<p> PREFACE</p><p>Background This letter cordially asks your government to provide us with information on nine chemicals which will be newly regulated in Japan.</p><p>The Japanese Government is now scrutinizing domestic regulations in order to respond to the addition of nine chemicals to the annexes of the Stockholm Convention on Persistent Organic Pollutants, which was adopted at its fourth meeting of the Conference of the Parties in May 2009. In order to protect human health and/or living organisms from hazardous chemicals released to the environment, Japan has implemented a strict chemical safety policy based on the “Act on the Evaluation of Chemical Substances and Regulation of their Manufacture, etc. (the Act)”. The Act restricts production, import and the use of “Class I Specified Chemical Substances”, which are prescribed by the Cabinet Order and defined as follows: a chemical which is (a) persistent, (b) bio-accumulative, and (c) hazardous to human health or the life and/or growth of top predators when ingested continuously. The Act also restricts import of products containing those chemicals, and those restricted products are prescribed by the Cabinet Order as well. Currently, sixteen chemical substances, including ten chemical substances listed on the Annex A and B of the Stockholm Convention, are prescribed as “Class I Specified” chemicals by the Cabinet Order. This time, the nine new chemical substances which will be added to the annexes of the Convention should accordingly be prescribed as such. Under the Article 13 of the Act, the Cabinet Order for import restriction of products shall be established with consideration of matters relating to the conditions of use, etc., of the “Class I Specified Chemical Substance” in foreign countries. For that purpose, it is essential for us to grasp the production and import volume of the chemical and also the import volume of products containing the chemical in foreign countries. Whenever we prescribe “Class I Specified” chemicals, we have conducted a comprehensive international survey on those chemicals and the products containing those chemicals. With kind cooperation of foreign governments, our list of products prescribed by the Cabinet Order successfully covers all kinds of products containing chemicals currently classified as “Class I Specified”. Once again, we would like to ask your government to cooperate to such a survey on the nine candidates of “Class I Specified” chemicals.</p><p>We truly appreciate your government’s assistance and cooperation and express our gratitude in advance. </p><p>Filling out the Questionnaire Please fill out the questionnaire attached below. When completing this form, please put as much information as necessary. If you would like to submit additional information to expand or clarify your responses, please feel free to do so.</p><p>1 Definitions “ product” : does not only refer to “primary products”, which are produced by using the listed chemical, but also includes “secondary products” etc., which are processed after the production.</p><p>2 QUESTIONNAIRE [I] Please fill out the information about your country’s contact point.</p><p>Contact Point </p><p>Country</p><p>SPAIN</p><p>Contact Person</p><p>Name : </p><p>Ms. Maj-Britt Larka Abellán, Deputy Director of Air Quality and Industrial Environment</p><p>Ms. Ana García González, Head of Service for Experts Groups Coordination National Focal Point for the Stockholm convention </p><p>Office -Agency/Ministry: </p><p>Ministry of the Environment and Rural and Marine Affairs</p><p>Mailing Address: </p><p>Agustín de Betancourt 25, 1º Madrid 28071</p><p>Phone: +34 91 453 53 63 (+country code)</p><p>Fax: +34 534 05 83</p><p>E-mail: [email protected] [email protected]</p><p>3 QUESTIONNAIRE [II] </p><p>This questionnaire relates to following 9 chemicals and their products containing them.</p><p> Lindane (Gamma HCH or Gamma hexachlorocyclohexane) Alpha hexachlorocyclohexane(Alpha HCH) Beta hexachlorocyclohexane(Beta HCH) Tetrabromodiphenyl ether and pentabromodiphenyl ether (2,2',4,4'- tetrabromodiphenyl ether (BDE-47) and 2,2',4,4',5-pentabromodiphenyl ether (BDE-99) and other tetra- and pentabromodiphenyl ethers present in commercial pentabromodiphenyl ether.) Hexabromodiphenyl ether and heptabromodiphenyl ether (2,2',4,4',5,5'- hexabromodiphenyl ether (BDE-153), 2,2',4,4',5,6'-hexabromodiphenyl ether (BDE-154), 2,2',3,3',4,5',6 heptabromodiphenyl ether (BDE-175), 2,2',3,4,4',5',6-heptabromodiphenyl ether (BDE-183) and other hexa- and heptabromodiphenyl ethers present in commercial octabromodiphenyl ether) Chlordecone Hexabromobiphenyl Pentachlorobenzene Perfluorooctane sulfonic acid, its salts and perfluorooctane sulfonyl fluoride</p><p>4 II-A Regulation of the chemicals on production, import and use </p><p>1. Are production, import and/or use of the chemicals listed below allowed in your country?