COMMISSION IMPLEMENTING REGULATION (EU) 2019/1976
of 25 November 2019
authorising the placing on the market of Phenylcapsaicin 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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‘Phenylcapsaicin |
Specified food category |
Maximum levels |
The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘phenylcapsaicin’. |
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Authorised on 19 December 2019. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: aXichem AB, Södergatan 26, SE 211 34, Malmö Sweden. During the period of data protection, the novel food phenylcapsaicin is authorised for placing on the market within the Union only by aXichem AB, 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 aXichem AB.’ |
Foods for special medical purposes as defined under Regulation (EU) No 609/2013 excluding foods for infants, young children and children under the age of 11 years |
2,5 mg/day |
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Food supplements as defined in Directive 2002/46/EC intended for the general population, excluding children under the age of 11 years |
2,5 mg/day |
Authorised Novel Food |
Specification |
‘Phenylcapsaicin |
Description/Definition: Phenylcapsaicin (N-[(4-hydroxy-3-methoxyphenyl)methyl]-7-phenylhept-6-ynamide, C21H23NO3, CAS no: 848127-67-3), is synthesized chemically via a two step synthesis process involving in a first step the production of the acetylenic acid intermediate through a reaction of phenyl acetylene with a carboxylic acid derivative, and in a second step a series of reactions of the acetylenic acid intermediate with vanillylamine derivative to produce phenylcapsaicin. Characteristics/Composition: Purity (% of dry matter): ≥ 98 % Moisture: ≤ 0,5 % Total synthesis related production by-products: ≤ 1,0 % N,N-dimethyl formamide: ≤ 880 mg/kg Dichloromethane: ≤ 600 mg/kg Dimethoxyethane: ≤ 100 mg/kg Ethyl acetate: ≤ 0,5 % Other solvents: ≤ 0,5 % Heavy metals: Lead: ≤ 1,0 mg/kg Cadmium: ≤ 1,0 mg/kg Mercury: ≤ 0,1 mg/kg Arsenic: ≤ 1,0 mg/kg Microbiological criteria: Total plate count: ≤ 10 CFU/g Coliforms: ≤ 10 CFU/g Escherichia coli: Negative/10 g Salmonella sp.: Negative/10 g Yeast and mould: ≤ 10 CFU/g CFU: Colony Forming Units’ |