Regulatory Wrap-up of the year 2024

This overview highlights the key regulatory developments in the EU throughout 2024, offering expert insights into updates on novel foods, health claims, food supplements, botanicals in food supplements, and medical devices. For tailored advice or assistance with specific regulatory questions, our experts are here to support you—don’t hesitate to reach out to us.

New guidance documents for regulated food products in the EU

EFSA issued several new guidance documents concerning the scientific requirements on applications for novel foods, traditional foods from third countries, new nutrient sources, and an administrative guidance for novel food applications that will all enter into force on February 1, 2025.

An updated guidance for food enzymes is expected soon. The new edition of the webtool for calculating the exposure to food enzymes through the diet (FEIM) went live. The substantially improved update of the DietEx webtool for the intake assessment of food additives and novel foods is currently in the beta-testing phase.

Risk assessment methodology and associated guidelines from EFSA:

EFSA published guidance documents on the risk-benefit analysis of foods and interpretation of epidemiological data in EFSA’s risk assessment.

Important for fermentation in food manufacturing and precision fermentation, a review was issued on the recent developments in Biotechnology applied to microorganisms. The respective guidance document is expected soon. EFSA has already launched the public consultation on the draft guidance on the characterisation and risk assessment of microorganisms used in food.

The reviews on the technological processing of novel food proteins and in vitro toxicity testing approaches of (novel) proteins will support the risk assessment of new protein sources and help applicants provide the appropriate information.

Still no Novel Food Approval for CBD in the EU

EFSA has not granted any approvals. None of the so far submitted dossiers gained approval as novel foods. The European Commission terminated some CBD applications in 2024, others were terminated by the applicants themselves (see OpenEFSA portal), all remaining applications are currently stuck in the EFSA clock stop except for one (see OpenEFSA portal).

In contrast, the UK Food Standards Agency granted the first novel food authorizations for CBD supplements, restricting the acceptable daily intake of 10mg only.

Upper levels for vitamins and minerals in food and food supplements in the EU:

After intense discussions and development of a harmonized methodology, upper levels for the vitamins A and its provitamin β-carotene, vitamin B6, D and E, folic acid/folate, and the minerals iron, manganese have been revised. EFSA’s Dietary Reference Value finder has been updated. Nonetheless, EU member states may allow individual levels of these micronutrients in foods and food supplements.

Some botanicals in food supplements,

are a matter of debate among EU member states, not only regarding health claims under Regulation (EC) 1924/2006. Triggered by the market reality and reports of occasional side effects related to the intake of botanical supplements, the Working Group “Food Supplements” of the European Heads of Food Safety Agencies (HoA WG FS) proposed 12 botanicals that shall be subject to a safety evaluation according to Article 8 of Regulation (EC) 1925/2006. However, the procedures have not yet been formally initiated

ECJ Clarifies Rules on Non-Specific Claims for Pending Herbal Health Claims

The German Federal Court of Justice has asked the European Court of Justice (ECJ) to clarify whether non-specific claims under Article 10 of the Claims Regulation can apply to herbal claims that have not yet been authorized.

The ECJ’s response is that, until the European Commission decides how to proceed with pending botanical claims, non-specific claims can only be made for those pending claims listed, provided the necessary conditions, including scientific evidence, are met.

“EU Parliament Demands Health Claims Overhaul, But Solutions Still Far Off”

The EU Parliament urged the European Commission to revise health claims regulations to harmonize standards, address “grey zones” and misleading marketing, and tackle issues like social media campaigns, missing nutritional profiles, and unresolved pending botanical claims. It also advocates for EFSA to evaluate the relevance of claims for EU consumers and supports prior consultations with applicants, though it remains still uncertain if or when a decision will be made.

Brexit’s Long Shadow: UK’s FSA Takes a Different Approach to Assess Health Claims than the EU

It is becoming increasingly clear that the UK FSA takes a significantly different approach to health claim assessments compared to the EU, as seen in its assessment of an application related to creatine and cognitive function. While ESFA evaluates studies with varying doses to provide a comprehensive view of the evidence, the UK requires that the evaluation must also demonstrate effectiveness at dosages below the condition of use. As a result, studies with higher doses as the condition of use were excluded. In addition to the dosage issue, the FSA uses the Cochrane risk of bias approach to assess study quality. While EFSA also evaluates study quality, its written opinions provide much more detailed reasoning, including actual study results, to explain how conclusions are reached. It appears that EFSA’s approach emphasizes the totality of the evidence with a focus on study results, while the UK follows a more formalistic approach with a stronger emphasis on study quality.

MDR (EU) 2017/745 now consolidated: In 2024, the EU MDR’s extended transition periods took effect, allowing manufacturers more time to achieve conformity for legacy devices. Regulation (EU) 2023/607 introduced staggered deadlines until 2027 or 2028 based on device risk class. Manufacturers had to apply to a notified body by 26 May 2024 and secure a signed contract by 26 September 2024 to keep their devices on the market. To handle these changes, notified bodies expanded their capacity, and the Medical Device Coordination Group provided guidance. Throughout 2024, patient safety and regulatory clarity remained key priorities as the industry adjusted to evolving requirements.

Paper Alert: A strategic roadmap to substantiate prebiotic health claims

a&r proudly contributed to the recently published paper “Prebiotics in Food and Dietary Supplements: A Roadmap to EU Health Claims.” This comprehensive publication delves into the scientific and regulatory landscape of prebiotics, highlighting the relevance of robust evidence supporting their health benefits across digestive, immune, metabolic, and cognitive domains.

Drawing on insights from a multistakeholder workshop, the paper outlines:

• EU regulatory criteria for health claims
• Current research gaps and challenges in substantiating health benefits
• A strategic roadmap to facilitate health claim approvals for prebiotics in the EU

This work represents a pivotal step in aligning scientific innovation with regulatory requirements, paving the way for broader recognition of prebiotic health benefits.