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. There are various laws and regulations related to chemical substances, including the Pollutant Release and Transfer Register (PRTR) Act, which require strict management. We recognize that it is a very important responsibility of a company that handles chemical substances to properly manage chemical substances and control their release into the atmosphere, sewers, and public waters. In addition to complying with the relevant laws and regulations, the SHIONOGI Group strives to control the release of chemical substances into the environment by setting its voluntary control criteria, which are stricter than those imposed by these laws and regulations.

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, the SHIONOGI Group submits relevant data to the authorities regarding the designated chemical substances it handles, and also manages the amounts of volatile organic compounds (VOCs) it uses, releases, and transfers. Under the PRTR Act, business operators are required to record and report to the authorities the amounts of designated chemical substances that are released into the atmosphere and rivers, disposed of, and recycled in their operations. The table below 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 to be registered under the PRTR Act (Unit: kg)
Substance name Amount used Amount released Amount transferred
Atmosphere Drainage
(public waters)
Soil Outside operating sites Sewers

N,N-Dimethylacetamide

5,646

0

0

0

5,646

0

N,N-Dimethylformamide

8,673

46

0

0

3,586

0

Acetonitrile

336,795

722

0

0

335,255

0

Chloroform

6,687

134

0

0

6,552

0

Dichloromethane
(methylene chloride)

181,430

110,551

2

0

52,889

0

Tributylamine

4,640

0

0

0

0

0

n-Hexane

6,122

0

0

0

5,798

0

Pyridine

19,570

0

0

0

11,362

0

VOC use and release into the atmosphere

Although the amount of VOCs handled by us increased due to an increase in plant production, the amount released into the atmosphere was below the FY2021 level due to appropriate management. We will continue our responsible management of the use, release, and transfer of chemical substances, controlling their release into the atmosphere, sewers, and public waters, to reduce the impact that our operations may have on the environment.

PCB

Polychlorinated biphenyls (PCBs) are mainly oily chemical substances made artificially. It has been reported that when they accumulate in the bodies of living organisms, they cause various symptoms. PCBs released into the environment are a cause of great concern in terms of global-scale contamination because they are resistant to decomposition in the environment but soluble in fat, resulting in their tendency to 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 equipment containing PCBs, whether being replaced or still in use, be appropriately managed to contain the impact of these substances.

In the SHIONOGI Group, appropriate management of PCB-containing equipment is assured by personnel specifically appointed for this task. At the same time, the treatment and disposal of PCB-containing equipment are proceeding. As of FY2022, we have completed the disposal of all equipment containing high concentrations of PCBs installed in the buildings and premises we own.

Fluorocarbons

In compliance with the Act on Rational Use and Proper Management of Fluorocarbons, the SHIONOGI Group identifies the relevant refrigeration, air-conditioning, and other types of applicable equipment that it possesses and operates, carries out simplified and periodic inspections, keeps related records, and calculates the amount of leakage. In FY2022, the SHIONOGI Groupʼs calculated fluorocarbons leakage was 630 tons-CO2. In compliance with the Kigali Amendment to the Montreal Protocol,*1 we are promoting a switch to fluorocarbon-free or low-GWP*2 equipment at the time of renewal.

*1 The Montreal Protocol on Substances that Deplete the Ozone Layer, based on the Vienna Convention for the Protection of the Ozone Layer, restricts substances likely to destroy the ozone layer, namely chlorofluorocarbons (CFCs) and hydrochlorofluorocarbons (HCFCs). The Kigali Amendment to the Montreal Protocol includes the restriction of production and consumption of hydrofluorocarbons (HFCs), a non-ozone-depleting fluorocarbon alternative with a high greenhouse effect.

*2 GWP: Global Warming Potential

Environmental and Safety Consideration of Chemical Processes

The SHIONOGI Group performs preliminary assessments of the safety of chemical substances and the danger of reactions and incompatibilities in the development stage of manufacturing and testing methods for pharmaceutical compounds and candidate compounds, and in the design stage of related equipment. We also examine production processes so as to enhance efficiency in terms of waste reduction, energy conservation, and the like in the manufacturing stage.

 

See the section “AMR” for more information on environmental release management of antimicrobials.