Chemical Substances Control Law

Transcription

1 Chemical Substances Control Law January 2011 Chemical Safety Office, Chemical Management Policy Division, Manufacturing Industries Bureau Ministry of Economy, Trade and Industry

2 Contents 1. Chemical Substances Control Law: Scope Chemical Substances Subject to the Chemical Substance Control Law 2. Amendment of the Chemical Substances Control Law in FY2009 (1) Amendment of the Chemical Substance Control Law: Overview (2) The Chemical Substance Control Law after the Amendment: the Whole Picture (From April 1, 2010 to March 31, 2011) (3) The Chemical Substance Control Law after the Amendment: the Whole Picture (From April 1, 2011) 3. Main Points of the Amended Chemical Substances Control Law of FY2010 (1) The Chemical Substance Control Law after the Amendment: the Whole Picture (2) Non-Persistent Substances are Included (3) Introduction of a Prior Confirmation System for Polymers of Low Concern (4) Information Delivery in the Supply Chain (Chemical Substances Subject to Type I Monitoring) (5) Measures Related to Class I Specified Chemical Substances (6) Measures Related to Class II Specified Chemical Substances (7) Summary 4. Main Points for Amended Chemical Substances Control Law of FY2011 and Thereafter (1) The Chemical Substance Control Law after the Amendment: the Whole Picture (2) Important Points for Amendment (Shift toward risk-based management) (3) Image of Screening Assessment and Risk Assessment (4) Screening Assessment/Risk Assessment and Use Category (5) Notification of the Amounts of Manufacture, Import, etc., for General Chemical Substances (6) Policy for Substances not Requiring Notification (7) Notification of the Amounts of Manufacture, Import, etc., regarding Priority Assessment Chemical Substances (new category) (8) Information Delivery in the Supply Chain (Priority Assessment Chemical Substances) (9) Handling of the Monitoring Chemical Substances (10) Reporting, etc., of Hazard Information (11) Summary 1

3 1. Chemical Substances Control Law: Scope 2

4 Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc. (Chemical Substances Control Law) Purpose Prevention of environmental pollution caused by those chemical substances that pose a risk of impairing human health or interfere with the inhabitation and/or growth of flora and fauna Overview Evaluation concerning New Chemical Substances Preliminary evaluation in connection with new substances that have not been manufactured and/or imported so far in Japan. Regulatory measures according to the properties of chemical substances Designation of Specified Chemical Substances, Monitoring Chemical Substances, etc., according to their properties. Grasp the actual amounts manufactured and imported, instruct the study of hazardous properties, the permission to manufacture and/or import, and restrictions on use, etc. Other measures including reporting of hazardous properties on chemical substances, etc. 3

5 Chemical Substances Subject to the Chemical Substance Control Law Chemical substances refers to chemical compound created by causing chemical reactions to occur to elements or compounds. The chemical substances subject to the Chemical Substance Control Law are those used for general industrial chemical products. Those substances that are subject to other regulations that are equally or more stringent regulations (Poisonous and Deleterious Substances Control Act) or more specific to the usage of the substance (Food Sanitation Act) are exempted from this law. Regulations on manufacturing, etc. Regulations on emissions Regulations on waste - Elements and natural products Chemical substances Chemical substances subject to the Chemical Substance Control Law General usage (industrial) - General industrial chemical products Specific usage [Food Sanitation Law] Foods, additives, containers and packaging, toys and detergents [Agricultural Chemicals Regulation Act] Agricultural chemicals [Fertilizers Regulation Act] Ordinary fertilizers [Act on Safety Assurance and Quality Improvement of Feeds] Feeds and feed additives [Pharmaceutical Affairs Act] Drugs, quasi-drugs, cosmetics, and medical equipment [Law concerning Prevention of Radiation Hazards due to Radioisotopes, etc.] Radioactive substances [Poisonous and Deleterious Substances Control Act] Specified poisons [Stimulant Drug Control Act] Stimulant and raw materials for stimulants [Narcotics and Psychotropics Control Act] Narcotics [Water Pollution Control Act] [Air Pollution Control Act] [Soil Contamination Countermeasures Act] [Waste Management and Public Cleansing Act] 4

