Since 22 February 2020, the rules on infant nutrition in Europe have changed. Directive 2006/141, previously in force, has been repealed by Delegated Regulation 2016/127 and 2016/128. The text will take effect as of 21 February 2021 with regard to infant formulas and follow-on formulas manufactured from protein hydrolysates. So what does this mean in practice? In this article, we will help you understand this new regulatory framework and the subsequent changes that will apply.
What is Delegated Regulation 2016/127 and 2016/128?
This text of 25 September 2015 supplements Regulation (EU) No. 609/2013 of the European Parliament and of the Council as regards “the specific compositional and information requirements for infant formula and follow-on formula and as regards requirements on information relating to infant and young child feeding.”
With regard to Foods for Special Medical Purposes (FSMP), Delegated Regulation 2016/128 will apply. These are products intended to meet specific physiological needs. For example, in the case of infant formulas, this refers to hypoallergenic, anti-regurgitation, preterm formulas, etc. In other words, products sold exclusively in pharmacies.
Repercussions of Delegated Regulation 2016/127 and 2016/128 on manufacturers.
The affects of these new rules concern a number of key areas, given that the scope of application is broad and numerous changes are involved.
Firstly, there is a commitment to reduce protein intake. It is now clearly established that infants with a diet higher in protein are more likely to be overweight. This is why, for some time now, we have seen reductions in infant formulas, and they have now become mandatory. For the past few years, consumers have noticed and appreciated this trend.
The rules also include an increase in the minimum level of linoleic acid C18:2 and in the maximum level of alpha-linolenic acid C18:3. These fatty acids are essential to the healthy development of babies’ brains and eyes. Overall, they help maintain normal infant growth and development. Babies absorb these fatty acids from their mother’s body, in particular during the last trimester, in preparation for the accelerated brain growth which takes place at this stage. Newborns also need them for their development.
L-Carnitine will also become mandatory in Infant Formulas, whereas it has been optional until now. Naturally present in breast milk, this nutrient is involved in the transfer of fatty acids across membranes and is currently considered critical for infants due to their reduced capacity for carnitine synthesis. Infants with diets deficient in L-Carnitine have low plasma and tissue L-Carnitine levels. They can develop disorders linked to fatty acid oxidation, metabolism of acetyl-CoA compounds, ketogenesis, and nitrogen balance.
Another important point is that DHA (docosahexaenoic acid) will be required in all formulas. It too was optional until now. Although DHA is essential for development, many infants are deficient. In infants, deficient DHA levels can lead to a decrease in neuron size, and visual and neurological impairments. According to Nutri-bébé, a study conducted by a French information centre dedicated to baby foods (SFAE), 80% of infants are deficient in DHA.
There are also a few changes in the minimum/maximum levels of vitamins & minerals. In particular, vitamin D, which contributes to the health of bones and teeth, and whose minimum requirement has been increased. Vitamins are essential to healthy infant development and strong immune systems. Between 0 and 3 years, infants grow spectacularly. Minerals are critical in supporting this important stage of their life: calcium, iron, zinc, magnesium and fluorine are essential to the healthy development of babies. Finally, restrictions on the addition of glucose are also among the repercussions of Delegated Regulation 2016/127.
In short, what are the key changes?
There are two categories of foods directly affected by this Delegated Regulation: infant formulas and follow-on formulas and Foods for Special Medical Purposes.
In concrete terms, the new regulation will update compositional requirements for infant formulas and follow-on formulas , require the inclusion of DHA in infant formulas and follow-on formulas, require the inclusion of L-carnitine in infant formulas, and prohibit claims on infant formulas.
Regarding FSMPs, changes include updates on compositional requirementsand the prohibition of claims and any promotional or communication practices targeting the general public for dietary foods for special medical purposes for infants between the ages of 0 and 12 months.