COMMISSION IMPLEMENTING REGULATION (EU) 2019/1294
of 1 August 2019
authorising the placing on the market of betaine as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470
(Text with EEA relevance)
Article 1
Article 2
Article 3
Article 4
ANNEX
Authorised novel food |
Conditions under which the novel food may be used |
Additional specific labelling requirements |
Other requirements |
Data Protection |
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‘Betaine |
Specified food category |
Maximum levels (*1) |
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. |
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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. |
Drink powders, isotonic and energy drinks intended for sportsmen |
60 mg/100 g |
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Protein and cereal bars intended for sportsmen |
500 mg/100 g |
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Meal replacements intended for sportsmen |
20 mg/100 g |
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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) |
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Foods for Special Medical Purposes as defined under Regulation (EU) No 609/2013 for adults |
400 mg/day |
Authorised Novel Food |
Specification |
‘Betaine |
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.’ |