# 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

> 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.

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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)