Chemical Substances

Approach to Chemical Substances｜Chemical Substance Management Initiatives｜Environmental and safety consideration of chemical processes

Approach to Chemical Substances

The process of pharmaceutical research, development, and manufacturing involves 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 as a company that handles chemical substances, it is our responsibility 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 (“SHIONOGI”) strives to control the release of chemical substances into the environment by setting its own voluntary control criteria, which are stricter than those imposed by these laws and regulations.

Chemical Substance Management Initiatives

PRTR

SHIONOGI manages designated chemical substances in accordance with the PRTR Act, under which it is mandatory to record, calculate, and publish the status of the release of chemical substances into the environment. We keep track of the amount of designated chemical substances that are released into the atmosphere and rivers, disposed of, and recycled in our operations, and submit the necessary reports. We also control the amount of volatile organic compounds (VOCs) we use, release, and transfer. Since designated chemical substances are properly treated and disposed of as waste materials, there is no release from our operating sites via sewage. (Designated chemical substances treated as waste materials are included in the amount transferred.)

Substances to be registered under the PRTR Act (Unit: kg)

Substance name^*1	Amount used	Amount released			Amount transferred
Substance name^*1	Amount used	Atmosphere	Drainage (public waters)	Soil	Outside operating sites	Sewers
N-Methyl-2-pyrrolidone	59,061	11	0	0	59,049	0
Chloroform	7,070	228	0	0	6,843	0
Dichloromethane (methylene chloride)	172,288	47,955	3	0	75,880	0
Tetrahydrofuran	233,608	3,383	0	0	107,177	0
Toluene	2,033	10	0	0	2,023	0
Hexane	6,682	516	0	0	6,166	0
Heptane (n-heptane)	1,103	11	0	0	1,092	0
Carbon disulfide	5,045	25	0	0	5,020	0
N,N-Dimethylformamide	33,337	54	0	0	2,091	0
Pyridine	6,175	0	0	0	4,949	0
4-Methyl-2-pentanone (methyl isobutyl ketone)	168,443	190	0	0	27,805	0
N,N-Dimethylacetamide	3,061	0	0	0	3,061	0
Tributylamine	2,995	0	0	0	3,061	0
Cyclohexane	1,590	16	0	0	1,574	0
G. total	702,491	52,400	3	0	302,730	0

*1 Name under the PRTR-SDS Law

Although the amount of VOCs used by us this fiscal year increased due to an increase in plant manufacturing, the amount released into the atmosphere was below the FY2022 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 synthetic, mainly oily chemical substances. 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. PCBs were previously used in numerous items, such as condensers, transformers, and ﬂuorescent light ballasts, and waste materials and equipment in use that contain PCBs must be strictly managed.

SHIONOGI appoints a manager to properly manage PCB-containing equipment for each organization or business site. Moreover, in accordance with the Act on Special Measures concerning Promotion of Proper Treatment of PCB Wastes (PCB Special Measures Act), we gradually proceeded with the proper disposal of PCB-containing equipment, and completed the disposal of all equipment containing high concentrations of PCBs installed in the buildings and premises we own by FY2022. We continue to take steps to complete the disposal of equipment containing low concentrations of PCBs 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 the relevant refrigeration and freezing, 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 FY2023, SHIONOGIʼs calculated fluorocarbons leakage was 727 tons-CO₂. In compliance with the Kigali Amendment to the Montreal Protocol,^*2 we are promoting a switch to fluorocarbon-free or low-GWP^*3 equipment at the time of renewal.

*2 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 restrictions on the production and consumption of hydrofluorocarbons (HFCs), a non-ozone-depleting fluorocarbon alternative with a high greenhouse effect.

*3 GWP: Global Warming Potential

Environmental and safety consideration of chemical processes

SHIONOGI 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 manufacturing 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 the environmental release management of antimicrobials.