment. …’
4 Directive 98/8, subject to the transitional arrangements referred to in paragraph 13 below, was repealed with effect from 1 September 2013 by Regulation No 528/2012 (in its initial version), which has been applicable since then.
5 Article 19 of that directive, entitled ‘Confidentiality’, provided, in paragraph 1: ‘Without prejudice to Council Directive 90/313/EEC of 7 June 1990 on the freedom of access to information on the environment [(OJ 1990 L 158, p. 56)], an applicant may indicate to the competent authority the information which he considers to be commercially sensitive and disclosure of which might harm him industrially or commercially and which he therefore wishes to be kept confidential from all persons other than the competent authorities and the [European] Commission. Full justification will be required in each case. Without prejudice to the information referred to in paragraph 3 …, Member States shall take the necessary steps to ensure the confidentiality of the full composition of product formulations if requested by the applicant.’
6 Under Article 3(1) of Regulation No 528/2012: ‘1. For the purposes of this Regulation, the following definitions shall apply: … (w) “technical equivalence” means similarity, as regards the chemical composition and hazard profile, of a substance produced either from a source different to the reference source, or from the reference source but following a change to the manufacturing process and/or manufacturing location, compared to the substance of the reference source in respect of which the initial risk assessment was carried out, as established in Article 54; …’
7 Article 19 of that regulation, entitled ‘Conditions for granting an authorisation’, provides, in paragraph 1: ‘A biocidal product other than those eligible for the simplified authorisation procedure in accordance with Article 25 shall be authorised provided the following conditions are met: (a) the active substances are included in Annex I or approved for the relevant product-type and any conditions specified for those active substances are met; … (c) the chemical identity, quantity and technical equivalence of active substances in the biocidal product and, where appropriate, any toxicologically or ecotoxicologically significant and relevant impurities and non-active substances, and its residues of toxicological or environmental significance, which result from uses to be authorised, can be determined according to the relevant requirements in Annexes II and III; …’
8 Article 30 of that regulation, entitled ‘Evaluation of applications’, provides in paragraph 3(a): ‘Within the 365-day period referred to in paragraph 1, the receiving competent authority shall: (a) draft a report summarising the conclusions of its assessment and the reasons for authorising the biocidal product or for refusing to grant an authorisation (the “assessment report”)’.
9 Article 54 of that regulation, entitled ‘Assessment of technical equivalence’, is worded as follows: ‘1. Where it is necessary to establish the technical equivalence of active substances, the person seeking to establish that equivalence (“the applicant”) shall submit an application to the [European Chemical Products Agency (ECHA)]. 2. The applicant shall submit all data that [ECHA] requires to assess technical equivalence. … 4. After giving the applicant the opportunity to submit comments, [ECHA] shall take a decision within 90 days of receipt of the application referred to in paragraph 1 and shall communicate it to Member States and to the applicant. 5. Where, in [ECHA’s] opinion …, additional information is necessary to carry out the assessment of technical equivalence, [ECHA] shall ask the applicant to submit such information within a time limit specified by [ECHA]. [ECHA] shall reject the application if the applicant fails to submit the additional information within the specified time limit. The 90-day period referred to in paragraph 4 shall be suspended from the date of issue of the request until the information is received. The suspension shall not exceed 180 days except where justified by the nature of the data requested or in exceptional circumstances. 6. Where appropriate, [ECHA] may consult the competent authority of the Member State which acted as the evaluating competent authority for the evaluation of the active substance. …’
10 Article 66 of Regulation No 528/2012, entitled ‘ Confidentiality’, provides: ‘1. Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents [(OJ 2001 L 145, p. 43)] and the rules of the Management Board of [ECHA], adopted in accordance with Article 118(3) of Regulation (EC) No 1907/2006 [of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ 2006 L 396, p. 1)], shall apply to documents held by [ECHA] for the purposes of this Regulation. 2. [ECHA] and the competent authorities shall refuse access to information where disclosure would undermine the protection of the commercial interests or the privacy or safety of the persons concerned. Disclosure of the following information shall normally be deemed to undermine the protection of the commercial interests or the privacy or safety of the persons concerned: (a) details of the full composition of a biocidal product; (b) the precise tonnage of the active substance or biocidal product manufactured or made available on the market; (c) links between a manufacturer of an active substance and the person responsible for the placing of a biocidal product on the market or between the person responsible for the placing of a biocidal product on the market and the distributors of the product; (d) names and addresses of persons involved in testing on vertebrates. However, where urgent action is essential to protect human health, animal health, safety or the environment or for other reasons of overriding public interest, [ECHA] or the competent authorities shall disclose the information referred to in this paragraph. 3. Notwithstanding paragraph 2, after the authorisation has been granted, access to the following information shall not in any case be refused: … (j) methods of analysis referred to in Article 19(1)(c); … 4. Any person submitting information related to an active substance or a biocidal product to [ECHA] or a competent authority for the purposes of this Regulation may request that the information in Article 67(3) and (4) not be made available, including a justification as to why the disclosure of the information could be harmful for that person’s commercial interests or those of any other party concerned.’
