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18.10.2018 EN Official Journal of the European Union C 376/12 COMMISSION IMPLEMENTING DECISION of 10 October 2018 laying down the final import response on behalf of the Union concerning the future import of certain chemicals pursuant to Regulation (EU) No 649/2012 of the European Parliament and of the Council and amending Commission Implementing Decision C(2016) 747 (2018/C 376/06) 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 chemicals ( 1 ) , and in particular the second subparagraph of Article 13(1) 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/EC ( 2 ) , 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 import 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 eighth meeting, held in Geneva from 24 April to 5 May 2017, 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 Commission on 15 September 2017 with a request for a decision regarding future import of the chemical. (3) Carbofuran has been added to Annex III to the Convention as a pesticide. The placing on the market and use of carbofuran as a component of plant protection products are prohibited under Regulation (EC) No 1107/2009 of the European Parliament and of the Council ( 3 ) . Furthermore, the placing on the market and use of carbofuran as a component of biocidal products are prohibited under Regulation (EU) No 528/2012 of the European Parliament and of the Council ( 4 ) . Therefore, consent under the Rotterdam Convention should not be given to the future import of carbofuran to the Union. (4) Trichlorfon has been added to Annex III to the Convention as a pesticide. The placing on the market and use of trichlorfon as a component of plant protection products are prohibited under Regulation (EC) No 1107/2009. Furthermore, the placing on the market and use of trichlorfon as a component of biocidal products are prohibited under Regulation (EU) No 528/2012. Therefore, consent under the Convention should not be given to the future import of trichlorfon to the Union. (5) Short-chain chlorinated paraffins (SCCPs) have been added to Annex III to the Convention as industrial chemicals. The production, placing on the market and use of SCCPs are prohibited, subject to specific derogations, under Regulation (EC) No 850/2004 of the European Parliament and of the Council ( 5 ) . Therefore, consent under the Convention should be given subject to specified conditions. (6) Tributyltin compounds have been added to Annex III to the Convention as industrial chemicals. The placing on the market and use of tributyltin compounds as industrial chemicals are allowed, subject to compliance with the conditions set out in Regulation (EC) No 1907/2006, in particular the restriction set out in Annex XVII to that Regulation on the manufacture, placing on the market and use of organostannic compounds. Therefore, consent under the Convention should be given subject to those conditions. (7) The placing on the market and use of ethylene oxide as a component in plant protection products are prohibited under Regulation (EC) No 1107/2009. The making available on the market and use of ethylene oxide as a component in biocidal products in accordance with Regulation (EU) No 528/2012 are only allowed with regard to certain products pursuant to Commission Delegated Regulation (EU) No 1062/2014 ( 6 ) . According to Article 89(2) of Regulation (EU) No 528/2012 Member States can still decide whether and under which conditions such products are to be authorised in their territory. (8) After the adoption of the import response for ethylene oxide laid down in Annex II to Commission Implementing Decision C(2016) 747 ( 7 ) there have been some regulatory developments in the Member States with regard to the making available on the market and use of ethylene oxide. Therefore, Implementing Decision C(2016) 747 should be amended accordingly, HAS DECIDED AS FOLLOWS: Article 1 The import responses for carbofuran, trichlorfon, short-chain chlorinated paraffins and tributyltin compounds are set out in Annex I. Article 2 Annex II to Implementing Decision C(2016) 747 is replaced by Annex II to this Decision. Done at Brussels, 10 October 2018. For the Commission Karmenu VELLA Member of the Commission ( 1 ) OJ L 201, 27.7.2012, p. 60 . ( 2 ) OJ L 396, 30.12.2006, p. 1 . ( 3 ) 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 ). ( 4 ) 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 ). ( 5 ) Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants and amending Directive 79/117/EEC ( OJ L 158, 30.4.2004, p. 7 ). ( 6 ) Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council ( OJ L 294, 10.10.2014, p. 1 ). ( 7 ) Commission Implementing Decision C(2016) 747 of 11 February 2016 adopting Union import decisions for certain chemicals pursuant to Regulation (EU) No 649/2012 of the European Parliament and of the Council and amending Commission Decisions 2005/416/EC and 2009/966/EC ( OJ C 61, 17.2.2016, p. 5 ). ANNEX I Text of image Import response for carbofuran Country: European Union (Member States: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom) SECTION 1 IDENTITY OF CHEMICAL 1.1 Common name Carbofuran 1.2 CAS number 1563-66-2 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 Text of image 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 carbofuran, 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). Furthermore, it is prohibited to make available on the market or use biocidal products containing carbofuran, 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). 