In response to the action target of minimizing adverse effects of chemical substances by 2020 agreed to at the World Summit on Sustainable Development (WSSD - commonly known as the Johannesburg Summit) held in 2002, chemicals management efforts have intensified worldwide in accordance with the international strategy Strategic Approach to International Chemicals Management (SAICM) adopted at the First International Conference on Chemicals Management (ICCM-1) held in 2006.
The International Council of Chemical Associations (ICCA) has promoted Global Product Strategy (GPS) activities for attaining the WSSD target, as the voluntary efforts of industries. GPS activities emphasize risk-based chemicals management throughout supply chains, and disclosure of information of risk management on chemical products.
The President of Mitsubishi Chemical Holdings assumes a role of setting directions for ICCA, as a member of its CEO group. Mitsubishi Chemical is also a member of the leadership group for chemical policy and health that plans and implements skill development programs and lectures in developing countries and for small- and medium-scale enterprises, geared toward attainment of the WSSD targets.
The Japan Chemical Industry Association (JCIA), a domestic organization, also engages in voluntary activities for strengthening risk-based chemicals management at businesses (Japan Initiative of Product Stewardship: JIPS), for promoting ICCA's GPS activities. Mitsubishi Chemical is also a member of the committee for promoting and strengthening JIPS. As part of strengthening JIPS promotion, the risk assessment guidance (2nd edition) was translated and publicized and briefings (for the workforce) were held on JIPS activities during fiscal 2011.
Mitsubishi Chemical began GPS activities voluntarily in 2009. These activities involve risk assessment on chemical substances manufactured by the company and management of them in accordance with the results, as well as publication of the results in safety summaries.
During 2009 and 2011, trial GPS risk assessment was conducted for seven substances, for example acetone, while standardizing risk assessment methods. Priority (high, medium, low and out of scope) was set regarding the risk assessment on chemical substances contained in each product. Assessment is to be completed by 2015 for substances ranked as high and medium, and by 2017 for those ranked as low, and safety summaries will be published as necessary. As the forerunner of GPS activities in Japan, we published a total of ten substances during the first half of 2012, starting with publications of safety summaries of four substances in January. Mitsubishi Chemical group companies also plan to complete GPS assessment for the subject substances concerned by 2018.Mitsubishi Chemical Corporation compiles information on product constituents, hazards and safe handling in the Safety Data Sheet (SDS)*1 that is presented to customers and partially disclosed on its website. We create the SDSs using a system we introduced in 2008. This system automatically creates SDSs by following the format of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS)*2, an international system for indicating hazards and toxicity of chemical substances. We also voluntarily create and distribute GHS-based SDSs of products whose SDSs are not required by law.
We are also a member of the Joint Article Management Promotion-consortium (JAMP)*3 and utilize MSDSplus*4 developed by the Consortium in efforts to provide data on chemical substances contained in products to all members of the supply chain.
*1 Safety Data Sheet (SDS): A document for providing information on the properties, hazards and toxicity, safety measures, and emergency responses concerning chemical substances when transferring or providing the chemical substances or products to other business entities *2 Globally Harmonized System of Classification and Labelling of Chemicals (GHS): A globally harmonized system of classification and labelling related to the hazards (hazards and toxicity) of chemicals *3 Joint Article Management Promotion-consortium (JAMP): A cross-industrial organization for appropriate management, disclosure and communication of information on chemical substances contained in components and formed products (articles) to supply chain members *4 MSDSplus: A common sheet for communicating information on chemical substances contained in products to all entities; from material manufacturers to those of final products
The Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc. (the "Act") was amended largely (the "amended Act") and was fully enforced in April 2011.
The Act is aimed at preventing adverse effects from hazardous chemical substances on humans, animals, and plants. Under this law, manufacturers and importers may not manufacture or import new chemical substances for commercial purposes unless they conduct specified safety tests on the substances, have them reviewed by the government, and receive permissions from the government. Depending on the results of the reviews, the government may prohibit the manufacture and import of the new chemical substances or impose strict restrictions or obligations, to protect people and the environment from hazardous chemical substances.
The amended Act regulates not only new chemical substances but all chemical substances including existing ones. In addition, the amended Act has shifted the management method from conventional hazard management to risk assessment*5, which is a global trend.
Accordingly, since the full enforcement of the amended Act in 2011, reporting has been mandated on the quantity of all chemical substances that are manufactured, imported, and used. Priority chemical substances, which are selected by the national government based on information from business entities, are given priority in risk assessment and classified as either substances the volume of manufacturing and imports of which need to be restricted (e.g., specified chemical substances) or general chemical substances confirmed to be low-risk.