6 2. Amendment of the Chemical Substances Control Law in FY2009 5

7 (1) Amendment of the Chemical Substance Control Law: Overview The current regulations and measures are reviewed and new measures necessary to rationalize regulations are implemented to reflect international trends. The amendment is also aimed at preventing the adverse influence of harmful chemical substances on humans, flora and fauna through implementation of comprehensive chemical substance management. Background and Needs of Amendment 1. Increased concerns for chemical substances (to ensure safety of the pubic both physically and mentally) 2. Needs to achieve international goals in chemical substance management To minimize the significant adverse effects of chemical substances on human health and the environment by 2020 (Agreement in the Environmental Summit in 2002). - New regulations (REACH) are already implemented in 2007 in Europe. The Chemical Substance Control Law (enactment in 1973) requires all new chemical substances (those manufactured or imported for the first time at the time of enactment or later) to go through prior evaluation. Existing chemical substances at the time of enactment have been subject to hazard assessment by the government, but assessment has not been completed for many of these chemical substances. 3. Unconformity with international conventions In an international convention (the Stockholm Convention), an agreement was made on exceptional use of certain substances that are subject to banning. With the current law, provisions on exceptional use are restrictive, imposing concern that certain uses that are essential to the industries of Japan cannot be ensured. (Reference) Related occurrences 1973 Chemical Substance Control Law enacted 2002 Agreement achieved at the Environmental Summit 2004 Stockholm Convention came into effect 2007 REACH came into effect (Europe) Amendment: Overview (1) Measures for the existing chemical substances Manufacturers and/or importers of all chemical substances, including existing chemical substances, will have an obligation to report the amount, etc. when manufacturing or importing more than a certain amount of the substance. Upon reception of the above report, the government will narrow down and prioritize the chemical substances for detailed safety assessment. The manufacturers and/or importers will be requested to submit information on the level/ type of hazard. Influences of such chemicals on human health, etc. will be evaluated and classified. Based on the results, manufacturing and use of the hazardous chemical substances and products containing these substances will be restricted. (2) Ensuring conformity with international rules Use under strict management will be ensured when a chemical substance is newly added to the list of restriction substances in international conventions. - Use for semiconductors, etc Each state will complete safety assessment 2018 Deadline of final registration for REACH 6

8 (2) The Chemical Substance Control Law after the Amendment: the Whole Picture (From April 1, 2010 to March 31, 2011) Existing chemical substances (Approx. 20,600 substances) (Chemical substances that were already manufactured/imported at the time of the promulgation of the Chemical Substance Control Law) Hazard assessment and evaluation (by the government) Persistent. Highly bioaccumulative. Long-term toxicity for humans or predator animals at higher trophic level Total manufacturing and import/year > 1 ton/year Total manufacturing and import/year 1 ton/year Notification and evaluation (Data are submitted by private corporations) Not readily biodegradable /not highly bioaccumulative New chemical substances Substances specified by Cabinet order (e.g., intermediates) Not readily biodegradable /not highly bioaccumulative 10 ton/year Polymers of Low Concern Confirmation (approval for manufacturing and/or import) Persistent/ highly bioaccumulative Suspected long-term toxicity for humans Suspected long-term toxicity for flora and fauna Chemical Substances Subject to Type I Monitoring [Persistent. Highly bioaccumulative. Toxicity unknown] - Mandatory reporting of actual amounts manufactured and/or imported, usage, etc. - Companies handling these substances are obliged to make utmost efforts to disclose information Designate a hazardous properties study Has long-term toxicity to humans or predator animals at higher trophic level Class I Specified Chemical Substance [Persistent. Highly bioaccumulative. Has long-term toxicity for humans or long-term toxicity predator animals at higher trophic level] - Prior permission is required for manufacture and/or import (virtually prohibited) - Import of certain products specified by Cabinet order is prohibited - Any uses other than specified by Cabinet order (for international consistency of requirements) are prohibited - Standards in handling of the substance and products specified by Cabinet order (products containing the substances) must be met. Mandatory labeling - Implementation of recall and other measures may be ordered Chemical Substances Subject to Type Ⅱ Monitoring [Suspected long-term toxicity for humans] - Mandatory reporting of actual amounts manufactured and/or imported, usage, etc. Designate a hazardous properties study Has long-term toxicity for humans Chemical Substances Subject to Type Ⅲ Monitoring [Suspected long-term toxicity for flora and fauna] - Mandatory reporting of actual amounts manufactured and/or imported, usage, etc. Designate a hazardous properties study Has long-term toxicity for flora and fauna in the human living environment Class II Specified Chemical Substance [Has long-term toxicity for humans or flora and fauna in the human living environment. Has risk. ] - Mandatory reporting of planned and actual amounts manufactured and imported - If deemed necessary, government issues orders to change the planned manufacture and import amounts - The government provides technical guidelines, recommendations on substances and products specified by cabinet order (products containing the substances) - Mandatory labeling for the products specified by Cabinet order 7

