G/SPS/N/EU/459  
 
12 January 2021  
(21-0397) Page: 1/3 
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) 2020/2120 
of 16 December 2020 amending Implementing Regulation (EU) 2016/1964 as regards the 
authorisation of a preparation of montmorillonite -illite as feed additive for all animal 
species (Text with EEA relevance) . Language(s):  English, French and Spanish . Number 
of pages:  6 
https://members.wto.org/crnattachments/2021/SPS/EEC/21_0376_00_e.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_0376_00_f.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_0376_00_s.pdf  
6. Description of content:  The use of a preparation of montmorillonite -illite as a feed 
additive was authorised for all animal species by Commission Implementing Regulation 
(EU) 2016/1964. In accordance with Article 13 of Regulation (EC) No 1831/2003, the 
Commission requested the European Food Safety Authority ( 'the Authority') to issue an 
opinion on whether the authorisation of a preparation of montmorillonite -illite as a feed 
additive would still meet the conditions laid down in Article 5 of Regulation 
(EC) No 1831/2003, considering a modification of the terms of that authorisation. 
The modific ation relates to the current authorisation for the use of the additive as 
anticaking agent in complementary feedingstuffs. The request was accompanied by the 
relevant supporting data. The Authority concluded in its opinions of 30 October 2014, 
10 September  2015 and 20 March 2020 that the proposed modification to the terms of 
authorisation of the preparation of montmorillonite -illite does not modify the previous 
conclusions that the additive does not have an adverse effect on animal health, consumer 
safety o r the environment. It also concluded that dust generated during normal handling 
of the additive has the potential to expose the whole of the respiratory tract of users to 
harmful substances (crystalline silica) for which no safe levels of exposure have bee n 
identified and that in the absence of data on the effects on skin and eyes, must be 
considered as irritant to skin and eyes and as a potential dermal sensitiser. Therefore, 
the Commission 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 has also concluded that the additive is efficacious as an anti -caking 
agent. The Authority does not consider that there is a need for specific requir ements of 
post-market monitoring. It also verified the report on the methods of analysis of the feed G/SPS/N/EU/459  
 
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  additives in feed submitted by the Reference Laboratory set up by Regulation 
(EC) No 1831/2003. The assessment of the proposed modification to the authoris ation 
shows that the conditions for authorisation, as provided for in Article 5 of Regulation 
(EC) No 1831/2003, are satisfied. Implementing Regulation (EU) 2016/1964 should 
therefore be amended accordingly.  
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 Commissio n (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 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 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  G/SPS/N/EU/459  
 
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  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