11 Under Article 67 of Regulation No 528/2012, entitled ‘Electronic public access’: ‘1. From the date on which the Commission adopts an implementing Regulation providing that an active substance is approved, as referred to in point (a) of Article 9(1), the following up-to-date information held by [ECHA] or the Commission on that active substance shall be made publicly and easily available free of charge: … (h) analytical methods referred to under Sections 5.2 and 5.3 of Title 1, and Section 4.2 of Title 2 of Annex II. 2. From the date on which a biocidal product is authorised, [ECHA] shall make publicly and easily available free of charge the following up-to-date information: (a) the terms and conditions of the authorisation; (b) the summary of the biocidal product characteristics; and (c) analytical methods referred to under Sections 5.2 and 5.3 of Title 1, and Section 5.2 of Title 2 of Annex III. 3. From the date on which the Commission adopts an implementing Regulation providing that an active substance is approved, as referred to in point (a) of Article 9(1), [ECHA] shall, except where the data supplier submits a justification in accordance with Article 66(4) accepted as valid by the competent authority or [ECHA] as to why such publication is potentially harmful for its commercial interests or any other party concerned, make publicly available, free of charge, the following up-to-date information on that active substance: … (e) the assessment report. 4. From the date on which a biocidal product is authorised, [ECHA] shall, except where the data supplier submits a justification in accordance with Article 66(4) accepted as valid by the competent authority or [ECHA] as to why such publication is potentially harmful for its commercial interests or any other party concerned, make publicly available, free of charge, the following up-to date information: (a) study summaries, or robust study summaries, of studies submitted to support the biocidal product authorisation; and (b) the assessment report.’
12 Article 91 of that regulation, entitled ‘Transitional measures concerning applications for biocidal product authorisations submitted under Directive [98/8]’, provides: ‘Applications for biocidal product authorisations submitted for the purposes of Directive [98/8] for which the evaluation has not been completed by 1 September 2013 shall be evaluated by the competent authorities in accordance with that Directive. …’
13 The first paragraph of Article 96 of Regulation No 528/2012 provides that, ‘without prejudice to Articles 86, 89 to 93 and 95 of this Regulation, Directive [98/8] is hereby repealed with effect from 1 September 2013.’
14 In accordance with the second paragraph of Article 97 of Regulation No 528/2012, that regulation was to apply from 1 September 2013.
15 Annex III to that regulation, in its version resulting from 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), provides, under Title 2, entitled ‘Micro-organisms’: ‘Core data set and additional data set Information required to support the authorisation of a biocidal product is listed in the table below. … Column 1 Information required: Column 2 All data is [core data set] unless indicated as [additional data set] Column 3 Specific rules for adaptation from column 1 … 2. Identity of the biocidal products … 2.5. Where the biocidal product contains an active substance that has been manufactured in locations or according to processes or from starting materials other than those of the active substance evaluated for the purpose of approval pursuant to Article 9 of this Regulation, evidence has to be provided that technical equivalence has been established in accordance with Article 54 of this Regulation or has been established, following an evaluation having started before 1 September 2013, by a competent authority designated in accordance with Article 26 of Directive [98/8]. …’
16 Annex VI to the regulation, entitled ‘Common principles for the evaluation of dossiers for biocidal products’, provides: ‘… Assessment General principles … 21. Where relevant the technical equivalence for every active substance contained in the biocidal product shall be established with reference to active substances already included in the list of approved active substances. …’
17 Under Article 3(1) of Directive 2003/4: ‘Member States shall ensure that public authorities are required, in accordance with the provisions of this Directive, to make available environmental information held by or for them to any applicant at his request and without his having to state an interest.’
18 Article 4(2) of that directive provides: ‘Member States may provide for a request for environmental information to be refused if disclosure of the information would adversely affect: … (d) the confidentiality of commercial or industrial information where such confidentiality is provided for by national or Community law to protect a legitimate economic interest, including the public interest in maintaining statistical confidentiality and tax secrecy; … The grounds for refusal mentioned in paragraphs 1 and 2 shall be interpreted in a restrictive way, taking into account for the particular case the public interest served by disclosure. In every particular case, the public interest served by disclosure shall be weighed against the interest served by the refusal. Member States may not, by virtue of paragraph 2(a), (d), (f), (g) and (h), provide for a request to be refused where the request relates to information on emissions into the environment. …’
19 Recital 117 of Regulation No 1907/2006 states: ‘EU citizens should have access to information about chemicals to which they may be exposed, in order to allow them to make informed decisions about their use of chemicals. A transparent means of achieving this is to grant them free and easy access to basic data held in [ECHA]’s database, including brief profiles of hazardous properties, labelling requirements and relevant Community legislation including authorised uses and risk management measures. [ECHA] and Member States should allow access to information in accordance with Directive [2003/4], Regulation [No 1049/2001] and [the Aarhus Convention].’
