Judgment of the General Court (Fourth Chamber) of 6 September 2013 — Sepro Europe v Commission

(Case T‑483/11)

‛Plant-protection products — Active substance flurprimidol — Non-inclusion of flurprimidol in Annex I to Directive 91/414/EEC — Regulation (EC) No 33/2008 — Accelerated assessment procedure — Manifest error of assessment — Rights of the defence — Proportionality — Obligation to state reasons’

1. Actions for annulment — Natural or legal persons — Measures of direct and individual concern to them — Commission decision refusing to register an active substance in Annex I to Directive 91/414 — Action by an undertaking applying for registration — Admissibility (Art. 263, fourth para., TFEU; Commission Regulation No 33/2008, Art. 13; Council Directive 91/414, Annex I; Commission Decision 2011/328) (see paras 28-31)

2. Agriculture — Approximation of laws — Placing of plant protection products on the market — Directive 91/414 — Procedure for inclusion of the active substances of those products in Annex I to the directive — Discretion of the Commission — Judicial review — Scope (Council Directive 91/414, Annex I) (see paras 37-40)

3. Agriculture — Approximation of laws — Placing of plant protection products on the market — Directive 91/414 — Procedure for inclusion of the active substances of those products in Annex I to the directive — Remaining scientific uncertainties concerning the existence or scope of risks for human health, animal health, or the environment — Application of the precautionary principle — Scope (Art. 191(2) TFEU; Council Directive 91/414, Arts 4(1)(b), 5(1)(b), and Annex I) (see paras 41-44, 61, 92)

4. EU law — Principles — Rights of defence — Scope — Procedure for registering active substances of plant-protection products in Annex I to Directive 91/414 — No right to submit additional data during the assessment procedure (Commission Regulation No 33/2008, Arts 18(3), and 20(2), second para; Council Directive 91/414, Annex I) (see paras 65, 66, 75)

5. Agriculture — Approximation of laws — Placing of plant protection products on the market — Directive 91/414 — Commission decision on the non-registration of an active substance in Annex I to that directive — Lack of sufficient information to conclude that no risks present — Consequences for the undertaking seeking registration in terms of the costs of preparing a new file and losses of commercial revenues — No breach of principle of proportionality (Council Directive 91/414, Art. 5(1), and Annex I) (see paras 83-85, 87)

6. Acts of the institutions — Statement of reasons — Obligation — Scope and limits — Commission decision refusing to register an active substance in Annex I to Directive 91/414 (Art. 296, second para., TFEU; Council Directive 91/414, Annex I; Commission Decision 2011/328) (see paras 101, 106)

7. Actions for annulment — Pleas in law — Lack of or inadequate statement of reasons — Plea distinct from that of the lawfulness of the contested decision (Arts 263 TFEU and 296 TFEU) (see para. 107)

Re:

APPLICATION for annulment of Commission Implementing Decision 2011/328/EU of 1 June 2011 concerning the non-inclusion of flurprimidol in Annex I to Council Directive 91/414/EEC (OJ 2011 L 153, p. 192).

Operative part

The Court:

1. Dismisses the action;