G/SPS/N/EU/589  
 
11 August 2022  
(22-6081) 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):  Preparations of a kind used in animal feeding (HS code(s): 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) 2022/1382 
of 8 August 2022 concerning the authorisation of a preparation of Propioniba cterium 
freudenreichii DSM 33189 and Lentilactobacillus buchneri  DSM 12856 as a feed additive for 
all animal species (Text with EEA relavance) . Language(s):  English, French and Spanish . 
Number of pages:  3 
https://members.wto.org/crnattachments/2022/SPS/EEC/22_5416_00_e.pdf  
https://members.wto.org/crnattachments/2022/SPS/EEC/22_5416_00_f.pdf  
https://members.wto.org/crnattachments/2022/SPS/EEC/22_5416_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(1) of Regulation (EC) No 1831/2003, 
an application was submitted for the authorisation of a preparation of 
Propionibact erium  freudenreichii  DSM 33189 and Lentilactobacillus buchneri  DSM12856. 
That 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 prepar ation of Propionibacterium freudenreichii  DSM 33189 and 
Lentilactobacillus  buchneri  DSM 12856 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 26 January 2022 that, under the 
proposed conditions of use, the preparation of Propionibacterium freudenreichii  DSM 33189 
and Lentilactobacillus buchneri  DSM 12856 does not have an adverse effect on animal 
health, consumer sa fety or the environment. It also concluded that the additive is not 
irritant for eyes and skin but should be considered a respiratory sensitiser and no 
conclusions could be drawn on the skin sensitisation potential of the additive. Therefore, 
the Commissio n considers 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 potential to 
improve the pr eservation of nutrients in silage prepared with easy and moderately difficult 
to ensile material. It also verified the report on the method of analysis of the feed 
additives in feed submitted by the Reference Laboratory set up by Regulation (EC) 
No 1831/20 03. The assessment of the preparation of Propionibacterium freudenreichii  
DSM 33189 and Lentilactobacillus buchneri  DSM12856 shows that the conditions for G/SPS/N/EU/589  
 
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  authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003 are satisfied. 
Accordingl y, the use of the preparation should be authorised as specified in the Annex to 
this Regulation.  
7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant protection, 
[ ] protect humans from animal/plant pest or disease, [  ] protect territ ory 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) : 8 August 2022  
Proposed date of publication (dd/mm/yy) : 9 August 2022  
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 twe ntieth 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