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Product Stewardship

Providing Safe Products

For human health and environmental protection, as well as for sustainable development, the Sound Chemicals and Waste Management scheme for chemical substances and waste, which takes into account product life cycles, is being proposed and is also being deployed by the International Council of Chemical Associations (ICCA). In addition, the Global Framework on Chemicals (GFC) for 2030 calls for the promotion of voluntary chemical substances management by multiple stakeholders, including industry.

As a member of the supply chain that aims for sustainable development, the Mitsui Chemicals Group is engaging in business and product development that incorporates those sound and voluntary perspectives on chemical substances management.

Product Risk Assessment

Mitsui Chemicals assesses the potential risks of all our products for workers who handle them, for general consumers who we anticipate will be the final users of our products, and for the environment.

We also assess risks for new products at the time of development, and for existing products when (1) materials or manufacturing methods are changed, (2) their applications are extended, (3) related laws and standards are revised, and (4) new scientific findings are announced.

For risk assessment for workers, we prioritize risks based on qualitative assessment using the Control Banding Method*¹ and proceed to quantitative assessment utilizing methods such as ECETOC TRA*², which is used for risk assessment in the European REACH regulation. For products that may pose a high risk depending on the handling conditions, we undertake risk communications with customers to ensure appropriate risk management as well as consider risk reduction through improving the compositions or developing alternative products, or doing both.

Going forward, we will also assess risks that support recycling in light of shifting to the circular economy.

*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).

*For risk assessment and management in works and distribution, see the following sections:

Occupational Health; Safety and Prevention; Environmental Protection; and Logistics.

The risk assessment of a product or brand is divided into five stages. A certain set of risk assessments is designated for each stage and the assessment task is shared among the R&D Laboratory, business divisions, Works, the RC & Quality Assurance Division, and the Safety & Environment Technology Division. The same applies to catalysts and additives used for materials or in the manufacturing process, and byproducts generated during manufacturing.

Stage	Role	Response Measures
Ⅰ	Tentative product concept setting	Gathering of safety-related information, conducting of collection and verification of information of chemicals in products
Ⅱ	Tentative product concept market opportunity assessment	Provide customers with safety information when supplying prototypes
Ⅲ	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 ↓ Implement product risk assessment ↓ Hold product safety conference^1 → Change^2 / cease development ↓ Implementation of risk management measures^*3 Submission of application for approval
Ⅳ	Full-scale market development
Ⅴ	Commercialization, release to market	Implement Change Control Implement risk assessment of existing products

*1 The internal standards are followed when it cannot be confirmed that the risk is sufficiently low, etc.

*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.

Risk Assessment and Blue Value™

Mitsui Chemicals has designed Blue Value™ to visualize how a product contributes to reducing the environmental impact at each stage of its life cycle from the viewpoint of product stewardship. Blue Value™ uses a simplified version of LIME2^*2, an environmental impact assessment method based on life cycle assessment (LCA)^*1, for screening evaluation in the application and certification process for target products, and conducts LCA throughout each life cycle stage from raw materials to disposal. Blue Value™ certification items include reducing CO₂, conserving resources, and coexisting with nature, and the impact areas cover global warming, ozone layer depletion, resource consumption, hazardous chemical substances, ecotoxicity, acidification, and others. Through the Blue Value™ application and certification process, we have evaluated 75% of existing products to date.

^*1 Life cycle assessment (LCA):

A technique to quantitatively assess environmental impacts associated with all the stages of a product's life, from raw materials, to manufacturing, processing, use, and disposal.

^*2 LIME2 (Life cycle Impact assessment Method based on Endpoint modeling):

Damage assessment-type life cycle environmental impact assessment method based on environmental conditions in Japan.

Voluntary Control of Chemicals

Chemical substances may be harmful to human health and the environment. Mitsui Chemicals is systematically reducing its use of chemicals of concern.

We specify chemicals subject to the following list (1) to (7), below, as Prohibited Substances, and we do not use, produce, or sell these substances. For substances the use of which is restricted or that require specific information disclosure, handling in each stage of purchasing, R&D, and manufacturing is strictly controlled. The use of substances categorized as (8) to (17) in the list are specifically determined according to product purposes.

