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EHS Report 2017

EHS:Environment, Health and Safety

Shionogi & Co., Ltd.


Editorial Policy

■ 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 (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.

■ Organizations
The 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.

Company Operating sites

Shionogi & Co., Ltd. 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)
Shionogi Administration Service Co., Ltd. (Osaka Prefecture)
Aburahi AgroResearch Co., Ltd.* (Shiga Prefecture)
C&O Pharmaceutical Technology (Holdings) Limited (Nanjing Plant, China)

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

■ Numerical data and graphs


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

■ Disclosure media
Shionogi’ 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).

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EHS Policy

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

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Contents

1. Shionogi and EHS ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 5

2. EHS Management ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 7

2-1 EHS Management System ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 7

2-2 Management Systems ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 8

2-3 EHS Audits ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 8

2-4 Initiatives Covering the Supply Chain ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 9

2-5 Compliance with EHS-related Laws and Regulations ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 9

2-6 EHS Education ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・10

2-7 Emergency Preparedness ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・10

2-8 Local Community Service ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・11

3. EHS Action Targets ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・12

4. Results ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・14

4-1 Energy Conservation and Global Warming Control ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・14

4-2 Resource Conservation and Waste Treatment ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・18

4-3 Water ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・20

4-4 Management of Chemical Substances ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・21

4-5 Biodiversity ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・23

4-6 Product Initiatives ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・24

4-7 Environmental Protection ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・25

4-8 Environmental Accounting ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・26

4-9 Occupational Health and Safety ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・27

4 -10 Health Management ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・28

5. Site Report ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・29

EHS Management Assessment ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・36

4
1. Shionogi and EHS

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.

EHS from procurement to disposal

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)

Research and Use and


Procurement CMC Manufacturing Distribution Sales
Development Disposal

Green purchase Development of Provision of environment Reuse and recycling of


environmentally and safety data containers and
CSR procurement
responsible products packaging materials
Code of conduct
Preliminary EHS Adequate disposal
guidelines for suppliers
assessment
Obtainment of
Process safety Low-emission vehicles,
environment and safety
data Chemical hazard prevention of road
control accidents

EHS data collection Guarantee of safety to


local communities
Prevention of dispersal of
chemical hazards, alien species, Assessment of whole
and genetically modified effluent(environmental
organisms impact)

Radio isotope control

Biohazard control CMC:Chemistry, Manufacturing and Control


This concept encompasses research into active pharmaceutical ingredient(API)processes,
Environmental impact assessment drug manufacturing and development, and quality assessment, including the development of
of pharmaceutical compounds pharmaceutical formulation, research on manufacturing methods, the installation of quality
standards, and the development of testing methods.

5
1. Shionogi and EHS

■ Shionogi and the Environment

Energy Water
Total energy GJ 1,656,508 Tap water 1,000 m3 289
Electricity MWh 87,127 Industrial water 1,000 m3 1,239
Town gas 1,000 m3 6,978
Propane gas (LPG) tons 341 Chemicals
Liquefied natural gas (LNG) tons 8,530
PRTR-designated chemicals tons 289
Heavy oil kL 328
Kerosene kL 1
Light oil kL 2 Containers and packaging materials
Gasoline kL 11 Quantity used tons 1,612
Gasoline (for sales vehicles) kL 1,801

INPUT

Research and Development Manufacturing Administration and Sales

Research on Administrative duties


Basic research and MRs’activities
Hospitals
manufacturing
and new drug
methods
exploration

API
manufacturing
Pre-clinical
tests

Drug product(DP)
manufacturing

Clinical tests
Pharmacies
Packaging

New drug
application Inspection

OUTPUT

Atmosphere Waste materials


CO(Scope1
2 used as fuel) tons-CO2 40,678 Generated tons 3,820
CO(Scope1used
2 for sales vehicles) tons-CO2 4,183 Released tons 4,966
CO(Scope2)
2 tons-CO2 27,086 Reused/recycled tons 3,929
NO(nitrogen
X oxides) tons 26 Waste put to landfill tons 65
SO(sulfur
X oxides) tons 0 PRTR-designated chemicals tons 148
Particulate matter tons 2
PRTR-designated chemicals tons 63 Containers and packaging materials
VOC tons 77 Consigned for reuse/recycling tons 224
CFC(Chloro Fluoro Carbon) tons-CO2 803

Waters
Sewers 1,000 m3 335
Public waters 1,000 m3 998
BOD(biochemical oxygen demand) tons 7
COD(chemical oxygen demand) tons 2
PRTR-designated chemicals tons 0
N(nitrogen) tons 8
P(phosphorus) tons 4

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2. EHS Management

 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

Plants

Laboratories
Environment committee
Offices
Health and safety committee
Sales offices

Group companies

7
2. EHS Management

 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.