9 (3) The Chemical Substance Control Law after the Amendment: the Whole Picture (From April 1, 2011) Existing chemical substances (Approx. 20,600 substances) (Chemical substances that were already manufactured/imported at the time of the promulgation of the Chemical Substance Control Law) Announced and assessed substances (Approx. 8,000 substances) (excluding those subject to regulatory classification) Total manufacturing and import/year > 1 ton/year New chemical substances Total manufacturing and import/year 1 ton/year Substances specified by cabinet order (e.g., intermediates) Polymers of Low Concern General chemical substances (7,000 to 8,000 estimated) Mandatory reporting of amounts manufactured and/or imported ( 1 ton/year, usage, etc. Risk to humans or flora and fauna in the human living environment is sufficiently low Decision based on exposure, hazard, etc. Persistent. Highly bioaccumulative Notification and evaluation (Data are submitted by private corporations) Decision based on exposure, hazard, etc. Persistent Not readily biodegradable/not highly bioaccumulative 10 ton/year Confirmation (approval for manufacturing and/or import) Risk to humans or flora and fauna in the human living environment is not sufficiently low g y Priority Assessment Chemical Substances (PACs) Monitoring Chemical Substances [Persistent. Highly bioaccumulative. Toxicity unknown] - Mandatory reporting of actual amounts manufactured and/or imported, usage, etc. [Suspected long-term toxicity for humans or flora and fauna in the human living environment. Suspected risk] - Mandatory reporting of actual amounts manufactured and/or imported, detailed usage, etc. - Companies handling these substances are obliged to make utmost efforts to disclose information Note: Type II and Type III Monitoring Chemical Substance discontinued. Priority Assessment Chemical Substances may be specified from the substances previously categorized in these types Report of handling status is required Designate a hazardous properties study Has long-term toxicity to humans or predator animals at higher trophic level Class I Specified Chemical Substances [Persistent. Highly bioaccumulative. Has long-term toxicity for humans or long-term toxicity for predator animals at higher trophic level] - Prior permission is required for manufacture and/or import (virtually prohibited) - Import of certain products specified by Cabinet order is prohibited - Any uses other than specified by Cabinet order (for international consistency of requirements) are prohibited - Standards in handling of the substance and products specified by Cabinet order (products containing the substances) must be met. Mandatory labeling - Implementation of recall and other measures may be ordered Report of toxicity and handling status is required Designate a hazardous properties study Has risk for humans or flora and fauna in the human living environment Class II Specified Chemical Substances [Has long-term toxicity for humans or flora and fauna in the human living environment. Has risk. ] - Mandatory reporting of planned and actual amounts manufactured and imported - If deemed necessary, government issues orders to change the planned manufacture and import amounts - The government provides technical guidelines, recommendations on substances and products specified by Cabinet order (products containing the substances) - Mandatory labeling for the products specified by Cabinet order 8

10 3. Main Points of the Amended Chemical Substances Control Law of FY

11 (1) The Chemical Substance Control Law after the Amendment: the Whole Picture (reposted) Existing chemical substances (Approx. 20,600 substances) (Chemical substances that were already manufactured/imported at the time of the promulgation of the Chemical Substance Control Law) Hazard assessment and evaluation (by the government) Persistent. Highly bioaccumulative. Long-term toxicity for humans or predator animals at higher trophic level Total manufacturing and import/year > 1 ton/year Total manufacturing and import/year 1 ton/year Notification and evaluation (Data are submitted by private corporations) Not readily biodegradable /not highly bioaccumulative New chemical substances Substances specified by Cabinet order (e.g., intermediates) Not readily biodegradable /not highly bioaccumulative 10 ton/year Polymers of Low Concern Confirmation (approval for manufacturing and/or import) Persistent/ highly bioaccumulative Suspected long-term toxicity for humans Suspected long-term toxicity for flora and fauna Chemical Substances Subject to Type ⅠMonitoring [Persistent. Highly bioaccumulative. Toxicity unknown] - Mandatory reporting of actual amounts manufactured and/or imported, usage, etc. - Companies handling these substances are obliged to make utmost efforts to disclose information Designate a hazardous properties study Has long-term toxicity to humans or predator animals at higher trophic level Class I Specified Chemical Substance [Persistent. Highly bioaccumulative. Has long-term toxicity for humans or long-term toxicity predator animals at higher trophic level] - Prior permission is required for manufacture and/or import (virtually prohibited) - Import of certain products specified by Cabinet order is prohibited - Any uses other than specified by Cabinet order (for international consistency of requirements) are prohibited - Standards in handling of the substance and products specified by Cabinet order (products containing the substances) must be met. Mandatory labeling - Implementation of recall and other measures may be ordered Chemical Substances Subject to Type Ⅱ Monitoring [Suspected long-term toxicity for humans] - Mandatory reporting of actual amounts manufactured and/or imported, usage, etc. Designate a hazardous properties study Has long-term toxicity for humans Chemical Substances Subject to Type III Monitoring [Suspected long-term toxicity for flora and fauna] - Mandatory reporting of actual amounts manufactured and/or imported, usage, etc. Designate a hazardous properties study Has long-term toxicity for flora and fauna in the human living environment Class II Specified Chemical Substance [Has long-term toxicity for humans or flora and fauna in the human living environment. Has risk. ] - Mandatory reporting of planned and actual amounts manufactured and imported - If deemed necessary, government issues orders to change the planned manufacture and import amounts - The government provides technical guidelines, recommendations on substances and products specified by cabinet order (products containing the substances) - Mandatory labeling for the products specified by Cabinet order 10

12 (2) Non-Persistent Substances are Included Since April 2010, non-persistent substances are added to those designated as Class II Specified Chemical Substances, Chemical Substances subject to Type II or Type III Monitoring. At a joint deliberative council meeting held in December last year between the Ministry of Health, Labour and Welfare, the Ministry of Economy, Trade and Industry and the Ministry of the Environment, 100 substances out of the existing nonpersistent substances were determined to be either Chemical Substances subject to Type II or Type III Monitoring. They were designated as Chemical Substances subject to Type II or Type III April (Among them are benzene, toluene, styrene, etc.). In addition, screening assessment will be carried out for all of the Chemical Substances subject to Type II and Type III Monitoring in order to select Priority Chemical Substances during this fiscal year. 11

