1 Judgment of the General Court of 25 October 2011 in Case T-262/10 Microban International Ltd and Microban (Europe) Ltd v Commission (not yet reported).

2 Triclosan is the commonly used name for the substance 2,4,4'-trichloro-2'-hydroxydiphenyl ether.

3 Commission Decision 2010/169/EU of 19 March 2010 concerning the non-inclusion of 2,4,4'-trichloro-2'- hydroxydiphenyl ether 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/EC, OJ 2010 L 75/25, (“Commission Decision 2010/169”).

4 See the Commission's (DG Sanco) unofficial explanatory document “References of the European and National Legislations, Working Document” available on the Internet at <http://ec.europa.eu/food/food/chemicalsafety/foodcontact/docs/ReferencesEur-NatLeg_20091026.pdf> (last accessed 13 January 2012).

5 Set out in Article 2 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 40/38.

6 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 220/18 (“Directive 2002/72”).

7 Directive 2002/72 has been repealed and replaced from 1 May 2011 by Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food, OJ 2011 L 12/1.

8 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/EEC, OJ 2004 L 338/4 (“Regulation 1935/2004”).

9 Supra, note 1, at paras. 53 to 69.

10 Joined cases T-172/98 and T-175/98 to T-177/98, Salamander v European Parliament and Council [2000] ECR II-2487, paragraph 52; Case C-386/96 P, Dreyfus v Commission [1998] ECR I-2309, para. 43.

11 Case 25/62 Plaumann & Co v Commission [1963] ECR 95, p. 107.

12 Case C-50/00 P Unión de Pequeños Agricultores v Council [2002] ECR I-6677, paras. 59–60.

13 Case C-50/00 P Unión de Pequeños Agricultores v Council [2002] ECR I-6677, paras. 36–47.

14 For example, the Cover Note from the Praesidium to the Convention on Articles on the Court of Justice and the High Court of 12 May 2003, at p. 20, gives the following explanation for amending the fourth paragraph of Article 230 EC: “Members of the circle who were in favour of amending the fourth paragraph of Article 230 expressed a preference for the option mentioning “an act of general application”. Some members, however, considered that the term “a regulatory act” would be more appropriate, since it would enable a distinction to be made between legislative acts and regulatory acts, maintaining a restrictive approach in relation to actions by individuals against legislative acts (for which the “of direct and individual concern” condition remains applicable) while providing for a more open approach to actions against regulatory acts. The Praesidium has adopted the latter approach and proposes that provision be made for actions by natural or legal persons against regulatory acts which are of direct concern to them without entailing implementing measures.”

15 Article 19(1) of the Treaty on European Union provides: “The Court of Justice of the European Union shall include the Court of Justice, the General Court and specialised courts. It shall ensure that in the interpretation and application of the Treaties the law is observed.”

16 Case T-16/04 Arcelor SA v European Parliament and Council [2010] ECR II-291, see comment by van Zeben, Josephine, “Possibilities for Locus Standi and Non-Contractual Damges for Private Parties under the European Emissions Trading Scheme”, 1 EJRR (2010), 477 et sqq Google Scholar.

17 Directive 2003/87/EC of the European Parliament and of the Council of 13 October 2003 establishing a scheme for greenhouse gas emission allowance trading within the Community and amending Council Directive 96/61/EC, OJ 2003 L 275/32.

18 Ibid, paras. 99–122.

19 Ibid, para. 123. In particular, the Court referred to the Member States’ broad discretion under Art. 9(1) and Art. 11(1) of Directive 2003/87 regarding the allocation of allowance quotas to various industrial sectors and the issuing and withdrawal of allowance to individual operators, ibid, para. 114.

20 See Orders of the General Court of 7 September 2010 in Case T-532/08 Norilsk Nickel Harjavalta and Umicore v Commission, para. 70 (not yet reported), and in Case T-539/08 Etimine and Etiproducts v Commission, para. 76 (not yet reported).

21 Order of the General Court of 6 September 2011 in Case T-18/10 Inuit Tapiriit Kanatami and Others v European Parliament and the Council (not yet reported).

22 Regulation (EC) No 1007/2009 of the European Parliament and of the Council of 16 September 2009 on trade in seal products, OJ 2009 L 286/36.

23 Supra note 21, at paras. 39–40.

24 Supra note 21, at para. 45.

25 Supra note 21, at para. 56.

26 Supra note 21, at paras. 57–66.

27 Supra note 21, at paras. 68–94.

28 Council Decision 1999/468 of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission, OJ 1999 L 184/23 (“Council Decision 1999/468”). Council Decision 1999/468 was repealed on 1 March 2011 by Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers, OJ 2011 L 55/13 (“Regulation 182/2011”). It is worth noting that under Article 12 of Regulation 182/2011, the regulatory procedure with scrutiny under Article 5a of Council Decision 1999/468 continues to apply for the purposes of existing basic acts making reference thereto.

