Product Stewardship / Product Safety / Quality Assurance

Basic Stance

Product Stewardship at Sumitomo Chemical

Under its Corporate Policy on Responsible Care (Safety, Health, the Environment and Product Quality), the Sumitomo Chemical Group promotes product stewardship*1 and works to provide products and services that satisfy customers and can be used with peace of mind.
To achieve the 2020 goal*2 proposed at the World Summit on Sustainable Development (WSSD) in 2002, it is now time for chemical management to be risk-based in regard to laws and regulations as well as company efforts to promote product stewardship on a global basis.
To achieve the 2020 goal, Sumitomo Chemical promotes voluntary initiatives to enhance product stewardship, including the Global Product Strategy (GPS)*3 /Japan Initiative of Product Stewardship (JIPS)*3 put forward by chemical industry associations, including the International Council of Chemical Associations (ICCA) and the Japan Chemical Industry Association. We actively participate in capacity-building activities, conduct risk assessments of our products, and perform risk-based management.

  1. Product stewardship: The assessment of risks and protecting people’s health and the environment from those risks throughout the product life cycle, which encompasses the entire supply chain from the development of chemical products to manufacture as well as sale, use/consumption, and disposal.
  2. 2020 goal: Ensure that chemicals are used and produced in ways that lead to the minimization of significant adverse effects on human health and the environment.
  3. GPS/JIPS: Initiatives that call on companies to conduct risk assessments of their products and to engage in appropriate chemical management based on risk in order to minimize risks throughout the supply chain. Under GPS/JIPS, toxicological information on chemical products is disclosed to the general public, including customers.

Ensuring Thorough Compliance

Sumitomo Chemical Group conscientiously adheres to various laws and regulations related to the manufacture, import, export, and sale of goods. We are working to ensure thorough compliance throughout our entire globally expanding group of companies.

Quality Assurance

The Group maintains its commitment to further improving product quality and is continually enhancing its global quality assurance system, which is tailored to each product, because the Group values the trust it has earned from customers and society and aims to further improve customer satisfaction.

Management System

As the highest body for deliberating and approving Sumitomo Chemical’s RC activities, the Responsible Care Committee is chaired by the president and comprises executive officers supervising the administrative departments and the four business sectors of the Company, and the General Manager of each Works. The Committee puts in place annual policies on RC activities, including chemical management and quality assurance activities; medium-term plans; and specific measures as they relate to Responsible Care. The Committee also analyzes and assesses the results of Responsible Care activities.

In addition, the Responsible Care Department oversees the Company’s chemical management and quality assurance management as well as supports each Group company’s chemical management and quality assurance management. Each department in charge of chemical management and quality assurance for Works and other departments promote appropriate chemical management and quality assurance management for their respective Works and department.

Organization of Chemical Management and Quality Assurance Activities

Goals and Results

For goals and results for Product Stewardship / Product Safety / Quality Assurance refer to the section entitled, “Social Activity Goals and Results.”

Examples of Initiatives

Risk Assessment and Management throughout the Entire Product Life Cycle

With regard to the chemicals (products) that it uses and sells, Sumitomo Chemical conducts risk assessments that span the entire product life cycle and all that could be affected, including internal operators, neighboring residents, the surrounding environment, customers, and consumers. The Company supports the Ministry of the Environment’s Eco-First program, having pledged to systematically conduct appropriate risk assessments for its products manufactured or sold in annual amounts of one ton or more by fiscal 2020 in line with the voluntary initiatives (GPS/JIPS) adopted by chemical industry associations. The results of these assessments are compiled into a safety summary and made publicly available online, including on the Japan Chemical Industry Association (JCIA)’s portal website In fiscal 2019, 13 new summaries were released, bringing the total publicly available safety summaries to date up to 57 (covering 56 substances).

In conducting chemical risk assessments, it is necessary to collect information regarding the hazards associated with each product and the levels of human and environmental exposure when products are handled. Based on the information needed for these risk assessments, we work to ensure that customers and employees handle chemical substances safely. To this end, we have created a collaborative framework centering on the Responsible Care Department and encompassing the frontlines of production and our internal research laboratories, which possess specialized technologies in risk assessment and safety engineering. To estimate exposure levels, the Company draws on projection models and expert insights in Japan and overseas and has developed its own simulation program. We also use the latest technology to efficiently conduct highly precise risk assessments. In line with our internal rules, during the development of new products, we collect data regarding risks and hazards for all handled substances before entering the production stage and survey and respond to all relevant laws and regulations.

