Commission Implementing Regulation (EU) 2023/2214 of 23 October 2023 amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use and the specifications of the novel foods partially defatted chia seed (Salvia hispanica) powders

Type Implementing Regulation
Publication 2023-10-24
State In force
Text As published
Department European Commission, SANTE
Source EUR-Lex
articles 4

This is the act as published. Later amendments are not folded into the text below: each one is a separate act in this repository and an entry in this law's history.

Reform history JSON API
Image omitted; see official source Official Journal of the European Union EN Series L
--- --- ---
2023/2214 24.10.2023

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(1) thereof,

Whereas:

HAS ADOPTED THIS REGULATION:

Article 1

The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

Article 2

Only the company Functional Products Trading Arica S.A./BENEXIA 9 is authorised to place on the market within the Union partially defatted chia seed (Salvia hispanica) powder with a high fibre content for use in cakes and pastries, processed fruit and vegetables (including vegetable-based dishes), bread and rolls, pasta based products and protein products for a period of 5 years from 13 November 2023, unless a subsequent applicant obtains an authorisation for that novel food without reference to the scientific data protected pursuant to Article 3 or with the agreement of Functional Products Trading Arica S.A./BENEXIA.

Article 3

The scientific data contained in the application file and fulfilling the conditions laid down in Article 26(2) of Regulation (EU) 2015/2283 shall not be used for the benefit of a subsequent applicant for a period of 5 years from the date of entry into force of this Regulation without the agreement of Functional Products Trading Arica S.A./BENEXIA.

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, 23 October 2023.

For the Commission

The President

Ursula VON DER LEYEN

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

Commission Implementing Regulation (EU) 2020/500 of 6 April 2020 authorising the placing on the market of partially defatted chia seed (Salvia hispanica) powders as novel foods under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (OJ L 109, 7.4.2020, p. 2).

4

Annex 20.

5

Annex 21.

6

Annex 22.

7

Annexes 23 to 41 and Annex 43.

8

EFSA Journal 2023;21(4):7904.

9

Address: Luis Pasteur 5850, Oficina 403, Quinto Piso; Vitacura, Santiago – Chile.

ANNEX

The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:

