Commission Delegated Regulation (EU) 2016/128 supplementing Regulation (EU) No. 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for food for special medical purposes.
Country
Type of law
Legislation
Date of original text
Abstract
This Regulation establishes the nutritional and compositional requirements to be met by food for special medical purposes to be placed on the market. The formulation of food for special medical purposes shall be based on sound medical and nutritional principles. Its use, in accordance with the manufacturer's instructions, shall be safe, beneficial and effective in meeting the specific nutritional requirements of the persons for whom it is intended, as demonstrated by generally accepted scientific data. Maximum residue limits for pesticides in such food products are established too.
Attached files
Date of consolidation/reprint
Date of text
Entry into force notes
This Regulation shall apply from 22 February 2019, except in respect of food for special medical purposes developed to satisfy the nutritional requirements of infants, to which it shall apply from 22 February 2020.
Notes
A consolidated version of the present Regulation, as last amended by the Commission Delegated Regulation (EU) 2021/1040, is attached.
Repealed
No
Serial Imprint
Official Journal of the European Union L 25, 2 February 2016, pp. 30-43.
Source language
English
Legislation status
in force
Legislation Amendment
No
Implemented by