Commission Implementing Regulation (EU) 2018/1559 of 17 October 2018 concerning the authorisation of cumin tincture (Cuminum cyminum L.) as a feed additive for all animal species (Text with EEA relevance.)

• CELEX: Implementing Regulation (EU) 2018/1559
• Articles: 3

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 a feed additive in animal nutrition subject to the conditions laid down in that Annex.

Article 2 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

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

Category: Sensory additives. Functional group: Flavouring compounds

2b161

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Cumin tincture

Additive composition

Cumin tincture of Cuminum cyminum L.

Characterisation of the active substance

Tincture from Cuminum cyminum L. seeds as defined by the Council of Europe  ( 1 ) .

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98 % ± 0,5 % of a water/ethanol (3:1, v/v) mixture;

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2 ± 0,5 % of plant derived compounds;

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total flavonoids ≤ 300 ppm;

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total polyphenols ≤ 560 ppm;

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total p-menth-3-en-7-al ≤ 8 ppm;

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phytochemical marker: 4-iso-propylbenzaldehyde (cuminaldehyde): 25 ± 5 ppm.

Liquid form

CoE No 161

Method of analysis

( 2 )

For the quantification of the phytochemical marker (4-iso-propylbenzaldehyde) in the feed additive: gas chromatography coupled with flame ionisation detection (GC-FID)

All animal species

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1.

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

2.

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

3.

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 %: 0,03 ml/kg feed’

4.

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 eyes 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.

7 November 2028

( 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