Presidential Decree No. 57 implementing Directive 99/21/EC on dietary foods for special medical purposes. Country/Territory Italy Document type Regulation Date 2002 Source FAO, FAOLEX Subject Food & nutrition Keyword Food quality control/food safety Nutrition Packaging/labelling Special dietary uses Standards Geographical area Alps, Europe, Europe and Central Asia, European Union Countries, Mediterranean, Southern Europe Abstract 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. Full text Italian Website www.parlamento.it References - Legislation Implements Legislative Decree No. 111 implementing Directive No. 89/398/EEC on foodstuffs intended for particular nutritional uses. Legislation | Italy | 1992 Keyword: Food quality control/food safety, Standards, Special dietary uses, International trade, Packaging/labelling, Offences/penalties Source: FAO, FAOLEX Commission Directive 1999/21/EC on dietary foods for special medical purposes. Legislation | European Union | 1999 Keyword: Food quality control/food safety, Packaging/labelling, Special dietary uses Source: FAO, FAOLEX Amended by Decree implementing Directive 2006/141/EC as regards the amendments to Directive 1999/21/EC on dietary foods for special medical purposes. Legislation | Italy | 2007 Keyword: Food quality control/food safety, Special dietary uses, Food additives, Standards Source: FAO, FAOLEX