Management of Chemical Substances

As a global healthcare company, the Eisai Group has established the ENW (Eisai Network 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).

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.

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.

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.

The Eisai Group established the Company-Wide Environment and Safety Committee as a decision-making body for deliberation of important environmental issues. The committee is promoting global activities such as reducing greenhouse gas emissions and effectively using resources and is also strengthening activities to identify environment-related risks and develop countermeasures. Moreover, as a consultative body promoting the environmental activities of Group companies in Japan, the Eisai Group also established the Environment and Safety Conference of Group Companies in Japan to share information and discuss relevant activities.

Each operational site of the Eisai Group has established its own unique management system to promote environmental activities. The Eisai Group's main production sites in Japan as well as the Suzhou Plant in China and Vizag Site in India have all acquired ISO 14001 certification and are conducting activities based on the ISO standard while striving to raise awareness through environmental education and environmental risk management training. 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 solve issues.

In addition to using our unique reagent management system to monitor the usage of reagents by the Eisai Group in Japan, we are also striving to reduce our usage of PRTR substances and control their release into the environment. In the event that the amount of PRTR substances used exceeds the designated limit, we report this matter to the relevant prefectural governments without delay.
The amount of chemical substances used in the manufacturing process depends largely on the volume of pharmaceutical products produced. Further, to maintain the quality of active pharmaceutical ingredients, it is not easy to change manufacturing conditions after entering the commercial production phase. Therefore, from the perspective of green sustainable chemistry＊, we are working from the research and development stage to reduce the amount of chemical substances used, utilize alternative solvents, and develop synthetic methods that reduce the amount of substances used.
In addition, We incorporate various means into the manufacturing processes to minimize their release into the atmosphere.

To this end, main production plants and research laboratories of the Eisai Group in Japan implement the same level of efforts as for PRTR substances to reduce the usage of VOCs and stipulate equipment operation procedures to minimize their release during production or research processes.

The Eisai Group in Japan is systematically disposing of and replacing fluorocarbon-based equipment with equipment that uses hydrofluorocarbons (HFC) or non-fluorocarbons (NON), which do not have ozone-depleting effects. Since fluorocarbons have a strong GHG effect, we conduct regular inspections to prevent leakage accidents. In the unlikely event of a leakage, we immediately share information and work to prevent recurrence. Whenever disposing of equipment, we ensure that all fluorocarbons are collected, destroyed and disposed of properly, and receive process certificates from the fluorocarbon recovery firm.

The total amount of PRTR substances handled by the Eisai Group in Japan in fiscal 2021 was 280 tons, a 22% decrease from the previous fiscal year. Although the production amount of anti-cancer drugs and drugs in the neurology area increased, the production amount of antiulcer drugs greatly decreased. As a result, eight substances were reported to the authorities, an increase of one substance from the previous fiscal year.

The graph below shows chronological changes in the amount of VOCs handled and released into the atmosphere of 55 substances (taken from the Ministry of the Environment’s list of 100 major VOCs, excluding PRTR substances) that are handled and released by plants and research laboratories of the Eisai Group in Japan. In fiscal 2021, total amount of VOCs used by the Eisai Group in Japan was 1,093 tons, a decrease of 6.4% compared with the previous fiscal year, due to a decrease in production of antiulcer drugs at the Kashima Plant. As a result of countermeasures taken at plants and research laboratories, the amount of VOCs released into the atmosphere was minimized to 23.6 tons, which is 2.2% of the amount of VOCs handled.

The amount of fluorocarbons leaked by Eisai Co., Ltd. in fiscal 2021, calculated based on the Act on Rational USE and Proper Management of Fluorocarbons, is equivalent to 5 tons of CO₂, which is far lower than the threshold for notification to the Ministry of Health, Labour and Welfare. According to the survey on the usage amount of fluorocarbons conducted in fiscal 2021, 92.4% of the fluorocarbons used at our major production and research sites in Japan are hydrofluorocarbons (HFCs) and 7.5% are hydrochlorofluorocarbons (HCFCs). These two types are nearly all of the fluorocarbons we use. Our use of chlorofluorocarbons (CFCs), which have powerful ozone-depleting potential, has decreased and the ratio is only 0.05% of the total.