Article 13 health claims: the EFSA evaluations
15 October 2009
The results of the European Food Safety Authority’s (EFSA) first series of article 13 health claims evaluations has been received with mixed feelings across the sector. Of the 94 EFSA scientific assessments summarising 523 health claims:
- less than one-third received a positive evaluation from EFSA, and these are limited to claims relating to basic functions of vitamins/minerals, dietary fibres and fatty acids for the maintenance of cholesterol levels, lactase contributing to the break down of lactose and sugar-free chewing gum for maintenance of dental health.
- more than two-thirds of the article 13 claims data analysed received a negative EFSA evaluation. This included data on a wide range of probiotics, herbal extracts, other ingredients and some vitamins and minerals, many of which have an important role in the present marketing of food supplements in the EU. For example, all joint maintenance claims for glucosamine, chondroitin sulphate, MSM, hyaluronic acid, EPA/DHA/DPA, shark cartilage and green lipped mussel extract were rejected. And not one of the probiotic or herbal extract claims submissions analysed in these first series was deemed sufficient by EFSA to provide a positive evaluation.
This raises the question of why there have been so many negative evaluations on similar categories of substances or types of claims all in one go. Indications from EFSA are that its NDA Panel chose this first series based on ease of decision: those for which a positive evaluation was easier to adopt (e.g. vitamins and minerals), and those for which EFSA realised lacked the sufficient characterisation (or other) data for it to perform a detailed claims assessment.
Almost half of the negative evaluations owed to a lack of characterising information on the substance on which the claim is based, rather than the evidence presented to support the claim itself. In many of these cases EFSA concluded that “a cause effect relationship has not been established”, even though EFSA was only unable to characterise the substance, and therefore did not go further to evaluate the evidence.
Some Member States have questioned why EFSA had not requested further information from them or the European Commission at an earlier stage to clarify key elements of submissions, as it had done for other claims. The significant negative outcome of this first series of assessments should not, however, be seen as fully indicative for the next series expected in February 2010. This second batch will include further evaluations on vitamins, minerals, certain plant substances and probiotics. However, it demonstrates clearly that few claims are now expected to make it through the process unscathed.
The European Commission intends to issue two lists of claims at some point after the EFSA assessment batches:
- A list of authorised article 13 health claims and their conditions of use.
- A list of non-authorised article 13 health claims, also to be included in the Community Register of claims.
The Commission has indicated that it intends to submit a proposal for a first partial Community Register to the Standing Committee for a potential vote at the end of January 2010. Should the Standing Committee adopt the text, a three-month scrutiny procedure by the European Parliament would follow. If the register is finally adopted, the Commission has indicated that claims included in the negative list will be given a six-month transition period before they need to be withdrawn from products on the market.
It is clear that this will have a significant impact on the currently established EU food supplement market, and it will have serious business and consumer consequences. Companies with claims included in the list of non-authorised claims may need to consider preparing an article 13.5 dossier as a second attempt towards achieving approval – a time-consuming and costly exercise, with still no guarantee of success.
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