G/SPS/N/EU/469  
 
17 March 2021  
(21-2233) 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) 2021/426 
of 10 March 2021 correcting Implementing Regulation (EU) No 1263/2011 as regards the 
authorisation of Lactococcus lactis  (NCIMB 30160) as a feed additive for all animal species 
(Text with EEA relevance) . Language(s):  English, French and Spanish . Number of 
pages:  3 
https://members.wto.org/crnattachments/2021/SPS/EEC/21_1974_00_e.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_1974_00_f.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_1974_00_s.pdf  
6. Description of content:  The use of the preparation of Lactococcus lactis  NCIMB 30160 
as a feed additive was authorised for all animal species by Commission Implementing 
Regulation (EU) No 1263/2011 for a 10 - year period. The authorisation was subsequently 
modified by Commission Implementing Regulation (EU) 2020/1092 in accordance with 
Article  13(2) of Regulation (EC) No 1831/2003, as regards the formulation of the additive. 
The intended modification did not concern the period of authorisation laid down in 
Implementing Regulation (EU) No 1263/2011, which was to run until 26 December 2021. 
Howev er, in the Annex to Implementing Regulation (EU) 2020/1092, it was mistakenly 
indicated that the period of authorisation for Lactococcus lactis  NCIMB 30160 was to run 
until 16 August 2030. That error was therefore inserted in Implementing Regulation 
(EU) No 1263/2011 through Implementing Regulation (EU) 2020/1092. For reasons of 
clarity and legal certainty, it is therefore necessary to correct Implementing Regulation 
(EU) No 1263/2011 as regards the end of period of authorisation for Lactococcus lactis  
NCIM B 30160. Implementing Regulation (EU) 2020/1092 provided that the modification 
to be brought to the terms of the authorisation of the additive Lactococcus lactis  
NCIMB  30160 only concerned the formulation of the additive. No reference was made to 
the need to modify the period of authorisation of that additive. In addition, Article 9(8) of 
Regulation (EC) No 1831/2003 prescribes that authorisations are granted for a period of 
10 years and such rule may not be derogated from through a modification to the term s 
of an authorisation. Moreover, the Register of feed additives continued to mention the 
date of 26 December 2021 as the expiry date of the authorisation of the additive 
Lactococcus lactis  NCIMB 30160, even after the adoption of Implementing Regulation 
(EU) 2020/1092. The absence of retroactive effect of the proposed correction would lead G/SPS/N/EU/469  
 
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  to a breach of the principle of non - discrimination between operators, as the granting of 
an extended period of authorisation from the date of entry.  
7. Objective and rat ionale: [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 t he 
international standard:   
9. Other relevant documents and language(s) in which these are available:    
10. Proposed date of adoption (dd/mm/yy) : 10 March 2021  
Proposed date of publication (dd/mm/yy) : 11 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 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  
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