G/SPS/N/EU/517  
 
30 November 2021  
(21-8995) 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) 2021/2095 
of 29 November 2021  concerning the authorisation of L -lysine base, L -lysine 
monohydrochloride and L -lysine sulphate as feed additives for all animal specie s (Text with 
EEA relevance) . Language(s):  English, French and Spanish . Number of pages:  8 
https://members.wto.org/crnattachments/2021/SPS/EEC/21_7413_00_e.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_7413_00_f.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_7413_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 
an authorisation. In accordance with Article 7 of Regulation (EC) No 1831/2003, 
applications were submitted for the authorisation of L -lysine base, L -lysine 
monohydro chloride and L -lysine sulphate. The applications were accompanied by the 
particulars and documents required under Article 7(3) of that Regulation. The applications 
concern the authorisation of L -lysine base and L -lysine monohydrochloride produced by 
Coryne bacterium glutamicum  KCCM 80183, L -lysine monohydrochloride and L -lysine 
sulphate produced by Corynebacterium glutamicum  CCTCC M 2015595 and L -lysine 
sulphate produced by Corynebacterium glutamicum  KCCM 80227 as feed additives for all 
animal species, to be  classified in the additive category 'nutritional additives ', functional 
group 'amino acids, their salts and analogues '. 
7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant protection, 
[ ] protect humans from animal/plant pest or dis ease, [  ] 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) :  G/SPS/N/EU/517  
 
- 2 - 
 
  [ ] 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:   
9. Other relevant documents and language(s) in which these are available:    
10. Proposed date of adoption (dd/mm/yy) : 29 November 2021  
Proposed date of publication (dd/mm/yy) : 30 November 2021  
11. Proposed date of entry into force: [  ] Six months from date of publication , and/or  
(dd/mm/yy) : This Regulation entered into force on the t wentieth day following 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