Commission Implementing Regulation (EU) 2018/461 of 20 March 2018 authorising an extension of use of taxifolin-rich extract 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) 2018/461
• Articles: 4

Article 1

1.   The entry in the Union list of authorised novel foods as provided for in Article 8 of Regulation (EU) 2015/2283 referring to the substance taxifolin-rich extract shall be amended as specified in the Annex to this Regulation.

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.

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 entry for ‘Taxifolin-rich extract’ in Table 1 (Authorised novel foods) is replaced by the following:

Authorised novel food

Conditions under which the novel food may be used

Additional specific labelling requirements

Other requirements

‘ Taxifolin-rich extract

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be “taxifolin-rich extract”’

Yogurt plain/Yogurt with fruits (*)

0,020 g/kg

Kephir (*)

0,008 g/kg

Buttermilk (*)

0,005 g/kg

Milk powder (*)

0,052 g/kg

Cream (*)

0,070 g/kg

Sour cream (*)

0,050 g/kg

Cheese (*)

0,090 g/kg

Butter (*)

0,164 g/kg

Chocolate confectionery

0,070 g/kg

Non-alcoholic beverages

0,020 g/l

Food supplements as defined in Directive 2002/46/EC intended for the general population, excluding infants, young children, children and adolescents younger than 14 years

100 mg/day

(*)

When used in milk products Taxifolin-rich extract may not replace in whole or in part, any milk constituent

(2)

The entry for ‘Definition’ for ‘Taxifolin-rich extract’ in in Table 2 (Specifications) is replaced by the following:

Authorised Novel Food

Specification

‘ Taxifolin-rich extract

Definition:

Chemical name: [(2R,3R)-2-(3,4 dihydroxyphenyl)-3,5,7-trihydroxy-2,3-dihydrochromen-4-one, also called (+) trans (2R,3R)- dihydroquercetin] and with no more than 2 % of the cis-form’