Contents
THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous chemicalsnote, and in particular Article 13(1), second subparagraph, thereof,After consulting the Committee, established by Article 133 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/ECnote,Whereas:
(1)The Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade (‘the Convention’) is implemented by Regulation (EU) No 649/2012. In accordance with that Regulation, the Commission is to provide the Secretariat of the Convention with final or interim responses on behalf of the Union concerning the future import of all chemicals that are subject to the Prior Informed Consent procedure (the ‘PIC procedure’).
(2)At its twelfth meeting, held in Geneva from 28 April to 9 May 2025, the Conference of the Parties to the Convention agreed to list certain chemicals in Annex III to the Convention with the effect that they became subject to the PIC procedure. A Decision Guidance Document for each chemical was sent to the Parties, including to the Commission for the Union, on 22 October 2025 with a request for an import response.
(3)Carbosulfan has been added to Annex III to the Convention as a pesticide. The placing on the market and use of carbosulfan as an active substance of plant protection products is not approved under Regulation (EC) No 1107/2009 of the European Parliament and of the Councilnote. Furthermore, the placing on the market and use of carbosulfan as an active substance of biocidal products is not approved under Regulation (EU) No 528/2012 of the European Parliament and of the Councilnote. Therefore, consent under the Rotterdam Convention should not be given to the future import of carbosulfan to the Union.
(4)Fenthion (ultra-low-volume formulations at or above 640 g active ingredient/L) has been added to Annex III to the Convention as a severely hazardous pesticide formulation. The placing on the market and use of fenthion as an active substance of plant protection products is not approved under Regulation (EC) No 1107/2009. Furthermore, the placing on the market and use of fenthion as an active substance of biocidal products is not approved under Regulation (EU) No 528/2012. Therefore, consent under the Rotterdam Convention should not be given to the future import of Fenthion (ultra-low-volume formulations at or above 640 g active ingredient/L) to the Union,
HAS DECIDED AS FOLLOWS:
Article Sole Article#
The import responses for carbosulfan and fenthion (ultra-low-volume formulations at or above 640 g active ingredient/L) shall be as set out in the Annex.
Form for import response
| Country: | European UnionMember States: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden. | |
| SECTION 1 | IDENTITY OF CHEMICAL | ||
| 1.1 | Common name | Carbosulfan | |
| 1.2 | CAS number | 55285-14-8 | |
| 1.3 | Category | ☒ Pesticide |
| ☐ Industrial | ||
| ☐ Severely hazardous pesticide formulation | ||
| SECTION 2 | INDICATION REGARDING PREVIOUS RESPONSE, IF ANY | |
| 2.1 | ☒ | This is a first-time import response for this chemical in the country. |
| 2.2 | ☐ | This is a modification of a previous response.Date of issue of the previous response: … |
| SECTION 3 | RESPONSE REGARDING FUTURE IMPORT | ||
| ☒ | Final decision (Fill in section 4 below) OR | ☐ | Interim response (Fill in section 5 below) |
| SECTION 4 | FINAL DECISION, PURSUANT TO NATIONAL LEGISLATIVE OR ADMINISTRATIVE MEASURES | |||
| 4.1 | ☒ | No consent to import | ||
| Is the import of the chemical from all sources simultaneously prohibited? | ☒ Yes | ☐ No | ||
| Is domestic production of the chemical for domestic use simultaneously prohibited? | ☒ Yes | ☐ No |
| 4.2 | ☐ | Consent to import |
| 4.3 | ☐ | Consent to import only subject to specified conditions | |||
| The specified conditions are: | |||||
| Are the conditions for import of the chemical the same for all sources of import? | ☐ Yes | ☐ No | |||
| Are the conditions for domestic production of the chemical for domestic use the same as for all imports? | ☐ Yes | ☐ No |
| 4.4 | National legislative or administrative measure upon which the final decision is based | |
| Description of the national legislative or administrative measure: | ||
