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EHS Report 2017 EHS:Environment, Health and Safety Shionogi & Co., Ltd.

ehs 2017 e - 塩野義製薬 · Periods This EHS report covers the period of the fiscal year 2016 (from April 1, 2016 through March 31, 2017) in Japan, and the calendar year 2016

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EHS Report 2017EHS:Environment, Health and Safety

Shionogi & Co., Ltd.

■PeriodsThis EHS report covers the period of the fiscal year 2016 (from April 1, 2016 through March 31, 2017) in Japan, and the calendar year 2016 (from January 1 through December 31, 2016) outside Japan with regard to events we achieved. There are also some contents of our activities immediately before or after these periods.

■OrganizationsThe report covers the Shionogi Group’s EHS activities at the business sites of Shionogi & Co., Ltd. and six Shionogi Group companies within Japan, as indicated in the table below. There is no special mention of matters that have changed from the previous year.On the pages that follow, the terms “Shionogi” and the “Company” refer to Shionogi & Co., Ltd. as a single entity and the Group companies located on the premises of Shionogi & Co., Ltd.; the term “domestic subsidiaries” refers to one Japanese manufacturing company (Shionogi Pharma Chemicals Co., Ltd.) and two Japanese non-manufacturing companies (Shionogi Administration Service Co., Ltd. and Saishin Igaku Co., Ltd.) that belong to the Shionogi Group; and the term “Shionogi Group” refers to all of the companies mentioned above collectively. With regard to the Nanjing Plant of C&O Pharmaceutical Technology (Holdings) Limited, a non-Japanese Shionogi Group company, its data are disclosed under “Site Data,” separately from the Shionogi Group’s data.

■Numerical data and graphsThe numerical data provided in the report are obtained by rounding off digits smaller than the units indicated. Accordingly, the actual sums of individual figures in the graphs and charts do not necessarily correspond to the total figures in the same graphs and charts. The CO2 equivalent conversion of energy sources is based on the numerical measures established in-house for the purpose of progress management. The productivity figures are based on consolidated sales.

■Reporting policyThe Environmental Reporting Guidelines of the Ministry of the Environment of Japan (2012 edition) are used as reference.

■Disclosure mediaShionogi’s EHS activities are externally reported as part of its Integrated Report. A more detailed report is available on Shionogi’s official website in the form of a copy of the current EHS Report. To certify the reliability and transparency of the publicly disclosed information and receive advice for future improvement, the EHS Report was subjected to a third-party assessment by experts of the Institute for Environmental Management Accounting (IEMA).

Shionogi & Co., Ltd.

Company

Head Office, Tokyo Branch Office, Human Health Care Division

Kuise Site (Hyogo Prefecture)

Settsu Plant (Osaka Prefecture)

Kanegasaki Plant (Iwate Prefecture)

Shionogi Pharmaceutical Research Center (“SPRC,” Osaka Prefecture)

Aburahi Facilities (Shiga Prefecture)

Group Companies Shionogi Pharma Chemicals Co., Ltd. (Tokushima Prefecture)

Shionogi Analysis Center Co., Ltd.* (Osaka Prefecture)

Saishin Igaku Co., Ltd. (Osaka Prefecture)

Shionogi Techno Advance Research Co., Ltd.* (Osaka Prefecture)

C&O Pharmaceutical Technology (Holdings) Limited (Nanjing Plant, China)

Shionogi Administration Service Co., Ltd. (Osaka Prefecture)

Aburahi AgroResearch Co., Ltd.* (Shiga Prefecture)

Operating sites

* Located on the premises of Shionogi & Co., Ltd.

Editorial Policy

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At Shionogi, we believe it essential to address global environmental issues and challenges relating to health and safety. In October 2015, we adopted the Shionogi Group EHS* Policy to improve our workplace environment and contribute to making our society a better and richer place. We strive to achieve this goal through our business activities, conducted in such a manner as to protect the global environment, prevent pollution, and support the health and safety of all those with whom we work together and in the local communities in which we operate. In conformity with this policy, we intend to contribute to society’s sustainable development through our EHS activities in the Shionogi Group and throughout its supply chain.

* EHS: Environment, Health and Safety

EHS Policy

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1. Shionogi and EHS

2. EHS Management

2-1 EHS Management System

2-2 Management Systems

2-3 EHS Audits

2-4 Initiatives Covering the Supply Chain

2-5 Compliance with EHS-related Laws and Regulations

2-6 EHS Education

2-7 Emergency Preparedness

2-8 Local Community Service

3. EHS Action Targets

4. Results

4-1 Energy Conservation and Global Warming Control

4-2 Resource Conservation and Waste Treatment

4-3 Water

4-4 Management of Chemical Substances

4-5 Biodiversity

4-6 Product Initiatives

4-7 Environmental Protection

4-8 Environmental Accounting

4-9 Occupational Health and Safety

4-10 Health Management

5. Site Report

EHS Management Assessment

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Contents

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Shionogi’s EHS is related to all aspects of its corporate activities from raw material procurement to research, development, manufacturing, sales, use, and disposal. In all stages of our business activities, our EHS response aims to protect the global environment, prevent pollution, support the health and safety of all those with whom we work and in the local communities in which we operate, accurately recording the quantities of energy consumption and waste material generation and other relevant data.

CMC:Chemistry, Manufacturing and ControlThis concept encompasses research into active pharmaceutical ingredient(API) processes, drug manufacturing and development, and quality assessment, including the development of pharmaceutical formulation, research on manufacturing methods, the installation of quality standards, and the development of testing methods.

Research and Development CMC Manufacturing Distribution Sales

Use and Disposal

Green purchase

CSR procurement

Code of conduct guidelines for suppliers

Obtainment of environment and safety data

EHS data collection

Prevention of dispersal of chemical hazards, alien species, and genetically modified organisms

Radio isotope control

Biohazard control

Environmental impact assessment of pharmaceutical compounds

Development of environmentally responsible products

Preliminary EHS assessment

Process safety

Chemical hazard control

Guarantee of safety to local communities

Assessment of whole effluent(environmental impact)

Provision of environment and safety data

Low-emission vehicles, prevention of road accidents

Reuse and recycling of containers and packaging materials

Adequate disposal

EHS from procurement to disposal

Procurement

Environmental impact control: CO2 emission reduction, waste reduction, water management, AMR management

Health and safety response: Operational accident prevention, prevention of accidents during commuting, chemical risk management, mental health management, overwork prevention

General: Extended EHS assessment and management (into the supply chain)

1. Shionogi and EHS

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■ Shionogi and the Environment

Total energyElectricityTown gasPropane gas (LPG)Liquefied natural gas (LNG)Heavy oilKeroseneLight oilGasolineGasoline (for sales vehicles)

1,656,508 87,127 6,978 341 8,530 328 1 2 11

1,801

GJMWh1,000 m3

tonstonskLkLkLkLkL

Energy

PRTR-designated chemicals 289tons

Chemicals

Quantity used 1,612tons

Containers and packaging materials

Tap waterIndustrial water

2891,239

1,000 m3

1,000 m3

Water

CO2(Scope1 used as fuel)CO2(Scope1used for sales vehicles)CO2(Scope2)NOX(nitrogen oxides)SOX(sulfur oxides)Particulate matterPRTR-designated chemicalsVOCCFC(Chloro Fluoro Carbon)

40,678 4,183 27,086

26 0 2 63 77 803

tons-CO2tons-CO2tons-CO2tonstonstonstonstons

tons-CO2

Atmosphere

SewersPublic watersBOD(biochemical oxygen demand)COD(chemical oxygen demand)PRTR-designated chemicalsN(nitrogen)P(phosphorus)

335 998 7 2 0 8 4

1,000 m3

1,000 m3

tonstonstonstonstons

Waters

Consigned for reuse/recycling 224tons

Containers and packaging materials

GeneratedReleasedReused/recycledWaste put to landfillPRTR-designated chemicals

3,820 4,966 3,929 65 148

tonstonstonstonstons

Waste materials

1. Shionogi and EHS

Research on manufacturing methods

Administrative duties and MRs’ activities Hospitals

Pharmacies

API manufacturing

Drug product(DP) manufacturing

Packaging

InspectionNew drug application

Clinical tests

Pre-clinical tests

Basic research and new drug exploration

Research and Development Manufacturing Administration and Sales

INPUT

OUTPUT

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 2-1 EHS Management System

To ensure Group-wide EHS management, the Shionogi Group appoints an EHS overall manager and an EHS overall management representative. The operating divisions of Shionogi & Co., Ltd. and the Shionogi Group companies appoint their respective EHS management representatives and supervisors. To set EHS-related goals and operate the EHS Management System, the Companywide EHS Committee and the Companywide EHS Management Representative Meeting deliberate on related matters and make decisions. With regard to measures for energy conservation and global warming control, the Energy Conservation Committee, placed under the Companywide EHS Committee, is in charge of medium- and long-term goal setting, progress control, the assessment of compliance with legal and regulatory restrictions, and the like. In April 2016, the EHS Office was established to pursue the Shionogi Group’s EHS management and promote EHS initiatives, providing the divisions and companies with necessary assistance, working on problem solving, and arranging for EHS audits within and outside the Group, including suppliers. The Group’s manufacturing plant outside Japan, C&O in China, also appoints persons responsible for the execution and management of environmental measures.

