Mitsui Chemicals

Product Stewardship

Product Stewardship Initiatives

Undertake Risk Assessments as Well as Risk Management Via the Supply Chain for All Products

On the basis of Product Stewardship, the Mitsui Chemicals Group takes a risk-based approach to the safety management of chemicals that extends to product life cycles.

New products undergo the prescribed risk assessments step by step, broken down into each of the five product development stages.
In accordance with Company rules, we conduct risk assessments from the viewpoints of product development (raw materials, physiochemical properties) and manufacturing (explosion risk, human health, environmental impact) and assign those assessments to the R&D Laboratory, business divisions, the Responsible Care (RC) & Quality Assurance Division, and the Safety & Environment Technology Department, respectively. In addition to the products themselves, we perform risk assessments that extend through the entire product life cycle, covering the raw materials, catalysts, and additives used in the manufacturing process, the byproducts that arise from the manufacturing process, and the chemical substances’ effects on operator safety and on the products.

In order to achieve the WSSD goals, the chemicals industry has been working as a whole globally to reinforce chemical management. The Mitsui Chemicals Group is also working to conduct risk assessments of all products by 2020 for those existing products that have already reached the market. At the same time, we are working to determine risk levels from the points of view of the exposure level and hazard and are systematically conducting risk assessments starting with high-priority products in order to reliably implement risk management based on these risk assessments. In fiscal 2016, worker risk assessment was carried out using the Control Banding Method*1, and from the total number of around 2,500 Company products we narrowed down the number of high-priority products to approximately 1,000. In fiscal 2017, the risk levels of the high-priority products from among these 1,000 products were calculated using tools such as ECETOC TRA*2, which is used for European REACH risk assessments. In fiscal 2018, along with expanding the assessment targets to low-priority products, risk assessment results will be provided to the customer and proposals made for risk reducing measures.

*1
Control Banding Method:
A chemical substance management method created by the International Labour Organization (ILO) with the aim of protecting workers from chemical substances.
*2
ECETOC TRA:
A targeted risk assessment (TRA) tool developed by the European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC).

Chemicals Management throughout Product Life Cycles

Mitsui Chemicals Product Development Guidelines

Stage Role Responsible Care Responses
Tentative product concept setting Gathering of safety-related information, conducting of surveys
Tentative product concept market opportunity assessment Provide customers with safety information when supplying prototypes
Preliminary market development by limited number of customers Notify those involved within the Company of safety information
Provide safety information to limited number of potential customers

Conduct risk assessment by application
Conduct operator/environmental risk assessment

Hold product safety conference*1 → Change*2/cease development

Implementation of risk management measures*3
Submission of application for approval
Full-scale market development
Commercialization, release to market Implement Change Control
Implement risk assessment of existing products
*1
Held when it cannot be confirmed that the risk is sufficiently low, etc., or in the event of conflicts arising with internal standards.
*2
Examples: Changes of materials, method of manufacture, specifications, etc.
*3
Examples: Restrictions on application/use conditions; in addition to SDS, information conveyed in technical documents.

Business/Product Development That Incorporates Sound Chemicals Management Perspectives

For human health and environmental protection as well as for sustainable development, the Sound Chemicals Management (SCM) of chemical substances and hazardous waste that takes into account product life cycles is being proposed and is also being deployed by the International Council of Chemical Associations (ICCA). The Mitsui Chemicals Group is also engaging in business and product development that incorporates SCM perspectives.
For example, in the Development Guidelines we set out the items to be checked at each of the five development stages, and at the tentative product concept setting stage we conduct surveys on the safety of product components of the product and legal information.

In recent years, social concerns with regard to the safety of chemical substances have been on the rise and reached the stage where even greater safety is being demanded. Under the European REACH regulations, risk assessments are conducted by the authorities, but due to the previously mentioned demands of society, there is a tendency for the judgments necessary to strengthen the regulations, such as the limitations of use imposed by the authorities, to be even more stringent on the basis of precautionary principles.
In response to this situation, we initiated activities from SCM perspectives, including disseminating information to research and business development departments and the raising of awareness. Specifically, we have defined the regulated substances and some of the substances of concern for our customers as substances to be managed, and from fiscal 2018 we will establish a mechanism to check whether the relevant substances are contained in products at the initial stages of development (product concept validation stage). In addition, we will initiate educational activities for research and development staff so that they can select substances ahead of their regulation.
Moreover, the Group is certifying products that have an environmental contribution value as Blue Value products. Although we have defined “harmonize with nature” as one of the assessment basis for the environmental impact assessment criteria used at that time of certification and reflect the degree of impact the product has on ecosystems and the environment, we must grasp the dynamics (for example, fate of substances and exposure to the human environment) of even more products and related substances in order to assess many of our products, including those under development and new products. Therefore, based on the latest reliable assessment models and data, we have begun the work of adding the necessary assessment factors (characterization factors) to the environmental impact assessment of chemical substances.

