ANNEX IISupplementary provisions
ANNEX II Import response for commercial pentabromodiphenyl ether FORM FOR IMPORT RESPONSE 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 - The United Kingdom withdrew from the European Union as of 1 February 2020. During the transition period, which ends on 31 December 2020, unless extended, Union law, with a few limited exceptions, continues to be applicable to and in the United Kingdom and any reference to Member States in Union law shall be understood as including the United Kingdom. SECTION 1 IDENTITY OF CHEMICAL 1.1 Common name Commercial pentabromodiphenyl ether including: — Tetrabromodiphenyl ether - Pentabromodiphenyl ether 1.2 CAS number 40088-47-9 - Tetrabromodiphenyl ether 32534-81-9 - Pentabromodiphenyl ether 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: …18 June 2014… 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: Pursuant to Regulation (EU) 2019/1021, the placing on the market and use of commercial pentabromodiphenyl ether is only allowed in accordance with Directive 2011/65/EU, where the following provisions apply: The import of commercial pentabromodiphenyl ether is only allowed for placing on the market and use in cables or spare parts for the repair, the reuse, the updating of functionalities or upgrading of capacity of the following: (a) electrical and electronic equipment (EEE) placed on the market before 1 July 2006; (b) medical devices placed on the market before 22 July 2014; (c) in vitro diagnostic medical devices placed on the market before 22 July 2016; (d) monitoring and control instruments placed on the market before 22 July 2014; (e) industrial monitoring and control instruments placed on the market before 22 July 2017; (f) all other EEE that was outside the scope of Directive 2002/95/EC and which is placed on the market before 22 July 2019; (g) EEE which benefited from an exemption and which was placed on the market before that exemption expired as far as that specific exemption is concerned. Spare parts are defined as a separate part of an EEE that can replace a part of an EEE. The EEE cannot function as intended without that part of the EEE. The functionality of EEE is restored or is upgraded when the part is replaced by a spare part. 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, the manufacturing, placing on the market and use of tetrabromodiphenyl ether and pentabromodiphenyl ether are, subject to certain exemptions, prohibited pursuant to Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants ( OJ L 169, 25.06.2019, p. 45 ). 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 ), which implements the UN Globally Harmonised System of Classification and Labelling of Chemicals in the Union, pentabromodiphenyl ether is classified as: Lact. – H 362 – May cause harm to breast-fed children. STOT RE 2 * – H 373 - May cause 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 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 Dr. Juergen Helbig Position of person in charge International Chemicals Policy Coordinator Telephone 32 2 298 85 21 Telefax 32 2 296 76 16 E-mail 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 I - 00100 Rome, Italy Tel: (+39 06) 5705 3441 Fax: (+39 06) 5705 6347 E-mail: 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 22) 917 8177 Fax: (+41 22) 917 8082 E-mail: pic@pic.int Import response for commercial octabromodiphenyl ether FORM FOR IMPORT RESPONSE 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 - The United Kingdom withdrew from the European Union as of 1 February 2020. During the transition period, which ends on 31 December 2020, unless extended, Union law, with a few limited exceptions, continues to be applicable to and in the United Kingdom and any reference to Member States in Union law shall be understood as including the United Kingdom. SECTION 1 IDENTITY OF CHEMICAL 1.1 Common name Commercial octabromodiphenyl ether including: — Hexabromodiphenyl ether — Heptabromodiphenyl ether 1.2 CAS number 36483-60-0 - Hexabromodiphenyl ether 68928-80-3 - Heptabromodiphenyl ether 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: …18 June 2014… 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: Pursuant to Regulation (EU) 2019/1021, the placing on the market and use of commercial octabromodiphenyl ether is only allowed in accordance with Directive 2011/65/EU, where the following provisions apply: The import of commercial octabromodiphenyl ether is only allowed for placing on the market and use in cables or spare parts for the repair, the reuse, the updating of functionalities or upgrading of capacity of the following: (a) electrical and electronic equipment (EEE) placed on the market before 1 July 2006; (b) medical devices placed on the market before 22 July 2014; (c) in vitro diagnostic medical devices placed on the market before 22 July 2016; (d) monitoring and control instruments placed on the market before 22 July 2014; (e) industrial monitoring and control instruments placed on the market before 22 July 2017; (f) all other EEE that was outside the scope of Directive 2002/95/EC and which is placed on the market before 22 July 2019; (g) EEE which benefited from an exemption and which was placed on the market before that exemption expired as far as that specific exemption is concerned. Spare parts are defined as a separate part of an EEE that can replace a part of an EEE. The EEE cannot function as intended without that part of the EEE. The functionality of EEE is restored or is upgraded when the part is replaced by a spare part. 