EHS Management, Environmental Action Plan and Compliance

A father and child ride bikes, illustrating Astellas’ focus on sustainability issues.
A father and child ride bikes, illustrating Astellas’ focus on sustainability issues.

EHS Management

Astellas' fundamental approach to the environment and the health and safety of its employees is detailed in the Astellas EHS Policy. Furthermore, Astellas is committed to organizational and ongoing efforts to uphold this approach, as outlined in the Astellas EHS Guidelines. Additionally, Astellas has established medium-term targets for its key priorities within its EHS Action Plan and is actively working to achieve those targets.
For governance related to the promotion of environmental sustainability, please refer to the governance section in “Climate Change Initiatives.”

Astellas Environment, Health & Safety Policy

The Astellas EHS Policy reflects the company’s overarching position on EHS issues. This policy is applicable to all domestic and international group companies and serves as the foundation for all our corporate activities.

Schematic illustrates a strategy tied to Astellas’ VISION to be on the forefront of healthcare change to turn innovative science into VALUE for patients.

Rules of conduct governing environment and safety activities

At Astellas, the environment is a metaphorical stakeholder in our business philosophy. To conscientiously fulfill our responsibilities to the environment, we implement specific measures and initiatives based on the Astellas Code of Conduct.

Astellas EHS Guidelines

The Astellas EHS Guidelines set forth unified standards that identify Astellas' aspirations in its EHS activities.

 

The guidelines qualitatively describe our aims, and concrete numerical targets, including their deadlines, will be stipulated through short- and medium-term action plans that will be updated every fiscal year. We ask outsourced manufacturers to cooperate in implementing the guidelines through assessments and other actions

Compliance with Laws, Regulations and Internal Guidelines

  1. Appoint the specific management representatives or statutory managers related to the EHS, security, disaster prevention, etc. and clarify their roles, authorities and responsibilities.
  2. Identify the specific laws/regulations and legal reform trends that apply to the Company related to the EHS, security, disaster prevention, etc. and clarify the clauses/standards applied and respond, with no omissions, 1.3 to the legal requirements in surveys, measurements, notifications to authorities etc.
  3. Establish higher standards, targets and rules voluntarily, and maintain higher control level in order to fulfill company’s legal responsibilities.
  4. Incorporate Astellas’ policy, guideline and action plan into the EHS activities at each business place consistently.
  5. Establish procedures for creation/storage of records and legal notification concerning EHS, security and disaster prevention.

Environment, Health & Safety Management

  1. Construct the EHS management system and promote its activities systematically and intentionally. 
  2. Identify the perspectives of environmental burdens and occupational health and safety risks, and make the objectives/targets by appropriate evaluation methods. Moreover, mitigate these burdens and risks continuously. 
  3. Aim to receive the third-party certification of management systems with consideration for environmental burden due to our business activities, occupational health and safety risks, influences to regional society and social demands. 
  4. With communicating and informing employees of the information related to the EHS issues timely and appropriately, collect and analyze the accidents inside/outside Company, near misses and KAIZEN suggestions from employees, and develop the preventive action.
  5. Implement the internal audits periodically to assess the operating level of management systems and compliance level with related laws/regulations and Company rules/procedures, and improve the management systems based on audits’ findings.
  6. Establish systems to hand down the skills, knowledge, experiences from experts to others related to the EHS, security, disaster prevention, etc.
  7. Establish systems to prevent accidents and trouble issues by providing risk/hazard notification to contractors related to consignment businesses inside the workplace.

Risk Management, and Response to Accident or other Emergency

  1. Establish procedures to assess the EHS risks related to accidents, disasters and malfunctions etc., and identify the perspectives of EHS risks and strive to mitigate risks. 
  2. Prioritize the identified risks at each site, and implement to mitigate risks continuously. 
  3. With analyzing the impact on the Company and the social influence due to accidents occurred at Company and/or other companies, enhance the minimizing risks from the business continuity and social responsibility points of views.
  4. Establish systems that clarify the roles of employees as regards the identified accidents or disasters, and then confirm their effectiveness regularly.
  5. Prepare systems for making contact and methods of response for both inside and outside the Company that clarify the roles of employees as regards accidents and emergencies, and then confirm their effectiveness regularly.
  6. Strive to build and maintain good communication with regional societies, and provide information properly about emergency responses and environmental risk.

