Nutrition & Health Claims

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)

Lists of Authorized Claims

Nutrition Claims

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”.

Health Claims

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 website.

Timetable

- Foods not complying with the new rules, which have been placed on the market or labeled before July 2007, may be marketed until July 31, 2009.
- Nutrient profiles to be developed by January 19, 2009 (delayed).
- Nutrition claims, authorized in a Member State before January 1, 2006 but not included in the Annex to Regulation 1924/2006, may continue to be used until January 19, 2010.
- An EU-list of permitted health claims and their conditions for use to be established by January 31, 2010 (delayed).
- Trademarks or brand names that can be interpreted as a nutrition or health claim but do not meet the requirements of the regulation must be phased out by January 19, 2022.

Reports

- Health Claims - EU Authorization Procedure GAIN report E48055 (May 2008)
- Nutrition & Health Claims - Update 2007 GAIN report E47090
- European Parliament passes new EU rules on nutrition and health claims GAIN report E36086 (May 2006)
- Nutrition & Health Claims: status of EU proposal GAIN report E36058 (April 2006)
- Clarifications on the proposal on nutrition and health claims GAIN report E23199 (October 2003)
- EU proposal on nutrition and health claims notified to the WTO GAIN report E23172 (September 2003)

Links

- Commission Regulation 1024/2009 on the authorization and refusal of certain health claims (October 30, 2009)
- Commission Regulation 1025/2009 refusing to authorize certain health claims (October 30, 2009)
- Commission Regulation 984/2009 refusing to authorize certain health claims (October 21, 2009)
- Commission Regulation 983/2009 on the authorization and refusal of certain health claims (October 21, 2009)

- Health Claims - Comments to the Commission on EFSA's opinions
- Fortified Foods - New EU rules
- DG Sanco: Nutrition & Health Claims
- EFSA

FOREIGN AGRICULTURAL SERVICE U.S. MISSION TO THE EUROPEAN UNION

Nutrition & Health Claims

FOREIGN AGRICULTURAL SERVICE
U.S. MISSION TO THE EUROPEAN UNION