Chemical Substances

Approach to Chemical Substance Management｜Initiatives for Chemical Substance Management｜Environmental and Safety Considerations in Chemical Processes

  • Approach to Chemical Substance Management

    Various chemical substances are used in pharmaceutical research, development, and production. Some of these substances can impact human health, ecosystems, and the global environment. Various laws and regulations are related to chemical substances, including the Pollutant Release and Transfer Register (PRTR) Act, which requires strict management. As a company that handles chemical substances, we recognize our responsibility to properly manage these substances and control their release into the atmosphere and wastewater. In addition to complying with relevant laws and regulations, the SHIONOGI Group (“SHIONOGI”) sets voluntary control criteria that are even stricter than regulatory standards and works to reduce the environmental release of chemical substances. 

Initiatives for Chemical Substance Management

PRTR

SHIONOGI manages designated chemical substances according to the PRTR system, which requires recording, calculating, and publishing the status of chemical substance releases into the environment. We keep track of the amount of designated chemical substances released into the atmosphere and rivers, disposed of, and recycled, and submit the necessary reports. We also manage the amount of volatile organic compounds (VOCs) used, released, and transferred. The designated chemical substances are properly treated and disposed of as waste materials; therefore, there is no release from our operating sites via sewage (the amount transferred includes the designated chemical substances treated as waste materials). 
Class 1 designated chemical substances under the PRTR Act
Substances Reported under the PRTR Act (Unit: kg)
Substance name*1 Usage amount Amount released Amount transferred
Atmosphere Drainage
(public waters)		 Soil Outside operating sites Sewers
N-Methyl-2-pyrrolidone 55,132 22 0 0 55,110 0
Chloroform 8,598 307 0 0 8,290 0
Dichloromethane (methylene chloride) 153,957 53,204 5 0 85,771 0
Tetrahydrofuran 152,855 2,761 0 0 85,839 0
Toluene 1,745 17 0 0 1,727 0
Hexane 6,437 365 0 0 6,072 0
Carbon disulfide 3,783 38 0 0 3,745 0
N,N-Dimethylformamide 10,605 60 0 0 5,577 0
Tributylamine 4,855 0 0 0 0 0
Pyridine 11,312 0 0 0 9,302 0
4-Methyl-2-pentanone (methyl isobutyl ketone) 141,099 176 0 0 26,577 0
N,N-Dimethylacetamide 12,990 0 0 0 5,615 0
Acetic anhydride 1,089 0 0 0 5 0
G. total 564,457 56,951 5 0 293,629 0
*1 Name under the PRTR system
VOC use and release into the atmosphere
The amount of VOCs handled decreased from FY2023 to FY2024 because of changes in the types of products manufactured. To reduce the environmental impact, we will continue to properly manage the use, release, and transfer of chemical substances and control their release into the atmosphere and wastewater. 

Polychlorinated biphenyl (PCB)

PCBs are synthetic, mainly oily chemical substances. It has been reported that PCBs cause various symptoms when they accumulate in the bodies of living organisms. PCBs are resistant to decomposition in the environment and soluble in fat; therefore, they tend to accumulate in living organisms through the food chain, raising concerns about global-scale environmental pollution. PCBs were previously used in items such as condensers, transformers, and fluorescent light ballasts, and strict management is required for waste and equipment containing PCBs.


SHIONOGI appoints managers for each organization and site to properly manage the PCB-containing equipment. In accordance with the Act on Special Measures concerning Promotion of Proper Treatment of PCB Wastes (PCB Special Measures Act), we have gradually proceeded with the proper disposal of PCB-containing equipment and completed the disposal of all equipment containing high concentrations of PCBs in our buildings and premises by FY2022. We continue to take steps to complete the disposal of equipment containing low PCB concentrations by March 31, 2027, the deadline set forth in the PCB Special Measures Act. 

Fluorocarbons

In compliance with the Act on Rational Use and Proper Management of Fluorocarbons, SHIONOGI identifies relevant refrigeration, freezing, and air-conditioning equipment; conducts simplified and periodic inspections; keeps records; and calculates leakage amounts. In FY2024, the calculated fluorocarbon leakage was 255 tons-CO2. In accordance with the Kigali Amendment to the Montreal Protocol*2, we are promoting the introduction of fluorocarbon-free or low-GWP*3 equipment when updating facilities. 
*2 Under the Montreal Protocol, based on the Vienna Convention, substances likely to destroy the ozone layer (chlorofluorocarbons [CFCs], hydrochlorofluorocarbons [HCFCs]) are regulated. The Kigali Amendment restricts the production and consumption of hydrofluorocarbons (HFCs), which do not deplete the ozone layer but have a high greenhouse effect.
*3 GWP: Global Warming Potential

Environmental and Safety Considerations in Chemical Processes

In the development of manufacturing and testing methods for pharmaceuticals and candidate compounds, and in the design stage of related equipment, SHIONOGI conducts preliminary assessments of the safety of chemical substances and the risks of reactions and incompatibilities. We also examine manufacturing processes to enhance efficiency in terms of waste reduction and energy conservation during production.


For details on the management of environmental release of antimicrobials, please refer to the AMR section.