EFSA ::. Nutrition and Health Claims

Nutrition and Health Claims

An increasing number of foods sold in the EU bear nutrition and health claims. A nutrition claim states or suggests that a food has beneficial nutritional properties, such as “low fat”, “no added sugar” and “high in fibre”. A health claim is any statement on labels, marketing or advertising that health benefits can result from consuming a given food, for instance that a food can help reinforce the body’s natural defences or enhance learning ability.

EU framework

EU decision makers adopted a Regulation on the use of nutrition and health claims for foods in December 2006. This Regulation lays down harmonised EU-wide rules for the use of health or nutritional claims on foodstuffs based on nutrient profiles.

One of the key objectives of this Regulation is to ensure that any claim made on a food label in the EU is clear and substantiated by scientific evidence. EFSA is responsible for verifying the scientific substantiation of the submitted claims, some of which are currently in use, some of which are proposed by applicants. This information serves as a basis for the European Commission and Member States, which will decide whether to authorise the claims.

EFSA’s tasks

EFSA’s work includes providing scientific advice on:

General advice on nutrition claims such as “source of omega-3 fatty acids defined in Article 8 of the Regulation.
“General Function” health claims such as “calcium is good for your bones” are defined by article 13.1 of the Regulation. These claims are based on generally accepted scientific evidence. A consolidated list of these claims is currently being evaluated by EFSA.
"New function” health claims defined under Article 13.5 of the Regulation are based on new scientific evidence and/or for which protection of proprietary data is requested. They require applicants to provide scientific evidence substantiating the claim proposed for a specific product or substance.
Claims regarding disease risk reduction and child development or health . These kinds of claims, defined under Article 14 of the Regulation, require applicants to provide scientific evidence substantiating the claim proposed for a specific product or substance.
Criteria for setting nutrient profiles . Nutrient profiles are nutritional requirements that foods must respect in order to bear nutrition and health claims. Nutrient profiles are established by the European Commission and Member States.

Applications for the authorisation of new function health claims and claims regarding disease risk reduction and child development and health must take into account EFSA technical guidance for applicants. The Authority assesses whether the claims are scientifically reliable and justified.

All applications are given an Application Number and are recorded with an EFSA-Q-Number in EFSA’s Register of Questions, where details on the status of each claim are provided.

How to submit an application

EFSA has produced guidance on how to submit claims applications, following an extensive consultation process with industry and other interested parties. Applicants wishing to submit a claim should follow EFSA’s guidance.

Opinion of the Panel on dietetic products, nutrition and allergies (NDA) on a request from the Commission related to scientific and technical guidance for the preparation and presentation of the application for authorisation of a health claim - Published: 26 July 2007

To complement the guidance published in 2007, EFSA published a document outlining answers to frequently asked questions (FAQs) about the preparation and presentation of applications for Article 14 and 13.5 claims. The revised FAQs takes into account the comments received during the consultation held in May 2009 as well as the discussions and comments received at a technical meeting with applicants held on 15 June 2009.

Frequently Asked Questions (FAQ) related to the EFSA assessment of Article 14 and 13.5 health claims applications - Published: 30 September 2009

Resources from the European Commission

Applicants may also consult the information and documents available from the European Commission regarding the regulatory framework.

Health and Nutrition claims – European Commission, DG Health and Consumers
Regulation (EC) No 1924/2006 of the European Parliament and of the Council on nutrition and health claims made on foods - 20 December 2006
Guidance on the implementation of Regulation (EC) N° 1924/2006 on nutrition and health claims made on foods - 14 December 2007
Commission Regulation (EC) No 353/2008 establishing implementing rules for applications for authorisation of health claims - 18 April 2008

Scientific Documents

Scientific Opinion on the Substantiation of a health claim related to Iodine and the growth of children pursuant to Article 14 of Regulation (EC) No 1924/2006

Published: 19 November 2009 Adopted: 15 October 2009

Briefing document for Member States and European Commission on the evaluation of Article 13.1 health claims

Published: 18 November 2009 Adopted: 11 November 2009

Scientific Opinion related to a notification from Genecor International BV on barley beta-amylase from unmalted barley to be used in starch degradation to produce glucose syrups rich in maltose pursuant to Article 6, paragraph 11 of Directive 2000/13/EC – for permanent exemption from labelling [1]

Published: 30 October 2009 Adopted: 15 October 2009

Scientific Opinion on the substantiation of a health claim related to glucosamine hydrochloride and reduced rate of cartilage degeneration and reduced risk of development of osteoarthritis pursuant to Article 14 of Regulation (EC) No 1924/2006 [1]

Published: 29 October 2009 Adopted: 15 October 2009

Scientific Opinion on the substantiation of a health claim related to OPC Premium^™ and the reduction of blood cholesterol pursuant to Article 14 of Regulation (EC) No 1924/2006 [1]

Published: 23 October 2009 Adopted: 15 October 2009

Scientific Opinion on the Substantiation of a health claim related to Iron and cognitive development of children pursuant to Article 14 of Regulation (EC) No 1924/2006

Published: 15 October 2009 Adopted: 19 November 2009

Scientific Opinion on the substantiation of health claims related to calcium and maintenance of bones and teeth (ID 224, 230, 231, 354, 3099), muscle function and neurotransmission (ID 226, 227, 230, 235), blood coagulation (ID 230, 236), energy-yielding metabolism (ID 234), function of digestive enzymes (ID 355), and maintenance of normal blood pressure (ID 225, 385, 1419) pursuant to Article 13(1) of Regulation (EC) No 1924/2006