G/SPS/N/EU/479  
 
14 April 2021  
(21-3072) 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):  Cereals with the exception of maize and rice ; milling products of 
barley, wheat, spelt, rye and oats, wheat gluten, processed cereal based foods for infants 
and young children  
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 Regulation (EU) amending Regulation (EC) 
No 1881/2006 as regards maximum levels of ergot sclerotia and ergot alkaloids in certain 
foods . Language(s):  English. Number of pages:  4+3 
https://members.wto.org/crnattachments/2021/SPS/EEC/21_2660_00.e.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_2660_01.e.pdf  
6. Description of content:  The draft Regulation revises the maximum levels set for ergot 
sclerotia in cereal grains with the exception of maize and rice and establishes maximum 
levels for ergot alkaloids in milling products of barley, wheat, spelt, rye and oats, wheat 
gluten, processed cereal based foods for infants and young children.  
7. Objec tive 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 sta ndard:  
[X] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) : Standard for Wheat and Durum Wheat 
(CXS 199-1995) - maximum level for ergot in wheat and durum wheat  
[ ] 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 st andard?  
[ ] Yes   [X] No  G/SPS/N/EU/479  
 
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  If no, describe, whenever possible, how and why it deviates from the 
international standard:  In the Commodity Standard CXS 199 -1995, a maximum level 
for ergot sclerotia of 0.5 g/kg in wheat and durum wheat has been established. 
The maximum level of 0.5 g/kg in the Codex standard is established as a quality factor. 
The establishment in this draft Regulation of a maximum level of 0.2 g/kg for ergot 
sclerotia in unprocessed wheat and durum wheat, which is lower than the Codex level 
established on quality considerations, has been established on safety considerations to 
ensure a low the level of ergot alkaloids in wheat and durum wheat derived products for 
human consumption. The level of 0.2 g/kg for ergot sclerotia in wheat and durum wh eat 
is readily achievable by applying good practices, e.g. by cleaning and sorting of the raw 
cereal grains before further processing such as milling. The Joint FAO/WHO Expert 
Committee on Food Additives assessed in its 91st meeting (Virtual meeting 1 -12 February 
2021) evaluated the risk for human health related to the presence of ergot alkaloids in 
food and came to the conclusion that certain exposure estimates exceeded the health 
based guidance value established for ergot al kaloids and that this may indicate a human 
health concern (Summary and Conclusions available at: Joint FAO/WHO Expert 
Committee on Food Additives, Ninety -first meeting (Safety evaluation of certain  food 
additives and contaminants) Summary and Conclusions. Issued 5 March 2021 . 
9. Other relevant documents and language(s) in which these are available:    
10. Proposed date of adoption (dd/mm/yy) : August 2021  
Proposed date of publication (dd/mm/yy) : August 2021  
11. Proposed date of entry into force: [  ] Six months from date of publication , 
and/or  (dd/mm/yy) : 1 January 2021  
[ ] Trade facilitating measure   
12. Final date for comments: [X]  Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 13 June 2021  
Agency or authority designated to handle comments: [X]  National Notification 
Authority, [X]  National Enquiry Point. Address, fax number and e -mail address 
(if avail able) 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