# L_2020221EN.01008701.xml

| 10.7.2020 | EN | Official Journal of the European Union | L 221/87 |
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10.7.2020

EN

Official Journal of the European Union

L 221/87

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COMMISSION IMPLEMENTING REGULATION (EU) 2020/996

of 9 July 2020

concerning the authorisation of the preparation of carvacrol, thymol, D-carvone, methyl salicylate and L-menthol as a feed additive for chickens for fattening, chickens reared for laying and minor poultry species reared for laying (holder of authorisation Biomin GmbH)

(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 authorisation. |
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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 authorisation.

| (2) | In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a preparation of carvacrol, thymol, D-carvone, methyl salicylate and L-menthol. That application was accompanied by the particulars and documents required under Article 7(3) of that Regulation. |
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(2)

In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a preparation of carvacrol, thymol, D-carvone, methyl salicylate and L-menthol. That application was accompanied by the particulars and documents required under Article 7(3) of that Regulation.

| (3) | That application concerns the authorisation of a preparation of carvacrol, thymol, D-carvone, methyl salicylate and L-menthol as a feed additive for chickens for fattening, chickens reared for laying and minor poultry species reared for laying, to be classified in the additive category ‛zootechnical additives’. |
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(3)

That application concerns the authorisation of a preparation of carvacrol, thymol, D-carvone, methyl salicylate and L-menthol as a feed additive for chickens for fattening, chickens reared for laying and minor poultry species reared for laying, to be classified in the additive category ‛zootechnical additives’.

| (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 15 May 2019 (2) that, under the proposed conditions of use, the preparation of carvacrol, thymol, D-carvone, methyl salicylate and L-menthol does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that exposure to users by inhalation is unlikely and that no conclusion could be drawn on skin or eyes sensitisation. 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. The Authority concluded that the additive has the potential to be efficacious in improving zootechnical performance in chickens for fattening and this conclusion can be extended to chickens reared for laying and to be extrapolated to minor poultry species reared for laying. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method 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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(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 15 May 2019 (2) that, under the proposed conditions of use, the preparation of carvacrol, thymol, D-carvone, methyl salicylate and L-menthol does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that exposure to users by inhalation is unlikely and that no conclusion could be drawn on skin or eyes sensitisation. 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. The Authority concluded that the additive has the potential to be efficacious in improving zootechnical performance in chickens for fattening and this conclusion can be extended to chickens reared for laying and to be extrapolated to minor poultry species reared for laying. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

| (5) | The assessment of the preparation of carvacrol, thymol, D-carvone, methyl salicylate and L-menthol 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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(5)

The assessment of the preparation of carvacrol, thymol, D-carvone, methyl salicylate and L-menthol 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.

| (6) | 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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(6)

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

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

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

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

Done at Brussels, 9 July 2020.

For the Commission

The President

Ursula VON DER LEYEN

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

1

(2)  
  EFSA Journal 2019;17(6):5724.

2

EFSA Journal

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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 of additive/kg of complete feedingstuff with a moisture content of 12 % | | |
| Category of zootechnical additives. Functional group: other zootechnical additives (improvement of zootechnical parameters) |
| 4d20 | Biomin GmbH | Preparation of carvacrol, thymol, D-carvone, methyl salicylate and L-menthol | Additive composition

  Preparation of:






  — | carvacrol (120–160 mg/g) |

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 of additive/kg of complete feedingstuff with a moisture content of 12 %

Category of zootechnical additives. Functional group: other zootechnical additives (improvement of zootechnical parameters)

4d20

Biomin GmbH

Preparation of carvacrol, thymol, D-carvone, methyl salicylate and L-menthol

Additive composition

Preparation of:

—

carvacrol (120–160 mg/g)

| — | thymol (1–3 mg/g) |
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—

thymol (1–3 mg/g)

| — | D-carvone (3–6 mg/g) |
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—

D-carvone (3–6 mg/g)

| — | methyl salicylate (10–35 mg/g) |
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—

methyl salicylate (10–35 mg/g)

| — | L-menthol (30–55 mg/g) |
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—

L-menthol (30–55 mg/g)

| — | amorphous silica (maximum 100 mg/g) |
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—

amorphous silica (maximum 100 mg/g)

| — | hydrogenated vegetable oil (maximum 700 mg/g) |
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—

hydrogenated vegetable oil (maximum 700 mg/g)

Solid encapsulated form

Chickens for fattening

Chickens reared for laying

Minor poultry species reared for laying

—

—

—

65

105

| 1. | 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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1.

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

| 2. | The additive shall not be used with other sources of carvacrol, thymol, D-carvone, methyl salicylate and L-menthol. |
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2.

The additive shall not be used with other sources of carvacrol, thymol, D-carvone, methyl salicylate and L-menthol.

| 3. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. 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 protections. |
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3.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. 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 protections.

30.7.2030

Characterisation of the active substance:

Carvacrol (CAS number: 499-75-2)

Thymol (CAS number: 89-83-8)

D-Carvone (CAS number:2244-16-8) Methyl salicylate (CAS number: 119-36-8)

| — | L-Menthol (CAS number: 2216-51-8) |
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—

L-Menthol (CAS number: 2216-51-8)

Analytical method
   (1)

For the quantification of the active substances:

Gas chromatography coupled with flame ionisation detection (GC-FID).

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(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

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