Infant formulas and follow-up formulas are strictly regulated in Europe. From 22 February 2020, all infant formulas, follow-on formulas (EU Delegated Regulation 2016/127) as well as infant food for special medical purposes (EU Delegated Regulation 2016/128) must comply with regulation changes. The only exception is for infant formula manufactured from protein hydrolysates, which must be compliant by 22 February 2021.
The changes refer to updated information on product composition (new minimum and maximum nutrient levels), new labelling requirements which will affect the presentation of the nutritional table and ingredients list (e.g. unit changes for some nutrients; re-labelling of some nutrients, e.g. folic acid will be listed as folate), and the communication to consumers will adhere to claim restriction, meaning no nutrition and health claims are permitted on infant formula, follow-on formula, or infant food for special medical purposes formulations. The only nutrition claims permitted on infant formula are ‘Contains DHA’ and ‘Lactose only’/‘Lactose-free’ where applicable.
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