13 (3) Introduction of a Prior Confirmation System for Polymers of Low Concern (1/2) Polymers of low concern are those polymers among new chemical substances that are confirmed by the Minister of Health, Labour and Welfare, the Minister of Economy, Trade and Industry and the Minister of the Environment to have no risk of causing damage to human health or the habitat, etc. of flora and fauna in the human living environment. * Standards related to new chemical substances that are polymers and that do not pose a risk of causing damage to human health or to the population and/or growth of flora and fauna in the human living environment by causing environmental pollution (Notification No.2 of 2009 by the Ministry of Health, Labour and Welfare, the Ministry of Economy, Trade and Industry and the Ministry of the Environment) 1. Polymers shall be those that fall under items 1 and 2 below: (1) Any chemical substance composed of an aggregation of those molecules that are produced by linkages of one or more types of monomeric units, in which the total weight of those molecules that are composed of 3 or more linkages makes up 50% or more of the weight of the whole substance and the total weight of those molecules with identical molecular weight is less than 50% of the weight of the whole substance; and (2) Any chemical substance whose number average molecular weight is 1,000 or more. In cases where the three Ministers confirm that a new chemical substance falls under the category of polymers of low concern, the new chemical substance will be exempted from mandatory notification of its manufacture and/or import. Any person who has received confirmation of a polymer of low concern will be subject to collect report and on-site inspection, as appropriate. 12

14 (3) Introduction of a Prior Confirmation System for Polymers of Low Concern (2/2) (1) Outline of the Criteria for Verifying Polymers of Low Concern A number average molecular weight of 1,000 or more No observed changes in weight under acids or alkalis No metal included except for Na, Mg, Ca and K Insoluble in water or organic solvents. Dissolution therein indicates that the polymer does not include any double or triple bonds between carbon atoms, any epoxy group and any sulfonic acid group. (2) Major Test Data Required at the Time of Application Molecular weight distribution Physicochemical property test Solubility test with respect to acid/alkali and water/organic solvents. (3) Characteristics of Application for Verifying Polymers of Low Concern The period between application and sending of notice is 4 weeks or less. Applications are accepted at any time. Once the notice of confirmation is obtained, no further application is necessary. No notification is required for the amount of manufacture, import, etc. The names of verified chemical substances will not be made public. 13

15 (4) Information Delivery in the Supply Chain (Chemical Substances Subject to Type I Monitoring) When Chemical Substances Subject to Type I Monitoring are transfers between business entities, the entity transferring the substance is obliged to make utmost efforts to inform the recipient that the substance is specified as the Type I Monitoring Chemical Substance etc. For Class II Specified Chemical Substances and Chemical Substances Subject to Type I Monitoring, the three relevant ministries and the competent ministers may instruct the business entity handling the substance to report the status of transaction. Supply chain Control of chemical substances in the supply chain Manufacturer of raw materials Chemical substances/preparation Articles Chemical preparation /products Articles Primary processing manufacturer Parts manufacturer Manufacturer of assembled products General consumers Supply chain Manufacturer of raw materials Manufacture and import (Examples of measures) - Prohibition of manufacture and import - Restriction on manufacture and import - Reduction of release through improvement of manufacturing facilities - Control of intermediates Primary processing manufacturer Use and processing Part manufacturer (Examples of control) - Restriction on use and intended use - Reduction of amount of use through improvement of manufacturing facilities - Review the needs and possibility of overuse - Improvement of recovery rate, achievement of thorough reuse, measures on handling - Shifting to alternative substance 14

16 (5) Measures Related to Class I Specified Chemical Substances Starting from FY2010, the use of Class I Specified Chemical Substances is allowed exceptionally in cases where they are essential in the manufacture of products, as far as there is no risk of environmental pollution (Essential Use). Specifically, 3 uses of PFOS have been designated as Essential Uses, namely: use of PFOS to make semiconductor etching agents, resists and business-purpose photographic films. Obligations Related to the Handling of Class I Specified Chemical Substances, etc. Business operators handling PFOS, as well as of semiconductor etching agents, resists, business-purpose photographic films and fire extinguishers/fire fighting chemicals for extinguishers/foam fire extinguishing agents (*), in which PFOS are used, need to satisfy the following obligations: 1. Obligation to comply with the technical standards for handling these objects (The method of storage, the method of work such as relocation, etc., of the objects, the obligation to keep records of the amount of storage, etc., the handling of leakage, and the like.) 2. Obligation of labeling in cases of transfer or provision of any of these objects (The fact that PFOS is contained, its percentage content, a precaution statement, the contact address of the person who placed the label) The term handlers refers to licensed manufacturers, as well as business users, conveyors, storage business operators, etc., of Class I Specified Chemical Substances, etc. *Foam fire extinguishing agent are not designated as any Essential Use, but PFOS are already used in a considerable number of products existing in the form of stock-piles, etc., and it is difficult to replace them with any alternate products in a short period of time in view of their nature that they are used only at times of disasters. Thus, the technical standards for handling these objects and the obligation of labeling have been set up with the aim of preventing any environmental pollution through them. For reference: the past schedule for related regulations May 26, 2010 Publication of the technical standards for handling PFOS as well as semiconductor etching agents, resists and businesspurpose photographic films [(1)] September 3, 2010 Publication of the technical standards for handling foam fire extinguishing agents, etc., [(2)] as well as the matters to be labeled regarding Class I Specified Chemical Substances and products containing such substances [(c)] October 1, 2010 Enforcement of the technical standards for handling the subject products [(1),(2)] and the matters to be labeling [(3)] 15