Scope of ISO14001-certified Sites and Operating Divisions


Shionogi & Co., Ltd. ●
Shionogi Analysis Center Co., Ltd.
Kuise Site, Settsu Plant, Kanegasaki Plant, (located within Settsu Plant)
Shionogi Pharmaceutical Research Center ●
Shionogi Pharma Chemicals Co., Ltd.

 2-3 EHS Audits

■ External audits
In 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 audits
The 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 audits
Separately 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.

8
2. EHS Management

 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 *PSCI: An NPO established in 2006 in the United States for
the purpose of promoting CSR purchase and procurement in
the manner in which we work, to realize CSR-conscious
the pharmaceutical industry, with 24 corporate members,
purchase and procurement in conformity with global standards, mainly Western pharmaceutical giants (as of the end of May
that is, purchase and procurement that respect high standards 2017)
in EHS, ethical conduct, labor practice, and so forth.

■ Green purchase
To 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.

 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.

Number of incidents of excess emissions Number of complaints relating


(emissions exceeding legal restrictions) (Cases) to the environment (Cases)

FY 2012 2013 2014 2015 2016 FY 2012 2013 2014 2015 2016

Shionogi 2 0 0 0 0 Shionogi 2 0 1 1 1

Group companies 0 0 0 0 0 Group companies 0 0 0 0 0

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2. EHS Management

 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.

Training for internal environmental auditor qualification

 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.

10
2. EHS Management

 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

11
3. EHS 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)
Phase 5 of the Shionogi Group Environmental
FY 2016 Environmental Action Targets
Protection Plan Targets
1. Promote energy conservation and global warming control CO2 emissions: reduced by 27% (70,070 tons-CO2)
measures. Specific energy efficiencies: Improved by 0.9% (from FY 2015)
・Reduce CO 2 emissions in FY 2020 by 33% from the FY 2005 benchmark (by ・ Renew high-voltage power distribution equipment. (Kuise Site)
40% in FY 2030). ・ Convert outdoor lamps and lighting to LED; switch to a high-efficiency AC
・Improve specific energy efficiencies by an annual average of 1%. system; discontinue transformers and control panels; improve the efficiency of
・Promote the introduction of highly energy-efficient equipment. 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)

2. Strengthen resource conservation and waste Amount of waste generated: reduced by 41% (3,945 tons)
treatment/disposal measures. Percentage of waste reused or recycled: 78%
・Reduce the amount of waste generated by 55% from the FY 2000 benchmark. ・Promote waste reduction by all divisions; consign reusable/recyclable waste to
・ Improve the percentage of waste reused or recycled to 73% or larger, and reduce service providers. (Kuise Site)
waste put to landfill. ・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 low-concentration PCB-containing waste according to
schedule. (Settsu and Kanegasaki Plants)
・Appropriately treat and dispose of the entirety of PCB-containing waste
・ Appropriately manage PCB-containing waste.
materials. (FY2022)
・ Appropriately manage CFC-using equipment. ・ Appropriately manage CFC-using equipment (inspection, leakage data recording).

4. Develop the management systems for the environment. ・ Hold information meetings on ISO14001:2015; hold educational and
awareness-raising programs for divisions; revise documents.
・Promote continued improvement in response to ISO14001:2015.
・Improve employees’understanding of the management systems for the
environment; raise employees’environmental awareness.

5. Protect a sound aquatic environment. ・ Confirm the appropriateness of drainage methods for new chemicals; raise
water-saving consciousness, and control tap and industrial water consumption.
・Depollute or decontaminate used water and return it to rivers.
(Settsu Plant)
・ Appropriately manage effluent treatment facilities; continue the water-saving
consciousness raising campaign.

6. Contribute to biodiversity preservation. ・ Preserve and manage rare plants, including endangered species, at Aburahi
Botanical Gardens; introduce rare plants growing in and around Aburahi to the
・Maintain and promote effective use of the Botanical Gardens.
Botanical Gardens to preserve seeds; turn the preservation and management
・Raise employees’awareness.
of plant species into educational opportunities. (Aburahi Facilities)
・ Appropriately manage gene recombination experiments; conduct educational
programs.

