G/SPS/N/EU/273  
 
26 September 2018  
(18-5947) 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 feeding (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) 2018/1254 
of 19 September 2018 concerning the denial of authorisation of riboflavin (80%) produced 
by Bacillus subtilis  KCCM -10445 as a feed additive belonging to the functional group of 
vitamins, pro -vitamins and ch emically well -defined substances having similar effect (Text 
with EEA relevance) . Language(s): English, French, Spanish.  Number of pages: 4 
https://members.wto .org/crnattachments/2018/SPS/EEC/18_5079_00_e.pdf  
https://members.wto.org/crnattachments/2018/SPS/EEC/18_5079_00_f.pdf  
https://members.wto.org/crnattachments/2018/SPS/EEC/18_5079_00_s.pdf  
6. Description of content: On the basis of Regulation (EC) No 1831/2003, the measure 
denies  the authorisation of the substance as a feed additive in the category of "nutritional 
additives" subsequent to the opinion of the European Food Safety Agency (EFSA) of 
7 March 2018 (published in the EFSA Journal 2018;16(3):5223). The measure concerns 
only riboflavin (80 %) produced by the specific strain Bacillus subtilis  KCCM -10445 and 
does not affect riboflavin produced by other strains, which are currently allowed on the 
EU market for use as a feed additive.  
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  
[ ] 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?  G/SPS/N/EU/273  
 
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  [X] Yes   [  ] No 
If no, describe, whenever possible, how and why it deviates from the 
international standar d:  
9. Other relevant documents and language(s) in which these are available:  
EFSA opinion of 7 March 2018:  
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2018.5223  (available in 
English)  
10. Proposed date of adoption (dd/mm/yy) : 19 September 2018  
Proposed date of publication (dd/mm/yy) : 20 September 2018  
11. Proposed date of entry into force: [ ] Six months from date of publication , 
and/or  (dd/mm/yy) : 10 October 2018  
[ ] 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 availa ble) 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