Case T-262/10

Microban International Ltd and

Microban (Europe) Ltd

v

European Commission

(Public health – List of additives which may be used in the manufacture of plastic materials and articles intended to come into contact with foodstuffs – Withdrawal by the original applicant of the application for inclusion of an additive on the list – Commission decision not to include 2,4,4’-trichloro-2’-hydroxydiphenyl ether in the list – Actions for annulment – Admissibility – Regulatory act – Whether directly concerned – No implementing measures – Legal basis)

Summary of the Judgment

1.      Actions for annulment – Natural or legal persons – Meaning of regulatory act for the purposes of the fourth paragraph of Article 263 TFEU – All acts of general application apart from legislative acts

(Art. 263, fourth para., TFEU)

2.      Actions for annulment – Natural or legal persons – Measures of direct and individual concern to them – Whether directly concerned – Criteria

(Art. 230, fourth para., EC; Art. 263, fourth para., TFEU)

3.      Actions for annulment – Natural or legal persons – Measures of direct concern to them –Commission Decision on the non-inclusion of an additive in the list of additives authorised under Directive 2002/72 – Action brought by undertakings using the additive concerned in the manufacture of their products – Admissibility

(Art. 263, fourth para., TFEU)

4.      Approximation of laws – Materials and articles intended to come into contact with foodstuffs – Commission Decision on the non-inclusion of an additive in the list of additives authorised under Directive 2002/72 – Legal basis – Article 11(3) of Regulation No 1935/2004 – Not permissible

(European Parliament and Council Regulation No 1935/2004, Art. 11(3); Commission Directive 2002/72)

5.      Approximation of laws – Materials and articles intended to come into contact with foodstuffs – Commission Decision on the non-inclusion of an additive in the list of additives authorised under Directive 2002/72 – Adoption of the decision following withdrawal of the application for inclusion by the original applicant

(European Parliament and Council Regulation No 1935/2004; Commission Directive 2002/72)

1.      The meaning of ‘regulatory act’ for the purposes of the fourth paragraph of Article 263 TFEU must be understood as covering all acts of general application apart from legislative acts.

In that regard, a decision by the Commission on the non-inclusion of an additive in the list of additives which may, under Directive 2002/72 relating to plastic materials and articles intended to come into contact with foodstuffs, be used in the manufacture of such materials and articles, taken on the basis of Article 11(3) of Regulation No 1935/2004 on materials and articles intended to come into contact with food and repealing Directives 80/590 and 89/109, constitutes a regulatory act within the meaning of the fourth paragraph of Article 263 TFEU. Such a decision is adopted by the Commission in the exercise of implementing powers and not in the exercise of legislative powers. Moreover, since it applies to all natural and legal persons who are engaged in the production and/or marketing of that additive and materials and articles containing that substance, that decision is of general application in that it applies to objectively determined situations and it produces legal effects with respect to categories of persons envisaged in general and in the abstract.

(see paras 21-25)

2.      Under the fourth paragraph of Article 263 TFEU, any natural or legal person may, under the conditions laid down in the first and second paragraphs, institute proceedings against an act addressed to that person or which is of direct and individual concern to them, and against a regulatory act which is of direct concern to them and which does not entail implementing measures.

As regards the concept of direct concern, the expression ‘of direct concern to them’ appears twice in the fourth paragraph of Article 263 TFEU. First, that provision reiterates the wording of the fourth paragraph of Article 230 EC in referring to ‘an act … which is of direct … concern to them’. Secondly, the fourth paragraph of Article 263 TFEU introduces the concept of ‘a regulatory act which is of direct concern to them and does not entail implementing measures’.

The condition of direct concern as laid down in the fourth paragraph of Article 230 EC, required that, first, the contested Community measure must directly affect the legal situation of the individual and, secondly, it must leave no discretion to the addressees of that measure, who are entrusted with the task of implementing it, such implementation being purely automatic and resulting from the impugned rules without the application of other intermediate rules. By allowing a natural or legal person to institute proceedings against regulatory acts of direct concern to them which do not entail implementing measures, the fourth paragraph of Article 263 TFEU pursues an objective of opening up the conditions for bringing direct actions. Accordingly, the concept of direct concern, as recently introduced in that provision cannot, in any event, be subject to a more restrictive interpretation than the notion of direct concern as it appeared in the fourth paragraph of Article 230 EC. Where it has been established that an applicant is directly concerned by a Commission decision, within the meaning of the concept of direct concern as laid down by the fourth paragraph of Article 230 EC, it must be held that he is also directly concerned by the contested decision within the meaning of the concept of direct concern as recently introduced in the fourth paragraph of Article 263 TFEU.

(see paras 18, 26-27, 32)

3.      A decision by the Commission on the non-inclusion of an additive in the list of additives which may, under Directive 2002/72 relating to plastic materials and articles intended to come into contact with foodstuffs, be used in the manufacture of such materials and articles, which has the consequence that the marketing of materials and articles containing that additive is prohibited, must be considered to directly affect the legal position of undertakings which buy that additive and use it to manufacture a product with antimicrobial and antibacterial properties, which is then sold on for use in the manufacture of plastic materials and articles intended to come into contact with foodstuffs.

(see paras 28, 30)

4.      A decision by the Commission on the non-inclusion of an additive in the list of additives which may, under Directive 2002/72 relating to plastic materials and articles intended to come into contact with foodstuffs, be used in the manufacture of such materials and articles, by which the Commission prohibited the marketing of a particular additive as an additive used for the manufacture of materials and articles intended to come into contact with foodstuffs, and, in order to do so, refused to include that additive on the positive list and removed that substance from the provisional list, cannot be based on Article 11(3) of Regulation No 1935/2004 on materials and articles intended to come into contact with food and repealing Directives 80/590 and 89/109. Article 11(3) of Regulation No 1935/2004 concerns only those cases in which the Commission intends to authorise the use and marketing, in the Union, of a substance incorporated in materials and articles intended to come into contact with foodstuffs.

(see paras 46-48)

5.      The Commission infringes the procedure laid down by Regulation No 1935/2004 on materials and articles intended to come into contact with food and repealing Directives 80/590 and 89/109 and by Directive 2002/72 relating to plastic materials and articles intended to come into contact with foodstuffs, where, following the withdrawal by the original applicant of the application for inclusion of an additive in the positive list, it adopts a decision not to include that additive in the list of additives which may be used in the manufacture of plastic materials and articles intended to come into contact with foodstuffs under Directive 2002/72, in the absence of a risk management decision within the meaning of recital 14 in the preamble to Regulation No 1935/2004.

(see paras 67, 69)