</p><p>N Name Production Import Use※ o 1 Lindane (Gamma HCH or Gamma No(prohibited) No(prohibited) No(prohibited) hexachlorocyclohexane) [CAS NO.</p><p>58-89-9] 2 Alpha hexachlorocyclohexane(Alpha No(prohibited) No(prohibited) No(prohibited) HCH) [CAS NO. 319-84-6] 3 Beta hexachlorocyclohexane(Beta No(prohibited) No(prohibited) No(prohibited) HCH) [CAS NO. 319-85-7] 4 Tetrabromodiphenyl ether and No(prohibited) No(prohibited) No(prohibited) pentabromodiphenyl ether (2,2',4,4'-</p><p> tetrabromodiphenyl ether (BDE-47,</p><p>CAS No: 40088-47-9) and 2,2',4,4',5- *Restricted: *Restricted:</p><p> pentabromodiphenyl ether (BDE-99,</p><p>CAS No: 32534-81-9) and other tetra- Any content higher than Any content higher than 0.1</p><p> and pentabromodiphenyl ethers 0.1 % by mass % by mass (substance,</p><p> present in commercial (substance, constituent of constituent of substances,</p><p> pentabromodiphenyl ether.) substances, or or preparations), may not</p><p> preparations), may not be be placed on the market or</p><p> placed on the market or used</p><p> used 5 Hexabromodiphenyl ether and No(prohibited) No(prohibited) No(prohibited) heptabromodiphenyl ether</p><p>(2,2',4,4',5,5'-hexabromodiphenyl</p><p> ether (BDE-153, CAS No: 68631-49- *Restricted: *Restricted:</p><p>2), 2,2',4,4',5,6'-hexabromodiphenyl</p><p> ether (BDE-154, CAS No: 207122- Any content higher than Any content higher than 0.1</p><p>15-4), 2,2',3,3',4,5',6 0.1 % by mass % by mass (substance,</p><p> heptabromodiphenyl ether (BDE-175, (substance, constituent of constituent of substances,</p><p>CAS No: 446255-22-7), substances, or or preparations), may not</p><p>2,2',3,4,4',5',6-heptabromodiphenyl preparations), may not be be placed on the market or</p><p> ether (BDE-183, CAS No: 207122- placed on the market or used</p><p>16-5) and other hexa- and used</p><p> heptabromodiphenyl ethers present in</p><p> commercial octabromodiphenyl ether)</p><p>5 6 Chlordecone [CAS NO. 143-50-0] No(prohibited) No(prohibited) No(prohibited)</p><p>7 Hexabromobiphenyl [CAS NO. No(prohibited) No(prohibited) No(prohibited) 36355-01-8]</p><p>8 Pentachlorobenzene [CAS NO. 608- No(prohibited) No(prohibited) No(prohibited) 93-5] 9 Perfluorooctane sulfonic acid [CAS Restricted Restricted Restricted NO. 1763-23-1], its salts [CAS NO.</p><p>29457-72-5 (lithium salt),</p><p>4021-47-0 (sodium salt), 2795-39-3</p><p>(potassium salt) , 29081-56-9</p><p>(ammonium salts),70225-14-8</p><p>(diethanolammonium salts)etc.]</p><p>Perfluorooctane sulfonyl fluoride Restricted Restricted Restricted</p><p>[CAS No. 307-35-7]</p><p>※” Use” means to incorporate or mix the chemical into some products. </p><p>2. Please summarize the regulation(s) and scientific knowledge which the regulation(s) are based on.</p><p>6 ● The production, placing on the market and use of Chlordecone, Hexabromobiphenyl and HCH isomers alfa and beta, including lindane, on their own, , is prohibited by the Regulation (CE) nº 850/2004, in order to ensure coherent and effective implementation of the Community's obligations under the Convention on Long-Range Transboundary Air Pollution on Persistent Organic Pollutants and the Stockholm Convention.</p><p>● The placing on the market and the use of PentaBDE and OctaBDE, on their own, is prohibited by the Directive 2003/11/EC, due to the need to reduce risks to protect health and environment. Any content higher than 0.1 % by mass, may not be placed on the market or used as a substance or as a constituent of substances or of preparations. </p><p>● Pentachlorobenzene could be found as impurity in the production of pentachloronitrobenzene (Quintozene). The placing on the market and the use of Quintozene was regulated by Council Directive 90/533/EEC of 15 October 1990 amending annex I to Directive 79/117/EEC prohibiting the placing on the market and use of plant protection products containing certain active substances. The use of Quintozene with more than 10 g/kg of Pentachlorobenzene was banned at that time. </p><p>The Commission Decision 2000/816/EC, 27 December 2000, decided the non-inclusion of Quintozene in Annex I to Council Directive 91/414/EEC and the withdrawal of all authorizations for plant-protection products containing this active substance. </p><p>● The marketing and use of perfluorooctane sulfonates is restricted by the Directive 2006/122/EC with the objective to introduce harmonised provisions with regard to PFOS, thus preserving the internal market whilst ensuring a high level of protection of human health and the environment: </p><p>(1) May not be placed on the market or used as a substance or constituent of preparations in a concentration equal to or higher than 0,005 % by mass.</p><p>(2) May not be placed on the market in semi-finished products or articles, or parts thereof, if the concentration of PFOS is equal to or higher than 0,1 % by mass 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 equal to or higher than 1 µg/m2 of the coated material.