The EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA Panel) has published two additional guidance documents for applicants who want to submit health claims for approval in the EU, and has also completed its further assessment of ‘general function’ health claims following submission of additional data by Member States.
The latest guidance documents give advice on the scientific requirements for the substantiation of health claims related to functions of the nervous system, including psychological functions, and those related to physical performance.
Specific issues addressed in the documents include: which claimed effects are considered to be beneficial physiological effects, and which studies/outcome measures are appropriate for the substantiation of function claims and disease risk reduction claims.
All of the guidance documents, which are based on the NDA Panel’s experience of evaluating claims, have been subject to public consultation and revised to take into account the comments received.
EFSA finalised its evaluations of all general function claims, other than those related to botanicals, in June 2011, having published a total of 341 opinions covering 2,758 claims. The European Commission and the Member States agreed that a limited number of these claims would be eligible for further assessment by EFSA, based on additional data submitted by Member States.
These included 74 claims related to micro-organisms, which the panel initially considered to be not sufficiently characterised, and 17 claims for which the NDA Panel concluded in its initial assessment that there was insufficient evidence to establish a cause and effect relationship between the consumption of the food and the claimed effect.
Source: EFSA
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