Management of Chemical Substances

Proper Management of Pollutant Release and Transfer Register (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 amounts of these substances handled, released into the environment and transferred as waste need to be understood and properly managed. Therefore, 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 to control their release into the environment. With regard to the usage of these substances exceeding the amount of the designated limit, we surely report this matter to the relevant prefectural governments without delay.

The amount of chemical substances used in the manufacturing processes depends largely on the volume of pharmaceutical products produced. To maintain the quality of active pharmaceutical ingredients, it is not easy to change manufacturing conditions after entering the commercial production phase. Therefore, we try to reduce the amount of chemical substances used by utilizing alternative solvents from the research and development stage and by developing synthesis processes that reduce the usage. At the same time, we actively promote the reuse of organic solvents and incorporate various means into the manufacturing processes to minimize their release into the atmosphere.

The total amount of PRTR substances handled by the Eisai Group in Japan during fiscal 2017 remained almost the same as the previous fiscal year’s level, coming to 267 tons. Notifications were made to authorities for eight substances, one more substance than in fiscal 2016. Although the amount of chemical substances used in the research and development stage for each theme fluctuated to a certain extent, the total amount used remained at the same level as the previous year.

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. In view of preventing air pollution, these substances need to be controlled to reduce their release into the atmosphere.

In response, main production plants and research facilities 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 operating procedures to minimize their release from production or research processes.

Management of Fluorocarbons

The Eisai Group in Japan is systematically getting rid of and renewing equipment that contains fluorocarbons and changing to equipment that uses hydrofluorocarbons (HFC) and non-fluorocarbons (NON), which do not have an ozone layer depletion effect. According to the survey on the amount of fluorocarbons used that was conducted in fiscal 2017, of the fluorocarbons used at the major production plants and research facilities in Japan, hydrofluorocarbon (HFC) accounted for 87.0% and hydro chlorofluorocarbons (HCFC) accounted for 12.7%. The survey found that mostly these two types of fluorocarbons were used. Chlorofluorocarbons (CFC) used, which have a strong ozone layer depletion effect, accounted for only 0.1% of the whole. The amount of fluorocarbons used at the major production plants and research facilities of the Eisai Group in Japan was equivalent to 37,118 tons of CO2.

Hydrofluorocarbons (HFC) have a strong greenhouse gas effect, however without any ozone layer depletion effect. We therefore conduct regular inspections to prevent leakage incidents, and at the same time, if a leakage incident should occur, we make efforts to immediately share information on and prevent the recurrence of incidents. When disposing of equipment, we properly destroy and dispose of fluorocarbons according to the Fluorocarbons Recovery and Destruction Law.

The leakage volume of fluorocarbons of Eisai Co., Ltd. in fiscal 2017 that we calculated under Act on Controlling Emissions of Fluorocarbons was equivalent to 321 tons of CO2, which fell below the threshold for notification to the Ministry of Health, Labour and Welfare.

Proper Management of Polychlorinated Biphenyl (PCB) Waste

We store PCB waste properly in enclosures with locks and warning signs and with measures to prevent vaporization, dispersion and leakage.
With respect to PCB waste stored at the Honjo Facility, Kawashima Plant and Tsukuba Research Laboratories, nine capacitors and 661 ballasts stored at the Honjo Facility have been disposed of during fiscal 2017. As a result, the situation of PCB waste that is yet to be disposed of is shown in the following table. We are reporting the disposal and storage status without delay to the relevant prefecture as required under the Law Concerning Special Measures Against PCB Waste.