Authorised Regulated Food and Feed Products for Great Britain

Definition/Description: N-Acetyl-D-neuraminic acid is a white to off-white crystalline powder

Authorised novel ID: NOVEL-95

Specification: https://www.legislation.gov.uk/eur/2018/1023#tgp2-tbl2-tbd1-tr2

Conditions under which the novel food may be used: Food category Maximum levels

Cereal bars 0.5 g/kg

Dairy analogues, including beverage whiteners 0.05 g/L (beverages); 0.25 g/kg (solids)

Flavoured drinks 0.05 g/L

Food supplements as defined in Directive 2002/46/EC ^[3] 300 mg/day for general population older than 10 years; 55 mg/day for infants; 130 mg/day for young children; 250 mg/day for children between 3 to 10 years of age

Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014 ^[2] 1.25 g/kg

Foods for special medical purposes for infants and young children as defined by Regulation (EU) No 609/2013 In accordance with the particular nutritional requirements of the infants and young children for whom the products are intended but in any case not higher than the maximum levels specified for the category mentioned in the table corresponding to the products.

Fruit and vegetable-based drinks 0.05 g/L

Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013 ^[1] 0.05 g/L of reconstituted formula

Processed cereal-based food and baby food for infants and young children as defined in Regulation (EU) No 609/2013 0.05 g/kg for solid foods

Speciality coffee, tea, herbal and fruit infusions, chicory; tea, herbal and fruit infusions and chicory extracts; tea, plant, fruit and cereal preparations for infusions 0.2 g/kg

Table-top sweeteners 8.3 g/kg

Total diet replacement foods for weight control as defined by Regulation (EU) No 609/2013 0.2 g/L (drinks); 1.7 g/kg (bars)

Unflavoured fermented milk-based products, heat treated after fermentation, flavoured fermented milk products including heat-treated products 0.05 g/L (beverages); 0.4 g/kg (solids)

Unflavoured pasteurised and sterilised (including UHT) milk-based products 0.05 g/L

Food category	Maximum levels
Cereal bars	0.5 g/kg
Dairy analogues, including beverage whiteners	0.05 g/L (beverages); 0.25 g/kg (solids)
Flavoured drinks	0.05 g/L
Food supplements as defined in Directive 2002/46/EC ^[3]	300 mg/day for general population older than 10 years; 55 mg/day for infants; 130 mg/day for young children; 250 mg/day for children between 3 to 10 years of age
Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014 ^[2]	1.25 g/kg
Foods for special medical purposes for infants and young children as defined by Regulation (EU) No 609/2013	In accordance with the particular nutritional requirements of the infants and young children for whom the products are intended but in any case not higher than the maximum levels specified for the category mentioned in the table corresponding to the products.
Fruit and vegetable-based drinks	0.05 g/L
Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013 ^[1]	0.05 g/L of reconstituted formula
Processed cereal-based food and baby food for infants and young children as defined in Regulation (EU) No 609/2013	0.05 g/kg for solid foods
Speciality coffee, tea, herbal and fruit infusions, chicory; tea, herbal and fruit infusions and chicory extracts; tea, plant, fruit and cereal preparations for infusions	0.2 g/kg
Table-top sweeteners	8.3 g/kg
Total diet replacement foods for weight control as defined by Regulation (EU) No 609/2013	0.2 g/L (drinks); 1.7 g/kg (bars)
Unflavoured fermented milk-based products, heat treated after fermentation, flavoured fermented milk products including heat-treated products	0.05 g/L (beverages); 0.4 g/kg (solids)
Unflavoured pasteurised and sterilised (including UHT) milk-based products	0.05 g/L

Additional specific labelling requirements: The designation of the novel food on the labelling of the foodstuffs containing it shall be 'N-acetyl-D-neuraminic acid'. Food supplements containing N-acetyl-D-neuraminic acid shall bear a statement that the food supplement should not be given to infants, young children and children under 10 years of age where they consume breast milk or other foods with added N-acetyl-D-neuraminic acid within the same twenty four hour period.

Other requirements: not specified

Data Protection: not specified

^[1] Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009
^[2] Commission Implementing Regulation (EU) No 828/2014 of 30 July 2014 on the requirements for the provision of information to consumers on the absence or reduced presence of gluten in food
^[3] Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements

Date of authorisation: Pre-1 January 2021 (from retained EU regulations)

Last updated: 01 January 2021

Link to legislation: Retained EU Regulations 2017/2470

Retained EU Regulations 2018/1023

N-Acetyl-D-neuraminic acid

Product details

Conditions of use

Dates

Legislation