Provisional text

delivered on 19 September 2024 (1)

Case C-809/23

Sumitomo Chemical Agro Europe SAS

Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail (ANSES),

Compagnie européenne de réalisations antiparasitaires SAS France (CERA),

intervening party:

Ministre de la transition écologique et de la cohésion des territoires

(Request for a preliminary ruling from the Conseil d’État (Council of State, France))

( Reference for a preliminary ruling – Biocidal products – Marketing authorisation – Regulation (EU) No 528/2012 – Request for access to information relating to an authorised product – Directive 2003/4/EC – Determination of the applicable legislation – Confidentiality – Trade secrets – Scope of access to information )

1.In the course of a procedure carried out to authorise the placing of biocidal products on the market, the competent French authority (2) prepared a report on the technical equivalence of various active substances, which was decisive for the grant of the requested authorisation.

2.A chemical company which questions the technical equivalence that was found to exist requested access to the abovementioned report. Believing it to contain technical information protected by trade secrecy, ANSES only provided that company with certain pages of the report, refusing it access to the rest.

3.In that context, the dispute concerns, first of all, whether access to the information at issue is governed by Directive 98/8/EC, (3) under which the authorisation was processed, or by Regulation (EU) No 528/2012, (4) which was in force at the time of the request for access to the report.

4.If, as I shall propose to the Court of Justice, Regulation No 528/2012 is applicable, it will still be necessary to clarify whether that regulation excludes the application of Directive 2003/4/EC (5) or whether, on the contrary, the two can be combined harmoniously.

5.The reference for a preliminary ruling will allow the Court to expand on its case-law on the reconciliation of the right of access to information, on the one hand, and the confidentiality inherent in the protection of trade secrets and commercial interests, on the other.

6.Recital 61 states:

‘Effective communication of information on risks resulting from biocidal products and risk management measures is an essential part of the system established by this Regulation. While facilitating access to information, competent authorities, the [European Chemicals Agency (‘the Agency’)] and the Commission should respect the principle of confidentiality and avoid any disclosure of information which could be harmful to the commercial interests of the person concerned, except where it is necessary for the protection of human health, safety or the environment or for other reasons of overriding public interest.’

7.Article 3 (‘Definitions’) states:

‘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;

….’

8.Article 66 (‘Confidentiality’), as amended by Regulation (EU) No 334/2014, (6) provides:

‘…

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;

…

However, where urgent action is essential to protect human health, animal health, safety or the environment or for other reasons of overriding public interest, the Agency 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);

…’

9.Article 67 (‘Electronic public access’), as amended by Regulation No 334/2014, states:

‘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 the Agency 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.

(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), the Agency shall, except where the data supplier submits a justification in accordance with Article 66(4) accepted as valid by the competent authority or the Agency 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.

…

(b) the assessment report.’

10.Article 91 (‘Transitional measures concerning applications for biocidal product authorisations submitted under Directive 98/8/EC’) reads:

‘Applications for biocidal product authorisations submitted for the purposes of Directive 98/8/EC for which the evaluation has not been completed by 1 September 2013 shall be evaluated by the competent authorities in accordance with that Directive.

….’

11.Article 96 (‘Repeal’), as amended by Regulation No 334/2014, states:

‘Without prejudice to Articles 86, 89 to 93 and 95 of this Regulation, Directive 98/8/EC is hereby repealed with effect from 1 September 2013.’

12.Article 97 (‘Entry into force’) reads:

‘This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from 1 September 2013.

….’

13.Article 4 (‘Exceptions’) provides:

‘…

…

(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.

…’

14.Article 11 (‘Repeal’) provides:

‘Directive 90/313/EEC is hereby repealed with effect from 14 February 2005.

References to the repealed Directive shall be construed as referring to this Directive and shall be read in accordance with the correlation table in the Annex.’

II. Facts, dispute and questions referred for a preliminary ruling

15.The company Sumitomo Chemical Agro Europe SAS (‘Sumitomo’) markets a biocidal product used to combat mosquitoes, known as ‘Vectobac’, the active substance of which (7) appears in the list of those accepted for inclusion in biocidal products according to Annex I to Directive 98/8.

16.On 30 August 2013, (8) Compagnie européenne de réalisations antiparasitaires SAS France (CERA) submitted applications to ANSES to place on the national market three biocidal products all having the same purpose, called ‘Aquabac XT’, ‘Aquabac DF3000’ and ‘Aquabac 200G’.

