Case T‑189/14

Deza, a.s.

v

European Chemicals Agency

(Access to documents — Regulation (EC) No 1049/2001 — Documents held by ECHA containing information submitted by an undertaking in connection with its application for authorisation to use di-(2-ethylhexyl)phthalate (DEHP) — Decision to disclose certain information considered confidential by the applicant — Exception relating to the protection of commercial interests — Concept of private life — Right to property — Obligation to state reasons)

Summary — Judgment of the General Court (Fourth Chamber), 13 January 2017

EU institutions — Right of public access to documents — Regulation No 1049/2001 — Exceptions to the right of access to documents — Protection of the decision-making process — Conditions — Concrete, actual and serious detriment to that process

Approximation of laws — Registration, evaluation, authorisation and restriction of chemicals — REACH Regulation — Dissemination on the internet of certain information concerning registered substances — Data corresponding to the DNEL and PNEC values of a substance — Justification on the basis of the principle of transparency

EU institutions — Right of public access to documents — Regulation No 1049/2001 — Exceptions to the right of access to documents — Protection of commercial interests — Overriding public interest justifying the disclosure of documents — Invocation of the principle of transparency — Need to put forward particular considerations in relation to the case

Approximation of laws — Registration, evaluation, authorisation and restriction of chemicals — REACH Regulation — Dissemination on the internet of certain information concerning registered substances — Information submitted in the context of an authorisation procedure — No infringement of the TRIPS Agreement

Approximation of laws — Registration, evaluation, authorisation and restriction of chemicals — REACH Regulation — Dissemination on the internet of certain information concerning registered substances — Data corresponding to the DNEL and PNEC values of a substance — Scope of the obligation to publish

EU institutions — Right of public access to documents — Regulation No 1049/2001 — Exceptions to the right of access to documents — Protection of commercial interests — Scope — Collection of scientific studies submitted in the context of a procedure for authorising a chemical substance — Inclusion — Condition

EU institutions — Right of public access to documents — Regulation No 1049/2001 — Exceptions to the right of access to documents — Refusal to grant access — Possibility of relying on general presumptions applicable to certain categories of documents — Subject-matter — No general presumption applying to documents submitted in the context of a procedure for authorising a chemical substance — No infringement of the right to property

In the matter of public access to documents held by EU institutions, it is open to the institutions and agencies concerned to base their decisions on general presumptions which apply to certain categories of documents, as considerations of a generally similar kind are likely to apply to requests for disclosure relating to documents of the same nature. The application of general presumptions is essentially dictated by the overriding need to ensure that the procedures at issue operate correctly and to guarantee that their objectives are not jeopardised. Accordingly, a general presumption may be recognised on the basis that access to the documents involved in certain procedures is incompatible with the proper conduct of such procedures and the risk that those procedures could be undermined, on the understanding that general presumptions ensure that the integrity of the conduct of the procedure can be preserved by limiting intervention by third parties. The application of specific rules provided for by a legal measure relating to a procedure conducted before an EU institution for the purposes of which the documents requested were produced is one of the criteria for recognising a general presumption. With regard to Regulation No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), unlike the situations to which the EU judicature have accepted that the general presumptions justifying refusal of access to documents apply, that regulation expressly governs the relationship between itself and Regulation No 1049/2001 regarding public access to European Parliament, Council and Commission documents. Article 118 of Regulation No 1907/2006 provides that Regulation No 1049/2001 applies to documents held by ECHA. It does not restrict the use of the documents in the file relating to an authorisation procedure for the use of a chemical substance. That regulation does not in fact provide for the limitation on access to the file to ‘parties concerned’ or ‘complainants’. No general presumption can therefore be inferred from the provisions of Regulation No 1907/2006. It cannot therefore be accepted that, in the context of an authorisation procedure provided for by Regulation No 1907/2006, the documents communicated to ECHA are to be regarded as being, in their entirety, clearly covered by the exception relating to the protection of the commercial interests of applicants for authorisation. In that regard, Article 8 of the ECHR and Article 17 of the Charter of Fundamental Rights of the European Union cannot be interpreted as laying down an automatic exception to the principle of disclosure for documents drawn up in the course of a private entity’s commercial activity. In the case of a request for access made by a third party to such documents, a proper and specific examination of each of them is required, except in cases where the Court of Justice and the General Court have accepted a general presumption of refusal of access to the documents in question. (see paras 34, 37, 39, 40, 163)

