Gerecht EU, 25-10-2011, nr. T-262/10

The applicants, Microban International Ltd and Microban (Europe) Ltd, are engaged in the manufacture and sale of antimicrobial and antibacterial additives designed to provide antimicrobial and antibacterial protection in a wide range of products. Microban International manufactures the additives and markets them throughout the world. Microban (Europe) is responsible for the marketing, within the European Union, of the additives manufactured by Microban International.

On 23 March 1998, RCC Registration and Consulting Company Ltd, acting on behalf of Ciba Inc. (‘Ciba’), submitted an application to the European Commission for the inclusion of 2,4,4'-trichloro-2'-hydroxydiphenyl ether (‘triclosan’) in the list of additives authorised by Commission Directive 90/128/EEC of 23 February 1990 relating to plastic materials and articles intended to come into contact with foodstuffs (OJ 1990 L 75, p. 19).

On 22 June 2000, the Scientific Committee on Food, which the Commission was required to consult pursuant to Article 3(3) of Council Directive 89/109/EEC of 21 December 1988 on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs (OJ 1989 L 40, p. 38), issued an opinion on a number of monomers and additives for food contact materials. In that opinion, the Committee decided, inter alia, that, although triclosan was a substance for which an acceptable or tolerable daily intake could not be established, its use could none the less be accepted.

On 15 November 2002, the Scientific Committee on Food having updated its guidelines, Ciba submitted a request for re-evaluation of triclosan.

On 15 March 2004, following the re-evaluation of triclosan, the European Food Safety Authority (‘EFSA’) — which replaced the Scientific Committee on Food by virtue of Article 62 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing EFSA and laying down procedures in matters of food safety (OJ 2002 L 31, p. 1) — adopted an opinion by which it confirmed the view taken by the Scientific Committee on Food in its opinion of 22 June 2000.

On 10 April 2008, triclosan was included in the provisional list of additives (‘the provisional list’) provided for by Article 4a(3) of Commission Directive 2002/72/EC of 6 August 2002 relating to plastic materials and articles intended to come into contact with foodstuffs (OJ 2002 L 220, p. 18). In accordance with Article 4a(4) of that directive, additives not included in the list of additives authorised at European Union level (‘the positive list’, the term used in the third subparagraph of Article 4(1) of that directive) may continue to be used subject to national law for as long as they are included in the provisional list.

On 21 April 2009, Ciba informed the Commission of its decision to withdraw its application for the authorisation of the use of triclosan as an additive for use in the manufacture of plastic materials and articles destined to come into contact with foodstuffs.

On 19 March 2010, the Commission adopted Decision 2010/169/EU concerning the non-inclusion of triclosan in the Union 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 (OJ 2010 L 75, p. 25; ‘the contested decision’). As the legal basis for that decision, the Commission cites Article 11(3) of Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109 (OJ 2004 L 338, p. 4), as amended.

In the contested decision, the Commission observed that Ciba had informed it of its decision to withdraw its application for the authorisation of the use of triclosan as an additive in the manufacture of plastic materials and articles intended to come into contact with foodstuffs. As there was no longer a valid application for the use of triclosan as an additive in plastics intended to come into contact with foodstuffs, the Commission concluded that that substance should not be included in Annex III to Directive 2002/72, which contains the positive list. The Commission stated that the substance should therefore be removed from the provisional list of additives. It considered it necessary, however, to provide for a transitional period during which the marketing of plastic materials and articles containing triclosan could continue to be authorised by the Member States.

The operative part of the contested decision is worded as follows:

By application lodged at the General Court Registry on 7 June 2010, the applicants brought the present action.

On 31 March 2011, the applicants lodged a request for priority treatment pursuant to Article 55(2) of the Court's Rules of Procedure.

Upon hearing the report of the Judge-Rapporteur, the Court decided to open the oral procedure and to give the case priority treatment pursuant to Article 55(2) of the Rules of Procedure.

The parties presented oral argument and replied to the questions put by the Court at the hearing on 28 September 2011.

