FOREIGN AGRICULTURAL SERVICE
Nutrition and Health Claims
In December 2006, the Council and the European Parliament adopted Regulation 1924/2006 on nutrition and health claims made on foods (published in Official Journal L 12 of January 18, 2007). This regulation sets EU-wide conditions for the use of nutrition claims such as "low fat" and health claims such as "helps lower cholesterol" based on nutrient profiles. Claims may only be used if a food product meets a certain profile, i.e. appropriate ratios of salt, fat and sugar. These profiles will be developed within two years of the regulation entering into force, based on an opinion of the European Food Safety Authority (EFSA). Nutrition claims can fail one criterion, i.e. if only one nutrient (salt, sugar or fat) exceeds the limit of the profile a claim can still be made provided the high level of that particular nutrient is clearly marked on the label. For example, a yogurt can make a low-fat claim even if it has a high sugar content but only if the label clearly states "high content of sugar". Health claims cannot fail any criteria. Generic descriptors that could imply an effect on human health, such as "digestive" or "cough drop", may apply for a derogation from the new rules. The regulation applies from July 1, 2007.
Guidance on the implementation of the Nutrition and Health Claims
Regulation (European Commission - published Jan. 2008)
A list of authorized nutrition claims and the conditions for use is published in the Annex to regulation 1924/2006. Commission Regulation 116/2010 expands the list of nutrition claims authorized in the EU and sets out conditions of use for the nutrition claims “source of omega-3 fatty acids”, “high omega-3 fatty acids”, “high monounsaturated fat”, “high polyunsaturated fat” and “high unsaturated fat”.
Within three years of the regulation entering into force, the Commission will compile an EU positive list of well-established health claims such as "calcium is good for your bones", based on Member States' lists of health claims already approved at national level. Disease reduction claims and claims referring to the health of children will require full authorization on a case-by-case basis, following the submission of a scientific dossier to EFSA.
On July 26, 2007, EFSA published its final guidance document on how companies can apply for health claim authorizations. The guidance document addresses what applicants need to include in their application, in particular concerning the scientific data and evidence required to support a claim. It also includes examples and clarifications regarding the type of information that must be submitted. EFSA's Nutrition, Dietetic Products and Allergies Panel will evaluate the wording of a health claim to ensure that it reflects the scientific evidence and is understandable in terms of its relevance for human health. Claims that are considered vague, confusing or misleading will not receive a favorable opinion.
Commission Regulation 353/2008, establishes implementing rules for applications for authorization of health claims. Commission Regulation 1169/2009 amends Regulation 353/2008 as regards the verification of the validity of applications by the Member States and withdrawal of applications. GAIN report E48055 describes how application dossiers for authorization of health claims should be prepared and presented.
The Community Register
of authorized and rejected health claims is now available on DG Sanco's