President and CEO

Corporate Executive Meeting

EHS overall manager (EHS officer)

Companywide EHS Committee

Energy Conservation Committee

EHS overall management representative

Companywide EHS Management Representative Meeting

Environment committeeHealth and safety committee

Plants

Laboratories

Offices

Sales offices

Group companies

2. EHS Management

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 2-2 Management Systems

Four Shionogi manufacturing and research sites with major environmental risks and Shionogi Analysis Center Co., Ltd., a Group company located on the premises of Shionogi & Co., Ltd., are collectively accredited with ISO14001 certification. Shionogi Pharma Chemicals Co., Ltd., a domestic manufacturing Group company, is also ISO14001-certified independently. Each year, the Shionogi Group is inspected by external organizations with regard to its conformity to and the effectiveness of its management system, which was also inspected and certified in FY 2016. The Kanegasaki Plant, Shionogi’s major manufacturing site, is accredited with OHSAS18001 certification for its occupational health and safety management system. As with ISO14001 certification, the plant has undergone an external audit each year to continuously have its OHSAS18001 certification renewed. At present, preparations are underway at the Settsu Plant for OHSAS18001 certification.

 2-3 EHS Audits

■External auditsIn FY 2016, the external audits for ISO14001 certification revealed no areas requiring correction for either Shionogi or Shionogi Pharma Chemicals Co., Ltd. Likewise, the external audit for OHSAS18001 revealed no areas for correction for the Kanegasaki Plant. Advice for improvement received during these audits was studied with great care, and necessary actions were taken accordingly.

■ Internal auditsThe internal audits conducted in FY 2016 for ISO14001 and OHSAS18001 certification confirmed the absence of major problems concerning system conformity and compliance. Consequently, we decided on the maintenance of the same level of management. At the same time, for continuous optimal operation of the two management systems, we intend to continue training for new and current internal auditors to maintain and further improve their competencies.

■EHS auditsSeparately from the internal audits, the EHS Office, the Group-wide division in charge of EHS-related affairs, performs EHS audits to check whether Shionogi’s operating sites and Group companies appropriately conduct and maintain EHS activities in compliance with the management systems while pursuing continuous improvement. Audits are particularly carefully conducted at high-risk manufacturing plants. In FY 2016, EHS audits were conducted at the Kanegasaki Plant, the Aburahi Facilities, and Shionogi Pharma Chemicals Co., Ltd., to inspect the status of their management system, compliance with related regulations, and adequacy of EHS risk management. At the Settsu Plant, the executive directors in charge of EHS affairs conducted an on-site inspection of environment-related equipment and facilities and joined the Environment Committee.

Scope of ISO14001-certified Sites and Operating Divisions

● Shionogi Analysis Center Co., Ltd. (located within Settsu Plant)

● Shionogi Pharma Chemicals Co., Ltd.

● Shionogi & Co., Ltd.

Kuise Site, Settsu Plant, Kanegasaki Plant, Shionogi Pharmaceutical Research Center

2. EHS Management

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FY

Shionogi

Group companies

2012

2

0

2013

0

0

2014

0

0

2015

0

0

2016

0

0

Number of incidents of excess emissions (emissions exceeding legal restrictions) (Cases)

FY

Shionogi

Group companies

2012

2

0

2013

0

0

2014

1

0

2015

1

0

2016

1

0

Number of complaints relating to the environment (Cases)

 2-4 Initiatives Covering the Supply Chain

To ensure thorough legal and regulatory compliance in the area of purchase and procurement and to take environmentally responsible actions, we have established a purchase and procurement policy, pursing our business activities accordingly. For example, we perform EHS audits of important suppliers, confirming their safety measures and environmental consideration in the manufacturing processes. At the manufacturing and research sites, environmental impact assessment is conducted regarding all aspects of their operations from the purchase of raw materials to disposal. Our network of awareness raising and communication covers not only high-risk in-house operations but also out-sourced services and waste disposal operators. Moreover, following the globalization of our supply sources, and to ensure a stable supply, we have joined the Pharmaceutical Supply Chain Initiative (PSCI), thereby adjusting the manner in which we work, to realize CSR-conscious purchase and procurement in conformity with global standards, that is, purchase and procurement that respect high standards in EHS, ethical conduct, labor practice, and so forth.

 2-5 Compliance with EHS-related Laws and Regulations

Environment-related laws and regulations vary, encompassing a whole range from waste management and energy management to the prevention of air and water pollution and the management of chemical substances. To ensure thorough compliance, we share information on legal and regulatory revisions at the operating sites, organize educational programs, compile relevant information and knowledge in manuals, and conduct a periodic assessment of legal and regulatory compliance. Up to the present, we have never been subjected to litigation or penalties for environment-related violations. As with environmental matters, we also promote legal and regulatory compliance and assessment with regard to health and safety affairs. In FY 2016, Shionogi Pharmaceutical Research Center received one case of complaint about noise, following a reducing valve breakdown, which caused steam to gush out of the safety valve. In response, the faulty reducing valve was replaced, and the inspection frequency was reviewed.Following the revision of the CFC Emission Act in April 2015, we received the Osaka Prefectural authorities for on-site inspections, which did not result in any instructions.

■Green purchaseTo facilitate searches for, and identification of, environment-friendly products, Shionogi’s intranet-based purchase system indicates corresponding products with a “green product mark,” thereby encouraging the purchase of environmentally responsible office supplies that conform to formally recognized standards, such as those of the Eco Mark and the Green Purchase Network.

*PSCI: An NPO established in 2006 in the United States for the purpose of promoting CSR purchase and procurement in the pharmaceutical industry, with 24 corporate members, mainly Western pharmaceutical giants (as of the end of May 2017)

2. EHS Management

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 2-6 EHS Education

We believe that it is essential that each and every employee be aware of the challenges of EHS initiatives and actively participate in related programs.For employees, we provide training programs on environment-related subjects and preliminary education relating to operations with high environmental impacts, such as the management of waste materials and the handling of chemical substances. At each operating site, the target and actual figures of CO2 emissions and the quantities of generated waste materials are clearly made known to encourage vigorous employee involvement. Education on health and safety is also carried out at each site in accordance with the risks it faces.In FY 2016, following ISO14001:2015, the certified operating sites organized in-house information meetings for managers and supervisors, personnel in charge, and internal auditors. Educational programs are also provided to future and current internal auditors for ISO14001 and OHSAS18001 certification so that they may succeed in their qualifications or continue improving their relevant skills.

 2-7 Emergency Preparedness

In preparation for earthquakes, fires, the leakage of toxic substances, and other eventualities, we have established response procedures and communication and reporting systems. We also carry out periodic training programs to reinforce our emergency preparedness, while reviewing the response procedures from time to time. In FY 2016, a joint tsunami evacuation drill was organized at the Kuise Site with the participation of local residents and governmental authorities. At the Kanegasaki Plant, personnel held a general disaster reduction drill with public firefighting authorities following a simulated scenario of a fire triggered by an earthquake.

Training for internal environmental auditor qualification

2. EHS Management

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 2-8 Local Community Service

As a corporate citizen, Shionogi engages in a variety of activities serving the local communities in collaboration with local governments and other organizations. Such activities include cleanup campaigns and the removal of illegal posters on or along public roads around the sites. In FY 2016, the Kanegasaki Plant cooperated in the holding of a convention organized on the theme of the environment and other events, and the Settsu Plant renewed its registration as a civic emergency support station and on Osaka Prefecture’s AED installation Map. The Aburahi Facilities also renewed their registration on the AED Map and provided support for local school education through the Botanical Gardens.Shionogi representatives sit on the Environment and Safety Committee of the Japan Pharmaceutical Manufacturers Association (JPMA), actively promoting the adoption of industrial guidelines and the planning of industrial-wide initiatives. We diligently work toward and observe the targets and criteria thus set for global warming control and waste reduction, continuously contributing to industry-wide achievement of targets and goals.