Authorised novel food Authorised novel food Conditions under which the novel food may be used Conditions under which the novel food may be used Additional specific labelling requirements Other requirements Data protection
‘Partially defatted chia seed (Salvia hispanica L.) powders Specified food category Maximum levels The designation of the novel food on the labelling of the foodstuffs containing it shall be “Partially defatted chia seed (Salvia hispanica) powder”
‘Partially defatted chia seed (Salvia hispanica L.) powders Powder with high protein content Unflavoured fermented milk products, including natural unflavoured buttermilk (excluding sterilised buttermilk) non-heat-treated after fermentation 0,7 % The designation of the novel food on the labelling of the foodstuffs containing it shall be “Partially defatted chia seed (Salvia hispanica) powder”
‘Partially defatted chia seed (Salvia hispanica L.) powders Powder with high protein content Unflavoured fermented milk products, heat-treated after fermentation 0,7 % The designation of the novel food on the labelling of the foodstuffs containing it shall be “Partially defatted chia seed (Salvia hispanica) powder”
‘Partially defatted chia seed (Salvia hispanica L.) powders Powder with high protein content Flavoured fermented milk products including heat-treated products 0,7 % The designation of the novel food on the labelling of the foodstuffs containing it shall be “Partially defatted chia seed (Salvia hispanica) powder”
‘Partially defatted chia seed (Salvia hispanica L.) powders Powder with high protein content Confectionery 10 % The designation of the novel food on the labelling of the foodstuffs containing it shall be “Partially defatted chia seed (Salvia hispanica) powder”
‘Partially defatted chia seed (Salvia hispanica L.) powders Powder with high protein content Fruit juices as defined by Council Directive 2001/112 /EC10 and vegetable juices 2,5 % The designation of the novel food on the labelling of the foodstuffs containing it shall be “Partially defatted chia seed (Salvia hispanica) powder”
‘Partially defatted chia seed (Salvia hispanica L.) powders Powder with high protein content Fruit nectars as defined by Directive 2001/112 /EC and vegetable nectars and similar products 2,5 % The designation of the novel food on the labelling of the foodstuffs containing it shall be “Partially defatted chia seed (Salvia hispanica) powder”
‘Partially defatted chia seed (Salvia hispanica L.) powders Powder with high protein content Flavoured drinks 3 % The designation of the novel food on the labelling of the foodstuffs containing it shall be “Partially defatted chia seed (Salvia hispanica) powder”
‘Partially defatted chia seed (Salvia hispanica L.) powders Powder with high protein content Food supplements as defined in Directive 2002/46 /EC excluding food supplements for infants and young children 7,5 g/day The designation of the novel food on the labelling of the foodstuffs containing it shall be “Partially defatted chia seed (Salvia hispanica) powder”
‘Partially defatted chia seed (Salvia hispanica L.) powders Powder with high fibre content Confectionery 4 % The designation of the novel food on the labelling of the foodstuffs containing it shall be “Partially defatted chia seed (Salvia hispanica) powder” Authorised for use in cakes and pastries, processed fruit and vegetables (including vegetable-based dishes), bread and rolls, pasta based products and protein products on 13 November 2023. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Functional Products Trading Arica S.A./BENEXIA, Luis Pasteur 5850, Oficina 403, Quinto Piso. Vitacura, Santiago – Chile. During the period of data protection, partially defatted chia seed (Salvia hispanica L.) powder with a high fibre content for use in cakes and pastries, processed fruit and vegetables (including vegetable-based dishes), bread and rolls, pasta based products and protein products is authorised for placing on the market within the Union only by Functional Products Trading Arica S.A./BENEXIA, unless a subsequent applicant obtains authorisation for the same 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 Functional Products Trading Arica S.A./BENEXIA. End date of the data protection: 13 November 2028.