17.The active substance of those three biocidal products is the same bacillus of the same serotype. However, the strain to which it belongs (9) does not appear in the list of substances approved at EU level.

18.CERA requested confidential treatment of any data provided to ANSES and covered by trade secrecy.

19.On 19 August 2019, ANSES granted the authorisations. It based its decision on a report assessing the active substances Bti-BMP 144 and Bti-AM65-52 to be technically equivalent. (10)

20.According to the referring court, on 11 February 2021, Sumitomo, which questions the technical equivalence of the substances at issue, asked ANSES to send it the report. (11)

21.ANSES only provided Sumitomo with access to part of the report (cover page, summary and a conclusion in the form of a table), on the basis that the rest included technical information protected by trade secrecy. In particular, the information not provided was:

– Part I, dealing with the methodology used by ANSES to determine whether the active substance contained in the Aquabac products (12) is technically equivalent to the active substance of the product Vectobac, (13) the latter having been approved at EU level.

– Also, the first section of Part II, which applies that methodology to the active substances in question. (14)

22.Sumitomo challenged ANSES’s decision before the tribunal administratif de Melun (Administrative Court, Melun, France), which, on 22 September 2022, upheld Sumitomo’s claim in part, but did not order ANSES to provide it with the full report or, in particular, the information to which I have referred in the preceding point. (15)

23.

Sumitomo brought an appeal on a point of law before the Conseil d’État (Council of State, France), which has decided to refer four questions to the Court of Justice for a preliminary ruling, the first, third and fourth of which I transcribe below:

‘(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?

…

(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? 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?’

III. Procedure before the Court of Justice

25. Sumitomo, ANSES, the French Government and the European Commission have submitted written observations, and the Court of Justice has not considered it necessary to hold a hearing.

26. As directed by the Court, in this Opinion, I shall not deal with the second question referred.

27. The parties all agree that requests for access to information relating to a biocidal product and submitted on or after 1 September 2013 must be examined in accordance with Regulation No 528/2012. That is also the case, in particular, with regard to information on biocidal products for which marketing authorisation was granted under Directive 98/8.

28. I agree with that assessment, in the light of Articles 96 and 97 of Regulation No 528/2012. According to the first paragraph of Article 96 and the second paragraph of Article 97, of Regulation No 528/2012, that regulation is applicable from 1 September 2013, the date on which Directive 98/8 was repealed.

29. Admittedly, the first paragraph of Article 96 of Regulation No 528/2012, as amended by Regulation No 334/2014, states that the repeal of Directive 98/8 is ‘without prejudice to Articles 86, 89 to 93 and 95’ of Regulation No 528/2012. However, the ‘transitional measures’ established in Articles 89 to 93 and 95 of Regulation No 528/2012 relate to situations different from that forming the subject matter of this reference for a preliminary ruling. Thus:

– Article 89 lists measures relating to: (i) the continuation of a work programme by the Commission (paragraph 1); (ii) the possibility of the Member States continuing temporarily to apply their systems for making biocidal products available on the market (paragraph 2); and (iii) authorisations within a specific period of time for biocidal products containing an approved active substance (paragraphs 3 and 4).

– Article 90 provides for measures concerning active substances evaluated under Directive 98/8. It provides, in particular, that, where their evaluation has not been completed by 1 September 2013, they are to be evaluated in accordance with Regulation No 528/2012 and, where relevant, Regulation (EC) No 1451/2007, and on the basis of the information submitted under Directive 98/8.

– Article 91 states that applications for biocidal product authorisations submitted under Directive 98/8 and for which the evaluation has not been completed by 1 September 2013 are, with certain exceptions, to be evaluated in accordance with that directive.

– Article 92 deals with the making available on the market and use of biocidal products authorised/registered in accordance with Directive 98/8 before 1 September 2013. It also provides that Regulation No 528/2012 is to apply to those products from that date.

– Article 93 lays down transitional measures concerning biocidal products which are not covered by the scope of Directive 98/8 but fall within the scope of Regulation No 528/2012 itself and contain or generate active substances that were available on the market or used in biocidal products on 1 September 2013.

– Last, Article 95 contains transitional measures concerning access to the dossier of an active substance in the context of the renewal of its approval.

30. In short, none of the transitional measures established in those provisions relates to requests such as that at issue in this case, that is to say, requests for access to information on an authorised biocidal product and the active substance it contains, in particular, on the technical equivalence with an approved active substance.

