Commission Implementing Regulation (EU) 2022/653 of 20 April 2022 concerning the authorisation of a preparation of the leaves extract of Melissa officinalis L. as a feed additive for all animal species (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2022/653
• 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 11 November 2022 in accordance with the rules applicable before 11 May 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 11 May 2023 in accordance with the rules applicable before 11 May 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 11 May 2024 in accordance with the rules applicable before 11 May 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

2b280-ex

Leaves extract of Melissa officinalis L.

Additive composition

Preparation of the leaves extract of Melissa officinalis L. (with a minimum content of 50 %) with maltodextrin and silicon dioxide.

Solid form

Characterisation of the active substance

Dried aqueous ethanol extract from Melissa officinalis L. leaves as defined by the Council of Europe  ( 1 )

Total phenolic compounds (total hydroxycinnamic acid derivatives):

≥ 10 %

Flavonoids: ≤ 3 mg/kg

Rosmarinic acid: 3-6 %

Dry matter ≥ 94 %

CAS number: 84082-61-1

Einecs number: 282-007-0

FEMA number: 2112

CoE number: 280

Analytical method  ( 2 )

For the quantification of rosmarinic acid (phytochemical marker) in the feed additive ( Melissa officinalis L. dry extract):

—

reversed phase high performance liquid chromatography coupled to spectrophotometric detection (HPLC-UV) (European Pharmacopoeia monograph 2524)

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 %: 100 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 leaves extract of Melissa officinalis L. with other authorised additives obtained from Melissa officinalis L. 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, eye and breathing protection.

11 May 2032

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

( 2 )   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.