EFSA has launched an open consultation on its draft scientific and technical guidance for the preparation and presentation of an application for authorisation of an infant and/or follow-on formula manufactured from protein hydrolysates.
This guidance document addresses the information and data to be submitted to EFSA on infant and follow-on formulae manufactured from protein hydrolysates with respect to the safety and suitability of the specific formula and/or the formula's efficacy in reducing the risk of developing allergy to milk proteins. The guidance will be further reviewed and updated with the experience gained from the evaluation of specific applications for authorisation, and in the light of future Community guidelines and legislation.
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.81 [at] efsa.europa.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.
Submit comments (deadline: 3 March 2017)