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: Text of image 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, which implements the UN Globally Harmonised System of Classification and Labelling of Chemicals in the EU, carbofuran is classified as: Acute Toxicity 2* – H 300 — Fatal if swallowed. Acute Toxicity 2* – H 330 — Fatal if inhaled. Aquatic Acute 1 – H 400 — Very toxic to aquatic life. Aquatic Chronic 1 – H410 — Very toxic to aquatic life with long lasting effects. (* = This classification shall be considered as a minimum classification) SECTION 7 DESIGNATED NATIONAL AUTHORITY Institution European Commission, DG Environment Address Rue de la Loi 200, 1049 Brussels, Belgium Name of person in charge Dr Juergen Helbig Position of person in charge International Chemicals Policy Coordinator Telephone +32 22988521 Telefax +32 22967616 Email address Juergen.Helbig@ec.europa.eu Date, signature of DNA and official seal: … PLEASE RETURN THE COMPLETED FORM TO: Secretariat for the Rotterdam Convention Food and Agriculture Organization of the United Nations (FAO) Viale delle Terme di Caracalla 00100 Rome ITALIA Tel. +39 0657053441 Fax +39 0657056347 Email: pic@pic.int OR Secretariat for the Rotterdam Convention United Nations Environment Programme (UNEP) 11-13, Chemin des Anémones CH-1219 Châtelaine, Geneva SWITZERLAND Tel. +41 229178177 Fax +41 229178082 Email: pic@pic.int Text of image Import response for trichlorfon Country: European Union (Member States: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom) SECTION 1 IDENTITY OF CHEMICAL 1.1 Common name Trichlorfon 1.2 CAS number 52-68-6 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 Text of image 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 European Union, it is prohibited to place on the market or use plant protection products containing trichlorfon, 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). Furthermore, it is prohibited to make available on the market or use biocidal products containing trichlorfon, 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). 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: Text of image 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, which implements the UN Globally Harmonised System of Classification and Labelling of Chemicals in the EU, trichlorfon is classified as: Acute Toxicity 4* – H 302 — Harmful if swallowed. Skin Sensitisation 1 – H 317 — May cause an allergic skin reaction. Aquatic Acute 1 – H 400 — Very toxic to aquatic life. Aquatic Chronic 1 – H 410 — Very toxic to aquatic life with long lasting effects. (* = This classification shall be considered as a minimum classification) SECTION 7 DESIGNATED NATIONAL AUTHORITY Institution European Commission, DG Environment Address Rue de la Loi 200, 1049 Brussels, Belgium Name of person in charge Dr Juergen Helbig Position of person in charge International Chemicals Policy Coordinator Telephone +32 22988521 Telefax +32 22967616 Email address Juergen.Helbig@ec.europa.eu Date, signature of DNA and official seal: … PLEASE RETURN THE COMPLETED FORM TO: Secretariat for the Rotterdam Convention Food and Agriculture Organization of the United Nations (FAO) Viale delle Terme di Caracalla 00100 Rome ITALIA Tel. +39 0657053441 Fax +39 0657056347 Email: pic@pic.int OR Secretariat for the Rotterdam Convention United Nations Environment Programme (UNEP) 11-13, Chemin des Anémones CH-1219 Châtelaine, Geneva SWITZERLAND Tel. +41 229178177 Fax +41 229178082 Email: pic@pic.int Text of image Import response for short-chain chlorinated paraffins Country: European Union (Member States: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom) SECTION 1 IDENTITY OF CHEMICAL 1.1 Common name Short-chain chlorinated paraffins 1.2 CAS number 85535-84-8 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 Text of image 4.2 ☐ Consent to import 4.3 ☒ Consent to import only subject to specified conditions The specified conditions are: In the European Union, the production, placing on the market and use of short-chain chlorinated paraffins (SCCPs), whether on their own, in preparations or as constituents of articles, are prohibited pursuant to Regulation (EC) No 850/2004. This prohibition also includes the import of short-chain chlorinated paraffins (SCCPs). By way of derogation, the placing on the market and use (including the import) of substances or preparations containing SCCPs in concentrations lower than 1 % by weight is allowed. 