1. Phenylcapsaicin 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 Applicant:
Company: aXichem AB;
Address: Södergatan 26, SE 211 34, Malmö, Sweden,
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 or with the agreement of aXichem AB.
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 and to the provisions of Directive 2002/46/EC.
The studies and reports 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 (EC) No 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 aXichem AB.
The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
ANNEXSupplementary provisions
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
‘ Phenylcapsaicin
Specified food category
Maximum levels
The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘phenylcapsaicin’.
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
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
(2)
In Table 2 (Specifications), the following entry is inserted in alphabetical order:
Authorised Novel Food
Specification
‘ Phenylcapsaicin
Description/Definition:
Phenylcapsaicin ( N -[(4-hydroxy-3-methoxyphenyl)methyl]-7-phenylhept-6-ynamide, C 21 H 23 NO 3 , 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’
