Commission Implementing Regulation (EU) 2017/307 of 21 February 2017 concerning the authorisation of dry grape extract of Vitis vinifera spp. vinifera as a feed additive for all animal species except for dogs (Text with EEA relevance. )

• CELEX: Implementing Regulation (EU) 2017/307
• Articles: 4

Article 1 Authorisation

The substance specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’, is authorised as feed additives in animal nutrition subject to the conditions laid down in that Annex.

Article 2 Transitional measures

1.   The substance specified in the Annex and premixtures containing that substance, which are produced and labelled before 14 October 2017 in accordance with the rules applicable before 14 March 2017 may continue to be placed on the market and used until the existing stocks are exhausted.

2.   Compound feed and feed materials containing the substance as specified in the Annex which are produced and labelled before 14 March 2018 in accordance with the rules applicable before 14 March 2017 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.

3.   Compound feed and feed materials containing the substance as specified in the Annex which are produced and labelled before 14 March 2019 in accordance with the rules applicable before 14 March 2017 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.

Article 3 Entry into force

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

Identification number of the additive

Name of the holder of authorisation

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg of active substance/kg of complete feedingstuff with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b485

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Dry grape extract

Additive composition

Dry grape extract of Vitis vinifera spp. vinifera

Characterisation of the active substance

Mixture of seed and skin extract as defined by the Council of Europe  ( 1 )

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≥ 80 % polyphenols expressed as catechin equivalent,

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≥ 60 % proanthocyanidins,

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≥ 0,75 %: anthocyanins and anthocyanidins,

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≤ 10 % water content.

CoE No 485

CAS number 85594-37-2

FEMA 4045

Method of analysis

( 2 )

For the determination of dry grape extract in the feed additive:

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high performance liquid chromatography coupled to UV detection (HPLC-UV) for the identification of gallic acid as the phytomarker, and

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spectrophotometry at 280 nm for the quantification of total polyphenols content, expressed as catechin equivalent.

All animal species except dogs

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1.

Dry grape extract of Vitis vinifera spp. vinifera may be placed on the market and used as an additive consisting of a preparation.

2.

The additive shall be incorporated into the feed in the form of a premixture.

3.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

4.

The recommended maximum content of the active substance shall be 100 mg/kg of complete feedingstuff with a moisture content of 12 %.

5.

On the label of the additive the following shall be indicated:

‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 100 mg/kg’.

6.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 100 mg/kg.

7.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eye contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

14 March 2027

( 1 )   Natural sources of flavourings — Report No 2 (2007)

( 2 )   Details of the methods of analysis are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports