Providing Safe Products
The Mitsui Chemicals Group is striving to achieve one of our goals for around 2020: “Mitsui Chemicals’ safety evaluations will garner the confidence of society; as an integral element in the value chain, the Company will work toward sustainable development and provide increasingly safe products.”
Undertake Risk Assessments as Well as Risk Management Via the Supply Chain for All Products
Based on the product stewardship approach, the Mitsui Chemicals Group assesses risks involved in the product lifecycle. This assessment is conducted at the development stage of a new product or brand. It is also conducted for a product already released to a market when changing its materials, production method, or usage; when applicable regulations and standards have been changed; and when a new scientific discovery is made concerning the chemicals contained in the product.
The development procedure of a new product is divided into five steps. A certain set of risk assessments is designated for each step and the assessment task is shared among the R&D Laboratory, business divisions, the Production & Technology Centers, the RC & Quality Assurance Division, and the Safety & Environment Technology Division.
The same applies to catalysts and additives used for materials or in the production process, and byproducts generated during manufacturing.
Other than the above, Mitsui Chemicals conducted risk assessments for all of our products in stages in order to contribute to attainment of the WSSD 2020 goal. 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 highest-priority products from among these 1,000 products were calculated for all possible use cases by utilizing tools such as ECETOC TRA,*2 which is used for risk assessments specified by the EU REACH regulation. In fiscal 2018, we expanded the assessment coverage to low-priority products and completed the risk assessment for all of our products.
*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).
Chemicals Management throughout Product Life Cycles
Mitsui Chemicals Product Development Guidelines
|Stage||Role||Responsible Care Responses|
|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
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
|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
Business/Product Development That Incorporates Sound Chemicals Management Perspectives
For human health and environmental protection as well as for sustainable development, the Sound Chemicals and Waste Management 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 Sound Chemicals and Waste Management 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, the first stage, we conduct identification with traceability of components of the product and gathering 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 stricter safety is being demanded. Under the European REACH regulations, risk assessments are proceeding 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 Sound Chemicals and Waste Management perspectives, including disseminating information to research and business development divisions and the raising of awareness. We designate the “reference substance list” according to global regulatory requirement including self-declaration request from downstream users or their sectors group. Out of such list, those whose manufacture and use are legally prohibited are specified as Prohibited Substances and such Prohibited Substances are not allowed to be detected in our products. We also specify Restricted Substances among the list, if their use or inclusion is restricted by customer requests or due to product usage purposes. In fiscal 2018, we provided our researchers with a tool that enables easy search for the list in the early stage of development of a product (verification stage of product concept). We are promoting use of this tool among researchers and developers so that they can avoid the substances in the list during the design stage with a view to the chemical regulations applied in later stages.
Mitsui Chemicals aims to provide products that are safe to human health and the environment and to contribute to 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 test data demanded by legal regulations. There are also cases in which animal test may be necessary. We have established the Group’s animal testing policy that declares on the 3R principles (of Replacement, the utilization of alternative methods; Reduction, reduction of the number of uses; and Refinement, the alleviation of suffering) and the internal regulations for the animal testing facility.
The chief of the institute that conducts animal testing (i.e. Director of the Chemicals Safety Department) appoints the Institutional Animal Care and Use Committee in accordance with the institution’s internal rules. The committee inspects all animal tests, including those outsourced, from the viewpoint of 3Rs before approving them. The committee also undertakes a self-inspection every year on the procedure and management of testing, facility and equipment propriety, and education and training, etc. The Institutional Animal Care and Use Committee and test managers document these processes and report to the chief of the testing institution.
Safety Assessment System
In November 2018, after 37 years, the Ministry of Environment revised the Standards relating to the Care and Keeping and Reducing the Pain of Laboratory Animals. To assimilate this revision, Mitsui Chemicals revised the internal rules of the institution and the Standard Operation Procedure (SOP). An annual external audit we received in fiscal 2018 again confirmed that our animal testing is performed appropriately based on the scientific viewpoint with consideration of animal welfare following the Act on Welfare and Management of Animals, the Standards relating to the Care and Keeping and Reducing the Pain of Laboratory Animals, and the Basic Guidelines by the Ministry of Health, Labour and Welfare.
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 of irritation, corrosiveness, and sensitivity, etc., as well as in regulations in different countries. Mitsui Chemicals is actively employing such new techniques.
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 toolbox,*1 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. Mitsui Chemical continues to expand and promote alternative methods to animal testing and contribute to their promotion.
*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.