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
Summary

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 Existing authorisations will need to be withdrawn.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:
NEU613.pdf

Orther Notice:


G/SPS/N/CAN/1594 - Proposed Maximum Residue Limit: Florylpicoxamid (PMRL2025-08)
G/SPS/N/CAN/1595 - Proposed Maximum Residue Limit: Linuron (PMRL2025-07)
G/SPS/N/BRA/2416 - Draft Resolution 1336, 12 June 2025
G/SPS/N/CAN/1559/Add.1 - Established Maximum Residue Limits: Bromoxynil
G/SPS/N/GBR/96 - New GB tMRLs (temporary MRLs) for mepiquat amending the GB MRL Statutory Register
G/SPS/N/GBR/97 - New GB MRL for mandipropamid amending the GB MRL Statutory Register
G/SPS/N/GBR/98 - New GB MRLs for acetamiprid amending the GB MRL Statutory Register.
G/SPS/N/GBR/99 - New GB MRLs for cycloxydim amending the GB MRL Statutory Register
G/SPS/N/CHL/831 - Modifica Resolución Exenta No 2.262 de 2022, que establece requisitos fitosanitarios para la importación a Chile de frutos frescos de piña (Ananas spp.) procedentes de todo origen
G/SPS/N/UKR/237/Add.1 - Draft Order of the Ministry of Agrarian Policy and Food of Ukraine "On Approval of Hygienic Requirements for Edible Caseins and Caseinates"
G/SPS/N/ZAF/83/Add.1 - Compulsory specification for dried abalone – VC 9108
G/SPS/N/CHL/796/Rev.1 - Modifica Resolución No 655 del 24 de enero de 2024, que establece requisitos fitosanitarios de importación para material vegetal de propagación como cultivo de tejido in vitro, de géneros y especies frutales, hortalizas, cultivos industriales, ornamentales y forestales, procedentes de todo origen
G/SPS/N/JPN/1345/Add.1 - Proposed revision of Ministerial Ordinance on the Specifications and Standards of Feeds and Feed Additives
G/SPS/N/NZL/784 - Citrus Plants for Planting - Import Health Standard
G/SPS/N/CHN/1325 - National Food Safety Standard of the P.R.C.: Pathogen limits for ready-to-eat food in bulk No. 1 Amendment
G/SPS/N/CHN/1326 - National Food Safety Standard of the P.R.C.: Raw Milk No. 2 Amendment
G/SPS/N/CHN/1327 - National Food Safety Standard of the P.R.C.: Sterilized milk No. 2 Amendment
G/SPS/N/UKR/244 - 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. 157 of 13 April 2016"
G/SPS/N/UGA/443 - DUS 2728:2024, Milking jelly - Specification, First Edition
G/SPS/N/ARE/295/Add.1 - National Guide to the Registration of Regulatory Authorities and Food Establishments exporting to the United Arab Emirates
G/SPS/N/EU/808/Add.1 - Classification of the substance ketoprofen with respect to its maximum residue limit in foodstuffs of animal origin
G/SPS/N/EU/860 - Draft Commission Implementing Regulation concerning the denial of the renewal of the authorisation of Patent Blue V as a feed additive for non-food producing animals and repealing Implementing Regulation (EU) No 643/2013
G/SPS/N/DOM/74 - Sanitary Regulations for Food and Beverages in the Dominican Republic
G/SPS/N/TPKM/642/Add.1 - The amendment of the "Quarantine Requirements for the Importation of Prepared Animal Feed"
G/SPS/N/BRA/2175/Add.2/Corr.1 - Ordinance SDA/MAPA No. 1.262, of 16 April 2025 - Amends Ordinance SDA/Mapa No. 1.237, of 28 January 2025, which establishes the phytosanitary requirements for the importation of Impatiens propagative material from any origin
G/SPS/N/GBR/95 - Model Health Certificate GBHC562 for raw petfood
G/SPS/N/USA/3517 - Florylpicoxamid; Pesticide Tolerances. Final rule
G/SPS/N/USA/3518 - Sulfentrazone; Pesticide Tolerances. Final rule
G/SPS/N/CHL/828/Add.1 - Resolución Exenta No 3.605 de 2025 que "Modifica la Resolución Exenta No 8.443/2022 que fija exigencias sanitarias para la importación a Chile de tripas de cerdo"