Kanegasaki Town Clean-up Campaign

Supporting local school education

Clean-up Campaign at Settsu Plant

2. EHS Management

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1. Promote energy conservation and global warming control measures.

・Reduce CO2 emissions in FY 2020 by 33% from the FY 2005 benchmark (by 40% in FY 2030).

・Improve specific energy efficiencies by an annual average of 1%.・Promote the introduction of highly energy-efficient equipment.

Phase 5 of the Shionogi Group Environmental Protection Plan Targets

CO2 emissions: reduced by 27% (70,070 tons-CO2)Specific energy efficiencies: Improved by 0.9% (from FY 2015)・ Renew high-voltage power distribution equipment. (Kuise Site)・ Convert outdoor lamps and lighting to LED; switch to a high-efficiency AC system; discontinue transformers and control panels; improve the efficiency of refrigerator operation control; improve process efficiency by introducing heat recovery equipment. (Settsu Plant)

・ Improve motor efficiency to the IE3 level (premium) in basic equipment building. (Kanegasaki Plant)

・ Discontinue air-conditioning at night and on holidays. (SPRC)・ Discontinue hot water pump operation at night, continue the discontinuation of waste water treatment station raw water pump operation. (Aburahi Facilities)

FY 2016 Environmental Action Targets

We set mid-term targets in all aspects of our business activities, including research and development, manufacturing, and sales, in consideration of domestic and international trends and Shionogi’s situation.With regard to environmental protection, we are currently working toward the action targets of Phase 5 of the Shionogi Group Environmental Protection Plan. This plan will be revised in the future as an EHS Plan, with health and safety action targets added. For the environment, we plan to continue with the introduction of high-efficiency equipment and the optimization of PCB-containing waste material treatment as measures for global warming control. For health and safety, we plan to work on the elimination of accidents resulting in worktime loss. With regard to chemicals and initiatives throughout the supply chain, we will continue our improvement efforts from both the environmental and the health and safety aspects.

Targets and Results of Phase 5 of the Shionogi Group Environmental Protection Plan (FY 2016-2020)

5. Protect a sound aquatic environment.・Depollute or decontaminate used water and return it to rivers.

・ Confirm the appropriateness of drainage methods for new chemicals; raise water-saving consciousness, and control tap and industrial water consumption. (Settsu Plant)

・ Appropriately manage effluent treatment facilities; continue the water-saving consciousness raising campaign.

6. Contribute to biodiversity preservation.・Maintain and promote effective use of the Botanical Gardens.・Raise employees’ awareness.

・ Preserve and manage rare plants, including endangered species, at Aburahi Botanical Gardens; introduce rare plants growing in and around Aburahi to the Botanical Gardens to preserve seeds; turn the preservation and management of plant species into educational opportunities. (Aburahi Facilities)

・ Appropriately manage gene recombination experiments; conduct educational programs.

2. Strengthen resource conservation and waste treatment/disposal measures.

・Reduce the amount of waste generated by 55% from the FY 2000 benchmark.・Improve the percentage of waste reused or recycled to 73% or larger, and reduce waste put to landfill.

Amount of waste generated: reduced by 41% (3,945 tons)Percentage of waste reused or recycled: 78%・Promote waste reduction by all divisions; consign reusable/recyclable waste to service providers. (Kuise Site)

・Maintain stable operation to reduce temporary waste (equipment stoppage, deviation, etc.); appropriately treat discarded reagents; thoroughly sort out office waste. (Settsu Plant)

・Recover usable materials from waste; reduce liquid waste. (Kanegasaki Plant)・Promote reuse of office supplies, research materials, and instruments and apparatuses. (SPRC)

・Improve testing efficiency; make effective use of idling objects; sort out waste paper for recycling; promote thermal recycling. (Aburahi Facilities)

3. Manage chemical substances appropriately.・Appropriately treat and dispose of the entirety of PCB-containing waste materials. (FY2022)

・Appropriately manage CFC-using equipment.

4. Develop the management systems for the environment.・Promote continued improvement in response to ISO14001:2015.・Improve employees’ understanding of the management systems for the environment; raise employees’ environmental awareness.

・ Appropriately treat low-concentration PCB-containing waste according to schedule. (Settsu and Kanegasaki Plants)

・ Appropriately manage PCB-containing waste.・ Appropriately manage CFC-using equipment (inspection, leakage data recording).

・ Hold information meetings on ISO14001:2015; hold educational and awareness-raising programs for divisions; revise documents.

3. EHS Action Targets

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3. EHS Action Targets

CO2 emissions: reduced by 29% (67,764 tons-CO2)Specific energy efficiencies: improved by 4.7% (from FY 2015)・High-voltage power distribution equipment was renewed. (Kuise Site)・Outdoor lamps and lighting were converted to LED; a switch was made to a high-efficiency AC system; transformers and control panels were discontinued; the efficiency of refrigerator operation control was improved; process efficiency was improved by introducing heat recovery equipment. (Settsu Plant)

・Motor efficiency was improved to the IE3 level (premium) in the basic equipment building; a switch was made to a high-efficiency AC system. (Kanegasaki Plant)

・Air-conditioning was discontinued at night and on holidays where possible. (SPRC)・Hot water pump operation was discontinued at night; the discontinuation of waste water treatment station raw water pump operation was sustained; the lighting in the cafeteria building was converted to LED. (Aburahi Facilities)

Results from FY 2016 Environmental Action Targets

CO2 emissions: reduced by 29% (68,178 tons-CO2)Specific energy efficiencies: improved by 1.9% (from FY 2015)・Switch to high-efficiency refrigeration equipment. (Kuise Site)・Convert lighting to LED; switch to a high-efficiency AC system; improve the operational efficiency by the number of boilers used; discontinue air-conditioning periodically by adjusting output. (Settsu Plant)

・Improve efficiency on the occasion of air-conditioning equipment renewal; renew ventilation and air-conditioning motors; improve pump motor efficiency to the IE3 level. (Kanegasaki Plant)

・Renew power receiving/distribution equipment; discontinue air-conditioning at night and on holidays. (SPRC)

・Discontinue hot water pump operation at night; continue the discontinuation of waste water treatment station raw water pump operation. (Aburahi Facilities)

FY 2017 Environmental Action Targets

・Regarding liquid waste resulting from washing equipment for new products, the volume to be disposed of, disposal sites, and drainage were examined, and action was taken in accordance with standards set to prevent water contamination by drainage. (Settsu Plant)

・The control method was switched from batch-based to level-based for the storage tank for distilled water supply for injections, among drug manufacturing water equipment, reducing the drainage of remaining water. (Settsu Plant)

・Educational programs were held on the theme of equipment management and drainage, improving employees’ awareness of environmental impact. (Settsu Plant)

・Effluent treatment facilities were appropriately managed, and water-saving efforts were continued.

・ Monitor drainage of new chemicals. (Settsu Plant)・ Consider vacuum pump water sealing and reduction of water used for cleansing. (Kanegasaki Plant)

・ Continue efforts for dosage control and water conservation.

・Rare plants, including endangered species, were preserved and managed at Aburahi Botanical Gardens.

・Aquatic plants, rare plants growing in and around Aburahi, were collected and introduced to the Botanical Gardens for cultivation.

・Programs were held at Aburahi Botanical Gardens, featuring interactions with primary and middle school pupils and college students. (Aburahi Facilities)

・Gene recombination experiments were appropriately conducted, as were educational programs. (SPRC, Aburahi Facilities)

・Educational programs on biodiversity were conducted, raising employees’ awareness.

・ Preserve and manage rare plants, including endangered species, at Aburahi Botanical Gardens.

・ Introduce rare plants growing in and around Aburahi to the Botanical Gardens to preserve seeds; select plants suited to the natural environment in Aburahi for cultivation.

・ Turn the preservation and management of plant species into educational opportunities for the local communities.

・ Exchange information with related organizations to continue initiatives for biodiversity preservation. (Aburahi Facilities)

・ Appropriately manage gene recombination experiments; conduct educational programs. (SPRC, Aburahi Facilities)

・ Provide information and educational opportunities to raise awareness of biodiversity.

