G/SPS/N/EU/463  
 
9 March 2021  
(21-1965) 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 use 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) 2021/363 
of 26 February 2021 concerning the authorisation of a preparation of fumonisin esterase 
produced by Komagataella phaffii DSM 32159 as a feed additive for all animal species 
(Text with EEA relevance) . Langua ge(s):  English, French and Spanish . Number of 
pages:  3 
https://members.wto.org/crnattachments/2021/SPS/EEC/21_1737_00_e.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_1737_00_f.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_1737_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 a preparation of fumonisin esterase  
produced by Komagataella phaffii  DSM 32159. That application was accompanied by the 
particulars and documents required under Article 7 of Regulation (EC) No 1831/2003. 
The application concerns the authorisation of a preparation of fumonisin esterase 
produ ced by Komagataella phaffii  DSM 32159 as a feed additive for all animal species, to 
be classified in the additive category "technological additives". The European Food Safety 
Authority ("the Authority") concluded in its opinion of 1 July 2020 that, under t he 
proposed conditions of use, the preparation of fumonisin esterase produced by 
Komagataella phaffii  DSM 32159 does not have an adverse effect on animal health, 
consumer safety or the environment. It also concluded that the additive is not toxic by 
inhala tion and the respiratory exposure is likely to be low but a risk of sensitisation via 
the respiratory route could not be excluded. The additive is non -irritant to skin and eyes 
and is not considered a as a dermal sensitiser. Therefore, the Commission consi ders that 
appropriate protective measures should be taken to prevent adverse effects on human 
health, in particular as regards the users of the additive. The Authority also concluded 
that the preparation concerned has the capability to degrade fumonisins i n fermenting 
feed (with a fumonisin content within the limits operating in the Union) but only in silages, 
not in other fermenting feeds. The Authority does not consider that there is a need for 
specific requirements of post -market monitoring. It also veri fied the report on the 
methods of analysis of the feed additive in feed submitted by the Reference Laboratory G/SPS/N/EU/463  
 
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  set up by Regulation (EC) No 1831/2003. The assessment of the preparation of fumonisin 
esterase produced by Komagataella phaffii DSM 32159 shows t hat 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.  
7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant pro tection, 
[ ] 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) : 26 February 2021  
Proposed date of publication (dd/mm/yy) : 1 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 a ddress 
(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