Masterstudiengang "Drug Regulatory Affairs"
Master-Thesis
The New Regulatory Framework for Health Claims in the Eurpean Union Impact on the Demarcation of Food to Medicinal Products? ***
Jörg Cselovszky (Abschlußjahr: 2007)
Language: English
On 30 December 2006, the new European Regulation (EC) No. 1924/2006 on nutrition and health claims made on foods was published. This Regulation was re-published in its corrected form (corrigendum) on 18 January 2007, amending the originally published legal text from 30 December to reflect finally the agreed Regulation. It came into force on 19 January 2007 and applies since 01 July 2007. For implementation of this Regulation various transitional measures are put in place.
This new Regulation puts in place EU wide harmonised rules for the use of nutrition and health claims in labelling, presentation and advertising of foods to the final consumer. It aims to ensure that any nutrition and health claim made is clear, accurate and scientifically substantiated and thus to protect consumers from misleading or false claims. It further aims to promote and protect innovation in the food sector and to ensure fair competition in the food sector.
Finally, only nutrition and health claims which are in conformity with the provisions of this Regulation will be allowed for foods placed on the market within the EU and delivered as such to the final consumer. However, for its full implementation further steps are needed such as the development of nutrient profiles, the establishment of the Community list of permitted health claims and the Community Register. In addition an amendment of Regulation No. 1924/2006 is under preparation in order to adopt transitional measures for health claims referring to childrens development and health and to implement a reference to the new regulatory procedure with scrutiny. Guidance will be developed for the interpretation of some aspects of the Regulation such as comparative claims and for distinction between the various types of claims.
Finally, only nutrition and health claims which are in conformity with the provisions of this Regulation will be allowed for foods placed on the market within the EU and delivered as such to the final consumer. However, for its full implementation further steps are needed such as the development of nutrient profiles, the establishment of the Community list of permitted health claims and the Community Register. In addition an amendment of Regulation No. 1924/2006 is under preparation in order to adopt transitional measures for health claims referring to childrens development and health and to implement a reference to the new regulatory procedure with scrutiny. Guidance will be developed for the interpretation of some aspects of the Regulation such as comparative claims and for distinction between the various types of claims.
It clearly has an impact on the demarcation of food versus medicinal products due to the establishment of the category of reduction of disease risk claims under Regulation No. 1924/2006 and further by the authorisation of health claims under food legislation (important in relation to product presentation to be considered as one criteria for classification of products).
All overall, the new Regulation No. 1924/2006 is an important step forward and offers a lot of new opportunities for industry, consumers and authorities - but also various challenges. The future will show if the rules as defined, are appropriate to ensure that the goals of this new legislation will be reached.
Pages: 52
All overall, the new Regulation No. 1924/2006 is an important step forward and offers a lot of new opportunities for industry, consumers and authorities - but also various challenges. The future will show if the rules as defined, are appropriate to ensure that the goals of this new legislation will be reached.
Pages: 52