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, the manufacturing, placing on the market and use of hexabromodiphenyl ether and heptabromodiphenyl ether are prohibited pursuant to Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants ( OJ L 169, 25.06.2019, p. 45 ). 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 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 Dr. Juergen Helbig Position of person in charge International Chemicals Policy Coordinator Telephone 32 2 298 85 21 Telefax 32 2 296 76 16 E-mail 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 I - 00100 Rome, Italy Tel: (+39 06) 5705 3441 Fax: (+39 06) 5705 6347 E-mail: 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 22) 917 8177 Fax: (+41 22) 917 8082 E-mail: pic@pic.int Import response for perfluorooctane sulfonic acid, perfluorooctane sulfonates, perfluorooctane sulfonamides and perfluorooctane sulfonyls FORM FOR IMPORT RESPONSE 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 - The United Kingdom withdrew from the European Union as of 1 February 2020. During the transition period, which ends on 31 December 2020, unless extended, Union law, with a few limited exceptions, continues to be applicable to and in the United Kingdom and any reference to Member States in Union law shall be understood as including the United Kingdom. SECTION 1 IDENTITY OF CHEMICAL 1.1 Common name Perfluorooctane sulfonic acid, perfluorooctane sulfonates, perfluorooctane sulfonamides and perfluorooctane sulfonyls 1.2 CAS number Relevant CAS numbers are: 1763-23-1 - Perfluorooctane sulfonic acid 2795-39-3 - Potassium perfluorooctane sulfonate 29457-72-5 - Lithium perfluorooctane sulfonate 29081-56-9 - Ammonium perfluorooctane sulfonate 70225-14-8 - Diethanolamine perfluorooctane sulfonate 56773-42-3 - Tetraethylammonium perfluorooctane sulfonate 251099-16-8 - Didecyldimethylammonium perfluorooctane sulfonate 4151-50-2 - N-Ethylperfluorooctane sulfonamide 31506-32-8 - N-Methylperfluorooctane sulfonamide 1691-99-2 - N-Ethyl-N-(2-hydroxyethyl) perfluorooctane sulfonamide 24448-09-7 - N-(2-hydroxyethyl)-N-methylperfluorooctane sulfonamide 307-35-7 - Perfluorooctane sulfonyl fluoride 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: …18 June 2014 … 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: Imports of perfluorooctane sulfonic acid and its derivatives (PFOS) must be in compliance with Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants ( OJ L 169, 25.06.2019, p. 45 ), which sets out the following: 1. The production, placing on the market and use of PFOS, whether on their own, in mixtures or as constituents of articles, shall be prohibited. 2. The prohibition shall not apply to PFOS occurring as an unintentional trace contaminant in substances, mixtures or articles, provided that (a) concentrations of PFOS are equal to or below 10 mg/kg (0,001 % by weight) when it occurs in substances or in mixtures or (b) concentrations of PFOS in semi-finished products or articles, or parts thereof, are lower than 0,1 % by weight calculated with reference to the mass of structurally or micro-structurally distinct parts that contain PFOS or, for textiles or other coated materials, if the amount of PFOS is lower than 1 μg/m 2 of the coated material. 3. If the quantity of PFOS released into the environment is minimised, production and placing on the market is allowed for the following specific uses provided that Member States report to the Commission every four years on progress made to eliminate PFOS: — mist suppressants for non-decorative hard chromium (VI) plating in closed loop systems. 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, the manufacturing, placing on the market and use of perfluorooctane sulfonic acid and its derivatives (PFOS) are prohibited pursuant to Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants ( OJ L 169, 25.06.2019, p. 45 ). However, that Regulation allows for specific exemptions, which are outlined in section 4.3. SECTION 5 NTERIM 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 ), which implements the UN Globally Harmonised System of Classification and Labelling of Chemicals in the Union, perfluorooctane sulfonic acid (CAS number 1763-23-1) is classified as: Acute Tox. 4 * - H302 - Harmful if swallowed. Acute Tox. 4 * - H332 – Harmful if inhaled. Carc. 2 - H351 – Suspected of causing cancer. Lact. - H362 – May cause harm to breast-fed children. STOT RE 1 - H372 - Causes damage to organs through prolonged or repeated exposure. Aquatic Chronic 2 - H411 - Toxic to aquatic life with long lasting effects. Repr. 1B - H360D - May damage the unborn child. (* = 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 Dr. Juergen Helbig Position of person in charge International Chemicals Policy Coordinator Telephone 32 2 298 85 21 Telefax 32 2 296 76 16 E-mail 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 I - 00100 Rome, Italy Tel: (+39 06) 5705 3441 Fax: (+39 06) 5705 6347 E-mail: 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 22) 917 8177 Fax: (+41 22) 917 8082 E-mail: pic@pic.int