Commission Implementing Regulation(EU) 2022/652 concerning the authorisation of bitter orange extract as a feed additive for certain animal species G/SPS/N/EU/561

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Notifying Member:EUROPEAN UNION

If applicable, name of local government involved:

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Agency responsible:European Commission, Health and Food Safety Directorate-General

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Products covered (provide tariff item number(s) as specified in national schedules deposited with the WTO; ICS numbers should be provided in addition, where applicable):Preparation of a kind used in animal nutrition (HS code: 2309)

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Regions or countries likely to be affected, to the extent relevant or practicable:

[X]    All trading partners

[ ]      Specific regions or countries:

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Title of the notified document:Commission Implementing Regulation(EU) 2022/652 concerning the authorisation of bitter orange extract as a feed additive for certain animal species (Text with EEA relevance).Language(s):English, French and Spanish.Number of pages:5

https://members.wto.org/crnattachments/2022/SPS/EEC/22_3041_00_e.pdf

https://members.wto.org/crnattachments/2022/SPS/EEC/22_3041_00_f.pdf

https://members.wto.org/crnattachments/2022/SPS/EEC/22_3041_00_s.pdf

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Description of content:Bitter orange extract was authorized 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. 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. 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 bitter orange extract for all animal species. The applicant requested bitter orange extract to be authorized also for use in water for drinking. However, Regulation (EC) No 1831/2003 does not allow the authorization of flavouring compounds for use in water for drinking. Therefore, the use of bitter orange extract in water for drinking should not be allowed. The European Food Safety Authority ('the Authority') concluded in its opinion of 23 June 2021 that, under the proposed conditions of use, bitter orange extract does not have adverse effects on animal health, consumer health or the environment. The Authority also concluded that bitter orange extract should be considered as an irritant to skin and eyes, and as 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. The Authority concluded, that bitter orange extract is recognized 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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Objective and rationale: [X] food safety, [ ] animal health, [ ] plant protection, [ ] protect humans from animal/plant pest or disease, [ ] protect territory from other damage from pests.

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Is there a relevant international standard? If so, identify the standard:

[X]      Codex Alimentarius Commission (e.g. title or serial number of Codex standard or related text):Code of practice on Good Animal Feeding CAC/RCP 54-2004

[ ]        World Organization for Animal Health (OIE) (e.g. Terrestrial or Aquatic Animal Health Code, chapter number):

[ ]        International Plant Protection Convention (e.g. ISPM number):

[ ]        None

Does this proposed regulation conform to the relevant international standard?

[X] Yes   [ ] No

If no, describe, whenever possible, how and why it deviates from the international standard:

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Other relevant documents and language(s) in which these are available:

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Proposed date of adoption (dd/mm/yy):20 April 2022

Proposed date of publication (dd/mm/yy):21 April 2022

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Proposed date of entry into force: [ ] Six months from date of publication, and/or(dd/mm/yy):This Regulation will enter into force on the twentieth day following its publication in the Official Journal of the European Union.

[X]    Trade facilitating measure

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Final date for comments: [ ] Sixty days from the date of circulation of the notification and/or (dd/mm/yy):Not applicable

Agency or authority designated to handle comments: [X] National Notification Authority, [X] National Enquiry Point. Address, fax number and e-mail address (if available) of other body:

European Commission

DG Health and Food Safety, Unit D2-Multilateral International Relations

Rue Froissart 101

B-1049 Brussels

Tel: +(32 2) 29 54263

Fax: +(32 2) 29 98090

E-mail: sps@ec.europa.eu

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Text(s) available from: [X] National Notification Authority, [X] National Enquiry Point. Address, fax number and e-mail address (if available) of other body:

European Commission

DG Health and Food Safety, Unit D2-Multilateral International Relations

Rue Froissart 101

B-1049 Brussels

Tel: +(32 2) 29 54263

Fax: +(32 2) 29 98090

E-mail: sps@ec.europa.eu