Execution Status of Law concerning the Evaluation and Regulation of Manufacture, etc. of Chemical Substances (CSCL) (2006)

Transcription

1 Execution Status of Law concerning the Evaluation and Regulation of Manufacture, etc. of Chemical Substances (CSCL) (2006) July 20, 2007 Chemical Safety Office, Chemical Management Policy Division, Manufacturing Industries Bureau, Ministry of Economy, Trade and Industry, Japan

2 Table of contents Outline of review and regulations according to the amended Law concerning the Evaluation and Regulation of Manufacture, etc. of Chemical Substances... 1 Trend of the number of notifications of new chemical... 2 Trend of the number of applications on small amount new chemical... 2 Use classification of new chemical in Use classification of small amount new chemical in Trend of the distribution ratio of the number of notifications of new chemical... 4 Trend of the distribution ratio of the number of applications on small amount new chemical... 5 Reason for judgment of non-specified chemical under Original CSCL... 6 Reason for judgment of non-specified and designated chemical under CSCL (amended in 1986)... 6 Reason for judgment of non-specified / monitoring chemical under CSCL (amended in 2003)... 6 Reason for judgment in 2006 (biodegradability, bioaccumulation, and toxicity)... 7 confirmation of intermediates and execution in reporting information on hazardousness in notification of new chemical... 9 Trend of the number of applications and confirmation relating to small amount new chemical Status of assessment... 13

3 Outline of review and regulations according to the amended Law concerning the Evaluation and Regulation of Manufacture, etc. of Chemical Substances Existing chemical Total manufacture and/or import per year Over 1 ton (Notification) New chemical Total manufacture and/or import per year Less than 1 ton Chemical that have extremely low likelihood of release into the environment (e.g. chemical intermediates, etc.) Hazard assessment of existing chemical Prior evaluation of persistence, bioaccumulation, long-term toxicity for humans, toxicity for plants and animals Prior confirmation Persistent Not highly bioaccumulative Annual production/import volume less than 10t Prior confirmation Approval for manufacture and/or import Persistent Highly bioaccumulative Persistent Not highly bioaccumulative Suspected long-term toxicity for humans Persistent Not highly bioaccumulative May have an adverse effect on the environment Ex-post monitoring (collection of reports, site-inspection) Type I Monitoring Chemical Substances Notification of quantity, manufactured and/or imported and use, etc. Guidance, advice, etc. (if necessary) Type Ⅱ Monitoring Chemical Substances ( Designated Chemical Substance before 2003 amendment of the law) Notification of quantity manufactured and/or imported and use, etc. Guidance, advice, etc. (if necessary) Type Ⅲ Monitoring Chemical Substances Notification of quantity manufactured and/or imported, and use, etc. Guidance, advice, etc. (if necessary) Government directs manufacturers and importers to conduct a hazard survey (if necessary) Persistent Highly bioaccumulative Has long-term toxicity for humans, or toxicity for top predators Government directs manufacturers and importers to conduct a hazard survey (if necessary) Persistent Not highly bioaccumulative Has long-term toxicity for humans Environmental residual is confirmed to have the potential to cause damage Government directs manufacturers and importers to conduct a hazard survey (if necessary) Persistent Not highly bioaccumulative Has toxicity for plants and animals in the living environment Environmental residual is confirmed to have the potential to cause damage Class I Specified Chemical Substances Class II Specified Chemical Substances Permission is required for manufacture and/or import (de facto prohibition) Any uses other than specified uses are prohibited Import of certain products specified by cabinet order is restricted Government orders to take actions, for example, recall products (when a substance or product is specified or is in violation of an ordinance), and other restrictions. Notification of planned and quantity manufactured and/or imported If necessary, government orders to change the planned manufacture and/or import volumes, etc. Government publishes technical guidelines, recommendations Mandatory labeling, recommendations from government, etc. Note: If a substance does not meet any of the abovementioned criteria, it will not be subject to regulation under the Chemical Substances Control Law Manufacturers and importers are required to report any information they learn about the toxicity of the chemical they handle. (Current revisions to the law are marked with ) -1-

4 Trend of the number of notifications of new chemical Import Manufacturing 500 notifications '74 '75 '76 '77 '78 '79 '80 '81 '82 '83 '84 '85 '86 '87 '88 '89 '90 '91 '92 '93 '94 '95 '96 '97 '98 '99 '00 '01 '02 '03 '04 '05 '06 Calender year Trend of the number of applications on small amount new chemical Import Manufacturing applications '74 '75 '76 '77 '78 '79 '80 '81 '82 '83 '84 '85 '86 '87 '88 '89 '90 '91 '92 '93 '94 '95 '96 '97 '98 '99 '00 '01 '02 '03 '04 '05 '06 Fiscal year -2-