‘Partially defatted chia seed (Salvia hispanica L.) powders Powder with high fibre content Fruit juices as defined by Directive 2001/112 /EC and vegetable juices 2,5 % The designation of the novel food on the labelling of the foodstuffs containing it shall be “Partially defatted chia seed (Salvia hispanica) powder” Authorised for use in cakes and pastries, processed fruit and vegetables (including vegetable-based dishes), bread and rolls, pasta based products and protein products on 13 November 2023. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Functional Products Trading Arica S.A./BENEXIA, Luis Pasteur 5850, Oficina 403, Quinto Piso. Vitacura, Santiago – Chile. During the period of data protection, partially defatted chia seed (Salvia hispanica L.) powder with a high fibre content for use in cakes and pastries, processed fruit and vegetables (including vegetable-based dishes), bread and rolls, pasta based products and protein products is authorised for placing on the market within the Union only by Functional Products Trading Arica S.A./BENEXIA, unless a subsequent applicant obtains authorisation for the same 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 Functional Products Trading Arica S.A./BENEXIA. End date of the data protection: 13 November 2028.
‘Partially defatted chia seed (Salvia hispanica L.) powders Powder with high fibre content Fruit nectars as defined by Directive 2001/112 /EC and vegetable nectars and similar products 4 % The designation of the novel food on the labelling of the foodstuffs containing it shall be “Partially defatted chia seed (Salvia hispanica) powder” Authorised for use in cakes and pastries, processed fruit and vegetables (including vegetable-based dishes), bread and rolls, pasta based products and protein products on 13 November 2023. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Functional Products Trading Arica S.A./BENEXIA, Luis Pasteur 5850, Oficina 403, Quinto Piso. Vitacura, Santiago – Chile. During the period of data protection, partially defatted chia seed (Salvia hispanica L.) powder with a high fibre content for use in cakes and pastries, processed fruit and vegetables (including vegetable-based dishes), bread and rolls, pasta based products and protein products is authorised for placing on the market within the Union only by Functional Products Trading Arica S.A./BENEXIA, unless a subsequent applicant obtains authorisation for the same 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 Functional Products Trading Arica S.A./BENEXIA. End date of the data protection: 13 November 2028.
‘Partially defatted chia seed (Salvia hispanica L.) powders Powder with high fibre content Flavoured drinks 4 % The designation of the novel food on the labelling of the foodstuffs containing it shall be “Partially defatted chia seed (Salvia hispanica) powder” Authorised for use in cakes and pastries, processed fruit and vegetables (including vegetable-based dishes), bread and rolls, pasta based products and protein products on 13 November 2023. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Functional Products Trading Arica S.A./BENEXIA, Luis Pasteur 5850, Oficina 403, Quinto Piso. Vitacura, Santiago – Chile. During the period of data protection, partially defatted chia seed (Salvia hispanica L.) powder with a high fibre content for use in cakes and pastries, processed fruit and vegetables (including vegetable-based dishes), bread and rolls, pasta based products and protein products is authorised for placing on the market within the Union only by Functional Products Trading Arica S.A./BENEXIA, unless a subsequent applicant obtains authorisation for the same 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 Functional Products Trading Arica S.A./BENEXIA. End date of the data protection: 13 November 2028.
‘Partially defatted chia seed (Salvia hispanica L.) powders Powder with high fibre content Food supplements as defined in Directive 2002/46 /EC excluding food supplements for infants and young children 12 g/day The designation of the novel food on the labelling of the foodstuffs containing it shall be “Partially defatted chia seed (Salvia hispanica) powder” Authorised for use in cakes and pastries, processed fruit and vegetables (including vegetable-based dishes), bread and rolls, pasta based products and protein products on 13 November 2023. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Functional Products Trading Arica S.A./BENEXIA, Luis Pasteur 5850, Oficina 403, Quinto Piso. Vitacura, Santiago – Chile. During the period of data protection, partially defatted chia seed (Salvia hispanica L.) powder with a high fibre content for use in cakes and pastries, processed fruit and vegetables (including vegetable-based dishes), bread and rolls, pasta based products and protein products is authorised for placing on the market within the Union only by Functional Products Trading Arica S.A./BENEXIA, unless a subsequent applicant obtains authorisation for the same 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 Functional Products Trading Arica S.A./BENEXIA. End date of the data protection: 13 November 2028.
