Infant and follow-on formula and food for special medical purposes
Guidance on infant and follow-on formula, the application form for infant and follow-on formula made from protein hydrolysates, and forms to notify the authority.
Latest change: Updated links to the corresponding legislation for Scotland in the document 'Commission Delegated Regulation (EU) 2016/127 (supplementing Regulation (EU) No 609/2013): guidance'.
AI Summary
This guidance document details the regulatory obligations for companies involved in manufacturing, distributing, or importing infant formula, follow-on formula, and foods for special medical purposes within Great Britain. Operating under the framework of Regulation (EU) 609/2013, which oversees foods for specific groups, the policy requires businesses to notify the appropriate authorities when these products are first introduced to the market. This process ensures that all specialized nutritional products adhere to established safety and quality standards. While this document is general guidance rather than an enforcement report against a specific company, it identifies the essential actions required for legal market participation. Specifically, stakeholders must use standardized digital forms to notify the government of new products or to seek authorization for formulas manufactured from protein hydrolysates. A key administrative requirement is the electronic submission of these documents; the authorities explicitly state that postal notifications will not be accepted. All forms must be sent to the designated email addresses provided within the guidance. These protocols are designed to assist both private companies and local enforcement authorities in maintaining compliance with the supplementing delegated acts of the overarching legislation.
The full document, source attachments, and change history are available on KeyPedia. Sign in to view.