| In the Union, it is prohibited to place on the market or use plant protection products containing carbosulfan, since that active substance has not been approved under Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1, ELI: http://data.europa.eu/eli/reg/2009/1107/oj).Furthermore, it is prohibited to make available on the market or use biocidal products containing carbosulfan, since that active substance has not been approved pursuant to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj). | ||
| SECTION 5 | INTERIM RESPONSE | |||
| 5.1 | ☐ | No consent to import | ||
| Is the import of the chemical from all sources simultaneously prohibited? | ☐ Yes | ☐ No | ||
| Is domestic production of the chemical for domestic use simultaneously prohibited? | ☐ Yes | ☐ No |
| 5.2 | ☐ | Consent to import |
| 5.3 | ☐ | Consent to import only subject to specified conditions | |||
| The specified conditions are: | |||||
| Are the conditions for import of the chemical the same for all sources of import? | ☐ Yes | ☐ No | |||
| Are the conditions for domestic production of the chemical for domestic use the same as for all imports? | ☐ Yes | ☐ No |
| 5.4 | Indication of active consideration in order to reach a final decision | ||
| Is a final decision under active consideration? | ☐ Yes | ☐ No |
| 5.5 | Information or assistance requested in order to reach a final decision | |
| The following additional information is requested from the Secretariat: | ||
| The following additional information is requested from the country that notified the final regulatory action: | ||
| The following assistance is requested from the Secretariat in evaluating the chemical: | ||
| SECTION 6 | RELEVANT ADDITIONAL INFORMATION, WHICH MAY INCLUDE: | |
| Is this chemical currently registered in the country? | ☐ Yes | ☒ No |
| Is this chemical manufactured in the country? | ☐ Yes | ☒ No |
| If yes to either one of these questions: | ||
| Is this intended for domestic use? | ☐ Yes | ☐ No |
| Is this intended for export? | ☐ Yes | ☐ No |
Other remarks
| In accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1, ELI: http://data.europa.eu/eli/reg/2008/1272/oj), which implements the UN Globally Harmonised System of Classification and Labelling of Chemicals in the Union, carbosulfan is classified as:Acute Tox. 2 * - H330 – Fatal if inhaledAcute Tox. 3 * - H301 – Toxic if swallowedSkin Sens. 1 - H317 – May cause an allergic skin reactionAquatic Acute 1 – H400 – Very toxic to aquatic lifeAquatic Chronic 1 – H410 - Very toxic to aquatic life with long lasting effects(* = This classification is to be considered as a minimum classification) |
| SECTION 7 | DESIGNATED NATIONAL AUTHORITY | |
| Institution | European Commission, DG Environment | |
| Address | Rue de la Loi 200, B-1049 Brussels, Belgium | |
| Name of person in charge | Peter Korytar | |
| Position of person in charge | Team Leader International Chemicals Policy | |
| Telephone | +32 2 299 17 86 | |
| Telefax | ||
| E-mail address | ENV-PIC@ec.europa.eu | |
| Date: | _________________________________ |
| Signature of DNA and official seal: | _____________________________ |
| PLEASE RETURN THE COMPLETED FORM TO: | ||
| Secretariat for the Rotterdam ConventionFood and Agriculture Organizationof the United Nations (FAO)Viale delle Terme di Caracalla00153 Rome, ItalyTel: (+39 06) 5705 2188Fax: (+39 06) 5705 3224E-mail: pic@fao.org | OR | Secretariat for the Rotterdam ConventionUnited Nations EnvironmentProgramme (UNEP)11-13, Chemin des AnémonesCH – 1219 Châtelaine, Geneva, SwitzerlandTel: (+41 22) 917 8296Fax: (+41 22) 917 8082E-mail: brs@un.org |
Form for import response
| Country: | European UnionMember States: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden. | |
| SECTION 1 | IDENTITY OF CHEMICAL | ||
| 1.1 | Common name | Fenthion (ultra-low-volume formulations at or above 640 g active ingredient/L) | |
| 1.2 | CAS number | 55-38-9 | |
| 1.3 | Category | ☐ Pesticide |
| ☐ Industrial | ||
| ☒ Severely hazardous pesticide formulation | ||
| SECTION 2 | INDICATION REGARDING PREVIOUS RESPONSE, IF ANY | |
| 2.1 | ☒ | This is a first time import response for this chemical in the country. |
| 2.2 | ☐ | This is a modification of a previous response.Date of issue of the previous response: … |
| SECTION 3 | RESPONSE REGARDING FUTURE IMPORT | ||
| ☒ | Final decision (Fill in section 4 below) OR | ☐ | Interim response (Fill in section 5 below) |
| SECTION 4 | FINAL DECISION, PURSUANT TO NATIONAL LEGISLATIVE OR ADMINISTRATIVE MEASURES | |||
| 4.1 | ☒ | No consent to import | ||
| Is the import of the chemical from all sources simultaneously prohibited? | ☒ Yes | ☐ No | ||