Management of Facilities and Vehicles

  1. Establish manuals for the operation and maintenance of facilities.
  2. Establish manuals for safety inspection of facilities, and conduct legal/ voluntary inspection periodically.
  3. Strive to mitigate safety risks resulting from structure/function of facilities, including by clearing obstacles from work places and displaying information about prediction of risk in an easy-to-understand format.
  4. As necessary, develop work environments that consider people with disabilities, including the promotion of barrier-free facilities and the installation of alarms for hearing-impaired.
  5. Strive to maintain/control facilities which might cause physical injuries such as electrification, explosion, fall, entanglement in an operating machine, and vehicles such as forklift.
  6. Establish standard for safe driving and rules for walking on the premise. Besides indicate them in an easy-to-understand format and communicate to employees and visitors.
  7. Proactively substitute mercury-free products for mercury products that are used in various facilities and equipment, and proceed with introducing the latest mercury-mitigated technology in the cases that mercury has to be unavoidably used.

Development of Products and Technologies

  1. Address the “Green Chemistry” proactively, and facilitate development of processes/products which take account of reduction of environmental burdens, effective use of resources, and occupational health and safety.
  2. In case of product design, development, process improvement, construction/introduction of facility, or licensing-in/licensing-out of product, implement the assessment based on “EHS Assessment Guideline”, and appropriately reflect results in them.
  3. Examine the control method and operating condition of facilities in consideration of environmental burdens at the commercialization /production stage and occupational health and safety.

Education and Training

  1. Execute systematic education and training in order to raise consciousness of employees concerning EHS and to facilitate activities for environmental conservation and occupational health and safety.
  2. Execute education and training periodically on the assumption of emergency situation such as accidents, disasters and breakdown/malfunction of equipment.
  3. Execute systematic education and training in order to raise knowledge and skill of employees in charge of the business whose environmental impacts are large and dangerous/hazardous.
  4. Execute education and training timely for new or relocated employees including workers of business partners, part-time and temporary employees.
  5. Develop specialists, statutory representatives and statutory qualified person in EHS according to appropriate plan.
  6. Define roles, authorities and responsibilities of managers concerning EHS clearly, moreover execute education and training in order to raise their skill and awareness.

Reponses to Environmental Issues (Biodiversity)

  1. Identify that various types of biodiversity that we are fortunate to possess in our own businesses and workplaces, and implement initiatives to continuously preserve biodiversity.
  2. Identify that various types of biodiversity that we harm the relationship with through our own businesses and workplaces, and implement initiatives to reduce any negative impacts.
  3. Establish a system for promoting the conservation of the biodiversity, and formulate the objectives and targets with a medium- to long-term perspective.
  4. As necessary, cooperate with stakeholders (including public bodies, NGOs/NPOs, and neighboring residents etc.) to address the conservation and sustainable use of biodiversity based on the size and characteristics of each workplace.
  5. Endeavor to educate and illuminate employees who have been inspired that the conservation of biodiversity, the sustainable use of its components is important.

Reponses to Environmental Issues (Energy Issues and Climate Change Countermeasures)

  1. Promote all-hands energy/resource conservation activities in all business activities.
  2. Astellas is committed to achieving its greenhouse gas (GHG) emission reduction targets generated by energy use, including by introducing equipment and processes that support the conservation of energy and resources, and by rigorous control of the air-conditioning temperature.
  3. Strive to achieve efficient logistics management, and cooperate with logistics companies in systematically reducing GHG emissions.
  4. Strive to reduce the number and efficiently utilize the vehicles used in business including sales activities, and promote the reduction of GHG emissions generated by from vehicles.
  5. Ensure a variety of energy sources, including by promoting the use of direct / indirect renewable energy.
  6. Identify the chlorofluorocarbon (CFCs) gas leakage amount from such sources as freezer storage units and air-conditioning units etc., and strive to systematically reduce the amounts.
  7. Give priority to those which take account of energy/resource conservation in case of installation of facilities, equipment, vehicles, raw materials, technologies etc.

