Commission Adopts Union List of EU Permitted Health Claims
Food manufacturers will have a period of 6 months to adapt their practices to the new requirements. As from the beginning of December 2012 all claims that are not authorised and not on hold/under consideration shall be prohibited.
17 May 2012 --- The EU Union list of 222 permitted generic health claims has been approved by the European Commission. The Commission noted in a statement that, “this list is based on sound scientific advice, will be used throughout the EU and will also help to remove misleading claims from the market before the end of the year.”
John Dalli, Commissioner in charge of Health and Consumer Policy, said: "Today's decision is the culmination of years of work and marks a major milestone in regulating health claims on food. The EU-wide list of permitted health claims will be available on-line and will allow consumers everywhere in the EU to make an informed choice. Non-scientifically backed claims will have to be removed from the market after a short transition period." The list also provides legal clarity to food manufacturers on the health claims they can or cannot make. The administrative burden will also be reduced, since all enforcement authorities will from now on be able to rely on one list of authorised health claims and their conditions of use to verify if a claim is misleading or not.
Commissioner Dalli added: "Some work remains to be done and the Commission – with the needed scientific background - will now focus on concluding its work by tackling those claims which are still under consideration."
Claims for which the authorisation process is complete will be listed in the Union Register of nutrition and health claims made on foods, as required by Regulation (EC) No 1924/2006 on nutrition and health claims made on foods. This Union Register is an interactive database and is on the Commission's website.
Food manufacturers will have a period of 6 months to adapt their practices to the new requirements. As from the beginning of December 2012 all claims that are not authorised and not on hold/under consideration shall be prohibited.
This Commission Regulation implements Regulation (EC) No 1924/2006 on nutrition and health claims made on foods, in particular Article 13(3). Member States submitted lists of about 44,000 health claims in 2008, which were consolidated by the Commission into a list of some 4,600. By 2010 these claims were sent to the European Food Safety Authority (EFSA) which conducted a scientific assessment of whether the claims could be substantiated. EFSA finalised its main body of work for all health claims other than those on botanical substances in June 2011. Member States agreed to authorise the claims listed in the Annex to this Commission Regulation during the Standing Committee on the Food Chain and Animal Health of 5 December 2011. Both the European Parliament and the Council considered this list under the scrutiny period, which ended with no objections on 27 April 2012.
The list adopted by the European Commission contains 222 claims, representing nearly 500 entries from the consolidated list. More than 1600 of these entries will not be authorised. For the rest, the authorisation process is in the process of being finalised. It is the responsibility of the Member States' authorities to enforce the rules on health claims.
The European food manufacturer group FoodDrinkEurope welcomed the official adoption by the European Commission of the list of permitted Article 13.1 health claims. The list is expected to be published shortly in the Official Journal of the European Union and has already been included in the Union Register, available on the DG Sanco website.
“FoodDrinkEurope welcomes the publication of this European-wide list as it provides Europe's food and drink industry with the legal clarity required. Consumers can now be confident that all claims made on products have been approved for use and are based on solid scientific evidence. “However, improvements are still needed to the way in which the Health Claims Regulation is applied. FoodDrinkEurope calls on the European Food Safety Authority (EFSA) to improve dialogue with applicants and provide clarity on the information needed to fully substantiate a health claim. Food manufacturers believe that improvements need to be made to the way that the Claims Regulation is applied and look forward to continuing to work together with the Commission and other stakeholders constructively in this respect,” the group said in a statement.
The European Federation of Associations of Health Product Manufacturers (EHPM) said that the list of rejected Article 13.1 claims published today alongside the permitted list in the Union Register of the European Commission is premature in light of the controversy surrounding the criteria used for their assessment,
EHPM said that it does not object to the publication of a list of permitted claims per se. However, it said that given that the criteria used for the assessment of many non-authorised claims are not appropriate for nutrition science, there should not be a rejected list in the Union Register at this time.
The organisation also highlighted that it still awaits the decision of the European Ombusdman regarding its complaint judged valid for consideration, which argues that the assessment of Article 13.1 claims is not in accordance with the requirements of the EU Nutrition and Health Claims Regulation.
