In general, the results of clinical trials, when presented in advertising, would be considered health claims. Health claims require authorisation by the European Commission after a scientific assessment by EFSA. Like a driving license, you have to pass an exam before driving, even if you are a very skilled driver. On the other hand, several health claims (mainly listed in Reg. (EU) 432/2012) have been authorised and can be used by all food businesses, as long as the relevant food products meet the conditions of use specified in the regulations. There are instances in which results of clinical trials can be used, but they are specific and do not concern communication of health benefits to consumers.
No, health claims on botanicals are permitted under transitional measures in article 28 of Regulation (EC) No 1924/2006. However, Member States may take different views on applying these transitional measures.
No health claims on probiotics have been authorised. The term “probiotic” is now permitted or tolerated, in several Member States, although rules are still changing. Italy considers that the claim “helps with the balance of the microbiota” is not a health claim, and can be used on labels of food supplements.
No, there are no other national provisions in Europe comparable to the Italian guidelines. However, there is the possibility to exploit claims whose evaluation by EFSA was blocked years ago (“pending” claims) as long as they comply with the general requirements set out in the claim Regulation and are supported by scientific evidence. The use of pending health claims can be a great opportunity for operators, but compliance with the conditions and scientific consistency must be verified.
Aesthetic effects such as skin elasticity do not fall within the application of Regulation (CE) 1924/2006 on claims. Beauty claims can be communicated as voluntary information when the company can scientifically substantiate the effects stated and communication is related to aesthetic effects only. However an accurate and expert regulatory assessment should be performed on a case by case basis.