17 (6) Measures Related to Class II Specified Chemical Substances In the past, technical guidelines for preventing environmental pollution have been announced regarding Class II Specified Chemical Substances. From now on, technical guidelines will be announced also regarding products using Class II Specified Chemical Substances designated by any Cabinet Order. In the past, business operators handling Class II Specified Chemical Substances have been obliged to label products designated by any Cabinet Order in which Class II Specified Chemical Substances are used. From now on, the obligation of labeling will also be assumed by handlers of those products in which Class II Specified Chemical Substances are used. Examples of products in which Class II Specified Chemical Substances are used: Dry cleaning fluids, metal cleaning fluids, etc., in which tetrachloroethylene is used. Technical Guidelines The structure of facilities, inspection and control, work instructions, treatment at the time of leakage, etc. are defined. Obligation of Labeling The fact that any Class II Specified Chemical Product is used in the product concerned, that the product concerned might harm human health, as well as handling instructions, should be included on a label on the container, packaging and invoice. Handlers subject to the technical guidelines and the obligation of labeling: In addition to manufacturers and importers of Class II Specified Chemical Substances, distributors, etc., of these substances are also subject to the guidelines and obligations. 16

18 (7) Summary Non-persistent substances are also subject to control. The polymers of low concern system is introduced to exclude polymers of low concern as exceptions from the evaluation of new chemical substances. International coordination is made for exceptional use of Class I Specified Chemical Substances. Technical guidelines are published and labeling are obligatory with regard to Class II Specified Chemical Substances. 17

19 4. Main Points for the Amended Chemical Substances Control Law of FY2011 and Thereafter 18

20 (1) The Chemical Substance Control Law after the Amendment: the Whole Picture (From April 1, 2011) (reposted) Existing chemical substances (Approx. 20,600 substances) (Chemical substances that were already manufactured/imported at the time of the promulgation of the Chemical Substance Control Law) Announced and assessed substances (Approx. 8,000 substances) (excluding those subject to regulatory classification) Total manufacturing and import/year > 1 ton/year New chemical substances Total manufacturing and import/year 1 ton/year Substances specified by cabinet order (e.g., intermediates) Polymers of Low Concern General chemical substances (7,000 to 8,000 estimated) Mandatory reporting of amounts manufactured and/or imported ( 1 ton/year, usage, etc. Risk to humans or flora and fauna in the human living environment is sufficiently low Decision based on exposure, hazard, etc. Persistent. Highly bioaccumulative Notification and evaluation (Data are submitted by private corporations) Decision based on exposure, hazard, etc. Persistent Not readily biodegradable/not highly bioaccumulative 10 ton/year Confirmation (approval for manufacturing and/or import) Risk to humans or flora and fauna in the human living environment is not sufficiently low g y Priority Assessment Chemical Substances (PACs) Monitoring Chemical Substances [Persistent. Highly bioaccumulative. Toxicity unknown] - Mandatory reporting of actual amounts manufactured and/or imported, usage, etc. [Suspected long-term toxicity for humans or flora and fauna in the human living environment. Suspected risk] - Mandatory reporting of actual amounts manufactured and/or imported, detailed usage, etc. - Companies handling these substances are obliged to make utmost efforts to disclose information Note: Type II and Type III Monitoring Chemical Substance discontinued. Priority Assessment Chemical Substances may be specified from the substances previously categorized in these types Report of handling status is required Designate a hazardous properties study Has long-term toxicity to humans or predator animals at higher trophic level Class I Specified Chemical Substances [Persistent. Highly bioaccumulative. Has long-term toxicity for humans or long-term toxicity for predator animals at higher trophic level] - Prior permission is required for manufacture and/or import (virtually prohibited) - Import of certain products specified by Cabinet order is prohibited - Any uses other than specified by Cabinet order (for international consistency of requirements) are prohibited - Standards in handling of the substance and products specified by Cabinet order (products containing the substances) must be met. Mandatory labeling - Implementation of recall and other measures may be ordered Report of toxicity and handling status is required Designate a hazardous properties study Has risk for humans or flora and fauna in the human living environment Class II Specified Chemical Substances [Has long-term toxicity for humans or flora and fauna in the human living environment. Has risk. ] - Mandatory reporting of planned and actual amounts manufactured and imported - If deemed necessary, government issues orders to change the planned manufacture and import amounts - The government provides technical guidelines, recommendations on substances and products specified by Cabinet order (products containing the substances) - Mandatory labeling for the products specified by Cabinet order 19

