Infant and Follow-on Formula: New regulations coming into force

On 22 February 2020, the new The regulations for infant formula (IF) and follow-on formula (FoF) are changing. Healthcare Professionals should make themselves familiar with the new regulations so that they can help and support parents.

Since 2016, IF and FoF have been regulated by the ‘Foods for Specific Groups’ (FSG) framework, specifying the nutritional composition, labelling and health claims. Under the FSG framework, the specific specialist Directive 2006/141/EC on IF and FoF has been updated and will be replaced by Commission Delegated Regulation (EU) 2016/127. This will apply from 22nd February 2020 (except in respect of IF and FoF manufactured from protein hydrolysates to which it shall apply from 21st February 2021).

To ensure compliance by 22 February 2020, manufacturers have been implementing the required changes, with some reformulated products already present in the market. Changes, based on the latest scientific research [1] into IF and FoF, are mainly compositional. The addition of docosahexaenoic acid (DHA) is now a mandatory requirement and a range of 20-50mg/100kcal has now been set. DHA, along with arachidonic acid (ARA), is a long-chain fatty acid present in breastmilk that plays an essential role in early infant development, particularly in the neural tissues of the retina and brain.[2]

Both DHA and ARA are preferentially transferred to the foetus across the placenta [3], their accumulation in the foetal brain mainly takes place during the third trimester and continues at very high rates up until two years of age. Intervention studies have shown the role of DHA supplementation in benefiting cognitive function, visual acuity and immune response.[4]

Other nutritional changes coming into force include an introduction of a maximum level for alpha-linolenic acid (ALA) and small increases in the minimum levels of copper, iodine, selenium, sodium, potassium, chloride, vitamin A and vitamin D. Some nutrients, such as vitamin B6, biotin, vitamin C and vitamin K, 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 niacin and pantothenic acid have changed from μg to mg.

Parents may notice a slight difference in the smell, appearance or taste of the products due to these changes. Settling issues may also be noticed, but these should only be temporary and minimal.



[1] 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

[2] Lien EL, Richard C, Hoffman DR (2018). DHA and ARA addition to infant formula: Current status and future research directions. Prostaglandins Leukot Essent Fatty Acids; 128: 26-40

[3] Haggarty P et al (1997). Long-chain polyunsaturated fatty acid transport across the perfused human placenta. Placenta; 18(8): 635-642

[4] Lauritzen L et al (2016). DHA Effects in Brain Development and Function. Nutrients; 8(1): 6