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SMA® NUTRITION: New EU Baby Formula Legislation

Adapting our baby formulas to comply with new legislation

New EU legislation* has been introduced that affects all infant formula, follow-on formula and infant foods for special medical purposes (FSMPs). This legislation is effective from February 2020** and reflects updates to previous regulations and the latest science to give babies the best start. All baby milk manufacturers must adhere to this legislation.


Parents may notice changes to the labels, and/or a slightly different taste or smell with their usual milk, and may ask you about these changes. We want to support you by providing information on how this legislation affects SMA® Nutrition products.


  • All products need to be reformulated
  • Omega 3 LCP (DHA) will be mandatory and at higher levels than previous formulations (20 mg/100 kcal minimum)
  • Changes to the minimum/maximum amounts of some nutrients, such as vitamin D, vitamin A, folic acid, iodine, linoleic acid, and others


  • Changes to how salt is declared
  • Folic acid to be declared as folate
  • Changes to permitted front of pack information


  • Applicable from 22 February 2020
  • Hydrolysed infant formula and follow-on formula must comply by 22 February 2021
  • 100% compliance with new rules for permitted claims (stricter rules on nutrition and health claims)


  • Enhanced restrictions on permitted claims
  • NO nutrition and health claims on infant formula apart from ‘Contains DHA’ (as required by legislation for all infant formula) and ‘Lactose free/Lactose only’
  • NO nutrition and health claims allowed for infant FSMPs 

SMA® Nutrition has already started to implement this new baby formula legislation across our product range. We will continue to update remaining formulations to ensure compliance by 22 February 2020.**

For more information on product changes please visit our product range section by clicking on the link or to speak to a member of our SMA® Nutrition Careline team please call    0800 0818180 (UK) or 1800 931832 (Ireland)

DHA, docosahexaenoic acid; FSMP, food for special medical purpose; LCP, long-chain polyunsaturated fatty acids.

* Delegated Regulation (EU) 2016/127 on infant formula and follow-on formula, and Delegated Regulation (EU) 2016/128 for food for special medical purposes.

** All infant formula, follow-on formula and infant FSMPs must comply by 22 February 2020; infant formula manufactured from protein hydrolysates must be compliant by 22 February 2021.

Dietary Folate Equivalent (DFE): 1 μg DFE = 1 μg food folate = 0.6 μg folic acid from formula.


The World Health Organisation (WHO) has recommended that pregnant women and new mothers be informed on the benefits and superiority of breastfeeding – in particular the fact that it provides the best nutrition and protection from illness for babies. Mothers should be given guidance on the preparation for, and maintenance of, lactation, with special emphasis on the importance of a well-balanced diet both during pregnancy and after delivery. Unnecessary introduction of partial bottle-feeding or other foods and drinks should be discouraged since it will have a negative effect on breastfeeding. Similarly, mothers should be warned of the difficulty of reversing a decision not to breastfeed. Before advising a mother to use an infant formula, she should be advised of the social and financial implications of her decision: for example, if a baby is exclusively bottle-fed, more than one can (400 g) per week will be needed, so the family circumstances and costs should be kept in mind. Mothers should be reminded that breast milk is not only the best, but also the most economical food for babies. If a decision to use an infant formula is taken, it is important to give instructions on correct preparation methods, emphasising that unboiled water, unsterilised bottles or incorrect dilution can all lead to illness.