- This case defined the meaning of ‘regulatory’ under paragraph 4 of Article 263 TFEU as referring acts of general application excluding legislative acts
- Microban (M) sought the annulment of a Commission decision that prohibited the marketing of a chemical, Triclosan, in the EU
- M buys Triclosan for the manufacture a antimicrobial product
- Issue arose as to the admissibility of the challenge under Article 264 TFEU
- The act is admissible under third possibility in paragraph 4 of Article 263 TFEU as a regulatory act of direct concern to the applicants, which does not entail any implementing measures
Is the decision a regulatory act?
- Regulatory acts are all acts of general application apart from legislative acts
- The decision was enacted using implementing powers conferred on the Commission
- It 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 (producers or marketers of Triclosan)
- Thus it is a regulatory act
Is the decision of direct concern to M?
- The contested community measure must directly affect the legal situation of the individual
- It must leave no discretion to its addresses who are tasked with implementing it, such implementation ‘being purely automatic and resulting from Community rules without the application of other intermediate rules’
- In the present case, the decision directly affects the legal position of M and leaves no discretion to member states who are addressees and have to implement it
- Though an established transitional period allowing Member States to extend marketing Triclosan until 1 November 2011 under national law, this is ancillary to the measure, the implementation of the ban is nonetheless not subject to discretion
Does the measure entail implementing measures?
- The subject of the contested decision is the non-inclusion of triclosan in the positive list
- Neither non-inclusion in the positive list nor removal from the provisional list required implementing measures on the part of the Member States
- The transitional provision does not itself require any implementing measure as intervention is purely optional
- Any intervention is intended to facilitate the implementation of the decision and is ancillary to the main purpose which the prohibition of marketing of Triclosan, which will apply without any implementing measures being necessary