Commission Implementing Regulation (EU) 2024/2061 of 30 July 2024 authorising the placing on the market of the juice of the stems of the Angelica keiskei plant (Ashitaba stem juice) as a novel food and amending Implementing Regulation (EU) 2017/2470

• CELEX: Implementing Regulation (EU) 2024/2061
• Articles: 5

Article 1

1.   Juice of the stems of the Angelica keiskei plant (‘Ashitaba stem juice’) is authorised to be placed on the market within the Union.

Juice of the stems of the Angelica keiskei plant (‘Ashitaba stem juice’) shall be included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470.

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

Article 2

Only the company Japan Bio Science Laboratory (JBSL)-USA, Inc.  ( 19 ) is authorised to place on the market within the Union the novel food referred to in Article 1, for a period of five years from 20 August 2024, 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 Japan Bio Science Laboratory (JBSL)-USA, Inc..

Article 3

The scientific studies and 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 five years from the date of entry into force of this Regulation without the agreement of Japan Bio Science Laboratory (JBSL)-USA, Inc..

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 following entry is inserted:

Authorised novel food

Conditions under which the novel food may be used

Additional specific labelling requirements

Other requirements

Data protection

‘ Juice of the stems of the Angelica keiskei plant (“Ashitaba stem juice”)

Specified food category

Maximum levels (expressed on the juice)

The designation of the novel food on the labelling of the foodstuffs containing it shall be “Ashitaba ( Angelica keiskei ) stem juice”.

The labelling of food supplements containing the juice of the stems of the Angelica keiskei plant (Ashitaba stem juice) shall bear a statement that they should be consumed by adults only, excluding pregnant and lactating women.

Authorised on 20 August 2024. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: “Japan Bio Science Laboratory (JBSL)-USA, Inc.”, 1547 Palos Verdes Mall No 131, Walnut Creek, California 94597, United States of America.

During the period of data protection, the novel food juice of the stems of the Angelica keiskei plant (“Ashitaba stem juice”) is authorised for placing on the market within the Union only by “Japan Bio Science Laboratory (JBSL)-USA, Inc.” 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 “Japan Bio Science Laboratory (JBSL)-USA, Inc.”.

End date of the data protection: 20 August 2029’

Food Supplements as defined in Directive 2002/46/EC for the adult population, excluding pregnant and lactating women

137 mg/day

(2)

in Table 2 (Specifications), the following entry is inserted in alphabetical order: [ OP, please insert in the EN version in alphabetical order. ] ‘

Authorised Novel Food

Specification

‘ Juice of the stems of the Angelica keiskei plant (‘Ashitaba stem juice’)

Description:

The novel food is a viscous yellow liquid obtained via physical means of the stems of mature Angelica keiskei (‘Ashitaba’) plants. Angelica keiskei is native to Japan and is called Ashitaba in Japanese, hence the reference to Ashitaba stem juice.

The juice is then pasteurised, mixed with cyclodextrins at an approximate ratio of 30 % of Ashitaba stem juice to 70 % cyclodextrins, and the mixture is then sterilised, freeze-dried, and sieved.

Source:

Angelica keiskei ( family Apiaceae)

Characteristics/Composition of the juice:

Chalcones (xanthoangelol +4-hydroxyderricin) (% w/v): 1,0–2,25

Carbohydrates (%): 5,0–7,5

Water (%): 90,0–95,0

Fat (% w/v): 0,1–0,3

Protein (% w/v): 0,15-0,45

Sum of angular-type dihydropyranocoumarins: ≤ 10 mg/kg

Sum of furanocoumarins: ≤ 100 mg/kg

Heavy metals:

Lead: ≤ 0,1 mg/kg

Arsenic: ≤ 0,3 mg/kg

Mercury: ≤ 0,1 mg/kg

Cadmium: ≤ 1,0 mg/kg

Microbiological criteria:

Total viable aerobic count: ≤ 1 000 CFU/g

Total yeast/moulds count: ≤ 100 CFU/g

Escherichia coli : Absence in 10 g

Coliforms: ≤ 30 CFU/g

Salmonella spp.: Absence in 25 g

CFU: Colony Forming Units’