The Parma-based agency – which is assessing all health claims submitted under the EU’s Nutrition & Health Claims Regulation – published 808 opinions on 19 October of which just 75 were positive. This translated to a success rate for the industry of just 9 percent.
Once again, most of the successful claims related to essential vitamins and minerals, though there were also positive opinions relating to dietary fibers and blood glucose control, bowel function and weight management. Claims linking fatty acids to brain function, vision and heart health, and live yogurt cultures with lactose digestion, also received the thumbs-up.
The latest batch of Article 13.1 opinions – the third to be published so far – takes to 1,745 the number of claims EFSA has assessed out of the 4,637 submitted by member states for inclusion on the so-called ‘Community List’ of general function claims, which are to be made available for any company to use. The vast majority of claims assessed so far have been rejected. There will be one further batch – in June 2011 – at which point the European Commission will begin the process of writing all of the EFSA opinions into law.
In a statement regarding the latest batch, EFSA said: “EFSA’s NDA Panel issued unfavorable opinions on many of the claims in this series due to the poor quality of the information provided to EFSA.
“Information gaps included for instance: inability to identify the specific substance on which the claim is based (eg claims on dietary fiber without specifying the particular fiber); lack of evidence that the claimed effect is indeed beneficial to the maintenance or improvement of body functions (eg claims on renal ‘water elimination’); lack of precision regarding the health claim being made (eg claims referring to terms such as ‘energy’ and ‘vitality’); or lack of human studies with reliable measures of the claimed health benefit.”
Trade body the European Federation of Associations of Health Product Manufacturers (EHPM) said it was not surprised by the general outcome of the latest batch. “The general trend that was observed with the two previous batches is confirmed: Many claims on vitamins and mineralswere favorably assessed, while most claims on ‘other substances’ were granted a negative opinion.
“This batch also contains a number of opinions rejecting a number of claims because the health effects or the substances are not sufficiently defined, or the effect is judged to fall out of the scope of the Article 13 list. While this may be justified, it is a sign of the lack of guidance in this process that has left many companies unaware of the requirements of the Article 13 list process and has resulted in submissions that are not adapted to the current EFSA evaluation.”
EFSA said it would “pursue its dialogue with stakeholders to further explain how it is carrying out its work and to provide applicants with more detailed information on the preparation of health claims applications”. The agency is to stage a series of claims-specific technical seminars, with the first – on the subject of gut and immune health – set to take place on 2 December.
To see all of the opinions in detail, click here: http://www.efsa.europa.eu/cs/Satellite.