Commission Implementing Regulation (EU) 2022/537 of 4 April 2022 concerning the authorisation of a preparation of lemon extract as a feed additive for all animal species (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2022/537
• Articles: 4

Article 1 Authorisation

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

Article 2 Transitional measures

1.   The preparation specified in the Annex and premixtures containing this preparation, which are produced and labelled before 25 October 2022 in accordance with the rules applicable before 25 April 2022 may continue to be placed on the market and used until the existing stocks are exhausted.

2.   Compound feed and feed materials containing the preparation as specified in the Annex which are produced and labelled before 25 April 2023 in accordance with the rules applicable before 25 April 2022 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 preparation as specified in the Annex which are produced and labelled before 25 April 2024 in accordance with the rules applicable before 25 April 2022 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

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

Category: Sensory additives. Functional group: Flavouring compounds

2b139a-ex

Lemon extract

Additive composition

Preparation of lemon extract derived from the fruit of Citrus limon (L.) Osbeck  ( 1 ) with propionic acid ≤ 1 %.

Liquid form

All animal species

-

-

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 per kg of complete feedingstuff with a moisture content of 12 %: 1 000 mg’.

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3.

5.

The mixture of lemon extract with other authorised additives obtained from Citrus limon (L.) Osbeck shall not be allowed in feedingstuffs.

6.

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 skin and eye protection.

25 April 2032

Characterisation of the active substance

Aqueous extract of the material remaining after the extraction of juice from the fruit of Citrus limon (L.) Osbeck as defined by the Council of Europe  ( 2 ) .

Dry matter: 51-53 %

Total polyphenols (expressed as

pyrogallol equivalents): ≥ 1 %

Eriocitrin: ≥ 4 000 mg/kg

Hesperidin: ≥ 2 000 mg/kg

Limonin: 36-92 mg/kg

Nomilin: 14-113 mg/kg

Citric acid: 4-7 %

Osidic compounds: ≥ 42 %

CAS number: 84929-31-7

Einecs number: 284-515-8

FEMA number: 2623

CoE number: 139a

Analytical method

( 3 )

For the quantification of the phytochemical marker (total polyphenols) in the feed additive:

—

spectrophotometry at 760 nm expressing the total polyphenols content as pyrogallol equivalent (European Pharmacopoeia monograph 2.8.14)

( 1 )   Synonym Citrus Limon (L.) Burm. f.

( 2 )   Natural sources of flavourings – Report No 2 (2007).

( 3 )   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.