# Infant and follow-on formula and food for special medical purposes

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/98c3a238-cb7a-42e6-9666-dfb94b681ec6
Type: Guidance
Published: March 25, 2013
Updated: April 3, 2024

> 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.

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## Content

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.

## Attachments

- [Commission Delegated Regulation (EU) 2016/127 (supplementing Regulation (EU) No 609/2013): guidance](/government/publications/infant-and-follow-on-formula-and-food-for-special-medical-purposes/commission-delegated-regulation-eu-2016127-supplementing-regulation-eu-no-6092013-guidance)
- [Notification of marketing of foods for particular nutritional uses, medical foods and infant formula: guidance](https://assets.publishing.service.gov.uk/media/5a750c9840f0b6360e472efc/PARNUTS_NOTIFICATION_GUIDANCE_2014.pdf)
- [Application for authorisation of an infant and/or follow-on formula manufactured from protein hydrolysates in Great Britain: form](https://assets.publishing.service.gov.uk/media/6143613ce90e070437d8bb0b/application-for-authorisation-of-infant-and-or-follow-on-formula-manufactured-from-protein-hydrolysates-gb.odt)
- [Application for authorisation of an infant and/or follow-on formula manufactured from protein hydrolysates in Great Britain: form](https://assets.publishing.service.gov.uk/media/614361488fa8f503ba3dc91d/application-for-authorisation-of-infant-and-or-follow-on-formula-manufactured-from-protein-hydrolysates-gb.docx)
- [Notification of infant formula: form](https://assets.publishing.service.gov.uk/media/622a0ecbd3bf7f1589ae0b50/Notification_of_IF.odt)
- [Notification of infant formula: form](https://assets.publishing.service.gov.uk/media/622a0ee98fa8f526d6df2552/Notification_of_IF.docx)
- [Notification of follow-on formula (FOF): form](https://assets.publishing.service.gov.uk/media/622a0dce8fa8f526d45ab5b1/Notification_of_FOF.odt)
- [Notification of follow-on formula (FOF): form](https://assets.publishing.service.gov.uk/media/622a0efc8fa8f526d3b37337/Notification_of_FOF.docx)
- [Notification of food for special medical purposes (FSMP): form](https://assets.publishing.service.gov.uk/media/6143335cd3bf7f05b694d6d4/notification-of-food-for-special-medical-purposes-fsmp.odt)
- [Notification of food for special medical purposes (FSMP): form](https://assets.publishing.service.gov.uk/media/6143336ad3bf7f05b9705173/notification-of-food-for-special-medical-purposes-fsmp.docx)