EFSA second batch of health claims 2010

In the latest batch of 31 opinions (grouped from 416 submissions) from EFSA’s NDA panel we can see that this process of assessment is setting a precedent for the acceptance of only vitamins and minerals. The big losers are not unexpected antioxidants and probiotic based claims which have been rejected across the board. For the industry this is scary especially for the likes of the superfruit / smoothie market and giants such as Innocent, known for their use of the term Antioxidant on marketing materials and commercial communications. The opinions relate not only to the lack of characterisation but in this batch many opinions negative due to a lack of association between the claimed effects in human clinical trials.

However, the few positives give hope to those in the blood pressure, sport, immune, and potentially for the first time the weight control markets. Vitamin D was given a positive opinion in relation to normal function of the immune system as well as normal muscular function. Potassium was gifted with claims such as; “maintenance of normal blood pressure”, and “normal muscular function”.

One of the most interesting areas gaining some positive views from EFSA was in relation to meal replacements for weight control. Claims approved included, “safe, effective & healthy weight loss; greater weight loss than with conventional calorie counting”, and “maintenance of weight loss”. However, these claims must be considered within the framework of Directive 96/8/EC.

The take home is that more damage will likely be reported in the mainstream press and for many companies this will mean PR in overdrive to reduce the commercial damage. The only way forward for those companies currently using such rejected claims (provided all opinions are adopted via EC) will be submissions via 13.5 or 13.4, which are more costly but give the applicant the opportunity to construct a more robust dossier in defence of their specific claims. Such a defence was never possible under 13.1 – 13.3 and this is a big reason for so many of the rejections.