Introduction
This advice will consider the legal avenues available to WaveFon to challenge the validity of Commission Regulation 454/2026 (‘the contested Regulation’), which bans the use of its newly patented material, Noktium. The primary method for a private company like WaveFon to challenge an EU act is the action for annulment under Article 263 of the Treaty on the Functioning of the European Union (TFEU). This advice will therefore focus on this procedure. It will first assess whether WaveFon has the legal standing, or locus standi, to bring such an action, which is a significant procedural hurdle. It will then analyse the potential substantive grounds upon which the contested Regulation could be annulled. The advice will conclude on the likely success of such a challenge.
The Action for Annulment under Article 263 TFEU
Article 263 TFEU allows the Court of Justice of the European Union (CJEU) to review the legality of acts of the Union’s institutions, including the Commission. If an action is successful, the Court will declare the act void under Article 264 TFEU. WaveFon, as a private company, is classified as a ‘non-privileged applicant’ under Article 263(4) TFEU, meaning it must satisfy strict conditions to be able to bring a challenge.
The contested act is Regulation 454/2026, adopted by the Commission. This is an act of a Union institution and is therefore, in principle, reviewable. A crucial preliminary point is the time limit. Under Article 263(6) TFEU, any action must be brought within two months of the publication of the measure. As the Regulation was adopted on 3 July 2026, WaveFon must act very quickly to initiate proceedings before the General Court.
Admissibility: Can WaveFon Bring a Challenge?
For a non-privileged applicant like WaveFon to challenge an EU act, it must prove it has standing. Article 263(4) TFEU provides three routes to establishing standing. An applicant can challenge:
- An act addressed to that person;
- An act which is of direct and individual concern to them; or
- A regulatory act which is of direct concern to them and does not entail implementing measures.
The contested Regulation is not addressed to WaveFon specifically; it is an act of general application applying to all mobile phone manufacturers. Therefore, WaveFon must rely on one of the latter two grounds.
1. Direct and Individual Concern
This is the traditional, and very strict, test for standing. WaveFon must show that the Regulation is of both direct and individual concern to it.
Direct Concern
An act is of direct concern if it directly affects the legal situation of the applicant and leaves no discretion to the addressees of the measure who are entrusted with its implementation (Case 21-24/72 International Fruit Company v Commission [1972] ECR 1219). Here, Regulation 454/2026 adds Noktium to the list of banned materials in Annex I of Regulation 96/2023. This ban is automatic and self-executing. It does not require any further action or discretion from Member States to take effect. The legal consequence for WaveFon—the inability to use Noktium in phones for sale in the EU—flows directly from the Regulation. Therefore, the requirement of direct concern is very likely to be satisfied.
Individual Concern
The test for individual concern is much more difficult to meet. The classic formulation comes from Plaumann & Co v Commission (Case 25/62) [1963] ECR 95, where the Court stated that an applicant must be affected by reason of certain attributes which are peculiar to them or by reason of circumstances in which they are differentiated from all other persons, and by virtue of these factors distinguishes them individually just as in the case of the person addressed.
At first glance, the Regulation appears to concern WaveFon as a member of an objectively determined class (mobile phone manufacturers) and not as an individual. However, the facts state that WaveFon has patented Noktium, giving it the sole right to use the material for twenty years. This fact could be used to distinguish WaveFon from all other economic operators. In Codorníu v Council (Case C-309/89) [1994] ECR I-1853, the applicant successfully argued it was individually concerned by a regulation that restricted the use of the term ‘crémant’, which it had used on its sparkling wines for many years under a registered trademark. The Court held that the applicant’s specific right (its trademark) was affected, which was sufficient to differentiate it from all other producers.
The parallel with WaveFon’s situation is strong. WaveFon holds a patent, which is a specific intellectual property right preventing any other company from using Noktium. The Regulation, by banning Noktium, specifically negates the commercial value of this unique right. It can be argued that this patent right places WaveFon in a factual situation which differentiates it from all other persons, thus satisfying the Plaumann test for individual concern.
2. Regulatory Act Not Entailing Implementing Measures
The Treaty of Lisbon introduced a third, more relaxed, path to standing. This allows a non-privileged applicant to challenge a ‘regulatory act’ which is of ‘direct concern’ and ‘does not entail implementing measures’.