Industrial Safety and Health Act: Substances subject to Prohibition on Manufacturing and Other Activities.
Industrial Safety and Health Act: Substances categorized as Group-1 Substances in the Ordinance on Prevention of Dangers Due to Specified Chemical Substances.
Act on the Regulation of Manufacture and Evaluation of Chemical Substances: Class I Specified Chemical Substances.
Poisonous and Deleterious Substances Control Act: Specified Poisonous Substances.
Act on the Protection of the Ozone Layer Through the Control of Specified Substances and Other Measures: Substances listed in Annexes A and B.
Act on the Prohibition of Chemical Weapons and the Regulation of Specific Chemicals: Specified substances (Schedule 1 Chemicals under the Chemical Weapons Convention).
Stockholm Convention on Persistent Organic Pollutants (POPs): Substances listed in Annexes A, B, and C.
(US) Toxic Substance Control Act (TSCA): Prohibited or restricted substances in Section 6.
(EU) ELV Directive.
(EU) RoHS Directive Annex II.
(EU) POPs Regulation Annex I.
(EU) REACH: Substances listed in the Substances of Very High Concern (SVHC) Candidate List and Annex XIV (Authorization List).
(EU) REACH Annex XVII (Restricted substances).
(EU) Medical Device Regulation (MDR): Substances listed in Annex I, 10.4.
(China) Measures for the Restriction of the Use of the Hazardous Substances of the Electrical and Electronic Products (China RoHS) Hazardous Substances.
Global Automotive Declarable Substance List (GADSL).
IEC 62474 DB Declarable substance groups and declarable substances.

The Group has a policy of reducing certain substances of concern through substitution. Examples of alternative approaches are shown in the table below.

Target	Examples of Substances of Concern	Policy
Reaction solvents in the manufacturing of various products	Toluene, Xylene DMF (N,N-dimethylformamide)	Substituted with less toxic substances
Additives for specific product groups	Diethanolamine	Substituting long-chain alkyldiethanolamine, etc. for additives that are concerned about the inclusion of diethanolamine
Urethane curing agent	MOCA (4,4'-Methylenebis(2-chloroaniline))	Substituted with less toxic substances

From FY2024, our company's scope of prohibited substances has newly expanded. Specifically, we have added (1) candidate substances prohibited in Japan and international treaties, and (2) substances already prohibited in principle outside Japan, such as substances subject to authorization in Europe and substances banned under TSCA in the U.S., to our list of prohibited substances. For products that use newly prohibited substances, we have started to prepare targets for response plans, such as substituting prohibited substances and strengthening controls in closed systems and use in intermediates, etc.

Safety Assessment and Animal Testing System

In the development and management of chemical products, animal testing may be unavoidably required in order to confirm safety and functionality as required by laws and regulations. Mitsui Chemicals established internal regulations compliant with various laws and regulations, such as “the Act on Welfare and Management of Animals”, “Standards Relating to the Care and Keeping and Reducing Pain of Laboratory Animals”, “Basic Guidelines for Animal Testing in Institutes Under the Jurisdiction of the Ministry of Health”, “Labour and Welfare (MHLW)”, and “Guidelines for Proper Conduct of Animal Experiments”, etc. Based on this, the Institutional Animal Care and Use Committee ensures appropriate animal testing by examining our animal experiments not only from the perspective of animal welfare—including the 3R principles (replacement: utilization of alternative methods; reduction: reducing the number of animal testing used; and refinement: alleviation of suffering), but also from ethical and scientific perspectives. Furthermore, we conduct annual self-inspections to ensure compliance with various laws, regulations, and internal institutional rules. Third-party certification by the Japan Medical Information Center* for these initiatives has been obtained since March 2020 (certification will be renewed in March 2023).

*The certification program was transferred to the Japan Pharmaceutical Information Center in April 2021 due to the dissolution of the Japan Health Sciences Foundation.

Acquisition of New Assessment Technologies

The Integrated Approaches to Testing and Assessment (IATA) is becoming widespread as a global trend in risk assessment. IATA is an approach that integrates existing data, and testing data in silico (techniques that predict harmfulness from a chemical substance's structure), in chemico (alternative testing methods to evaluate chemical reactions), and in vitro (alternative testing that use cultured cells, etc. instead of using animals) to make animal testing a last resort. IATA has been adopted under the OECD testing guidelines as well as in regulations in different countries. Mitsui Chemicals is actively employing such methods. ADRA^*1, which was developed in a project in which we participated, was adopted in the OECD Guidelines for the Testing of Chemicals in 2019. We continued to attend the subsequent validation. We also participate in the Long-range Research Initiative of the Japan Chemical Industry Association and JaCVAM^*2, contributing to the development and dissemination of alternative methods to animal testing.

*1 ADRA:
Amino Acid Derivative Reactivity Assay. In chemico alternative method for skin sensitization.

*2 JaCVAM:
Japanese Center for the Validation of Alternative Methods.