</p><p>(3) By way of derogation, paragraphs 1 and 2 shall not apply to the following items, nor to substances and preparations needed to produce them: (a) photoresists or anti reflective coatings for photolithography processes, (b) photographic coatings applied to films, papers, or printing plates, (c) mist suppressants for non-decorative hard chromium (VI) plating and wetting agents for use in controlled electroplating systems where the amount of PFOS released into the environment is minimised, by fully applying relevant best available techniques developed within the framework of Council Directive 96/61/EC of 24 September 1996 concerning integrated pollution prevention and control, (d) hydraulic fluids for aviation.</p><p>(4) By way of derogation from paragraph 1, fire-fighting foams that have been placed on the market before 27 December 2006 can be used until 27 June 2011.</p><p>(5) Paragraphs 1 and 2 shall apply without prejudice to Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergent.</p><p>7 (6) Member States shall establish and communicate to the Commission an inventory that covers: (a) processes that are subject to derogation in paragraph 3(c) and the amounts of PFOS used in and released from them, (b) existing stocks of fire-fighting foams containing PFOS.</p><p>7) As soon as new information on details of uses and safer alternative substances or technologies for the uses becomes available, the Commission shall review each of the derogations in paragraph 3(a) to (d) so that: (a) the uses of PFOS will be phased out as soon as the use of safer alternatives is technically and economically feasible, (b) a derogation can only be continued for essential uses for which safer alternatives do not exist and where the efforts undertaken to find safer alternatives have been reported on, (c) releases of PFOS into the environment have been minimised, by applying best available techniques.</p><p>(8) The Commission shall keep under review the ongoing risk assessment activities and the availability of safer alternative substances or technologies related to the uses of perfluorooctanoic acid (PFOA) and related substances and propose all necessary measures to reduce identified risks, including restrictions on marketing and use, in particular when safer alternative substances or technologies, that are technically and economically feasible, are available.’</p><p>Perfluorooctanoic acid (PFOA) and its salts are suspected to have a similar risk profile to PFOS, and consequently, risk reduction measures, including restrictions on marketing and use, if appropriate, are applied for both.</p><p>In Spain, the marketing and use restrictions of perfluorooctane sulfonates (PFOS) are based on the Order PRE/347/2008 which regulates the use, re-use or placing on the market of perfluorooctane sulfonates (PFOS). This legislation entered into force in Jun, 2008.</p><p>8 II-B Amount of the chemical on production and export</p><p>1. What are the production volumes of the chemicals listing below? (year 1999-2008)</p><p>No. Name Use Year Production volume (ton/year) 1 Lindane (Gamma HCH or Gamma Production is prohibited since -</p><p> hexachlorocyclohexane) [CAS NO. 58-89-9] 2004</p><p>2 Alpha hexachlorocyclohexane(Alpha HCH) Production of technical HCH is -</p><p>[CAS NO. 319-84-6] prohibited since 2004</p><p>3 Beta hexachlorocyclohexane(Beta HCH) Production of technical HCH is -</p><p>[CAS NO. 319-85-7] prohibited since 2004</p><p>4 Tetrabromodiphenyl ether and - No production pentabromodiphenyl ether (2,2',4,4'-</p><p> tetrabromodiphenyl ether (BDE-47, CAS No:</p><p>40088-47-9) and 2,2',4,4',5- Production in EU is prohibited pentabromodiphenyl ether (BDE-99, CAS since 2003 No: 32534-81-9) and other tetra- and</p><p> pentabromodiphenyl ethers present in</p><p> commercial pentabromodiphenyl ether.)</p><p>5 Hexabromodiphenyl ether and - No production heptabromodiphenyl ether (2,2',4,4',5,5'-</p><p> hexabromodiphenyl ether (BDE-153, CAS</p><p>No: 68631-49-2), 2,2',4,4',5,6'- Production in EU is prohibited hexabromodiphenyl ether (BDE-154, CAS since 2003 No: 207122-15-4), 2,2',3,3',4,5',6</p><p> heptabromodiphenyl ether (BDE-175, CAS</p><p>No: 446255-22-7), 2,2',3,4,4',5',6-</p><p> heptabromodiphenyl ether (BDE-183, CAS</p><p>No: 207122-16-5) and other hexa- and</p><p> heptabromodiphenyl ethers present in</p><p> commercial octabromodiphenyl ether)</p><p>6 Chlordecone [CAS NO. 143-50-0] - No production</p><p>Production in EU is prohibited </p><p> since 2004</p><p>9 7 Hexabromobiphenyl [CAS NO. 36355-01-8] - No production</p><p>Production in EU is prohibited </p><p> since 2004</p><p>8 Pentachlorobenzene [CAS NO. 608-93-5] No production -</p><p>See section II-A</p><p>9 Perfluorooctane