Draft EU Regulations for Infant Formula and Special Foods


Posted By: Selerant RSA

 

The European Commission has published the latest drafts of the Delegated Regulations supplementing 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.

Pursuant to Article 11(1) of Regulation (EU) No 609/2013, the European Commission had to prepare the Delegated Regulations supplementing Reg. 609/2013 as regards the specific compositional and information requirements for: a)  infant and follow-on formula, b) cereal-based food and baby food, and c) for food for special medical purposes.

Rules for these food categories are currently laid down by Directive 2006/141/EC, Directive 2006/125/EC and Directive 1999/21/EC, respectively, all adopted under the repealed framework of Directive 2009/39/EC and shall all be repealed from the date of application of the delegated acts

The Changes

More specifically, the changes include:

  • Draft Commission Delegated Regulation 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 (See here)

Regarding compositional criteria, the new draft regulation requires some changes in the micronutrients limits as well as the mandatory addition of DocosaHexaenoic Acid (a ω-3 fatty acid) to all formulae. With respect to labeling, some changes are proposed in order to align with the new Labeling rules laid down by Regulation (EU) No 1169/2011.

  • Draft Commission Delegated Regulation supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for processed cereal-based food and baby food (See here)

The draft delegated regulation incorporates the requirements laid down by the current Directive as well as some modifications for alignment with the new labeling framework. The Annex with the daily reference intakes is also updated in order to be consistent with the rules for infant and follow-on formulae.

  • Draft Commission Delegated Regulation 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 (See here)

With respect to compositional requirements only few changes are introduced for the food for special medical purposes for infants. Regarding labeling, the draft rules require the increase of certainty on the intended use of the products. It is also proposed to forbid health and nutrition claims to be made on this type of foodstuffs given that they are supposed to be used under medical supervision and that they should not be advertised directly to consumers.

Entry into force

The new rules shall fully apply 4 years after the entry into force, allowing food businesses to adapt to the new requirement.

Final date for comments is Tuesday, 18 August 2015. The delegated acts are expected to be adopted in September 2015.