31. In the absence of specific transitional provisions, requests for access to information must comply with the rules in force at the time of their submission. In this case, that time was after 1 September 2013, the date on which Directive 98/8 was repealed, and when Regulation No 528/2012 was applicable.

32. The fact that the information requested relates to biocidal products authorised under Directive 98/8 does not alter the foregoing. Article 91 of Regulation No 528/2012 defines such products as those for which the evaluation, for the purposes of their authorisation, had not been completed at the time when that regulation became applicable, that is to say, 1 September 2013.

33. As Sumitomo and the French Government have observed, an application for authorisation to place a biocidal product on the market, on the one hand, and requests for access to information relating to an authorised biocidal product, on the other, give rise to two different procedures:

– Applications for authorisation to place a biocidal product on the market must comply with Directive 98/8, if the relevant evaluation had not been completed by 1 September 2013.

– Requests for access to information such as that submitted by Sumitomo (on 11 February 2021) must comply with Regulation No 528/2012, which was in force and fully applicable at that time.

34. Were that not the case, as the French Government notes, the principle of equal treatment with regard to the exercise of the right to information would be unjustifiably compromised. The extent and scope of that right must be as determined by the rules in force at the time when it is exercised, irrespective of the date on which the subject matter of the information requested was given formal expression.

35. Starting from the premiss that the request for access to information is governed, in the present case, by Regulation No 528/2012, I shall examine the third and fourth questions referred jointly, partially altering the order in which they are posed.

36. The referring court wishes to know whether Articles 66 and 67 of Regulation No 528/2012 establish a specific and comprehensive regime with regard to access to information on biocidal products and their active substances.

37. The question arises because Articles 66 and 67 of Regulation No 528/2012 do not refer to Directive 2003/4. That omission could be interpreted as ‘[disapplying] 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.’

38. As the Commission has observed, even if the referring court does not cite the second subparagraph of Article 4(2) of Directive 2003/4, its question refers implicitly to it. That subparagraph contains both the obligation to weigh the public interest against the commercial interest and the prohibition on refusing requests for information relating to emissions into the environment.

39. It is, then, a matter of determining whether Articles 66 and 67 of Regulation No 528/2012 exclude the application of the second subparagraph of Article 4(2) of Directive 2003/4.

40. I agree with the parties who argue that the silence of Articles 66 and 67 of Regulation No 528/2012 does not imply the inapplicability of Directive 2003/4 to requests for access to documents prepared for the purposes of that regulation.

41. In particular, as the French Government and the Commission assert, if the opposite were true, the result would be to disregard the international commitments made by the European Union when it signed the Aarhus Convention. Directive 2003/4, according to recital 5 of that directive, was adopted precisely to respond to the need to ensure the compatibility of EU law with that convention.

42. The Court of Justice has ruled that ‘by establishing that the confidentiality of commercial or industrial information may not be invoked against the disclosure of “information relating to emissions into the environment”, the second subparagraph of Article 4(2) of Directive 2003/4 allows for specific application of that rule and of the principle of the widest possible access to the environmental information held by or for public authorities.’

43. That statement, and the others contained in paragraphs 53 to 58 of the judgment in Bayer CropScience and Stichting De Bijenstichting, imply that:

– The second subparagraph of Article 4(2) of Directive 2003/4 implements a ‘specific application’ of the second subparagraph of Article 4(4) of the Aarhus Convention.

– The disclosure of information on emissions into the environment is obligatory, even if the protection of trade secrecy is invoked.

– The grounds for refusing a request for access to environmental information must be interpreted restrictively.

As its title suggests, Directive 2003/4 regulates ‘public access to environmental information’. Regulation No 528/2012, on the other hand, governs ‘the making available on the market and use of biocidal products’.

46.They are, then, two legislative instruments with different effects on the subject matter of the original dispute, namely access to a report prepared in the context of a procedure to authorise the placing on the market of three biocidal products.

47.Given the subject matter of each, the intention behind the two instruments appears not to be the same:

–Article 66 of Regulation No 528/2012 safeguards the confidentiality of information generated in the course of procedures for the authorisation and placing on the market of biocidal products. For such purposes, it provides that, in principle, (26) access to information is to be refused where disclosure would undermine the protection of commercial interests.

–Directive 2003/4, in contrast to the general principle of refusing access to information on the basis of the protection of commercial interests, establishes, in Article 4(2), the irrelevance of such interests to access to information on emissions into the environment.