A ‘regulatory act’ has been defined by the CJEU as an act of general application which is not a legislative act (Inuit Tapiriit Kanatami v Parliament and Council, Case C-583/11 P [2013] ECLI:EU:C:2013:625). Regulation 454/2026 was adopted by the Commission under a delegated power (Article 3 of Regulation 96/2023). This makes it a delegated act under Article 290 TFEU. As it was not adopted through a legislative procedure, it is a non-legislative act. As it applies to all manufacturers, it is of general application. It is therefore a ‘regulatory act’ for the purposes of Article 263(4).
As established above, the Regulation is of ‘direct concern’ to WaveFon.
The final condition is that the act ‘does not entail implementing measures’. This means that no further measures are needed at either the EU or national level for the act to take effect. The Regulation directly amends Annex I, and the ban on Noktium is effective immediately without any need for national legislation to be passed. Therefore, it does not seem to entail implementing measures.
On this basis, WaveFon appears to have a very strong claim for standing under the ‘regulatory act’ limb of Article 263(4), which is generally seen as easier to satisfy than the traditional Plaumann test (Chalmers et al., 2019).
Grounds for Annulment
Assuming WaveFon establishes standing, it must then put forward one of the grounds for annulment listed in Article 263(2) TFEU. The most relevant ground on these facts is the infringement of an essential procedural requirement.
The parent act, Regulation 96/2023, stated in Article 3 that the Commission "should consult with all mobile phone manufacturers affected by any such proposed delegated act before adopting it." The facts clearly state that "WaveFon was not consulted". As the sole patent holder for Noktium, WaveFon is undoubtedly a "manufacturer affected" by a regulation that bans its use.
The failure to follow a prescribed consultation procedure can constitute an infringement of an essential procedural requirement, leading to the annulment of the resulting act. The right to be heard is a general principle of EU law, and where a specific procedural step is mandated by the legislature, it is intended to ensure the institution acts with full knowledge of the relevant facts. In Roquette Frères v Council (Case 138/79) [1980] ECR 3333, the Court annulled a regulation because the Council had failed to await the European Parliament's opinion, which was a required step in the legislative process. The Court held that this consultation was an "essential" part of the institutional balance. Similarly, the requirement to consult affected parties in Article 3 is designed to ensure the Commission makes an informed decision. Its failure to consult WaveFon, the party most affected, is a clear procedural error and is likely to be considered 'essential', justifying the annulment of Regulation 454/2026.
A secondary argument could be made under the ground of ‘infringement of the Treaties or of any rule of law relating to their application’. This would involve a challenge based on the principle of proportionality, which is a general principle of EU law (Article 5(4) TEU). WaveFon could argue that a total ban on Noktium is a disproportionate measure. The Commission's action is based on a "concern" that the material "may not be safe". Proportionality requires that a measure is both appropriate and necessary to achieve its objective. A complete ban, in response to an unproven risk, could be seen as excessive, especially given the material’s stated benefits. WaveFon could argue that a less restrictive measure, such as requiring further safety testing or labelling, would have been more proportionate.
Conclusion
WaveFon has a strong case to bring an action for annulment against Commission Regulation 454/2026.
Firstly, it is highly likely that WaveFon will be granted standing to bring the case before the General Court. It has a compelling argument that it is of ‘direct and individual concern’ due to its patent on Noktium, following the precedent in Codorníu. Alternatively, and perhaps more straightforwardly, it can bring a challenge under the ‘regulatory act’ provisions of Article 263(4), as the contested Regulation is a non-legislative act of general application which is of direct concern to WaveFon and does not entail implementing measures.
Secondly, on the substance of the case, WaveFon has a very strong ground for annulment based on the infringement of an essential procedural requirement. The Commission’s clear failure to consult WaveFon, as explicitly required by the parent legislation, is a significant procedural flaw that would likely lead the Court to annul the Regulation.
It is therefore advised that WaveFon should immediately instruct lawyers to commence proceedings under Article 263 TFEU, ensuring the action is brought within the strict two-month time limit.
References
Chalmers, D., Davies, G. and Monti, G. (2019) European Union Law: Text and Materials. 4th edn. Cambridge: Cambridge University Press.
Cases
Codorníu v Council (Case C-309/89) [1994] ECR I-1853
International Fruit Company v Commission (Joined Cases 21-24/72) [1972] ECR 1219
Inuit Tapiriit Kanatami and Others v Parliament and Council (Case C-583/11 P) [2013] ECLI:EU:C:2013:625
Plaumann & Co v Commission (Case 25/62) [1963] ECR 95
Roquette Frères v Council (Case 138/79) [1980] ECR 3333
Treaties
Consolidated Version of the Treaty on the Functioning of the European Union [2012] OJ C326/47
