Authorised Regulated Food and Feed Products for Great Britain

Definition/Description: Betaine (N,N,N-trimethylglycine or carboxy-N,N,N-trimethylmethanaminium), in anhydrous (CH3)3N+CH2COO – (CAS No: 107-43-7) and monohydrate (CH3)3N + CH2COO – .H2O (CAS No: 590-47-6) forms is obtained from processing of sugar beets (i.e. molasses, vinasses or betaine-glycerol).

Specification: https://www.legislation.gov.uk/eur/2019/1294#Legislation-1-1-1-3-3-1-3-3-1-5-1-0

Conditions under which the novel food may be used: Food category Maximum levels ^[7]

Drink powders, isotonic and energy drinks intended for sportsmen 60 mg/100 g

Foods for Special Medical Purposes as defined under Regulation (EU) No 609/2013 for adults 400 mg/day

Meal replacements intended for sportsmen 20 mg/100 g

Protein and cereal bars intended for sportsmen 500 mg/100 g

Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 500 mg/100 g (bar); 136 mg/100 g (soup); 188 mg/100 g (porridge); 60 mg/100 g (beverages)

Food category	Maximum levels ^[7]
Drink powders, isotonic and energy drinks intended for sportsmen	60 mg/100 g
Foods for Special Medical Purposes as defined under Regulation (EU) No 609/2013 for adults	400 mg/day
Meal replacements intended for sportsmen	20 mg/100 g
Protein and cereal bars intended for sportsmen	500 mg/100 g
Total diet replacement for weight control as defined in Regulation (EU) No 609/2013	500 mg/100 g (bar); 136 mg/100 g (soup); 188 mg/100 g (porridge); 60 mg/100 g (beverages)

Additional specific labelling requirements: The designation of the novel food on the labelling of the foodstuffs containing it shall be 'betaine'.
The labelling of foods containing betaine shall bear a statement that the foods should not be used if food supplements containing betaine are consumed the same day.

Data Protection: Authorised on 22 August 2019 . This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: DuPont Nutrition Biosciences ApS, Langebrogade 1 Copenhagen K, DK-1411, Denmark . During the period of data protection, the novel food betaine is authorised for placing on the market within the Union only by DuPont Nutrition Biosciences ApS unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of DuPont Nutrition Biosciences ApS. End date of the data protection: 22 August 2024.

^[7] Maximum use levels in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer.

Link to legislation: Retained EU Regulations 2017/2470

Retained EU Regulations 2019/1294

Betaine