Risk Management for Product Safety

As for risk assessments of product safety, it is necessary to assess the risks of chemical substances in products as well as the risks associated with product applications and uses. Taking into consideration not only their use by our direct customers but also the use and disposal of such products by their end-users, we conduct risk assessments of applications and uses using failure mode and effects analysis (FMEA)*4 and other methods in addition to chemical substance risk assessments. Sumitomo Chemical conducts rigorous risk assessments of new products and reassesses items already on the market. In fiscal 2019, we performed 73 risk assessments, including 38 reassessments. Going forward, we will continue to conduct rigorous risk assessments of new products and steadily proceed with reassessments of products already on the market. By fiscal 2020, we plan to complete risk reassessments of all our products. In addition, we are supporting Group companies in conducting similar product risk assessments and countermeasures.

  1. FMEA: A systematic method of analysis for detecting potential malfunctions and defects with the objective of their prevention

Providing Products and Services of Stable Quality

The Sumitomo Chemical Group is proud to provide its customers with products and services from a variety of fields centered on chemicals. In order to continue to supply our customers with products and services of stable quality, we have established quality assurance systems based on quality management systems and manufacturing and quality management guidelines, such as ISO 9001*5 and GMP,*6 appropriate for each product and service. In addition to maintaining thorough day-to-day product quality control, we are committed to further improving product quality.

When a problem related to the quality of our products or services occurs, we grasp the facts and determine the scope of impact in line with internal rules. We then take immediate action, such as contacting affected customers and replacing products. We subsequently work to identify the root cause of the problem, formulate and implement recurrence prevention measures, and implement those measures. Moreover, from the perspective of preventing recurrence of similar quality problems, depending on the severity of the problem, we disseminate information related to the root cause and recurrence prevention measures within the Company and to Group companies. We are committed to ensuring prevention problems in the first place.

Flowchart of How We Handle Quality Problems

  • Flowchart of How We Handle Quality Problems

However, in fiscal 2019, there were three major product quality problems recorded by the Sumitomo Chemical Group. Working to determine the causes underlying these problems, we are promoting strict preventive measures.

We are also improving quality assurance (including quality compliance) for the entire Group by widely disseminating information on responses to quality problems that arise within the Group and sharing activities and information related to product quality and safety. Furthermore, in order to continue supplying products and services of stable quality worldwide while addressing growing supply chain diversification accompanying its business expansion and the increasingly sophisticated needs of customers, the Group is enhancing its global quality assurance system through measures that include strengthening management of overseas suppliers and contractors.

  1. ISO 9001: The international standards on quality management systems issued by the International Organization for Standardization (ISO).
  2. Good Manufacturing Practice (GMP): Guidelines relating to manufacturing and quality management of pharmaceuticals.

The Information Sharing System and Ensuring thorough Compliance

The governments of Europe, the Americas, China, and the Asia Pacific region hold considerable sway over trends in global laws and regulations. To ensure thorough compliance, we post product stewardship specialists at our regional headquarters in these areas and are constructing a system to swiftly collect information related to regulatory trends. As for China, South Korea, Taiwan, Southeast Asia, and India, all of which have recently seen rapid and major changes in the legislative environment, together with Group companies we have been responding appropriately to the chemical regulations of each country.

As a response to the REACH regulation in Europe, which is a world leader in terms of laws and regulations, we are moving forward with appropriate legal registration, managing our supply chain, and properly transferring data. In addition, our local Group company Sumitomo Chemical Europe is drawing up letters about its registration status in response to its customers’ wishes as well as a declaration of conformity, which states the status of compliance and certificate acquisition with regard to various regulations.

In fiscal 2019, there were no reports of violations of regulations for Sumitomo Chemical products and services at any stage of their life cycles.

Effective Use of SuCCESS

In order to appropriately manage and effectively use information on chemicals handled by the Company, such as their composition, toxicological information (risks and hazards), and regulatory requirements, Sumitomo Chemical has developed the comprehensive chemical management system (SuCCESS).*7 This system is used in order to respond to inquiries from customers concerning substances contained in our products and precisely comply with laws and regulations in Japan and around the world, such as the REACH regulation in Europe. We also use this system to create SDS*8 in around 40 languages to comply with GHS*9 and accurately and efficiently communicate hazard information throughout the supply chain. This system is also being proactively rolled out to Group companies. We had installed the system at 13 Group companies in Japan and overseas as of fiscal 2019. In addition, we began using SuCCESS to calculate the manufactured volumes reported to the government under the chemical substances control law via a substance volume tracking (SVT) system as well as to calculate exported volumes.

