Masterarbeit

The new European Health Claims Regulation establishing a List of permitted Health Claims: Questions around its Application and the current State of Discussion to the “Claims on Hold” and to the “Botanicals” as well as a comparative

Claudia Callies-Klüpfel (2013)

Summary

Language: English

On 16 May 2012 a list of 222 permitted health claims has been approved by the Commission per Regulation EU 432/2012.The regulation is based on Art. 13.3 of Regulation1924/2006/EC. The focus of this list is mainly on vitamins and minerals to the disappointment of many business operators.

The high amount of rejected health claims is based on EFSAs standard for the scientific evaluation of health claims. Hence, as reason for the rejections EFSA declared predominantly the insufficient characterization of the food/food constituent and the insufficient scientific evidence.
With respect to the about 1,600 Health Claims on botanicals currently still on hold negative assessments are expected because in particular for these ones a cause and effect relationship between the consumption of botanicals and the beneficial physiological effect may not be demonstrated. Qualified clinical studies in healthy people are even more difficult to realize for botanicals. Thus, the Commission presented a discussion paper to invite the Member States to provide their opinion for 2 offered options regarding the evaluation of Health Claims on botanicals. With the presented Option 2 a new approach would be introduced by justifying the evidence of a Health Claim based on “traditional use”. This new approach shall closely follow the requirements for the scientific assessment as applied for traditional medicinal products. But this proposal is to perceive critically, in particular regarding the fact that the most of the health claims on botanicals are applied for botanicals which are used in both, medicinal product and food supplement.
All overall, too many difficulties and restrictions around the application of the Health Claims and different common understanding also in respect to the safety issues within the European Union still exist. Thus, a switch from a herbal medicinal to a botanical food supplement would not be attractive even if Option 2 was preferred by the Member States and the European Commission.
Possibly, the use of a disclaimer as commonly accepted in the USA would contribute to solve the problems with regard to the level of evidence of the substantiation of Health Claims.

Pages: 70, Annexes: pages :2