The applicants claim that the Court should:

The Commission contends that the Court should:

While not formally raising an objection of inadmissibility, the Commission argues that the action is inadmissible in so far as the contested decision is not a regulatory act requiring no implementing measures within the meaning of the fourth paragraph of Article 263 TFEU, and is not of individual concern to the applicants.

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.

In the present case, it is common ground that the applicants are not addressees of the contested decision. Accordingly, under the fourth paragraph of Article 263 TFEU, the applicants may bring an action for annulment against that decision only if it is either a regulatory act which is of direct concern to them and does not require implementing measures, or a decision of direct and individual concern to them.

It must first be established that the contested decision is a regulatory act within the meaning of the fourth paragraph of Article 263 TFEU.

In that regard, it must be recalled that, according to the case-law, 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 (order of the General Court of 6 September 2011 in Case T-18/10 Inuit Tapiriit Kanatami and Others v Parliament and Council [2011] ECR II-0000, paragraph 56).

In the present case, the legal basis cited by the contested decision is Article 11(3) of Regulation No 1935/2004. That article provides that a measure taken by the Commission on the basis of that article is to be adopted in accordance with the procedure referred to in Article 5a(1) to (4) and (5)(b) of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (OJ 1999 L 184, p. 23), as amended. Accordingly, the contested decision was adopted by the Commission in the exercise of implementing powers and not in the exercise of legislative powers.

Moreover, the contested 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.

As is apparent from paragraph 9 above, the subject of the contested decision is the non-inclusion of triclosan in the positive list. Pursuant to Article 4a(6)(b) of Directive 2002/72, triclosan has also been removed from the provisional list as a result of that non-inclusion. The direct consequence of the non-inclusion in the positive list and removal from the provisional list is thus that triclosan can no longer be marketed in the Union after 1 November 2011. Thus the contested decision applies to all natural and legal persons who are engaged in the production and/or marketing of triclosan and materials and articles containing that substance.

It follows that the contested decision should be considered to be a regulatory act within the meaning of the fourth paragraph of Article 263 TFEU.

Second, as regards the concept of direct concern, it must be observed that the expression ‘of direct concern to them’ appears twice in the fourth paragraph of Article 263 TFEU. Firstly, 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’.

First, as regards the condition of direct concern as laid down in the fourth paragraph of Article 230 EC, it has been held that that condition required that, firstly, the contested Community measure must directly affect the legal situation of the individual and, secondly, it must leave no discretion to its addressees, who are entrusted with the task of implementing it, such implementation being purely automatic and resulting from Community rules without the application of other intermediate rules (see Case C-386/96 P Dreyfus v Commission [1998] ECR I-2309, paragraph 43, and Joined Cases C-445/07 P and C-455/07 P Commission v Ente per le Ville vesuviane and Ente per le Ville vesuviane v Commission [2009] ECR I-7993, paragraph 45).

In the present case, as mentioned in paragraph 24 above, the consequence of the contested decision is that the marketing of materials and articles containing triclosan intended to come into contact with foodstuffs is prohibited. Given that, as was made clear at the hearing, the applicants buy triclosan 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, the contested decision directly affects their legal position.

Moreover, it must be observed that the contested decision leaves no discretion to the Member States, which are the addressees of the decision and, in that capacity, are responsible for implementing it. According to Article 2 of that decision, materials and articles containing triclosan may continue to be marketed until 1 November 2011, subject to national law, which means that the Member States have the option of prohibiting the marketing of such materials and articles before that date. Although the Member States thus have a measure of discretion as to the date from which they wish to prohibit the marketing of triclosan, the implementation of that ban is none the less automatic and mandatory as of 1 November 2011. Moreover, it must be pointed out that the transitional period laid down by Article 2 of the contested decision is intended to facilitate the implementation of the measure consisting in non-inclusion of triclosan in the positive list, so that it is ancillary to that measure.

It follows that the applicants must be considered to be directly concerned by the contested decision within the meaning of the concept of direct concern as laid down in the fourth paragraph of Article 230 EC.

Second, as regards the concept of direct concern as recently introduced in the fourth paragraph of Article 263 TFEU, the question fairly arises as to whether that concept must be subject to a different interpretation from that developed in the case-law set out in paragraph 27 above.