5 平成 18 年新規化学物質の用途別分類 Use classification of new chemical in 2006 Use classification of new chemical in 2006 cases (%) Polymers and raw materials for polymers Raw materials for pharmaceuticals and agricultural chemicals ポリマー ホ リマー原料 Polymers and raw materials for polymers Raw materials for pharmaceuticals and 医薬 農薬原料 agricultural chemicals 染料 顔料 塗料 Dye stuff, pigments, and paints Photosensitive, pressure-sensitive, and 感光 圧 熱材料 heat-sensitive materials 電子工業材料 Electronic industrial materials Stabilizers, antioxidizing agents, and antiaging agents Adhesives 安定剤 酸化防止剤 老化防止剤 接着剤 殺菌剤 殺虫剤 防カビ剤 Disinfectants, insecticides, and fungicides 溶剤 Solvents 液晶中間体 Intermediates for liquid crystals その他 Others Dye stuff, pigments, and paints Photosensitive, pressure-sensitive, and heat-sensitive materials Electronic industrial materials Stabilizers, antioxidizing agents, and antiaging agents Adhesives Disinfectants, insecticides, and fungicides Solvents Intermediates for liquid crystals Others Total 平成 18 年度少量新規化学物質の用途別分類 Use classification of small amount new chemical in 2006 Electronic industrial materials 電子工業材料 (semiconductors) ( 半導体 ) Liquid crystals and liquid crystal 液晶 液晶材料 materials Fragrant materials and intermediates 香料 香料中間体 for fragrant materials Synthetic resins 合成樹脂 Intermediates for pharmaceuticals (for export) Raw materials for polymers (monomers) 医薬品中間体 ( 輸出用 ) ポリマー原料 ( モノマー ) 顔料 塗料 インキ Pigments, paints and ink 写真感光材料 Photographic sensitive materials 染料 Dye stuff 感光性樹脂 Photosensitive resins その他 Others Use classification of small amount new chemical in 2006 cases Electronic industrial materials (semiconductors) 2619 Liquid crystals and liquid crystal materials 2117 Intermediates for pharmaceuticals (for export) 932 Raw materials for polymers (monomers) 856 Fragrant materials and intermediates for fragrant materials 817 Synthetic resins 813 Photographic sensitive materials 701 Pigments, paints and ink 688 Dye stuff 642 Photosensitive resins 608 Others 6894 Total

6 Trend of the distribution ratio of the number of notifications of new chemical 60.0 % From 1987 to Synthetic resins Photographic sensitive materials Adhesives Pigments, paints, and ink Electronic industrial materials Raw materials and intermediates for pharmaceuticals Raw materials for polymers Dye stuff and intermediates for dye stuff Others -4-

7 Trend of the distribution ratio of the number of applications on small amount new chemical 50.0 % 45.0 From 1987 to Liquid crystals and liquid crystal materials Photographic sensitive materials Dye stuff Electronic industrial materials Fragment materials and intermediate for fragment materials Raw materials for polymers Pigments, paints, and ink Synthetic resins Photographic sensitizers and desensitizers Catalyst Photosensitive resins Others -5-

8 Reason for judgment of non-specified chemical under Original CSCL Reason for judgment of non-specified/designated chemical under CSCL (amended in 1986) Reason for judgment of non-specified/monitoring chemical under CSCL (amended in 2003) 0.3% 17.1% 20.3% 0.1% 8.9% 3.2% 2.9% 0.8% 13.5% 82.6% Ready biodegradable Non-biodegradable and not highly bioaccumulative No long-term toxicity 66.1% No suspicion for long-term toxicity Ready biodegradable Designated chemical No long-term toxicity No suspicion for long-term toxicity Ready biodegradable 84.4% Type Ⅱ monitoring chemical (not Type Ⅲ monitoring chemical ) Type Ⅱ monitoring chemical and Type Ⅲ monitoring chemical Type Ⅲ monitoring chemical (not Type Ⅱ monitoring chemical ) Reason for judgment of non-specified chemical under Original CSCL Reason for judgment of non-specified/designated chemical under CSCL (amended in 1986) Reason for judgment of non-specified/monitoring chemical under CSCL (amended in 2003) cases (%) cases (%) cases Ready biodegradable No suspicion for long-term No suspicion for long-term toxicity Non-biodegradable toxicity Ready biodegradable and not highly Ready biodegradable Type Ⅱ monitoring chemical (not bioaccumulative Designated chemical Type Ⅲ monitoring chemical substance) No long-term toxicity Type Ⅱ monitoring chemical and Total No long-term toxicity Type Ⅲ monitoring chemical Total Type Ⅲ monitoring chemical (not Type Ⅱ monitoring chemical ) (%) Total

9 Reason for the judgment of biodegradability in 2006 Reason for the judgment of bioaccumulation in 2006 Reason for the judgment of toxicity in 2006 Known information Known information Known information Polymer FS Biodegradation test Polymer FS Bioconcentration test Screening toxicity Polymer FS Partition coefficient test Reason for the judgment of biodegradability in 2006 Reason for the judgment of bioaccumulation in 2006 Reason for the judgment of toxicity in 2006 cases (%) cases (%) cases (%) Biodegradation test Bioconcentration test Screening toxicity Polymer flow scheme Partition coefficient test Polymer flow scheme Known information, etc. 2 1 Polymer flow scheme Known information, etc. 0 0 Total Known information, etc Total Total Since these figures include derivative materials and exclude notifications of the same materials, the numbers are different from those described in the data on the number of notification. -7-