Amount of waste generated: reduced by 43% (3,820 tons)Percentage of waste reused or recycled: 79%・Waste reduction was promoted at all divisions. (Kuise Site)・Stable operation led to less temporary waste (equipment stoppage, deviation, etc.); process review led to less waste; the treatment method was changed for liquid waste resulting from equipment cleansing, improving the rate of reuse/recycling. (Settsu Plant)

・Recovery of usable materials from waste was promoted; liquid waste was reduced; measures to contain antibiotics were studied in connection with the disposal of containers. (Kanegasaki Plant)

・The reuse and sales of office supplies, research materials, and instruments and apparatuses were promoted; metal scrap was sorted out, and its reuse and recycling were promoted. (SPRC)

・Waste paper were sorted out to promote recycling; thermal recycling was promoted. (Aburahi Facilities)

Amount of waste generated: reduced by 49% (3,427 tons)Percentage of waste reused or recycled: 77%・Maintain stable operation to reduce temporary waste (equipment stoppage, deviation, etc.). (Settsu Plant)

・Recover usable materials from waste; reduce liquid waste; promote recovery of usable materials by sorting out waste plastics. (Kanegasaki Plant)

・Promote reuse and recycling of waste materials generated in new processes (Kanegasaki Plant)

・Low-concentration PCB-containing waste was appropriately treated according to schedule. (Settsu and Kanegasaki Plants)

・PCB-containing waste was appropriately managed through locking, anti-leakage measures, reporting, etc.

・CFC-using equipment was appropriately managed through inspection, maintenance records, and leakage reports, etc.

・Six information meetings were held on ISO14001: 2015 for division managers in charge of environmental affairs, and personnel in charge of execution and promotion.

・Response to the revision was made by revising or producing documents, such as tables of risks at operating sites, division-wise skill management tables, and reports on the assessment of compliance with legal and other requirements.

・ Appropriately treat and dispose of PCB-containing waste according to schedule. ・ Execute appropriate management all the way to the completion of treatment/disposal.

・ Appropriately manage CFC-using equipment (inspection, leakage data recording).

・ Receive inspection for transition to ISO14001: 2015 to continue certification.・ Improve environmental awareness in accordance with the revised requirements.・ Promote improvement activities closely related to actual operations. (Kanegasaki Plant)

13

0

50,000

100,000

0

50,000

100,000

 4-1 Energy Conservation and Global Warming Control

■ CO2 EmissionsThe Shionogi Group is actively working on CO2 emission reduction to contribute to global warming alleviation. The Federation of Pharmaceutical Manufacturers’ Associations of Japan (FPMAJ) has adopted the goal of reducing CO2 emissions by pharmaceutical manufacturers in 2020 by 23% from the FY 2005 benchmark as part of FPMAJ’s action plan to realize a low-emission society. The Shionogi Group has followed by setting similar or even more ambitious targets, working toward higher energy efficiency, concretely an annual 1% improvement in specific energy efficiencies, and installing highly energy-efficient equipment that consumes less energy. Moreover, we have been continuously reviewing our operational methods. In FY 2014, at the Kanegasaki Plant, the energy supply equipment underwent fuel conversion, and a cogeneration power system was installed, thereby largely reducing the plant’s CO2 emissions. Other actions include the introduction of hybrid vehicles, data collection on greenhouse gas emissions throughout the supply chain, and a switch to non-CFC-using equipment has also been under consideration.At the Nanjing Plant of C&O Pharmaceutical Technology (Holdings) Ltd. in China, the use of biomass, comprising leftover materials from lumber mills, has commenced.

2016(FY)2015201420132012

CO2 emissions and productivity (sales/CO2 emissions)

89,155 83,927 68,194 69,420 67,764

31.734.5

40.244.7

50.0(tons-CO2)

ProductivityCO2 emissions

2016(FY)2015201420132012

CO2 emissions by scope

50,723 46,590 36,609 41,569 40,678

38,432 37,337

31,586 27,851 27,086

(tons-CO2)

Scope 2: Indirect emissions from energy sources

Scope 1: Direct emissions (fuel-derived only)

4. Results

14

0

2,500,000

2016(FY)2015201420132012

Consumption by energy type Total energy and productivity(Sales/total energy)

■Energy Consumption

(GJ) Sales/total energyTotal energy

Electricity    Town gas     LNG

LPG     Heavy oil A    Light oil

Kerosene    Gasoline

0

2,500,000

2016(FY)2015201420132012

(GJ)

4. Results

14.0 14.716.2

18.320.5

2,024,176 1,971,469 1,693,485 1,697,382 1,656,5081,250,0001,250,000

0

1,000

2,000

3,000

■ Vehicles for sales activitiesTo reduce CO2 and gas emissions by improving fuel efficiency, Shionogi is promoting the introduction of hybrid vehicles (HV) to be rented to our medical representatives (MRs). The replacement of conventional automobiles by HVs has already been completed all over Japan, except in cold regions. Moreover, vehicles are also equipped with safety devices to reduce the number of road accidents.

0

2,000

4,000

6,000

2016(FY)2015201420132012

CO2 emissionsFuel consumption

Fuel consumed by vehicles for sales activity and CO2 emissions

2,488 2,284 2,290 2,031 1,801

5,7785,304 5,317

4,7164,183

(kL) (tons-CO2)

15

(FY 2016 actual figures, Shionogi & Co., Ltd. alone; unit: tons-CO2)

■ Greenhouse gas emissions throughout the supply chain (Scope 3)The company’s business activities form a supply chain with purchase and sales. For truly effective CO2 emission control, it is important to know how much greenhouse gases are emitted not only through the company’s own activities but also throughout the supply chain.At Shionogi, we measure our greenhouse gas emissions throughout the supply chain of purchase/procurement, manufacturing, distribution, and sales in accordance with the “Basic Guidelines on Accounting for Greenhouse Gas Emissions Throughout the Supply Chain” published by the Ministry of the Environment and the Ministry of Economy, Trade and Industry of Japan.

Scope1:Direct emissions from the company’s fuel use and industrial processesScope2:Indirect emissions from the consumption of electricity and thermal energy purchased by the companyScope3:Indirect emissions from the supply chain other than Scope 1 or 2

Purchased goods and services145,475

Waste generated in operations4,110

Disposal of sold products850

Fuel and energy-related activities not included in Scope 1 or 2 3,015

Capital goods98,022

Distribution and delivery (upstream)

 -Plant to warehouse 201 -Warehouse storage 351 -Warehouse to wholesalers 313

Shionogi

Energy-derived indirect emissionsElectricity consumption26,456

Business travel 521Employee commuting819

4. Results

The calculation bases are as indicated in the “Basic Guidelines on Accounting for Greenhouse Gas Emissions Throughout the Supply Chain (Ver. 2.4)” of the Ministry of the Environment and the Ministry of Economy, Trade and Industry of Japan.

Category

      Fuel used

Vehicles for sales activities

Energy-derived indirect emissions

Purchased goods and services

Capital goods

Fuel and energy-related activities not included in Scope 1 or 2

Distribution and delivery

 -Plant to warehouse

 -Warehouse storage

 -Warehouse to wholesalers

Waste generated in operations

Business travel

Employee commuting

Disposal of sold products

FY 2016 results

39,970

4,183

26,456

145,475

98,022

3,015

201

351

313

4,110

521

819

850

FY 2015 results

40,960

4,716

27,246

147,108

52,945

3,093

240

333

246

4,305

562

1,473

924

FY 2014 results

36,213

5,317

30,966

146,941

21,948

3,487

225

349

273

3,680

745

1,421

889

Calculation basis

Amount of fuel used as defined under the Energy Conservation Act

Fuel used for vehicles for sales activities

Amount of electricity purchased as defined under the Energy Conservation Act

Purchase price of raw materials and products purchased

Acquisition price of fixed assets newly acquired in the year

Amount of electricity purchased

・Not including distribution and delivery of raw materials ・Downstream transportation and delivery of products (weight and distance)

 -Plant to warehouse

 -Warehouse storage

-Warehouse to wholesalers

Weight of waste materials classified by type

Number of employees

Travel expenses calculated for each means of transportation(calculated based on the number of employees until FY 2015)

Amount used by type as classified under the Containers and Packaging Recycling Act

Scope1

Scope2

Scope3

(Shionogi alone) (Unit: ton-CO2)

Direct emissionsFuel used 39,970

Vehicles for sales activities 4,183

Direct emissions

16

4. Results

■ AccoladesRanked “S” in the system of assessing companies by class under the Energy Conservation Act

In FY 2016, the system was established under the Energy Conservation Act to evaluate and classify companies into four ranks (S, A, B, and C) depending on their energy conservation initiative and publicly announce companies’ environmental performance. Shionogi was ranked “S” for the second consecutive year as an excellent company promoting advanced energy-saving initiatives.