20 Article 6 of Regulation (EC) No 1367/2006 of the European Parliament and of the Council of 6 September 2006 on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to Community institutions and bodies (OJ 2006 L 264, p. 13) states, in paragraph 1: ‘As regards Article 4(2), first and third indents, of Regulation (EC) No 1049/2001, with the exception of investigations, in particular those concerning possible infringements of Community law, an overriding public interest in disclosure shall be deemed to exist where the information requested relates to emissions into the environment. As regards the other exceptions set out in Article 4 of Regulation (EC) No 1049/2001, the grounds for refusal shall be interpreted in a restrictive way, taking into account the public interest served by disclosure and whether the information requested relates to emissions into the environment.’
21 It follows from the provisions of Articles L.300-1, L.300-2 and L.311-1 of the code des relations entre le public et l’administration (Code on relations between the public and the administrative authorities) that the administrative authorities are required to communicate the administrative documents they hold, subject to the exceptions laid down in Title I of Book III of that code.
22 Under Article L.311-6 of the code: ‘The following administrative documents shall not be supplied save to the person concerned: 1° Administrative documents the supply of which would compromise … a trade secret, which includes the confidentiality of processes, economic and financial information and commercial or industrial strategies … …’
23 Article L.124-4 of the code de l’environnement (Environmental Code) provides: ‘I.-After assessing the interest of supplying certain information, the public authority may refuse the request for environmental information if consultation or supply thereof adversely affects: 1° The interests referred to in Articles L.311-5 to L.311-8 of the Code on relations between the public and the administrative authorities, with the exception of those referred to in subparagraphs (e) and (h) of paragraph 2 of Article L.311-5; …’
24 Article L.124-5 of the Environmental Code provides: ‘… II-The public authority may refuse a request for information on emissions of substances into the environment only if consultation or supply thereof adversely affects: 1° The conduct of French foreign policy, public security, or national defence; 2° The course of judicial proceedings or the investigation of offences which may give rise to criminal sanctions; 3° Intellectual property rights.’
25 Article L.521-7 of the Environmental Code, which was also applicable to information concerning active substances and biocidal products pursuant to Article L.522-12 of that code, the provisions of which transposed Article 19 of Directive 98/8 before being repealed, following the entry into force of Regulation No 528/2012, provides: ‘I.-The person who sent to the administrative authority information which that person claims is a trade secret may indicate which items of information that person considers to be commercially sensitive, the disclosure of which might harm him or her, and which that person wishes to be kept secret from all persons other than the administrative authority. In that case, justification will be required by the administrative authority which will assess the merits of the request. … II.-The administrative authority shall take all appropriate steps to ensure that information recognised by it or by the competent authority of a Member State of the European Community or by [ECHA] as constituting a trade secret is accessible only to persons designated by it. … …’
26 The applicant in the main proceedings markets Vectobac, a biocidal product for mosquito control, the active substance of which is Bacillus thuringiensis israelensis, serotype H14, strain AM65-52 (Bti-AM65-52). That substance is on the list of active substances with requirements agreed at Community level for inclusion in biocidal products set out in Annex I to Directive 98/8.
27 On 30 August 2013, according to the information provided by the Conseil d’État (Council of State, France), CERA submitted applications to ANSES for authorisation to place on the market ‘Aquabac XT’, ‘Aquabac DF3000’ and ‘Aquabac 200G’, three biocidal products the active substance of which is the same bacillus of the same serotype as the active substance referred to in the preceding paragraph, but the strain of which is BMP 144 (Bti-BMP 144). The intended purpose of those goods is identical to that of the Vectobac product.
28 The authorisations sought were granted by three ANSES decisions of 19 August 2019, based on a report drawn up by the latter, which concluded that the active substances Bti-BMP 144 and Bti-AM65-52 were technically equivalent.
29 It is apparent from the documents before the Court that, by letter of 11 February 2021, the applicant in the main proceedings asked ANSES to send it that report.
30 ANSES sent the applicant pages 1, 2 and 23 of the report, corresponding, respectively, to the cover page, the summary and a conclusion in the form of a table, but refused to send the remaining pages on the ground that they contained information covered by a trade secret.
31 The applicant in the main proceedings brought an action before the tribunal administratif de Melun (Administrative Court, Melun, France) seeking annulment of the decision of the Director-General of ANSES of 8 August 2021 refusing to give access, in full, to the report at issue in the main proceedings. By judgment of 22 September 2022, that court annulled that decision in so far as it refused to disclose point 2.2 of the report, at pages 21 and 22 thereof, ordered ANSES to do so and dismissed the remainder of the claims of the applicant in the main proceedings.
32 The applicant in the main proceedings brought an appeal before the referring court, claiming that the court should, inter alia, set aside that judgment in so far as it dismissed the remainder of its claims and, ruling on the substance of the case, grant its application.
