Chemical Legislation and Regulations Updates: Japan

Transcription

1 2012/CTI2/CD/FOR/002 Morning Session II Chemical Legislation and Regulations Updates: Japan Purpose: Information Submitted by: Japan APEC Chemical Regulators Forum Singapore 30 March 2012

2 CHEMICAL LEGISLATION & REGULATIONS UPDATES : JAPAN Takashi Fukushima Director for Chemical Management Policy Chemical Management Policy Division METI Contents CSCL Step-wise risk assessment Annual report Screening Annual report GHS implementation ti IHSL PRTR law Road map 2 1

3 Step-wise risk assessment Assessment process CSCL chemical inventory (20,000) Existing chemicals + evaluated new chemicals Notified chemical substances(6,000) Screening assessment Designation of PACSs(???) Risk assessment (I) Risk assessment (II) Industry s role -Notify annual quantity of manufacture etc. (mandatory) - Submit hazard information (voluntary) - Notify annual quantity of manufacture etc. with detailed usage (mandatory) - Submit requested hazard information - Report requested handling situation - Conduct administratively instructed hazardous properties study (long-term toxicity test) (mandatory) Class II specified chemical substances -Notify planned annual quantity of manufacture etc. -Technical guidance for use etc. 3 Information to be used Hazard Exposure Risk Assessment Steps R A (I) Screening Scre eening Long term Use amount Detail us se amount Degra dability Bioaccu umulation Degra dability Hal lf life ()Physical chemical prop perty P R T R Evaluation I Evaluation II Evaluation III Government order to collect data on long term effect to humans and the environment Risk assessment (II) Moni itoring Indiv vidual han dling inform mation REDs are newly added to the previous step. or :Essential, or :Use if available. Exposure evaluation Rough Detailed Hazard evaluation in detail 4 2

4 Annual report : Notice for exporters What information will be required from importers? Based on the amendment of the CSCL, exporters in other economies should provide the following information to importers in Japan. Chemical identity (IUPAC name and CAS/MITI number.) Concentration in mixtures* Note:Existing chemical substances: No need to inform Intentional additives and unintentional contaminations if the concentration rate is less that 10%. PACS: No need to inform unintentional contaminations if the concentration rate is less than1%. Intentional additives must be notified regardless of concentration rate in Mixtures. Guidance to allow joint reporting with third party METI published a guide to allow reporting jointly with a third party. Importers initiate the process in case of difficulty in fulfilling their legal obligation. The guidance is applicable only to annual reporting of general chemicals under CSCL. Number of notifications in accordance with this guidance : 7 notifications (6 companies) 5 Annual report : Exemptions Annual reporting will be exempted for certain chemicals. Those chemicals will be designated by 3 ministers by the end of FY2010. Selection criteria and initial lists are already published. Three categories for exemption. - Evaluated polymers (Polymer flow-scheme and PLC) - Initial selections are from past new chemical notifications. - Polymers in existing chemicals will be added when certain data will be provided by industry. - Chemicals in the environment* - Metal oxides in earth's crust. - Easily degradable chemicals to specific ions in the water. - Biological chemicals in human body etc. - Chemicals covered under existing market regulation - Petroleum Products. *Regulated chemicals covered by other laws are excluded. 6 3

5 Annual report : General chemicals and PACSs General chemicals Reference article Article 8 Article 9 PACSs* Purpose Screening Risk Assessment Identification of PACSs Focusing of class II candidate Requirements Chemical identity (MITI No., CAS No.(if available)) Volume manufactured, imported (previous fiscal year) Use category and shipped volume Chemical identity (MITI No., CAS No.(if available)) Volume manufactured, imported(previous fiscal year) Use category (detailed) and shipped volume Place of production or export Threshold h 11 ton/year 11 ton/year >10% in mixture >1% in mixture Applicability of the Applicable Not applicable joint reporting Number of reports (as of June 2011) 31,000 reports 1,400 companies 800 reports 300 companies *88 substances are designated as PACSs from ex-type Ⅱ/Ⅲ monitoring chemical substances. (April 2011) 7 Screening assessment STEP1 : Classification of exposure Notified information : Annual quantity of manufacture etc. / use category STEP2 : Classification of hazard Hazard information collected by the government Hazard information submitted by the industries Aggregate the data for target chemical substances of each assessment using MITI number or CAS number Apply threshold* Emission factor table Repeated dose toxicity Carcinogenicity Mutagenicity Classification of hazard Class1 Class2 Class3 Class4 No data available No data available *1 *2 Estimation of environmental release Classification of exposure *Threshold for risk assessment: Total annual quantity of manufacture etc. is less than 10t/year Reproduction toxicity Hazard class Highest class in the four categories will be chosen *1: CSCL screening scale based on GHS, previous CSCL rule etc. *2: If no data available, default class (class 2) will likely be applied for repeated dose toxicity and mutagenicity. (default class will not be applied for carcinogenicity and reproductive toxicity) No data is not considered Not hazardous 8 4

