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Management of Chemical Substances

Policy and Basic Concept

As a global healthcare company, the ӰҵGroup has established the ENW (ӰҵNetwork Companies) Environmental Protection Policy and conducts business activities with an emphasis on global environmental protection. It is stated in our Action Guidelines that we will “5. Prevent environmental pollution by promoting proper management of chemical substances and reducing their use” and as such, we are promoting these initiatives in our business activities on a global scale.

With regard to PRTR (Pollutant Release and Transfer Register) substances and VOC (Volatile Organic Compounds), which have a potential impact on the environment, we are working to reduce the amount of chemical substances used, utilize alternative solvents, and develop synthesis methods that reduce the amount of substances used, in order to prevent air pollution. We are also incorporating various means into our manufacturing processes to minimize their release into the atmosphere. In addition, to prevent global warming we are reducing emissions of fluorocarbons, including hydrochlorofluorocarbons (HCFCs) and chlorofluorocarbons (CFCs) that have ozone-depleting effects and strong greenhouse effects, and shifting to hydrofluorocarbons (HFCs) and non-fluorocarbons (NON).

Targets and Actions

Proper Management of PRTR Substances

Chemical substances that are used in the research and development and production of pharmaceutical products include some substances subject to the PRTR system that could have an impact on the environment. The amount of these substances handled, released into the environment and transferred as waste need to be understood and properly managed.

Volatile Organic Compounds (VOCs) Release Control

VOCs, such as ethyl acetate, acetone and methanol, are highly volatile and turn into gas in the atmosphere, and as is the case with NOx discharged from production plants, cause the generation of photochemical oxidants. From the viewpoint of preventing air pollution, these substances need to be controlled to reduce their release into the atmosphere.

Management of Fluorocarbons

Fluorocarbons including hydrochlorofluorocarbons (HCFCs) and chlorofluorocarbons (CFCs) used in air conditioners and refrigerants in buildings have ozone-depleting effects and strong greenhouse effects, and reducing their emissions and shiftng to hydrofluorocarbons (HFCs) and non-fluorocarbons (NON) is necessary from the perspective of preventing global warming.

Structures and Systems

Under the supervision of the Board of Directors, the ӰҵGroup has established the Company-wide Environment and Safety Committee chaired by the Corporate Officer responsible for Environmental and Safety Affairs. The Committee deliberates and makes decisions on important agenda items related to environmental safety. In addition to promoting global activities such as reduction of GHG emissions and efficient use of resources, the Committee contributes to the strengthening of activities to identify environmental risks in Japan and overseas and establish countermeasures to address these risks. Important environmental issues related to the entire ӰҵGroup that are discussed by the Committee are reported to the Executive Committee, the highest decision-making body of the business execution departments, for deliberation, resolution, and implementation. Resolutions of the Companywide Environment and Safety Committee are shared with the ӰҵGroup companies in Japan and overseas at meetings of the Domestic ӰҵNetwork Environment and Safety Conference and Global Eisai Carbon Neutrality Information Sharing Meeting, and the Group work together in addressing these issues.

Each operational site has established its own environmental management system and promotes environmental activities. The main production sites in Japan as well as the Suzhou Plant in China and Vizag Site in India have all obtained ISO 14001 certification and are conducting activities in accordance with the ISO standards, while also striving to raise environmental awareness through activities such as facilitating environmental education and training to address environmental risks. In addition to complying with environmental laws, ordinances and agreements, we periodically conduct internal environmental audits by a department specializing in internal auditing to identify and resolve issues.

Structure to Promote Environmental Management

Operational Sites Certified under ISO 14001

  • Kawashima Plant and Kashima Plant, Ӱҵ.
  • Fukushima Plant, EA Pharma Co., Ltd.
  • Suzhou Plant, ӰҵChina Inc.
  • Vizag Site, ӰҵPharmaceuticals India Pvt. Ltd.

Initiatives

Proper Management of PRTR Substances

Chemical substances used in R&D and the manufacture of pharmaceutical products include PRTR substances that may have an impact on the environment. The amount of chemical substances used, released into the environment and transferred to waste disposal site must be properly monitored. For this reason, the ӰҵGroup in Japan uses its own reagent management system to monitor the use of reagents and strives to reduce the use of PRTR substances, and curb their release into the environment. When PRTR substance is used in an amount exceeding the specified amount, it must be reported to the relevant prefectural governments without delay.

The amounts of chemical substances used in the manufacturing process depends largely on the amounts of pharmaceutical products. In the commercial production stage, however, it is not easy to change the manufacturing process because of the need to maintain quality of the API. For green sustainable chemistry*, we aim to reduce our environmental impact from R&D stage by reducing the use of chemical substances and developing synthesis methods using alternative solvents. When highly volatile PRTR substances are used, we strive to control their release into the atmosphere as much as possible and incorporate them into our manufacturing processes.

  • Chemical technology that considers the environment and supports the sustainable development of society.

Volatile Organic Compounds (VOCs) Release Control

Our major plants and laboratories in Japan are working to reduce the amounts of VOCs used as well as PRTR substances. At the same time, we have established equipment operation methods to minimize emissions from our processes.

Management of Fluorocarbons

The ӰҵGroup in Japan is systematically eliminating and replacing equipment that uses chlorofluorocarbons (CFCs) with equipment that uses hydrofluorocarbons (HFCs) or non-fluorocarbon refrigerants, which do not deplete the ozone layer. Because CFCs have a strong greenhouse effect, we regularly inspect our equipment to prevent leakage, and in the unlikely event of a leak, we promptly share information and take action to prevent recurrences. At the time of equipment disposal, we ensure that all fluorocarbons have been properly collected, destroyed, and disposed of, and obtains a disposal certificate from the contractors.

Data

Proper Management of PRTR Substances

The total amount of PRTR substances used by the ӰҵGroup in Japan was 328 tons, a 17% increase from the previous fiscal year. This was due to an increase in analytical solvents used for HPLC analysis, and the manufacture of anti-cancer drugs and drugs in the neurology and gastrointestinal fields. We reported eight substances as PRTR substances, the same as in the previous fiscal year.

Volatile Organic Compounds (VOCs) Release Control

The figure below shows changes over time in the volume of 55 of the 100 major VOCs specified by the Ministry of the Environment, excluding PRTR substances, used at the plants and laboratories of ӰҵGroup in Japan and released into the atmosphere. In fiscal 2022, the ӰҵGroup in Japan used 1,114 tons of VOCs, about the same amount as in the previous year. Due to measures taken at plants and research laboratories, emissions into the atmosphere were kept at 37.1 tons (3.3% of the total amount of VOCs handled).

Management of Fluorocarbons

Based on the Act on Rational Use and Appropriate Management of Fluorocarbons, our fiscal 2022 emissions of fluorocarbons were 327 t-CO2. This is the seventh consecutive year since the Act took effect that our emissions have been below the threshold (i.e., 1,000 t-CO2) to be reported to the Ministry of Health, Labour and Welfare.

* Received an A rating in the second assessment survey on compliance with “Act on Rational Use and Appropriate Management of Fluorocarbons” by the Japan Refrigerants and Environment Conservation Organization (JRECO).