Reponses to Environmental Issues (Management of Chemical Substances)

  1. Strive to achieve zero emission of hazardous chemical substances and pharmaceutical products to the environment by properly identifying the volumes of these substances and products handled/produced, released into the air, water and soil, and transferred.
  2. Provide employees with a healthy work environment by measuring the working environment on a regular basis, in order to prevent employees’ exposure to hazardous substances.
  3. Build a database and management system of information on chemical substances (Safety Data Sheets), including the safety of chemicals and of products developed in-house, and the physicochemical properties in order to disseminate to the employees. Also rigorously manage chemical substances, including the proper storage, use, and disposal of them.
  4. Establish a management system of chemical substances, and conduct regular stocktaking and internal audit to ensure legal compliance and safety risk mitigation.
  5. Create procedures as regards the proper management, use and disposal for hazardous substances that especially need to be controlled, including poisonous substances/drugs, CFCs, PCBs, narcotics, psychotropic drugs, radioactive substances, mercury, and bio-hazardous substances, and disseminate to employees.
  6. Regularly carry out special health checks on all employees who engage in operations treating substances designated as hazardous either by law or in the company’s own regulations, and take necessary measures appropriately. Meanwhile take record on operating time and abnormalities, and keep them appropriately.
  7. In case of transferring of chemical substances to other organization, or outsourcing of transportation, storage or disposal of chemical substances, provide information on environmental impacts, safety data and contact telephone number and address for use in an emergency. Meanwhile establish procedures against accidents and emergencies.

Reponses to Environmental Issues (Recycling Resources)

  1. Promote the 3Rs (Reduce volume of withdrawal; Reuse; Recycle), including water, raw materials, packaging materials, and other equipment.
  2. Aim the "zero" volume of landfill disposal due to appropriate waste management, such as waste sorting, recycling, minimizing the volume of raw material use, etc.
  3. Ensure appropriate selection of suitable waste treatment companies and contracts in case of outsourcing of waste treatment, and build a relationship of trust by regular communication.
  4. Concerning outsourcing of waste transportation, provide information on environmental impacts, safety data and contact telephone number and address for use in an emergency. Meanwhile establish procedures against accidents and emergencies.

Reponses to Environmental Issues (Countermeasures against air, water, and soil pollution)

  1. Apply voluntary control items and values for air/water pollution substances (including bioassay test) to minimize the environmental impacts.
  2. Concerning regulated air, water, and soil pollutants, ensure necessary actions such as measurements, record, consideration and report.
  3. Strive to move the underground pipes to above-ground and maintain the condition of underground tanks to prevent leakages.
  4. Develop preventive actions in response to the emission of pollutants into the air, water, or soil environment even in the case of accidents and emergencies. Moreover, introduce backup systems against the events that might cause major environmental impacts.

Reponses to Environmental Issues (Control of Sensory Nuisance Sources)

  1. Identify the source of sensory nuisances and take appropriate countermeasures to aim at zero complaints from neighboring residents and employees.

Harmonious coexistence with local society

  1. Appoint representative responsible for ensuring good communication between the Company and public bodies, industry groups, and neighboring residents, and establish a risk communication system to communicate with society.
  2. Build the relationship of trust with local community by regularly communicating on EHS initiatives in the workplace.
  3. Contribute to regional societies by proactively joining in regional activities, including culture, sports and other social contribution activities. 
  4. Develop systems such as opening up a Company facility as an emergency refuge area in the event of a disaster in response to a request from the region.
  5. In case of construction of new buildings or the extension/renovation of existing buildings, consider environmental balance and keep harmonized appearance.

Supply Chain Management

  1. Evaluate and identify risks related to the EHS issues in the supply chain (raw materials procurement, production, logistics, and sales), and strive to maintain and improve corporate value by avoiding reputation risk and supply chain disruption risk.
  2. Identify the impact of accidents or disasters at business partners on business, and raise the level of risk management while conducting mutual cooperation. Moreover, as necessary, take risk diversification measures.
  3. Conduct assessments, both regularly and from time to time, of risks related to EHS at business partners (written surveys, on-site audits, etc.), and give priority to transactions with low-risk business partners. As necessary, take risk countermeasures such as requiring improvements to be made at business partners for whom there is a concern about risk.
  4. In purchasing of raw materials, equipment and fixtures, consider their function and environmental impact comprehensively, and prioritize products whose environmental burden are lower.

