Presidential Decree No. 57 implementing Directive 99/21/EC on dietary foods for special medical purposes.

This Presidential Decree lays down the compositional and labelling requirements to be met by dietary foodstuffs intended for special medical purposes, referred to in Annex I to Legislative Decree No. 111 of 27 January 1992. The above-said dietary foodstuffs must be safe and shall meet the special nutritional requirements of the persons for whom they are intended, in accordance with generally accepted scientific data and principles. Without any prejudice to article 4 of Legislative Decree no. 111, the labelling shall indicate full details of product identification as established by article 4. The manufacturer may place new dietary foodstuffs into the market only if a sample of the labelling has been previously forwarded to the Ministry of Health. In case of detection of harmful effects on human beings, the Ministry for Health shall apply the necessary measures as provided for in article 5, paragraph 4. Three Annexes, concerning essential components as well as values, are attached.