G/SPS/N/EU/597  
6 September 2022  
(22-6650) 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):  Meat and edible meat offal (HS code(s): 02); Cereals (HS code(s): 
10) 
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:  Draft Commission Regulation amending Annexes II and 
III to Regulation (EC) No 396/2005 of the European Parlia ment and of the Council as 
regards maximum residue levels for isoxaben, novaluron and tetraconazole in or on 
certain products (Text with EEA relevance) . Language(s):  English . Number of pages:  
4 + annexes  
https://members.wto.org/crnattachments/2022/SPS/EEC/22_6009_01_e.pdf  
https://members.wto.org/crnattachments/2022/SPS/EEC/22_6009_00_e.pdf  
https://members.wto.org/crnattachments/2022/SPS/EEC/22_6009_02_e.pdf  
https://members.wto.org/crnattachments/2022/SPS/EEC/22_6009_03_e.pdf  
6. Description of content:  The proposed draft Regulation concerns the review of existing 
MRLs for isoxaben, novaluron and tetraconazole in certain food commodities. MRLs for 
these substances in certain commodities are lowered or raised. Lower MRLs are set after 
deleting old uses which are not authorised any more in the European Union or for which 
a human health concern may not be excluded  
7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant protection, 
[ ] protect humans from animal/plant pest or dis ease, [  ] 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) : Codex Maximum Residue Limits for novaluron (217)  
 https://www.fao.org/fao -who-codexalimentarius/codex -
texts/dbs/pestres/pestici de-detail/en/?p_id=217  
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  G/SPS/N/EU/597  
 
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  [ ] None  
Does this proposed regulation conform to the relevant international standard?  
[ ] Yes   [X] No  
If no, describe, whenever possible, how and why it deviates from the 
international standard:  Novaluron is not approved in the European Union. The 
European Food Safety Authority published a r easoned opinion on the review of the existing 
maximum residue (MRLs) for novaluron. Based on the above, Regulation (EC) No 
396/2005 should be amended accordingly  
9. Other relevant documents and language(s) in which these are available:  
Regulation (EC) No 396/2005 of the European Parliament and of the Council of 
23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant 
and animal origin and amending Council Directive 91/414/EEC  
http://eur -lex.europa.eu/legal -content/EN/ALL/?uri=CELEX%3A32005R0396  
European Food Safety Authority; Reasoned opinion on the review of the existing 
maximum residue levels for isoxaben according to Ar ticle 12 of Regulation (EC) 
No 396/2005. EFSA Journal 2022;20(1):7062  
https://doi.org/10.2903/j.efsa.2022.7062  
European Food Safety Authority; Reasoned opinion on the review of the existing 
maximum r esidue levels for novaluron according to Article 12 of Regulation (EC) 
No 396/2005. EFSA Journal 2022;20(1):7041  
https://doi.org/10.2903/j.efsa.2022.7041  
European Food Safety Authority; Reasoned opin ion on the review of the existing 
maximum residue levels for isoxaben according to Article 12 of Regulation (EC) 
No 396/2005. EFSA Journal 2022;20(1):7111  
https://doi.org/10.2903/j.efsa.2022.7111  
 (available in English)  
10. Proposed date of adoption (dd/mm/yy) : February 2023  
Proposed date of publication (dd/mm/yy) : April 2023  
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  
[ ] Trade facilitating measure   
12. Final date for comments: [X]  Sixty days from the date of circulation of the 
notification and/or (dd/m m/yy) : 5 November 2022  
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/597  
 
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  13. Text(s) available from: [X]  National Notification Autho rity, [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