# L_2022207EN.01001901.xml

| 9.8.2022 | EN | Official Journal of the European Union | L 207/19 |
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9.8.2022

EN

Official Journal of the European Union

L 207/19

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COMMISSION IMPLEMENTING REGULATION (EU) 2022/1383

of 8 August 2022

concerning the authorisation of olibanum extract from Boswellia serrata Roxb.ex Colebr. as a feed additive for horses and dogs

(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) | Olibanum extract 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)

Olibanum extract 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 olibanum extract from Boswellia serrata Roxb. ex Colebr. for horses and dogs. |
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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 olibanum extract from Boswellia serrata Roxb. ex Colebr. for horses and dogs.

| (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 European Food Safety Authority (‘the Authority’) concluded in its opinion of 27 January 2022 (3) that, under the proposed conditions of use, olibanum extract from Boswellia serrata Roxb. ex Colebr. does not have adverse effects on animal health, consumer health or the environment. The Authority also concluded that olibanum extract from Boswellia serrata Roxb. ex Colebr. should be considered as a non-irritant to skin and eyes, but in the absence of data, no conclusion could be drawn on its potential to be a dermal 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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(5)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 27 January 2022 (3) that, under the proposed conditions of use, olibanum extract from Boswellia serrata Roxb. ex Colebr. does not have adverse effects on animal health, consumer health or the environment. The Authority also concluded that olibanum extract from Boswellia serrata Roxb. ex Colebr. should be considered as a non-irritant to skin and eyes, but in the absence of data, no conclusion could be drawn on its potential to be a dermal 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.

| (6) | The Authority further concluded, that olibanum extract from Boswellia serrata Roxb. ex Colebr. 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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(6)

The Authority further concluded, that olibanum extract from Boswellia serrata Roxb. ex Colebr. 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.

| (7) | The assessment of olibanum extract from Boswellia serrata Roxb. ex Colebr. 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 substance should be authorised as specified in the Annex to this Regulation. |
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(7)

The assessment of olibanum extract from Boswellia serrata Roxb. ex Colebr. 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 substance should be authorised as specified in the Annex to this Regulation.

| (8) | Certain conditions should be provided for to allow better control. In particular, a recommended content should be indicated on the label of the additives. Where such content is exceeded, certain information should be indicated on the label of premixtures. |
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(8)

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

| (9) | Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the substance 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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(9)

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

| (10) | 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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(10)

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 substance 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 substance specified in the Annex and premixtures containing this substance, which are produced and labelled before 28 February 2023 in accordance with the rules applicable before 29 August 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 substance as specified in the Annex which are produced and labelled before 29 August 2023 in accordance with the rules applicable before 29 August 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 substance as specified in the Annex which are produced and labelled before 29 August 2024 in accordance with the rules applicable before 29 August 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, 8 August 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 (OJ L 270, 14.12.1970, p. 1).

2

(3)  
  EFSA Journal 2022;20(3):7158.

3

EFSA Journal

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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 additive/kg of complete feed with a moisture content of 12 % |
| Category: Sensory additives. Functional group: Flavouring compounds |
| 2b2816-ex | Olibanum extract | Additive composition

  Dry extract of olibanum from Boswellia serrata Roxb. ex Colebr.
  Solid form
  Methyleugenol ≤ 0,009 %
  Estragole ≤ 0,028 %

  Characterisation of the active substance

  Dry extract of olibanum produced by extraction from the oleoresin of Boswellia serrata Roxb. ex Colebr. as defined by the Council of Europe (1).
  Olibanum oil:
  FEMA number: 2816
  Boswellic acids: ≥ 65 %
  11-keto-β-boswellic acid (KBA): 2,53-3,86 %
  CAS number: 17019-92-0
  3-O-acetyl-11-keto β-boswellic acid (AKBA): 2,35–3,57 %
  CAS number: 67416-61-9

  Analytical method
   (2)

  For the determination of 11-keto-β-boswellic acid and 3-O-acetyl-11-keto-β-boswellic acid (phytochemical markers) in the feed additive (olibanum extract):






  — | high performance liquid chromatography (HPLC) with spectrophotometric (UV) detection – European Pharmacopeia monograph ‘Indian Frankincense (Olibanum indicum)’ |

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

Category: Sensory additives. Functional group: Flavouring compounds

2b2816-ex

Olibanum extract

Additive composition

Dry extract of olibanum from Boswellia serrata Roxb. ex Colebr.

Solid form

Methyleugenol ≤ 0,009 %

Estragole ≤ 0,028 %

Characterisation of the active substance

Dry extract of olibanum produced by extraction from the oleoresin of Boswellia serrata Roxb. ex Colebr. as defined by the Council of Europe (1).

Olibanum oil:

FEMA number: 2816

Boswellic acids: ≥ 65 %

11-keto-β-boswellic acid (KBA): 2,53-3,86 %

CAS number: 17019-92-0

3-O-acetyl-11-keto β-boswellic acid (AKBA): 2,35–3,57 %

CAS number: 67416-61-9

Analytical method
   (2)

For the determination of 11-keto-β-boswellic acid and 3-O-acetyl-11-keto-β-boswellic acid (phytochemical markers) in the feed additive (olibanum extract):

—

high performance liquid chromatography (HPLC) with spectrophotometric (UV) detection – European Pharmacopeia monograph ‘Indian Frankincense (Olibanum indicum)’

Horses

Dogs

-

-

-

| 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. | Mixture with other additives containing methyleugenol and estragole is not permitted. |
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3.

Mixture with other additives containing methyleugenol and estragole is not permitted.

| 4. | On the label of the additive the following shall be indicated: |
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4.

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 %:

| — | horses: 100 mg; |
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—

horses: 100 mg;

| — | dogs: 330 mg.’ |
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—

dogs: 330 mg.’

| 5. | 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 4. |
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5.

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 4.

| 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 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 and breathing protection.

29 August 2032

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(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://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

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