MIL-OSI Europe: Answer to a written question – Harmonisation of nutritional composition and labelling requirements for young child formula in the EU – E-000696/2025(ASW)

Regulation (EU) No 609/2013[1] regulates a limited number of categories of food that constitute a partial or sole source of nourishment for certain population groups and that are vital for the management of certain conditions and/or are essential to satisfy the nutritional requirements of certain clearly identified vulnerable population groups. Also, foods intended to replace the whole of the daily diet are covered as total diet replacement for weight control.

Article 12 of that regulation requires the Commission to analyse in a report, after consulting the European Food Safety Authority (EFSA), the necessity, if any, of special provisions for milk-based drinks and similar products intended for young children.

The report[2], adopted by the Commission in 2016, concludes that there is no need for specific rules for this category of foods as the correct and complete application of existing measures of EU food law seems sufficient to adequately regulate the composition of young-child formulae and the communication on the characteristics of the products.

In particular, the report notes that there is no reported safety issue with regard to young-child formulae and refers to EFSA’s opinion[3] whereby these products have ‘no unique role’ and ‘cannot be considered as a necessity to satisfy the nutritional requirements of young children’ when compared to other foods that may be included in their normal diet.

In light of the Better Regulation principles and the rules on the internal market, the Commission does not intend to propose the adoption of specific rules on young-child formula.

• [1] 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, OJ L 181, 29.6.2013, p. 35.
• [2] Report from the Commission to the European Parliament and the Council on young child formulae, COM(2016) 169 final.
• [3] Scientific Opinion on nutrient requirements and dietary intakes of infants and young children in the European Union, https://www.efsa.europa.eu/en/efsajournal/pub/3408