Posted on: 10/4/2012
Orla Clayton, Arthur Cox
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The European Commission has adopted a list of 222 EU approved health claims for use on foods, which are permitted for use in commercial communications to consumers. A number of other claims remain 'on hold' and will be the subject of further consideration.
Regulation 432 / 2012 (establishing the list of approved health claims) was published in the Official Journal on May 25, 2012 and came into effect on June 14, 2012. The list itself will come into effect six months later, on December 14, 2012. This means that food business operators in the European Union have between now and then to remove any of the claims which have been rejected by the Commission from any packaging, labeling and marketing materials attached to their products.
In July 2012 a trade association representing health food manufacturers, along with a number of UK and Dutch companies, challenged the Regulation in the European courts. They claim that by keeping certain claims on hold for further consideration, the Commission's actions lack transparency, are discriminatory and are not in accordance with good administration. They are also challenging the assessment criteria used to develop the list which they claim failed to ensure adequate collaboration with national food authorities lacks legal certainty and fails to satisfy the duty to give reasons.
Regulation 1924 / 2006 (on Nutrition and Health Claims made on Foods) provided that health claims under Article 13 were to be submitted to the European Food Safety Authority (EFSA) by January 31, 2008 so that the science behind each claim could be assessed and considered. Over 40,000 claims were submitted by Member States and were whittled down in to a consolidated list of 4,600 claims. The vast majority of claims have been rejected with the 222 permitted claims, which have been published in the Regulation, comprising the conclusion of that process. However, many claims are still on hold and under consideration and so, further additions to the permitted list of claims will be made on an ongoing basis. These health claims may continue to be used until EFSA's consideration is completed.
Examples of health claims which have been approved are "calcium contributes to normal muscle function" and "fluoride contributes to the maintenance of tooth mineralization". Manufacturers should be aware that the health claims can only be used in conjunction with specific conditions which are also detailed in the recently published Regulation.
The permitted health claims are available to be checked online, on the Community Register (http://ec.europa.eu/nuhclaim) as is a list of the claims rejected by EFSA. It is therefore possible for manufacturers to look at the permitted wording and the conditions on the use of a claim online.
Pursuant to Regulation 1924/2006, nutrition claims, i.e. claims which state, suggest or imply that a food has particular beneficial nutritional properties such as "source of protein" or "high fiber", can also be accessed on the Community Register. Claims relating to the reduction of disease risk and to children's development and health are outside the scope of the new Regulation. In addition, claims made in a non-commercial context, such as advice issued by public health authorities and bodies, are not caught.
The timeframe for compliance with the new Regulation is a challenging one. From December 14, 2012 on, products carrying claims, which have been rejected by EFSA would need to be withdrawn from the market (within the European Union). Therefore, much may rest on the speed at which the European courts can deliver judgment on the challenge to the Commission's decision. Ultimately, Member States will be responsible for enforcement. The precise means of enforcement are not yet clear.
Food business operators, operating in the European Union, should carefully check existing packaging, labeling and marketing materials to ensure that only approved claims are used and that they comply with the conditions for use as set down by EFSA, on the understanding that this issues is subject to determination of the European courts.
Orla Clayton is a senior associate with Arthur Cox in Dublin, Ireland. She is the chair of DRI International Young Lawyer Committee.