Management System Regulatory Compliance and Distributing the Safety Use Information Providing Safe Products

Regulatory Compliance and Distributing the Safety Use Information

The Mitsui Chemicals Group promotes measures to achieve goals for around 2020; we will continue to ensure that we comply with all statutory and regulatory requirements in an exhaustive and comprehensive manner, and measures will be put in place to prevent any violation with respect to the Group’s manufacturing and shipping activities.

Compliance with New or Revised Regulations Related to Chemical Substances

Many countries are now enacting or renewing regulations related to chemical substance management towards achieving the WSSD 2020 goal. The approach taken by the EU REACH regulation has been adopted in many countries after being modified to suit the country’s unique situation. At the same time, countries that are advanced in chemical substance management are also revising their regulations to address issues concerning existing chemical handling measures. The Mitsui Chemicals Group is keeping pace with the latest enforced regulations.

The Mitsui Chemicals Group completed the registration of phase-in substances specified by the EU REACH regulation by June 2018. We established a group-wide organization to systematically accelerate chemical registration in accordance with the REACH regulation in 2007.

In Korea, the amended Act on Registration and Evaluation, etc. of Chemicals (including its subordinate regulations) came into force in early 2019. This is the Korean version of the REACH (K-REACH) regulation that covers existing chemical substances that are manufactured or imported at a mass of one ton or more per year. Including pre-notification, which is a preliminary chemical substances registration, we are working to be compliant with these new regulations by the end of June 2019.

In the US, the TSCA Inventory Notification Requirements rule was implemented under the Toxic Substances Control Act (TSCA), in August 2017. Mitsui Chemicals has completed the notification of the chemicals that are listed in the existing chemical substances inventory and that were imported or manufactured in the last ten years.

In Japan, the Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc. was revised and the criteria of reporting chemical substances in small production volumes was changed in January 2019. The reporting criteria used to be the amount of production or import but now it is based on the amount of emissions. Therefore, we systematically obtained usage information for our products from customers and completed the designated report. As for this change in the Act, we participated in the Policy Coordinating Committee under the Japan Chemical Industry Association, negotiating for the changes to be executable in an efficient and effective manner.

Through active participation in industry initiatives, such as those of the Japan Chemical Industry Association (JCIA), and through close exchanges of information with local consultants, the Mitsui Chemicals Group quickly obtains the regulatory information from each country. At the same time, the Group works to ensure thorough compliance. Moreover, in 2017 we established an organization on a regular basis to accurately collect local legal and regulatory information through our affiliates. As part of this move, we held a legal and regulatory expert committee to exchange information that was jointly attended by experts in regulation from our European, American, Chinese, and Taiwanese affiliates. In fiscal 2019, we plan to expand this system to Southeast Asia.

Led by the Global Chemical Regulation Compliance Team, in which business divisions and all corporate divisions participate, Mitsui Chemicals investigated and rapidly implemented Group-wide response measures in divisions across the company. Going forward, we will continue to respond in a planned manner to newly enacted and revised regulations, including REACH regulation of Europe, K-REACH regulation of Korea, and TSCA of U.S., manage the progress of this response, and ensure full compliance.

Thorough Management for Chemicals placing on the market

The promulgation of national laws, including European REACH regulation, marks the beginning of the registration of products and chemical substances, but the management of risks, such as the imposing of restrictions and the granting of approvals by regulatory authorities after registration, does not end after a product is released to the market. Regulatory requirements after launch to the market are also becoming more sophisticated and complicated, and it is essential to promptly and precisely implement appropriate responses.

We respond to changes in, for example, risk assessments and risk management from a range of perspectives that include a variety of changes after release to the market, such as changes in regulations; the addition of regulated substances; the ascertaining of new hazard information; changes of product application; changes in raw materials/manufacturing methods; and toxicity based on internal regulations. It is thought, however, that the responses to be made will become progressively more complex in the years to come due to the regulations covering chemicals becoming even more stringent, as a result of revisions to the regulation and the formulation of new regulation in each country, and due to progress made in the evaluation of substances, including under European REACH regulation. To better respond to such a variety of changes of this kind, we will work to reinforce the further chemicals management system and ensure management when changes are made.

Establish a Structure for Authoring and Distributing the Adequate Safety Data Sheet According to Regulatory Requirements

Information on all the products, raw materials and chemical substances handled by Mitsui Chemicals is controlled in an integrated manner by a chemical product safety information system (MiCSIS). Through coordination between this system and ERP (Enterprise Resources Planning) software, we have reinforced both the expeditious provision of information to customers and compliance relating to chemical regulations, such as the confirmation of legal compliance with domestic and foreign regulations, the management of production/import quantities, and the automatic authoring of safety information, such as multilingual SDS, product labels, MSDSplus*1, etc. Going forward, we will also comply with chemSHERPA*2, a new scheme for conveying information about chemical substances contained in products.
Mitsui Chemicals Group is carrying out system upgrades to enable us to share product-related regulatory and safety information. In addition, the automation of SDS authoring was completed in China, following on from Europe, the United States, South Korea and Taiwan. System compatibility with major export destination countries was also completed.
In addition to developing a system to enable us to share information on regulations and safety with our affiliates in Japan and overseas, we will strive to communicate information that will enable us to respond to diversifying regulations and customer demands. As a part of such efforts, regional experts in NAFTA, Europe, China check the local regulatory requirements and finalize SDSs for each country in order to provide the adequate SDSs for our products.

*1MSDSplus:
A basic information sheet used to communicate information about chemical substances contained in products, as recommended by the Joint Article Management Promotion-consortium (JAMP).

*2chemSHERPA:
CChemical information Sharing and Exchange under Reporting Partnership in supply chain. A scheme for conveying information about chemical substances contained in products. The Ministry of Economy, Trade and Industry is developing and promoting this scheme in aims of having the scheme utilized globally.

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