33 That court states that the undisclosed extracts from the report at issue in the main proceedings concern: - Part I, on the methodology used by ANSES to determine whether the active substance contained in Aquabac products is technically equivalent to that in the Vectobac product and - the first subsection of Part II, which implements that methodology for the active substances at issue and contains information on (i) the identity and contact details of the applicant and the manufacturer of the active substance contained in Aquabac products; (ii) the location of the plant in which it is manufactured; (iii) the name of the active micro-organism; (iv) the classification of the active substance, (v) its manufacturing process; (vi) the active substance content in the biocidal products at issue; (vii) details of the relevant toxins and metabolites, fermentation residues and contaminants; (viii) the ‘analytical profile’ consisting of comparing the composition of five batches of the biocidal products at issue; (ix) the analytical methods for identifying the pure active micro-organism in the active micro-organism as manufactured and; (x) the analytical methods for determining impurities and toxins, fermentation residues and contaminants in that micro-organism.
34 The referring court points out that the report requested was drawn up in the context of the examination of the applications for an authorisation for the placing on the market of Aquabac biocidal products submitted by CERA before 1 September 2013 and that ANSES applied Article 91 of Regulation No 528/2012 and therefore examined those applications and then issued those authorisations, in accordance with the national provisions transposing Directive 98/8. In those circumstances, that court seeks to determine, in the first place, whether a request for access to that report must be examined in the light of the rules on confidentiality laid down by the national provisions transposing Article 19 of that directive or in the light of Articles 66 and 67 of that regulation.
35 In the second place, if the answer as regards the applicability of Directive 98/8 is in the affirmative, the referring court is uncertain as to the interpretation of Article 19(3)(f) and (k) thereof.
36 In the third place, assuming that the dispute in the main proceedings falls within the scope of Regulation No 528/2012, that court’s questions concern the interpretation of Article 66(3)(j) of that regulation and of Article 67(1)(h), (3)(e) and (4) thereof.
37 In that regard, the referring court notes that Articles 66 and 67 of Regulation No 528/2012 do not refer to Directive 2003/4, although Article 19 of Directive 98/8 provided that it was to apply without prejudice to Directive 90/313, which was repealed and replaced by Directive 2003/4. In those circumstances, that court asks whether the EU legislature intended to define, in Regulation No 528/2012, a specific and comprehensive regime for the communication to the public of information on biocidal products and their active substances and, thus, to disapply the provisions of Directive 2003/4.
38 In the fourth place, the resolution of the dispute in the main proceedings also depends on whether the classification of ‘information on emissions into the environment’ within the meaning of the second subparagraph of Article 4(2) of Directive 2003/4, assuming that it is applicable, may apply to information held by the competent authority following the examination of the technical equivalence of an active substance with an approved active substance.
39 In those circumstances, the Conseil d’État (Council of State) decided to stay proceedings and to refer the following questions to the Court of Justice for a preliminary ruling: ‘(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, having examined that application on the basis of the national provisions transposing Directive [98/8] 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], 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], Article 19 of which applies without prejudice to Directive 2003/4 …: [(a)] 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[;] [(b)] 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: [(a)] 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[;] [(b)] 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[;] [(c)] 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[;] [(d)] 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 [2021/525] of 19 October 2020 amending Annexes II and III to Regulation No 528/2012? 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?’
40 By its first question, the referring court asks, in essence, whether, where an application for authorisation of a biocidal product has been submitted under Directive 98/8 and has been examined, then approved, by the competent national authority in accordance with the national provisions transposing that directive, a request for access to information on that product and, in particular, on the technical equivalence of the active substance contained therein with an approved active substance, must be assessed in the light of Article 19 of Directive 98/8 or Articles 66 and 67 of Regulation No 528/2012, where that request for access was submitted after the date on which that regulation became applicable.
41 In the present case, it is apparent from the documents before the Court that the request for access at issue in the main proceedings was lodged on 11 February 2021. It concerns the Aquabac biocidal products for which the authorisation for the placing on the market was sought, according to the information provided by the referring court, on 30 August 2013.
42 In so far as the applicant in the main proceedings submits, in its written observations, that, in reality, the applications for authorisation were lodged on 6 October 2013, thus after the entry into force of Regulation No 528/2012, it should be stated that, in accordance with the Court’s settled case-law, in the preliminary ruling procedure under Article 267 TFEU, based on a clear separation of functions between the national courts and the Court of Justice, the national court alone has jurisdiction to find and assess the facts in the dispute in the main proceedings. In that context, the Court is empowered to rule solely on the interpretation or validity of EU law in the light of the factual and legal situation as described by the referring court, in order to provide that court with such guidance as will assist it in resolving the dispute before it (judgment of 24 October 2019, État belge, C‑35/19, EU:C:2019:894, paragraph 28 and the case-law cited).
43 Consequently, it is on the basis of the facts set out by the Conseil d’État (Council of State) in the order for reference that the questions referred must be answered.
44 In accordance with the second paragraph of Article 97 of Regulation No 528/2012, that regulation became applicable from 1 September 2013. It was with effect from that date that Directive 98/8 was repealed, pursuant to the first paragraph of Article 96 of that regulation, without prejudice to Articles 86, 89 to 93 and 95 of that regulation.
45 The first paragraph of Article 91 of Regulation No 528/2012 provides that applications for biocidal product authorisations submitted for the purposes of Directive 98/8 for which the evaluation has not been completed by 1 September 2013 are to be evaluated by the competent authorities in accordance with that directive.
