G/SPS/N/EU/561  
 
26 April 2022  
(22-3320) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  NOTIFICATION  
1. Notifying Member:  EUROPEAN UNION  
If applicable, name of local government involved:   
2. Agency responsible:  European Commission, Health and Food Safety Directorate -General  
3. 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)  
4. Regions or countries likely to be affected, to the extent relevant or practicable : 
[X] All trading partners   
[ ] Specific regions or countries:   
5. 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  
6. 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 extra ct 
to be authorized also for use in water for drinking. However, Regulation (EC) 
No 1831/2003 does not allow the authori zation of flavouring compounds for use in water 
for drinking. Therefore, the use of bitter orange extract in water for drinking should n ot 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 environmen t. 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 a dverse 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 furt her 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.  G/SPS/N/EU/561  
 
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  7. Objective and rationale: [X]  food s afety, [  ] animal health, [  ] plant protection, 
[ ] protect humans from animal/plant pest or disease, [  ] protect territory from 
other damage from pests.   
8. 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 stand ard:  
9. Other relevant documents and language(s) in which these are available:    
10. Proposed date of adoption (dd/mm/yy) : 20 April 2022  
Proposed date of publication (dd/mm/yy) : 21 April 2022  
11. 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   
12. Final date for comments: [  ] Sixty days fr om 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 ot her 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  
13. 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