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Public consultation on the draft scientific opinion on the safety and suitability for use by infants of follow-on formulae with a protein content of at least 1.6 g/100 kcal

EFSA has launched an open consultation on its draft scientific opinion on the safety and suitability for use by infants of follow-on formulae (FOF) with a protein content of at least 1.6 g/100 kcal.

For the scientific assessment, the NDA Panel considered: a) the dietary protein requirements of infants in the second half of the first year of life, b) the protein content of breast milk during the first year of lactation, c) dietary protein intake of infants in Europe from breast milk, formula and complementary food (CF), d) the overall contribution that a FOF with a protein content of 1.6 g/100 kcal could make towards protein requirements in the target population, assuming access to CF with a sufficient quality, following established feeding guidelines in Europe (e.g. from Member States), and e) the application submitted by the food business operator, including two intervention studies in healthy term infants.

The Panel concluded that the use of FOF with a protein content of at least 1.6 g/100 kcal from intact cow’s milk protein or goat’s milk protein otherwise complying with the requirements of relevant EU legislation is safe and suitable for infants living in Europe with access to complementary foods with a sufficient quality. This conclusion does not apply to infant formula (IF). The Panel also concluded that the safety and suitability of FOF with a protein content of at least 1.6 g/100 kcal manufactured from either protein hydrolysates or soy protein isolates cannot be established with the available data. The same conclusion applies to IF.

In line with EFSA’s policy on openness and transparency and in order for EFSA to receive comments from the scientific community and stakeholders, EFSA has launched a public consultation on the draft document developed by the NDA Panel of EFSA.

Interested parties are invited to submit written comments by 3 March 2017. Please use the electronic template provided to submit comments and refer to the line and page numbers. Please note that after 2 hours your working session will expire and comments submitted after that time will not be recorded and transmitted. If you would like to submit additional data to support your comments or files send an email to: NDA.PublicConsult.82 [at] efsa.europa.eu (NDA[dot]PublicConsult[dot]82[at]efsa[dot]europa[dot]eu). Please note that comments will not be considered if they:

  • are submitted after the closing date of the public consultation;
  • are not related to the contents of the document;
  • contain complaints against institutions, personal accusations, irrelevant or offensive statements or material;
  • are related to policy or risk management aspects, which are out of the scope of EFSA's activity.  

EFSA will assess all comments from interested parties which are submitted in line with the criteria above. The comments will be further considered by the relevant EFSA Panel and taken into consideration if found to be relevant.

All comments submitted will be published. Comments submitted by individuals in a personal capacity will be presented anonymously. Comments submitted formally on behalf of an organisation will appear with the name of the organisation.