Mitsubishi Chemical Corporation identified the volumes of manufacture, imports, shipments, and uses of all the chemical substances subject to yearly reporting, and reported the results to the government in June 2011. These data will be beneficial in risk assessments of chemical substances conducted by the government. At the same time, they will be valuable guidelines for the entire company in studying the risk assessment of chemical substances.
We believe it will be beneficial not only for the global environment but also for a company to operate businesses using safe substances as much as possible through risk management.
*5 Management done by considering not only hazards but also exposure (the extent of impact on people and the environment given the volume manufactured, volume used, and uses, etc. of chemical substances)To comply with EU Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) that came into force on June 2007, the Mitsubishi Chemical Group in 2006 established the cross-sectional MCC Group REACH Project. We continue to conduct activities for ensuring compliance with REACH and performance of obligations from the viewpoint of a manufacturer and a processor that exports products to the EU, while thoroughly analyzing each aspect of complicated legal systems and sharing specific measures to address the situation.
In fiscal 2011, our focus was on preparing for the registration of substances whose annual imports into the EU is less than 1,000 tons, surveying the content of substances of very high concern (SVHC) in products exported to the EU, and responding to the results of surveys, and providing information and support to Group companies and only representatives under REACH regulation in Europe for ensuring their compliance with laws and regulations.For existing substances with annual imports into the EU of 100 tons or more but less than 1,000 tons (deadline for registration: May 31, 2013), we resolved issues and produced the necessary information, while compiling an action plan for their registrations through face-to-face meetings with operational divisions and only representatives under REACH regulation responsible for individual subject substances. Currently, we are proceeding steadily with preparations for the registrations in accordance with the action plan.
In EU, additional SVHC*6 are announced several times a year. An importer intending to import into the EU formed products with an SVHC content of 0.1% or higher is obliged to provide users with the content information of the products. Every time an additional SVHC is announced, the Mitsubishi Chemical Group conducts detailed research on the SVHC content of products it exports to EU and provides information to importers or customers as needed.
Projects for inspecting compliance with REACH have started throughout the EU, resulting in rising awareness of the importance of information to be managed under REACH. To Group companies in EU including Mitsubishi Chemical Europe GmbH and only representatives appointede by the Mitsubishi Chemical Group, which are directly obliged to comply with REACH, we continually provide the latest information that must be managed legally (including the annual volume of imports of subject substances and information related to registration) as needed.
To complete as early as possible the applications for registration of substances should be registered by 2013 , we are preparing for registration steadily by seeking cooperation from related SIEF*7 and customers.
In addition, we will continue to ensure full compliance in our response to additional SVHC announced continually and to CLP*8, under which notification is mandatory even for samples that are small.
Initiatives to provide society with safe and beneficial chemical substances
Michi Watanabe
Environmental Safety and Quality Department
Mitsubishi Chemical Corporation
At Mitsubishi Chemical Corporation, we believe it our mission to propose new business models and provide differentiated products in diverse fields, including optical materials, fluorescent materials, and batteries, toward the achievement of KAITEKI society. To support these efforts, we need to engage in research and development of new chemical substances with superior properties. Naturally, it is essential to assess correctly the impact of such chemical substances on the safety of human bodies and the environment and confirm fully that they will not have any negative impact on our future.
In Japan, laws and regulations including the Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc. (the "Act") make it mandatory that new chemical substances should be subject to specified safety assessments and should be reviewed by the national government through comprehensive evaluations of their risks, before they are manufactured or imported.
At Mitsubishi Chemical Corporation, the Environmental Safety and Quality Department, which I belong to, serves as the point of contact for responding to laws and regulations, including the Act, and takes overall control of chemical substances handled by operational divisions. Under the Act, Mitsubishi Chemical Corporation lodges more than 150 applications per year concerning new chemical substances, including new substances in small quantities, and manages them using a database to ensure appropriate safety assessment. Where safety of a substance cannot be fully confirmed as a result of a safety assessment, we may cease development of the substance. In addition, the amendment of the Act has made it vital to continue to manage chemical substances after their market launch, as well as to ensure compliance with laws and regulations before their launch.
The Act is a highly complex, difficult law. To ensure compliance with this law, each person engaged in research, development, manufacturing, or business operations of chemical substances must fully understand the gist and purposes of the law and respond to it appropriately and properly. To this end, as the department in charge of managing chemical substances, the Environmental Safety and Quality Department regularly holds briefings on laws and regulations to ensure compliance.
As the department responsible for chemicals management, we are committed to strengthening these activities to provide society with safe, beneficial chemical substances.