IN Brief:
- The General Court dismissed Kerry’s challenge to three 2024 Commission non-renewal decisions.
- The judgment finds applicants must demonstrate product safety rather than requiring regulators to prove harm.
- Transitional arrangements differ by food category, with later deadlines for specified cheese, meat and fish products.
The General Court of the European Union has dismissed a challenge brought by Kerry Inc. and Kerry Ingredients (UK) Ltd against the European Commission’s refusal to renew authorisations for three smoke flavouring primary products. In its judgment of 11 November, the court upheld the Commission’s 2024 decisions, leaving existing transition measures in place for food businesses that use the affected ingredients. The judgment confirms that companies applying for authorisation or renewal must provide sufficient evidence of safety under EU law.
The case, T-523/24, concerns Zesti Smoke Code 10 (SF-002), SmokEz C-10 (SF-005) and SmokEz Enviro-23 (SF-006). Kerry had sought the annulment of decisions refusing renewal and related changes to the EU list of authorised smoke flavouring primary products. The products had previously been authorised for a ten-year period under the European regulatory framework. Kerry sought renewal in 2022, but scientific reviews published by the European Food Safety Authority raised concerns over components with possible genotoxic effects.
Smoke flavouring primary products are distinct from conventional smoking methods. They can be made by capturing and processing smoke-derived material to produce ingredients used to impart a smoke character in foods. Such ingredients have applications in meat, cheese, sauces, snacks and other formulated products, although the permitted uses and relevant transition deadlines are not identical across categories. Reformulating a food can require more than substituting one flavour note, because processing method, flavour delivery and the characteristics of the finished product can interact.
In September 2023, EFSA’s assessments identified concerns over the genotoxicity of certain components of the three products. The court noted that estimated exposure to two substances known to be genotoxic in vivo when administered orally exceeded the relevant threshold of toxicological concern. Kerry criticised the approach used to assess the products, including the reliance on chemically identified constituents. The judges rejected those criticisms, finding that EFSA had considered the exposure associated with components of concern rather than relying solely on identification of a hazard.
EU legislation places the burden of demonstrating safety on applicants seeking authorisation or renewal. The Commission and EFSA are not required first to establish that the ingredient is harmful in order to decline renewal. The court therefore upheld the refusal without claiming that every use of the products had been shown to cause harm. The legal test was therefore the sufficiency of the safety evidence submitted, rather than proof of harm from every use of each flavouring.
Kerry also argued that removing the products could lead some food businesses back towards traditional smoking processes, which the company viewed as potentially more harmful. The court found that an increase in traditional smoking had not been demonstrated and that such a possibility would not require the Commission to maintain authorisations lacking sufficient safety evidence. The judges also rejected arguments that economic and environmental consequences should overturn the non-renewal decisions. The transitional periods were considered a means of allowing adjustment rather than a basis for disregarding the safety assessment.
Commission Implementing Regulation (EU) 2024/2067 set differentiated transition periods for previously compliant foods containing the affected primary products. In food categories outside the listed exceptions, the last permitted date for placing such foods on the market was 1 July 2026. For specified cheese, meat, processed fish and fish roe categories, the deadline is 1 July 2029. Products placed on the market within the relevant deadline may remain there until their minimum durability or use-by date. The rules are product- and category-specific, and manufacturers must verify the applicable conditions rather than applying the later date to all foods.
The earlier 2026 deadline has now passed. A manufacturer seeking to maintain a smoke-flavoured product for the EU market therefore needs a formulation and authorisation basis appropriate to its category, while those in the specified groups with a 2029 deadline retain a defined adjustment period. Technical work may include identifying permitted alternatives, checking changes in taste and appearance, verifying processing stability, adjusting ingredient declarations and validating shelf-life requirements. Substitution cannot be presumed technically neutral simply because an alternative produces a similar flavour impression.
The judgment leaves the 2024 non-renewal decisions and their existing transition timetable intact; it does not introduce a separate ban or extend either deadline. Kerry has said it is disappointed and is reviewing the judgment, but the outcome of any possible further appeal is not established. The immediate manufacturing position remains governed by the applicable EU authorisations, the category-specific phase-out arrangements and the safety evidence required for any future ingredient application.
