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.
Applies to England
Documents
Details
These guidance documents will be relevant to:
- companies that manufacture, process, distribute, use, sell or import infant formula and follow-on formula
- those local authorities who are responsible for enforcing the legislation in this area
They may also be of interest to relevant third sector organisations.
Under Regulation (EU) 609/2013 (the overarching regulation on foods for specific groups) there is a requirement to notify the authority when infant and follow-on formula and foods for special medical purposes are first placed on the market. Notification is required to establish compliance with the regulation and its supplementing delegated acts.
The 3 notification forms (ODT and Word versions) are aimed at companies that manufacture, process, distribute, use, sell or import infant formula and follow-on formula and foods for special medical purposes in Great Britain.
The application form (ODT and Word versions) is aimed at companies that are seeking authorisation of infant formula and/or follow-on formula manufactured from protein hydrolysates for use in Great Britain.
We are unable to receive postal notifications of infant formula, follow-on formula or food for special medical purposes. Please return the forms using the email addresses provided in the forms.
Last updated 3 April 2024 + show all updates
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Updated links to the corresponding legislation for Scotland in the document 'Commission Delegated Regulation (EU) 2016/127 (supplementing Regulation (EU) No 609/2013): guidance'.
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Updated "Notification of infant formula: formula", the "Notification of follow-on formula (FOF): form" and "Commission Delegated Regulation (EU) 2016/127 (supplementing Regulation (EU) No 609/2013): guidance" to reflect the application date for Commission Delegated Regulation (EU) 2016/127 to infant and follow-on formula made from protein hydrolysates from 22 February 2022. Updated "Commission Delegated Regulation (EU) 2016/127 (supplementing Regulation (EU) No 609/2013): guidance" to reflect the 1981 WHO Code on the Marketing of Breastmilk Substitutes and appropriate complementary feeding. Updated "Notification of infant formula: formula" and the "Notification of follow-on formula (FOF): form" to provide further differentiation between the notification of new products and the re-notification of products. Removed guidance document "Infant formula and follow-on formula regulations 2007 (as amended): guidance".
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Added message: 'Unfortunately, due to COVID-19 we are currently unable to receive postal notifications of infant formula, follow-on formula or food for special medical purposes. Please return the forms using the email addresses provided in the forms.'
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(1) Added: 'Commission Delegated Regulation (EU) 2016/127 (supplementing Regulation (EU) No 609/2013): guidance' document. (2) Added: 'Application for authorisation of an infant and/or follow-on formula manufactured from protein hydrolysates in Great Britain: form'. (3) To simplify the requirement to notify the relevant authority when foods for special medical purposes and infant and follow-on formula are placed on the market, the 2 previous notification forms ('Infant formula notification form' and 'Medical foods notification form') have been replaced with 3 forms: 'Notification of infant formula', 'Notification of follow-on formula (FOF)' and 'Notification of food for special medical purposes (FSMP)'.
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Two attachments have been updated. The 'medical food notification form' has been updated with current DHSC branding and contact details. It has also been updated to reflect the 'Commission Delegated Regulation 2016/128' implemented by the 'Food for Specific Groups (Information and Compositional Requirements) (Amendment) (England) Regulations 2019'. The 'infant formula notification form' has been updated with current DHSC branding and contact details.
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Added updated medical food notification form and Infant formula notification form.
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Documents replaced 13 May 2013
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First published.