G/SPS/N/EU/505  
 
2 September 2021  
(21-6568) 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) 2021/1425 
of 31 August 2021 concerning the authorisation of manganese chelate of lysine and 
glutamic acid as feed additive for all animal species (Text with EEA relevance) . 
Language(s):  English, French and Spanish . Number of pages:  5 
https://members.wto.org/crnattachments/2021/SPS/EEC/21_5519_00_e.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_5519_00_f.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_5519_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 of Regulation (EC) No 1831/2003, an 
application was submitted for the authorisation of manganese chelate of lysine and 
glutamic acid. The application was accompanied by the particulars and documents required 
under Article 7(3) of Regulation (EC) No 1831/2003. The application concerns the 
authorisation of the preparation of manganese chelate of lysine and glutamic acid as a 
feed additive for all animal species to be classified in the additive category 'nutritional 
additives' and the functional group 'compounds of trace elements'. The European Food 
Safety Authority ('the Authority') concluded in its opinions of 10 January 2020 a nd 
27 January 2021 that, under the proposed conditions of use, manganese chelate of lysine 
and glutamic acid does not have an adverse effect on animal health, consumer safety or 
the environment. The Authority concluded that the handling of the additive pos es a risk to 
users by inhalation and that it should be considered as an eye irritant, skin and respiratory 
sensitiser. Therefore, the Commission considers that appropriate protective measures 
should be taken to prevent adverse effects on human health, in p articular as regards the 
users of the additive. The Authority concluded that the additive is efficacious in chickens 
for fattening; this conclusion can be extended to all other animal species. The Authority 
does not consider that there is a need for specif ic requirements of post -market monitoring. 
It also verified the report on the method of analysis of the feed additive in feed submitted 
by the Reference Laboratory set up by Regulation (EC) No 1831/2003. The assessment of 
manganese chelate of lysine and gl utamic acid shows that the conditions for authorisation, 
as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, 
the use of that preparation should be authorised as specified in the Annex to this 
Regulation.  G/SPS/N/EU/505  
 
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  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 standard:   
9. Other relevant documents and language(s) in which these are available:    
10. Proposed date of adoption (dd/mm/yy) : 31 August 2021  
Proposed date of publication (dd/mm/yy) : 1 September 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 numb er 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