Delegated regulation 2016/127 - Supplement to Regulation 609/2013 as regards the specific compositional and information requirements for infant formula and follow-on formula and as regards requirements on information relating to infant and young child feeding - Main contents
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Commission Delegated Regulation (EU) 2016/127 of 25 September 2015 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for infant formula and follow-on formula and as regards requirements on information relating to infant and young child feeding| Legal instrument | delegated regulation |
|---|---|
| Number legal act | Delegated regulation 2016/127 |
| CELEX number i | 32016R0127 |
| Document | 25-09-2015; Date of adoption |
|---|---|
| Publication in Official Journal | 02-02-2016; OJ L 25 p. 1-29 |
| Effect | 22-02-2016; Entry into force Date pub. +20 See Art 14 22-02-2020; Application See Art 14 22-02-2022; Application Partial application See Art 14 And 32021R0572 |
| End of validity | 31-12-9999 |
2.2.2016 |
EN |
Official Journal of the European Union |
L 25/1 |
COMMISSION DELEGATED REGULATION (EU) 2016/127
of 25 September 2015
supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for infant formula and follow-on formula and as regards requirements on information relating to infant and young child feeding
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (1), and in particular Article 11(1) thereof,
Whereas:
(1) |
Commission Directive 2006/141/EC (2) lays down harmonised rules on infant formula and follow-on formula in the framework of Directive 2009/39/EC of the European Parliament and of the Council (3). |
(2) |
Directives 2009/39/EC and 2006/141/EC are repealed by Regulation (EU) No 609/2013. That Regulation lays down general compositional and information requirements for different categories of food, including infant formula and follow-on formula. The Commission has to adopt specific compositional and information requirements for infant formula and follow-on formula, taking into account the provisions of Directive 2006/141/EC. |
(3) |
Infant formula is the only processed foodstuff which wholly satisfies the nutritional requirements of infants during the first months of life until the introduction of appropriate complementary feeding. In order to safeguard the health of those infants, it is necessary to ensure that infant formula is the only product marketed as suitable for such use during that period. |
(4) |
The essential composition of infant formula and follow-on formula must satisfy the nutritional requirements of infants in good health as established by generally accepted scientific data. |
(5) |
Infant formula and follow-on formula are sophisticated products that are specially formulated for a vulnerable group of consumers. In order to ensure the safety and suitability of such products, detailed requirements should be laid down on the composition of infant formula and follow-on formula, including requirements on energy value, macronutrient and micronutrient content. These requirements should be based on the latest scientific advice of the European Food Safety Authority (‘the Authority’) in its opinion on the essential composition of infant and follow-on formulae (4). |
(6) |
In order to ensure innovation and product development, the voluntary addition to infant formula and follow-on formula of ingredients not covered by specific requirements of this Regulation should be possible. All ingredients used in the manufacture of infant formula and follow-on formula should be suitable for infants and their suitability should have been demonstrated, when necessary, by appropriate studies. It is the responsibility of food business operators to demonstrate such suitability and of national competent authorities to consider, on a case-by-case basis, whether this is the case. Guidance on the design and conduct of appropriate studies has been published by expert scientific groups such as the Scientific Committee on Food, the UK Committee on the Medical Aspects of Food and Nutrition Policy, and the European Society for Paediatric Gastroenterology, Hepatology and Nutrition. Such guidance should be taken into consideration in... |
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