Commission Implementing Regulation (EU) 2018/1123 of 10 August 2018 authorising the placing on the market of 1-methylnicotinamide chloride 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) 2018/1123
• Articles: 5

Article 1

1.   1-methylnicotinamide chloride 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: Pharmena SA

Address: ul. Wolczanska 178, 90 530 Lodz, Poland

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 Pharmena SA.

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.

4.   The authorisation provided for in this Article shall be without prejudice to the provisions of Directive 2002/46/EC.

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 data protection 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 of Pharmena SA.

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

‘ 1-Methylnicotinamide chloride

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be “1- Methylnicotinamide chloride”.

Food supplements containing 1-Methylnicotinamide shall bear the following statement:

This food supplement should be consumed by adults only excluding pregnant and lactating women

Authorised on 2 September 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: Pharmena SA, Wolczanska 178, 90 530 Lodz, Poland. During the period of data protection the novel food 1-methylnicotinamide chloride is authorised for placing on the market within the Union only by Pharmena S.A. 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 Pharmena S.A.

End date of the data protection: 2 September 2023’.

Food Supplements as defined in Directive 2002/46/EC for the adult population excluding pregnant and lactating women

58 mg/day

(3)

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

Authorised Novel Food

Specification

‘ 1-Methylnicotinamide chloride

Definition:

Chemical name: 3-carbamoyl-1-methyl-pyridinium chloride

Chemical formula: C 7 H 9 N 2 OCl

CAS No: 1005-24-9

Molecular weight: 172,61 Da

Description

1-Methylnicotinamide chloride is white or off-white, crystalline solid produced by a chemical synthesis process.

Characteristics/Composition

Appearance: White – off-white, crystalline solid

Purity: ≥ 98,5 %

Trigonelline: ≤ 0,05 %

Nicotinic Acid: ≤ 0,10 %

Nicotinamide: ≤ 0,10 %

Largest unknown impurity: ≤ 0,05 %

Sum of unknown impurities: ≤ 0,20 %

Sum of all impurities: ≤ 0,50 %

Solubility: soluble in water and methanol. Practically insoluble in 2-propanol and dichloromethane

Moisture: ≤ 0,3 %

Loss on drying: ≤ 1,0 %

Residue on ignition: ≤ 0,1 %

Residual Solvents and Heavy Metals

Methanol: ≤ 0,3 %

Heavy metals: ≤ 0,002 %

Microbiological criteria:

Total aerobic microbial count: ≤ 100 CFU/g

Mould/yeast: ≤ 10 CFU/g

Enterobacteriaceae: absence in 1 g

Pseudomonas aeruginosa : absence in 1 g

Staphylococcus aureus : absent in 1 g

CFU: Colony Forming Units’