2010 and 2011 will be challenging years for companies manufacturing, importing or handling chemical substances in Japan. Major amendments 20 May 2009 to the “Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc” (or Chemical Substances Control Law), sometimes referred to as Japanese REACH, will soon come into effect in two phases: 1 April 2010 and 1 April 2011. While the Chemical Substances Control Law aims to prevent chemical substances from adversely affecting human health, flora and fauna. However the amendments correspond with the increased attention and concern of chemical safety and enhance its consistency with the global chemical control aids: WSSD (World Summit on Sustainable Development), Stockholm Convention on POPs (Persistent Organic Pollutants), and chemical regulations in other parts of the world such as EU REACH and US TSCA.
Phase I Japanese REACH
So what are the major impacts to chemical operations? The amended law shifts the Japanese chemical control system from hazard-based to risk-based. In Phase 1 implementation, the use of the restricted chemicals with long-term toxicity will be accepted for essential use under stringent control, and new polymers with low concern can be exempted from the notification requirements. At the same time, non-persistent (biodegradable) chemicals will also become subject to control, while the regulatory target of the present Law has been limited to the chemical substances that are persistent in the environment. Chemical control will also be expanded through the supply chain – handlers of chemical substances or products containing them will be responsible for hazard communication (incl. labelling, reporting of hazard information and new findings on hazards) and be required to comply with the technical handling guidelines.
Phase II Japanese REACH
In Phase 2 implementation, the new chemical classification will be introduced, prioritizing chemical substances for prompt hazard assessments. Manufacturers and importers of chemical substances with high priority for hazard assessments will have to notify the detailed use of the substances, label them, and report to the competent ministries on obtained hazard information. Another large impact to manufacturers and importers at this stage is the mandatory annual reporting on ANY chemical substances manufactured or imported into Japan in amounts of one ton or more. While the present law mainly aims to evaluate hazardous properties of new chemical substances, the amendments introduce greater control over existing chemicals that have not been regulated in Japan. These changes would require companies to evaluate and re-structure their chemical inventory management and communication processes through the supply chain.
Comparison with EU REACH
Although the amended Chemical Substances Control Law is often called Japanese REACH, there are some differences between the law and EU REACH due to the different backgrounds from which the schemes and principles came. The Chemical Substances Control Law was initially created in the 1970s to regulate PCBs, which caused a major health hazard. It has been expanded to include more chemicals with similar properties to PCBs (i.e. persistent, bioaccumulative, and long-term toxicity for humans, higher mammals or flora and fauna). Although non-persistent chemical substances are controlled this time with amendments, the classification of chemical substances is designed based on those properties in the amended Law and it may not necessarily correspond to SVHC (Substances of Very High Concern) under EU REACH. The regulatory scope of the amended Law is limited to substances, mixtures and intermediates, excluding products unless they are specified. The significant role of chemical risk assessments and specifications of hazard communication remains for the Japanese government to decide, and not the industry. The pertinent ministries are: Ministry of Economy, Trade and Industry, Ministry of Health, Labour and Welfare, and Ministry of the Environment.
Nevertheless, the competent ministries have been issuing many ordinances or public notices to shape the new chemical control structure in recent months; in December 2009 alone, a series of amendments was adopted with respect to specifications of hazard communication, criteria for polymers with low concern, and streamlined notification processes. Foreseeing the full implementation of the new chemical management system in April 2011, a number of regulatory updates are expected throughout 2010. There will be lot of changes that companies must keep up with not only to ensure their compliance status but also to avoid loss of any business opportunities in Japan.
Are you ready for the change? Enhesa can help you keep up with the regulatory updates and prepare for the upcoming changes with the monthly Monitoring Reports, Compliance Calendars including a series of compliance deadlines and consultation. If you have any questions about how Enhesa can help your company meet the challenges of Japanese REACH compliance, please contact us at firstname.lastname@example.org.
EHS consultant & Country Manager for Japan