Update on Chemical Regulation in Japan - Industrial Safety and Health Act

Transcription

1 2016/SOM1/CD/017 Agenda Item: 6A Update on Chemical Regulation in Japan - Industrial Safety and Health Act Purpose: Information Submitted by: Japan 16 th Chemical Dialogue Lima, Peru 23 February 2016

2 APEC 16 th Chemical Dialogue ( CD16 ) Update on Chemical regulation In Japan Industrial Safety and Health Act February 23, Westin Lima Hotel & Convention Center Lima, Peru Japan Chemical Industry Association (JCIA) 1 Japan s Chemical Regulations Frame Hazard Exposure Work Environments Consumers Via Environmental effects Pollusion by emmissions Waste Impact on human health Impact on the environment Acute Toxicity Long - term Toxicity Effects on the living environment (including animals and plants) Depletion of the ozone layer Law for the Control of Poisonous and Deleterious Substances Industrial Safety & Health Act Agricultural Chemicals Regulation Law AgriculturalChemicals Regulation Law Food Sanitation Law PharmaceuticalAffairs Law Building Standards Law Law Concering the Control of Hazardous Household Goods Law for the Control of Poisonous and Deleterious Substances Law for PRTR and Promotion of Chemical Management AgriculturalChemicals Regulation Law Chemical Substances Control Law (CSCL) Ozone Layer Protection Law Air Pollution Control Law Water Pollution Control Law Soil Pollution Law for Farms Waste Disposal Law, and others. * * Measures have been taken to collect CFCs contained in specific products in laws such as the Freon Collection & Destruction Copyright Law JCIA all right reserved 2 1

3 ISHA was amended in June 2014 The provisions have been entered into force no later than June 2016 from 2014 Certain amendments to the Industrial Safety and Health Act (ISHA) were announced on 25 June to enhance the measures of workers safety and their health coping with Change of recent social conditions and Trend of Industrial accident (outbreak of case of bile duct cancer) 1 Employers are required to assess the risk of certain chemical substances. Effective date no later than June 2016 (Provision regarding this item shall be issued by government decree.) 3 ISHA : Key Amendments Point Scope Expansion of Mandatory Risk assessment and GHS Labelling requirements Current Prohibited 8 substances Such as Asbestos Severe Health Hazard (no enough preventive measures) After Amendment Prohibited Specified requirement ( Effoet-obligation for Risk assessment) Labelling requirement ( Effoet-obligation for Labelling) SDS requirement ( Effoet-obligation for SDS) 116 substances 640 substances Approx. 60,000 substances High Health Hazard Such as (especial in high risk process) PCB Bile duct Cancer prone Hazardous substances with certain degree of hazard Substances with no identified hazard and risk Involving health Threat (Risk level developing on usage and application) Expansion Specified requirement Risk Assessment obligation ( Effoet-obligation for Risk assessment) Labelling requirement ( Effoet-obligation for Labelling) SDS requirement ( Effoet-obligation for SDS) 4 2

4 Industry Action In Japan, amendment of ISHA has introduced the obligation to perform Risk Assessment at workplace Big impacts and burden for not only Chemical Industries but also all stakes holder who are handling 640 substances. To comply with this regulatory requirement, a high degree of expertise and significant efforts to gather relevant chemical safety information and to carry out scientific risk assessments. However, except some big chemical manufacturers, especially for SMEs there should not be sufficient resources available for these tasks and it is very costly. JCIA was fully aware of this issue and came up with an idea to develop a new & user-friendly tool. JCIA BIGDr:Base of Information Gathering, sharing & Disseminating for Risk management of chemical products 5 JCIA BIGDr Original Concept for New Portal 6 3

5 JCIA BIGDr Five Primary Functions Block-2 Block-4 JCIA BIGDr Ver2.3 April, 2015 Hazard info. DBs Portal GSS uploading records Regulation info. DBs Portal of Japanese company Link list GPS/JIPS Helpdesk Block-1 How to use BIGDr 7 Block-3 Risk assessment & GSS creation tool GSS Maker RA support contents (Seminar Materials etc.) Block-5 General Info. Gathering Chemi-maga External DB to be referred by JCIA BIGDr Ver.2.3 DB Establish NB Substance GHS (Japan) NITE Japanese Government (MHLW, METI, MOE) [ 2,886 GHS (EU) EU EU CLP (Annex Ⅵ) 3,905 GHS (Korea) NIER Korea GHS Classification 781 GPS Chemicals Portal ICCA GPS Safety Summary of Japanese Company - CHRIP NITE Hazard, Risk assessment & Regulatory information 9,000 Nikkaji Web JST Japan Chemical Substance Dictionary Web service; from literature 210,000 WebKis-Plus NIES Use, production volume, exposure, risk assessment and accident 7,000 SDS/ OHSL MHLW Model SDS based on GHS 2,711 GHS/ OHSL MHLW Model label based on GHS 2,218 JECDB MHLW/NIHS Repeated dose toxicity, reproductive and developmental toxicity, 277 mutagenicity, etc. of existing chemical substances Chemical Products JCIA Component, composition, use and hazard and contact information of 5,899 Information DB chemical products by chemical companies SIDS (environmental) MOE Screening risk assessment report of Chemical Substance 371 SIDS (Japan) NITE/CERI Screening risk assessment report of PRTR Substance 265 SIDS (OECD) OECD SIAR of Chemical Substance 1,166 8 JCIA BIGDr Hazard info. DB Portal 4

6 JCIA BIGDr Hazard info. DB Portal (cont d) Search Results Example: Formaldehyde(CAS ) List format Matrix format Click here, then it takes you the corresponding site. CHRIP site 9 JCIA BIGDr GSS Maker Powerful Interface to ECETOC-TRA GSS Maker (Excel, Japanese/English) Main Unit Setting parameters, Run button, Display of RC Results by ECETOC TRA GSS Unit Output of GSS DB Unit Data table of target substance, Correspondence table RC results and GSS 10 ECETOC-TRA (Excel, English) Run Risk Characterization by posting parameters to ECETOC TRA Extract only necessary result of RC and Create GSS semi-automatically 5

7 JCIA BIGDr Look Up GSS Documents Substance Name List Block-4 GSS uploading records of Japanese company Company Name List Link list of all uploaded GSS of Japanese companies Substance Name List and Company Name List Update on a monthly As of March 2015, 382 GSSs have been recorded PDF of GSS opens in one click 11 JCIA BIGDr Now & Future Building & Promoting horizontal network via. workshops etc. Not only JCIA s members but also other all stakeholders, SMEs and downstream users etc. Japanese unique issue handling (2015-) Strict duty to carry out worker s RA for designated 640 chemicals from 2016 Recommend to use BIGDr as RA tool to comply with Industrial Safety and Health law. Future plan Information sharing functions etc. Targeting quasi-standard RA support system in Japan Expand accessible Global DB and develop JCIA BIGDr English Version supported by ICCA (Already Started) Japan Chemical Industry Association. All rights reserved 6

8 Thank you for your attention! Risk based Chemical Control legislations have been strengthened globally. Watch carefully, and take action the right way. 13 7