   
  
G/SPS/N/EU/458  
 
12 January 2021  
(21-0395) 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):  HS Code 2309 - Preparation of a kind used in animal nutrition  
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) 2020/2118 
of 16 December 2020 concerning the renewal of the authorisation of Pediococcus 
pentosaceus  DSM 16244 as a feed additive for all animal species and repealing Regulation 
(EU) No 514/2010 (Text with EEA relev ance) . Language(s):  English, French and 
Spanish . Number of pages:  3 
https://members.wto.org/crnattachments/2021/SPS/EEC/21_0375_00_e.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_0375_00_f.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_0375_00_s.pdf  
6. Description of content:  Pediococcus pentosaceus  DSM 16244 was authorised for 
10 years as  a feed additive for all animal species by Commission Regulation 
(EU) No 514/2010. In accordance with Article 14 of Regulation (EC) No 1831/2003, an 
application was submitted for the renewal of the authorisation of Pediococcus pentosaceus  
DSM 16244 as a fe ed additive for all animal species, requesting the additive to be 
classified in the additive category 'technological additives'. That application was 
accompanied by the particulars and documents required under Article 14 of that 
Regulation. The European Fo od Safety Authority ( 'the Authority') concluded in its opinion 
of 25 May 2020 that the applicant has provided evidence that the additive complies with 
the existing conditions of authorisation. The Authority concluded that Pediococcus 
pentosaceus  DSM 16244 does not have an adverse effect on animal health, consumer 
safety or the environment. It also concluded that is not irritant to skin and eyes but 
considered a skin and respiratory sensitiser. Therefore, the Commission considers that 
appropriate protective measures should be taken to prevent adverse effects on human 
health, in particular as regards to users of the additive. The assessment of Pediococcus 
pentosaceus  DSM 16244 shows that the conditions for authorisation, as provided for in 
Article 5 of Regulat ion (EC) No 1831/2003, are satisfied. Accordingly, the authorisation 
of that additive should be renewed as specified in the Annex to this Regulation. As a 
consequence of the renewal of the authorisation of Pediococcus pentosaceus  DSM 16244 
as a feed additi ve under the conditions laid down in the Annex to this Regulation, 
Regulation (EU) No 514/2010 should be repealed.  G/SPS/N/EU/458  
 
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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) : 16 December 2020  
Proposed date of publication (dd/mm/yy) : 17 December 2020  
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 t he 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 applicabl e 
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  
 