The procedure for applying for authorisation is governed by Regulation No 1907/2006, which establishes an EU procedure for authorising the use of chemical substances. Article 118 of that regulation provides that Regulation No 1049/2001 applies to documents held by ECHA. It follows that the principle that the public should have the widest possible access to the documents, as envisaged in recital 4 and Article 1 of Regulation No 1049/2001, must in principle be respected with regard to the documents held by ECHA. The principle that the public should have the widest possible access to the documents is nonetheless subject to certain limits based on reasons of public or private interest. Regulation No 1049/2001, in particular in recital 11 and Article 4 thereof, provides for a system of exceptions requiring institutions and bodies not to disclose documents in the event that such disclosure would undermine one of these interests. In the case of an application for access to information concerning scientific studies and their contents, submitted in the context of an authorisation procedure, it does not appear that disclosure of the mere collection of descriptive data contained therein, which are publicly available, is sufficient to undermine protection of the commercial interests of the applicant for authorisation. The latter has to demonstrate how, in the present case, the collection of scientific data constitutes sensitive commercial data and how, as a result its disclosure, its commercial interests would be undermined. Even if it were accepted that the applicant’s work systemising public information may have some commercial value, it is only if the assessments made by the latter in that compilation work gave added value – namely that they consisted, for example, in new scientific conclusions or considerations relating to an inventive strategy giving an undertaking a commercial advantage over its competitors – that they would then fall amongst the commercial interests of which Article 4(2) of Regulation No 1049/2001 ensures protection. (see paras 50, 51, 60, 67)

See the text of the decision. (see paras 52-54)

See the text of the decision. (see paras 55, 56)

Under the first paragraph of Article 48(2) of the Rules of Procedure, new pleas in law may not be introduced in the course of the proceedings unless they are based on matters of law or of fact which have come to light in the course of the procedure. A plea which amplifies a submission put forward previously, whether directly or by implication, and which is closely connected with that submission, will be declared admissible. Moreover, the prohibition laid down in Article 48(2) of the Rules of Procedure concerns only new pleas in law and does not prevent the applicants submitting new arguments based on pleas already contained in the application. (see para. 91)

It is apparent both from Article 119(1)(f) of Regulation No 1907/2006 and from Annex I thereto that, given the importance of the data corresponding to the Derived No-Effect Level (DNEL) and Predicted No Effect Concentration (PNEC) values for the protection of public health and the environment, the chemical safety assessment of a substance and the resulting data should cover all identified uses and cover all stages of the substance’s life cycle and the data must be published. The obligation to publish provided for by the above provision does indeed apply to the DNEL and PNEC values contained in the chemical safety report attached to the application for authorisation. As regards the scope of the obligation to publish the information referred to in Article 119(1)(f) of Regulation No 1907/2006, that obligation extends to the minimum information on the method of derivation or prediction of the DNEL and PNEC values and their correlation with other values. That minimum information is necessary in order to understand what the DNEL and PNEC values represent and to determine to what they relate. The Court must therefore accept that, if the values alone were published without any explanation as to their meaning, the abovementioned provision would lose its effectiveness. (see paras 105, 108)

Where there are EU rules in a sphere concerned by the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), EU law will apply, which will mean that it is necessary, as far as possible, to adopt an interpretation in keeping with the TRIPS Agreement, although no direct effect may be given to the provision of that agreement at issue. In that regard, Regulations Nos 1049/2001 and 1907/2006 must be interpreted in such a way as to ensure that they comply with the content of Article 39(2) and (3) of the TRIPS Agreement. However, that provision cannot imply that the protection afforded to intellectual property rights takes precedence over the presumption in favour of the disclosure of information submitted in connection with an application for authorisation for the use of a chemical substance. In that sense, an approach whereby information submitted in the context of an authorisation procedure for a chemical substance constitutes commercial secrets (confidential information) within the meaning of Article 39(2) of the TRIPS Agreement amounts to disapplying Article 119 of Regulation No 1907/2006. Such an approach must be rejected, since, in reality, it challenges the legality of that provision in the light of Article 39(2) and (3) of the TRIPS Agreement. (see paras 116, 149, 151)

See the text of the decision. (see paras 123, 124)

As regards an application for access seeking disclosure of the DNEL and PNEC values appearing in a report on chemical safety and the analysis of alternatives submitted in the context of an authorisation procedure for use of a chemical substance, even if those values were regarded as falling within the commercial interests of the applicant for authorisation, Article 119(1)(f) of Regulation No 1907/2006 provides that they are automatically available to the public. That obligation to have access to that information is justified in recital 117 of the same regulation by the need to give EU citizens information about the substances to which they may be exposed in order to allow them to make informed decisions about the use that they wish to make of those chemicals. It is clear from Article 119(1) of Regulation No 1907/2006 and recital 117 thereof that the EU legislature considered that the disclosure of was a matter of a significant interest. The legislature itself weighed the interests and concluded that the interest in the disclosure of the information relating to the DNEL and PNEC values mattered more that the applicant’s interest in their non-disclosure, since this information concerned some of the most important interests that existed, namely those relating to human health and the environment. Those factors are capable of establishing that the principle of transparency is of particularly pressing concern and capable of prevailing over the reasons justifying the refusal to disclose the information at issue. The same is true of the NOAEL exposure values — that is, those indicating the maximum no-observed-adverse-effect level — contained in the approaches, methods and reflections. (see paras 127-129)

See the text of the decision. (see para. 133)

See the text of the decision. (see para. 161)