On 1 April 2011, amendments to the Chemical Substances Control Law (official name: Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc. / 化学物質の審査及び製造等の規制に関する法律), commonly referred to as Japanese REACH, became fully enforceable. The amendments introduce requirements that will impact most importers and manufacturers of chemical substances.
Under these amendments, handlers of Class 1 and Class 2 Specified Chemical Substances, and products containing these substances, are subject to hazard communication requirements and compliance with technical standards or technical guidelines. The use of restricted chemicals with long-term toxicity became acceptable for essential use under stringent controls while non-persistent (biodegradable) chemicals became subject to controls. Previously, the scope of the Law was limited to chemical substances that are persistent in the environment. The amendments also rolled out a new classification system for industrial chemicals introducing prioritization of chemical substances for prompt risk assessments. Manufacturers and importers of chemical substances that are considered high priority for risk assessments have to provide authorities with detailed information on the use of the substances, label them, and report to the competent ministries any hazard information obtained about the substances. In one of the most significant changes, annual reporting regarding the import or manufacture of 1 ton of more of all chemical substances (except for those exempted) became mandatory.
These amendments were triggered by multiple factors, including an increase in public concerns about chemical safety and international developments in chemical management, such as the World Summit on Sustainable Development 2002, the Stockholm Convention on Persistent Organic Pollutants, REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) in EU and TSCA (Toxic Substances Control Act) in the U.S.
The amendments transformed the Japanese chemical management system from a hazard-based to a risk-based framework in order to achieve more comprehensive chemical evaluation and risk management. The Japanese REACH now evaluates chemicals with the focus not only on the hazard of the subject chemical itself but also on the potential level of exposure to humans and flora and fauna in the environment if there is a release incident. The chemical evaluation is to be carried out for chemicals, including existing chemicals, which were not subject to the notification or risk assessment requirements under the previous legislation.
Comparison with EU REACH
Despite the fact that the amended Chemical Substances Control Law is often referred to as the Japanese REACH after the European Union REACH, there are variations between the systems. The Japanese REACH requires the reporting of chemicals that have already been manufactured or imported in Japan, while the EU REACH only requires registration prior to placing chemicals on the market. While the EU REACH places the responsibility for hazard and risk assessment on industry, the responsibility for assessment remains with the government under the Japanese REACH.
The annual reports required under the Japanese REACH focus on the quantity and use of chemicals and the locations of manufacturing/import and shipping destinations. In contrast with the EU
REACH, business operators do not need to include technical dossiers (i.e. physical and chemical properties, health and environmental hazards) or chemical safety reports in the annual report for most chemicals. Chemicals contained in articles are, in principle, not within the reporting scope of the Japanese REACH except for those specified under the Act. Mixtures may be subject to the reporting requirements under the Japanese REACH when they are deemed to be raw materials for chemical products (e.g. paints imported in bulk containers). Final chemical products (e.g. import of chemical products in small containers, pharmaceutical products, cosmetics, agricultural chemicals), polymers of low concern, or chemicals manufactured/imported for research purpose are not subject to the reporting requirement. In addition, chemicals approved by the METI, MHLW (Ministry of Health, Labor and Welfare) and MOE (Ministry of Environment) that no risk assessments are required and included in the List of Chemicals Not Requiring Report are exempted from the annual reporting requirements. The list includes, among others, inorganic substances, organic monomers, polymers, organic compounds such as chemically-modified starch and chemically-modified grease, and medical compounds.
Key Impact: Reporting requirements for all chemicals now mandatory – first deadline is coming on 30 June 2011
One of the challenges that business operators face under the amendments is the significant expansion to mandatory annual reporting requirements. From 1 April 2011, business operators who manufacture or import 1 ton or more of any chemicals (except for specified exempt chemicals) in/to the Japanese market in a year must submit an annual report to the METI regardless of the classification category of the chemicals. Previously, such reporting requirements applied only to the designated chemicals under the legislation. The first reporting deadline to applicable business operators is 30 June 2011 for the chemicals they manufactured or imported between 1 April 2010 and 31 March 2011.
For the annual reporting, a business operator must first obtain a company code from the METI by submitting company information (e.g. company name, address, name of the president and a person in charge). The METI developed a software system for business operators to assist with the annual reporting process. The system provides useful functions to facilitate the process such as a data conversion tool to convert electronic data (e.g. chemical inventory in Excel) to the reporting format. It also contains a chemical search function to identify chemical classifications, national identification numbers, and CAS number. Annual reporting can be made manually by submitting a paper-based report or CD-ROM or electronically through a system called e-Gov. A business operator who wishes to make the annual reporting electronically must make an application to the METI prior to using e-Gov. These processes require a certain lead time prior to the actual annual reporting.
Importance of Purpose of Use
One of the most confusing rules for business operators with the annual reporting is how to actually identify an appropriate purpose of use for a chemical. The purpose of use is one of the key information requirements and needs to be selected from a list provided by the METI. The list provides approximately 50 purposes of use (such as intermediates and solvents), broken down into 280 sections. The list in English is available at http://www.meti.go.jp/policy/chemical_management/english/files/use%20category.pdf.
Based on the selection of the purpose of use and other information from the annual reporting (e.g. amount manufactured or imported), the government will estimate the amount of chemicals released into the environment through different routes (i.e. air and water body). The estimated amount of environmental release will be used as a basis for screening and risk evaluations of the reported chemicals, in addition to determing the hazard of such chemicals. It is important that the government obtainaccurate data recarding the purpose of use as this is information is used to assess the risk of chemicals. Addtionally, the estimated amount for environmental release can vary depending on the purpose of use even for the same chemical. The worst case scenario, which assumes that the whole amount of the chemical is released into the environment, will be applied when ‘Others’ is selected as the purpose of use in the reports. This would result in a possibly artifically inflated risk factor . In summary, identifying the correct purpose of use is very important in maintaining the accuracy of the chemical risk assessment. This may not be difficult for companies who manufacture chemicals and use them for their own products. However, for upstream chemical manufacturers who produce and sell chemicals to downstream users, confirming the ultimate purpose of use of their manufactured chemicals is not always easy, especially when downstream users do not disclose such information for confidentiality reasons. In such cases, the upstream user is allowed to choose ‘Others’ from the list of purpose of use. However, the METI instructs business operators to use their best efforts to verify the purpose of use thereby increasing the accuracy of the screening and risk evaluations of the chemicals.
Business operators in Japan are currently working to ensure compliance with the new reporting requirement by the first deadline on 30 June 2011.
If you are seeking for more information on the Japanese REACH, and how your company can ensure it is in compliance, please contact Enhesa at firstname.lastname@example.org.
Miyo Ikushima, Japan EHS Consultant