Cogeneration Award for the Kanegasaki Plant

In February 2017, the Kanegasaki Plant was honored with the Excellence Award in the industrial category of the Cogeneration Awards 2016 organized by the Advanced Cogeneration and Energy Utilization Center Japan. The Kanegasaki Plant received this award for its introduction in FY 2014 of an LNG-fueled turbine cogeneration system, thereby realizing energy conservation, the shaving of peak power demand, and a business continuation plan (BCP).

■ Chlorofluorocarbons (CFCs)In April 2015, the revised CFC Emissions Act came into force, making it mandatory for companies to inspect refrigeration and air-conditioning equipment and report leakage. Accordingly, Shionogi began listing applicable equipment, conducting simplified and periodic inspections, putting together records, and calculating the amount of leakage. In FY 2016, Shionogi’s calculated CFC leakage amounted to 803 tons-CO2. In the meantime, we are considering steps to switching to CFC-free or low-GWP equipment on the occasion of equipment renewal in anticipation of the enforcement of the Kigali amendment of the Montreal Protocol on Substances that Deplete the Ozone Layer.

■ Climate change risks and opportunitiesRising average atmospheric temperatures are expected to increase the number of infectious disease outbreaks, modify the distribution of organisms transmitting infectious diseases, and deteriorate the aquatic environment, seriously undermining social infrastructure and expanding the need for medicines for infectious diseases. This situation poses a risk to a pharmaceutical company if it fails to fulfill its social responsibility by offering necessary treatment drugs. It can also lead to an important business opportunity for a pharmaceutical company.In view of this, Shionogi is pursuing several policy measures to be able to provide necessary treatment medications, maintaining the production of its existing drugs for infectious diseases, promoting the research and development of drugs for new infectious diseases, including neglected tropical diseases (NTDs), tackling antimicrobial resistance (as a signatory of the Davos Declaration on Antibiotic Resistance), and contributing to and receiving benefits from the Global Health Innovative Technology (GHIT) Fund for the development of antibiotics.The growing frequency of natural disasters near the locales where Shionogi’s overseas suppliers are based poses the risk of infrastructural collapse, making it difficult to maintain manufacturing and supply systems. Considering the above situation, Shionogi has been making special efforts to construct and maintain a stability-assured supply system for pharmaceutical products by selecting the most suitable suppliers and securing several vendors based on careful selection.

17

4. Results

0

2,500

5,000

0

2,500

5,000

 4-2 Resource Conservation and Waste Treatment

■ Waste TreatmentAs part of its voluntary action plan to realize a reuse and recycling-oriented society, FPMAJ has adopted the goals of reducing the amount of industrial waste put to landfill in FY 2020 by 70% from the FY 2000 actual figure and reusing or recycling at least 55% of industrial waste in FY 2020. The Shionogi Group sets its numerical targets for FY 2020 to contribute to the achievement of these goals, considering the manufacturing situations at the operating sites and the progress of related measures.Waste materials generated within the Shionogi Group mainly include waste oils generated in the manufacturing processes, sludge from used water treatment, and plastics used as product containers. We are practicing the “3R” approach (reduce, reuse and recycle), trying to reduce the amount of waste by improving the manufacturing processes, recovering valuable parts from waste liquids, plastics and metals for reuse and recycling.At Shionogi, the recycling rate is obtained by the amount sold plus the amount reused/recycled divided by the amount of waste generated, and the landfill rate is defined as the amount put to landfill divided by the amount of waste generated.

2016(FY)2015201420132012

Sales/waste generatedWaste generated

Amount of waste generated and productivity (sales/amount generated)

4,564 4,275 3,509 3,944 3,820

62.067.8

78.1 78.6

88.7

2016(FY)2015201420132012

Recycling rateWaste reused/recycled

Amount of waste reused/recycled and recycling rate

4,671 4,177 3,129 3,436 3,929

77 7671 71

79

0

75

150

Waste oil63%Sludge

15%

Waste plastic8%

Paper6%

Other8%

2016(FY)2015201420132012

Landfill rateWaste put to landfill

Amount of waste put to landfill and landfill rate

124 77 89 123 65

2.01.4

2.02.5

1.3

Breakdown of waste generated (FY 2016 actual)

(tons)

(tons) (tons)

18

4. Results

■ Prevention of illegal dumpingTo prevent illegal dumping of industrial waste, Shionogi takes great care in selecting the business operators to whom we consign waste transportation, treatment or disposal. Our selection is based on evaluation of their business licenses, treatment/disposal facilities, operational conditions, document management status, implementation of emergency drills, and so forth, which are inspected using our contractor evaluation sheet. Once the operators are selected, we appropriately control contractual documents, licenses and manifests, and conduct at least one on-site inspection per year for each operator.

■ Reuse and recycling of product containers and packaging materialsIn compliance with the Containers and Packaging Recycling Act, a part of the containers and packaging materials used for the products sold by Shionogi are reused or recycled. At Shionogi, we are striving to reduce environmental impact by modifying container materials and packaging forms, while making sure to maintain and improve product quality.

■ In-house reuse/recycling of resourcesOrganic solvents used in pharmaceutical ingredient manufacturing at the Kanegasaki Plant, such as dichloromethane, ethyl acetate, and methanol, are collected in-house for reuse, thereby realizing a more effective use of resources and reducing waste.

Plastic

Paper

Glass (transparent)

Glass (brown)

Amount used

929

638

38

7

Amount consigned for reuse/recycling

197

17

8

2

Reuse/recycling contracting expense: 9,094,000 yen

FY 2016 results (tons)

19

4. Results

(FY)

0

1,000

2,000

0

1,000

2,000

 4-3 Water

It is said that 70% of the earth’s surface is covered with water. Nevertheless, water is a resource whose shortage is a great concern for the future since the portion of water that is usable is actually small due to the world’s population increase and other factors. To protect this precious resource, the Shionogi Group strives to reduce its consumption of both tap water and industrial water by accurately measuring the actual quantities used. For the quality of treated water released into the environment, the Group constantly monitors quality indicators for abnormality, maintaining voluntary control values that are much stricter than the legally and regulatory mandatory ones. In the facilities where antimicrobials are produced, antimicrobials contained in waste water are inactivated to the level that does not have any problems before being sent to in-house waste water treatment facilities. Upon the introduction of each new product, we confirm that its pharmaceutical ingredients contained in treated waste water do not have any impacts on the natural environment.

2016(FY)2015201420132012

Sewers Public waters

Drainage

499 474 433 348 335

1,185 1,098 1,021 985 998

20162015201420132012

Sales/water useWater use

Water consumption and productivityTesting the activity of an antibiotic

1,874 1,735 1,583 1,567 1,528

151167 173

198222

Before inactivation(inhibition circle formed)

After inactivation (inhibition circle not formed)

(1,000m3)

0

1,000

2,000

2016(FY)2015201420132012

Tap water Industrial water Underground water

Water consumption

412 376 332 303 289

1,453 1,351 1,251 1,264 1,239

88

1 0 0

(1,000m3)

(1,000m3)

20

4. Results

(FY)

(tons)

0

100

200

300

400

500

 4-4 Management of Chemical Substances

Numerous types of chemical substances are used in the research, development and manufacturing of pharmaceutical compounds. Some of them can adversely impact human health, ecosystems, and the global environment. For this reason, Shionogi makes sure to appropriately manage chemical substances in accordance with our voluntary management criteria that are stricter than those imposed by related laws and regulations. Needless to say, we rigorously control their release into the atmosphere and waterways.

■ PRTRIn compliance with the Pollutant Release and Transfer Register (PRTR) Act, under which it is mandatory to record, calculate, and publish chemical substances released into the environment, Shionogi submits relevant data to the authorities and manages the use, release, and transfer of volatile organic compounds (VOC). We intend to continue the appropriate management of such use, release, and transfer to reduce the impact that our operations have on the environment.