46 It follows, moreover, from point 2.5 of Title 2 of Annex III to Regulation No 528/2012, in its version resulting from Delegated Regulation 2021/525, that, where technical equivalence is required in the context of an authorisation procedure conducted under that regulation, evidence has to be provided that that equivalence has been established in accordance with Article 54 thereof ‘or has been established, following an evaluation having started before 1 September 2013, by a competent authority designated in accordance with Article 26 of Directive [98/8]’.
47 Those provisions concern the procedure for authorisation for the placing on the market of a biocidal product. By contrast, as the Advocate General stated in points 29 and 30 of his Opinion, none of the transitional measures established in Articles 89 to 93 and 95 of Regulation No 528/2012 relates to a request such as that at issue in the main proceedings, that is to say, a request for access to information on an authorised biocidal product and the active substance it contains, in particular, on its technical equivalence with an approved active substance.
48 Furthermore, as the Advocate General also observed, in essence, in point 33 of his Opinion, applications for authorisation to place biocidal products on the market and requests for access to information on authorised biocidal products are evaluated by the competent authority in the context of two different procedures.
49 Therefore, in the absence of transitional provisions applicable to a request for access to information, such as that at issue in the main proceedings, submitted after 1 September 2013 and relating to an active substance contained in a biocidal product authorised under Directive 98/8, and, in particular, to the technical equivalence of that active substance with another approved active substance, the assessment of that request is governed by the provisions of that regulation.
50 In the light of all the foregoing considerations, the answer to the first question is that Articles 96 and 97 of Regulation No 528/2012 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 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.
51 Given the answer to the first question, there is no need to answer the second question.
52 It is appropriate to examine Question 3(c) first and then Question 3(b) and (d) together, before answering Question 3(a).
53 By Question 3(c), the referring court asks, in essence, whether Article 66(3)(j) of Regulation No 528/2012 must be interpreted as meaning that, in response to a request for access based on that provision, the competent authority is required to disclose any detailed information on the methods of analysis referred to in Article 19(1)(c) of that regulation, including where disclosure of that information would compromise a trade secret, or only general information on the nature of those methods and any conclusions that may be drawn from them.
54 According to the first subparagraph of Article 66(2) of Regulation No 528/2012, ECHA and the competent authorities are to refuse access to information where disclosure would undermine the protection of the commercial interests or the privacy or safety of the persons concerned. The second subparagraph of that provision lists the information the disclosure of which is normally deemed to undermine such protection or safety.
55 Article 66(3)(j) of that regulation provides that, notwithstanding paragraph 2 of that Article 66, after the authorisation has been granted, access to the ‘methods of analysis referred to in Article 19(1)(c)’ of that regulation is not in any case to be refused.
56 As the Advocate General observed, in essence, in points 83 and 84 of his Opinion, the unequivocal wording of Article 66(3) of Regulation No 528/2012 and, more specifically, the expression ‘in any case’, indicate that, after the authorisation for the placing on the market has been granted, access to the information on the methods of analysis referred to in Article 19(1)(c) of Regulation No 528/2012 may not be refused on any grounds whatsoever.
57 The latter provision requires, as part of the conditions for granting an authorisation for the placing on the market for a biocidal product other than those eligible for the simplified authorisation procedure, that, inter alia, the chemical identity, quantity and technical equivalence of active substances in the biocidal product can be determined according to the relevant requirements in Annexes II and III to that regulation.
58 Article 19(1)(c) of Regulation No 528/2012 therefore expressly mentions, among the factors subject to an evaluation carried out in accordance with the methods of analysis referred to in that article and which may lead to the grant of an authorisation to place the biocidal product at issue on the market, the technical equivalence of the active substances contained in that product. Consequently, since Article 66(3)(j) of that regulation prohibits any refusal of access to the ‘methods of analysis referred to in Article 19(1)(c)’ thereof, it must apply to the methods which have made it possible to establish, inter alia, that equivalence, as defined in Article 3(1)(w) of that regulation and referred to, inter alia, in point 2.5 of Title 2 of Annex III to that regulation.
59 Furthermore, in so far as Article 66(3)(j) of Regulation No 528/2012 lays down an obligation, for the competent authority, to ensure access to information on the methods of analysis which have been used for the purposes of granting the authorisation for the placing on the market concerned, that provision cannot, as the Advocate General observed, in essence, in point 82 of his Opinion, be interpreted as concerning only the provision of general information on the nature of those methods. On the contrary, it must be interpreted as requiring the provision of precise and complete information on those methods. By contrast, and as the Advocate General also noted, that obligation is limited to the methods of analysis and does not, therefore, extend to the results or conclusions obtained as a result of applying those methods.
60 In the light of all the foregoing considerations, the answer to Question 3 (c) is that Article 66(3)(j) of Regulation No 528/2012 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.
