New guidance published by EFSA will assist applicants in preparing and presenting dossiers for authorisation of infant and/or follow-on formulae manufactured from protein hydrolysates. It will also help applicants in preparing dossiers to assess a product’s efficacy in reducing the risk of infants becoming allergic to milk proteins.
Regulatory rules dating back to 2006 were revised in 2016. The revision was based on scientific advice by EFSA on the need to establish the safety and suitability of each protein hydrolysate used in the manufacture of formula. EFSA had also advised that clinical studies be conducted to demonstrate a formula’s potential to reduce the risk of infants developing allergy to milk proteins.
What kind of data do applicants need to submit?
EFSA’s technical and scientific guidance details the type of data and information applicants need to provide. The required information should include:
- Characterisation of the hydrolysed infant or follow-on formulae, including a description of the manufacturing process;
- Information about the nutritional safety and suitability of the formula, including information on the history of use; and/or
- Information on the product’s efficacy in reducing the risk of developing an allergy to milk proteins.
The guidance presents a common format for the organisation of the information applicants need to provide. A well-structured application will help the Scientific Panel on Dietetic Products, Nutrition and Allergies (NDA Panel) to carry out its evaluation and deliver its scientific advice effectively and consistently.
Prior to finalising the guidance, EFSA presented the document to the public and invited feedback. EFSA received and considered over 80 comments from seven interested parties including a governmental organisation, food business operators and industry associations.
What is protein hydrolysate formula?
Formulas manufactured from protein hydrolysates contain protein which has been partially broken down to different degrees with the aim of reducing the risk of infants developing allergies.