Änderungen vergleichen: 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)
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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)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 12 thereof,
Whereas:
(1) Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list may be placed on the market within the Union.
(2) Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 (2) establishing a Union list of authorised novel foods was adopted.
(3) On 4 June 2020, the company Pharmanutra S.p.A. (‘the applicant’) submitted an application to the Commission pursuant to Article 10(1) of Regulation (EU) 2015/2283 to place cetylated fatty acids on the Union market as a novel food. The applicant requested cetylated fatty acids to be used in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (3). The application specified that the food supplements are intended for use by the adult population at the maximum use level of 2,1 g per day.
(4) The applicant also submitted a request to the Commission for the protection of proprietary data for a number of data submitted in support of the application. Namely, bacterial reverse mutation assay (4);
in vitro
micronucleus test (5); 14-day toxicity study in rats (6); 13-week toxicity study in rats (7); summary table of statistically significant observations in toxicity studies (8); certificates of analysis, batch testing and methods of analysis (9); stability data (10).
(5) In accordance with Article 10(3) of Regulation (EU) 2015/2283, the Commission consulted the European Food Safety Authority (‘the Authority’) on 20 July 2020, requesting it to provide a scientific opinion by carrying out an assessment of cetylated fatty acids as a novel food.
(6) On 26 May 2021, the Authority adopted its scientific opinions on the ‘Safety of Cetylated Fatty Acids as a Novel Food pursuant to Regulation (EU) 2015/2283’ (11). That opinion is in line with the requirements of Article 11 of Regulation (EU) 2015/2283.
(7) In that opinion, the Authority concluded that the novel food, cetylated fatty acids, is safe at an intake level of 1,6 g per day for the adult population. This safe intake level is lower than the maximum intake level of 2,1 g per day proposed by the applicant. As indicated by the Authority, the highest dose tested in a subchronic toxicity study in rats was considered as the no-observed-adverse effect level (NOAEL). By applying the default uncertainty factor and a default body weight for the adult population, that results in an intake of 1,6 g per day.
(8) Therefore, the opinion of the Authority gives sufficient grounds to establish that cetylated fatty acids when used in food supplements for the adult population with maximum level of 1,6 g per day fulfil the conditions for placing on the market in accordance Article 12(1) of Regulation (EU) 2015/2283.
(9) The food supplements containing cetylated fatty acids should not be consumed by persons under 18 years of age and therefore, a labelling requirement should be provided in order to properly inform the consumers about that.
(10) In its opinion, the Authority also concluded that the bacterial reverse mutation assay;
in vitro
micronucleus test; 13-week toxicity study in rats; summary table of statistically significant observations in toxicity studies; certificates of analysis, batch testing and methods of analysis; and stability data served as a basis to establish the safety of the novel food. The Authority also noted that it could not have reached that conclusion without those data, claimed by the applicant as proprietary.
(11) The Commission requested the applicant to further clarify the justification provided with regard to their proprietary claim over those data and to clarify their claim to an exclusive right of reference to those data, as required under Article 26(2)(b) of Regulation (EU) 2015/2283.
(12) The applicant declared that, at the time of the submission of the application, they held proprietary and exclusive rights of reference to those data under national law, and that therefore third parties cannot lawfully access or use those data or refer to those data.
(13) The Commission assessed all the information provided by the applicant and considered that the applicant has sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283. Therefore, the bacterial reverse mutation assay (12);
in vitro
micronucleus test (13); 13-week toxicity study in rats (14); summary table of statistically significant observations in toxicity studies (15); certificates of analysis, batch testing and methods of analysis (16); stability data (17) contained in the applicant’s file should not be used by the Authority for the benefit of any subsequent applicant for a period of five years from the date of entry into force of this Regulation. Accordingly, the placing on the market within the Union of cetylated fatty acids should be restricted to the applicant for that period.
(14) However, restricting the authorisation of cetylated fatty acids and of the reference to the data contained in the applicant’s file for the sole use of the applicant, does not prevent other applicants from applying for an authorisation to place on the market the same novel food, provided that their application is based on legally obtained information supporting such authorisation under Regulation (EU) 2015/2283.
(15) The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly.
(16) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1
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.
Article 2
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.
