Commission Implementing Regulation (EU) 2019/506 of 26 March 2019 authorising the placing on the market of D-ribose 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) 2019/506
• Articles: 5

Article 1

1.   D-ribose 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: Bioenergy Life Science, Inc.

Address: 13840 Johnson St. NE, Minneapolis, Minnesota, 55304, USA;

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 same novel food without reference to the data protected pursuant to Article 2 of this Regulation or with the agreement of Bioenergy Life Science, Inc.

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

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 fulfilling the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283, 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 of Bioenergy Life Science, Inc.

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)

the following last column is added in Table 1 (Authorised novel foods):

‘Data Protection’

(2)

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

Authorised novel food

Conditions under which the novel food may be used

Additional specific labelling requirements

Other requirements

Data Protection

‘ D-ribose

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘D-ribose’.

The labelling of foods containing D-ribose shall bear a statement that the foods should not be used if food supplements containing D-ribose are consumed the same day.

Authorised on 16 April 2019. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: Bioenergy Life Science, Inc., 13840 Johnson St. NE, Minneapolis, Minnesota, 55304, USA. During the period of data protection, the novel food D-ribose is authorised for placing on the market within the Union only by Bioenergy Life Science, Inc. 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 Bioenergy Life Science, Inc.

End date of the data protection: 16 April 2024 (5 years).’

Cereal bars

0,20 g/100 g

Fine bakery wares

0,31 g/100 g

Chocolate confectionery (excluding chocolate bars)

0,17 g/100 g

Milk-based drinks (excluding malts and shakes)

0,08 g/100 g

Drinks intended to meet the expenditure of intense muscular effort especially for sportsmen, isotonic and energy drinks

0,80 g/100 g

Bars intended to meet the expenditure of intense muscular effort especially for sportsmen

3,3 g/100 g

Meal replacement for weight control (as drinks)'

0,13 g/100 g

Meal replacement for weight control (as bars)

3,30 g/100 g

Confectionery

0,20 g/100 g

Tea and infusions (in powder form to be reconstituted)

0,23 g/100 g

(3)

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

Authorised Novel Food

Specification

‘ D-ribose

Description

D-ribose is an aldopentose monosaccharide which is produced by fermentation using a transketolase-deficient strain of Bacillus subtilis .

Chemical formula: C 5 H 10 O 5

CAS No: 50-69-1

Molecular mass: 150,13 Da

Characteristics/Composition

Appearance: Dry with powdery texture, white to slightly yellow in colour

Specific rotation [α] D

25 : – 19,0° to – 21,0°

D-ribose purity (% dry basis):

-HPLC/RI  ( *1 ) Method 98,0–102,0 %

Ash: < 0,2 %

Loss on drying (moisture): < 0,5 %

Clarity on solution: ≥ 95 % transmittance

Heavy metals

Lead: ≤ 0,1 mg/kg

Arsenic: ≤ 0,1 mg/kg

Cadmium: ≤ 0,1 mg/kg

Mercury: ≤ 0,1 mg/kg

Microbiological criteria

Total plate count: ≤ 100 CFU  ( *2 ) /g

Yeast: ≤ 100 CFU/g

Moulds: ≤ 100 CFU/g

Coliforms: ≤ 10 CFU/g

Salmonella sp: Negative/25 g

( *1 )   HPLC/RI: High-performance liquid chromatography coupled with refractive index detection.

( *2 )   CFU: Colony-forming unit’