Nevertheless, it must be observed that, according to case-law, 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 (see, to that effect, Inuit Tapiriit Kanatami and Others v Parliament and Council, paragraph 21 above, paragraph 50). 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. Since it has been established, at paragraph 30 above, that the applicants were directly concerned by the contested 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 they are 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.

Third, as regards the question whether or not the contested decision entails implementing measures within the meaning of the fourth paragraph of Article 263 TFEU, it must be repeated that, as observed at paragraphs 24 and 28 above, the subject of the contested decision is the non-inclusion of triclosan in the positive list. Consequently, pursuant to Article 4a(6)(b) of Directive 2002/72, the contested decision also removed that substance from the provisional list. Moreover, in order to facilitate the implementation of the non-inclusion of the substance on the positive list and its consequent removal from the provisional list, the contested decision introduced, as an ancillary measure, a transitional period, during which the marketing of materials and articles containing triclosan could be authorised, and which was to expire on 1 November 2011.

In that regard, firstly, it must be observed that neither non-inclusion in the positive list nor removal from the provisional list required implementing measures on the part of the Member States. Under Article 4a(4) of Directive 2002/72, only additives appearing in the provisional list can continue to be used after 1 January 2010. Moreover, under Article 4a(6)(b) of Directive 2002/72, an additive is to be removed from the provisional list when a decision is taken by the Commission not to include it in the positive list. Accordingly, the decision not to include it had the immediate consequence of its removal from the provisional list and a prohibition on the marketing of triclosan, without the Member States needing to adopt any implementing measure.

In addition, it must be emphasised that, as the applicants observed, Commission Directive 2004/19/EC of 1 March 2004 amending Directive 2002/72 (OJ 2004 L 71, p. 8), and Commission Directive 2008/39/EC of 6 March 2008 amending Directive 2002/72 (OJ 2008 L 63, p. 6), introduced into Directive 2002/72 Article 4a(4) and Article 4a(6)(b) respectively. It follows from the application of Article 2 of Directive 2004/19 and Article 2 of Directive 2008/39 that Article 4a(4) and Article 4a(6)(b) of Directive 2002/72 respectively have been transposed into the law of the Member States. Consequently, it cannot be considered that the prohibition on the marketing of triclosan, following its non-inclusion in the positive list and its removal from the provisional list, required the adoption of implementing measures.

Second, the transitional provision, allowing the possibility of marketing triclosan to be extended until 1 November 2011, does not in itself require any implementing measure on the part of the Member States, as any intervention by those States before 1 November 2011 is purely optional.

Third, although, in the latter situation, the transitional provision may give rise to implementing measures on the part of the Member States, it must be repeated that it is intended to facilitate the implementation of the contested decision, in that its effect is to prohibit the marketing of triclosan, so that the natural and legal persons affected by that prohibition may make the necessary arrangements. It is thus ancillary to the main purpose of the contested decision which is the prohibition on the marketing of triclosan which, from 1 November 2011, will apply without any implementing measure being necessary.

Having regard to the foregoing observations, it cannot be held that the contested decision entails implementing measures.

It follows that that decision constitutes a regulatory act of direct concern to the applicants, which does not entail any implementing measures, so that the plea of inadmissibility raised by the Commission must be dismissed without it being necessary to consider whether it was of individual concern to the applicants.

In support of their application, the applicants put forward four pleas in law. The first alleges an error of law in the choice of legal basis for the contested decision. The second alleges a breach of the procedure laid down by Regulation No 1935/2004 and Directive 2002/72. The third alleges a breach of the principle of the protection of legitimate expectations. The fourth alleges infringement of the principles of sound administration, transparency and legal certainty.

Under Article 87(2) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party's pleadings. Since the Commission has failed in its submissions and the applicants have applied for costs, the Commission must be ordered to pay the costs.

On those grounds,

THE GENERAL COURT (Fourth Chamber, Extended Composition)

hereby:

Pelikánová

O'Higgins

Vadapalas

Jürimäe

Van der Woude

Delivered in open court in Luxembourg on 25 October 2011.

[Signatures]