Notice - Notification of WTO Members: Draft Commission Implementing Regulation concerning the non-renewal of the approval of the active substance oxamyl, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of

WTO code G/SPS/N/EU/613
Date notice 31/01/2023
Notice type Regular
Title Draft Commission Implementing Regulation concerning the non-renewal of the approval of the active substance oxamyl, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of

This draft Commission Implementing Regulation provides that the approval of the active substance oxamyl is not renewed in accordance with Regulation (EC) No 1107/2009. EU member States shall withdraw authorisations for plant protection products containing oxamyl as an active substance. The non-renewal of approval is based on the first evaluation of the substance for use as a pesticide active substance in the European Union under Regulation (EC) No 1107/2009. The substance was formerly assessed and approved under Directive 91/414/ EEC.

In order for an active substance to be approved in accordance with Regulation (EC) No 1107/2009 (concerning the placing of plant protection products on the market), it must be demonstrated that the substance is not harmful to human health, animal health or the environment. Criteria are listed in Article 4 of the Regulation (and also detailed in Annex II thereto) which must be met to enable approval. During the evaluation and peer-review of oxamyl, a number of concerns and areas that could not be finalised finalized were identified. These are detailed in the conclusion of the European Food Safety Authority (EFSA) and reported here after: The operators' exposure is unacceptable (min 112% of the AEOL and min 389% of the AAOEL) even when the use of PPE is considered; The preliminary consumer dietary risk assessment did indicate a large exceedance of the acute reference dose (ARfD) for all the representative uses: 1,538% (potatoes, children), 1,223% (watermelons, children), 656% (cucumbers, children) and 581% (tomatoes, children) even when oxamyl residues at the LOQ of 0.01mg/kg were considered. These concerns and areas that could not be finalised mean that oxamyl does not meet the approval criteria as outlined in Regulation (EC) No 1107/2009 and its approval cannot be renewed. Existing authorisations will need to be withdrawn. EU member States must withdraw existing plant protection products containing oxamyl at the latest by six months from the date of entry into force. A period of grace in line with Article 46 of Regulation No 1107/2009 is allowed for and shall expire at the latest 12 months from the entry into force (allowing for a final season of use).

This decision only concerns the placing on the market of this substance and plant protection products containing it. Following non-approval and the expiry of all grace periods for stocks of products containing this substance, separate action will likely be taken on Maximum Residue Limits and a separate notification will be made in accordance with SPS procedures. 

Product Oxamyl (pesticide active substance)
Country European Union

File attach:

Orther Notice:

