New regulation on infant formulas: what and when?

European Parliament - Wed, 07/27/2016

For some time now, the European Parliament is trying to redefine/put in order the wide set of regulations that used to govern food intended for infants. Thus, a new regulation has been launched recently, specifically for infant formulas, where new requirements on their composition are introduced, as well as some novel specifications on advertising in an attempt to foster and defend breastfeeding.

Which are the changes introduced by the new regulation?

General requirements regarding composition and information for every category of infant foods were already set in 2013 (Regulation 609/2013).

From this year 2016 onwards, we should take into account two new regulations as well. These new regulations complement the aforementioned and tackle the specific compositional and informational requirements regarding two particular infant food categories: infant formula and follow-on formula (Regulation 2016/127) and food for special medical purposes (Regulation 2016/128).

According to these new regulations, and as a noteworthy novelty, the minimum required quantity of docosahexaenoic acid (DHA) added must be 20 mg for every 100 kcal for all formulas intended for infants from the moment of birth (Regulation 2016/127) which implies an amount greater than the current one in most commercial formulas.

Other aspects worth highlighting are the new requirements regarding the composition of protein hydrolysates whose features of the protein profile are specified.

Regarding foods for special medical purposes, the Regulation 2016/128 states a greater flexibility with the creation of innovative products as long as they are proven to be innocuous, beneficial and effective for their addressees on the basis of generally accepted scientific data.

When are the new regulations entering into force?

Infant formulas must meet all these requirements by 2019 and 2020 (Regulation 128 and 127, respectively). The Regulation governing those specific infant formulas containing protein hydrolysates shall come into force by 2021.

The composition of the food for special medical purposes shall be adapted to the new regulation by 2020.

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