G/SPS/N/EU/642  
13 June 2023  
(23-4021) Page: 1/4 
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 and 
V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as 
regards maximum residue levels for (Z) -13-hexadecen -11-yn-1-yl acetate, (Z ,Z,Z,Z) -
7,13,16,19 -docosatetraen -1-yl isoburyrate, acrinathrin, azimsulfuron, famoxadone, methyl 
nonyl ketone, prochloraz and sodium hypochlorite in or on certain products (Text with EEA 
relevance) . Language(s):  English . Number of pages:  5+ Annexes  
https://members.wto.org/crnattachments/2023/SPS/EEC/23_10185_00_e.pdf  
https://members.wto.org/crnattachments/2023/SPS/EEC/23_10185_01_e.pdf  
https://members.wto.org/crnattachments/2023/SPS/EEC/23_10185_02_e.pdf  
https://members.wto.org/crnattachments/2023/SPS/EEC/23_10185_03_e.pdf  
https://members.wto.org/crnattachments/2023/SPS/EEC/23_10185_04_e.pdf  
https://members.wto.org/crnattachments/2023/SPS/EEC/23_10185_05_e.pdf  
6. Description of content:  The proposed draft Regulation concerns the update of existing 
MRLs for (Z) -13-hexadecen -11-yn-1-yl acetate, (Z,Z,Z,Z) -7,13,16,19 -docosatetraen -1-yl 
isoburyrat e, acrinathrin, azimsulfuron, famoxadone, methyl nonyl ketone, prochloraz and 
sodium hypochlorite in certain food commodities. MRLs for these substances in certain 
commodities are changed. Lower MRLs are set after deleting old uses which are not 
authorised  any more in the European Union as the approval of the use of the active 
substance has expired.  
7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant protection, 
[ ] protect humans from animal/plant pest or disease, [  ] protect territo ry from 
other damage from pests.   G/SPS/N/EU/642  
 
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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 famoxadone (208) 
https://www.fao.org/fao -who-codexalimentarius/codex -
texts/dbs/pestres/pesticid e-detail/en/?p_id=208  
− Codex Maximum Residue Limits for prochloraz (142) https://www.fao.org/fao -
who-codexalimentarius/codex -texts/dbs/pestres/pesticide -detail/en/?p_id=142  
[ ] World Organization for Ani mal 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 standard:  The current EU policy is to align EU MRLs with CXLs if the 
following conditions are fulfilled: (i) that the European Union sets MRLs for the commodity 
under consid eration; (ii) that the current EU MRL is lower than the CXL; and (iii) that the 
CXL is acceptable to the European Union with respect to its policy objective of ensuring a 
high level of consumer protection, including aspects on supporting data and extrapola tions.  
Where the European Union considers that a proposed CXL is not acceptable, it makes a 
reservation to the Codex Committee on Pesticide Residues (CCPR). Reservations made by 
the European Union, concerning some of the active substances envisaged by the  draft 
Regulation, are listed in the relevant CCPR reports:  
http://www.fao.org/fao -who-codexalimentarius/committees/committee/ related -
meetings/en/?committee=CCPR . 
For famoxadone, based on the Statement of European Food Safety Authority on 
famoxadone ( https://efsa.onlinelibrary.wiley .com/doi/full/10.2903/j.efsa.2023.7932 ), the 
current MRL for table grapes could not exclude the risk for consumers and should be 
therefore lowered.  
Prochloraz is no longer approved as an active substance in the European Union since 
31 December 2021. Prochl oraz MRLs were last reviewed in 2020 by Commission 
Regulation (EU) 2020/192 in accordance with Article 12(1) of Regulation (EC) 
No 396/2005. The review was based on the European Food Safety Authority's (EFSA) 
reasoned opinion on the existing MRLs 
(https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2018.5401 ). EFSA proposed 
to change the residue definition for enforcement to the sum of prochloraz, BTS  44595 
(M201 -04) and BTS 44596 (M201 -03), expressed as prochloraz. In the reasoned opinion 
EFSA noted that the definition differs from the residue definition (Sum of prochloraz and its 
metabolites containing the 2,4,6 -trichlorphenol moiety, expressed as pr ochloraz) set by 
Codex Alimentarius.  
For that reason, the Commission established tentative MRLs based on CXLs with specific 
footnotes requiring the missing information on residue trials in relation with the new 
residue definition to be submitted by 13 Febr uary 2022. The information was not 
submitted by that deadline. Therefore, with the current draft Regulation it is proposed to 
delete the MRLs, including the ones based on CXLs.  
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 Implementing Regulation (EU) 2016/638 of 22 April 2016 withdrawing 
the approval of the active substance Z -13-hexadecen -11-yn-1-yl acetate, in 
accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the G/SPS/N/EU/642  
 
