Synthetic beta-carotene safe for use in medical infant formula: EFSA

Currently in the EU the use of colours in foodstuffs is prohibited in any food for infants and young children including these prescribed medical foods.

However the trade group Specialised Nutrition Europe (SNE), formerly IDACE, has filed a number of applications for safety assessments of additives including carotenes (E 160a) at 5 mg per kg, acesulfame K (E 950) at 450 mg/kg, sucralose (E 955) at 400 mg/kg and beetroot red betanin (E 162) at 20 mg/kg.

SNE argues these additives are needed to ensure “appealing and palatable foods”​ for sick children whose compliance with prescribed diets is vital.

SNE executive director Aurélie Perrichet said the beta carotene opinion​​ was “​positive news”.​  

“Synthetic beta-carotene, as a colouring additive, is important for designing FSMPs in young children. The acceptability of special medical foods is considered by physicians and paediatricians to be a vital component of treatment, particularly in younger age groups,” ​she told us.

“Not only are FSMPs prepared to the highest technological standards but they must also have an acceptable sensory profile to ensure they are ingested i.e. taste, appearance and reconstitution properties.”​

If children refused to eat the medical foods, this may result in malnutrition, illness or rapid deterioration of health, she said. 

“This can have serious implications for the effective dietary management of certain medical conditions. The addition of colours greatly improves the appearance and palatability of some FSMPs, thus enhancing their acceptability, particularly in children over one year of age.”​

Membership agreements meant she could not give details of how many SNE members – which include national trade associations from 16 European countries – use the ingredient.

The beta-carotene opinion follows a positive safety opinions on SNE’s sucralose application​​ in January.