Inuit and Microban: ECJ explains notion of ‘regulatory act’

dr. Agne Limante 

Post-Graduate Diploma candidate in EU Law, King’s College London; PhD in EU law, Vilnius University


After the Lisbon Treaty came into force, actions for the annulment of EU legal acts are regulated by Article 263 TFEU[i], which has revised and replaced Article ex 230 EC[ii]. Among other changes related to annulment actions, the Lisbon Treaty also revised locus standi requirements for private applicants. The present wording of Article 263(4) TFEU allows “any natural or legal person <…> [to] 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 does not entail implementing measures” (emphasis added). The novelty and relaxation of standing lies in this last scenario – the abolishment of the obligation to prove ‘individual concern’ when seeking annulment of a regulatory act not entailing implementing measures.

Ever since the drafting of the Treaty Establishing a Constitution for Europe, the exact meaning of the ‘regulatory act’ has been one of the most debated topics among scholars concerned with the locus standi requirements in annulment actions[iii]. This was mainly caused by the fact that neither the Constitution for Europe, nor the Lisbon Treaty, contains a definition of a regulatory act or uses this wording in other articles. For long time the legal writings were based solely on the travaux preparatoire of the Treaties and opinions of scholars, waiting for the EU Court of Justice to have the final word.

The mystery has been revealed in autumn 2011 when Court of Justice of European Union (CJEU) delivered its first judgements addressing the notion of the ‘regulatory act’ – in Inuit Tapiriit Kanatami[iv] and Microban[v] cases. Due to the fact that they are likely to become the seminal cases on this topic, they are worth taking a closer look at.

Inuit Tapiriit Kanatami case

On 6 September 2011, the General Court issued an Order in the case Inuit Tapiriit Kanatami and Others[vi], wherein it applied Article 263 TFEU and, for the first time, interpreted the notion of ‘regulatory act’. The case concerned the European Parliament and Council Regulation No. 1007/2009 on trade in seal products[vii]. The applicants (a group of companies, associations and natural persons) based their claim on Article 263 TFEU and sought the annulment of the contested regulation, stating that it is a regulatory act and therefore relaxed standing rules should be applied. The respondents (the European Parliament and the Council), supported by the Netherlands and the Commission, raised three pleas of inadmissibility, alleging, respectively, that the contested regulation is not a regulatory act, that it does not entail implementing measures and that it does not individually concern the applicants. As a result, the examination of admissibility of the action revolved around the interpretation of a regulatory act.

Taking a literal point of view, the Court noted that it is apparent from the ordinary meaning of the word ‘regulatory’ that these are the acts of general application. The Court also pointed out that regulatory acts do not include legislative acts. Such an interpretation of the word ‘regulatory’, and of the equivalent word in the different language versions of the TFEU, as opposed to the word ‘legislative’, according to the Court, is also apparent from a number of other provisions of the TFEU, in particular Article 114 TFEU, concerning the approximation of the ‘provisions laid down by law, regulation or administrative action in Member States’.

Carrying out historical interpretation, the Court referred to the process that led to the adoption of Article 263 TFEU, which was the drafting of its predecessor Article III-365 of the draft Treaty establishing a Constitution for Europe. The Court stated that it is apparent from the cover note of the Praesidium of the Convention[viii] that, in spite of the proposal for an amendment to the Article 230(4) EC mentioning ‘an act of general application’, the Praesidium adopted another option, that of mentioning ‘a regulatory act’. Such a wording enabled a distinction to be made between legislative acts and regulatory acts, maintaining a restrictive approach in relation to actions by individuals against legislative acts[ix].

Finally, using a teleological method of interpretation, the Court observed that the purpose of that provision is to allow a natural or legal person to institute proceedings against an act of general application which is not a legislative act, which is of direct concern to them and does not entail implementing measures, thereby avoiding the situation in which such a person would have to infringe the law to have access to the court. On the other hand, the conditions of admissibility of an action for annulment of a legislative act still remain more restrictive than in the case of proceedings instituted against a regulatory act – a legislative act may form the subject-matter of an action for annulment brought by a natural or legal person only if it is of direct and individual concern to them.

Having carried out such analysis, the Court concluded that ‘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. As further analysis of the Court revealed, legislative acts for this purpose are differentiated by the procedure, which led to their adoption.

Microban case

After the General Court has explained the meaning of ‘regulatory act’ in the Inuit Tapiriit Kanatami case, it still had yet to define the meaning of ‘direct concern’ and the lack of ‘implementing measures’ in this context. This was done in Microban case[x].

The measure challenged by the applicants in Microban case was a Commission decision on non-inclusion of triclosan in the ‘positive list’ of authorised substances. The decision was adopted using Commissions implementing powers. Therefore, according to the classification of legal acts provided for in the Treaty, it was a decision falling within the ambit of implementing acts. As, due to its scope, it was also an act of general application, the Court concluded, referring to the Inuit Tapiriit Kanatami case, that the contested decision should be considered to be a regulatory act.