48.Like the Commission, however, I take the view that the two instruments can be interpreted as being consistent. In my understanding, this case proves that, far from being mutually exclusive, the two complement each other.

49.Sumitomo’s interest in the proceedings before the referring court is strictly commercial. It plans to use the information to which it is requesting access (access which has been refused) to question the technical equivalence of certain active substances used in biocidal products which a competitor undertaking has been authorised to place on the market. Consequently, its claim falls within the scope of Article 66 of Regulation No 528/2012.

50.However, to the extent – and only to the extent – that the information requested by Sumitomo is related to ‘emissions into the environment’, the competent authority must comply with Article 4(2) of Directive 2003/4. Access to that information would, then, have to be granted, even where the other party objects on grounds of the confidentiality of commercial information.

51.The fact that Sumitomo invokes the usefulness of that information for defending its interests in proceedings in which it is disputing the technical equivalence at issue does not preclude the foregoing: Directive 2003/4 guarantees access to environmental information without it being necessary to state an interest. (27)

52.The principle of confidentiality on the basis of the protection of commercial interests (which applies to the procedures regulated in Regulation No 528/2012) exists in opposition to the principle of the disclosure of information on emissions into the environment (enshrined in Directive 2003/4).

53.The interaction between the two principles is, therefore, determined by the environmental significance of the information requested. More specifically: by whether the information concerned, having been recorded in the course of the procedure to authorise the placing of a biocidal product on the market, is strictly related to the emissions into the environment of the biocidal product undergoing that procedure.

54.In all other respects, it could be argued that Article 66 of Regulation No 528/2012 is not inherently contrary to a consideration of the public interest in disclosing certain information, as a counterweight to the individual interest in maintaining its confidentiality for commercial reasons.

55.From that perspective, without it needing to be stated expressly (as Article 4(2) of Directive 2003/4 does), the weighing up of both categories of interests is necessary when adjudicating on an application for access to information submitted under Regulation No 528/2012.

56.Admittedly, Article 66(2) of Regulation No 528/2012 states that the disclosure of certain information ‘normally’ undermines the protection of commercial interests. However, it also authorises the disclosure of that information where urgent action is essential to protect, inter alia, the environment.

57.In so far as that is an assumption that applies ‘normally’ (and to which, therefore, there may be particular exceptions) and does not rule out the need for disclosure in certain circumstances, the competent authority will be obliged to consider the public interest in accessing the information, together with the private interest in preserving its confidentiality. There is nothing that requires that authority automatically to give priority to the latter.

58.In conclusion, in response to the first part of the third question referred, I propose that Articles 66 and 67 of Regulation No 528/2012 do not exclude the application of Directive 2003/4.

Information on emissions into the environment within the meaning of Article 4(2) of Directive 2003/4 (fourth question referred)

59.The referring court wishes to know, in essence, whether ‘information on emissions into the environment’ within the meaning of Article 4(2) of Directive 2003/4 includes that contained in the assessment of the technical equivalence of the active substances at issue in the dispute.

60.As the Commission has observed, (28) it is the responsibility of the referring court, which has at its disposal the report on equivalence and the request for confidentiality made by CERA, to establish what sort of information each of them contains.

61.The Court can, however, provide the referring court with some guidance for determining when, in general, the information appearing in a procedure to assess the technical equivalence of active substances may be classified as ‘information on emissions into the environment’.

62.First, ‘emissions into the environment’ within the meaning of the second subparagraph of Article 4(2) of Directive 2003/4 ‘[includes], inter alia, the release into the environment of products or substances such as … biocides and substances contained in those products, to the extent that that release is actual or foreseeable under normal or realistic conditions of use.’ (29)

63.Second, ‘information on emissions into the environment’ also includes ‘information on emissions as such, namely information concerning the nature, composition, quantity, date and place of those emissions [and] also data concerning the medium to long-term consequences of those emissions on the environment.’ (30)

64.Third, the concept of ‘information on emissions into the environment’ excludes both information which does not relate to such emissions caused by the product in question and information relating to hypothetical emissions. (31)

65.Starting from those premisses (and reiterating that it is the responsibility of the referring court to determine whether the report at issue in the dispute does, strictly speaking, contain information on emissions into the environment), I concur with the assessment by the Commission and the French Government: (32) in principle, such information does not appear to be included in a dossier the purpose of which is to assess the technical equivalence of various active substances, that is to say, to compare the substance approved at EU level with that contained in another biocidal product in the process of being authorised.

