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

• CELEX: Implementing Regulation (EU) 2023/2214
• Articles: 5

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.

Schedules & Appendices

ANNEX

ANNEX

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

(1)

in Table 1 (Authorised novel foods), the entry for ‘Partially defatted chia seed ( Salvia hispanica ) powders’ is replaced by the following:

Authorised novel food

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”

Powder with high protein content

Unflavoured fermented milk products, including natural unflavoured buttermilk (excluding sterilised buttermilk) non-heat-treated after fermentation

0,7 %

Unflavoured fermented milk products, heat-treated after fermentation

0,7 %

Flavoured fermented milk products including heat-treated products

0,7 %

Confectionery

10 %

Fruit juices as defined by Council Directive 2001/112 /EC  ( *1 ) and vegetable juices

2,5 %

Fruit nectars as defined by Directive 2001/112 /EC and vegetable nectars and similar products

2,5 %

Flavoured drinks

3 %

Food supplements as defined in Directive 2002/46 /EC excluding food supplements for infants and young children

7,5 g/day

Powder with high fibre content

Confectionery

4 %

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.

Fruit juices as defined by Directive 2001/112 /EC and vegetable juices

2,5 %

Fruit nectars as defined by Directive 2001/112 /EC and vegetable nectars and similar products

4 %

Flavoured drinks

4 %

Food supplements as defined in Directive 2002/46 /EC excluding food supplements for infants and young children

12 g/day

Cakes and pastries

5 g/100 g

Processed fruit and vegetables (including vegetable-based dishes)

10 g/100 g

Bread and rolls

10 g/100 g

Pasta based products

8 g/100 g

Protein products

10 g/100 g

(2)

in Table 2 (Specifications), the entry for ‘Partially defatted chia seed ( Salvia hispanica ) powders’ is replaced by the following:

Authorised novel food

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 %

Powder with high protein content

Powder with high fibre content

Particle size

≤ 130 μm

≤ 400 μm

Chemical composition:

Salvia hispanica powder with high protein content

Salvia hispanica powder with high fibre content

Moisture

≤ 9,0 %

≤ 9,0 %

Protein

≥ 40,0 %

≥ 24,0 %

Fat

≤ 17 %

≤ 12 %

Fibre

≤ 30 %

≥ 50 %

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’

( *1 )   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 ).’