This report meets the obligation set for the Commission by Regulation (EU) No 609/2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control "FSG Regulation").
The report examines the necessity, if any, of special provisions in terms of composition and labelling for milk-based drinks and similar products intended for young children. It is based on two scientific opinions by the European Food Safety Authority (EFSA), a market study carried out for EFSA and extensive consultation with national competent authorities and interested parties.
The market for young child formulae in the EU: young-child formulae are not defined in EU legislation. They can be described as specifically processed/formulated protein-based drinks intended to satisfy the nutritional requirements of young children aged 1-3 years.
The market in young-child formulae experienced growth in almost all the countries reviewed in the period 2008-2012. In 2012, retail market size can be estimated to more than 42 000 tonnes and retail market value to more than EUR 500 million. While the number of manufacturers is small, EU manufacturers are leaders in the global scene.
The report arrives at the following conclusions:
EFSA’s advice: the European Food Safety Authority issued scientific advice on young child formulae in 2013, stating that young-child formulae are one of the means to increase n-3 polyunsaturated fatty acids, iron and vitamin D intakes of infants and young children (these were identified by EFSA as nutrients, together with iodine, at risk of inadequacy for some infants and young children in the EU).
According to EFSA, however, no unique role of young-child formulae can be identified, so they cannot be considered as necessary to satisfy the nutritional requirements of young children when compared with other foods that may be included in their normal diet.
In its opinion of 26 June 201429, EFSA noted, in addition, that formulae consumed during the first year of life can continue to be used by young children and therefore, it did not consider it necessary to propose specific compositional criteria for young child formulae.
No safety issues: the report notes that the composition of young-child formulae is varied. However, the content of different nutrients in these products is generally within the ranges of permitted concentrations in follow-on formulae. There is no reported safety issue with respect to these products. However, some young-child formulae may contain substances (e.g. sugars, flavours) in amounts that are generally not recommended for young children. Others may lack the nutrients identified by EFSA as being at risk of inadequate intake for young children.
The Commission considers that the correct and complete application of the general framework of EU food law seems sufficient to adequately regulate the composition of young-child formulae (e.g. food additives, addition of vitamins and minerals or use of novel substances) and the communication on the characteristics of the products (e.g. food information, nutrition and health claims).
Forecast for post-2016: after 20 July 2016, the situation will evolve in those Member States that today classify young-child formulae as dietetic foods as a consequence of the repeal of Directive 2009/39/EC, which provides that, as a general requirement, the nature or composition of the products ‘shall be such that the products are appropriate for the particular nutritional use intended’.
As of this date, all young-child formulae in the market in the EU will be classified in the same way (normal foods fortified in certain nutrients) and will have to comply with the relevant existing horizontal rules of EU food law.
The Commission feels that it is not possible to foresee many developments after 2016, given that no concrete information exists on how operators or consumers will adapt to the new legal framework or on how Member States will react at national level to their inability to apply Directive 2009/39/EC. In any event, all draft national rules will be assessed by the Commission in order to verify compliance with EU law.