Food for special medical purposes (DADFMS): application of Delegated Regulation 2016/128
The delegated Regulation (EU) 2016/128 supplementing Regulation (EU) No 609/2013 as regards the specific compositional and information requirements for food for special medical purposes applies (instead of Directive 1999/21/EC) since 22 February 2019 for FSMP developed to satisfy the nutritional requirements of people other than infants.
The main changes in comparison with Directive 1999/21/EC are the following:
- Clarification on the nutrition declaration linked to FIC Regulation (1169/2011).
- Ban of the use of nutrition and health claims (voluntary) on FSMP.
For FSMP developed to satisfy the nutritional requirements of infants, this Regulation shall apply from 22 February 2020, as the delegated Regulation (EU) 2016/127 concerning infant formula and follow-on formula.