This advice will assess the legal options available to WaveFon, a Finnish mobile phone manufacturer, to challenge the validity of Commission Regulation 454/2026 (‘the contested Regulation’) before the Court of Justice of the European Union (CJEU). The contested Regulation effectively bans the use of Noktium, a material invented and patented by WaveFon. This advice will first consider whether WaveFon can successfully bring an action to challenge the Regulation, known as the rules on admissibility or standing. Secondly, it will analyse the potential legal arguments, or grounds for annulment, that WaveFon could use to argue that the Regulation is unlawful.
The primary route for a private party like WaveFon to challenge an EU act is an action for annulment under Article 263 of the Treaty on the Functioning of the European Union (TFEU). If successful, the CJEU can declare the act void under Article 264 TFEU.
Admissibility of the Action (Locus Standi)
For WaveFon to bring a successful challenge, it must first demonstrate that it has the right to do so, known as locus standi or standing. As WaveFon is not a Member State or an EU institution (known as privileged applicants), it is a non-privileged applicant and must satisfy the stricter conditions set out in Article 263(4) TFEU.
Article 263(4) provides three routes to standing for a natural or legal person. The applicant can challenge:
- An act addressed to them.
- An act which is of direct and individual concern to them.
- A regulatory act which is of direct concern to them and does not entail implementing measures.
The contested Regulation is a regulation of general application and is not a decision addressed specifically to WaveFon, so the first route is not available. We must therefore consider the second and third routes.
Direct and Individual Concern
This is the traditional, and very strict, test for standing. WaveFon must show that the contested 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, such as Member States, who are entrusted with its implementation (Case 294/83 Les Verts v Parliament). The contested Regulation adds Noktium to Annex I of Regulation 96/2023, which has the immediate and automatic legal effect of banning its use in mobile phones for sale in the EU. No further action is required by Member States to implement this ban. This directly affects WaveFon’s legal and commercial position, as it prevents them from using their patented material. Therefore, the requirement of direct concern is likely to be met.
Individual Concern This is a more difficult hurdle. The classic test was set out in Plaumann v Commission (Case 25/62), which states that an applicant is individually concerned only if the decision affects them "by reason of certain attributes which are peculiar to them or by reason of circumstances in which they are differentiated from all other persons". It is not enough to be part of a general economic group, such as a mobile phone manufacturer.
WaveFon’s position, however, seems strong. It is not just any manufacturer; it is the inventor and sole patent holder of Noktium for the next twenty years. This patent means that no other company in the EU can legally use Noktium. The effect of the Regulation, while drafted in general terms (banning the substance 'Noktium'), in practice only affects WaveFon at the present time and for the foreseeable future. This situation is comparable to that in Codorníu v Council (Case C-309/89). In that case, the applicant was a producer of sparkling wine that had long used the term ‘crémant’ and had registered a trademark for it. A Council regulation restricted the use of the term ‘crémant’ to wines produced in France and Luxembourg. The Court found that Codorníu was individually concerned because the regulation affected its specific trademark rights. Similarly, WaveFon could argue that the contested Regulation affects its specific patent rights, distinguishing it from all other mobile phone manufacturers. On this basis, WaveFon is arguably individually concerned.
Regulatory Act
The Treaty of Lisbon introduced a third route to standing to make it easier to challenge certain acts. WaveFon could challenge the contested Regulation if it is a "regulatory act which is of direct concern… and does not entail implementing measures."
Regulatory Act The CJEU has defined a "regulatory act" as a non-legislative act of general application (Inuit Tapiriit Kanatami v Parliament and Council, Case C-583/11 P). Regulation 96/2023 was adopted under the ordinary legislative procedure, making it a legislative act. However, the contested Regulation, 454/2026, was adopted by the Commission under a delegated power given in Article 3. The problem description explicitly calls these "non-legislative" regulations. Therefore, the contested Regulation is a delegated act, which falls under the definition of a regulatory act.
Direct Concern and No Implementing Measures As established above, the Regulation is of direct concern to WaveFon. The final question is whether it "entails implementing measures". This means the act should not require further substantive measures to be taken at the national or EU level for it to take effect. The contested Regulation is self-executing; the ban on Noktium applies immediately upon its entry into force without any need for Member State governments to pass further laws. Therefore, it does not appear to entail implementing measures.
Given these points, WaveFon has a very high chance of establishing standing. It can likely satisfy the strict Plaumann test and, failing that, has a very strong alternative claim under the "regulatory act" limb of Article 263(4).