21 (2) Important Points for Amendment (Shift toward risk-based management) Risk-based Management Properties inherent in chemical substances Degree of Hazard Exposure to chemical substances in humans and/or organisms in the environment Risk Assessment Degree of Exposure The degree of risk is estimated through comparison between the exposure and the hazard by chemical substances (Risk Assessment). Hazard > Amount of exposure: No need to be concerned over the risk (1) Even chemical substances with unconfirmed hazards can be made the subject of management whenever there is concern over their impact on human health. (2) A variety of chemical substances can be utilized if the exposure, including the manner of handling and using the substances, is controlled and managed to eliminate risks. (3) The exposure, as well as the hazard, of chemical substances exhibiting strong toxicity can be strictly controlled and managed. 20

22 (3) Image of Screening Assessment and Risk Assessment Low Risk Low Risk Low Risk Class II Specified Chemical Substances Risk Assessment (Secondary) Designate a hazardous properties study Risk Assessment (Primary) Priority Assessment Chemical Substance Screening Assessment General Chemical Substances Priority Assessment Chemical Substance Degree of Hazard High Low High to be sufficiently low-risk High High High High Cannot High be High determined Medi um Medi um Medi um High High Can Low be determined to be sufficiently low-risk Medi um Medi um High Low Low Medi um Medi um Unclassified High Low Degree of Exposure General Chemical Substance General Chemical Substances No change from the present state Environmental Release (Exposure) 21 Risk = Hazard

23 (4) Screening Assessment/Risk Assessment and Use Category What is Use Category? A common use category is set up for chemical substances in order to classify them into about 50 use categories and about 280 sub use categories. An emission factor is established for each use category to estimate the amount of emission. Amount of environmental release = amount of shipment (or amount of manufacture) emission factor (*The emission factor is lower for substances that fall under the category of polymers). When the use information is unclear, 98 Other raw materials/additives is selected. When the sub use category is unclear, z Others is selected. However, when 98 Other raw materials/additives is selected, a risk assessment (screening assessment) is carried out on the assumption that the whole amount of the chemical substance handled might be released into the environment. Therefore, it is important to grasp the precise use information in order that an appropriate assessment can be implemented. Object Substance Fineness of the Use Employed Digit Number of the Code to be Stated in a Notification General chemical substance Use category Double digits (double-digit number) Priority Assessment Chemical Substance (PACs) Use category + sub use category Triple digits ( double-digit number + single letter) Monitoring chemical substance Use category + sub use category Triple digits (double-digit number + single letter) Class II Specified Chemical Substance Use category + sub use category Triple digits (double-digit number +single letter) New chemical substance Use category Double digits (double-digit number) Low production volume (LPV) chemical substance Use category Double digits (double-digit number) Small volume new chemical substance Use category Double digits (double-digit number) Polymer of low concern Use category Double digits (double-digit number) 22

24 (Reference) Image of Use Category Use categories (50 categories) are exclusively stated regarding general chemical substances Use Category code (#) Use Category Sub Use Category code Sub Use Category 01 Intermediates a Synthetic raw materials, polymerization raw materials, prepolymers b Polymerization initiators z Others Solvents Solvents for paints, varnishes, coatings, printing inks, copying 02 and biocidal products a Solvents for paints, solvent diluents b Solvents for paint removers, c Solvents for varnishes d Solvents for coatings, solvents for resist inks e Solvents for printing inks, solvents for electronic devices, solvents for inks and ink detergents f Solvents for biocidalid products z Others Solvents for adhesives, pressure sensitive adhesives and 03 sealants a Solvents for adhesives, solvents for pressure sensitive adhesives b Solvents for adhesive removers, solvents for paste removers c Solvents for adhesion d Solvents for sealants z Others Use category and sub use category (about 280 categories) are stated regarding Monitoring Chemical Substances, Priority Assessment Chemical Substances and Class II Specified Chemical Substances. 23

25 (5) Notification of the Amounts of Manufacture, Import, etc., for General Chemical Substances (1) Subjects of Notification Persons who have manufactured or imported general chemical substances, pursuant to the provisions of the Chemical Substances Control Law. Chemical substances manufactured or imported in an amount of 1 ton or more per company (1) Chemical substances of less than 1 ton in amount, (2) Use for testing and research, and (3) Substances, etc., requiring no notification designated by the 3 relevant Ministers Chemical substances each of which makes up 10% or more by weight of a mixture The manufacture of those chemical substances that are entirely consumed within the manufacturer company (intermediate products for in-house use), regardless of whether this is within the same establishment or not, will be exempt from mandatory notification. Caution: The import of those chemical substances to be consumed entirely within the importer company will be subject to mandatory notification. (2) Details of Notification The format prescribed by METI related Ordinance for Enforcement of Chemical Substances Control Law (Format No. 11) should be used. The amount of manufacture, the amount of import and the amount of shipment in the previous year should be notified in 1 significant ifi digit. e.g.: 12,499t 10,000t, 1,894t 2,000t, 13t 10, 0.8t No change required The use should be notified according to about 50 use categories (double digits) The CAS number (if known) should be stated (in the Other Numbers column). (3) Time of Notification Notification should be made between April 1 and June 30 inclusive (by paper, electronically, by CD, etc.). (4) Handling of Data Notified These data should be used in the screening to select Priority Assessment Chemical Substances from general chemical substances. With regard to the amount of manufacture or import, the total national amount should be announced in allowing for some margin. However, consideration should be made in the case where the number of manufacturers or importers is small. What are General Chemical Substances? (1) Chemical substances listed in the register of existing chemical substances (2) Newly announced chemical substances (3) Former Class II and Class III Monitoring Chemical Substances *In respect to (1) to (3), substances designated as Priority Assessment Chemical Substances, etc., are excluded. (4) Chemical substances for which the designation for Priority Assessment Chemical Substance has been cancelled (5) New chemical substances before announcement, which have received the notice of decision 24