61 By Question 3(b) and (d), the referring court asks, in essence, whether Article 67 of Regulation No 528/2012 must be interpreted as meaning that the communication, in full or in part, of a report establishing the technical equivalence of an approved active substance with the active substance contained in a biocidal product, drawn up when examining an application for authorisation to place that product on the market, falls within the scope of Article 67(1)(h), (3)(e) or (4)(b) of that regulation. The referring court also asks whether Article 67(1)(h), which requires the ‘analytical methods referred to under … Section 4.2 of Title 2 of Annex II’ to be made publicly available, must be interpreted as in fact referring to point 4.3 of Title 2 of Annex II to Regulation No 528/2012, formerly point 4.2 of that title, which became point 4.3 thereof after Delegated Regulation 2021/525 entered into force.
62 In that regard, it should be noted that Article 67 of Regulation No 528/2012 requires ECHA and, in paragraph 1 thereof, the Commission to make certain information publicly available, free of charge, and is therefore not addressed to the competent authorities of the Member States.
63 However, that Article 67 establishes a normative framework of reference for transparency that is also relevant for the assessment by the competent authority of a Member State, under Regulation No 528/2012, of the merits of a request for access to information on a biocidal product authorised in accordance with Directive 98/8 or on the basis of technical equivalence established, under point 2.5 of Title 2 of Annex III to that regulation, by a competent authority designated in accordance with Article 26 of that directive.
64 Article 67 of Regulation No 528/2012 provides that information be made publicly available, free of charge, on the one hand, ‘from the date on which the Commission adopts an implementing Regulation providing that an active substance is approved’, in accordance with paragraphs 1 and 3 thereof, and, on the other hand, ‘from the date on which a biocidal product is authorised’, in accordance with paragraphs 2 and 4 thereof.
65 In the present case, the request for access to the information at issue does not fall within the first but falls within the second scenario. That request does not concern documents for a procedure for the approval of an active substance, governed by the provisions of Chapter II of Regulation No 528/2012, but concerns documents relating to a procedure for the authorisation of biocidal products, on the basis of technical equivalence of an active substance contained therein with another substance already approved and included in the EU list of approved active substances, under Chapters IV to VI of that regulation.
66 Accordingly, neither paragraph (1)(h) nor paragraph (3)(e) of Article 67 of Regulation No 528/2012 can apply in the context of a dispute such as that at issue in the main proceedings.
67 As regards the second scenario referred to in paragraph 64 above, and, more specifically, Article 67(4)(b) of Regulation No 528/2012, which refers to the ‘assessment report’, it should be noted that that concept is defined in Article 30(3)(a) of that regulation as the ‘report [drawn up by the receiving competent authority] summarising the conclusions of [the] assessment and the reasons for authorising the biocidal product or for refusing to grant an authorisation’.
68 It is true that the appraisal of the technical equivalence of the active substance contained in a biocidal product with an active substance already approved constitutes a stage prior to the authorisation of such a product, if so requested. In that regard, first of all, Article 54 of Regulation No 528/2012, governing the assessment of technical equivalence, refers to the ‘assessment’ which is to lead to the adoption of a decision as to whether active substances are technically equivalent. Next, it is apparent from point 2.5 of Title 2 of Annex III to that regulation, in its version resulting from Delegated Regulation 2021/525, that such technical equivalence may be established, following an ‘evaluation’ having started before 1 September 2013, by a competent authority designated in accordance with Article 26 of Directive 98/8. Lastly, Annex VI to Regulation No 528/2012, which defines, in accordance with its title, the common principles for the evaluation of dossiers for biocidal product, states in point 21 that, ‘where relevant the technical equivalence for every active substance contained in the biocidal product shall be established with reference to active substances already included in the list of approved active substances’. However, it does not follow from those provisions that decisions taken by ECHA under Article 54 of that regulation or by the competent authority of a Member State, with a view to establishing that technical equivalence, constitute an ‘assessment report’ within the meaning of Article 30(3)(a) of that regulation.
69 Accordingly, neither Article 67(1)(h) of Regulation No 528/2012, nor Article 67(3)(e) of that regulation, nor Article 67(4)(b) thereof requires a report such as that at issue in the main proceedings to be made publicly available.
70 In those circumstances, there is no need to answer the first part of Question 3(d), as recalled in the second sentence of paragraph 61 above.
71 In the light of the foregoing considerations, the answer to Question 3(b) and (d) is that Article 67(1)(h), Article 67(3)(e) and Article 67(4)(b) of Regulation No 528/2012 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.
72 By Question 3(a), the referring court asks, in essence, whether Articles 66 and 67 of Regulation No 528/2012 must be interpreted as 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 exclude the application, by those authorities, of the national provisions transposing the second subparagraph of Article 4(2) of Directive 2003/4.
73 As regards, in the first place, Articles 66 and 67 of Regulation No 528/2012, since, as is apparent from paragraph 62 above, Article 67 of that regulation is not addressed to the competent authorities of the Member States, only Article 66 thereof is relevant for the examination of Question 3(a).