Grounds for Annulment
Once standing is established, WaveFon must present substantive legal arguments, or grounds, to have the Regulation annulled. Article 263(2) TFEU provides four grounds: lack of competence, infringement of an essential procedural requirement, infringement of the Treaties or any rule of law relating to their application, and misuse of powers.
Infringement of an Essential Procedural Requirement
This appears to be WaveFon’s strongest ground for challenge. Article 3 of the parent Regulation (96/2023) explicitly stated that the Commission "should consult with all mobile phone manufacturers affected" before adopting a delegated act to amend Annex I. The facts clearly state that "WaveFon was not consulted before Regulation 454/2026 was adopted."
WaveFon is undoubtedly a "manufacturer affected" by the proposed act; its unique product is the very subject of the ban. The right to be heard is a general principle of EU law, and where a specific duty to consult is included in the empowering legislation, failure to adhere to it is a serious procedural error. In cases concerning the legislative process, the Court has held that failure to consult the Parliament where required by the Treaty constitutes an infringement of an essential procedural requirement that leads to the annulment of the act in question (Roquette Frères v Council, Case 138/79). It is highly likely that the CJEU would view the specific consultation requirement in Article 3 as an essential part of the procedure designed to ensure the Commission makes informed decisions. The failure to consult WaveFon is therefore a clear infringement and a strong basis for annulling the contested Regulation.
Infringement of the Treaties or any Rule of Law
WaveFon could also argue that the Regulation infringes general principles of EU law, which fall under this ground.
The Principle of Proportionality The principle of proportionality, a general principle of EU law, requires that measures adopted by EU institutions must be appropriate and necessary to achieve their legitimate objective, and the burden they impose must not be excessive in relation to the objective (R v Minister of Agriculture, Fisheries and Food, ex p Fedesa, Case C-331/88). The Commission’s objective is presumably to protect public health and safety. However, the Commission is only "concerned that Noktium may not be safe." A complete and immediate ban based only on a "concern" may be a disproportionate measure. WaveFon could argue that less restrictive measures were available, such as requiring further safety testing, imposing labelling requirements, or setting limits on the use of Noktium, rather than an outright prohibition. The success of this argument would depend on the scientific evidence available to the Commission, but the burden would be on the Commission to show that a total ban was a necessary and proportionate response.
Fundamental Rights WaveFon could also argue that the ban infringes its fundamental rights, as protected by the EU Charter of Fundamental Rights. Specifically, the ban interferes with its freedom to conduct a business (Article 16) and its right to property (Article 17), which includes intellectual property such as patents. While these rights are not absolute and can be restricted in the public interest, any such restriction must be lawful, necessary and genuinely meet objectives of general interest recognised by the Union. This argument is closely linked to the principle of proportionality.
Conclusion
In conclusion, WaveFon has strong prospects of successfully challenging Commission Regulation 454/2026 before the CJEU.
First, it is highly likely to be granted standing under Article 263(4) TFEU. Its position as the sole patent holder for Noktium gives it a compelling case for being individually concerned under the Plaumann test. In the alternative, it has an extremely strong case under the "regulatory act" route, as the contested Regulation is a non-legislative act of direct concern that does not entail implementing measures.
Second, WaveFon has a very clear and strong ground for annulment: the Commission's infringement of an essential procedural requirement by failing to consult WaveFon as expressly required by the parent legislation. This procedural failure alone should be sufficient to have the Regulation declared void. Further arguments based on the principle of proportionality and the infringement of WaveFon's fundamental rights to property and to conduct a business also have a reasonable chance of success and should be raised.
My advice to WaveFon is to proceed with an action for annulment.
References
Cases
- Codorníu v Council (Case C-309/89) [1994] ECR I-1853
- Inuit Tapiriit Kanatami and Others v Parliament and Council (Case C-583/11 P) [2013] ECLI:EU:C:2013:625
- Les Verts v European Parliament (Case 294/83) [1986] ECR 1339
- Plaumann v Commission (Case 25/62) [1963] ECR 95
- R v Minister of Agriculture, Fisheries and Food, ex p Fedesa (Case C-331/88) [1990] ECR I-4023
- Roquette Frères v Council (Case 138/79) [1980] ECR 3333
Treaty Provisions
- Consolidated Version of the Treaty on the Functioning of the European Union [2012] OJ C326/47
