Commission Memo (MEMO/07/267), 28 June 2007
What are health and nutrition claims?
Nutrition claims are those used on labels or in advertising/marketing campaigns, which make an assertion about a particular nutritional property of a food. Examples include “high in vitamin C”, “low fat”, “no added sugar“and “high fibre”. Health claims maintain that there is a relationship between a specific food and improved health, or that a food can reduce the risk of a particular disease. Examples include “calcium is good for your bones”.
What is the aim of the new EU legislation on health and nutrition claims on food?
The Regulation on Health and Nutrition Claims aims to ensure that consumers are not misled by unsubstantiated, exaggerated or untruthful claims about foodstuffs. With the new legislation, consumers will be able to rely on clearer and more accurate information on food labels, enabling them to be properly informed on the food they choose. This ties in with the EU campaign for healthier lifestyle choices, as well as the Commission's consumer protection objectives. The Regulation also aims to provide food producers and manufacturers with clear, harmonised rules that would ensure fair competition and help protect innovation in the food industry, by ensuring that manufacturers making genuine health and nutrition claims are not competing with false or inaccurate claims.
What products will be covered by the Health and Nutrition Claims legislation?
The Regulation will apply to any food or drink product produced for human consumption to be sold on the EU/ Member States ' market. The new rules do not cover cosmetics, medicine or pet food products.
How will it be decided which health claims can or cannot be used?
For many well-established ‘function' health claims (such as “calcium may be good for your bones”), an EU positive list will be drawn up by the Commission, on the basis of claims submitted by Member States. These health claims will then be allowed to be carried on any label so long as the producer can verify the link between the claim and the product, and the food complies with the nutrient profiles.
For certain other health claims – disease risk reduction claims and claims referring to the health of children – authorisation will be required on a case-by-case basis, following the submission of a scientific dossier to the European Food Safety Authority (EFSA) for assessment. Likewise, health claims based on new scientific data will have to be submitted to EFSA for evaluation before they can be authorised for use. It was agreed during negotiations between the European Parliament and Council that a simplified procedure should be set up for the authorisation of these health claims, in order to encourage innovation in the food industry.
Under this simplified procedure, if the EFSA Opinion on the claim is positive, the Commission will take a decision on whether or not to authorise it after simple consultation of Members States. However, if EFSA gives a negative Opinion, the standard Comitology procedure will be used to decide whether or not to authorise the claim i.e. Member State experts will vote on a Commission proposal in the Standing Committee on the Food Chain and Animal Health.
What does the Regulation set out in terms of nutrient profiles of foodstuffs and the claims they can carry?
Under the Health and Nutrition Claims Regulation, food that does not fit a set nutrient profile (i.e. which is too high in salt, sugar and/or fat) will not be allowed to carry any health or nutrition claims. This is because claims are used to present products as having an additional health or nutritional benefit. In most cases, consumers perceive products carrying certain claims to be better for their health and wellbeing. However, at the moment, a food which is high in fat, salt and/or sugar, can still use claims such as “rich in vitamin C” or “high in fibre” to attract consumers, even if the overall health and nutritional benefits of the product are low. The Health and Nutrition Claims Regulation aims to prevent consumers from being misled in this way, by tying the use of health or nutrition claims to certain conditions related to the nutrient profiles (i.e. level of fat, sugar, salt etc) of foods. These nutrient profiles will be based on the scientific opinion of the European Food Safety Authority (EFSA).
What is the procedure for establishing these nutrient profiles?
The nutrient profiles will be based on the scientific opinion of the European Food Safety Authority (EFSA). The Commission will consult the relevant stakeholders, and present proposals for nutrient profiles to Member State experts in the Standing Committee on the Food Chain and Animal Health. If the Standing Committee backs these proposed nutrient profiles, they will be adopted by the Commission (Comitology procedure) and will enter into force following publication in the Official Journal of the European Communities.
What rules are set out for trademarks and brand names?
The Regulation will apply to any trademark that can be construed as a health or nutrition claim. Within 15 years, existing brand names suggesting health benefits (such as promises of weight loss) and which do not meet the requirements of the Regulation must be phased out and removed from the market. No new trademarks or brand names which imply health or nutritional benefits will be allowed to be put on the EU market unless the claims implied can be substantiated, in line with the provisions of the Regulation. However, certain generic descriptors (e.g. Digestives, aperitifs) may apply for derogation from this rule.
What does the Regulation provide for alcoholic products?
Food and beverages containing more than 1,2 % alcohol will not be allowed to make health or nutrition claims under the proposed legislation, unless the claim refers to a reduction in alcohol or energy content (calories). This is because the over consumption of alcohol is associated with health problems that the EU and Member State authorities are working to reduce or eliminate, and therefore alcohol should not be promoted on the basis of its nutritional properties.
Will any health and nutrition claims be completely banned?
Yes. Information in labelling, marketing or advertising about the nutritional or health benefits of foods which is not clear, accurate or substantiated will not be permitted. In addition, claims referring to rates or amounts of weight loss, as well as claims referring to recommendations of individual doctors will be banned. Health claims on alcoholic beverages above 1.2 % will also not be allowed, except those referring to a reduction in alcohol or energy content, due to the link between alcohol and other health and social problems.
Are there any benefits for the food industry in the new rules?
The Regulation has many benefits to offer the food industry. Firstly, it recognises the importance of a clear regulatory environment for the food industry, which will allow greater legal security and a more predictable environment for food operators. The new rules will also serve to support innovation, as manufacturers will be encouraged to develop food and drink products for which health and nutrition claims can genuinely be made. It is also a way of preventing unfair competition from unscrupulous manufacturers using false or misleading claims. It should be noted that health and nutrition claims are voluntarily put on products by producers as a marketing tool. If positive claims cannot be established, the Regulation does not oblige anyone to make negative claims about the product.
What measures will start to apply immediately from July 1st, and what provisions are subject to a transitional period?
From July 1 2007, certain measures are immediately effective e.g. the ban on alcoholic beverages carrying claims, except those referring to a reduction in energy or alcohol content.
Also, new products put on the market must respect the conditions for nutritional claims which are set out in detail in the Annex of the Regulation e.g. the can only be labelled low fat if the product contains less than 3g of fat per 100g or 1.5g of fat per 100ml. Products already labelled or on the market before January 2007 may remain on the market with the old labels until January 2010. During this time, Member States can submit new claims that they want added to the Annex. From 2010, only nutritional claims included in the EU Annex will be allowed to be used.
Nutritional profiles will take 2 years to set – one year for an EFSA evaluation and one year for agreement with Member States through Comitology. Once they have been set, there will be another 2 year period before they begin to apply, to allow operators time to adjust.
For health function claims, Member States have one year to submit health claims they would like included in the EU positive list. It will take another 2 years after that for EFSA to evaluate these claims, and for a Comitology decision to be taken on a final list that can be used. This 3 year period will allow operators sufficient time to adapt to the new EU requirements.
The Commission will propose the same transitional period for the use of claims referring specifically to children's development and health. This proposal will be sent to the European Parliament and Council for adoption.
With regard to trade marks, existing brand names which suggest health benefits but do not meet the requirements of the Regulation must be entirely removed from the market within 15 years. This timeframe was considered to be a reasonable period for companies to make the necessary adjustments and changes to their branding.
See also: 28 June 2007 HEALTH CLAIMS - New rules on Health Claims and Fortified Food begin to apply