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
.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 10 February 2022.
For the Commission
The President
Ursula VON DER LEYEN
(1)
OJ L 327, 11.12.2015, p. 1
.
(2) Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (
OJ L 351, 30.12.2017, p. 72
).
(3) Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (
OJ L 183, 12.7.2002, p. 51
).
(4) Thompson, 2017. Report, Cetilar: Reverse Mutation Assay ‘Ames Test’ using Salmonella typhimurium and Escherichia coli Salmonella typhimurium and Escherichia coli. Envigo Study Number: NW13QW. 4 December 2017 (unpublished).
(5) Morris, 2017. Report, Cetilar: micronucleus test in human lymphocytes in vitro. Envigo Study Number: SL29LL. Issue Date: 9 November 2017 (unpublished).
(6) Piras, 2019. Final Report. 14-day repeated oral toxicity study in CRl CD (SD) Rat of the product named Cetilar. NB/080118 (unpublished).
(7) Piras, 2020. Final Report. 13-week repeated oral toxicity study of T/08/041 in CD ISG (SD) rats with concominant recovery study. NB/080118 (unpublished).
(8) Appendix B3. Piras (2020) (unpublished).
(9) Annex III (unpublished).
(10) Annex IV (unpublished).
(11) EFSA Journal 2021;19(7):6670.
(12) Thompson, 2017. Report, Cetilar: Reverse Mutation Assay ‘Ames Test’ using Salmonella typhimurium and Escherichia coli Salmonella typhimurium and Escherichia coli. Envigo Study Number: NW13QW. 4 December 2017 (unpublished).
(13) Morris, 2017. Report, Cetilar: micronucleus test in human lymphocytes in vitro. Envigo Study Number: SL29LL. Issue Date: 9 November 2017 (unpublished).
(14) Piras, 2020. Final Report. 13-week repeated oral toxicity study of T/08/041 in CD ISG (SD) rats with concominant recovery study. NB/080118 (unpublished).
(15) Appendix B3. Piras (2020) (unpublished).
(16) Annex III (unpublished).
(17) Annex IV (unpublished).
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 |
|
|
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’ |
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)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 12 thereof,
Whereas:
(1) Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list may be placed on the market within the Union.
(2) Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 (2) establishing a Union list of authorised novel foods was adopted.
(3) On 4 June 2020, the company Pharmanutra S.p.A. (‘the applicant’) submitted an application to the Commission pursuant to Article 10(1) of Regulation (EU) 2015/2283 to place cetylated fatty acids on the Union market as a novel food. The applicant requested cetylated fatty acids to be used in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (3). The application specified that the food supplements are intended for use by the adult population at the maximum use level of 2,1 g per day.
(4) The applicant also submitted a request to the Commission for the protection of proprietary data for a number of data submitted in support of the application. Namely, bacterial reverse mutation assay (4);
in vitro
micronucleus test (5); 14-day toxicity study in rats (6); 13-week toxicity study in rats (7); summary table of statistically significant observations in toxicity studies (8); certificates of analysis, batch testing and methods of analysis (9); stability data (10).
(5) In accordance with Article 10(3) of Regulation (EU) 2015/2283, the Commission consulted the European Food Safety Authority (‘the Authority’) on 20 July 2020, requesting it to provide a scientific opinion by carrying out an assessment of cetylated fatty acids as a novel food.
(6) On 26 May 2021, the Authority adopted its scientific opinions on the ‘Safety of Cetylated Fatty Acids as a Novel Food pursuant to Regulation (EU) 2015/2283’ (11). That opinion is in line with the requirements of Article 11 of Regulation (EU) 2015/2283.
(7) In that opinion, the Authority concluded that the novel food, cetylated fatty acids, is safe at an intake level of 1,6 g per day for the adult population. This safe intake level is lower than the maximum intake level of 2,1 g per day proposed by the applicant. As indicated by the Authority, the highest dose tested in a subchronic toxicity study in rats was considered as the no-observed-adverse effect level (NOAEL). By applying the default uncertainty factor and a default body weight for the adult population, that results in an intake of 1,6 g per day.
