
New EU legislation on infants formulae
New EU legislation on infants formulae
The European Commission has introduced new legislation affecting all infant formula, follow-on formula and infant food for special medical purposes to satisfy the specific nutritional requirements of infants and to reflect the latest scientific advances in nutrition. This requires all infant formula manufacturers to adjust their products to comply with the new legislation by February 22, 2020.1,2
What do you need to know as a healthcare professional?
Composition changes:1
- Docosahexaenoic acid (DHA) is now a mandatory ingredient at a range of 20‑50mg/100kcal
- Increase maximum level of alpha-linoleic acid (ALA) of 100mg/100kcal
- Increase in the minimum level of linoleic acid and choline
- Increase in the minimum level of vitamin A, vitamin D, sodium, copper, folic acid and iodine
- Lower minimum level of vitamin C, vitamin K, vitamin B6, and manganese.
Nutrition labelling changes:1
Some labelling changes will occur:
- Folic acid will be declared as folate
- Unit changes for some nutrients such as niacin and pantothenic acid have changed from μg to mg.
Compliance:1,2
- From 22 February 2020, all infant formula, follow-on formula (EU Delegated Regulation 2016/127) and infant food for special medical purposes (EU Delegated Regulation 2016/128) must comply with the changes
- Infant and follow-on formula manufactured from protein hydrolysates must be compliant by 22 February 2021
- Products compliant with the current legislation placed in market or labelled before 22 February 2020 may continue to be marketed until stocks are exhausted.
Communication changes:1
- There will be further restrictions on claims on the product
- ‘Contains DHA’ and ‘Lactose only’/‘Lactose-free’ are the only claims that will be permitted, where applicable
- Relevant information on the product composition will be provided. However, nutritional or health claims will not be permitted.

For more information about product changes, please contact your local representative on our customer careline for advice +44 (0) 1895 230575.