69,638

9,849

157,157

2,590

18,972

8,516

11,122

9,243

677

906

Atmosphere

3,396

241

59,404

0

130

0

26

224

0

0

Public waters

0

0

3

0

0

0

0

0

0

0

Soil

0

0

0

0

0

0

0

0

0

0

Outside operating sites

60,287

9,608

60,102

2,590

5

0

5,526

9,019

0

906

Sewers

0

0

0

0

0

0

0

0

0

0

Amount transferredAmount released

Acetonitrile

Chloroform

Dichloromethane (methylene chloride)

N,N-dimethylacetamide

N,N-dimethylformamide

Tributylamine

Pyridine

N-hexane

Benzene

Formaldehyde

Amount usedSubstance name

Substances to be registered under the PRTR Act (kg)

20162015201420132012

Amount used of Type 1 chemicals designated under the PRTR Act

Amount released Amount transferred

Type 1 chemicals designated under the PRTR Act

110

451

209

345

168

279

170

377

235

289

148

7450 61 63

21

(FY)

(tons)

0

1,000

2,000

■ PCBPolychlorinated biphenyls (PCBs), hard to degrade in the environment and easy to concentrate in the body of living organisms through the food chain, is a cause of great concern in terms of global-scale contamination. In the past, PCBs were used in many items such as condensers, transformers, and fluorescent light ballasts. Any materials containing PCBs, whether waste or currently in use, must be appropriately managed to contain their impact. At Shionogi, personnel in charge supervise the appropriate management of PCB-containing materials, while continuing their treatment and disposal according to a mid-term plan. The disposal of all PCB-containing material is expected to be completed by 2021.

■ AMRAMR stands for “antimicrobial resistance,” that is, resistance to antimicrobials (antibiotics and synthetic antimicrobials) and other antimicrobial agents.AMR is said to be principally caused by the inappropriate or excessive administration of antimicrobials. At the same time, release from manufacturing plants is also believed to be a major factor in the emergence of bacteria resistant to antimicrobials. Therefore, it is important and necessary to devise countermeasures from various aspects. Shionogi, engaged in the development, manufacture and sale of antimicrobials for many years, has always strictly controlled the release of antimicrobials into the environment. In September 2016, we signed the “AMR Industry Roadmap” with 12 global pharmaceutical companies at the World Economic Forum in Davos, to take the lead in preventing the release of antimicrobials into the environment.The signatory companies are expected to expand their commitment to release control throughout their supply chains, specify their control techniques in the form of a roadmap, and offer them to all antimicrobial manufacturers so that they will also join in this worldwide effort to combat AMR.

Davos Declaration on Antimicrobial Resistance:https://www.ifpma.org/wp-content/uploads/2016/09/Roadmap-for-Progress-on-AMR-FINAL.pdf

20162015201420132012

Amount of VOC used Release into the atmosphere

VOC use and release into the atmosphere

1,844

131

1,353

149

755

88

987

116

1,196

77

4. Results

22

4. Results

 4-5 Biodiversity

Following JPMA’s Basic Principles and Action Guidelines for Biodiversity announced in January 2012, the Shionogi Group began taking action so that its environmental activities would also serve to protect biodiversity. In concrete terms, we began adjusting the contents of employee education and conducted research in compliance with the Act Concerning the Conservation and Sustainable Use of Biological Diversity through Regulations on the Use of Living Modified Organisms (“Cartagena Act”) and the Invasive Alien Species Act.At Shionogi’s Aburahi Botanical Gardens, rare plants, including endangered species, are cultivated and protected, considering their adaptability to the environment of Shionogi’s operating sites. At the Botanical Gardens, We organize educational programs open to primary and middle school pupils and college students, with focus on the preservation and management of plants. Shionogi intends to continue these activities, supporting school education in the local communities with the use of the Botanical Gardens.

■ Safety assessment of chemical processesTo ensure that our chemical processes are safe and environment-friendly, Shionogi performs preliminary assessment of the safety of chemicals and the danger of reaction and incompatibility in the stages of developing manufacturing and testing methods for pharmaceutical compounds and candidate compounds and designing equipment. We also study highly efficient manufacturing processes that enable us to reduce waste and conserve energy. In FY 2016, we conducted the safety evaluation and education of 18 articles and 41 processes in total.Shionogi representatives regularly participate in the process safety study group’s events organized by JPMA. The events include lectures on danger in chemical processes and safety assessment, reports on cases, and factory visits. They enable Shionogi to collect useful information, which we make use to improve the safety of our chemical processes.

Workshop for primary school students

23

 4-6 Product Initiatives

In addition to Cymbalta capsules, Shionogi has also adopted biomass bottles (plant-derived polyethylene bottles) for Irbetan and Pirespa tablets. Biomass bottles are pharmaceutical packaging containers made of polyethylene derived from materials left over in sugarcane processing. By switching to biomass bottles from conventional ones made from petroleum-derived polyethylene, we can reduce CO2 emissions, while also conserving fossil fuel resources. Since sugarcane-derived polyethylene accounts for over 90% of the raw materials of our biomass bottles, they conform to the standards stipulated by the Japan BioPlastics Association for biomass plastic identification labeling (the product container bears the label, as shown in the photo).Moreover, we have also modified the packaging materials and volume to make the products more environment-friendly.

Biomass plastic identification labeling system

Biomass plastic products are those that contain organic (such as plant-derived) materials in excess of a specified percentage as their plastic component. The Japan BioPlastics Association certifies products that meet the criteria and permits them to bear the mark.

4. Results

Front view Side view

24

0

50

100

150

0

5

10

15

 4-7 Environmental Protection

■ Prevention of Air pollution, water and soil contaminationTo prevent air pollution, Shionogi strictly observes the regulatory values for NOx, SOx and particulate matter, while reducing SOx generation through boiler fuel conversion. To prevent contamination in sewers and rivers, We have adopted voluntary control values for pollutants far stricter than the legal and regulatory values and carry out permanent supervision with the use of TOC meters and oil content monitoring devices. At the Kanegasaki Plant, Aburahi Facilities, and Shionogi Pharma Chemicals, used water is treated and purified in dedicated facilities situated on the premises before it is released into nearby rivers.At the Kanegasaki Plant, which handles large quantities of chemicals, voluntary control values are applied to prevent soil contamination, and measurements are taken periodically. The measurements have always been well below the applicable environmental criteria.

2016(FY)2015201420132012

NOx(Nitrogen oxides)

SOx(Sulfur oxides)

Air pollutant (SOx and NOx) emissions

26

80

21

43

6

28

1

26

0

2016(FY)2015201420132012

BOD(Biochemical oxygen demand)

COD(Chemical oxygen demand)

Drainage load (BOD, COD)

13.7

4.0

11.5

3.9

8.0

3.7

8.4

3.8

7.2

1.8

143143

4. Results

(tons) (tons)

25

 4-8 Environmental Accounting

Shionogi has adopted environmental accounting, following the Environmental Accounting Guidelines of the Ministry of the Environment of Japan, to measure its environmental protection costs and benefits from related activities and to quantitatively manage initiatives for environmental protection. In FY 2016, our main investment items included the replacement of air-conditioning systems and lighting fixtures with higher-efficiency models, resulting in global warming control cost. The main cost items included a pollution prevention cost through the maintenance and management of exhaust gas and waste water treatment facilities and dichloromethane absorption and recovery equipment, and a resource circulation cost for waste treatment and disposal. The actual benefits included profit from the sale of waste liquids and metal scrap and a reduction in energy cost (for electricity and gas) realized by the revision of manufacturing and air-conditioning equipment.

Accounting scopeAccounting covers the period from April 1, 2016 through March 31, 2017, and Shionogi and domestic subsidiaries.Environmental protection costs were calculated by proportional distribution according to the percentages related to environmental protection.Economic benefits from environmental protection measures were calculated by taking into account only effects that can be calculated based on verifiable grounds (actual effects).

Environmental protection costs

Environmental protection benefit (actual positive effects)

Key activitiesInvestment(in 1,000 yen)

13,697 698,678

Cost (in 1,000 yen)Category

(1) Business area cost

0 9,094(2) Upstream/downstream cost

0 377,945

・ Maintenance and management of exhaust gas treatment equipment

・ Maintenance and management of waste water treatment facilities

・ Dichloromethane-processing equipment・ Measurement and analysis cost for the above

① Pollution prevention cost

0 222,715

・ Recycling and treatment of waste solvents・ Recycling and treatment of general waste materials・ Recycling and treatment of industrial waste・ Treatment and disposal of RI waste

Consignment of reuse of containers and packaging

0 190(6) Environmental remediation cost ・ Penalty imposed for pollutants

13,697 1,040,884Total

15,728Benefit Business income from recycling of waste

10,776Cost reduction Reduction in energy and water expenses

26,504Total

Amount of money (in 1,000 yen)Description

0 0(4) R&D cost

0 332,263(3) Administration cost・ Maintenance and operation of environment management systems

・ Development and maintenance of green zones

0 660(5) Social activity cost・ Contribution to environment organizations・ Communication with local communities

③ Resource circulation cost

13,697 98,017

・ Renewal of air-conditioning system, refrigerators, transformers, and lighting fixtures

・ Operational improvement of manufacturing and air-conditioning facilities

② Global environment protection cost

Breakdown

4. Results

26

 4-9 Occupational Health and Safety

Shionogi has a management system to ensure employees’ health and safety and create a comfortable workplace environment. Health and safety committee meetings are held, to devise measures for preventing occupational accidents and enhance workplace health and safety.