As regards the concept of ‘direct concern’ as re-introduced in the Article 263(4) TFEU, the Court decided to continue to interpret it in the same way as it appeared in Article 230(4) EC. Elaborating on the concept of lack of implementing measures, the Court noted that the Commission decision on non-inclusion of triclosan in the ‘positive list’ had the immediate consequence of the removal from the provisional list and a prohibition on the marketing of triclosan. Though an established transitional period allowing Member States to extend marketing triclosan until 1 November 2011 might have given rise to implementing measures by the Member States, these measures, according to the Court, were optional and ancillary to the main purpose of the contested decision, namely the prohibition of the marketing of triclosan. For this main purpose Member States did not need to adopt any implementing measures, therefore, the Court held that the contested decision did not entail implementing measures and ruled the application admissible.

Concluding remarks

Having in mind the case-law discussed above, ‘regulatory acts’ seem to include delegated (Article 290 TFEU) and implementing acts (Article 291 TFEU) as long as they are acts of general application[xi]. Therefore, the relaxation of private applicants’ standing would most probably have an impact on possibilities to challenge Commission regulations, as large part of them should fall under the concept of a ‘regulatory act’. The new rules will potentially have far-reaching effects in such areas as, environmental law, as in those areas the main principles are usually laid down in a legislative act (directive or regulation), while the details are left to the Commission to implement. On the other hand, regulations adopted by the Parliament and the Council acting together through legislative procedure should be classified as legislative acts and relaxation provided for in the Treaty of Lisbon would not apply, requiring private applicants to prove that they are directly and individually concerned.

It is worth noting that at least to some extent, differentiating regulatory and legislative acts by the procedure according to which they were adopted is not fully in line with the previous case law of the Court. In numerous cases the Court made it clear that in order to ascertain whether a legal act whose annulment is sought is open to challenge, it is necessary to look to its substance as the form in which it is cast is, in principle, irrelevant[xii]. However, at this point it seems that when deciding whether the act at issue is regulatory or legislative, the Court will simply base its analysis on the legal basis of the act and the procedure chosen. In Inuit Tapiriit Kanatami and Others[xiii] the Court clearly stated that it is apparent from Article 289(1) and (3) TFEU that legal acts adopted according to the procedure defined in Article 294 TFEU, referred to as ‘the ordinary legislative procedure’, constitute legislative acts and categorised the contested regulation as a legislative act.

[i] Treaty on the Functioning of the European Union 2009

[ii] European Communities Treaty 2002

[iii] See, for example; Barents, Rene ‘The Court of Justice after the Treaty of Lisbon’ 47 CMLRev (2010) p709-728; Damian Chalmers, Gareth Davies, Giorgio Monti, European Union Law. Text and Materials (2nd edition, Cambridge University Press, 2010) p 414; Albors-Llorens, Albertina, ‘Edging Towards Closer Scrutiny? The Court of Justice and Its Review of the Compatibility of General Measures With the Protection of Economic Rights and Freedoms’ in Anthony Arnull, Catherine Barnard, Michael Dougan & Eleanor Spaventa (eds.) Constitutional Order of States: Essays in EU Law in Honour of Alan Dashwood (Hart Publishing, 2011) p 245-267.

[iv] 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.

[v] Case T-262/10 Microban International and Microban (Europe) v Commission [2011] ECR II-0000.

[vi] Case T-18/10 Inuit Tapiriit Kanatami and Others v Parliament and Council [2011] ECR II-0000.

[vii] The contested regulation was adopted on the basis of the EC Treaty, whereas the action for annulment came after the TFEU entered into force. Considering which article, 230 EC or 263 TFEU, should be applied, the Court stated that in accordance with the maxim tempus regit actum the question of the admissibility of an application must be resolved on the basis of the rules in force at the date on which it was submitted and, second, that the conditions of admissibility of an action are judged at the time of bringing the action, that is, the lodging of the application (see also Case T-532/08 Norilsk Nickel Harjavalta and Umicore [2010] ECR I‑0000, and Case T-539/08 Etimine and Etiproducts [2010] ECR I‑0000, para 76 and the case-law cited).

[viii] Secretariat of the European Convention, CONV 734/03

[ix] See also Oral presentation by M. Gil Carlos Rodríguez Iglesias, President of the Court of Justice of the European Communities, to the “discussion circle” on the Court of Justice on 17 February 2003, CONV 572/03; and Oral presentation by M. Bo Vesterdorf, President of the Court of First Instance of the European Communities, to the “discussion circle” on the Court of Justice on 24 February 2003, CONV 575/03.

[x] Case T-262/10 Microban International and Microban (Europe) v Commission [2011] ECR II-0000.

[xi] According to the case law, a decision is of general application when it applies to objectively determined situations and it produces legal effects with respect to categories of persons envisaged in general and in the abstract.

[xii] Case 60/81 IBM v Commission [1981] ECR 2639, Case C‑147/96 Netherlands v Commission [2000] ECR I‑4723, and, more recently, Case C-322/09 P NDSHT v Commission [2010] ECR I-0000.

[xiii] Case T-18/10 Inuit Tapiriit Kanatami and Others v Parliament and Council [2011] ECR II-0000