Through these efforts, the Mitsui Chemicals Group aims to provide products that will enable even more of a contribution to human health, environmental protection and sustainable development.

Put in Place a Safety Evaluation Platform That Engenders the Confidence of Society and Acquire Cutting-edge Technologies

The development of chemical products and chemicals management requires the safety tests demanded by legal regulations. There are also cases in which animal test may be necessary, but we are formulating internal institutional rules for the Group’s animal testing guidelines and animal testing facilities based on the 3R principles (of replacement, the utilization of alternative methods; reduction, reduction of the number of uses; and refinement, the alleviation of suffering) as required by legal regulations and the basic guidelines of the Ministry of Health, Labour and Welfare. Based on these rules, the Institutional Animal Care and Use Committee was established and pre-screening of all animal testing and animal testing facilities are approved by the head of the testing institution. Testing and testing management, facility and equipment propriety, and education and training are checked through a self-inspection and evaluation every year. These activities are documented and reported to the head of the testing institution through the Institutional Animal Care and Use Committee. In fiscal 2017, self-inspections and evaluations, as well as facilities, were verified by an outside expert, thereby confirming that these are appropriately managed.

As a global risk assessment trend, the Integrated Approaches to Testing and Assessment (IATA), the Organisation for Economic Co-operation and Development (OECD) risk assessment method, are gaining in popularity. Under this method, in silico (techniques that predict harmfulness from a chemical substance’s structure) and in vitro (an alternative test method that does not utilize animal testing) are integrated with existing data, and animal experiments only carried out when necessary. In addition, the IATA has been incorporated into the OECD testing guidelines for irritants, corrosives and sensitivity, and has been introduced into each country’s regulations. In order to respond to these new legal requirements and to further enhance reliability, we are actively working to acquire advanced technologies.
For example, in fiscal 2017, in an effort to contribute to establishing the technologies for an alternative method to animal testing, we took initiatives and produced results that improved the precision of irritation prediction in the OECD QSAR* toolbox (one of the in silico techniques) and participated in the OECD guideline project for an alternative method for sensitivity testing in cooperation with the Japanese Center for the Validation of Alternative Methods (JaCVAM). We presented the results of reach at the Japanese Society for Alternatives to Animal Experiments. We will continue to enhance efforts towards animal testing alternatives and contribute to their promotion.

*
QSAR:
Quantitative Structure-Activity Relationships.

New Safety Assessment System

New Safety Assessment System

Participation in Industry Chemicals Management Initiatives

One international initiative taken to achieve the World Summit on Sustainable Development (WSSD) goals is UN Environment’s SAICM*1. Having concluded an agreement with UN Environment to promote the implementation of SAICM, the International Council of Chemical Associations (ICCA) provides support in a number of areas, including human resources and financing. The ICCA intends to contribute to sound chemicals management aimed at SAICM through Responsible Care and the Global Product Strategy (GPS)*2. Each country's chemical industry association is conducting activities aimed at achieving the WSSD target under the ICCA.

To achieve the WSSD goals, the Mitsui Chemicals Group endorses and proactively participates in the voluntary initiatives encouraged by the ICCA.

One activity for the ICCA has been Capacity Building. This is an activity that, especially in developing countries, supports the ability to develop sound chemicals management. Since fiscal 2015, Mitsui Chemicals employees have co-chaired the ICCA’s Capacity Building Task Force and displayed leadership qualities in support activities designed to improve sound chemicals management and sustainability throughout the world.

In Japan, the JCIA is promoting GPS/JIPS*3 activities to achieve the WSSD goals, and the company is a key member in reinforcing those activities. In fiscal 2017, we actively participated in and contributed to JCIA activities, for example by having Mitsui Chemicals employees serve as lecturers at JCIA-sponsored seminars.

*1
SAICM (Strategic Approach to International Chemicals Management):
A strategic approach to international chemicals management. Established to promote advances in a number of areas to achieve the WSSD goals, such as risk reduction based on scientific risk assessment, preventive approaches, the collection and provision of information on hazardous chemical substances, improvements in each country’s chemical substance management system, and the promotion of technical cooperation in developing countries.
*2
Global Product Strategy (GPS):
In order to minimize the risk from chemicals throughout the supply chain, each company conducts risk assessments on its chemical products. In addition to implementing appropriate risk-based management, they engage in voluntary efforts to disclose to society in general, including customers, information on product safety and risk. GPS is thus designed to strengthen product stewardship.
*3
GPS / JIPS(Global Product Strategy / Japan Initiative of Product Stewardship):
Name given to GPS activities in Japan.