‘Partially defatted chia seed (Salvia hispanica L.) powders Powder with high fibre content Cakes and pastries 5 g/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be “Partially defatted chia seed (Salvia hispanica) powder” Authorised for use in cakes and pastries, processed fruit and vegetables (including vegetable-based dishes), bread and rolls, pasta based products and protein products on 13 November 2023. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Functional Products Trading Arica S.A./BENEXIA, Luis Pasteur 5850, Oficina 403, Quinto Piso. Vitacura, Santiago – Chile. During the period of data protection, partially defatted chia seed (Salvia hispanica L.) powder with a high fibre content for use in cakes and pastries, processed fruit and vegetables (including vegetable-based dishes), bread and rolls, pasta based products and protein products is authorised for placing on the market within the Union only by Functional Products Trading Arica S.A./BENEXIA, unless a subsequent applicant obtains authorisation for the same 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 Functional Products Trading Arica S.A./BENEXIA. End date of the data protection: 13 November 2028.
‘Partially defatted chia seed (Salvia hispanica L.) powders Powder with high fibre content Processed fruit and vegetables (including vegetable-based dishes) 10 g/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be “Partially defatted chia seed (Salvia hispanica) powder” Authorised for use in cakes and pastries, processed fruit and vegetables (including vegetable-based dishes), bread and rolls, pasta based products and protein products on 13 November 2023. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Functional Products Trading Arica S.A./BENEXIA, Luis Pasteur 5850, Oficina 403, Quinto Piso. Vitacura, Santiago – Chile. During the period of data protection, partially defatted chia seed (Salvia hispanica L.) powder with a high fibre content for use in cakes and pastries, processed fruit and vegetables (including vegetable-based dishes), bread and rolls, pasta based products and protein products is authorised for placing on the market within the Union only by Functional Products Trading Arica S.A./BENEXIA, unless a subsequent applicant obtains authorisation for the same 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 Functional Products Trading Arica S.A./BENEXIA. End date of the data protection: 13 November 2028.
‘Partially defatted chia seed (Salvia hispanica L.) powders Powder with high fibre content Bread and rolls 10 g/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be “Partially defatted chia seed (Salvia hispanica) powder” Authorised for use in cakes and pastries, processed fruit and vegetables (including vegetable-based dishes), bread and rolls, pasta based products and protein products on 13 November 2023. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Functional Products Trading Arica S.A./BENEXIA, Luis Pasteur 5850, Oficina 403, Quinto Piso. Vitacura, Santiago – Chile. During the period of data protection, partially defatted chia seed (Salvia hispanica L.) powder with a high fibre content for use in cakes and pastries, processed fruit and vegetables (including vegetable-based dishes), bread and rolls, pasta based products and protein products is authorised for placing on the market within the Union only by Functional Products Trading Arica S.A./BENEXIA, unless a subsequent applicant obtains authorisation for the same 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 Functional Products Trading Arica S.A./BENEXIA. End date of the data protection: 13 November 2028.
‘Partially defatted chia seed (Salvia hispanica L.) powders Powder with high fibre content Pasta based products 8 g/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be “Partially defatted chia seed (Salvia hispanica) powder” Authorised for use in cakes and pastries, processed fruit and vegetables (including vegetable-based dishes), bread and rolls, pasta based products and protein products on 13 November 2023. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Functional Products Trading Arica S.A./BENEXIA, Luis Pasteur 5850, Oficina 403, Quinto Piso. Vitacura, Santiago – Chile. During the period of data protection, partially defatted chia seed (Salvia hispanica L.) powder with a high fibre content for use in cakes and pastries, processed fruit and vegetables (including vegetable-based dishes), bread and rolls, pasta based products and protein products is authorised for placing on the market within the Union only by Functional Products Trading Arica S.A./BENEXIA, unless a subsequent applicant obtains authorisation for the same 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 Functional Products Trading Arica S.A./BENEXIA. End date of the data protection: 13 November 2028.