(8) Therefore, the opinion of the Authority gives sufficient grounds to establish that cetylated fatty acids when used in food supplements for the adult population with maximum level of 1,6 g per day fulfil the conditions for placing on the market in accordance Article 12(1) of Regulation (EU) 2015/2283.
(9) The food supplements containing cetylated fatty acids should not be consumed by persons under 18 years of age and therefore, a labelling requirement should be provided in order to properly inform the consumers about that.
(10) In its opinion, the Authority also concluded that the bacterial reverse mutation assay;
in vitro
micronucleus test; 13-week toxicity study in rats; summary table of statistically significant observations in toxicity studies; certificates of analysis, batch testing and methods of analysis; and stability data served as a basis to establish the safety of the novel food. The Authority also noted that it could not have reached that conclusion without those data, claimed by the applicant as proprietary.
(11) The Commission requested the applicant to further clarify the justification provided with regard to their proprietary claim over those data and to clarify their claim to an exclusive right of reference to those data, as required under Article 26(2)(b) of Regulation (EU) 2015/2283.
(12) The applicant declared that, at the time of the submission of the application, they held proprietary and exclusive rights of reference to those data under national law, and that therefore third parties cannot lawfully access or use those data or refer to those data.
(13) The Commission assessed all the information provided by the applicant and considered that the applicant has sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283. Therefore, the bacterial reverse mutation assay (12);
in vitro
micronucleus test (13); 13-week toxicity study in rats (14); summary table of statistically significant observations in toxicity studies (15); certificates of analysis, batch testing and methods of analysis (16); stability data (17) contained in the applicant’s file should not be used by the Authority for the benefit of any subsequent applicant for a period of five years from the date of entry into force of this Regulation. Accordingly, the placing on the market within the Union of cetylated fatty acids should be restricted to the applicant for that period.
(14) However, restricting the authorisation of cetylated fatty acids and of the reference to the data contained in the applicant’s file for the sole use of the applicant, does not prevent other applicants from applying for an authorisation to place on the market the same novel food, provided that their application is based on legally obtained information supporting such authorisation under Regulation (EU) 2015/2283.
(15) The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly.
(16) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1
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.
Article 2
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.
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
.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 10 February 2022.
For the Commission
The President
Ursula VON DER LEYEN
(1)
OJ L 327, 11.12.2015, p. 1
.
(2) Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (
OJ L 351, 30.12.2017, p. 72
).
(3) Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (
OJ L 183, 12.7.2002, p. 51
).
(4) Thompson, 2017. Report, Cetilar: Reverse Mutation Assay ‘Ames Test’ using Salmonella typhimurium and Escherichia coli Salmonella typhimurium and Escherichia coli. Envigo Study Number: NW13QW. 4 December 2017 (unpublished).
(5) Morris, 2017. Report, Cetilar: micronucleus test in human lymphocytes in vitro. Envigo Study Number: SL29LL. Issue Date: 9 November 2017 (unpublished).
(6) Piras, 2019. Final Report. 14-day repeated oral toxicity study in CRl CD (SD) Rat of the product named Cetilar. NB/080118 (unpublished).
(7) Piras, 2020. Final Report. 13-week repeated oral toxicity study of T/08/041 in CD ISG (SD) rats with concominant recovery study. NB/080118 (unpublished).
(8) Appendix B3. Piras (2020) (unpublished).
(9) Annex III (unpublished).
(10) Annex IV (unpublished).
(11) EFSA Journal 2021;19(7):6670.
(12) Thompson, 2017. Report, Cetilar: Reverse Mutation Assay ‘Ames Test’ using Salmonella typhimurium and Escherichia coli Salmonella typhimurium and Escherichia coli. Envigo Study Number: NW13QW. 4 December 2017 (unpublished).
(13) Morris, 2017. Report, Cetilar: micronucleus test in human lymphocytes in vitro. Envigo Study Number: SL29LL. Issue Date: 9 November 2017 (unpublished).
(14) Piras, 2020. Final Report. 13-week repeated oral toxicity study of T/08/041 in CD ISG (SD) rats with concominant recovery study. NB/080118 (unpublished).
(15) Appendix B3. Piras (2020) (unpublished).
(16) Annex III (unpublished).
(17) Annex IV (unpublished).
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 |
|
|
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’ |
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