sulfonic acid [CAS NO. - No production 1763-23-1], its salts [CAS NO. 29457-72-5</p><p>(lithium salt), 4021-47-0 (sodium salt), 2795- See restrictions in section II-A: 39-3 (potassium salt) , 29081-56-9</p><p>(ammonium salts),70225-14-8 ● Regulation in EU, year 2006 (diethanolammonium salts)etc.] </p><p>● Legislation in Spain, year 2008</p><p>Perfluorooctane sulfonyl fluoride [CAS No. - No production 307-35-7]</p><p>See restrictions in section II-A:</p><p>● Regulation in EU, year 2006</p><p>● Legislation in Spain, year 2008</p><p>2. What are the export volumes of the chemicals listed below to each country respectively? (year 1999-2008)</p><p>No. Name Country Year Export volume (ton/year) 1 Lindane (Gamma HCH or Gamma</p><p> hexachlorocyclohexane) [CAS NO. 58-</p><p>89-9]</p><p>2 Alpha hexachlorocyclohexane(Alpha</p><p>HCH) [CAS NO. 319-84-6]</p><p>3 Beta hexachlorocyclohexane(Beta HCH)</p><p>[CAS NO. 319-85-7]</p><p>4 Tetrabromodiphenyl ether and</p><p> pentabromodiphenyl ether (2,2',4,4'-</p><p> tetrabromodiphenyl ether (BDE-47, CAS</p><p>No: 40088-47-9) and 2,2',4,4',5-</p><p> pentabromodiphenyl ether (BDE-99, 10 CAS No: 32534-81-9) and other tetra-</p><p> and pentabromodiphenyl ethers present</p><p> in commercial pentabromodiphenyl</p><p> ether.)</p><p>5 Hexabromodiphenyl ether and</p><p> heptabromodiphenyl ether (2,2',4,4',5,5'-</p><p> hexabromodiphenyl ether (BDE-153,</p><p>CAS No: 68631-49-2), 2,2',4,4',5,6'-</p><p> hexabromodiphenyl ether (BDE-154,</p><p>CAS No: 207122-15-4), 2,2',3,3',4,5',6</p><p> heptabromodiphenyl ether (BDE-175,</p><p>CAS No: 446255-22-7), 2,2',3,4,4',5',6-</p><p> heptabromodiphenyl ether (BDE-183,</p><p>CAS No: 207122-16-5) and other hexa-</p><p> and heptabromodiphenyl ethers present</p><p> in commercial octabromodiphenyl ether)</p><p>6 Chlordecone [CAS NO. 143-50-0]</p><p>7 Hexabromobiphenyl [CAS NO. 36355-</p><p>01-8]</p><p>8 Pentachlorobenzene [CAS NO. 608-93-</p><p>5]</p><p>9 Perfluorooctane sulfonic acid [CAS NO.</p><p>1763-23-1], its salts [CAS NO. 29457-</p><p>72-5 (lithium salt), 4021-47-0</p><p>(sodium salt), 2795-39-3 (potassium salt)</p><p>, 29081-56-9 (ammonium salts),70225-</p><p>14-8 (diethanolammonium salts)etc.] </p><p>Perfluorooctane sulfonyl fluoride [CAS</p><p>No. 307-35-7]</p><p>3. What are the volumes of the use of chemicals listed below? (year 1999-2008)</p><p>11 No. Name Use Year Volume (ton/year) 1 Lindane (Gamma HCH or Gamma Public health and Use is prohibited since 2007 -</p><p> hexachlorocyclohexane) [CAS NO. 58- veterinary topical </p><p>89-9] insecticide See note 1 below for more details</p><p>2 Alpha hexachlorocyclohexane(Alpha None Use of technical HCH is prohibited -</p><p>HCH) [CAS NO. 319-84-6] since 2004</p><p>3 Beta hexachlorocyclohexane(Beta HCH) None Use of technical HCH is prohibited -</p><p>[CAS NO. 319-85-7] since 2004</p><p>4 Tetrabromodiphenyl ether and Flame retardant additive Use in EU is prohibited since 2003 -</p><p> pentabromodiphenyl ether (2,2',4,4'-</p><p> tetrabromodiphenyl ether (BDE-47, CAS See restrictions in section II-A</p><p>No: 40088-47-9) and 2,2',4,4',5-</p><p> pentabromodiphenyl ether (BDE-99,</p><p>CAS No: 32534-81-9) and other tetra-</p><p> and pentabromodiphenyl ethers present</p><p> in commercial pentabromodiphenyl</p><p> ether.)</p><p>5 Hexabromodiphenyl ether and - Flame retardant additive Use in EU is prohibited since 2003 heptabromodiphenyl ether (2,2',4,4',5,5'-</p><p> hexabromodiphenyl ether (BDE-153, See restrictions in section II-A CAS No: 68631-49-2), 2,2',4,4',5,6'-</p><p> hexabromodiphenyl ether (BDE-154,</p><p>CAS No: 207122-15-4), 2,2',3,3',4,5',6</p><p> heptabromodiphenyl ether (BDE-175,</p><p>CAS No: 446255-22-7), 2,2',3,4,4',5',6-</p><p> heptabromodiphenyl ether (BDE-183,</p><p>CAS No: 207122-16-5) and other hexa-</p><p> and heptabromodiphenyl ethers present</p><p> in commercial octabromodiphenyl ether)</p><p>6 Chlordecone [CAS NO. 143-50-0] Use in EU is prohibited since 2004 - Pesticide</p><p>7 Hexabromobiphenyl [CAS NO. 36355- - Flame retardant additive Use in EU is prohibited since 2004 01-8]</p><p>8 Pentachlorobenzene [CAS NO. 608-93- Impurity of Quintozene, Quintozene was prohibited in 2000 -</p><p>5]</p><p>9 Perfluorooctane sulfonic acid [CAS NO. Fire fighting foams - See restrictions in section II-A: 1763-23-1], its salts [CAS NO. 29457-</p><p>12 72-5 (lithium salt), 4021-47-0 Surface Treatment of ● Regulation in EU, year 2006</p><p>(sodium salt), 2795-39-3 (potassium salt) Metals and Plastics</p><p>, 29081-56-9 (ammonium salts),70225- ● Legislation in Spain, year 2008 </p><p>14-8 (diethanolammonium salts)etc.] Textiles or other coated </p><p>Perfluorooctane sulfonyl fluoride [CAS materials, - See restrictions in section II-A: No. 307-35-7] Leather goods ● Regulation in EU, year 2006</p><p>(a) photoresistant or anti ● Legislation in Spain, year 2008 reflective coatings for </p><p> photolithography </p><p> processes;</p><p>(b) photographic coatings</p><p> applied to films, papers, </p><p> or printing plates;</p><p>(c) mist suppressants for </p><p> non-decorative hard </p><p> chromium (VI) plating </p><p> and wetting agents for </p><p> use in controlled </p><p> electroplating systems; </p><p>(d) hydraulic fluids for </p><p> aviation</p><p>Note 1: It is prohibited to produce, use or place on the market lindane (gamma-HCH). The chemical, whether on its own, in preparations or as a constituent of articles, was banned by 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 229, 29.6.2004, p.5). By way of derogation, Member States could allow the following uses: (a) until 1.9.2006: - Professional remedial and industrial treatment of lumber, timber and logs; - Indoor industrial and residential applications; (b) until 31.12.2007: - Technical HCH for use as an intermediate in chemical manufacturing; - Products in which at least 99% of the HCH isomer is in the gamma form (lindane) are restricted for use as public health and veterinary topical insecticide.</p><p>13 II-C Regulation of products containing the chemicals on production, import</p><p> and use 1. Are production, import and/or use of products which contain the chemicals listed below allowed in your country?</p><p>N Name Production Import Use※ o 1 Lindane (Gamma HCH or Gamma No(prohibited) No(prohibited) No(prohibited)</p><p> hexachlorocyclohexane) [CAS NO.</p><p>58-89-9]</p><p>2 Alpha hexachlorocyclohexane(Alpha No(prohibited) No(prohibited) No(prohibited)</p><p>HCH) [CAS NO. 319-84-6]</p><p>3 Beta hexachlorocyclohexane(Beta No(prohibited) No(prohibited) No(prohibited)</p><p>HCH) [CAS NO. 319-85-7]</p><p>4 Tetrabromodiphenyl ether and No(prohibited) No(prohibited) No(prohibited)</p><p> pentabromodiphenyl ether (2,2',4,4'-</p><p> tetrabromodiphenyl ether (BDE-47,</p><p>CAS No: 40088-47-9) and 2,2',4,4',5- *Restricted: *Restricted:</p><p> pentabromodiphenyl ether (BDE-99,</p><p>CAS No: 32534-81-9) and other tetra- Any content higher than Any content higher than 0.1</p><p> and pentabromodiphenyl ethers 0.1 % by mass, (in % by mass, (in articles),</p><p> present in commercial articles), may not be may not be placed on the</p><p> pentabromodiphenyl ether.) placed on the market or market or used</p><p> used</p><p>5 Hexabromodiphenyl ether and No(prohibited) No(prohibited) No(prohibited)</p><p> heptabromodiphenyl ether</p><p>(2,2',4,4',5,5'-hexabromodiphenyl</p><p> ether (BDE-153, CAS No: 68631-49- *Restricted: *Restricted:</p><p>2), 2,2',4,4',5,6'-hexabromodiphenyl</p><p> ether (BDE-154, CAS No: 207122- Any content higher than Any content higher than 0.1</p><p>15-4), 2,2',3,3',4,5',6 0.1 % by mass, (in % by mass, (in articles),</p><p> heptabromodiphenyl ether (BDE-175, articles), may not be may not be placed on the</p><p>CAS No: 446255-22-7), placed on the market or market or used</p><p>2,2',3,4,4',5',6-heptabromodiphenyl used</p><p> ether (BDE-183, CAS No: 207122-</p><p>16-5) and other hexa- and</p><p> heptabromodiphenyl ethers present in</p><p> commercial octabromodiphenyl ether)</p><p>6 Chlordecone [CAS NO. 143-50-0] No(prohibited) No(prohibited) No(prohibited)</p><p>14 7 Hexabromobiphenyl [CAS NO. No(prohibited) No(prohibited) No(prohibited)</p><p>36355-01-8]</p><p>8 Pentachlorobenzene [CAS NO. 608- No(prohibited) No(prohibited) No(prohibited)</p><p>93-5]</p><p>9 Perfluorooctane sulfonic acid [CAS Restricted Restricted Restricted</p><p>NO. 1763-23-1], its salts [CAS NO.</p><p>29457-72-5 (lithium salt), See section II-A</p><p>4021-47-0 (sodium salt), 2795-39-3</p><p>(potassium salt) , 29081-56-9</p><p>(ammonium salts),70225-14-8</p><p>(diethanolammonium salts)etc.] </p><p>Perfluorooctane sulfonyl fluoride Restricted Restricted Restricted</p><p>[CAS No. 307-35-7]</p><p>※ .”Use” means to use products which contain the chemicals here. </p><p>2. Please summarize the regulation(s) and scientific knowledge which the regulation(s) are based on.</p><p>15 See section II-A.2</p><p>● In Spain, the marketing and use restrictions of Perfluorooctane Sulfonates (PFOS) is based on the Order PRE/374/2008 which regulates the use, re-use or placing on the market of perfluorooctane sulfonates (PFOS). As from 27 June 2008, the following will apply:</p><p>The risks posed to health and environment by PFOS have been assessed in accordance with the principles of Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances1. The risk assessment identified a need to reduce the risks to health and the environment.