The UK Food Safety Authorities are notifying Members of an authorization of four novel food products for use in the GB market and a change to the conditions of use of one novel food and its specification for an existing authorization.
The authorizations cover novel food products to be used as components in infant followon formula. The following products are classified as "human-identical milk oligosaccharides (HiMOs)". The manufactured HiMOs are identical in structure to the same molecules present in breast milk.
o 3'-Sialyllactose (3'-SL) sodium salt,
o 6'-Sialyllactose (6'-SL) sodium salt.
Terms for entry to the list of authorized novel foods:
• Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products
• Flavoured fermented milk-based products including heat-treaded products
• Unflavoured fermented milk-based products
• Beverages (flavoured drinks, excluding drinks with a pH less than 5)
• Cereal bars
• Infant formula as defined under Retained EU Regulation 609/2013
• Follow-on formula as defined under Retained EU Regulation 609/2013
• Processed cereal-based drinks and baby food for infants and young children as defined under Retained EU Regulation 609/2013
• Milk-based drinks and similar products intended for young children
• Total diet replacement foods for weight control as defined in Retained EU Regulation 609/2013
• Food for special medical purposes as defined under Retained EU Regulation 609/2013 (only applicable to 3'-Sialyllactose (3'-SL) sodium salt)
• Food supplements as defined in the Food Supplements Regulation 2003 for England, excluding food supplements for infants and young children
o 2'-Fucosyllactose/difucosyllactose mixture (2'-FL/DFL) (note this consists of a change to the conditions of use and specifications, not a new authorization)
• Milk-based drinks and similar products intended for young children.
The below products are Docosahexaenoic acid (DHA) rich oils derived from marine algae. DHA is mandatory in infant and follow-on formula in the UK under retained Commission Delegated Regulation 2016/127.
o Schizochytrium sp. (WZU477) oil
• Infant formula and follow-on formula as defined in retained Regulation (EU) No 609/2013.
o Schizochytrium sp. (FCC-3204) oil
• Food supplements as defined in The Food Supplements Regulations 2003 for England, excluding food supplements for infants and young children
• Infant and follow-on formula.
These authorizations are made on the basis of the uses and specifications set out in the consultations linked in section 9.
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