G/SPS/N/USA/3516 - Food Additives Permitted in Feed and Drinking Water of Animals; Selenium; Final Amendment; Order
G/SPS/N/UKR/243 - Draft Resolution of the Cabinet of Ministers of Ukraine "On Amendment to Clause 3 of the Resolution of the Cabinet of Ministers of Ukraine No. 537 of 7 May 2022".
G/SPS/N/USA/3310/Add.2 - Listing of Color Additives; Myoglobin; Confirmation of Effective Date
G/SPS/N/EU/859 - Draft Commission Implementing Regulation withdrawing from the market oct-2-enal, dec-2-enal, 2-hexenal, 3,5- octadiene-2-one, dec-2-enoic acid, phenethyl propionate, methyl decanoate, ethyl dec-2-enoate, ethyl dec-4-enoate, butylamine, 3-methylbutane-1-thiol, 2-methylfuran, 2-acetyl-5-methylfuran, 2-acetyl-3- methylpyrazine and picoline beta (3-methylpyridine) as feed additives for cats and and dogs (Text with EEA relevance)
G/SPS/N/UKR/233/Add.1 - Draft Resolution of the Cabinet of Ministers of Ukraine "On Approval of Certain Acts of the Cabinet of Ministers of Ukraine on State Registration of Genetically Modified Organisms"
G/SPS/N/BRA/2410 - Draft Resolution 1332, 20 May 2025
G/SPS/N/BRA/2411 - Draft Resolution 1334, 20 May 2025
G/SPS/N/BRA/2412 - Draft Resolution 1333, 20 May 2025
G/SPS/N/BRA/2415 - Draft - Establishes the phytosanitary requirements for the importation of Lobelia erinus and Lobelia x speciosa propagative material from any origin
G/SPS/N/EU/857 - Draft Commission Implementing Regulation concerning the authorisation of eucalyptus tincture from Eucalyptus globulus Labill. as a feed additive for certain animal species. (Text with EEA relevance)
G/SPS/N/EU/858 - Draft Commission Implementing Regulation concerning the authorisation of celery seed essential oil from Apium graveolens L. and caraway essential oil from Carum carvi L. as feed additives for certain animal species. (Text with EEA relevance)
G/SPS/N/GBR/78/Add.2 - Amendments to Commission Implementing Regulation (EU) 2019/2072
G/SPS/N/KGZ/36 - Draft Decision of the Collegium of the Eurasian Economic Commission on Amendments to the Regulation on Common Veterinary (Sanitary and Veterinary) Requirements for Goods Subject to Veterinary Control (Surveillance) and Draft Decision of the Collegium of the Eurasian Economic Commission on Amendments to the Veterinary Certificate for Honey Bees, Bumblebees, Alfalfa Leafcutting Bee Cocoons, Crickets, and Entomophagous Insects Exported to the Customs Territory of the Eurasian Economic Union (Form No. 18)
G/SPS/N/UKR/242 - The Order of the Ministry of Health of Ukraine No. 583 "On Approval of Amendments to the State Medical and Sanitary Norms for Safe Usage of Pesticides and Agrochemicals" of 4 April 2025
G/SPS/N/ARE/295 - National Guide to the Registration of Regulatory Authorities and Food Establishments exporting to the United Arab Emirates
G/SPS/N/TPKM/638/Add.1 - The Amendment of Standards for Specification, Scope, Application and Limitation of Food Additives
G/SPS/N/ARM/59 - Draft Decision of the Collegium of the Eurasian Economic Commission on Amendments to the Common Veterinary (Sanitary and Veterinary) Requirements for Goods Subject to Veterinary Control (Surveillance) and Draft Decision of the Collegium of the Eurasian Economic Commission on Amendments to the Veterinary Certificate for Honey Bees, Bumblebees, Alfalfa Leafcutting Bee Cocoons, Crickets, and Entomophagous Insects Exported to the Customs Territory of the Eurasian Economic Union (Form 18)
G/SPS/N/BRA/2371/Add.1 - Draft Resolution 1306, 24 January 2025
G/SPS/N/BRA/2372/Add.1 - Draft Resolution 1307, 24 January 2025
G/SPS/N/BRA/2373/Add.1 - Draft Resolution 1308, 24 January 2025
G/SPS/N/BRA/2374/Add.1 - Draft Resolution 1309, 24 January 2025