</p><p>The Scientific Committee on Health and Environmental Risks (hereinafter ‘SCHER’) has been consulted. SCHER concluded that PFOS fulfil the criteria for classification as very persistent, very bioaccumulative and toxic. PFOS also have a potential for long range environmental transport and have the potential to produce adverse effects and therefore fulfil the criteria for being considered as persistent organic pollutants (POPs) under the Stockholm Convention2. SCHER identified a need for further scientific risk assessment of PFOS but it also agreed that risk reduction measures might be necessary to avoid the re-occurrence of former uses. According to SCHER, on-going critical uses in the aviation industry, the semiconductor industry and the photographic industry do not appear to pose a relevant risk to the environment or human health, if releases into the environment and workplace exposure are minimised. With regard to fire-fighting foams, SCHER agrees that health and environmental risks of substitutes should be assessed before a final decision can be taken. SCHER also agrees with restricting the use of PFOS in the plating industry, if there are no other measures available that could be applied to reduce the emissions during metal plating to a significantly lower level.</p><p>1 OJ L 84, 5.4.1993, p. 1. Regulation as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1). 2 Council Decision 2006/507/EC of 14 October 2004 concerning the conclusion, on behalf of the European Communi ty, of the Stockholm Convention on Persistent Organic Pollutants (OJ L 209, 31.7.2006, p. 1).</p><p>16 II-D Content in the product, amount of products on production and</p><p> export *Notice: Perfluorooctane sulfonic acid (PFOS), its salts and perfluorooctane sulfonyl fluoride (PFOSF) are added to the list of the Annex B of the Convention on Persistent Organic Pollutants with acceptable purposes and specific exemptions. Some countries, such as China and India, have required continuous use of these substances for products, such as carpets, leather, apparel, textile, upholstery, paper and packaging, rubber, plastics, insect baits for control of leaf cutting ants, and insecticides for control of red imported fire ant and termites. Thus, it is desirable to describe products containing PFOS, its salts and PFOSF in detail as possible for the purpose of this questionnaire, like ‘filler with silicon rubber system for sealing’ and ‘adhesive agent for electric and electronic parts’, because these information needs to determine target products for regulation. </p><p>1. Please describe the average contents of the chemical in products and their production volume. (year 1999-2008)</p><p>N Content Year Volume of o. Name Product (wt%) the product (ton/year) 1 Lindane (Gamma HCH or Pesticide/biocide 1-90 % (w/w)? Production is prohibited since -</p><p>Gamma products 2004. Exempted uses </p><p> hexachlorocyclohexane) [CAS prohibited since 2007</p><p>NO. 58-89-9]</p><p>2 Alpha None - Production of technical HCH is -</p><p> hexachlorocyclohexane(Alpha prohibited since 2004</p><p>HCH) [CAS NO. 319-84-6]</p><p>3 Beta None - Production of technical HCH is -</p><p> hexachlorocyclohexane(Beta prohibited since 2004</p><p>HCH) [CAS NO. 319-85-7]</p><p>4 Tetrabromodiphenyl ether and E&E applications: No production -</p><p> pentabromodiphenyl ether - (2,2',4,4'-tetrabromodiphenyl ● Office equipment Production in EU is prohibited </p><p> ether (BDE-47, CAS No: data processing, since 2003</p><p>40088-47-9) and 2,2',4,4',5- telecommunications</p><p> pentabromodiphenyl ether See restrictions in section II-A</p><p>(BDE-99, CAS No: 32534-81- ● household</p><p>9) and other tetra- and products</p><p> pentabromodiphenyl ethers</p><p>17 present in commercial ● industrial</p><p> pentabromodiphenyl ether.) electrical equipment</p><p>● brown products</p><p>● other electrical</p><p> equipment</p><p>5 Hexabromodiphenyl ether and No production - E&E applications: heptabromodiphenyl ether - (2,2',4,4',5,5'- Production in EU is prohibited ● Office equipment hexabromodiphenyl ether since 2003 data processing, (BDE-153, CAS No: 68631-49- telecommunications 2), 2,2',4,4',5,6'- See restrictions in section II-A</p><p> hexabromodiphenyl ether ● household (BDE-154, CAS No: 207122- products 15-4), 2,2',3,3',4,5',6</p><p> heptabromodiphenyl ether ● industrial (BDE-175, CAS No: 446255- electrical equipment 22-7), 2,2',3,4,4',5',6-</p><p> heptabromodiphenyl ether ● brown products (BDE-183, CAS No: 207122-</p><p>16-5) and other hexa- and ● other electrical heptabromodiphenyl ethers equipment present in commercial</p><p> octabromodiphenyl ether)</p><p>6 Chlordecone [CAS NO. 143- No production - - 50-0]</p><p>Production in EU is prohibited </p><p> since 2004</p><p>7 Hexabromobiphenyl [CAS No production - - NO. 36355-01-8]</p><p>Production in EU is prohibited </p><p> since 2004</p><p>8 Pentachlorobenzene [CAS NO. It may be generated as a -</p><p>608-93-5] byproduct or impurity during - the production of chlorinated</p><p> organic compounds</p><p>See regulation of Quintozene,</p><p> year 1990/1991 </p><p>9 Perfluorooctane sulfonic acid Fire fighting foams No production -</p><p>18 [CAS NO. 1763-23-1], its