※ Frequency rate: Frequency of accidents, the number of employees killed or injured in occupational accidents per one million total working hours

※ Severity rate: Severity of accidents, the number of work days lost due to occupational accidents per one thousand total working hours

The numbers of accidents cited above are those of Shionogi & Co., Ltd. alone, excluding accidents during commuting.

FY

Occupational accidents

Those resulting in worktime loss

2014

23

5

2015

14

0

2016

17

5

(Cases)

FY

Frequency rate

Severity rate

2014

0.54

0.00

2015

0.00

0.00

2016

0.57

0.00

4. Results

27

 4-10 Health Management

In February 2017, Shionogi was selected for the 2017 list of the Health & Productivity Stocks and registered as one of the Companies with Excellent Health Management (White 500). The Health & Productivity Stocks are selected by the Ministry of Economy, Trade and Industry of Japan and the Tokyo Stock Exchange, to recognize TSE-listed companies for their leading employee health management initiatives undertaken from a strategic, managerial perspective. We were selected for the second consecutive years. In accordance with Shionogi’s corporate philosophy to “supply the best possible medicine to protect the health and well-being of the patients we serve,” Shionogi announced the Shionogi Health Declaration 2014. The Declaration expresses our commitment to enhancing and maintaining the good health of all of our employees and their families, implementing measures for health enhancement, and realizing a workplace environment in which all employees can fully demonstrate their abilities, all through concerted efforts by the Company, occupational health physicians, and the corporate health insurance association.

● Non-smoking companyIn 2009, the representatives of the Company, occupational health physicians, and the corporate health insurance association issued a statement expressing their intention to realize a smoke-free company. Accordingly, we are promoting to reduce the employee smoking rate to zero, taking actions such as limiting smoking zones and offering financial assistances by the health insurance association for the challenge of quitting smoking.

● Fitness eventsTo increase opportunities for physical activities, we organize walking events.

● Data use and collaboration for employee health enhancementThe Company and the health insurance association work together to enhance employees’ health, by sharing their health insurance claim data to detect early signs of ailments and prevent deterioration. The rate of participation in periodic physical checkup is 100%.

● Mental healthMeasures are put in place to realize a workplace environment that does not affect employee mental health. For example, educational and training programs are organized for employees including executives, counseling is available, legally recognized tests are conducted to check employees’ stress levels, and advice and supervision are addressed to employees working for many hours. Moreover, support is provided to employees on leave due to mental ill health to assist them in returning to work and reconciling therapy with work.

4. Results

28

(FY)

(FY)

■ Kuise Site

2012

10,502

0

0

0

0

0

0

1,091

115

2013

10,814

0

0

0

0

0

0

1,075

100

2014

10,239

0

0

0

0

0

0

970

100

2015

9,958

0

0

0

0

0

0

986

89

2016

10,359

0

0

0

0

0

0

1,006

81

Item

Electricity

Gasoline

Kerosene

Light oil

Heavy oil A

Propane gas (LPG)

Liquefied natural gas (LNG)

Town gas

Water

Unit

1,000 kWh

kL

kL

kL

kL

tons

tons

1,000 m3

1,000 m3

Energy and resource consumption

2012

5,589

208

0.6

105

0

1

0

1

2013

5,645

342

1.2

89

0

0

0

0

2014

5,238

237

0.2

77

0

0

0

0

2015

5,191

180

0.2

73

0

0

0

0

2016

5,354

192

0.0

57

0

0

0

0

Item

CO2 emissions

Waste generated

Waste put to landfill

Drainage (sewers)

Drainage (public waters)

NOx

SOx

BOD

COD

Unit

tons-CO2

tons

tons

1,000 m3

1,000 m3

tons

tons

tons

tons

Impact released (emissions)

8,810

Atmosphere

44

Public waters

0

Soil

0

Outside operating sites

8,765

Sewers

0

Amount transferredAmount released

Acetonitrile

Amount usedSubstance name

Substances to be registered under the PRTR Act (kg)

5. Site Report

29

(FY)

(FY)

■ Settsu Plant

2012

30,187

3

0

1

0

0

0

4,045

223

2013

26,606

2

0

0

0

0

0

3,784

224

2014

21,165

2

0

1

0

0

0

2,933

193

2015

20,864

1

0

1

0

0

0

3,036

173

2016

19,549

1

0

1

0

0

0

2,899

152

Item

Electricity

Gasoline

Kerosene

Light oil

Heavy oil A

Propane gas(LPG)

Liquefied natural gas(LNG)

Town gas

Water

Unit

1,000kWh

kL

kL

kL

kL

tons

tons

1,000 m3

1,000 m3

Energy and resource consumption

2012

18,113

688

0.6

156

0

3

0

3

3

2013

16,454

462

1.3

158

0

4

0

2

3

2014

12,919

373

1.3

190

0

2

0

3

3

2015

13,055

459

1.7

126

0

4

0

2

3

2016

12,356

390

1.0

108

0

3

0

1

1

Item

CO2 emissions

Waste generated

Waste put to landfill

Drainage (sewers)

Drainage (public waters)

NOx

SOx

BOD

COD

Unit

tons-CO2

tons

tons

1,000 m3

1,000 m3

tons

tons

tons

tons

Impact released (emissions)

2,067

Atmosphere

0

Public waters

0

Soil

0

Outside operating sites

2,067

Sewers

0

Amount transferredAmount released

Acetonitrile

Amount usedSubstance name

Substances to be registered under the PRTR Act (kg)

5. Site Report

30

(FY)

(FY)

■ Kanegasaki Plant

2012

38,002

6

0

2

10,733

14

0

0

1,063

2013

38,146

5

0

2

6,640

14

2,531

0

951

2014

28,232

0

0

0

989

14

6,361

0

906

2015

17,115

5

0

0

233

13

8,970

0

990

2016

14,900

5

0

0

325

14

8,530

0

938

Item

Electricity

Gasoline

Kerosene

Light oil

Heavy oil A

Propane gas(LPG)

Liquefied natural gas(LNG)

Town gas

Water

Unit

1,000 kWh

kL

kL

kL

kL

tons

tons

1,000 m3

1,000 m3

Energy and resource consumption

2012

42,062

2,720

95

0

958

134

25

3

2013

37,862

2,606

50

0

864

71

21

2

2014

29,512

1,920

53

0

807

37

6

2

2015

30,747

2,360

98

0

829

20

1

2

2016

29,055

2,261

43

0

818

18

0

3

Item

CO2 emissions

Waste generated

Waste put to landfill

Drainage (sewers)

Drainage (public waters)

NOx

SOx

BOD

COD

Unit

tons-CO2

tons

tons

1,000 m3

1,000 m3

tons

tons

tons

tons

Impact released (emissions)

1,070

18,972

40,488

155,256

8,516

11,122

677

Atmosphere

0

130

3,054

59,149

0

26

0

Public waters

0

0

0

3

0

0

0

Soil

0

0

0

0

0

0

0

Outside operating sites

1,070

5

31,479

58,455

0

5,526

0

Sewers

0

0

0

0

0

0

0

Amount transferredAmount released

N,N-dimethylacetamide

N,N-dimethylformamide

Acetonitrile

Dichloromethane (methylene chloride)

Tributylamine

Pyridine

Benzene

Amount usedSubstance name

Substances to be registered under the PRTR Act (kg)

5. Site Report

31

Pharmaceutical Research Center

(FY)

(FY)

■ Pharmaceutical Research Center

2012

27,152

0

0

0

3

0

0

3,126

200

2013

27,611

0

0

0

1

0

0

3,573

195

2014

27,577

0

0

0

2

0

0

2,670

149

2015

28,224

0

0

0

1

0

0

2,522

134

2016

28,647

0

0

0

3

0

0

2,625

157

Item

Electricity

Gasoline

Kerosene

Light oil

Heavy oil A

Propane gas(LPG)

Liquefied natural gas(LNG)

Town gas

Water

Unit

1,000 kWh

kL

kL

kL

kL

tons

tons

1,000 m3

1,000 m3

Energy and resource consumption

2012

15,142

476

16

200

0

2

6

2013

16,274

464

17

195

0

2

6

2014

14,243

451

16

149

0

2

3

2015

14,099

464

15

134

0

2

3

2016

14,464

466

16

157

0

2

3

Item

CO2 emissions

Waste generated

Waste put to landfill

Drainage (sewers)

