Approach to chemical substances

The research, development and manufacturing of pharmaceutical products involve the use of numerous types of chemical substances. Some of them can adversely impact human health, ecosystems, and the global environment.

The handling of chemical substances is governed by the Pollutant Release and Transfer Register (PRTR) Act and various other laws and regulations. It goes without saying that Shionogi strictly adheres to these rules. We also make sure to appropriately manage chemical substances by regulating their release into the atmosphere, sewers and public waters in accordance with our voluntary criteria, which are stricter than those imposed by related laws and regulations. We consider these actions to be important as a company  in terms of compliance and reputation.

PRTR

In compliance with the PRTR Act, under which it is mandatory to record, calculate and publish the status of release of chemical substances into the environment, Shionogi submits relevant data to the authorities and manages the amounts of volatile organic compounds (VOCs) we use, release, and transfer. In the future, we will continue our responsible management of VOC use, release and transfer to reduce the impact that our operations may have on the environment.

Under the PRTR Act, business operators are required to record and report to the authorities the amounts of chemical substances that are released into the atmosphere and rivers, disposed of, and recycled in their operations. The table on the following page lists the headings under which this reporting is made. The “amount transferred” to “outside operating sites” refers to the amount handled as waste. 

Class 1 designated chemical substances under the PRTR Act
Substances subject to the PRTR Act(Unit: kg)
Substance name Amount used Amount released Amount transferred
Atmosphere Public waters Soil Outside operating sites Sewers
N,N-Dimethylacetamide 1,314 0 0 0 1,314 0
N,N-Dimethylformamide 16,599 79 0 0 9,424 0
Acetonitrile 138,062 1,317 0 0 132,873 0
Chloroform 6,703 258 0 0 6,445 0
Dichloromethane (methylene chloride) 148,977 70,427 4 22,160 35,580 0
Tributylamine 7,319 0 0 0 0 0
Toluene 1,756 18 0 0 1,739 0
n-Hexane 6,552 494 0 0 6,058 0
Pyridine 18,623 391 0 0 9,489 0
Trietylamine 13,583 0 0 0 13,204 0
Benzene 596 0 0 0 0 0
VOC use and release into the atmosphere

In FY2020, the amount of chemical substances used increased due to the leakage of dichloromethane and an increase in production volume. In the future, we will continue our responsible management of use, release and transfer of chemical substances to reduce the impact that our operations may have on the environment. 

PCB

Polychlorinated biphenyls (PCBs) are oily chemical substances made artificially. It has been reported that when they accumulate in the bodies of living organisms, they cause various symptoms. 

PCBs are a cause of great concern in terms of global-scale contamination because they do not easily biodegrade in the environment but easily accumulate in the bodies of living organisms through the food chain. In the past, PCBs were used in numerous items, such as condensers, transformers and fluorescent light ballasts. It is therefore imperative that all materials containing PCBs, whether they are being replaced or are still in use, be appropriately managed to contain their impact.

At Shionogi, appropriate management of PCB-containing materials is assured by personnel specifically appointed for this task. At the same time, the treatment and disposal of PCB-containing materials are continued according to a medium-term plan.

Although Shionogi expected to complete the disposal of all currently known PCB-containing materials in FY2020, it changed the completion time to the 2nd Quarter of FY2021 to ensure thorough response and completed the disposal. This will be followed by inspection to ensure there are no oversights.

Environmental and safety assessment of chemical processes

Shionogi performs preliminary assessment of the safety of chemicals and the danger of reaction and incompatibility in the development stage of manufacturing and testing methods or pharmaceutical compounds and candidate compounds and in the designing stage of related equipment. We also continue to explore production processes so as to enhance efficiency in terms of waste reduction, energy conservation, and the like in the manufacturing stage.