Product Stewardship

Product Risk Assessment

Mitsui Chemicals assess the potential risks of all new products for workers who handle its products and for general consumers who are assumed to be the final users.
We also re-assess risks concerning 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.
Going forward, we will also assess risks that support recycling in light of the circular economy.

For risk assessment for workers, we conduct qualitative assessment using the Control Banding Method^*1. If there is a concern about the risk, we also conduct quantitative assessment using tools such as ECETOC TRA^*2, which is used for risk assessments in accordance with the EU REACH regulations. 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 development of alternative products, or both.

*1Control Banding Method:
A chemical substance management method created by the International Labour Organization (ILO) with the aim of protecting workers from chemical substances.

*2ECETOC 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.

Risk Assessment for New Products

The risk assessment of a new product and a new 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.

Product Development Guidelines

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

*2Examples: Changes of materials, method of manufacture, specifications, etc.

*3Examples: Restrictions on application/use conditions; in addition to SDS, information conveyed in technical documents.

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 (16) in the list are specifically determined according to product purposes.

Safety Assessment and Animal Testing System

The development of chemical products and chemicals management requires legally-specified safety tests. There are also cases in which animal test may be necessary. Mitsui Chemicals established “the Institutional Animal Care and Use Committee“, and specifies internal regulations compliant with “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. “The Institutional Animal Care and Use Committee“ ensures appropriate animal testing by examining all the animal experiments conducted directly by Mitsui Chemicals or commissioned to external institutes from the viewpoints 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), animal ethics, and scientific necessity. These initiatives are subject to self-checks every year to ensure compliance with the latest laws and standards. We received certification^* by the Japan Health Sciences Foundation in March 2020 confirming that our animal testing was compliant with the MHLW’s basic guidelines.

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

Safety Assessment System

Acquisition of New Assessment Technologies

The Integrated Approaches to Testing and Assessment (IATA) is becoming widespread as a global trend of 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) and in vitro (alternative testing without 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 advanced 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 participated in activities led by JaCVAM^*2 and contributed to the dissemination of alternative methods to animal testing through the evaluation of testing methods.

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

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