Changes to Infant Formula Regulations – Are You Ready?

July 2016 saw the end of European directive 2009/39/EC on food for particular nutritional uses (PARNUTS) and the replacement with regulation 609/2013 on foods for specific groups (FSG). This reclassified such foodstuffs into 4 groups:

  • Infant formula (IF) & follow-on formula (FOF).
  • Processed cereal-based food and baby food
  • Food for special medical purposes
  • Total diet replacement for weight control

The new framework means all food falling into one of the four categories must comply both with general food law and the new FSG framework and delegated regulations. Delegated regulations for infant formula and special medical purposes now exist, but we are still to see new regulations for the other two groups. EU 2016/128 covers food for special medical purposes and came into force in February this year. The delegated regulation for infant formula (EU 2016/127) is coming into force in February 2020, at which point the old 2006/141/EC directive will be repealed in entirety. Most of the changes are minor and shouldn’t require companies to reformulate, however some changes are significant and, reviewing current products on the market, will require reformulation in order to be compliant by 22nd Feb 2020. Reformulation isn’t as simple as just adding/removing a few nutrients. The composition and stability of the product also needs to be considered. The changes are based on the 2014 EFSA scientific opinion on nutrient requirements and dietary intakes of infants and young children. Interestingly, some of the changes are in contrast to the current CODEX 2007 standard for IF and FOF. Re-labelling, and how you calculate folic acid content also now must be taken into consideration, with the change to dietary folate equivalents amongst other minor unit changes.

The biggest change is the increase in the minimum level of choline to be added to infant formula, increasing by 18 mg/100 kcal from 7 mg/100 kcal to 25 mg/100 kcal. The reason behind this is based on the EFSA opinion on nutrient requirements back in 2013 that a choline intake of 130 mg/day was adequate for infants below 6 months. Based on a 500 kcal/day diet, this means the CODEX level would not be near sufficient to reach that level. Another interesting increase is that of vitamin D from 2.5 µg/100 kcal to 3.0 µg/100 kcal. As noted by EFSA in their 2018 opinion on tolerable upper intakes for vitamin D for infants, this new level could lead to some infants exceeding the 25 µg/day upper level (UL) from formulae alone.

Amongst the minor increases and decreases, there have been several significant decreases based on ULs for certain nutrients. The most significant is the reduction of maximum permitted iodine. The UL for iodine is set at 200 µg/day for children aged 1 to 3 years, based on biochemical changes in thyroid stimulation hormone levels. The previous limit of 50 µg/100 kcal, and a 500 kcal diet, could lead to an excessive iodine intake. The new level of 29 µg/100 kcal reduces this chance. Further changes of interest are summarised below, however it should be noted, that the maximum limits are not targets to aim for, more levels that should not be exceeded. Excess nutrients must be stored or excreted by the infant, which can put a strain on their metabolism. The reductions for zinc, iodine and vitamin A are based on the assumption of a 500 kcal/day diet from formula. An infant taking a formula containing the current maximum permitted levels could potentially lead to an intake above the ULs for these nutrients.

  • Copper – increase from minimum 35 µg/100 kcal to 60 µg/100 kcal
  • Potassium – increase from minimum 60 mg/100 kcal to 80 mg/100 kcal
  • Zinc – reduction from 1.5 mg/100 kcal to 1.0 mg/100 kcal
  • Vitamin A – reduction in maximum level from 180 µg-RE/100 kcal to 114 µg-RE/100 kcal
  • Linoleic acid – increase in minimum content from 300 mg/100 kcal to 500 mg/100 kcal