The European Commission recently adopted guidelines which clarify requirements under EU Regulations regarding the use of health claims and the provision of certain ‘mandatory information’ in the labelling, presentation and advertising of food. The Regulations have imposed a more restrictive regime regarding the use of health claims, with the result that claims such as ‘probiotic’ and ‘antioxidant’ are no longer permitted to be made in relation to foods. The recent controversy regarding the presence of horse meat in processed meat products is likely to result in greater scrutiny of the labelling, presentation and advertising of food. It would therefore seem worthwhile for those involved in the food industry to review their current practices in this regard to ensure that they are compliant with applicable laws, regulations and guidelines, including those in respect of health claims.
The use of nutrition and health claims on and in respect of food which is placed on the market in the EU is governed primarily by Regulation (EC) No. 1924/2006 (the “Regulation”). Nutrition claims and health claims are generally prohibited, unless they appear on a list of authorised claims and are made in accordance with the Regulation. For these purposes, ‘health claim’ is defined broadly and covers any message or representation, including words, statements, pictures, logos etc., which states, suggests or implies a relationship between food and health, other than a message or representation which is mandatory under Community or national law.
The list of authorised health claims is maintained by the European Commission, in consultation with the European Food Safety Authority (“EFSA”). In May 2012 the Commission adopted a list of 222 authorised health claims and identified various health claims which had been considered but rejected for want of scientific evidence substantiating the claim. The list of rejected claims includes, for example, ‘probiotic’ related claims, much to the disappointment of yogurt manufacturers such as Danone, who were obliged to cease making such claims in respect of their products when the list came into force in December 2012.
General principles applicable to health claims in the labelling, presentation and advertising of food are set out in Chapter II of the Regulation. These include requirements that health claims must not be false, ambiguous or misleading, that they must be based on and substantiated by generally accepted scientific evidence and that claims referring to the rate or amount of weight loss as a result of consuming certain foods may not be made. In addition to these general principles, specific conditions regarding the manner in which health claims may be made are set out in Article 10 of the Regulation. With a view to ensuring consistency in their interpretation by national authorities responsible for implementing the Regulation and clarifying their application for the benefit of food business operators, on 24 January 2013 the Commission adopted guidelines on the implementation of these conditions.
Under Article 10(2), there are up to four items of ‘mandatory information’ which must be included in the labelling of food, or where no such labelling exists, in the presentation and advertising of food. ‘Labelling’ is broadly construed to include all information relating to the food placed on packaging or other associated material delivered with the food to the final consumer, while advertising encompasses all promotion of the supply of food by a food business operator. The four items of ‘mandatory information’ are:
- a statement indicating the importance of a balanced diet and healthy lifestyle;
- the quantity of the food and the pattern of consumption required to obtain the claimed beneficial effect;
- where appropriate, a statement addressed to persons who should avoid the food; and
- where appropriate, a warning for foods that could be a health risk if consumed to excess.
The Guidelines clarify that Article 10(2) should be construed in light of a general principle, set out in Article 12 of Regulation (EU) 1169/2011 on the provision of food information to consumers, that consumers should always have the mandatory information available to them when making a decision about the purchase of food. As regards distance selling of food where a consumer cannot view some or all of the labelling, the mandatory information must be included in the presentation and advertising of the food (i.e. on the relevant website, catalogue, leaflet, etc). In relation to the latter two items of mandatory information, the application of which will vary according to the circumstances, the Guidelines emphasise that authorisation for the use of a particular health claim may be subject to additional restrictions regarding information to be provided to consumers, so food business operators should verify whether any such additional restrictions are mentioned in the relevant entry in the list of authorised health claims.
The Guidelines also clarify the interpretation of Article 10(3), which deals with references to general, non-specific benefits, such as “for a healthy diet” or “good for you”. While there is no need for general statements of health benefits to be authorised by the Commission, they must be accompanied by an authorised health claim and the relevant mandatory information. The accompanying authorised claim must bear some relevance to the general statement of health benefits. The Guidelines state that food business operators must be able to demonstrate the link between the authorised claim and the more general statement of heath benefit. They also confirm that in respect of health claims which were identified as not being authorised on the basis that they are too general, while such health claims may not be made pursuant to Article 10(2), they may be made as a general health claim under Article 10(3), provided that they are accompanied by an authorised health claim.