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: Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants and amending Directive 79/117/EEC (OJ L 158, 30.4.2004, p. 7) stipulates that the production, placing on the market and use of short-chain chlorinated paraffins (SCCPs), whether on their own, in preparations or as constituents of articles, are prohibited. By way of derogation, the production, placing on the market and use of substances or preparations containing SCCPs in concentrations lower than 1 % by weight or articles containing SCCPs in concentrations lower than 0,15 % by weight are allowed. 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: Text of image 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, which implements the UN Globally Harmonised System of Classification and Labelling of Chemicals in the EU, short-chain chlorinated paraffins are classified as: Carc. 2 – H 351 — Suspected of causing cancer. Aquatic Acute 1 – H 400 — Very toxic to aquatic life. Aquatic Chronic 1 – H 410 — Very toxic to aquatic life with long lasting effects. SECTION 7 DESIGNATED NATIONAL AUTHORITY Institution European Commission, DG Environment Address Rue de la Loi 200, 1049 Brussels, Belgium Name of person in charge Dr Juergen Helbig Position of person in charge International Chemicals Policy Coordinator Telephone +32 22988521 Telefax +32 22967616 Email address Juergen.Helbig@ec.europa.eu Date, signature of DNA and official seal: … PLEASE RETURN THE COMPLETED FORM TO: Secretariat for the Rotterdam Convention Food and Agriculture Organization of the United Nations (FAO) Viale delle Terme di Caracalla 00100 Rome ITALIA Tel. +39 0657053441 Fax +39 0657056347 Email: pic@pic.int OR Secretariat for the Rotterdam Convention United Nations Environment Programme (UNEP) 11-13, Chemin des Anémones CH-1219 Châtelaine, Geneva SWITZERLAND Tel. +41 229178177 Fax +41 229178082 Email: pic@pic.int Text of image Import response for tributyltin compounds Country: European Union (Member States: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom) SECTION 1 IDENTITY OF CHEMICAL 1.1 Common name Tributyltin compounds, i.e. all tributyltin compounds including Tributyltin oxide Tributyltin fluoride Tributyltin methacrylate Tributyltin benzoate Tributyltin chloride Tributyltin linoleate Tributyltin naphthenate 1.2 CAS number 56-35-9 — Tributyltin oxide 1983-10-4 — Tributyltin fluoride 2155-70-6 — Tributyltin methacrylate 4342-36-3 — Tributyltin benzoate 1461-22-9 — Tributyltin chloride 24124-25-2 — Tributyltin linoleate 85409-17-2 — Tributyltin naphthenate 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 Text of image 4.2 ☐ Consent to import 4.3 ☒ Consent to import only subject to specified conditions The specified conditions are: In the European Union, the placing on the market and use (including import) of tributyltin compounds as industrial chemicals are allowed, subject to compliance with the conditions set out in Regulation (EC) No 1907/2006, in particular the restriction with regard to organostannic compounds laid down in Annex XVII to that Regulation, which stipulates that organostannic compounds: 1. Shall not be placed on the market, or used, as substances or in mixtures where the substance or mixture is acting as biocide in free association paint. 2. Shall not be placed on the market, or used, as substances or in mixtures where the substance or mixture acts as biocide to prevent the fouling by micro-organisms, plants or animals of: (a) all craft irrespective of their length intended for use in marine, coastal, estuarine and inland waterways and lakes; (b) cages, floats, nets and any other appliances or equipment used for fish or shellfish farming; (c) any totally or partly submerged appliance or equipment. 3. Shall not be placed on the market, or used, as substances or in mixtures where the substance or mixture is intended for use in the treatment of industrial waters. 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: 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/EC (OJ L 396, 30.12.2006, p. 1), in particular the restriction with regard to organostannic compounds laid down in Annex XVII to that Regulation stipulates that the placing on the market and use (including import) of tributyltin compounds as industrial chemicals are allowed, subject to compliance with certain conditions. 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 Text of image 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, which implements the UN Globally Harmonised System of Classification and Labelling of Chemicals in the EU, tributyltin compounds are classified as follows (It should be noted that the below classification applies to all tributyltin compounds with the exception of those individual compounds that have a different classification): Acute Tox. 3 – H 301 (Toxic if swallowed.) Acute Tox. 4* – H 312 (Harmful in contact with skin.) Skin Irrit. 2 – H 315 (Causes skin irritation.) Eye Irrit. 