Di Renzo Regulatory Affairs
Pills
Dietetics

The availability of dietetic products allows or makes it easier for individuals who have certain intestinal absorption conditions or who have a disturbed metabolism or who are in a special physiological condition, to satisfy their nutritional needs. Such conditions can also be consistent with a good state of health, as in the case of sportsmen, indicated by the provision as a category of possible users of dietetic products.  The definition of “dietetics” is not allowed for products intended for babies and for infants that are in good health.

Food supplements have been regulated at a community level by directive 2002/46/CE and adopted in Italy by the legislative decree n. 169 of the 21st of May 2004. Regarding enriched foods a specific community provision is attended. Such foods have to meet particular criteria for the composition and for the labelling; moreover the manufacturing sites are subject to ministerial authorisation.  The legislation in this sector tends to expand and to continuously renew as a consequence of the constant attention given by the European Community and the EFSA (European Food Safety Authority) to food products, dietetics and to Health in general.

In this sector we provide the following services:

    • Legislation information concerning products for infants, food supplements, enriched foods, dietetic products (gluten free, low/free salt, for sportsmen, for diabetics, for special medical purposes)
    • Organise the procedures of notification to the Ministry of Health
    • Technical support on the conformity of the labelling, of the composition and of the claims
    • Adjustment to the European Regulation 1942/2006 regarding nutritional indications and health provided by food products
    • Organise graphic layout of labels through our graphics department and execution of a packaging design.