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Commission Delegated Regulation (EU) 2016/128 supplementing Regulation (EU) No. 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for food for special medical purposes.

Country/Territory
European Union
Document type
Legislation
Date
2015
Source
FAO, FAOLEX
Original source
Official Journal of the European Union L 25, 2 February 2016, pp. 30-43.
Subject
Food & nutrition
Keyword
Special dietary uses Standards MRL-maximum residue limit Packaging/labelling Food quality control/food safety Pesticides
Geographical area
European Union Countries
Entry into force notes
This Regulation shall apply from 22 February 2019, except in respect of food for special medical purposes developed to satisfy the nutritional requirements of infants, to which it shall apply from 22 February 2020.
Abstract

This Regulation establishes the nutritional and compositional requirements to be met by food for special medical purposes to be placed on the market. The formulation of food for special medical purposes shall be based on sound medical and nutritional principles. Its use, in accordance with the manufacturer's instructions, shall be safe, beneficial and effective in meeting the specific nutritional requirements of the persons for whom it is intended, as demonstrated by generally accepted scientific data. Maximum residue limits for pesticides in such food products are established too.

Full text
English
Website
eur-lex.europa.eu

References - Legislation

Implements

Regulation (EU) No. 609/2013 of the European Parliament and of the Council on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control.

Legislation | European Union | 2013

Keyword: Food quality control/food safety, Breastfeeding/infant food, Food additives, Special dietary uses, Standards, Nutrition

Source: FAO, FAOLEX

Repeals

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

Implemented by

Food for Specific Groups (Information and Compositional Requirements) (England) (Amendment) Regulations 2019 (S.I. No. 44 of 2019).

Legislation | United Kingdom | 2019

Keyword: Food quality control/food safety, Special dietary uses, Breastfeeding/infant food, Packaging/labelling, Offences/penalties, Nutrition

Source: FAO, FAOLEX

Cabinet Regulation No. 819 of 2018 on Procedures for Registration of Foods for Specific Groups and Procedures for Payment of the State Fee

Legislation | Latvia | 2018

Keyword: Breastfeeding/infant food, Business/industry/corporations, Nutrition, Public health, Registration, Royalties/fees, Special dietary uses, Food quality control/food safety

Source: FAO, FAOLEX

Food for Specific Groups (Information and Compositional Requirements) (Wales) (Amendment) Regulations 2020 (W.S.I. No. 92 (W. 14) of 2020).

Legislation | United Kingdom | 2020

Keyword: Food quality control/food safety, Breastfeeding/infant food, Food additives, Special dietary uses, Standards, Enforcement/compliance, Offences/penalties, Nutrition

Source: FAO, FAOLEX

Foods for Specific Groups (Medical Foods for Infants) and Addition of Vitamins, Minerals and Other Substances (Scotland) Amendment Regulations 2020 (S.S.I. No. 7 of 2020).

Legislation | United Kingdom | 2020

Keyword: Food quality control/food safety, Breastfeeding/infant food, Food additives, Special dietary uses, Standards, Offences/penalties, Nutrition

Source: FAO, FAOLEX

European Union (Food Intended for Infants and Young Children, Food for Special Medical Purposes, and Total Diet Replacement for Weight Control) Regulations 2019 (S.I. No. 425 of 2019).

Legislation | Ireland | 2019

Keyword: Food quality control/food safety, Special dietary uses, Classification/declassification, Standards, Packaging/labelling, Breastfeeding/infant food, Food additives, Residues, Inspection, Enforcement/compliance, Offences/penalties, Nutrition

Source: FAO, FAOLEX

Food Safety (Information and Compositional Requirements) (Amendment) Regulations (Northern Ireland) 2019 (S.R. No. 9 of 2019).

Legislation | United Kingdom | 2019

Keyword: Food quality control/food safety, Breastfeeding/infant food, Food additives, Special dietary uses, Packaging/labelling, Nutrition

Source: FAO, FAOLEX