Health claims in Europe: new legislation and PASSCLAIM for substantiation.

A regulation on nutrition and health claims made on foods was introduced in the European Union in 2007. This Regulation provides opportunities for the use of health claims on foods in Europe, including reduction of disease risk claims. The Regulation will be fully implemented by January 2010. A community list of permitted and rejected claims will be established and made available to the public. Some European countries have applied voluntary codes of practice on health claims for foods, awaiting the Regulation. Experience with scientific evaluation and use of health claims has been gained using these codes with regard to both generic claims that are closely related to official nutrition recommendations and to product-specific claims based on human intervention studies with the product. The European Commission supported a concerted action project, "Process for the Assessment of Scientific Support for Claims on Foods" (PASSCLAIM). This project reviewed the scientific state of the art in diet and health areas regarded most likely for health claims. The main purpose of the PASSCLAIM project was to define a set of generally applicable criteria for the scientific substantiation of health claims. These criteria were considered to be a scientifically robust tool for evaluating the quality of the data submitted in support of health claims on foods. PASSCLAIM is useful in assisting applicants for a health claim to prepare their supporting dossiers as well as in aiding agencies responsible for evaluating the scientific evidence for the claim.