# L_2022119EN.01007901.xml

| 21.4.2022 | EN | Official Journal of the European Union | L 119/79 |
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21.4.2022

EN

Official Journal of the European Union

L 119/79

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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)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,

Whereas:

| (1) | Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such an authorisation. Article 10(2) of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2). |
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(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such an authorisation. Article 10(2) of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

| (2) | The leaves extract of Melissa officinalis L. was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for all animal species. That additive was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003. |
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(2)

The leaves extract of Melissa officinalis L. was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for all animal species. That additive was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003.

| (3) | In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of a preparation of the leaves extract of Melissa officinalis L. for all animal species. |
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(3)

In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of a preparation of the leaves extract of Melissa officinalis L. for all animal species.

| (4) | The applicant requested the additive to be classified in the additive category ‘sensory additives’ and in the functional group ‘flavouring compounds’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. |
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(4)

The applicant requested the additive to be classified in the additive category ‘sensory additives’ and in the functional group ‘flavouring compounds’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (5) | The applicant requested the preparation of the leaves extract of Melissa officinalis L. to be authorised also for use in water for drinking. However, Regulation (EC) No 1831/2003 does not allow the authorisation of flavouring compounds for use in water for drinking. Therefore, the use of the preparation of the leaves extract of Melissa officinalis L. in water for drinking should not be allowed. |
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(5)

The applicant requested the preparation of the leaves extract of Melissa officinalis L. to be authorised also for use in water for drinking. However, Regulation (EC) No 1831/2003 does not allow the authorisation of flavouring compounds for use in water for drinking. Therefore, the use of the preparation of the leaves extract of Melissa officinalis L. in water for drinking should not be allowed.

| (6) | The European Food Safety Authority (‘the Authority’) concluded in its opinions of 28 January 2020 (3) and 29 September 2021 (4) that, under the proposed conditions of use, the preparation of the leaves extract of Melissa officinalis L. does not have adverse effects on animal health, consumer health or the environment. The Authority also concluded that the exposure of users to dusts from the additive is not of concern. However, no data was provided on irritant properties for eyes or skin, thus no conclusion could be drawn on these aspects. Due to the nature of the additive, it may be assumed to be potentially both a skin and respiratory sensitiser. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. |
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(6)

The European Food Safety Authority (‘the Authority’) concluded in its opinions of 28 January 2020 (3) and 29 September 2021 (4) that, under the proposed conditions of use, the preparation of the leaves extract of Melissa officinalis L. does not have adverse effects on animal health, consumer health or the environment. The Authority also concluded that the exposure of users to dusts from the additive is not of concern. However, no data was provided on irritant properties for eyes or skin, thus no conclusion could be drawn on these aspects. Due to the nature of the additive, it may be assumed to be potentially both a skin and respiratory sensitiser. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive.

| (7) | The Authority concluded, that the preparation of the leaves extract of Melissa officinalis L. is recognised to flavour food and its function in feed would be essentially the same as that in food, therefore, no further demonstration of efficacy is considered necessary. It also verified the report on the methods of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. |
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(7)

The Authority concluded, that the preparation of the leaves extract of Melissa officinalis L. is recognised to flavour food and its function in feed would be essentially the same as that in food, therefore, no further demonstration of efficacy is considered necessary. It also verified the report on the methods of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

| (8) | The assessment of the preparation of the leaves extract of Melissa officinalis L. shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised as specified in the Annex to this Regulation. |
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(8)

The assessment of the preparation of the leaves extract of Melissa officinalis L. shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised as specified in the Annex to this Regulation.

| (9) | Certain conditions should be provided for to allow better control. In particular, a recommended content should be indicated on the label of the feed additive. Where such content is exceeded, certain information should be indicated on the label of premixtures. |
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(9)

Certain conditions should be provided for to allow better control. In particular, a recommended content should be indicated on the label of the feed additive. Where such content is exceeded, certain information should be indicated on the label of premixtures.

| (10) | The fact that the preparation of the leaves extract of Melissa officinalis L. is not authorised for use as a flavouring in water for drinking does not preclude its use in compound feed which is administered via water. |
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(10)

The fact that the preparation of the leaves extract of Melissa officinalis L. is not authorised for use as a flavouring in water for drinking does not preclude its use in compound feed which is administered via water.

| (11) | Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the preparation concerned, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation. |
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(11)

Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the preparation concerned, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

| (12) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
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(12)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

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.

Official Journal of the European Union

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 20 April 2022.

For the Commission

The President

Ursula VON DER LEYEN

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(1)  
  OJ L 268, 18.10.2003, p. 29.

1

(2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs

2

(OJ L 270, 14.12.1970, p. 1).

(3)  EFSA Journal 2020;18(2):6016.

3

(4)  EFSA Journal 2021;19(10):6904.

4

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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) |

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

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| 1. | The additive shall be incorporated into the feed in the form of a premixture. |
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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. |
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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’. |
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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. |
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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. |
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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. |
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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

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

1

(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.

2

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