66.As the French Government has also noted, (33) the approval of an active substance does not, in itself, authorise its emission into the environment. That approval 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’. (34) Those conditions are not those relating to the emission of the substance on its own, but rather those corresponding to the biocidal product containing it.

67.Consequently, the fourth question referred may be answered to the effect that the information recorded in the procedure to establish the technical equivalence of an active substance with another active substance approved previously does not, in principle, constitute ‘information on emissions into the environment’ within the meaning of Article 4(2) of Directive 2003/4. The referring court, in the light of the information actually gathered in that procedure, will have the final word in that regard.

Communication of assessment reports on the technical equivalence of active substances (second part of the third question referred)

68.The referring court requests the interpretation of Article 67(3) and (4) of Regulation No 528/2012. It wishes to know, in essence, whether the report at issue constitutes an ‘assessment report’ within the meaning of Article 67(3)(e) of Regulation No 528/2012 and, therefore, whether it has to be made publicly available, free of charge, except where it has been agreed that it should be treated as confidential.

69.In accordance with Article 67(3) of Regulation No 528/2012, from the date on which an active substance is approved, the European Chemicals Agency is to make certain up-to-date information on active substances publicly available, free of charge, unless the data supplier requests confidential treatment. The information which, as a rule, must be made publicly available includes ‘the assessment report’ (Article 67(3)(e)).

70.It is true that the report at issue was prepared in the course of a procedure for the authorisation of biocidal products conducted by a national authority. It might, then, be considered that a provision such as Article 67(3) of Regulation No 528/2012, which is in principle restricted to the information to be provided by the European Chemicals Agency, does not apply.

71.However, for the purposes relevant here, given that the information in question was prepared in the course of a procedure governed by Directive 98/8 in respect of which the conditions for access to information are laid down in Regulation No 528/2012, I believe that Article 67(3) of that regulation is, by analogy, applicable to the national authority. (35)

72.In literal terms, the ‘assessment report’ referred to in Article 67(3)(e) of Regulation No 528/2012 is that which is mentioned expressly in Article 8 of that regulation. It is the report which, in accordance with Article 8(1) of Regulation No 528/2012, the ‘evaluating competent authority’ is to send the Agency, after evaluating an application for the approval of an active substance. (36)

73.Assessing the technical equivalence of certain active substances with certain others potentially constitutes a stage prior to the authorisation of a particular biocidal product, where it has been requested. (37) However, as both ANSES (38) and the French Government have noted, (39) Article 54 of Regulation No 528/2012 does not refer to any formal report which has to be prepared in the course of the procedure intended to establish that equivalence.

74.In simple terms, as the Commission observes, (40) Article 54 of Regulation No 528/2012 relates to the assessment which must lead to a decision being taken regarding the technical equivalence of the active substances concerned. In none of its paragraphs does it state that that assessment must be recorded, specifically, in a report.

75.The procedure regulated in Article 54 of Regulation No 528/2012 begins with an application (paragraph 1) accompanied by the data necessary for the Agency to assess it (paragraph 2). Where information in addition to that submitted by the applicant is necessary, the Agency is to request it from the applicant (paragraph 5). The Agency may also consult the competent authority of the Member State (paragraph 6). The procedure concludes with a decision establishing or rejecting the equivalence sought and an appeal may be brought against that decision (paragraph 7).

76.Naturally, the applicant is entitled to know the decision and the grounds for it and, therefore, the reasons forming the basis of the decision taken with regard to the technical equivalence. Since an assessment report is not essential in that procedure, the right of access guaranteed by Article 67 of Regulation No 528/2012 does not cover that report. If such a report existed, access to it would fall within the scope of the right to effective legal protection, but not under the right to access public information.

77.In summary, the communication of a report on the technical equivalence of certain active substances with certain others is not governed by Article 67(3)(e) of Regulation No 528/2012. That is the response which I suggest to the second part of the third question referred.

Information on the methods of analysis relating to the technical equivalence of active substances, after the authorisation has been granted (third part of the third question referred)

78.The referring court requests the interpretation of Article 66(3) of Regulation No 528/2012. It wishes to know, in particular, whether, in accordance with that provision, it is possible to obtain any detailed information on certain methods of analysis, 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’.

