Commission Implementing Regulation (EU) 2018/469 of 21 March 2018 authorising the placing on the market of an extract of three herbal roots (Cynanchum wilfordii Hemsley, Phlomis umbrosa Turcz. and Angelica gigas Nakai) 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. )

• CELEX: Implementing Regulation (EU) 2018/469
• Articles: 4

Article 1

1.   An extract of three herbal roots ( Cynanchum wilfordii Hemsley, Phlomis umbrosa Turcz. and Angelica gigas Nakai) as specified in the Annex to this Regulation shall be included in the Union list of authorised novel foods as provided for in Article 8 of Regulation (EU) 2015/2283.

2.   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.

3.   The authorisation provided for in this Article shall be without prejudice to the provisions of Directive 2002/46/EC.

Article 2

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

Article 3

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)

the following entry is inserted in Table 1 (Authorised novel foods) in alphabetical order:

Authorised novel food

Conditions under which the novel food may be used

Additional specific labelling requirements

Other requirements

‘ Extract of three herbal roots ( Cynanchum wilfordii Hemsley, Phlomis umbrosa Turcz. and Angelica gigas Nakai)

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be “extract of three herbal roots ( Cynanchum wilfordii Hemsley, Phlomis umbrosa Turcz. and Angelica gigas Nakai)”.

The labelling of food supplements containing the extract of mixture of the three herbal roots shall bear a statement in close proximity to the list of ingredients indicating that it should not be consumed by individuals with known celery allergy.’

Food Supplements as defined in Directive 2002/46/EC for adult population

175 mg/day

(2)

the following entry is inserted in Table 2 (Specifications) in alphabetical order:

Authorised Novel Food

Specification

‘ Extract of three herbal roots ( Cynanchum wilfordii Hemsley, Phlomis umbrosa Turcz. and Angelica gigas Nakai)

Description/Definition:

The mixture of the three herbal roots is yellowish brown fine powder produced by hot-water extraction, concentration by evaporation, and spray drying

Composition of the extract of mixture of the 3 herbal roots:

Cynanchum wilfordii root: 32,5 % (w/w)

Phlomis umbrosa root: 32,5 % (w/w)

Angelica gigas root: 35,0 % (w/w)

Specifications:

Loss on drying: NMT 100 mg/g

Assay:

Cinnamic acid: 0,012 – 0,039 mg/g

Shanzhiside methyl ester: 0,20 – 1,55 mg/g

Nodakenin: 3,35 – 10,61 mg/g

Methoxsalen: < 3 mg/g

Phenols: 13,0 – 40,0 mg/g

Coumarins: 13,0 – 40,0 mg/g

Iridoids: 13,0 – 39,0 mg/g

Saponins: 5,0 – 15,5 mg/g

Nutritive components:

Carbohydrates: 600 – 880 mg/g

Proteins: 70 – 170 mg/g

Fats: < 4 mg/g

Microbiological parameters:

Total viable plate count: < 5 000 CFU/g

Total mould and yeast: < 100 CFU/g

Coliform bacteria: < 10 CFU/g

Salmonella : Negative/25 g

Escherichia coli : Negative/25 g

Staphylococcus aureus : Negative/25 g

Heavy metals:

Lead: < 0,65 mg/kg

Arsenic: < 3,0 mg/kg

Mercury: < 0,1 mg/kg

Cadmium: < 1,0 mg/kg

CFU: Colony Forming Units’