SubscribeNutrition and Health Claims Regulation (1924/2006): Food legislation: requirements and impact of Article 13 and 14
The Nutrition and Health Claims Regulation applies from 01 July 2007.
The Nutrition and Health Claims Regulation aims to harmonise claims made on foods marketed within the EU to ensure that any consumer receives accurate information. Exaggerated or unsubstantiated nutrition or health benefit claims will no longer be permitted.
The Regulation applies to all foods, including food supplements, foods for particular nutritional uses (PARNUTS), natural mineral waters and water intended for human consumption.
Nutrition and Health Claims Regulation
It applies to nutrition and health claims made in commercial communications, whether in the labelling, presentation or advertising of foods, to be delivered to the final consumer. It does not apply to claims made in non-commercial communications, such as dietary guidelines, scientific journals or advice issued by public health authorities.
What is a claim?
The nutrition and health claims legislation defines a ‘claim’ as any message or representation, which is not mandatory under Community or national legislation, including pictorial, graphic or symbolic representation, in any form, which states, suggests or implies that a food has particular characteristics.
Trademarks which may be considered as nutrition or health claims are also regulated by this legislation. Products existing before 01 January 2005 bearing such trade marks or brand names may continue to be marketed until 19 January 2022.
Nutrition Claims
A nutrition claim is any claim which states, suggests or implies that a food has particular beneficial nutritional properties due to the energy, nutrients or other substances provided, not provided or provided in reduced/increased amounts e.g. high in fibre
Health Claims
A health claim is any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health e.g. aids digestion”.
Health claims are divided into the following 3 categories:
Article 13 Claims
Health claims other than those referring to the reduction of disease risk and to children's development and health i.e. claims describing or referring to either the role of a nutrient or other substance in growth, development and the functions of the body; or psychological and behavioural functions; or (without prejudice to Directive 96/8/EC), slimming or weight-control or a reduction in the sense of hunger or an increase in the sense of satiety or to the reduction of the available energy from the diet. e.g. calcium makes healthy bones
Article 13(5) Claims
Health claims based on newly developed scientific evidence and/or applications which include a request for the protection of proprietary data.
These claims require a detailed submission for assessment by the European Food Safety Authority (EFSA).
Article 14 Claims
Article 14 claims include reduction of disease risk claims and claims referring to children’s development and health.
These claims require a detailed submission to for assessment by EFSA.
Reduction of disease risk claim is any health claim that states, suggests or implies that the consumption of a food category, a food or one of its constituents significantly reduces a risk factor in the development of a human disease. e.g. x reduces the risk of heart disease.
If the health claims solely refers to the development and health of children, and where the scientific substantiation is only valid for children, there must be data provided on this population e.g. calcium is good for children’s growth.
No claims relating to treating or curing a human disease, or referring to such properties are permissible since these are medicinal claims.
If in the naming of the substance e.g. antioxidant, there is a function or effect on health, then the content claim is considered a health claim.
EFSA must give an opinion within five months of receiving a valid application, if more information is needed, two month extension is allowed. EFSA will check two criteria:
- That the health claim is substantiated by scientific evidence.
- That the wording of the health claim complies with the criteria laid down in the regulation.
The EU Commission will adopt the list of claims, along with conditions for their use, by 31 January 2010 at the latest.
Prohibited Health Claims
Prohibited health claims include:
- claims which suggest that health could be affected by not consuming the food
- claims which make reference to the rate or amount of weight loss
- claims which make reference to recommendations of individual doctors or health professionals and other associations not referred to in Article 11 of the Regulation.
Nutrient Profiles
Foods must comply with specific nutrient profiles in order to bear nutrition and health claims. These nutrient profiles are to be established by the Commission by 19 January 2009 at the latest. This work is now ongoing.
Food Labelling Requirements
When a nutrition or health claim is made nutrition labelling is required (Group 2 format as set out in Article 4(1), 90/496/EEC. If the amount of substances to which a nutrition or health claim relates is not in the labelling, this must be stated in the same field of vision as the nutrition information according to (Article 6 90/496/EEC) on food labelling requirements.
Food supplements making a nutrition or health claim must have the nutrition information must be provided in accordance with Article 8, 2002/46/EC.
The following information must be also included in the labelling, or if no such labelling exists, in the presentation and advertising:
- a statement indicating the importance of a varied and balanced diet and a healthy lifestyle
- the quantity of the food and pattern of consumption required to obtain the claimed beneficial effect
- where appropriate, a statement addressed to persons who should avoid using the food, and
- An appropriate warning for products that are likely to present a health risk if consumed to excess.
Status of Article 13 Health Claims in September 2008
In July 2008 the European Commission requested a scientific opinion from EFSA on a draft list of health claims, based on 44,000 claims supplied by Member States. EFSA has formally written in September 2008 to discuss with the Commission how best to undertake this work, as curently presented the list lacks consisitency and may include claims which may not comply with the Regulation. Botanicals are mentioned as a particlular area of concern which should be further considered jointly with the EMEA.
Status of Article 14 Health Claims in September 2008
In August 2008 EFSA adopted its first series of opinions on health claims under Article 14.
Only one claim relating to plant sterols and lower/reduced blood cholesterol and reduced risk of coronary heart disease has been accepted, with exact claim wording defined.
Seven rejected applications failed to demonstrate causality between consumption of specific nutrients or foods and intended health benefits. Two claims were rejected linking dairy product consumption with ideal body weight and reduced incidence of dental caries in children, on the basis that causality was not proven but also because the kind of dairy products in question were not sufficiently defined.
The EFSA opinion is not binding and requires ratification by the EC and Member States. The surprising rejection of some claims by EFSA raises a question about both the original submission quality, and assessment criteria. The evaluation process is still at a very early stage.