26 (6) Policy for Substances not Requiring Notification (1/2) (1) Basis for Selection Chemical substances that are recognized from the results of determination by high molecular flow scheme, etc., that they do not need to go through any risk assessment Chemical substances that essentially exist in nature in large amounts Chemical substances that exist in nature, water areas or the atmosphere in large amounts such as in the Earth s crust (Silicon dioxide, aluminum oxide, etc.) Chemical substances that degrade in the environment exclusively into those ions indicated by notice of existing knowledge (Sodium chloride, magnesium sulfate, etc.) By Chemical substances that are either essential or important for the biotic activities of living bodies (Citric acid, oleic acid, etc.) * Excluding those chemical substances that are subject to control by other laws and regulations from the viewpoint of preventing human health hazards or environmental pollution Chemical substances regarding which restriction on marketing might be imposed by other laws from the viewpoint of preventing environmental pollution, as in the case of the Chemical Substances Control Law. Act Concerning the Maintenance of Quality of Gasoline, etc. (gasoline, kerosene, etc.) 25

27 (6) Policy for Substances not Requiring Notification (2/2) (2) Polymers Not Requiring Notification New chemical substances that received a determination equivalent to the non-hazardous determination by High Molecular Flow Scheme in, or later, limited however, only to those substances whose names have been announced. April 2004 New chemical substances that received a determination equivalent to non-hazardous determination by High Molecular Flow Scheme during the period from April 1987 to March (Limited only to those having no risk of ecological impact). Existing chemical substances that are recognized to be either equivalent to non-hazardous determination by High Molecular Flow Scheme or to satisfy the criteria for confirmation of polymers of low concern. (3) Publication of the List The list was published as a result of collecting opinions: August 2010 ( consideration made for publication of and/or addition to the list of candidates for Substances Not Requiring Notification). Opinions collected again on the list of candidates for Substances Not Requiring Notification for publication of the list in around January Substances Not Requiring Notification will be announced by the end of March Substances will be added every year. *An advertisement is placed on the website of the Chemical Substances Control Law, asking for provision of information on the safety assessment of polymers. 26

28 (Supplement) Frequently Asked Questions: About cases where notification is not required The following cases are not subject to the obligation to notify the amount of manufacture or import of general chemical substances or Priority Assessment Chemical Substances (PACs). (Notification is not required). * Implementation of the Law Concerning the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc. (Notice by the Director General) <1> Cases where notification is not necessary due to lack of applicability to manufacturing of chemical substances as in the Chemical Substance Control Law - Cases where chemical substances purchased from a company in Japan are sold as is - Cases where chemical substances purchased from a company in Japan are made into a product based on a mixing, forming, or purification process, etc. that does not cause chemical reactions <2> Cases where notification is not necessary due to lack of applicability to importing of chemical substances as in the Chemical Substance Control Law (3) Cases where products that possess specific shapes or mixtures that are sold to general consumers ( product as in the Chemical Substance Control Law) are imported *1 *1 Please note that handling of products that make use of specified chemical substances differ. <3> Other cases where notifications are specified as being unnecessary due to laws, etc. (4) Cases where the total of the amount of chemical substances manufactured in Japan and the amount of chemical substances imported into Japan during FY2010 is less than 1 ton per company for each chemical substance (5) Cases where chemical substances are manufactured or imported for testing and research purposes (6) Cases where the substances have been confirmed as being an intermediate, etc., polymers of low concern, or low production (7) Cases where a substance excepted from notification *2 (substances designated by the 3 Ministers as there being no necessity to conduct risk assessment) was manufactured or imported *2 Substances excepted from notification are planned on being added every year. 27

29 (7) Notification of the Amounts of Manufacture, Import, etc., regarding Priority Assessment Chemical Substances (new category) (1/2) (1) Subjects of Notification Notification is obligatory under the provisions of the Chemical Substances Control Law on persons who have manufactured or imported Priority Assessment Chemical Substances. Chemical substances that are manufactured or imported in an amount 1 ton or more per company regarding 1 chemical substance Chemical substances containing 1% or more by weight of impurities in the case of mixtures (Intended products are subject to the obligation of notification regardless of their percent by weight). The manufacture of those chemical substances that are entirely consumed within the manufacturer company (intermediate products for in-house use), regardless of whether this is within the same establishment or not, will be exempt from mandatory notification. Caution: The import of those chemical substances to be consumed entirely within the importer company will be subject to mandatory notification. (2) Details of Notification The format prescribed by METI related Ordinance for Enforcement of the Chemical Substances Control Law(Format 12) should be used. The amounts of manufacture, import and shipment (for each prefecture) in the previous fiscal year should be notified using the actual figures. Both the category of use (in double digits) and the detailed category of use (in single digit) should be notified regarding use. The CAS number (if known) should be stated (in the column Other Numbers). (3) Time of Notification Notification should be made between April 1 and June 30, inclusive (by paper, electronically, by CD, etc.) (4) Handling of Notified Data To be utilized for the risk assessment of Priority Assessment Chemical Substances Substances for which the amounts of manufacture and import exceed 100 tons in total actual figures, the total amount should be announced using the actual figure. 28