12
3. EHS Action Targets

Results from FY 2016 Environmental Action Targets FY 2017 Environmental Action Targets

CO2 emissions: reduced by 29% (67,764 tons-CO2) CO2 emissions: reduced by 29% (68,178 tons-CO2 )
Specific energy efficiencies: improved by 4.7% (from FY 2015) Specific energy efficiencies: improved by 1.9% (from FY 2015)
・High-voltage power distribution equipment was renewed. (Kuise Site) ・Switch to high-efficiency refrigeration equipment. (Kuise Site)
・Outdoor lamps and lighting were converted to LED; a switch was made to a ・Convert lighting to LED; switch to a high-efficiency AC system; improve the
high-efficiency AC system; transformers and control panels were discontinued; the operational efficiency by the number of boilers used; discontinue
efficiency of refrigerator operation control was improved; process efficiency was air-conditioning periodically by adjusting output. (Settsu Plant)
improved by introducing heat recovery equipment. (Settsu Plant) ・Improve efficiency on the occasion of air-conditioning equipment renewal;
・Motor efficiency was improved to the IE3 level (premium) in the basic equipment renew ventilation and air-conditioning motors; improve pump motor efficiency
building; a switch was made to a high-efficiency AC system. (Kanegasaki Plant) to the IE3 level. (Kanegasaki Plant)
・Air-conditioning was discontinued at night and on holidays where possible. (SPRC) ・Renew power receiving/distribution equipment; discontinue air-conditioning at
・Hot water pump operation was discontinued at night; the discontinuation of waste night and on holidays. (SPRC)
water treatment station raw water pump operation was sustained; the lighting in the ・Discontinue hot water pump operation at night; continue the discontinuation of
cafeteria building was converted to LED. (Aburahi Facilities) waste water treatment station raw water pump operation. (Aburahi Facilities)

Amount of waste generated: reduced by 43% (3,820 tons) Amount of waste generated: reduced by 49% (3,427 tons)
Percentage of waste reused or recycled: 79% Percentage of waste reused or recycled: 77%
・Waste reduction was promoted at all divisions. (Kuise Site) ・Maintain stable operation to reduce temporary waste (equipment stoppage,
・Stable operation led to less temporary waste (equipment stoppage, deviation, etc.); deviation, etc.). (Settsu Plant)
process review led to less waste; the treatment method was changed for liquid ・Recover usable materials from waste; reduce liquid waste; promote recovery of
waste resulting from equipment cleansing, improving the rate of reuse/recycling. usable materials by sorting out waste plastics. (Kanegasaki Plant)
(Settsu Plant) ・Promote reuse and recycling of waste materials generated in new processes
・Recovery of usable materials from waste was promoted; liquid waste was reduced; (Kanegasaki Plant)
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)

・Low-concentration PCB-containing waste was appropriately treated according to ・ Appropriately treat and dispose of PCB-containing waste according to schedule.
schedule. (Settsu and Kanegasaki Plants) ・ Execute appropriate management all the way to the completion of
・PCB-containing waste was appropriately managed through locking, anti-leakage treatment/disposal.
measures, reporting, etc. ・ Appropriately manage CFC-using equipment (inspection, leakage data recording).
・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 ・Receive inspection for transition to ISO14001: 2015 to continue certification.
charge of environmental affairs, and personnel in charge of execution and promotion. ・Improve environmental awareness in accordance with the revised requirements.
・Response to the revision was made by revising or producing documents, such as ・Promote improvement activities closely related to actual operations.
tables of risks at operating sites, division-wise skill management tables, and reports (Kanegasaki Plant)
on the assessment of compliance with legal and other requirements.

・Regarding liquid waste resulting from washing equipment for new products, the ・ Monitor drainage of new chemicals. (Settsu Plant)
volume to be disposed of, disposal sites, and drainage were examined, and action ・ Consider vacuum pump water sealing and reduction of water used for
was taken in accordance with standards set to prevent water contamination by
cleansing. (Kanegasaki Plant)
drainage. (Settsu Plant)
・The control method was switched from batch-based to level-based for the storage ・ Continue efforts for dosage control and water conservation.
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.

