G/SPS/N/EU/467  
 
17 March 2021  
(21-2243) 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 Implemening Regulation 2021/420 of 
9 March 2021 correcting Implementing Regulation (EU) 2020/1097 concerning the 
authorisation of lutein -rich and lutein/zeaxanthin extracts from Tagetes erecta  as feed 
additives for poultry (except turkeys) for fattening an d laying and for minor poultry 
species for fattening and laying (Text with EEA relevance) . Language(s):  English, French 
and Spanish . Number of pages:  5 
https://members.wto.org/crnattachments/2021/SPS/EEC/21_1972_00_e.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_1972_00_f.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_1972_00_s.pdf  
6. Description of content:  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. Article 10(2) of Regulation (EC) No 1831/2003 provides for the re -
evaluation of additives authorised pursuant to Council Directive 70/524/EEC and Artic le 4 
for the authorisation of a new use of an additive. Lutein -rich and lutein/zeaxanthin 
extracts from Tagetes erecta  were authorised by Commission Implementing Regulation 
(EU) 2020/1097  concerning the authorisation of lutein -rich and lutein/zeaxanthin ex tracts 
from Tagetes erecta  as feed additives for poultry (except turkeys) for fattening and laying 
and for minor poultry species for fattening and laying. The European Food Safety Authority 
("the Authority") concluded in its opinion of 3 April 2019  that th e maximum proposed use 
level of 80 mg total carotenoids/kg of complete feed for lutein -rich and lutein/zeaxanthin 
extracts is safe for poultry for fattening (except turkeys), minor poultry for fattening, 
poultry for laying (except turkeys) and minor poultr y for laying. By mistake, the heading 
of the sixth and seventh columns of the Annex to Implementing Regulation 
(EU) 2020/1097 refers to "mg of active substance of kg of complete feeding stuff with a 
moisture content of 12 %". That reference is not correct as the EFSA opinion refers to the 
"total carotenoids". It is therefore appropriate to correct the heading of the sixth and 
seventh columns of the table in the Annex to that Implementing Regulation to reflect the 
wording appearing in the EFSA opinion of 3 A pril 2019. The references to "poultry for 
fattening (except turkeys)" and "poultry for laying, (except turkeys)" have been modified 
to "chickens for fattening" and "laying hens". This change does not affect or modify the 
categories of animals currently aut horised, as the term "poultry" covers turkeys for laying G/SPS/N/EU/467  
 
- 2 - 
 
  and fattening, chickens for fattening and laying hens. Therefore, it is more appropriate to 
refer directly to chickens for fattening and laying hens.  
7. 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.   
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) : 9 March 2021  
Proposed date of publication (dd/mm/yy) : 10 March 2021  
11. Proposed date of entry into force: [  ] Six months from date of publication , 
and/or  (dd/mm/yy) : This Regulation shall enter into force on the twentieth day 
following that of its publication in the Official Journal of the European Union.  
[X] Trade facilitating measure   
12. 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 availab le) 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  
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