Betaine: authorised novel food in the EU
Betaine is on the Union list of authorised novel foods (Implementing Regulation (EU) 2017/2470). Conditions of use and maximum levels by food category: 5 entries, quoted below.
- Regulation
- Implementing Regulation (EU) 2017/2470, Annex, Table 1
- Listed as
- Betaine
- Text version
- Consolidated text of 10 August 2026
- Version
- Consolidated text of 10 August 2026
- Official source
- Implementing Regulation (EU) 2017/2470, Annex, Union list of novel foods
Conditions of use and maximum levels
Table 1, column "Conditions under which the novel food may be used", as written:
- Drink powders, isotonic and energy drinks intended for sportsmen: 60 mg/100 g
- Protein and cereal bars intended for sportsmen: 500 mg/100 g
- Meal replacements intended for sportsmen: 20 mg/100 g
- Total diet replacement for weight control as defined under 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)
- Foods for Special Medical Purposes as defined under Regulation (EU) No 609/2013 for adults: 400 mg/day
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.
Specification (Table 2)
Table 2 of the Annex, row with the same name, as written:
Description/Definition:
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).
Characteristics/Composition
Appearance: Free-flowing white crystals
Betaine: ≥ 99,0 % (w/w on dry weight basis)
Moisture: ≤ 2,0 % (anhydrous); ≤ 15,0 % (monohydrate)
Ash: ≤ 0,1 %
pH: 5,0-7,0
Residual protein: ≤ 1,0 mg/g
Heavy metals:
Arsenic: < 0,1 mg/kg
Mercury: < 0,005 mg/kg
Cadmium: < 0,01 mg/kg
Lead: < 0,05 mg/kg
Microbiological criteria:
Total viable count: ≤ 100 CFU/g
Coliforms: Negative/10 g
Salmonella sp.: Negative/25 g
Yeast: ≤ 10 CFU/g
Mould: ≤ 10 CFU/g
CFU: Colony Forming Units.
Source and version
Implementing Regulation (EU) 2017/2470, Annex, Union list of novel foods, Table 1. Consolidated text of 10 August 2026. The text above is copied from that document without change except that amendment markers are removed. It is not advice and it does not decide whether a particular product is covered.
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