Fundamental reappraisal of claims process needed, says industry

The European Commission (EC) should undertake a discussion of the specificities and limitations of nutritional research and reappraise the claims evaluation process before rejecting claims based on EFSA opinions, three industry associations have said.

Commenting jointly on the fourth batch of claims opinions published by the European Food Safety Authority (EFSA) last week, European associations The European Federation of Associations of Health Product Manufacturers (EHPM), the European Responsible Nutrition Alliance (ERNA) and The European Botanical Forum (EBF) said that continued reliance in the assessment process on criteria which are unfeasible and inappropriate for the majority of claims, is contributing to the high number of negative EFSA opinions.

The groups stated that on initial evaluation of the latest batch of opinions, trends have remained consistent in EFSA's assessment criteria as compared to the third batch published last year, despite weaknesses in the approach.

The three associations again highlighted these weaknesses last month in a letter to

Basil Mathioudakis, head of the EC's food law unit.

These weaknesses include the discrepancy between the way in which the information has been compiled and presented and the way in which EFSA is carrying out its assessments; EFSA's almost exclusive reliance on randomized controlled trials demonstrating measurable and meaningful improvements of health (also called the pharmaceutical approach); and the way in which the claims legislation is being interpreted, which the groups believe is unduly restrictive making it impossible to acknowledge and assess a number of health effects.

They further addressed EFSA's focus on isolated food components, which they said often do not exist in isolation, rather than on foods; the expectation that evidence should show improvement rather than maintenance of physiological functions; the fact that the approach is biased towards effects on reductions of disease risk factors, leaving many more general health effects unaddressed; and the lack of no visible consideration of existing consensus and views or opinions of leading experts in the various research fields.

The groups urged the European Commission not to take decisions to prohibit claims on the basis of negative EFSA opinions, but to allow these claims to be resubmitted for evaluation based on an alternative and more appropriate approach to consider the totality and a weighing of the evidence to provide a balanced view on the strength, consistency and plausibility of health benefits of food components.