Commission Implementing Regulation (EU) 2022/187 of 10 February 2022 authorising the placing on the market of cetylated fatty acids 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)
1. Cetylated fatty acids 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: Pharmanutra S.p.A.,
address: Via Delle Lenze 216/b, 56122 Pisa, Italy
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 Pharmanutra S.p.A.
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.
The studies contained in the application file on the basis of which the novel food referred to in Article 1 have been assessed by the Authority, claimed by the applicant as proprietary and without which the novel food 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 Pharmanutra S.p.A.
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 .
Supplementary provisions
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:
Authorised novel food
Conditions under which the novel food may be used
Additional specific labelling requirements
Other requirements
Data protection
‘ Cetylated fatty acids
Specified food category
Maximum levels
1.
The designation of the novel food on the labelling of the food supplements containing it shall be ‘cetylated fatty acids preparation’.
2.
The labelling of food supplements containing the novel food shall bear a statement that those food supplements should not be consumed by persons under 18 years of age.
Authorised on 3 March 2022. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.
Applicant: Pharmanutra S.p.A., Via Delle Lenze 216/b, 56122 Pisa, Italy. During the period of data protection, the novel food cetylated fatty acids is authorised for placing on the market within the Union only by Pharmanutra S.p.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 Pharmanutra S.p.A.
End date of the date protection: 3 March 2027’
Food supplements as defined in Directive 2002/46/EC for the adult population
1,6 g/day
(2)
in Table 2 (Specifications), the following entry is inserted:
Authorised Novel Food
Specification
‘ Cetylated fatty acids
Description/Definition:
The novel food concerns primarily a mixture of cetylated myristic acid and cetylated oleic acid synthesised from cetyl alcohol, myristic acid and oleic acid, and to a lesser degree, other cetylated fatty acids and other compounds from olive oil.
Characteristics/composition:
Ester content: 70-80 %, of which: Cetyl oleate: 22-30 %, Cetyl myristate: 41-56 %
Triglycerides: 22-25 %
Acid value (mg KOH/g): ≤ 5
Saponification value (mg KOH/g): 130-150
Microbiological criteria:
Total aerobic microbial count: ≤ 1 000 CFU/g
Yeasts and moulds: ≤ 100 CFU/g
KOH: potassium hydroxide
CFU: colony forming units’
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
