Commission Implementing Regulation (EU) 2019/111 of 24 January 2019 concerning the authorisation of hop extract (Humulus lupulus L. flos) as a feed additive for weaned piglets, pigs for fattening and minor porcine species weaned and for fattening (Text with EEA relevance.)

• CELEX: Implementing Regulation (EU) 2019/111
• 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

mg/kg of complete feed with a moisture content of 12 %

Category: Sensory additives. Functional group: Flavouring compounds

2b233

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Hop extract (strobiles) rich in beta acids

Additive composition

Preparation of supercritical carbon dioxide extract of Humulus lupulus L. flos extract treated with potassium hydroxide to form potassium salts of the beta acids and dissolved in propylene glycol.

The specifications of the additive are:

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Beta-acids: 40 ± 1,5 %

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Alpha acids: 0,4 ± 0,3 %

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Hop oils: 1,5 ± 0,3 %

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Propylene glycol: 20 ± 15 %

—

Moisture < 8 %

—

Ash: 10 ± 2 %

—

Other resins: 25 ± 8 %

—

8-Prenylnaringenin < 500 mg/kg

—

Xanthohumol < 500 mg/kg

—

2-Methyl-2-buten-2-ol < 10 mg/kg

Characterisation of the active substance

Humulus lupulus L. flos flowers (strobiles) pelleted and further extracted with supercritical carbon dioxide extraction

Liquid viscous form

CAS number: 8060-28-4

CoE No 233

Analytical method

( 1 )

For the quantification of hops beta-acids in the feed additive:

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reversed phase high performance liquid chromatography with UV detection (HPLC-UV) – ring-trial validated European Brewery Convention (EBC) method 7.7

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Weaned piglets and pigs for fattening

—

Minor porcine species weaned and for fattening

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—

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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 and premixtures the following shall be indicated:

‘Recommended maximum content of the additive of complete feedingstuff with a moisture content of 12 %: 50 mg/kg’

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.

14 February 2029

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