29 Supra note 1, at para. 22.

30 Supra note 1, at paras. 23–24.

31 Supra note 1, at para. 25.

32 Supra note 1, at para. 27.

33 Supra note 1, at para. 28.

34 Supra note 1, at para 29.

35 Supra note 1, at para. 32.

36 Supra note 1, at para. 32.

37 Supra note 1, at para. 33.

38 Supra note 1, at paras. 34–35.

39 Supra note 1, at para. 37.

40 Supra note 1, at para. 39.

41 It is notable that the legal basis for the contested act, Article 11(3) of Regulation No 1935/2004 through which the comitology procedure under Council Decision 1999/468 was applied, was found to be wrong and accordingly grounds for annulment. Supra, note 1, at paras. 41–52.

42 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006, OJ 2008 L 353/1 (“Regulation 1272/2008”). See in particular Art. 53. In Case T-532/08 and Case T-539/08, supra note 20, the applicants’ challenges to the first amendment to technical progress of Regulation 1272/2008 as regards the harmonised classification of certain nickel and borate substances were held inadmissible as the applicants did not meet the test of individual concern under Article 230, fourth paragraph, EC. It appears likely that any future harmonised classification measure would be held to be a regulatory act and accordingly the new standing rules would apply.

43 See Art. 11(4) and Art. 16(2) of Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market, OJ 1998 L 123/1; see Art. 13(2) of Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC, OJ 2009 L 309/1.

44 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/ EEC, 93/105/EC and 2000/21/EC, OJ 2006 L 396/1 (the “REACH Regulation”). See in particular Art. 64(8) for the authorisation procedure and Art. 73 for the restrictions procedure. A challenge to Commission Regulation (EU) No 366/2011 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annex XVII (Acrylamide), OJ 2011 L 101/12 is currently pending before the General Court (Case T-368/11 Polyelectrolyte Producers Group and Others v Commission).

45 Since 5 January 2010, the “L” (L for legislation) series of the Official Journal of the European Union, contains a separate section entitled “non-legislative acts”.

46 Supra note 21, at para. 63

47 The most commonly used legislative procedure is the “ordinary legislative procedure” defined at Article 294 TFEU, whereby acts are adopted jointly by the European Parliament and the Council. The adoption of acts by a “special legislative procedure” is provided for in certain cases.

48 Therefore in a case similar to Case T-16/04 Arcelor, supra note 16, where the contested act was a Directive adopted by the European Parliament and the Council, the contested act would be a legislative act and the standing rules applicable to regulatory acts would not apply.

49 See Article 59 of the REACH Regulation. Decisions to add substances to the Candidate list have so far been adopted by the European Chemicals Agency. However, where the Agency’s Member State Committee does not agree unanimously on a proposal to add a substances to the Candidate list the Commission prepares a proposal which is decided upon via the comitology procedure (from 1 March 2011 that procedure is governed by Regulation 182/2011, supra note 27).

50 See, for example, Case T-93/10 Bilbaína de Alquitranes, SA and Others v ECHA; Case T-94/10 Rütgers Germany and Others v ECHA; Case T-95/10 Cindu Chemicals and Others v ECHA; Case T-96/10 Rütgers Germany and Others v ECHA, pending before the General Court.

51 Order of the General Court of 21 September 2011 in Case T-1/10 PPG GEIE and SNF SAS v ECHA ( not yet reported).

52 Order of the General Court of 21 September 2011 in Case T-343/10 Etimine SA and Ab Etiroducts Oy v ECHA (not yet reported).

53 As regards the authorisation procedure, Art. 56 of the REACH Regulation provides that where a substance is included in Annex XIV a manufacturer, importer or downstream user cannot place that substance on the market unless an authorisation has been granted or an exemption from the requirement to obtain an authorisation has been obtained. A transitional period, known as a sunset date, is provided during which the substance can remain on the market (Art. 58 of the REACH Regulation).

54 As regards the restrictions procedure, Art. 67(1) of the of the REACH Regulation provides that where a substance is subject to restriction under Annex XVII, it cannot be manufactured, placed on the market or used unless it complies with the conditions of that restriction.

55 Supra note 16.

56 Supra notes 16 and 19. It should be recalled that discretion on the part of Member States is also a key factor in the test of direct concern, see Case T-223/01 Japan Tobacco Inc. and JT International SA v European Parliament and Council [2002] ECR II-3529, paras. 45–57.

57 See for example Art. 2 of Commission Implementing Regulation (EU) No 1278/2011 of 8 December 2011 approving the active substance bitertanol, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market., and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 and Commission Decision 2008/934/EC, OJ 2011 L 327/49.

58 Under case law, notifiers of plant protection product active substances are held to be directly and individually concerned by Commission decisions thereon and hence have standing to bring legal challenges against those decisions, irrespective of their classification as a regulatory act, e.g. Case T-420/05 Vischim Srl v Commission [2009] ECR II-3841, paras 76–78; Case T-326/07 Cheminova AS and Others v Commission [2009] ECR II-2685, paras. 66–67.

59 Supra note 37.

60 Supra note 21, at para. 50.

61 Case T-13/99 Pfizer Animal Health SA v Council [2002] ECR II- 3305, para. 31.