EHS Assessment

Astellas conducts a companywide EHS assessment every fiscal year, in line with the Astellas EHS Guidelines, in order to evaluate the progress of EHS activities throughout the Astellas Group. Societal demands and problem awareness at each site are shared through an exchange of opinions between the EHS Management Department and each site. In this manner, one objective of assessments is to ensure that Astellas’ aspirations are aligned in the same direction. In addition, Astellas conducts assessments of Contracted Manufacturing Organizations (CMOs) in the value chain based on the same guidelines. In fiscal 2025, Astellas conducted on-site assessments of 7suppliers, and carried out risk assessments related to such matters as the operational status of wastewater treatment plants and waste storage facilities, employees' working environments and initiatives to prevent employees from being exposed to chemical substances. In cases where items were pointed out, Astellas indicated an improvement proposal, requested a plan for corrective measures to be drawn up, and is currently following up on progress of the improvements based on the corrective measures plan. Astellas continues risk management in the value chain through assessments to maintain an environment that ensures the stable supply of pharmaceuticals.

Product Assessment System

The total environmental load resulting from the production, sale, distribution and disposal of products is determined almost entirely at the research and development stages. With regard to the production and sales of pharmaceutical products, it is necessary to obtain government approval for each product. Since government approval also covers production methods and packaging specifications, when there are changes in either approved production methods or packaging, new approval must be obtained even if the changes are related to work safety or reducing the environmental impact. Therefore, these changes are very time-consuming and costly. Astellas has introduced a product assessment system as a tool that requires efforts to minimize the environmental load at every stage, particularly research and development, production, distribution, and disposal.

Under this assessment system, we examine issues such as the reduction of air pollutant emissions and the excessive use of packaging, safety measures at production sites, the prevention of exposure of employees to hazardous substances prior to the commencement of mass production, including development based on green chemistry, and response to law and regulation requirements.

 

When conducting product assessments, an assessment team conducts EHS assessments in stages for the development of products. The results determine whether the development of the product can move on to the next stage.


Specifically, the assessment must identify raw materials or processes that might have a negative impact on the environment and/or employee health and safety. The progress on remedial measures must be assessed, and action plans evaluated. Countermeasures being considered are evaluated in the subsequent stages of the assessment.

Product Assessment System

Education and Training

In order to promote further improvements in its EHS activities, the Company acknowledges the critical need to ensure that all employees have a correct understanding of their own roles and responsibilities.


To this end, we are working to develop employees professionally qualified in EHS matters and improve our skill base through a wide variety of training programs, including specialized education for employees engaged in roles requiring specialist knowledge and skills in areas such as environmental conservation or hazardous operations.


We also explain our policies and site rules to construction workers at our business sites, raw materials suppliers and waste transport and disposal contractors, and request cooperation with our EHS activities.

ISO Certification Status of Astellas Production Sites

Company nameCommercial manufacturing sitesObtained ISO certification (Month-Year)
Astellas Pharma Inc.Takahagi Technology CenterISO14001 (July 1998)
Yaizu Technology CenterISO14001 (October 2000)
Toyama Technology CenterISO14001 (March 2000)
Astellas Ireland Co., Ltd.Dublin Plant

ISO14001 (March 1997)

ISO45001 (September 2020)

Kerry Plant

ISO14001 (December 2003)

ISO45001 (December 2018)

ISO46001 (September 2024)

ISO50001 (April 2012)

Astellas Pharma China, Inc.Shenyang Plant

ISO14001 (October 2001)

ISO45001 (April 2025)

ISO22301 (March 2026)

ISO50001 (March 2026)

Environmental Action Plan

Our Environmental Action Plan sets out short-term and medium-term targets for our activities regarding the key points of the Astellas Environment, Health & Safety Guidelines. We renew our action plans on a rolling basis, by reviewing progress and conditions during the previous year and incorporating our findings into our action plan for the following year.

For details on climate change measures, please refer to “Climate Change Initiatives.”

