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.)

• CELEX: Implementing Regulation (EU) 2019/1294
• Articles: 5

Article 1

1.   Betaine as specified in the Annex to this Regulation shall be included in the Union list of authorised novel foods established in Implementing Regulation (EU) 2017/2470.

2.   For a period of five years from the date of entry into force of this Regulation only the initial Applicant:

Company: DuPont Nutrition Biosciences ApS;

Address: Langebrogade 1 DK-1411 Copenhagen K, Denmark,

is authorised to place on the market within the Union the novel food referred to in paragraph 1, unless a subsequent applicant obtains authorisation for the novel food without reference to the data protected pursuant to Article 2 of this Regulation or with the agreement of DuPont Nutrition Biosciences ApS.

3.   The entry in the Union list referred to in paragraph 1 shall include the conditions of use and labelling requirements laid down in the Annex to this Regulation.

4.   The authorisation provided for in this Article shall be without prejudice to the provisions of Regulation (EU) No 609/2013.

Article 2

The studies contained in the application file on the basis of which the novel food referred to in Article 1 has been assessed by the Authority, claimed by the Applicant as proprietary and without which the novel food could not have been authorised, shall not be used for the benefit of a subsequent applicant for a period of five years from the date of entry into force of this Regulation without the agreement pf DuPont Nutrition Biosciences ApS.

Article 3

The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

Article 4

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Schedules & Appendices

ANNEX

ANNEX

The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:

(1)

in Table 1 (Authorised novel foods), the following entry is inserted in alphabetical order:

Authorised novel food

Conditions under which the novel food may be used

Additional specific labelling requirements

Other requirements

Data Protection

‘ 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.

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

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

(2)

the following entry is inserted in Table 2 (Specifications) in alphabetical order:

Authorised Novel Food

Specification

‘ Betaine

Description/Definition:

Betaine (N,N,N-trimethylglycine or carboxy-N,N,N-trimethylmethanaminium), in anhydrous (CH 3 ) 3 N + CH 2 COO – (CAS No: 107-43-7) and monohydrate (CH 3 )3N + CH 2 COO – .H 2 O (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.’

( *1 )   Maximum use levels in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer.’;