30 (7) Notification of the Amounts of Manufacture, Import, etc., regarding Priority Assessment Chemical Substances (new category) (2/2) Place of Manufacture General Chemical Substances - Priority Assessment Chemical Substances Name and location of establishment Amounts of Manufacture and Import Annual amounts of manufacture and import Annual amount of manufacture by prefecture Amount of import by country or territory Amount of Shipment By use category By prefecture and by use category Use Category About 50 categories About 280 categories 29

31 (8) Information Delivery in the Supply Chain (Priority Assessment Chemical Substances) When Priority Assessment Chemical Substances are transferred between business entities, the entity transferring the substance is obliged to make the utmost efforts to inform the recipient that the substance is specified as the Priority Assessment Chemical Substance etc. For Class II Specified Chemical Substances, Monitoring Chemical Substances, and Priority Assessment Chemical Substances, the three relevant ministries and the competent ministers may instruct the business entity handling the substance to report the status of transaction. Supply chain Control of chemical substances in the supply chain Manufacturer of raw materials Chemical substances/preparation Articles Chemical preparation /products Articles Primary processing manufacturer Parts manufacturer Manufacturer of assembled products General consumers Supply chain Manufacturer of raw materials Manufacture and import (Examples of measures) - Prohibition of manufacture and import - Restriction on manufacture and import - Reduction of release through improvement of manufacturing facilities - Control of intermediates Primary processing manufacturer Use and processing Part manufacturer (Examples of control) - Restriction on use and intended use - Reduction of amount of use through improvement of manufacturing facilities - Review the needs and possibility of overuse - Improvement of recovery rate, achievement of thorough reuse, measures on handling - Shifting to alternative substance 30

32 (9) Handling of the Monitoring Chemical Substances Classifications of Chemical Substances subject to Type II Monitoring and Type III Monitoring are to be discontinued after the PACs (Priority Assessment Chemical Substances) are established Classification of Chemical Substances subject to Type I Monitoring will be renamed Monitoring Chemical Substances and remain effective - Under the system of Chemical Substances subject to Type II Monitoring, chemical substances that pose a risk of harming human health are designated and the manufacturers and importers of such substances are requested to report the amount of manufacture or import. - Under the system of Chemical Substances subject to Type III Monitoring, chemical substances that have a risk of imposing adverse effects on the habitats of or the growth of plants and animals are designated and the manufacturers and importers of such substances are requested to report the amount of manufacture or import. - Classifications of Chemical Substances subject to Type II and Type III Monitoring are to be discontinued after the new classification of the PACs is made effective under the amended Law in order to assess the toxicity of the substances to human health and flora and fauna. - The classification of Chemical Substances subject to Type I Monitoring, the predecessor of Class I Specified Chemical Substances. 31

33 (10) Reporting, etc., of Hazard Information (1/2) Cases where reporting to any government office is required (1) Cases where a company already has any unpublished knowledge within itself (cases for due diligence). Priority Assessment Chemical Substances, Monitoring Chemical Substances and Class II Specified Chemical Substances are subject to mandatory notification. No penalty will be applied. Knowledge Subject to Reporting Physicochemical properties (melting point, boiling point, etc.) Degradability (photo degradability, hydrolizability, etc.) Accumulative property (bioaccumulative property, etc.) Toxicity, etc., to humans (chronic toxicity, teratogenicity, pharmacological properties, etc.) Toxicity to flora and fauna (impact on plants, birds and fish) Other toxicologically important impacts (including any knowledge about any product of a substance in cases where the substance is susceptible to chemical change and the product falls under any of the cases described above). (2) Cases where new tests, etc., have been conducted to obtain knowledge concerning hazard (obligatory cases) General chemical substances, Priority Assessment Chemical Substances, Monitoring Chemical Substances and Class II Specified Chemical Substances are subject to mandatory notification. Penalty will be applied. 1) Knowledge of any persistent property (substances shown to be persistent under persistence test in microorganisms, etc.) 2) Knowledge of any high enrichment property (substances shown to have high enrichment property in enrichment test of fishes and shellfishes, etc.) 3) Knowledge of any long-term toxicity to human health (chronic toxicity, teratogenicity, etc.) 4) Knowledge of any toxicity to flora and fauna (toxicity to aquatic plants, impact on the reproduction of birds, etc.) 5) Where chemical changes easily occur and the products fall within the cases described above, knowledge about the products. 32