74 In accordance with point (a) of the second subparagraph of Article 66(2) of Regulation No 528/2012, disclosure of ‘details of the full composition of a biocidal product’ is normally deemed to undermine the protection of commercial interests. By way of exception to that rule, ‘where urgent action is essential to protect … the environment or for other reasons of overriding public interest’, the competent authorities are nevertheless required, in accordance with the third subparagraph of that paragraph, to disclose that information. Moreover, after the authorisation has been granted, access to information falling within 1 of the 13 categories referred to in Article 66(3) of Regulation No 528/2012, which include, under point (j), the ‘methods of analysis referred to in Article 19(1)(c)’ thereof, is not in any case to be refused.
75 In the second place, under Article 3(1) of Directive 2003/4, Member States are to ensure that public authorities, within the meaning of point 2 of Article 2 thereof, are required to make available environmental information which falls within one of the six categories of information set out in point 1 of Article 2 of that directive, and which is held by or for them, to any applicant at his or her request and without his or her having to state an interest, unless the request is caught by one of the derogations provided for in Article 4 of that directive.
76 In accordance with point (d) of the first subparagraph of Article 4(2) of Directive 2003/4, Member States may provide for a request for environmental information to be refused if disclosure thereof would adversely affect ‘the confidentiality of commercial or industrial information where such confidentiality is provided for by national or [EU] law to protect a legitimate economic interest’. The penultimate sentence of the second subparagraph of Article 4(2) of that directive provides, in that regard, that ‘in every particular case, the public interest served by disclosure shall be weighed against the interest served by the refusal’.
77 Furthermore, under the second subparagraph of Article 4(2) of Directive 2003/4, the EU legislature introduced an exception to the derogation provided for in point (d) of the first subparagraph of Article 4(2) of that directive. Thus, in accordance with the last sentence of the second subparagraph of Article 4(2) of that directive, the confidentiality of commercial or industrial information cannot justify the refusal of a request for access to environmental information concerning ‘information on emissions into the environment’.
78 As regards, in the third place, the relationship between Article 66 of Regulation No 528/2012 and Article 4(2) of Directive 2003/4, it should be noted that, unlike Article 19 of Directive 98/8, which provided, in paragraph 1 thereof, that it was to apply ‘without prejudice to Directive [90/313]’, neither Article 66 of Regulation No 528/2012 nor any other provision of that regulation contains a similar statement referring to Directive 2003/4, which repealed and replaced Directive 90/313.
79 However, the absence of such a reference cannot be interpreted as precluding the application of Directive 2003/4 to requests for access to documents drawn up for the purposes of implementing that regulation or, as the case may be, in accordance with the transitional measures provided for by that regulation, Directive 98/8.
80 First, Regulation No 528/2012 does not state that its provisions on confidentiality derogate from, and impose limits on, the general scheme for access to environmental information. On the contrary, Article 66(1) of that regulation expressly provides that Regulation No 1049/2001 and the rules of the Management Board of ECHA, adopted in accordance with Article 118(3) of Regulation No 1907/2006, ‘shall apply to documents held by [ECHA] for the purposes of this Regulation’.
81 In that regard, the Court has already held that Article 6 of Regulation No 1367/2006 adds specific rules concerning requests for access to environmental information to Regulation No 1049/2001 (judgment of 14 November 2013, LPN and Finland v Commission, C‑514/11 P and C‑605/11 P, EU:C:2013:738, paragraph 79). Article 6(1) lays down a rule similar to that laid down in the second subparagraph of Article 4(2) of Directive 2003/4.
82 Moreover, recital 117 of Regulation No 1907/2006 states that ‘[ECHA] and Member States should allow access to information in accordance with Directive [2003/4], Regulation [No 1049/2001] and [the Aarhus Convention]’.
83 Second, the use of the adverb ‘normally’ in the second subparagraph of Article 66(2) of Regulation No 528/2012 suggests that information falling within one of the four categories listed therein are not to be protected against disclosure in all events and that the competent authorities of the Member States have a margin of discretion in that regard. In addition, the third subparagraph of that paragraph 2 expressly requires those authorities to weigh the protection of the commercial interests against the public interests served by the disclosure of that information.
84 Thus, it is not apparent that, with the provisions of Regulation No 528/2012 on confidentiality, the EU legislature intended to provide for a specific and comprehensive regime such as to preclude access to information relating to emissions into the environment, in accordance with the national provisions adopted to transpose Directive 2003/4. In that respect, it is clear from the statement of reasons in Commission Proposal of 12 June 2009 for a Regulation of the European Parliament and of the Council concerning the placing on the market and use of biocidal products (COM(2009) 267 final) that the confidentiality provisions of Directive 98/8 were to be slightly modified and aligned with those of Regulation No 1907/2006, in order to facilitate their application by ECHA.
85 Third, as the Advocate General observed in point 41 of his Opinion, an interpretation to the contrary would result in disregard for the international commitments made by the European Union upon its signing of the Aarhus Convention, which provides, in point (d) of the first subparagraph of Article 4(4), that the confidentiality of commercial and industrial information cannot be invoked against the disclosure of information on emissions which is relevant for the protection of the environment.
86 It follows from recital 5 of Directive 2003/4 that that directive was adopted precisely to respond to the need to ensure the compatibility of EU law with the Aarhus Convention.
