Nutrition and health claims review

Each claim, exactly as worded, is checked against the list of authorised nutrition claims in the Annex to Regulation (EC) No 1924/2006 and against the list of authorised health claims established by Regulation (EU) No 432/2012, verifying that the conditions of use — minimum quantity, form of the nutrient, target population — are met as the authorisation requires. Where the claim concerns an ingredient or substance whose EFSA assessment is still pending, the opinion says so expressly and assesses the risk of using it in the meantime. Where the literal wording is not covered but an authorised claim of equivalent scope exists, the opinion proposes the alternative wording that would be.

Outside the transitional rules, the system is harmonised: an authorised claim used within its conditions of use may be made throughout the Union, and an unauthorised health claim is prohibited in every Member State. For authorised claims, one review therefore serves the whole internal market.

Claims on botanical substances receive separate treatment. Their assessment by EFSA has been suspended for more than a decade, and the judgment of the Court of Justice of the European Union of 30 April 2025 in Case C-386/23, Novel Nutriology, confirmed that, while that suspension lasts, they fall under the general prohibition of unauthorised health claims unless the specific claim is covered by the transitional rules of Article 28 of Regulation (EC) No 1924/2006. The opinion assesses whether the botanical claim in question falls within those transitional rules or within the general prohibition.

It does not include preparing the scientific dossier for a new health claim not yet on the lists, which is a separate and more extensive procedure before EFSA. Nor does it include the review of the rest of the advertising piece or campaign in which the claim appears — visuals, context, channel — which is covered by the food advertising review.

Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods, and Commission Regulation (EU) No 432/2012 of 16 May 2012 establishing a list of permitted health claims made on foods, other than those referring to the reduction of disease risk and to children's development and health. For botanical substances, the transitional rules of Article 28 of Regulation (EC) No 1924/2006 and the judgment of the Court of Justice in Case C-386/23.

Through the quote form, the company provides the exact wording of each claim, the product, and the dose or reference quantity on which it is based. Each claim is checked against the current lists and the opinion is delivered with an individual assessment of each one within the stated timeframe.

If the doubt is not whether a specific claim is covered, but whether the product as a whole risks being reclassified as a medicinal product because of its function or presentation, the right service is the borderline products assessment.