Results of Fiscal 2025

ItemGoalFiscal 2025 Results
Measures to Address Climate ChangeReduce GHG emissions (Scope 1 + Scope 2) by 63% by fiscal 2030 (Base year: fiscal 2015) (Emissions in the base year: 201 kilotons) [1.5°C target]Ratio to base year 60% decrease
(Emissions: 81 kilotons)
Reduce GHG emissions (Scope 3) by 37.5% by fiscal 2030 (Base year: fiscal 2015) [well below 2°C target]Ratio to base year 19% decrease 

(Emissions: 1,124 kilotons)
Measures for the Conservation of Natural ResourcesEnhance water resource productivity*1 by around 20% of the fiscal 2016 result by the end of fiscal 2025Ratio to base year 126% improvement
Waste managementImprove waste generated per unit of revenue*2 by around 10% of the fiscal 2016 result by the end of fiscal 2025Ratio to base year 52% improvement
BiodiversityQuadruple the biodiversity index by fiscal 2025 from the fiscal 2005 levelRatio to base year 8.7 times

*1 Water resource productivity = Revenue (billions of yen)/Water resources withdrawn (1,000 m3) (For research and production sites in Japan and overseas)

*2 Waste generated per unit of revenue = Volume of waste generated (tons)/Revenue (billions of yen) (For research and production sites in Japan and overseas)

The current Environmental Action Plan targets for resource use, waste management, and biodiversity reached their final year in FY2025. We plan to establish new targets for these areas.

With regard to climate change, we have obtained SBTi (Science Based Targets initiative)validation for our FY2030 targets announced in January 2023, and we are planning to update these targets by January 2028.

Compliance

Response to Accidents and Emergencies

Being prepared for emergency situations caused by an accident or natural disaster can help to prevent an environmental catastrophe and minimize damage. Accordingly, we have developed specific measures and procedures for these situations. Moreover, we conduct regular education sessions and training drills, and reconfirm and test the validity of our procedures, communication networks and the division of roles focusing on risks that are recognized as a high priority. In this manner, we continue to work diligently to reduce environmental risk.

In particular, the discharge of harmful substances could lead to the pollution of rivers as well as cause problems at public sewage treatment plants. This in turn could have a grave impact on regional communities. In preparation for accidents and emergency situations, we are systematically implementing measures for the prevention of environmental pollution, including the installation of backup equipment, while working to reduce the risk of pollution. In addition, to avoid accidents and other problems, we are bolstering efforts to optimize the operation and management of wastewater treatment systems, and monitor and measure the quality of water draining out of our plants to confirm compliance with relevant effluent standards.

Compliance with environmental laws and regulations

In fiscal 2025, There was an instant deviation of sewage pH limit due to trouble in neutralization process. Astellas reported the incident to the local government in a timely manner and has taken appropriate preventive measures. Over the past five years, there were two incidents as below. Astellas reported these incidents to the local government and implemented response measures based on its instructions.

  • Takahagi Technology Center: Water (fiscal 2023)
  • Tsukuba Research Center: Water (fiscal 2022)

Environment-related accidents and complaints

In fiscal 2025, a liquid waste leak occurred due to expansion upon freezing of contents inside the transfer pipeline. Regarding accidental fugitive emission of fluorinated gases, annual emission data (in CO2 equivalent unit) is disclosed on page "Environment Initiatives". The numbers of environment-related fine payments and complaints are summarized in the table below.

 FY2021FY2022FY2023FY2024FY2025
Fine payment0001*10
Complaints0011*20

*1It turned out that an outsourced vendor did not test one of parameters on discharged wastewater in one of periodic tests and Astellas paid 145 USD.

*2There was a complaint about the sound of the emergency fire alarm during its periodic test.

Soil contamination assessments

In FY2025, a contaminated area was designated at the Takaoka Plant in accordance with the Soil Contamination Countermeasures Act. Appropriate measures have been implemented in consultation with the relevant authorities to prevent the spread of contamination.

The substances exceeding the regulatory standards are as follows:

  • Fluorine and its compounds
  • Lead and its compounds

Based on the results of soil investigations conducted over the past five years, no other instances of contamination have been identified.