   
  
G/SPS/N/EU/486  
 
29 April 2021  
(21-3664) Page: 1/3 
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) 2021/669 
concerning the authorisation of technically pure L -lysine monohydrochloride and liquid 
L-lysine base produced by Corynebacterium casei  KCCM 80190 or Corynebacterium 
glutamicum  KCCM 80216 or Corynebacterium glutamicum  KCTC 12307BP as feed 
additives for all animal species (Text with EEA relevance) . Language(s):  English, French 
and Spanish . Number of pages:  7 
https://members.wto.org/crnattachments/2021/SPS/EEC/21_3138_00_e.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_3138_00_f.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_3138_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.  
In accordance with Article 7(1) of Regulation (EC) No 1831/2003, applications were 
submitted for the authorisation of liquid L -lysine base and technica lly pure L -lysine 
monohydrochloride as nutritional feed additives for use in feed and in water for drinking 
for all animal species. These applications were accompanied by the particulars and 
documents required under Article 7(3) of Regulation (EC) No 1831/ 2003.  
The applications concern the authorisation of L -lysine base, liquid, and L -lysine 
monohydrochloride, technically pure, produced by Corynebacterium casei  KCCM 80190 or 
Corynebacterium glutamicum  KCCM 80216 or Corynebacterium glutamicum  
KCTC  12307BP as  feed additives for all animal species to be classified in the additive 
category 'nutritional additives', functional group 'amino acids, their salts and analogues'.  
The European Food Safety Authority ('the Authority') concluded in its opinions of 
30 Septem ber 2020  and 18 November 2020  that, under the proposed conditions of use, 
L-lysine base, liquid, and L -lysine monohydrochloride, technically pure, produced by 
Corynebacterium casei  KCCM 80190 or Corynebacterium glutamicum  KCCM 80216 or 
Corynebacterium glut amicum  KCTC 12307BP do not have an adverse effect on animal 
health, consumer health or the environment. The Authority could conclude on the safety 
for the user of the L -lysine base, liquid, and L -lysine monohydrochloride, technically pure, 
produced by Corynebacterium glutamicum  KCCM 80216 and Corynebacterium G/SPS/N/EU/486  
 
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  glutamicum  KCTC 12307BP. It stated that of L -lysine monohydrochloride, technically 
pure, and L -lysine base, liquid, produced by Corynebacterium casei  KCCM 80190 are 
considered hazardous by inhalation and that L -lysine monohydrochloride, technically 
pure, produced by Corynebacterium casei  KCCM 80190 is a mild eye irritant. Therefore, 
appropriate protective measures should be taken to prevent adverse eff ects on human 
health, in particular as regards the users of the additive. The Authority concluded that 
L-lysine base, liquid, and L -lysine monohydrochloride, technically pure, produced by 
Corynebacterium casei  KCCM 80190 or Corynebacterium glutamicum  KCCM 80216 or 
Corynebacterium glutamicum  KCTC 12307BP, are effective sources of the essential amino 
acid L -lysine for all animal species. For the supplemental L -lysine to be fully efficacious in 
ruminants, it should be protected against degradation in the rumen . In its opinions, 
the Authority referred to a previous statement concerning potential nutritional imbalances 
for amino acids and hygienic concerns, when they are administered via water for drinking. 
However, the Authority did not propose a maximum content  for the supplementation with 
L-lysine. Thus, it is appropriate to indicate on the label of the additive, and premixtures 
containing it, an alert to take into account the dietary supply with all the essential and 
conditionally essential amino acids, partic ularly in the case of supplementation with 
L-lysine as amino acid via water for drinking.  
7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant protection, 
[ ] protect humans from animal/plant pest or disease, [  ] protect territory fro m 
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 relev ant 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) : 23 April 2021  
Proposed date of publication (dd/mm/yy) : 26 April 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  G/SPS/N/EU/486  
 
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  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  
 