10 confirmation of intermediates, closed system, and export only in 2006 reporting information on hazardousness in 2006 confirmations Intermediates Closed systems Import Manufacturing Export only 2 39 reporting (Fiscal year) Biodegradability Bioaccumulation Toxicity Ecotoxicity to humans Fiscal year -8-

11 Execution status of CSCL notifications of new chemical (Original CSCL) Calendar year (January to March) Subtotal notifications Manufacturing Import Those that correspond to the Paragraph 1, Article 4 of the Original CSCL Manufacturing Import Judgment based on biodegradability Manufacturing Import Judgment based on bioaccumulation Manufacturing Import Judgment based on long-term toxicity Manufacturing Import (January to March for 1987.) -9-

12 notifications of new chemical (CSCL amended in 1986) Calendar year 87 (April to December) (January to March) Subtotal notifications Manufacturing Import Those that correspond to Item 3, Paragraph 1, Article 4 of CSCL (1986) Manufacturing Import Ready biodegradable Manufacturing Import No suspicion for long-term toxicity Manufacturing Import No long-term toxicity Manufacturing Import designated chemical Manufacturing Import * The number of notifications includes the notifications of the same materials and the number of notifications of materials that have been withdrawn. * From April to December for 1987 and from January to March for * The number for import includes the notifications from overseas in accordance with the provisions stipulated in 2, Article 5 of the CSCL(1986) (export). -10-

13 notifications of new chemical (CSCL amended in 2003) Calendar year 04 (April to December) Subtotal notifications Manufacturing Import Those that correspond to Item 5, Paragraph 1, Article 4 of the CSCL (2003) Manufacturing Import Biodegradable Manufacturing Import No suspicion for long-term toxicity Manufacturing Import No long-term toxicity Manufacturing Import Type II monitoring chemical Manufacturing Import Type III monitoring chemical Manufacturing Import Type II and Type III monitoring chemical (included in the above figures) Manufacturing Import Those that correspond to each Item of Paragraph , Article 4-2 of the CSCL(low production volume) * The number of notifications includes the notifications of the same and the reports according to Paragraph 7, Article 4-2 of the CSCL (continuation of the examination of new chemical whose production volume is small.) * The number for import includes the notifications from overseas in accordance with the provisions stipulated in Article 5-2 of the CSCL (export). -11-

14 Trend of the number of applications and confirmations of small amount new chemical Fiscal year Applications Manufacturing Import Confirmation (included in the above figures) Manufacturing Import Fiscal year Applications Manufacturing Import Confirmation (included in the above figures) Manufacturing Import

15 Status of the assessment of existing chemical (Original CSCL amended in 1986) Calendar year Results of assessment 40 * * * * * * * * * Biodegradable Not highly bioconcentrative Highly bioconcentrative as Class I specified chemical as designated chemical * as Class II specified chemical Calendar year Results of assessment *4 60 Ready biodegradable (3) 15 (14) Not highly bioconcentrative Highly bioconcentrative as Class I specified chemical as designated chemical *5 (6) as Class II specified chemical (*1) The reason why a substance is reduced from the figure of 1975, two are reduced from the figure of 1976, and three are reduced from the figure of 1977 is as follows. Since reconfirmation tests of the six that had been judged as degradable revealed that they are not degradable, bioconcentration tests were conducted in 1999 and The results of tests were not highly bioconcentrative. (*2) The reason why two are reduced from the figure of 1978 and a substance is reduced from the figure of 1979 is that the assessment of the three was changed from not highly bioconcentrative to highly bioconcentrative in (*3) The reason why five are reduced from the figure of 1982 and three are reduced from the figure of 1983 and a substance is reduced from the figure of 1975 is that the assessment of the nine was changed from not highly bioconcentrative to highly bioconcentrative in 2002 and (*4) The reason why a substance is reduced from the figure of 1987 and a substance is reduced from the figure of 2003 is that polybromobiphenyl (the numbers of bromine is limited to two to five) that contains the two was judged as highly bioconcentrative in (*5) Figures in parentheses indicate the cancellation of designation due to the change from designated chemical to Class II specified chemical. -13-

16 Status of assessment of existing chemical (CSCL amended in 2003) Calendar year Total Results of assessment Ready biodegradable Not highly bioconcentrative Highly bioconcentrative as Class I specified chemical as Class II specified chemical as Type I monitoring chemical *6 as Type II monitoring chemical as Type III monitoring chemical (23) (*6) Adding the three notified on January 29, 2007 and eight notified on May 31, 2007 the current total number of Type I monitoring chemical is