G/SPS/N/CAN/484/Add.1 - Updated "Policy on Listeria monocytogenes in ready-to-eat foods"
G/SPS/N/CHE/82/Add.7 - Amendment of Annex 1 to the Ordinance on phytosanitary products (OPPh)
G/SPS/N/CAN/1469/Add.1 - Established Maximum Residue Limits: Ipflufenoquin
G/SPS/N/THA/419/Add.1 - Thai Agricultural Standard entitled "Good Agricultural Practices for Pig Farms"
G/SPS/N/CAN/1463/Add.1 - Established Maximum Residue Limits: Florylpicoxamid
G/SPS/N/THA/634 - Approval procedure of the production facility of animal feed exportation to the Kingdom of Thailand.
G/SPS/N/AUS/563 - Proposal to amend Schedule 20 of the revised Australia New Zealand Food Standards Code (21 March 2023)
G/SPS/N/EU/629 - Draft Commission Regulation amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of polyglycerol polyricinoleate (E 476) and the Annex to Commission Regulation (EU) No 231/2012 as regards specifications for glycerol (E 422), polyglycerol esters of fatty acids (E 475) and polyglycerol polyricinoleate (E 476)
G/SPS/N/NZL/709/Add.1 - Amendment to the Ministry for Primary Industries (MPI) Import health standard 155.02.06: Importation of Nursery Stock
G/SPS/N/USA/3372 - Azoxystrobin; Pesticides Tolerances. Final Rule
G/SPS/N/BRA/2120/Add.1 - Draft Resolution number 1125, 23 November 2022
G/SPS/N/BRA/2125/Add.1 - Draft Resolution number 1132, 15 December 2022
G/SPS/N/BRA/2128/Add.1 - Draft Resolution number 1133, 15 December 2022
G/SPS/N/CAN/1496 - Regulations amending the Health of Animals Regulations (Livestock identification and traceability)
G/SPS/N/EU/628 - Commission Delegated Regulation (EU) 2023/647 of 13 January 2023 amending Delegated Regulation (EU) 2020/686 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards the approval of germinal product establishments and the traceability and animal health requirements for movements within the Union of germinal products of certain kept terrestrial animals
G/SPS/N/CHL/745 - Public consultation on the proposed amendment to Articles 169, 173 and 452 of the Food Health Regulations
G/SPS/N/EU/627 - Draft Commission Implementing Regulation concerning the non-renewal of the approval of the active substance dimoxystrobin, 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 and Commission Implementing Regulation (EU) 2015/408 (Text with EEA relevance)
G/SPS/N/THA/631 - The DLD order on temporary suspension of importation of live domestic pigs and wild pigs and their carcasses from Viet Nam to prevent the spread of African Swine Fever
G/SPS/N/BRA/2092/Add.1 - Draft Resolution number 1122, 27 October 2022
G/SPS/N/BRA/2116/Add.1 - Draft Resolution number 1131, 24 November 2022
G/SPS/N/BRA/2117/Add.1 - Draft Resolution number 1128, 23 November 2022
G/SPS/N/BRA/2118/Add.1 - Draft Resolution number 1127, 23 November 2022
G/SPS/N/BRA/2119/Add.1 - Draft Resolution number 1126, 23 November 2022
G/SPS/N/BRA/2143 - Draft Resolution number 1149, 10 March 2023.
G/SPS/N/BRA/2144 - Draft Resolution number 1150, 10 March 2023.
G/SPS/N/CAN/1494 - Proposed Maximum Residue Limit: Mefentrifluconazole (PMRL2023-19).
G/SPS/N/CAN/1495 - Proposed Maximum Residue Limit: Prothioconazole (PMRL2023-20)
G/SPS/N/SAU/474/Add.1 - Final draft of Health Certificate for Exporting Feed Products to the Kingdom of Saudi Arabia ("Animal origin or containing animal protein" and "Plant origin")
G/SPS/N/USA/3366 - Pydiflumetofen; Pesticide Tolerances. Final Rule
G/SPS/N/MDA/20 - Order No. 51 from 8 February 2023 on the approval of the Regulation regarding the temporary intensification of official customs controls and emergency measures undertaken during the entry into the Republic of Moldova of certain goods from certain countries
G/SPS/N/TPKM/599/Add.1 - Those foods, food additives, food utensils, food containers or packaging classified under 12 specific CCC codes
G/SPS/N/TPKM/611 - Draft of "Suspension of the Importation of Deer Velvet, Deer Antler, Deer Penis (and Testis) and Deer Antler Glue from Listed Countries/zones (listed by the World Organisation for Animal Health) with Reported Case(s) of Chronic Wasting Disease"
G/SPS/N/ARM/43 - Eurasian Economic Commission Council Draft Decision on amendments to Chapter II of the Single List of Goods, subject to sanitary and epidemiological supervision (control) on the customs border and customs area of the Eurasian Economic Union
G/SPS/N/ARM/44 - Eurasian Economic Commission Collegium Draft Decision on amendments to the Section 12 of the Chapter II of the Common sanitaryepidemiological and hygienic requirements for products subject to sanitary-epidemiological supervision (control).
G/SPS/N/NZL/710 - Draft Import Health Standard: Grain and Seeds for Consumption, Feed or Processing
G/SPS/N/UKR/198 - Draft Order of the Ministry of Agrarian Policy and Food of Ukraine "On Amendments to the Order of the Ministry of Agrarian Policy and Food of Ukraine No. 813 of 20 October 2022 and Approval of the Requirements for Certain Quality Indicators for Poultry Meat".
G/SPS/N/ECU/289 - Resolution No. 202 that updates the list of plagas cuarentenarias not present in Ecuador
G/SPS/N/EU/626 - Commission Implementing Regulation (EU) 2023/516 of 8 March 2023 amending Implementing Regulation (EU) 2020/2236 as regards the model animal health certificate for the entry into the Union of consignments of aquatic animals intended for certain aquaculture establishments, for release into the wild or for other purposes, excluding direct human consumption
G/SPS/N/USA/3371 - Mandestrobin; Pesticide Tolerances. Final Rule
G/SPS/N/CHE/89 - Amendment of the FOEN Ordinance on phytosanitary measures for forests; SR 916.202.2
G/SPS/N/TPKM/610 - The Draft Amendment of Standards for Specification, Scope, Application and Limitation of Food Additives
G/SPS/N/CAN/1488 - Proposed Maximum Residue Limit: Cyantraniliprole (PMRL2023-18)
G/SPS/N/CAN/1489 - Proposed Maximum Residue Limit: Pyrethrins (PMRL2023-15)
G/SPS/N/CAN/1490 - Proposed Maximum Residue Limit: Piperonyl Butoxide (PMRL2023-16)
G/SPS/N/CAN/1491 - Health Canada's Proposal to revise certain permitted uses of aluminum-containing food additives
G/SPS/N/CAN/1492 - Notice of Modification to the List of Permitted Food Enzymes to Enable the Use of Transglutaminase from Streptomyces mobaraensis M2020197 in Various Foods
G/SPS/N/CAN/1493 - Notice of Modification to the List of Permitted Food Additives to Extend the Use of Acetic Acid to 2'-Fucosyllactose
G/SPS/N/CHN/1277 - National Food Safety Standard of the P.R.C.: Maximum Residue Limits for Pesticides in Foods.
G/SPS/N/URY/69 - Draft Resolution of the Directorate-General of Agricultural Services, prohibiting the importation, registration and renewal of phytosanitary products based on the active ingredients carbofuran, methyl parathion, trichlorfon, dichlorvos and cyhexatin
G/SPS/N/USA/3370 - Innophos, Inc.; Filing of Color Additive Petition