EU Health Claims Regulation Published

Today, a new Commission Regulation (EU) No 432/2012 establishing a list of permitted health claims for use on foods (other than those referring to the reduction of disease risk and to children’s development and health) has been published in the Official Journal (“Health Claims Regulation”). The Health Claims Regulation will apply from 14 December 2012. After this date, only health claims that are on the Community approved list will be permitted. This transitional period is intended to give the food industry time to adapt to the fact that claims not on the positive list will no longer be allowed.

The rules will be directly applicable to all food business operators in the EU and it will be the responsibility of the national authorities to enforce them. Anyone will be able to use the approved claims provided their conditions of use are met. Some flexibility with the wording of claims will be allowed provided those adjusted claims have the same meaning for consumers as the listed permitted health claims and they are not misleading.

The Health Claims Regulation’s positive list contains 222 authorised ‘general function’ health claims (e.g. ‘calcium is needed for the maintenance of normal bones’) and the conditions under which they can be used on foods in the EU. These are health claims, other than those referring to the reduction of disease risk or to children’s development and health, which are based on generally accepted scientific evidence and are well understood by the average consumer. The draft Regulation originally proposed 224 health claims but, following discussions in December 2011, two were removed.

Whilst this sounds like a large number of authorised claims, it is important to remember that the European Food Safety Authority (“EFSA”) reviewed a consolidated list of over 2,700 claims that had been submitted by member states. Those health claims that did not receive a favourable scientific assessment from the EFSA are not included in the positive list of authorised claims. These non-authorised claims will, however, be entered in the ‘Union Register’ with reasons why they have not been authorised, together with all the authorised claims and their conditions of use.

The EFSA has been widely criticised by the food industry for applying disproportionate scientific standards to assessing health claims and providing insufficient guidance. The majority of the claims (e.g. for probiotics) have been rejected due to substantiation issues.
Health claims (apart from claims referring to the reduction of disease risk or to children’s development and health) can be classified under 4 broad headings:

1. Authorised claims: These permitted claims are listed in the Health Claims Regulation and will also be included in the ‘Union Register’ together with their specific conditions of use.
2. Non-permitted claims: These claims will be inserted into the ‘Union Register’ making it clear why they are not authorised. After 14 December 2012 they will be considered as non-compliant and prohibited under the Health Claims Regulation.
3. ‘On hold’ claims: Certain claims (e.g. botanicals, caffeine) have been put ‘on hold’. These claims can continue to be used until an authorisation decision is taken provided they comply with the conditions laid down in the Nutrition and Health Claims Regulation 1924/2006 and existing applicable national provisions.
4. Non-specific health claims (e.g. ‘helps keep you healthy’ or ‘improves vitality’): These claims will not be allowed unless they are accompanied by a specific approved health claim from the Community list. Areas of uncertainty still remain for industry, including in the making of factual statements about the presence of an ingredient. For example, in relation to a statement such as ‘contains Bifidobacterium’ there have been various views that it could be a statement about an ingredient, a nutrition claim, an implied health claim or an explicit health claim depending upon the target audience and the context in which it is presented.

As the Health Claims Regulation will apply from 14 December, companies are advised to take action now to prepare amendments to their labelling and advertising if a health claim they currently use is not on the positive list. Enforcement activity on such claims has been fairly lenient up until now but there is likely to be a period of greater enforcement action once the final rules are in force.

Whilst this is a big constraint for companies promoting “rejected” health claims, the Health Claims Regulation provides opportunities for all companies to use approved health claims in line with the recommended specific conditions of use in promoting their products without needing to submit a dossier.

A copy of the legislation can be found here.