Food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control

2011/0156(COD)

PURPOSE: to draw up new rules for food intended for vulnerable population groups, such as infants and young children.

LEGISLATIVE ACT: 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 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

CONTENT: the Regulation replaces Directive 2009/39/EC on foodstuffs intended for particular nutritional uses, as well as a certain number of Commission acts implementing that Directive. It establishes compositional and information requirements for the following categories of food:

  • infant formula and follow-on formula;
  • processed cereal-based food and baby food;
  • food for special medical purposes;
  • total diet replacement for weight control.

The Commission may decide, by means of implementing acts, whether a given food falls within the scope of this Regulation and, if so, to which specific category of food a given food belongs.

In order to ensure a high level of health protection in relation to the persons for whom the food is intended, the precautionary principle as set out in Regulation (EC) No 178/2002 shall apply.

The Regulation also establishes a single Union list of categories of substances (such as vitamins, minerals, amino-acids or others) that are permitted to be added to the categories of food covered by this Regulation.

General and specific requirements: the Regulation stipulates the general compositional and information requirements for categories of food covered by the Regulation. Food referred shall not contain any substance in such quantity as to endanger the health of the persons for whom it is intended.

For substances which are engineered nanomaterials, compliance with the requirements shall be demonstrated on the basis of adequate test methods, where appropriate.

The labelling, presentation and advertising of foods shall provide information for the appropriate use of such foods, and shall not mislead, or attribute to such foods the property of preventing, treating or curing a human disease, or imply such properties.

The Commission is empowered to adopt, by 20 July 2015, delegated acts laying down the specific compositional or information requirements for each category of food. The specific requirements concern, among other things, the use of pesticides on products as well as pesticide residues in these foodstuffs.

Infant formulae and follow-on formulae: the Regulation stipulates that the labelling, presentation and advertising of infant formula and follow-on formula shall be designed so as not to discourage breast-feeding. Nor should they include pictures of infants, or other pictures or text which may idealise the use of such formulae.

Milk-based drinks for young children, foods for sportspeople: these are excluded from the scope of the new rules. However, the Commission, after consulting the European Food Safety Authority, shall present, before 20 July 2015, a report on the necessity, if any, of provisions for food intended for sportspeople.

Gluten-free or very low gluten or lactose: the current rules on the use of “gluten-free” and “very low gluten” shall be governed by the provisions of Regulation (EU) No 1169/2011on food information to consumers. The same applies in regard to the rules governing the absence or reduced presence of lactose in food.

Technical guidelines: the Commission may adopt technical guidelines to facilitate compliance by food business operators, in particular SMEs, with this Regulation.

ENTRY INTO FORCE: 19/07/2013.

DELEGATED ACTS: the Commission is empowered to adopt delegated acts in order to take into account technical progress, scientific developments or consumers’ health. The power to adopt such acts is conferred on the Commission for a period of five years starting on 19 July 2013. The delegation of power shall be tacitly extended for periods of an identical duration unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. Should the European Parliament or the Council object to it, the delegated act does not enter into force.