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New Regulation for Infant Formula and Follow-on Formula

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The EU Regulation (Eu) No. 2016/127 Replaces the German Regulation on Dietary Foods

Apr 2020. The Delegated Regulation (EU) No. 2016/127 for infant formula and follow-on formula supplementing Regulation (EU) No. 609/2013 has been in force since 20 February 2020 and thus replaces the German Regulation on Dietary Foods (Verordnung über diätetische Lebensmittel, Diätverordnung (DiätV)). This does not apply to infant formula and follow-on formula manufactured from protein hydrolysates. For those, the new regulation will apply from 22 February 2021.

The Following Changes are Associated with the New Regulation for Infant Formula and Follow-on Formula:

Composition

  • Docosahexaenoic acid (DHA) for infant formula and follow-on formula and carnitine for infant formula - now mandatory, previously optional
  • Existing limit values ​​have been changed, including a new lower limit for protein and an adjustment of the minimum or maximum limits for vitamins and minerals

Labelling

  • Changed classification of nutrients in the nutritional table (e.g. GOS/FOS will be partially allocated to fibre)
  • Folic acid will be listed as folate
  • Due to necessary adjustments of the composition, changes in the order of the list of ingredients can occur

Communication to consumers

  • Expansion of the advertising ban for infant formulas - that is why nutrition claims are limited. Only the following information for infant formula is possible if applicable: "contains DHA", "lactose only" or "lactose-free".

Do you Have Any Questions about Infant Formula and Follow-on Formula?

Your personal account manager or our experts Sarah Kuntz and Annette Hufnagel will be glad to answer your questions about the new regulation or other questions about infant formula and follow-on formula. We will be happy to advise you.