Guidance

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.

• From: Department of Health and Social Care
• Published: 25 March 2013
• Last updated: 3 April 2024
  Show all updates

  1. 3 April 2024

     Updated links to the corresponding legislation for Scotland in the document 'Commission Delegated Regulation (EU) 2016/127 (supplementing Regulation (EU) No 609/2013): guidance'.

  2. 14 March 2022

     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".

  3. 24 September 2021

     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.'

  4. 20 September 2021

     (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)'.

  5. 26 February 2019

     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.

  6. 3 October 2016

     Added updated medical food notification form and Infant formula notification form.

  7. 13 May 2013

     Documents replaced 13 May 2013

  8. 25 March 2013

     First published.

Applies to England

Documents

Commission Delegated Regulation (EU) 2016/127 (supplementing Regulation (EU) No 609/2013): guidance

HTML

Notification of marketing of foods for particular nutritional uses, medical foods and infant formula: guidance

PDF, 136 KB, 21 pages

Application for authorisation of an infant and/or follow-on formula manufactured from protein hydrolysates in Great Britain: form

ODT, 56.5 KB

This file is in an OpenDocument format

Application for authorisation of an infant and/or follow-on formula manufactured from protein hydrolysates in Great Britain: form

MS Word Document, 93.9 KB

Notification of infant formula: form

ODT, 34.4 KB

This file is in an OpenDocument format

Notification of infant formula: form

MS Word Document, 56.7 KB

Notification of follow-on formula (FOF): form

ODT, 33.8 KB

This file is in an OpenDocument format

Notification of follow-on formula (FOF): form

MS Word Document, 56.3 KB

Notification of food for special medical purposes (FSMP): form

ODT, 32.9 KB

This file is in an OpenDocument format

Notification of food for special medical purposes (FSMP): form

MS Word Document, 78.6 KB

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.