6 STEP3 : Prioritization matrix Expos sure class Exposure Class Hazard class Class1 Class2 Class3 Class4 Class1 High High High High Class2 High High High Medium Class3 High High Medium Medium Class4 High Medium Medium Class5 Medium Medium Total national emissions (tons) Class1 Over 10,000 Class2 1,000 10,000 Class Class Class Designated by the government as PACSs Further review Remain in general chemical substances NOTE: -Threshold value for risk assessment will be applied -Opportunities for industry to submit hazard information are given before designation of PACSs -Similar methodology is adopted to eco-toxicity. -List of PACSs will be reconsidered based on annual reporting and new hazard information. 9 Progress so far By the end of fy2010 Screening method approval by the joint council. 1 st batch screening of former type II & III monitoring chemicals. Development of exemption criteria. On April 1 st 2011 Designation of 88 PACSs from former type II & III monitoring chemicals(1 st batch) Publication of exempted chemicals (some 1500 chemicals) By the end of fy2011 First annual report of manufacturing & import. (June 30, 2011) Publication of reliability criteria. (September 11, 2011) Publication risk assessment method.(january 31, 2012) Publication of the result of data-gap study. (Up-dated on October 31, 2011) 2 nd batch screening of general chemicals*.(council review: January 27, Publish March 22, 2012) Publication of additional exempted chemicals (mainly polymers).(march 22, 2012) 10 5

7 2 nd batch screening of general chemicals Category Reviewed chemicals under OECD/HPV program* IARC Class 1, 2 &3* Carcinogenicity class 1A, 1B and 2 by GHS classification by the government* Former designated chemicals* Type II & III designated in fy 2010 *: Limited to the chemicals which are not yet screened. End point Human health (Limited to genotoxicity and repeated dose toxicity) and eco toxicity Carcinogenicity Carcinogenicity Eco toxicity Type II: Human health Type III: Eco toxicity 8 chemicals are judged to be Priority Assessment Chemical Substances among some 440 chemicals from the human health aspect and 170 chemicals from the environmental aspect. 8 chemicals are designated as PACSs on March 22, Strengthen GHS implementation by the IHSL Newly oblige to make effort to label and provide SDS for any person to sell or provide substances and mixtures which fulfils specified conditions*. NOTE: Any substances or mixtures which has any of physical hazard or health hazard by applying annex A of JIS Z7253 MHLW will provide guidance to implement above obligations. Publish of ministerial order : January 27 th 2012 Enter into force : April 1 st 2012 ALL Chemicals Prohibited :8 substances Permission Required: 7 Substances Controlled under Special Rules: 104 Substances MSDS Delivery Required: 640 Substances Advised Under Guidance: Approx. 800 substances strongly mutagenic substances. Advised Under Guidance: Classified to have physical hazard and health hazard Present obligation (mandatory) New obligation to make effort 12 6

8 Strengthen GHS implementation by the PRTR law 1. Amendment of Guidance on chemicals management Newly oblige to make effort to improve management of chemicals by companies by adding to the items relating utilization of information under the guidance on chemicals management based on article 3 of the PRTR law to follow GHS related two JISs(7252 &7253). 2. Amendment of ministerial order (Ministerial order on MSDS) Harmonize information items to be proved by SDS to the 16 items listed in GHS. Newly introduce obligation to make effort to include the contents of each item based on new JIS(7253). NOTE:IHSL will also publish a guidance, which clarify that new JIS based SDS will be considered to be consistent to IHSL regulations, so that the SDS format under two laws will be unified. Newly y oblige to make effort of labeling based on new JIS(7253). 3. Planned schedule Public consultation :From Feb. 17, 2012(1 month) Publish on national gazette etc.:april 2012 Enter into force(substances) :June 1 st 2012 Enter into force(mixture) :April 1 st Road map (personal view) NOTE: This road map shall not be considered as the view of the government. FY2011 FY2012 FY2013 FY2014 FY2015 and later Regu ulations Infrastructure Review of legal system Publish Introduction of MSDS and labeling for all hazardous chemicals (obligation to make effort) information gathering scheme of substances Integration of JISs Integrate MSDS-JIS(JISZ7250)& Labelle-JIS(JISZ7251) Revision of Classification JIS Implementation on substances JISZ7253 Publish A few years preparation period for mixtures Revise classification JIS (JISZ7252) Addition of physical hazard, etc. Publish Mixtures Support for industry New software development for Classification of Mixture Software development to add new functions such as the function to import the classification result of the substance classification result Information infrastructure development for mixture Launching an information gathering scheme of substances Development of a GHS classification database GHS classification and model MSDS by government (some 200 in FY 2011) 14 7