   
  
G/SPS/N/EU/581  
 
21 July 2022  
(22-5529) 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):  Cereals (HS Codes: 1001, 1002, 1003, 1004, 1005, 1006, 1007, 
1008), foodstuffs of animal origin (HS Codes: 0201, 0202, 0203,  0204, 0205, 0206, 0207, 
0208, 0209, 0210) and certain products of plant origin, including fruit and vegetables  
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, III, 
IV and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as 
regards maximum residue levels for benzalkonium chloride (BAC), c hlorpropham, 
didecyldimethylammonium chloride (DDAC), flutriafol, metazachlor, nicotine, profenofos, 
quizalofop -P, sodium aluminium silicate, thiabendazole and triadimenol in or on certain 
products (Text with EEA relevance) . Language(s):  English . Number of pages:  9 
https://members.wto.org/crnattachments/2022/SPS/EEC/22_4797_00_e.pdf  
https://members.wto.org/crnattachments/2022/SPS/EEC/22_4797_01_e.pdf  
https://members.wto.org/crnattachments/2022/SPS/EEC/22_4797_02_e.pdf  
https://members.wto.org/crnattachments/2022/SPS/EEC/22_4797_03_e.pdf  
https://members.wto.org/crnattachments/2022/SPS/EEC/22_4797_04_e.pdf  
https://m embers.wto.org/crnattachments/2022/SPS/EEC/22_4797_05_e.pdf  
6. Description of content:  The proposed draft Regulation concerns the update of existing 
MRLs for benzalkonium chloride (BAC), chlorpropham, didecyldimethylammonium chloride 
(DDAC), flutriafol, m etazachlor, nicotine, profenofos, quizalofop -P, sodium aluminium 
silicate, thiabendazole and triadimenol in certain food commodities. MRLs for these 
substances in certain commodities are changed. Lower MRLs are set after deleting old uses 
which are not aut horised any more in the European Union or for which a human health 
concern may not be excluded. Some temporary MRLs are lowered based on monitoring 
data. 
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.   G/SPS/N/EU/581  
 
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  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 chlorpropham 
(201), flutriafol (248), profenofos (171), thiabendazole (65) and triadimenol (168). 
The list of Codex MRLs is available at: http://www.fao.org/fao -who-
codexalimentarius/codex -texts/dbs/pestres/pesticides/en . 
[ ] 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?  
[ ] Yes   [X] No  
If no, describe, whenever possible, how and why it deviates from the 
international stand ard: The approvals of sodium aluminium silicate and triadimenol for 
their use in plant protection products were not renewed. In addition, the European Food 
Safety Authority published reasoned opinions on the modification of the existing maximum 
residue (MR Ls) for flutriafol and metazachlor and thiabendazole. Temporary MRLs were 
established in the E uropean Union for benzalkonium chloride (BAC), chlorpropham, 
didecyldimethylammonium chloride (DDAC), nicotine and profenofos, and those MRLs were 
planned to be r evised based on monitoring data. 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  
− Commission Regulation (EU) No 1119/2014 of 16 October 2014 amending Annex III to 
Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards 
maximum residue levels for ben zalkonium chloride and didecyldimethylammonium 
chloride in or on certain products  
https://eur -lex.europa.eu/legal -content/EN/ALL/?uri=OJ%3AJOL_2014_304_R_0004  
− Comm ission Regulation (EU) 2021/155 of 9 February 2021 amending Annexes II, III 
and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council 
as regards maximum residue levels for carbon tetrachloride, chlorothalonil, 
chlorpropham, dimetho ate, ethoprophos, fenamidone, methiocarb, omethoate, 
propiconazole and pymetrozine in or on certain products  
https://eur -lex.europa.eu/legal -content/EN/TXT/?uri=CELEX%3A 32021R0155  
− Commission Regulation (EU) No 812/2011 of 10 August 2011 amending Annex III to 
Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards 
maximum residue levels for dimethomorph, fluopicolide, mandipropamid, metrafenone , 
nicotine and spirotetramat in or on certain products  
https://eur -lex.europa.eu/legal -content/EN/TXT/?uri=CELEX%3A32011R0812  
− Commission Regulation (EU) No 1096/2014 of 15 October 2014 amending Annexes II, 
III and V to Regulation (EC) No 396/2005 of the European Parliament and of the 
Council as regards maximum residue levels for carbaryl, procymidone and profenofos 
in or on certain products  
https://eur -lex.europa.eu/legal -content/EN/ALL/?uri=CELEX%3A32014R1096  
− Commission Implementing Regulation (EU) 2019/324 of 25 February 2019 amending 
Implementing Regulation (EU) No 540/2011 as regards  the approval periods of the 
active substances bifenthrin, carboxin, FEN 560 (also called fenugreek or fenugreek 
seed powder), pepper dust extraction residue and sodium aluminium silicate  
https://eur -lex.europa.eu/legal -
content/EN/TXT/?uri=CELEX%3A32019R0324&qid=1657271100325  
− Reasoned opinion on the evaluation of confirmatory data followin g the Article 12 MRL 
review and setting of an import tolerance for flutriafol in cucurbits (inedible peel)  
https://doi.org/10.2903/j.efsa.2020.6315  
− Reasoned opinion on the evaluation of confirmatory data following the Article 12 MRL G/SPS/N/EU/581  
 
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  review and modification of the existing maximum residue levels for metazachlor in 
various commodities  
https://doi.org/10.2903/j.efsa.2019.5819  
− Reasoned Opinion on th e modification of the existing maximum residue levels and 
setting of import tolerances for thiabendazole in various crops  
https://doi.org/10.2903/j.efsa.2021.6586  
(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: [X]  Six months from date of publication , 
and/or  (dd/mm/yy) :  
[ ] Trade facilitating measure   
12. Final date for comments: [X]  Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 19 September 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  
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  
 