79.Article 66(3)(j) of Regulation No 528/2012 provides that, after the authorisation has been granted, access to certain information, including that relating to ‘methods of analysis referred to in Article 19(1)(c)’ of that regulation, is not to be refused.

80.Article 19(1) of Regulation No 528/2012, for its part, lays down the conditions for granting authorisation for a biocidal product that is ineligible for the simplified authorisation procedure in accordance with Article 25 of that regulation. In particular, Article 19(1)(c) refers to the possibility of the ‘technical equivalence of active substances in the biocidal product … [being] determined according to the relevant requirements in Annexes II and III’.

81.Reading Article 66(3)(j) of Regulation No 528/2012 together with Article 19(1)(c) of the same regulation, it emerges that, after the authorisation has been granted, information on the methods of analysis that have made it possible to determine the technical equivalence of the active substances of the authorised biocidal product cannot be refused.

In my view, which once again coincides with that of the Commission and the French Government, (41) the obligation to allow access to information is strictly limited to the methods of analysis and does not, therefore, extend to the results or conclusions obtained as a result of applying those methods. As is logical, it will not be sufficient to provide general information on the nature of the methods of analysis, but rather information on those methods in their entirety.

83. The unequivocal wording (‘in any case’) of Article 66(3) of Regulation No 528/2012 indicates that information on the methods of analysis cannot be refused under any circumstances; even, therefore, if its disclosure could endanger trade secrets.

84. Paragraph 3 of Article 66 constitutes an explicit exception to the principle of confidentiality established in paragraph 2 of the same provision. Although paragraph 2 requires access to information to be refused where disclosure of that information would undermine the protection of the commercial interests or the privacy or safety of the persons concerned, that prohibition, at all events, ceases to apply ‘after the authorisation has been granted’, as stated in paragraph 3 (‘notwithstanding paragraph 2’).

85. Accordingly, I propose to respond to the third part of the third question referred that, once the authorisation to place a biocidal product on the market has been granted, detailed information on the methods of analysis that have made it possible to determine the technical equivalence of the active substances of the authorised biocidal product cannot be refused.

5. Access to the analytical methods referred to in Article 67(1)(h) of Regulation No 528/2012 (fourth part of the third question referred)

86. Among the information which, in accordance with Article 67(1) of Regulation No 528/2012, must be made publicly available from the date on which an active substance is approved, point (h) refers to ‘analytical methods referred to under Sections 5.2 and 5.3 of Title 1, and Section 4.2 of Title 2 of Annex II’.

87. As regards Section 4.2 of Title 2 of Annex II, the original version of that section referred to ‘Methods used for monitoring purposes to determine and quantify residues (viable or non-viable)’. However, following the adaptation of Annex II by Delegated Regulation (EU) 2021/525, (42) Section 4.2 became worded as follows: ‘Analytical methods for the analysis of the micro-organism as manufactured’, while the original wording of that section was reproduced in a new section: Section 4 3.

88. That being so, the referring court poses two questions:

–Whether Article 67(1)(h) of Regulation No 528/2012 in fact refers to the current Section 4.3 of Annex II.

–If the provision is to be construed as referring to the current Section 4.2 of Annex II, whether the right of access to information on the ‘analytical methods for the analysis of the micro-organism as manufactured’ makes it possible to obtain detailed information on those methods, even if trade secrets could be affected, or only general information on the nature of those methods and any conclusions that may be drawn from them.

89. The parties do not dispute that Article 67(1)(h) of Regulation No 528/2012 refers, now as much as previously, to the content originally found in Section 4.2 and which is now located in Section 4.3 of Annex II to that regulation; that is to say, to the ‘methods used for monitoring purposes to determine and quantify residues (viable or non-viable)’.

90. As Sumitomo has noted, (43) recital 16 of Delegated Regulation 2021/525 makes it clear that the Commission’s intention was not to alter the subject matter of the accessible information set out in Article 67(1)(h) of Regulation No 528/2012. The new wording was intended to eliminate the ‘overlaps and irrelevant information requirements’ for micro-organisms that were present in the original text of Title 2 of Annexes II and III.

91. The delegated powers granted in Article 85 of Regulation No 528/2012 did not authorise the Commission to go further, as they only allowed ‘the provisions of this Regulation to be adapted to scientific and technical progress’. Such adaptation did not require the amendment of Article 67 as regards delimiting the content of the information accessible to the public. (44)

92. The second of the two questions posed by the referring court in this part of the third question referred has, then, become redundant, in so far as the methods about which information has to be provided under Article 67(1)(h) of Regulation No 528/2012 are not the ‘analytical methods for the analysis of the micro-organism as manufactured’ referred to in Section 4.2 and to which the question is confined.