salts -</p><p>[CAS NO. 29457-72-5 Surface Treatment of See restrictions in section II-A:</p><p>(lithium salt), 4021-47-0 Metals and Plastics</p><p>(sodium salt), 2795-39-3 ● Regulation in EU, year </p><p>(potassium salt) , 29081-56-9 Textiles or other 2006</p><p>(ammonium salts),70225-14-8 coated materials,</p><p>(diethanolammonium salts)etc.] ● Legislation in Spain, year </p><p>Leather goods 2008 </p><p>Perfluorooctane sulfonyl No production</p><p> fluoride [CAS No. 307-35-7] (a) photoresistant or </p><p> anti reflective See restrictions in section II-A: coatings for </p><p> photolithography ● Regulation in EU, year </p><p> processes; 2006 (b) photographic </p><p> coatings applied to ● legislation in Spain, year </p><p> films, papers, or 2008 printing plates;</p><p>(c) mist suppressants </p><p> for non-decorative </p><p> hard chromium (VI) </p><p> plating and wetting </p><p> agents for use in </p><p> controlled </p><p> electroplating </p><p> systems; </p><p>(d) hydraulic fluids </p><p> for aviation</p><p>E&E equipment using brominated flame retardants:</p><p>Ref: European Brominated Flame Retardants Industry Panel (EBFRIP); http://www.ebfrip.org/ Ref. Association of plastics manufacturers in Europe; http://www.plasticseurope.org/</p><p>PFOS and related satls; Restricted uses: Ref: Order PRE/374/2008</p><p>19 2. Please describe export volumes of the product using the chemicals below to each product respectively. (year 1999-2008)</p><p>No. Year Export volume of Name Product the product (ton/year) 1 Lindane (Gamma HCH or Gamma</p><p> hexachlorocyclohexane) [CAS NO. 58-</p><p>89-9]</p><p>2 Alpha hexachlorocyclohexane(Alpha</p><p>HCH) [CAS NO. 319-84-6]</p><p>3 Beta hexachlorocyclohexane(Beta HCH)</p><p>[CAS NO. 319-85-7]</p><p>4 Tetrabromodiphenyl ether and</p><p> pentabromodiphenyl ether (2,2',4,4'-</p><p> tetrabromodiphenyl ether (BDE-47, CAS</p><p>No: 40088-47-9) and 2,2',4,4',5-</p><p> pentabromodiphenyl ether (BDE-99,</p><p>CAS No: 32534-81-9) and other tetra-</p><p> and pentabromodiphenyl ethers present</p><p> in commercial pentabromodiphenyl</p><p> ether.)</p><p>5 Hexabromodiphenyl ether and</p><p> heptabromodiphenyl ether (2,2',4,4',5,5'-</p><p> hexabromodiphenyl ether (BDE-153,</p><p>CAS No: 68631-49-2), 2,2',4,4',5,6'-</p><p> hexabromodiphenyl ether (BDE-154,</p><p>CAS No: 207122-15-4), 2,2',3,3',4,5',6</p><p> heptabromodiphenyl ether (BDE-175,</p><p>CAS No: 446255-22-7), 2,2',3,4,4',5',6-</p><p> heptabromodiphenyl ether (BDE-183,</p><p>CAS No: 207122-16-5) and other hexa-</p><p> and heptabromodiphenyl ethers present</p><p> in commercial octabromodiphenyl ether)</p><p>6 Chlordecone [CAS NO. 143-50-0]</p><p>7 Hexabromobiphenyl [CAS NO. 36355-</p><p>01-8]</p><p>8 Pentachlorobenzene [CAS NO. 608-93-</p><p>5]</p><p>9 Perfluorooctane sulfonic acid [CAS NO. 20 1763-23-1], its salts [CAS NO. 29457-</p><p>72-5 (lithium salt), 4021-47-0</p><p>(sodium salt), 2795-39-3 (potassium salt)</p><p>, 29081-56-9 (ammonium salts),70225-</p><p>14-8 (diethanolammonium salts)etc.]</p><p>Perfluorooctane sulfonyl fluoride [CAS</p><p>No. 307-35-7]</p><p>There is no specific information with respect to export and export volumes of products using the target chemicals, for the period 2003-2009.</p><p>Ref: European Brominated Flame Retardants Industry Panel (EBFRIP); http://www.ebfrip.org/ Ref. Association of plastics manufacturers in Europe; http://www.plasticseurope.org/ Ref: Spanish Foreign Trade Statistics; http://customs.camaras.org/</p><p>21 3. Please describe volumes of the use of products contained the chemicals below to each product respectively. (year 1999-2008)</p><p>No. Year Volume Name Use (ton/year ) 1 Lindane (Gamma HCH or Gamma Public health and Use is prohibited since 2007 -</p><p> hexachlorocyclohexane) [CAS NO. 58- veterinary topical </p><p>89-9] insecticide</p><p>2 Alpha hexachlorocyclohexane(Alpha None Use of technical HCH is prohibited -</p><p>HCH) [CAS NO. 319-84-6] since 2004</p><p>3 Beta hexachlorocyclohexane(Beta HCH) None Use of technical HCH is prohibited -</p><p>[CAS NO. 319-85-7] since 2004</p><p>4 Tetrabromodiphenyl ether and Flame retardant Use in EU is prohibited since 2003 -</p><p> pentabromodiphenyl ether (2,2',4,4'- additive</p><p> tetrabromodiphenyl ether (BDE-47, CAS See restrictions in section II-A</p><p>No: 40088-47-9) and 2,2',4,4',5-</p><p> pentabromodiphenyl ether (BDE-99,</p><p>CAS No: 32534-81-9) and other tetra-</p><p> and pentabromodiphenyl ethers present</p><p> in commercial pentabromodiphenyl</p><p> ether.)