87 Thus, by establishing that the confidentiality of commercial or industrial information may not be invoked against the disclosure of ‘information on emissions into the environment’, the second subparagraph of Article 4(2) of Directive 2003/4 allows for specific application of the rule set out in paragraph 85 above and of the principle of the widest possible access to the environmental information held by or for public authorities (judgment of 23 November 2016, Bayer CropScience and Stichting De Bijenstichting, C‑442/14, EU:C:2016:890, paragraph 57).
88 In the light of the foregoing, the answer to Question 3(a) is that Article 66 of Regulation No 528/2012 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.
89 By its fourth question, the referring court asks, in essence, whether 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 applicable to information contained in a report drawn up by the competent authority following the examination of the technical equivalence of an active substance, contained in an authorised biocidal product, with an approved active substance.
90 In that regard, the Court held, first, that ‘emissions into the environment’ within the meaning of the second subparagraph of Article 4(2) of Directive 2003/4 must be interpreted as including, inter alia, the release into the environment of products or substances such as plant protection products or biocides and substances contained in those products, to the extent that that release is actual or foreseeable under normal or realistic conditions of use (judgment of 23 November 2016, Bayer CropScience and Stichting De Bijenstichting, C‑442/14, EU:C:2016:890, paragraph 81).
91 Second, it specified that ‘information on emissions into the environment’, within the meaning of that provision, must be interpreted as covering not only information on emissions as such, namely information concerning the nature, composition, quantity, date and place of those emissions but also data concerning the medium to long-term consequences of those emissions on the environment (judgment of 23 November 2016, Bayer CropScience and Stichting De Bijenstichting, C‑442/14, EU:C:2016:890, paragraph 87).
92 The public must have access, for that purpose, not only to information on emissions as such, but also to information concerning the medium to long-term consequences of those emissions on the state of the environment, such as the effects of those emissions on non-targeted organisms. The public interest in accessing information on emissions into the environment is specifically to know not only what is, or foreseeably will be, released into the environment, but also to understand the way in which the environment could be affected by the emissions in question (judgment of 23 November 2016, Bayer CropScience and Stichting De Bijenstichting, C‑442/14, EU:C:2016:890, paragraph 86).
93 ‘Information on emissions into the environment’ thus covers data from studies the purpose of which is to assess the actual or foreseeable emissions of the product or substance in question into the environment under circumstances representing normal or realistic conditions of use of that product or substance, or to analyse the effects of those emissions, such as studies which seek to establish the toxicity, effects and other aspects of a product or substance under the most unfavourable realistic conditions which could possibly occur, and studies carried out in conditions as close as possible to normal agricultural practice and conditions which prevail in the area where that product or substance is to be used (see, to that effect, judgment of 23 November 2016, Bayer CropScience and Stichting De Bijenstichting, C‑442/14, EU:C:2016:890, paragraphs 89 and 91).
94 That concept also covers the information on residues present in the environment following application of the product concerned and the studies on the measurement of that substance’s drift at the time of that application (judgment of 23 November 2016, Bayer CropScience and Stichting De Bijenstichting, C‑442/14, EU:C:2016:890, paragraph 95).
95 By contrast, it excludes information which does not concern emissions from the product or substance in question into the environment, as well as information which relates to hypothetical emissions, that is to say, emissions which are not actual or foreseeable under circumstances representing normal or realistic conditions of use (see, to that effect, judgment of 23 November 2016, Bayer CropScience and Stichting De Bijenstichting, C‑442/14, EU:C:2016:890, paragraphs 77 to 80 and 100).
96 As the French Government points out, the purpose of the assessment of the technical equivalence of an active substance, contained in a biocidal product, with an approved active substance is not, a priori, to examine the possible effects on health or the environment linked to the emission of a substance into the environment, but it is merely to compare two substances by taking into consideration information concerning the exact composition of those substances and the manufacturing processes.
97 Furthermore, as the French Government also noted, the authorisation for the placing on the market is granted for the product containing the substance, in the light of the risks or hazards which it may present under normal or realistic conditions of use. Those conditions are not those relating to the emission of the substance alone, but those corresponding to the biocidal product incorporating it.
98 It is thus apparent that a technical report on the equivalence of an active substance, contained in a biocidal product, with an approved active substance, such as that at issue in the main proceedings, is not, in principle, likely to contain ‘information on emissions into the environment’ within the meaning of the second subparagraph of Article 4(2) of Directive 2003/4.
99 However, it is ultimately for the referring court to ascertain whether the report at issue in the main proceedings contains such information.
100 In particular, it is for that court to ascertain whether that report contains information concerning the nature, composition, quantity, date or place of the foreseeable emissions, under circumstances representing normal or realistic conditions of use, of the active substance contained in Aquabac products or, as the case may be, information relating to residues that may be present in the environment following the application of those products.
101 In the light of all of the foregoing considerations, the answer to the fourth question is that 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.
102 Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the referring court, the decision on costs is a matter for that court. Costs incurred in submitting observations to the Court, other than the costs of those parties, are not recoverable.