Official Journal of the European Union

C series

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C/2025/83

6.1.2025

(Case T-523/24)

(C/2025/83)

Language of the case: English

Parties

Applicants: Kerry Inc. (Beloit, Wisconsin, United States), Kerry Ingredients (UK) Ltd (Bristol, United Kingdom) (represented by: E. Righini, S. Troch, F. Eicher, T. Milleville and K. Beikos-Paschalis, lawyers)

Defendant: European Commission

Form of order sought

The applicants claim that the Court should:

—Annul, in their entirety, Commission Implementing Decisions (EU) No 2024/2066 (OJ L 2024/2066), (EU) No 2024/2079 (OJ L 2024/2079) and (EU) No 2024/2078;

—Annul Commission Implementing Regulation (EU) No 2024/2067, in so far as the applicants’ products are concerned;

—Order the Commission to pay the applicants’ legal costs and other fees and expenses incurred in connection with the present application for annulment.

Pleas in law and main arguments

In support of the action, the applicants rely on seven pleas in law.

1.First plea in law, alleging that the Commission and the European Food Safety Authority (EFSA), respectively in their capacity as risk manager and risk assessor, failed to accomplish their mandates under Articles 8(1) and 9(1) of Regulation No 2065/2003 of the European Parliament and of the Council of 10 November 2003, which is to assess whether the applicants’ products and their intended use present risks to human health.

2.Second plea in law, alleging that EFSA and the Commission committed manifest errors of assessment in their risk assessment of the applicants’ products, thus vitiating the contested acts. Instead of taking into account the results of the studies conducted by the applicants using chemical-specific data, which consistently demonstrate that the applicants’ products do not present a risk to human health, EFSA confined its assessment to a mere comparison with a generic, non-chemical specific threshold. The present plea consists of three limbs:

—Under the first limb, the applicants maintain that EFSA’s approach and methodology is contrary to its own guidance.

—In the second limb, the applicants assert that the genotoxicity assessment conducted by EFSA is contrary to the principle of scientific excellence.

—In the alternative, under the third limb of this plea, it is argued that EFSA’s guidance documents are inconsistent with the legal requirements for risk assessments and should be declared illegal, pursuant Article 277 TFEU.

3.Third plea in law, alleging that the Commission violated Article 9(1) of Regulation No 2065/2003 by failing to carry out a full risk management assessment. Apart from relying on the erroneous findings of EFSA, the Commission also failed to take into account other legitimate factors, such as the health effects of the unavoidable return to traditional smoking.

4.Fourth plea in law, alleging that the Commission violated the principle of proportionality when it adopted the contested acts.

5.Fifth plea in law, alleging that the contested acts lack a valid legal basis, as Regulation No 2065/2003 violates the principle of non-discrimination, which in turn results in the Commission violating the principle of non-discrimination when adopting the contested acts. There are two limbs to this plea:

—By the first limb, it is argued that, by establishing an obligatory ex ante market authorisation regime only for smoke flavouring primary products and not for traditional smoking, Regulation No 2065/2003 violates the principle of non- discrimination and should therefore be declared illegal (ex Article 277 TFEU).

—By the second limb, the applicants maintain that the contested acts violate the principle of non-discrimination.

6.Sixth plea in law, alleging that the Commission and the EFSA violated the applicants’ right to be heard.

7.Seventh plea in law, alleging that the Commission violated the obligation to provide adequate reasoning and the principle of sound administration. This plea also has two limbs, as follows:

—First, the applicants argue that the contested decisions, being only nine paragraphs and less than two pages long, do not provide any reasoning for the refusal to reauthorise the applicants’ products and therefore violate the duty to state reasons.

—By the second limb, the applicants maintain that the Commission violated the principle of sound administration by failing: (i) to conduct a proper risk management (see third plea); (ii) to hear the applicants during the administrative procedure (see sixth plea), and (iii) to state the reasons for adopting the contested acts (see the first limb of the present plea).

Commission Implementing Decision (EU) No 2024/2066 refusing the renewal of the authorisation of Zesti Smoke Code 10 (SF-002) as a smoke flavouring primary product (OJ L 2024/2066).

Commission Implementing Decision (EU) No 2024/2079 refusing the renewal of the authorisation of SmokEz C-10 (SF-005) as a smoke flavouring primary product (OJ L 2024/2079).

Commission Implementing Decision (EU) No 2024/2078 of 31 July 2024 refusing the renewal of the authorisation of SmokEz Enviro-23 (SF-006) as a smoke flavouring primary product (OJ L 2024/2078).

(<span class="oj-super">4</span>) Commission Implementing Regulation (EU) No 2024/2067 of 31 July 2024 amending Implementing Regulation (EU) No 1321/2013 as regards the deletion of entries SF-001 to SF-010 from the Union list of authorised smoke flavouring primary products (OJ L 2024/2067).

(<span class="oj-super">5</span>) Regulation No 2065/2003 of the European Parliament and of the Council of 10 November 2003 on smoke flavourings used or intended for use in or on foods (OJ 2003, L 309, p. 1).

ELI: http://data.europa.eu/eli/C/2025/83/oj

ISSN 1977-091X (electronic edition)

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