</p><p>5 Hexabromodiphenyl ether and - Flame retardant Use in EU is prohibited since 2003 heptabromodiphenyl ether (2,2',4,4',5,5'- additive hexabromodiphenyl ether (BDE-153, See restrictions in section II-A CAS No: 68631-49-2), 2,2',4,4',5,6'-</p><p> hexabromodiphenyl ether (BDE-154,</p><p>CAS No: 207122-15-4), 2,2',3,3',4,5',6</p><p> heptabromodiphenyl ether (BDE-175,</p><p>CAS No: 446255-22-7), 2,2',3,4,4',5',6-</p><p> heptabromodiphenyl ether (BDE-183,</p><p>CAS No: 207122-16-5) and other hexa-</p><p> and heptabromodiphenyl ethers present</p><p> in commercial octabromodiphenyl ether)</p><p>6 Chlordecone [CAS NO. 143-50-0] - Pesticide Use in EU is prohibited since 2004</p><p>7 Hexabromobiphenyl [CAS NO. 36355- - Flame retardant Use in EU is prohibited since 2004 01-8] additive</p><p>8 Pentachlorobenzene [CAS NO. 608-93- Impurity of Quintozene It may be generated as a byproduct -</p><p>5] or impurity during the production </p><p> of chlorinated organic compounds </p><p>22 See regulation of Quintozene in </p><p> section II-A</p><p>9 Perfluorooctane sulfonic acid [CAS NO. Fire fighting foams - See restrictions in section II-A: 1763-23-1], its salts [CAS NO. 29457-</p><p>72-5 (lithium salt), 4021-47-0 Surface Treatment of ● Regulation in EU, year 2006 (sodium salt), 2795-39-3 (potassium salt) Metals and Plastics</p><p>, 29081-56-9 (ammonium salts),70225- ● Legislation in Spain, year 2008 14-8 (diethanolammonium salts)etc.] Textiles or other coated </p><p>Perfluorooctane sulfonyl fluoride [CAS materials, - See restrictions in section II-A: No. 307-35-7] Leather goods ● Regulation in EU, year 2006</p><p>(a) photoresistant or ● legislation in Spain, year 2008 anti reflective coatings </p><p> for photolithography </p><p> processes;</p><p>(b) photographic </p><p> coatings applied to </p><p> films, papers, or </p><p> printing plates;</p><p>(c) mist suppressants </p><p> for non-decorative hard</p><p> chromium (VI) plating </p><p> and wetting agents for </p><p> use in controlled </p><p> electroplating systems; </p><p>(d) hydraulic fluids for </p><p> aviation</p><p>23 II-E Concerned issues </p><p>Have there been any problems caused by production, import or use of the chemicals or products which contain it, regarding environmental pollution or hazard to human health and/or ecosystems? If so, please describe. N Name Product Concern o 1 Lindane (Gamma HCH or Gamma Contaminated soils at historic production sites - hexachlorocyclohexane) [CAS NO.</p><p>58-89-9]</p><p>2 Alpha hexachlorocyclohexane(Alpha -</p><p>HCH) [CAS NO. 319-84-6]</p><p>3 Beta hexachlorocyclohexane(Beta -</p><p>HCH) [CAS NO. 319-85-7]</p><p>4 Tetrabromodiphenyl ether and - Diffuse pollution (biota, sediments, sewage</p><p> pentabromodiphenyl ether (2,2',4,4'- sludge) reported in scientific publications</p><p> tetrabromodiphenyl ether (BDE-47, (Chemosphere 71(2008) 1079-1086; </p><p>CAS No: 40088-47-9) and 2,2',4,4',5- Environmental Pollution 146 (2007) 188-195; </p><p> pentabromodiphenyl ether (BDE-99, Chemosphere 69 (2007) 1278-1286)</p><p>CAS No: 32534-81-9) and other tetra-</p><p> and pentabromodiphenyl ethers Analytical detection of PentaBDE in food</p><p> present in commercial reported in scientific publications </p><p> pentabromodiphenyl ether.) (Analytica Chimica Acta 565 (2006)208-213; </p><p>Toxicology 248(2008) 25-32)</p><p>Analytical detection of PentaBDE in humans</p><p> reported in scientific publications </p><p>(Chemosphere 66(2007)377-383; </p><p>Analytica Chimica Acta 597 (2007) 121-128)</p><p>5 Hexabromodiphenyl ether and Diffuse pollution (biota, sediments, sewage</p><p> heptabromodiphenyl ether sludge) reported in scientific publications - (2,2',4,4',5,5'-hexabromodiphenyl (Chemosphere 71(2008) 1079-1086; </p><p> ether (BDE-153, CAS No: 68631-49- Chemosphere 69 (2007) 1278-1286)</p><p>2), 2,2',4,4',5,6'-hexabromodiphenyl</p><p> ether (BDE-154, CAS No: 207122-</p><p>15-4), 2,2',3,3',4,5',6</p><p> heptabromodiphenyl ether (BDE-175,</p><p>CAS No: 446255-22-7),</p><p>2,2',3,4,4',5',6-heptabromodiphenyl</p><p> ether (BDE-183, CAS No: 207122-</p><p>24 16-5) and other hexa- and</p><p> heptabromodiphenyl ethers present in</p><p> commercial octabromodiphenyl ether)</p><p>6 Chlordecone [CAS NO. 143-50-0] - Group 2B: Possibly carcinogenic to humans</p><p>Endocrine disruptor</p><p>7 Hexabromobiphenyl [CAS NO. - 36355-01-8]</p><p>8 Pentachlorobenzene [CAS NO. 608- - 93-5]</p><p>9 Perfluorooctane sulfonic acid [CAS - The risks posed to health and environment by PFOS have been assessed in accordance with the NO. 1763-23-1], its salts [CAS NO. principles of Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and 29457-72-5 (lithium salt), control of the risks of existing substances3. The risk assessment identified a need to reduce the 4021-47-0 (sodium salt), 2795-39-3 risks to health and the environment.</p><p>(potassium salt) , 29081-56-9</p><p>(ammonium salts),70225-14-8</p><p>(diethanolammonium salts)etc.]</p><p>Perfluorooctane sulfonyl fluoride -</p><p>[CAS No. 307-35-7]</p><p>Thank you very much for your cooperation [End]</p><p>3 OJ L 84, 5.4.1993, p. 1. Regulation as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1). 25</p>
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