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 hazardous waste, which 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 engaging in business and product development that incorporates those perspectives, as a member of the supply chain that aims at sustainable development.
Product Risk Assessment
Mitsui Chemicals assess the potential risks for all new products. We also assess risks concerning existing products when materials or manufacturing methods are changed, their applications are extended, related laws and standards are revised, and new scientific findings are announced. As our business fields diversify, we plan to conduct risk assessments on both new and existing products to suit new applications, as well as for disposal and recycling.
As one of the certification criteria for Blue Value™, we adopt comparative risk assessments of our new products against market-standard products and our existing product lineup.
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
|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
*1Held when it cannot be confirmed that the risk is sufficiently low, etc., or in the event of conflicts arising with internal standards.
*2Examples: Changes of materials, method of manufacture, specifications, etc.
*3Examples: Restrictions on application/use conditions; in addition to SDS, information conveyed in technical documents.
Risk Assessment for Existing Products
Mitsui Chemicals has conducted risk assessments for our existing products since fiscal 2015. Worker risk assessment was carried out using the Control Banding Method,*1 and from the total number of around 2,500 products we narrowed down the number of high-priority products to approximately 1,000. The risk levels of the highest-priority products from among these 1,000 products were calculated for all possible use conditions by utilizing tools such as ECETOC TRA,*2 which is used for quantitative assessments specified by the EU REACH regulation.
We continuously conduct product risk assessments. For products that may pose a high risk depending on the handling conditions, we undertake risk communications with customers to ensure their appropriate risk management.
*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).
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.
- 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.
- Global Automotive Declarable Substance List (GADSL).
- IEC 62474 DB Declarable substance groups and declarable substances.
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.
In fiscal 2018, in an effort to contribute to establishing technologies for alternatives to animal testing, we participated in activities to improve the precision of predicting irritation in the OECD QSAR*1 toolbox, one of the in silico approaches, to develop an assessment flow that produces more objective results. We published our development at a European toxicity conference Eurotox 2018 and in an academic journal*2. Also, ADRA*3, developed in a project in which we participated, was adopted in the OECD Guidelines for the Testing of Chemicals in 2019. We also participated in activities led by JaCVAM*4, which disseminates alternative methods to animal testing.
*1QSAR: Quantitative Structure－Activity Relationships.
*2Atsutoshi Abe, Takuhito Sezaki, Katsutoshi Kinoshita, Development of a read-across workflow for skin irritation and corrosion predictions, SAR AND QSAR IN ENVIRONMENTAL RESEARCH 30 (2019), pp.279–298
*3ADRA: Amino acid Derivative Reactivity Assay. A test method to detect the first key event that leads to an Adverse Outcome Pathway (AOP) in skin sensitization.
*4JaCVAM: Japanese Center for the Validation of Alternative Methods. An organization under the Center for Biological Safety and Research, National Institute of Health Science.