New EU Regulation on Foods for Special Medical Purposes for infants

On 22 February 2020, the new European Commission Delegated Regulation (EU) 2016/128 [1] on Foods for Special Medical Purposes (FSMPs) intended for infants will come into force. It is important to remember that up until this date, manufacturers can comply with either the current or new regulations. After this date only FSMPs intended for infants which comply with the new regulation can be manufactured, however you may still see products which comply with the previous regulations being dispensed until stocks are depleted.

The new regulation updates, but largely retains, the existing rules.[2] However, the new legislation brings in marketing restrictions and some significant compositional changes based on the latest scientific research on formula milks.[3]

Compositional changes

The new regulations for FSMPs intended for infants include an increase in the minimum level of vitamin A, vitamin D,sodium, copper, folic acid and iodine. While other nutrients such as vitamin C, vitamin K, vitamin B6 and manganese have had lower minimum levels set. These changes may result in updated nutritional declarations on product labels.

Small labelling changes will also occur, such as folic acid to be declared as folate, while the units for thiamin,riboflavin, vitamin B6, manganese and fluoride have changed from mg to μg.

The macronutrient compositional changes align to the new infant formula and follow-on formula regulations (Delegated Regulation (EU) 2016/127 [4] as of 22 February 2020) (Table 1). This includes the introduction of a maximum level for alpha-linolenic acid (ALA), and an increase in the minimum level of linoleic acid and choline. Research into the health benefits of docosahexaenoicacid (DHA) for infants has brought about the mandatory addition of DHA, of which a range of 20-50 mg/100kcal has been set. The changes can be seen in Table 1.

Due to the formulation changes, parents may notice a slight difference in the smell, appearance or taste of the products; settling issues may also be noticed but these should only be temporary and minimal. In both cases, parents should be reassured that the formulation changes are based on the latest scientific evidence and made for the benefit of their baby’s nutrition.

It is important that healthcare professionals are familiar with these changes so they can help and support parents. Manufacturers will endeavour to provide timely information to healthcare professionals, explaining the compositional changes.

Deviations from the regulations

As in previous legislation, variations in the amount of each nutrient in FSMPs intended for infants may be necessary depending on the patient’s medical condition.For example, deviations in micronutrient content from the listed values within the regulation may occur if the product is specifically formulated for a specific disease,disorder or clinical condition where a reduced or increased amount of a vitamin, mineral or trace element,such as sodium or vitamin B12, is required. Evidence will be needed to justify such deviations.


The new Delegated Regulation has more closely aligned communication practices for FSMPs intended for infants with the regulation of infant and follow-on formula,including the labelling and presentation and advertising of the product. However, it is important for FSMPs intended for infants to be distinguished from infant and follow-on formula by the labelling, presentation and advertising, and that healthcare professionals should still be able to assess the suitability of different products for their intended use through appropriate communications.

Table 1: Values for macro and micronutrients for FSMPs intended for infants

(The current regulations and the new regulations which come into force on 22 February 2020)

[1] EU Commission Delegated Regulation (EU) 2016/128 supplementing Regulation (EU)No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for food for special medical purposes

[2] Directive 1999/21/EC on dietary foods for special medical purposes.

[3] EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies) (2014). Scientific Opinion on the essential composition of infant and follow-on formulae. EFSA Journal; 12(7): 3760

[4] EU Commission Delegated Regulation (EU) 2016/127 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for infant