‘Partially defatted chia seed (Salvia hispanica L.) powders Powder with high fibre content Protein products 10 g/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be “Partially defatted chia seed (Salvia hispanica) powder” Authorised for use in cakes and pastries, processed fruit and vegetables (including vegetable-based dishes), bread and rolls, pasta based products and protein products on 13 November 2023. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Functional Products Trading Arica S.A./BENEXIA, Luis Pasteur 5850, Oficina 403, Quinto Piso. Vitacura, Santiago – Chile. During the period of data protection, partially defatted chia seed (Salvia hispanica L.) powder with a high fibre content for use in cakes and pastries, processed fruit and vegetables (including vegetable-based dishes), bread and rolls, pasta based products and protein products is authorised for placing on the market within the Union only by Functional Products Trading Arica S.A./BENEXIA, unless a subsequent applicant obtains authorisation for the same 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 Functional Products Trading Arica S.A./BENEXIA. End date of the data protection: 13 November 2028.
Authorised novel food Specification Specification Specification
‘Partially defatted chia seed (Salvia hispanica) powders Description/Definition: The novel foods are partially defatted chia seed (Salvia hispanica) powders obtained by pressing and grinding of the whole seeds of Salvia hispanica L. Physical–sensorial: Foreign matter: 0,1 % Description/Definition: The novel foods are partially defatted chia seed (Salvia hispanica) powders obtained by pressing and grinding of the whole seeds of Salvia hispanica L. Physical–sensorial: Foreign matter: 0,1 % Description/Definition: The novel foods are partially defatted chia seed (Salvia hispanica) powders obtained by pressing and grinding of the whole seeds of Salvia hispanica L. Physical–sensorial: Foreign matter: 0,1 %
‘Partially defatted chia seed (Salvia hispanica) powders Powder with high protein content Powder with high fibre content
‘Partially defatted chia seed (Salvia hispanica) powders Particle size ≤ 130 μm ≤ 400 μm
‘Partially defatted chia seed (Salvia hispanica) powders
‘Partially defatted chia seed (Salvia hispanica) powders Chemical composition: Chemical composition: Chemical composition:
‘Partially defatted chia seed (Salvia hispanica) powders Salvia hispanica powder with high protein content Salvia hispanica powder with high fibre content
‘Partially defatted chia seed (Salvia hispanica) powders Moisture ≤ 9,0 % ≤ 9,0 %
‘Partially defatted chia seed (Salvia hispanica) powders Protein ≥ 40,0 % ≥ 24,0 %
‘Partially defatted chia seed (Salvia hispanica) powders Fat ≤ 17 % ≤ 12 %
‘Partially defatted chia seed (Salvia hispanica) powders Fibre ≤ 30 % ≥ 50 %
‘Partially defatted chia seed (Salvia hispanica) powders Microbiological criteria: Total plate count: ≤ 10 000 CFU/g Yeasts: ≤ 500 CFU/g Moulds: ≤ 500 CFU/g Staphylococcus aureus: ≤ 10 CFU/g Coliforms: < 100 MPN/g Enterobacteriaceae: ≤ 100 CFU/g Bacillus cereus: ≤ 50 CFU/g Escherichia coli: Not detected in 10 g Listeria monocytogenes: Not detected in 25 g Salmonella spp.: Absence in 25 g Contaminants: Arsenic: ≤ 0,1 ppm Cadmium: ≤ 0,1 ppm Lead: ≤ 0,1 ppm Mercury: ≤ 0,1 ppm Total aflatoxins: ≤ 4 ppb Ochratoxin A: ≤ 1 ppb’ Microbiological criteria: Total plate count: ≤ 10 000 CFU/g Yeasts: ≤ 500 CFU/g Moulds: ≤ 500 CFU/g Staphylococcus aureus: ≤ 10 CFU/g Coliforms: < 100 MPN/g Enterobacteriaceae: ≤ 100 CFU/g Bacillus cereus: ≤ 50 CFU/g Escherichia coli: Not detected in 10 g Listeria monocytogenes: Not detected in 25 g Salmonella spp.: Absence in 25 g Contaminants: Arsenic: ≤ 0,1 ppm Cadmium: ≤ 0,1 ppm Lead: ≤ 0,1 ppm Mercury: ≤ 0,1 ppm Total aflatoxins: ≤ 4 ppb Ochratoxin A: ≤ 1 ppb’ Microbiological criteria: Total plate count: ≤ 10 000 CFU/g Yeasts: ≤ 500 CFU/g Moulds: ≤ 500 CFU/g Staphylococcus aureus: ≤ 10 CFU/g Coliforms: < 100 MPN/g Enterobacteriaceae: ≤ 100 CFU/g Bacillus cereus: ≤ 50 CFU/g Escherichia coli: Not detected in 10 g Listeria monocytogenes: Not detected in 25 g Salmonella spp.: Absence in 25 g Contaminants: Arsenic: ≤ 0,1 ppm Cadmium: ≤ 0,1 ppm Lead: ≤ 0,1 ppm Mercury: ≤ 0,1 ppm Total aflatoxins: ≤ 4 ppb Ochratoxin A: ≤ 1 ppb’
10

Council Directive 2001/112/EC of 20 December 2001 relating to fruit juices and certain similar products intended for human consumption (OJ L 10, 12.1.2002, p. 58).’

ELI: http://data.europa.eu/eli/reg_impl/2023/2214/oj

ISSN 1977-0677 (electronic edition)

Reading this document does not replace reading the official text published in the Official Journal of the European Union. We assume no responsibility for any inaccuracies arising from the conversion of the original to this format.

This text is published under EUR-Lex's own terms of reuse, not a Legalize or public-domain licence. EUR-Lex
Creative Commons Attribution 4.0 International (CC BY 4.0)
© European Union, https://eur-lex.europa.eu — Source: EUR-Lex (Publications Office of the European Union). Reused under the Creative Commons Attribution 4.0 International (CC BY 4.0) licence. Only EU legislation published in the printed Official Journal of the European Union is deemed authentic; consolidated texts are reproduced here for documentation purposes and have been reformatted to Markdown.