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) (c. 1123)

ANNEX U.K.

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: C7H9N2OCl 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’