  1. Sumitomo Chemical Comprehensive Environmental, Health & Safety Management System (SuCCESS)
  2. Safety Data Sheets (SDS): SDSs include information on the safe handling of chemical products (properties, handling methods, safety measures, etc.) and should be created in compliance with the Japanese Industrial Standards (JIS) and the standards set by the International Organization for Standardization (ISO).
  3. Globally Harmonized System of Classification and Labeling of Chemicals (GHS): In 2003, the United Nations established these global rules for how to convey information about the classification and degree of hazards for chemical substance

SuCCESS comprehensive chemical management system

  • SuCCESS comprehensive chemical management system

Providing Toxicological Information

To ensure its products are handled safely, Sumitomo Chemical uses SDSs and labels to provide customers with toxicological and regulatory information about the chemical substances they contain and the hazard data consolidated in SuCCESS. Furthermore, especially regarding products requiring warnings about their handling, we create yellow cards that are a simplified version of their SDSs. This provides logistics operators with the information they need to ensure they can respond appropriately to an emergency situation during transportation.

Sharing Information on Chemicals in Products

Countries and regions around the world are moving forward with regulations on chemicals in products, as represented by the European Union’s RoHS Directive*10 and REACH Regulation.*11 Because the content and required action for these regulations differs by country, region, and product field, we need to properly manage the chemicals present in not only final products but also raw materials and parts, and we need to accurately share this information on the chemicals present across the supply chain.

As a founding member of the Joint Article Management Promotion-consortium (JAMP), Sumitomo Chemical encourages acquiring and sharing information using chemSHERPA, which is an information-sharing scheme promoted by JAMP, and provides information in response to customer demands.

  1. RoHS Directive: An EU law related to restricting the use of specific hazardous substances, such as those in electric and electronic equipment
  2. *2 REACH Regulation: A regulation related to the registration, evaluation, authorization, and restriction of chemicals within the EU

Laboratory Animal Welfare

In the process of developing useful chemical substances, a large variety of safety assessments are required. With this in mind, Sumitomo Chemical is actively developing new assessment methods, including structureactivity relationship approaches, and minimizing the use of laboratory animals for safety assessments. However, assessments of impact on humans, animals, and the environment cannot be completed without conducting experiments using laboratory animals. Sumitomo Chemical therefore advocates the humane treatment of laboratory animals and applies the 3Rs*12 of replacement, reduction, and refinement to conduct animal studies appropriately with due consideration for animal welfare.

  1. The 3Rs: From the Law for the Humane Treatment and Management of Animals
    Replacement: To the greatest extent possible, replace methods that involve animals with those that do not.
    Reduction: To the greatest extent possible, reduce the number of animals used.
    Refinement: To the greatest extent possible, refine methods to minimize the suffering of animals.

Latest Emergency Issue

Microplastics and marine plastic pollution have become a global problem in recent years. Recognizing the importance of this issue, Sumitomo Chemical quickly agreed to the measures of the Japan Plastics Industry Federation and bolstered its internal education system. We also participate in the International Council of Chemical Associations (ICCA) and Japan Chemical Industry Association’s task force. We are working to keep abreast of the latest issues and are also proposing our comments to the aforementioned organizations.

Looking Ahead

Sumitomo Chemical promotes appropriate risk-based chemical management and is working to achieve its goal of completing product safety risk assessments of all Group products and confirming the effectiveness of related strategies and measures by fiscal 2020.

In response to strong social demand for the proper management of chemicals, the pace of establishment and revision of laws and regulations relating to chemical management is expected to pick up in even more countries and regions in the near future.

Closely collaborating with Group companies in Japan and overseas, Sumitomo Chemical consistently undertakes thorough compliance initiatives that involve carefully studying information on the regulatory trends as well as enhancing the functions of its comprehensive chemical management system (SuCCESS).

To improve customer satisfaction, the entire Group will continue to work to sustain its product and service quality improvements and to achieve an optimal product quality assurance system amid changing business conditions.