93. In any event, the answer would be no different from that which I have proposed to the question regarding the interpretation of Article 66(3)(j) of Regulation No 528/2012, for the reasons I set out when addressing that question.

94. In summary, Article 67(1)(h) of Regulation No 528/2012 must be interpreted as referring to the current Section 4.3 of Title 2 of Annex II to that regulation.

95. In the light of the foregoing, I propose that the Court of Justice answer the first, third and fourth questions referred for a preliminary ruling by the Conseil d’État (Council of State, France) as follows:

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 and 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

must be interpreted as meaning that requests for access to information relating to authorised biocidal products and submitted on or after 1 September 2013, pursuant to 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, must be examined in accordance with Articles 66 and 67 of Regulation No 528/2012.

Articles 66 and 67 of Regulation No 528/2012 do not preclude the application of Directive 2003/4.

The information recorded in a procedure to assess the technical equivalence of an active substance with another active substance that has already been approved does not, in principle, constitute ‘information on emissions into the environment’ within the meaning of Article 4(2) of Directive 2003/4.

The public availability of a report on the technical equivalence of an active substance with another active substance that has already been approved is not governed by Article 67(3)(e) of Regulation No 528/2012.

In accordance with Article 66(3)(j) of Regulation No 528/2012, once the authorisation to place a biocidal product on the market has been granted, detailed information on the methods of analysis that have made it possible to determine the technical equivalence of the active substance of the authorised biocidal product cannot be refused. The obligation to communicate that information does not extend to the results or conclusions obtained by applying those methods.

Article 67(1)(h) of Regulation No 528/2012 refers to the current Section 4.3 of Title 2 of Annex II to that regulation.

—

1 Original language: Spanish.

2 Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail (National Agency for Food, Environmental and Occupational Health and Safety, France; ‘ANSES’).

3 Directive 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).

4 Regulation 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).

5 Directive 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).

6 Regulation of the European Parliament and of the Council of 11 March 2014 amending Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products, with regard to certain conditions for access to the market (OJ 2014 L 103, p. 22).

7 The active substance is called Bacillus thuringiensis israelensis, serotype H14, strain AM65-52 (Bti-AM65-52).

8 Sumitomo maintains that CERA submitted the applications on 6 September 2013. See, in that regard, footnote 18 to this Opinion.

9 Strain BMP 144 (Bti-BMP 144).

10 According to the account of the facts given in the order for reference (paragraph 1), that report is ‘un rapport d’évaluation qui conclut à l’équivalence technique des substances actives’ (‘an assessment report which concludes that the active substances are technically equivalent’). Sumitomo states that ANSES was the author of the report.

11 In its written observations (paragraph 14), Sumitomo states that it asked ‘to be sent a copy of the information relating to CERA’s active substance Bti-BMP 144’.

12 Bacillus thuringiensis israelensis, serotype H14, strain BMP 144 (Bti-BMP 144).

13 Bacillus thuringiensis israelensis, serotype H14, strain AM65-52 (Bti-AM65-52).

14 That section contains information on the identity and particulars of the applicant and of the manufacturer of the active substance BMP 144; the location of the manufacturing plant; the name of the active micro-organism; the classification of the active substance; its manufacturing process; the active substance content in the biocidal products at issue; the identity of the relevant toxins and metabolites; the fermentation residues and contaminants; the ‘analytical profile’ consisting of comparing the composition of five batches of the biocidal products at issue; the analytical methods for identifying the pure active micro-organism in the active micro-organism as manufactured; and the analytical methods for determining impurities and toxins, fermentation residues and contaminants in that micro-organism.

15 According to the order for reference, having viewed the document in its entirety, the court of first instance, in its judgment, held ‘that it could be disclosed, in addition to the three pages already provided, as regards Section 2.2, which appears on pages 21 and 22’.

16 Article 86 does not contain any transitional measures. It confines itself to deeming that the active substances included in Annex I to Directive 98/8 have been approved under Regulation No 528/2012.