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  Council, and amendi ng Commission Implementing Regulation (EU) No 540/2011"  
http://data.europa.eu/eli/reg_impl/2016/638/oj  
− "Commission Implementing Regulation (EU) 2016/636 of 22 April 2016 withdrawing 
the approva l of the active substance Z,Z,Z,Z -7,13,16,19 -docosatetraen -1-yl 
isobutyrate, in accordance with Regulation (EC) No 1107/2009 of the European 
Parliament and of the Council, and amending Commission Implementing Regulation 
(EU) No 540/2011"  
https://eur -lex.europa.eu/eli/reg_impl/2016/636/oj  
− "European Food Safety Authority Statement on the pesticide active substances that do 
not require a review of the existing maximum residue levels under Artic le 12 of 
Regulation (EC) No 396/2005" (12 February 2019)  
https://doi.org/10.2903/j.efsa.2019.5591  
− "Commission Implementing Regulation (EU) 2021/1450 of 3 September 2021 
amending Implementing Regulati on (EU) No 540/2011 as regards the approval periods 
of the active substances acrinathrin and prochloraz"  
https://eur -lex.europa.eu/eli/reg_impl/2021/1450/oj  
− "European Food Safety Authority  opinion on the review of the existing maximum 
residue levels for prochloraz according to Article 12 of Regulation (EC) No 396/2005"  
http://data.europa.eu/eli/reg/2020/192/oj  
− "Commission Implementin g Regulation (EU) 2021/1379 of 19 August 2021 concerning 
the non -renewal of approval of the active substance famoxadone, in accordance with 
Regulation (EC) No 1107/2009 of the European Parliament and of the Council 
concerning the placing of plant protectio n products on the market, and amending 
Commission Implementing Regulation (EU) No 540/2011"  
https://eur -lex.europa.eu/eli/reg_impl/2021/1379/oj  
− "European Food Safety Authority Statement on  the targeted risk assessment for 
famoxadone"  
https://doi.org/10.2903/j.efsa.2023.7932  
− "Commission Implementing Regulation (EU) 2017/781 of 5 May 2017 withdrawing the 
approval of the active substance  methyl nonyl ketone, in accordance with Regulation 
(EC) No 1107/2009 of the European Parliament and of the Council concerning the 
placing of plant protection products on the market, and amending Commission 
Implementing Regulation (EU) No 540/2011"  
https://eur -lex.europa.eu/eli/reg_impl/2017/781/oj  
− "European Food Safety Authority Statement on the pesticide active substances that do 
not require a review of the existing maximum residue levels under Article 12 of 
Regulation (EC) No 396/2005" (12 December 2017)  
https://doi.org/10.2903/j.efsa.2017.5080  
10. Proposed date of adoption (dd/mm/yy) : 19 January 2024  
Proposed date of publication (dd/mm/yy) : 19 February 2024  
11. Proposed date of entry into force: [  ] Six months from date of publication , and/or  
(dd/mm/yy) : 8 September 2024  
[ ] Trade facilitating measure   
12. Final date for comments: [X]  Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 12 August 2023  
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 A4 -Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels  
Tel: +(32 2) 29 54263  
E-mail: sps@ec.europa.eu  G/SPS/N/EU/642  
 
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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 A4 -Multilateral International Relations  
Rue Froissart  101 
B-1049 Brussels  
Tel: +(32 2) 29 54263  
E-mail: sps@ec.europa.eu