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 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.
A targeted risk assessment (TRA) tool developed by the European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC).
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
*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.
Risk Assessment and Blue Value™
Mitsui Chemicals has designed the Blue Value™ Index to visualize how a product contributes to reducing the environmental impact in each stage of its life cycle from the viewpoint of product stewardship. The Blue Value™ Index is a simplified quantitative life cycle assessment (LCA) method for screening assessments called LIME2 (life-cycle impact assessment method based on endpoint modeling). It enables life cycle assessment to be performed throughout the different stages, from raw materials to disposal. The evaluation categories of the Blue Value™ Index include "Reduction of GHG emissions," "Saving of energy, electricity, fuel," "3Rs, ease of sorting, and conservation of resources," "Ecosystem conservation (human health)," "Ecosystem conservation (environmental organisms)," and "Prevention of environmental contamination." The impact areas covered include "Global warming," "Ozone depletion," "Mineral resource consumption," "Fossil fuel consumption," "Harmful chemical substances," "Ecotoxicity," and "Acidification." We have assessed 87% of existing products using the Blue Value™ Index.
Since fiscal 2020, we have been conducting detailed assessments using the Blue Value™ Index in stage III of the Product Development Guidelines, in which market development starts, to discover Blue Value™ candidate products and accelerate their development, with the goal of accelerating and promoting product innovation development that incorporates environmental contribution.
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. 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.
Amino Acid Derivative Reactivity Assay. In chemico alternative method for skin sensitization.
Japanese Center for the Validation of Alternative Methods.