17 Commission Regulation of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (OJ 2007 L 325, p. 3).

18 The referring court is unequivocal as regards the date of submission, by CERA, of the applications for authorisation to place the three biocidal products at issue on the market: 30 August 2013. That would mean that, in accordance with Article 91 of Regulation No 528/2012, the authorisations were granted, on 19 August 2019, under Directive 98/8. Sumitomo, on the other hand, maintains that the applications were submitted on 6 September 2013, that is to say, on a date when they should have been processed in accordance with Regulation No 528/2012 (paragraph 12 of its written observations). The Court must, however, confine itself to the facts as they are presented by the referring court.

19 Paragraphs 19 and 16 of their respective written observations.

20 Paragraph 38 of its written observations. The French Government also emphasises the ‘operational complexity’ which would be involved in processing requests for information on a biocidal product on the basis of the legislation applied in order to place the product on the market.

21 Conversely, Article 19(1) of Directive 98/8 expressly mentioned the instrument which Directive 2003/4 replaced, that is to say, 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).

22 Paragraph 17 of the order for reference.

23 UN/ECE Convention on access to information, public participation in decision-making and access to justice in environmental matters, done at Aarhus, Denmark, 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).

24Judgment of 23 November 2016, <i>Bayer CropScience and Stichting De Bijenstichting</i> (C‑442/14, EU:C:2016:890) (‘the judgment in <i>Bayer CropScience and Stichting De Bijenstichting</i>’), paragraph 57.

25Judgment of 22 December 2010, <i>Ville de Lyon</i> (C‑524/09, EU:C:2010:822, paragraph 36).

26Only <i>in principle</i>, because, as I shall go on to analyse, the final subparagraph of Article 66(2) requires disclosure ‘where urgent action is essential to protect … the environment or for other reasons of overriding public interest’.

27Judgment of 19 December 2013, <i>Fish Legal and Shirley</i> (C‑279/12, EU:C:2013:853, paragraph 36).

28Paragraph 75 of the Commission’s written observations.

29The judgment in <i>Bayer CropScience and Stichting De Bijenstichting</i>, paragraph 81.

30The judgment in <i>Bayer CropScience and Stichting De Bijenstichting</i>, paragraph 87.

31The judgment in <i>Bayer CropScience and Stichting De Bijenstichting</i>, paragraph 100.

32Paragraph 53 of their respective written observations.

33Paragraph 54 of the French Government’s written observations.

34The judgment in <i>Bayer CropScience and Stichting De Bijenstichting</i>, paragraph 81.

35An assessment of the technical equivalence between an active substance which has not yet been approved and another which has constitutes an alternative to the full assessment of an active substance awaiting approval. Hence, also by analogy, the provisions regarding the approval of active substances could be applied to procedures for the approval of biocidal products in which the technical equivalence of actives substances has been found to exist.

36Reference to an ‘assessment report’ appears in other provisions of Regulation No 528/2012: in Article 67(4)(b), relating to the report on the assessment prior to the authorisation of a biocidal product; in Article 30(3)(a), where it is required during the national procedure for the authorisation of a biocidal product; in the second subparagraph of Article 34(4), relating to the evaluation of applications for mutual recognition in parallel of biocidal products which have not yet been authorised in any Member State; in Article 44(1), which requires it to be prepared in the context of the EU authorisation procedure for biocidal products; and in Article 71(6)(c), which provides for the inclusion of the ‘assessment report of the biocidal product’ in the Register for Biocidal Products.

37According to the Commission (paragraph 53 of its written observations), for a biocidal product to be authorised, its active substance must either be listed in Annex I to Regulation No 528/2012, have been approved in accordance with Article 9 of that regulation or have been assessed as equivalent to another active substance in accordance with Article 54, also of Regulation No 528/2012.

38Paragraphs 17 and 23 of its written observations.

39Paragraph 61 of its written observations.

40Paragraph 49 of its written observations.

41Paragraphs 66 and 76 of their respective written observations.

42Commission Delegated Regulation 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). Regulation adopted under the delegated powers granted to the Commission by Article 85 of Regulation No 528/2012 to adapt Annexes II, III and IV of that regulation to scientific and technical progress.

43Paragraph 55 of Sumitomo’s written observations.

44In short, as the French Government argues in paragraphs 85 and 87 of its written observations, everything points to this being an ‘anomaly’ arising because the Commission has not amended Article 67(1)(h) of Regulation No 528/2012 to reflect the numbering under which the original content of Section 4.2 appears following the adoption of Delegated Regulation 2021/525. This is nothing that cannot be rectified with a new delegated regulation.