Case T‑746/15

Biofa AG

v

European Commission

(Action for annulment — Plant protection products — Implementing Regulation (EU) 2015/2069 — Approval of the basic substance sodium hydrogen carbonate — Lack of direct concern — Inadmissibility)

Summary — Order of the General Court (Second Chamber), 9 November 2016

Actions for annulment—Natural or legal persons—Measures of direct and individual concern to them—Whether directly concerned—Criteria—Commission Regulation approving the basic substance sodium hydrogen carbonate—Action brought by a company holding a marketing authorisation for a fungicide with a potassium hydrogen carbonate basis—Not directly concerned—Inadmissibility

(Art. 263 TFEU; European Parliament and Council Regulation No 1107/2009, eighteenth recital and Arts 28(2)(a), and 59(1); Commission Regulations No 540/2011 and No 2015/2069)

Whether a person is directly affected, within the meaning of Article 263 TFEU, depends on two cumulative conditions. First, the contested EU measure must directly affect the legal situation of that individual and, second, there must be no discretion left to the addressees of that measure who are responsible for its implementation, that implementation being purely automatic and resulting from the EU rules alone without application of other intermediate rules.

In the context of an annulment action brought by a company holding a marketing authorisation for a fungicide with a potassium hydrogen carbonate basis against Implementing Regulation 2015/2069 approving the basic substance sodium hydrogen carbonate in accordance with Regulation No 1107/2009 concerning the placing of plant protection products on the market, and amending the annex to Implementing Regulation No 540/2011, Implementing Regulation 2015/2069 does not directly affect that company’s legal situation, since that implementing regulation merely allows the use, for plant protection purposes, of a product different from that which is marketed by the company.

In that regard, Article 59(1) of Regulation No 1107/2009, which provides that the data protection enjoyed by an applicant for authorisation for placing on the market or use of a plant protection product containing an active substance who submitted a test or study report concerning that substance prohibits the Member State which received that report from using it for the benefit of other applicants for authorisation, except in the cases provided for in that regulation, is aimed, as follows from recital 39 of Regulation No 1107/2009, at protecting the major investment that may have been made by the applicant for authorisation who submitted the report at issue against use by another competing applicant.

It therefore cannot be interpreted as protecting that applicant for authorisation from references to the report in question made by the European Food Safety Authority (EFSA) in the context of the approval, by the Commission, of a basic substance. As is stated in recital 18 of Regulation No 1107/2009, ‘substances which are not predominantly used as plant protection products may be of value for plant protection, [even though] the economic interest of applying for approval may be limited’. Thus, a substance is approved as a basic substance not for the benefit of individual applicants, but for the benefit of all users, and such approval therefore does not fall within the scope of the protection afforded by Article 59(1) of Regulation No 1107/2009. Moreover, as is apparent from Article 28(2)(a) of that regulation, the approval of a substance as a basic substance permits only the ‘use’ of that substance for plant protection purposes, and not the placing of that substance on the market as a plant protection product, a fact which confirms an individual applicant’s lack of economic interest in such an approval.

Moreover, whilst it cannot be ruled out that the contested regulation might have repercussions on the marketing possibilities of the product of the company concerned, such economic consequences arising out of that regulation do not affect the company’s legal situation, but only its factual situation. In that regard, the mere fact that a measure may exercise an influence on an applicant’s substantive position cannot suffice to allow it to be regarded as directly concerned by the measure.

(see paras 16, 29, 32-34, 37-39)