2 – H 319 (Causes serious eye irritation.) STOT RE 1 – H 372 ** (Causes damage to organs through prolonged or repeated exposure.) Aquatic Acute 1 – H 400 (Very toxic to aquatic life.) Aquatic Chronic 1 – H 410 (Very toxic to aquatic life with long lasting effect.) Repr. 1B – H360FD (May damage fertility. May damage the unborn child.) (* = This classification shall be considered as a minimum classification.) (** = Information on the route of exposure is not available.) SECTION 7 DESIGNATED NATIONAL AUTHORITY Institution European Commission, DG Environment Address Rue de la Loi 200, 1049 Brussels, Belgium Name of person in charge Dr Juergen Helbig Position of person in charge International Chemicals Policy Coordinator Telephone +32 22988521 Telefax +32 22967616 Email address Juergen.Helbig@ec.europa.eu Date, signature of DNA and official seal: … Text of image PLEASE RETURN THE COMPLETED FORM TO: Secretariat for the Rotterdam Convention Food and Agriculture Organization of the United Nations (FAO) Viale delle Terme di Caracalla 00100 Rome ITALIA Tel. +39 0657053441 Fax +39 0657056347 Email: pic@pic.int OR Secretariat for the Rotterdam Convention United Nations Environment Programme (UNEP) 11-13, Chemin des Anémones CH-1219 Châtelaine, Geneva SWITZERLAND Tel. +41 229178177 Fax +41 229178082 Email: pic@pic.int ANNEX II Text of image Import response for ethylene oxide Country: European Union (Member States: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom) SECTION 1 IDENTITY OF CHEMICAL 1.1 Common name Ethylene oxide 1.2 CAS number 75-21-8 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: 03/2017 … 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 Text of image 4.2 ☐ Consent to import 4.3 ☒ Consent to import only subject to specified conditions The specified conditions are: For plant protection products In the European Union, it is prohibited to place on the market (including import) or use plant protection products containing ethylene oxide, since that active substance has not been approved under Regulation (EC) No 1107/2009. For biocidal products Ethylene oxide is under review in accordance with Regulation (EU) No 528/2012 for uses covered by product type 2 and therefore the making available on the market and use of biocidal products containing ethylene oxide is only allowed for uses covered by product-type 2, which are disinfectants and algaecides not intended for direct application to humans or animals as defined in Annex V to that Regulation. Responses of individual Member States of the European Union for ethylene oxide in biocidal products falling within product-type 2 are as follows: Member States that consent to import, subject to any national restrictions that may apply: Belgium, Denmark, France, Germany, Estonia, Ireland, Latvia, Luxembourg, Sweden, UK. Member States that consent to import, subject to prior written authorisation: Austria, Bulgaria, Croatia, Finland, Hungary, Italy, Lithuania, Netherlands, Poland, Portugal, Slovenia. Member States that consent to import only for sterilisation of surgical tools in accordance with Council Directive 93/42/EC concerning medical devices (OJ L 169, 12.7.1993, p. 1), subject to prior written authorisation: Cyprus, Greece, Slovakia, Spain, Romania. Member States that do not consent to import: Czech Republic, Malta. 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: Plant protection products 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) prohibits to place on the market or use plant protection products containing ethylene oxide. Biocidal products Ethylene oxide has not been approved as an active substance under 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). It is, however, under review and listed in Annex II to Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p. 1). Consequently, in the European Union, the making available on the market and use of biocidal products containing ethylene oxide is only allowed for uses covered by product-type 2 (disinfectants and algaecides not intended for direct application to humans or animals) as defined in Annex V to Regulation (EU) No 528/2012. 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 Text of image 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, which implements the UN Globally Harmonised System of Classification and Labelling of Chemicals in the EU, ethylene oxide is classified as: Press. Gas Flam. Gas 1 – H 220 – Extremely flammable gas. Skin Irrit. 2 – H 315 – Causes skin irritation. Eye Irrit. 2 – H 319 – Causes serious eye irritation. Acute Tox. 3* – H 331 – Toxic if inhaled. STOT SE 3 – H 335 – May cause respiratory irritation. Muta. 1B – H 340 – May cause genetic defects. Carc. 1B – H 350 – May cause cancer. (* = This classification shall be considered as a minimum classification) Text of image SECTION 7 DESIGNATED NATIONAL AUTHORITY Institution European Commission, DG Environment Address Rue de la Loi 200, 1049 Brussels, Belgium Name of person in charge Dr Juergen Helbig Position of person in charge International Chemicals Policy Coordinator Telephone +32 22988521 Telefax +32 22967616 Email address Juergen.Helbig@ec.europa.eu Date, signature of DNA and official seal: … PLEASE RETURN THE COMPLETED FORM TO: Secretariat for the Rotterdam Convention Food and Agriculture Organization of the United Nations (FAO) Viale delle Terme di Caracalla 00100 Rome ITALIA Tel. +39 0657053441 Fax +39 0657056347 Email: pic@pic.int OR Secretariat for the Rotterdam Convention United Nations Environment Programme (UNEP) 11-13, Chemin des Anémones CH-1219 Châtelaine, Geneva SWITZERLAND Tel. +41 229178177 Fax +41 229178082 Email: pic@pic.int