Drainage (public waters)

NOx

SOx

BOD

COD

Unit

tons-CO2

tons

tons

1,000 m3

1,000 m3

tons

tons

tons

tons

Impact released (emissions)

13,496

8,836

1,902

9,243

906

Atmosphere

249

221

255

224

0

Public waters

0

0

0

0

0

Soil

0

0

0

0

0

Outside operating sites

13,247

8,615

1,647

9,019

906

Sewers

0

0

0

0

0

Amount transferredAmount released

Acetonitrile

Chloroform

Dichloromethane (methylene chloride)

N-hexane

Formaldehyde

Amount used

Substance name

Substances to be registered under the PRTR Act (kg)

5. Site Report

32

■ Aburahi Facilities

2012

2,611

3

7

0

616

3

0

0

38

2013

2,832

5

7

0

590

23

0

0

30

2014

2,941

5

7

0

32

326

0

0

25

2015

2,340

5

4

0

0

301

0

0

16

2016

2,485

5

1

0

0

327

0

0

15

Item

Electricity

Gasoline

Kerosene

Light oil

Heavy oil A

Propane gas(LPG)

Liquefied natural gas(LNG)

Town gas

Water

Unit

1,000kWh

kL

kL

kL

kL

tons

tons

1,000 m3

1,000 m3

Energy and resource consumption

Substances to be registered in compliance with the PRTR Act: None

2012

2,483

83

3

0

30

2

1

0

0

2013

2,543

43

2

0

29

1

0

0

0

2014

1,973

167

13

0

20

2

0

0

0

2015

1,626

43

2

0

12

2

0

0

0

2016

1,738

41

1

0

8

2

0

0

0

Item

CO2 emissions

Waste generated

Waste put to landfill

Drainage (sewers)

Drainage (public waters)

NOx

SOx

BOD

COD

Unit

tons-CO2

tons

tons

1,000 m3

1,000 m3

tons

tons

tons

tons

Impact released (emissions)

(FY)

(FY)

5. Site Report

33

■ Shionogi Pharma Chemicals Co., Ltd.

2012

2,037

0

0

0

101

0

0

114

197

2013

3,214

0

0

0

32

0

0

260

204

2014

2,895

0

0

0

14

0

0

254

194

2015

3,811

0

0

0

0

0

0

359

150

2016

4,455

0

0

0

0

0

0

366

172

Item

Electricity

Gasoline

Kerosene

Light oil

Heavy oil A

Propane gas(LPG)

Liquefied natural gas(LNG)

Town gas

Water

Unit

1,000 kWh

kL

kL

kL

kL

tons

tons

1,000 m3

1,000 m3

Energy and resource consumption

2012

1,197

92

0.0

0

197

0

1

1

1

2013

1,732

152

0.3

0

204

0

0

1

1

2014

1,566

203

0.0

0

194

0

0

0

0

2015

2,067

261

0.6

0

145

1

1

2016

2,292

313

1.2

0

172

1

0

Item

CO2 emissions

Waste generated

Waste put to landfill

Drainage (sewers)

Drainage (public waters)

NOx

SOx

BOD

COD

Unit

tons-CO2

tons

tons

1,000 m3

1,000 m3

tons

tons

tons

tons

Impact released (emissions)

1,520

4,777

1,013

Atmosphere

0

48

20

Public waters

0

0

0

Soil

0

0

0

Outside operating sites

1,520

4,729

993

Sewers

0

0

0

Amount transferredAmount released

N,N-dimethylacetamide

Acetonitrile

Chloroform

Amount usedSubstance name

Substances to be registered under the PRTR Act (kg)

(FY)

(FY)

5. Site Report

34

(FY)

(FY)

■ C&O Pharmaceutical Technology (Holdings) Ltd. Nanjing Plant

2012

4,455

1,585

141

2013

3,900

1,574

161

2014

8,017

242

449

201

2015

7,044

0

302

180

2016

9,004

0

534

236

Item

Electricity

Coal

Propane gas (LPG)

Water

Unit

1,000 kWh

tons

tons

1,000 m3

Energy and resource consumption

2012

7,213

491

0

2013

6,748

288

0

2014

8,243

76

0

2015

6,470

53

11

63

0

2016

10,012

153

19

74

0

Item

CO2 emissions

Waste generated

Waste put to landfill

Drainage (sewers)

Drainage (public waters)

Unit

tons-CO2

tons

tons

1,000 m3

1,000 m3

Impact released (emissions)

5. Site Report

35

To improve the reliability and transparency of the disclosure of our EHS activities, we asked experts from the Institute for Environmental Management Accounting (IEMA) to assess the Shionogi Group’s EHS consideration and management status and advise us on our future activities.This year, the experts visited with us at the Head Office and the Kuise Site, to interview the management team and verify the EHS data.

EHS経営評価意見書EHS Management Assessment

(L-R) Yoshiaki Kamoya, Senior Executive Officer, Shionogi; Prof. Katsuhiko Kokubu and Ms. Eriko Nashioka, of IEMA; and Mikio Kabaki, head of Shionogi’s EHS Office

Audit at the Kuise Site

36

2.EHSマネジメントEHS Management Assessment

EHS Management Assessment

An outline of the objectives and executed actionsAs a third party unrelated to the business operation of Shionogi & Co., Ltd., we have assessed the company’s management activities with a focus on the environment, health, and safety (“EHS activities”) as described in the EHS Report 2017 compiled by the company. We present our views to improve the reliability of the report.To find out how Shionogi’s EHS activities are planned and implemented, and how the performance data resulting from the activities and constituting the basis of the disclosed information are compiled, evaluated and used, we visited the company’s divisions, interviewing personnel, including Mr. Yoshiaki Kamoya (Senior Executive Officer in charge of EHS affairs), inspected related documents, and asked questions to personnel in charge. At the Kuise Site, we verified that the operations had been conducted in accordance with the designated systems, with regard to the source documents of the disclosed numerical data.

AssessmentShionogi & Co., Ltd. established the EHS Office in April 2016. While EHS is a traditional term, the pharmaceutical industry attaches importance to EHS as a broad notion inclulding CSR. Shionogi has decided to publish an EHS report separately from its integrated report, to present the former as a data book providing detailed information on the company’s environmental, health and safety initiatives not covered in the integrated report. This “double disclosure,” that is, publishing the integrated report to present the company’s overall policy and the EHS report to disclose information on concrete activities, demonstrates Shionogi’s sufficient and expansive information disclosure.At present, the data contained in the EHS report is mainly related to the environment. Provision of more information on health and safety is expected in the future. Given Shionogi’s social recognition for its health-related activities, as attested by its selection on the Health & Productivity Stocks list, Shionogi should set an example for other companies in terms of information disclosure in this area. In the integrated report, considerable space is given to sustainable development goals (SDGs), and Shionogi expresses its intention to focus on “Goal 3. Health and well-being for all.” Since this is an extremely significant point in the company’s overall CSR activities, we suggest that Shionogi disclose more detailed information on this theme in a future EHS report.Society’s interest has shifted from CSR data to corporate strategies for CSR activities and effects. To have EHS report positioned from this stand point will make the EHS report an important tool more effective to CSR management.The calculated environmental performance data were found to have no major errors, within the range covered by our basic verification.

< The Kuise Site >The reorganization of the Shionogi Group was completed, and the Kuise Site was positioned as a CMC research center (relating to drug manufacturing methods, etc.). The Kuise Site used to be Shionogi’s oldest plant, but it now manufactures only some of our compounds. For this reason, large numbers of chemicals have been used as a research center and the strict management system is indispensable. The employees’ environmental awareness is high because the Site was initially a plant. Good management conditions of drainage and disposal have been maintained since the time when it was a manufacturing site. We have confirmed its appropriate management that matches the Site’s current situation. While the Shionogi Group’s overall EHS action goals are still considered at the moment, the Site has had its own goals, including those concerning health and safety, for more than 10 years, and has carried out activities in the PDCA process. We have also observed that the Site’s activities quickly reflect various aspects of social trends. We expect the Site to continue its activities to lead the overall Group.

October 20, 2017Institute for Environmental Management Accounting (IEMA)

Katsuhiko Kokubu (Professor, Kobe University Graduate School/Director of IEMA)Eriko Nashioka (Representative Director/certified public accountant, licensed tax accountant)

37

Published by EHS Office, Shionogi & Co., Ltd.In October 2017