| Is domestic production of the chemical for domestic use simultaneously prohibited? | ☒ Yes | ☐ No |
| 4.2 | ☐ | Consent to import |
| 4.3 | ☐ | Consent to import only subject to specified conditions | |||
| The specified conditions are: | |||||
| Are the conditions for import of the chemical the same for all sources of import? | ☐ Yes | ☐ No | |||
| Are the conditions for domestic production of the chemical for domestic use the same as for all imports? | ☐ Yes | ☐ No |
| 4.4 | National legislative or administrative measure upon which the final decision is based | |
| Description of the national legislative or administrative measure: | ||
| In the Union, it is prohibited to place on the market or use plant protection products containing fenthion, since that active substance has not been approved under Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1, ELI: http://data.europa.eu/eli/reg/2009/1107/oj).Furthermore, it is prohibited to make available on the market or use biocidal products containing fenthion, since that active substance has not been approved pursuant to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj). | ||
| SECTION 5 | INTERIM RESPONSE | |||
| 5.1 | ☐ | No consent to import | ||
| Is the import of the chemical from all sources simultaneously prohibited? | ☐ Yes | ☐ No | ||
| Is domestic production of the chemical for domestic use simultaneously prohibited? | ☐ Yes | ☐ No |
| 5.2 | ☐ | Consent to import |
| 5.3 | ☐ | Consent to import only subject to specified conditions | |||
| The specified conditions are: | |||||
| Are the conditions for import of the chemical the same for all sources of import? | ☐ Yes | ☐ No | |||
| Are the conditions for domestic production of the chemical for domestic use the same as for all imports? | ☐ Yes | ☐ No |
| 5.4 | Indication of active consideration in order to reach a final decision | ||
| Is a final decision under active consideration? | ☐ Yes | ☐ No |
| 5.5 | Information or assistance requested in order to reach a final decision | |
| The following additional information is requested from the Secretariat: | ||
| The following additional information is requested from the country that notified the final regulatory action: | ||
| The following assistance is requested from the Secretariat in evaluating the chemical: | ||
| SECTION 6 | RELEVANT ADDITIONAL INFORMATION, WHICH MAY INCLUDE: | |
| Is this chemical currently registered in the country? | ☐ Yes | ☒ No |
| Is this chemical manufactured in the country? | ☐ Yes | ☒ No |
| If yes to either one of these questions: | ||
| Is this intended for domestic use? | ☐ Yes | ☐ No |
| Is this intended for export? | ☐ Yes | ☐ No |
Other remarks
| In accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1, ELI: http://data.europa.eu/eli/reg/2008/1272/oj), which implements the UN Globally Harmonised System of Classification and Labelling of Chemicals in the Union, fenthion is classified as:Muta.2 – H341 - Suspected of causing genetic defectsAcute Tox. 3 * - H331 – Toxic if inhaledAcute Tox. 4 * - H312 – Harmful in contact with skinAcute Tox. 4 * - H302 – Harmful if swallowedSTOT RE 1 - H372 – Causes damage to organs through prolonged or repeated exposureAquatic Acute 1 – H400 – Very toxic to aquatic lifeAquatic Chronic 1 – H410 - Very toxic to aquatic life with long lasting effects(* = This classification is to be considered as a minimum classification) |
| SECTION 7 | DESIGNATED NATIONAL AUTHORITY | |
| Institution | European Commission, DG Environment | |
| Address | Rue de la Loi 200, B-1049 Brussels, Belgium | |
| Name of person in charge | Peter Korytar | |
| Position of person in charge | Team Leader - International Chemicals Policy | |
| Telephone | +32 2 299 17 86 | |
| Telefax | ||
| E-mail address | ENV-PIC@ec.europa.eu | |
| Date: | _____________________________________ |
| Signature of DNA and official seal: | __________________________________ |
| PLEASE RETURN THE COMPLETED FORM TO: | ||
| Secretariat for the Rotterdam ConventionFood and Agriculture Organizationof the United Nations (FAO)Viale delle Terme di Caracalla00153 Rome, ItalyTel: (+39 06) 5705 2188Fax: (+39 06) 5705 3224E-mail: pic@fao.org | OR | Secretariat for the Rotterdam ConventionUnited Nations EnvironmentProgramme (UNEP)11-13, Chemin des AnémonesCH – 1219 Châtelaine, Geneva, SwitzerlandTel: (+41 22) 917 8296Fax: (+41 22) 917 8082E-mail: brs@un.org |
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