・Rare plants, including endangered species, were preserved and managed at ・ Preserve and manage rare plants, including endangered species, at Aburahi
Aburahi Botanical Gardens. Botanical Gardens.
・Aquatic plants, rare plants growing in and around Aburahi, were collected and ・ Introduce rare plants growing in and around Aburahi to the Botanical Gardens to
introduced to the Botanical Gardens for cultivation. preserve seeds; select plants suited to the natural environment in Aburahi for
・Programs were held at Aburahi Botanical Gardens, featuring interactions with cultivation.
primary and middle school pupils and college students. (Aburahi Facilities) ・ Turn the preservation and management of plant species into educational
・Gene recombination experiments were appropriately conducted, as were opportunities for the local communities.
educational programs. (SPRC, Aburahi Facilities) ・ Exchange information with related organizations to continue initiatives for
・Educational programs on biodiversity were conducted, raising employees’ biodiversity preservation. (Aburahi Facilities)
awareness. ・ Appropriately manage gene recombination experiments; conduct educational
programs. (SPRC, Aburahi Facilities)
・ Provide information and educational opportunities to raise awareness of biodiversity.

13
4. Results

 4-1 Energy Conservation and Global Warming Control

■ CO2 Emissions
The 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.

CO2 emissions and productivity CO2 emissions by scope


(sales/CO2 emissions)

CO2 emissions Productivity Scope 2: Indirect emissions from


energy sources
Scope 1: Direct emissions
(tons-CO2) (tons-CO2)
(fuel-derived only)
100,000 50.0 100,000

44.7
40.2

34.5
31.7 38,432 37,337

31,586 27,851 27,086


50,000 50,000

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

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

0 0
2012 2013 2014 2015 2016(FY) 2012 2013 2014 2015 2016(FY)

14
4. Results

■ Energy Consumption

Consumption by energy type Total energy and productivity


(Sales/total energy)
Electricity    Town gas     LNG
LPG     Heavy oil A    Light oil Total energy Sales/total energy
(GJ) (GJ)
2,500,000 Kerosene     Gasoline 2,500,000
20.5
18.3
16.2
14.7
14.0

1,250,000 1,250,000

2,024,176 1,971,469 1,693,485 1,697,382 1,656,508

0 0
2012 2013 2014 2015 2016(FY) 2012 2013 2014 2015 2016(FY)

■ Vehicles for sales activities


To 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.

Fuel consumed by vehicles for sales activity and CO2 emissions

Fuel consumption CO 2 emissions


(kL) (tons-CO2)
3,000 6,000

5,778
5,304 5,317

4,716
2,000 4,000
4,183

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


1,000 2,000

0 0
2012 2013 2014 2015 2016(FY)

15
4. Results

■ 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.

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

Distribution and delivery


Purchased goods and Shionogi (upstream)
services  -Plant to warehouse 201
145,475 Energy-derived
 -Warehouse storage 351
indirect emissions
 -Warehouse to wholesalers 313
Electricity consumption
26,456

Capital goods Direct emissions Waste generated in operations


98,022 Fuel used 39,970 4,110
¥ Vehicles for
sales activities 4,183

Fuel and energy-related Business travel


activities not included in 521 Disposal of sold products
Scope 1 or 2 Employee commuting 850
3,015 819

Scope1:Direct emissions from the company’s fuel use and industrial processes
Scope2:Indirect emissions from the consumption of electricity and thermal energy purchased by the company
Scope3:Indirect emissions from the supply chain other than Scope 1 or 2

(Shionogi alone) (Unit: ton-CO2)

Category FY 2014 results FY 2015 results FY 2016 results Calculation basis

      Fuel used 36,213 40,960 39,970 Amount of fuel used as defined under the Energy
Scope1 Direct emissions Conservation Act
Vehicles for sales activities 5,317 4,716 4,183 Fuel used for vehicles for sales activities

Amount of electricity purchased as defined under


Scope2 Energy-derived indirect emissions 30,966 27,246 26,456
the Energy Conservation Act

Purchased goods and services 146,941 147,108 145,475 Purchase price of raw materials and products purchased

Acquisition price of fixed assets newly acquired in


Capital goods 21,948 52,945 98,022
the year

Fuel and energy-related activities


3,487 3,093 3,015 Amount of electricity purchased
not included in Scope 1 or 2

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

 -Plant to warehouse 225 240 201  -Plant to warehouse


Scope3
 -Warehouse storage 349 333 351  -Warehouse storage

 -Warehouse to wholesalers 273 246 313 -Warehouse to wholesalers

Waste generated in operations 3,680 4,305 4,110 Weight of waste materials classified by type

Business travel 745 562 521 Number of employees

Travel expenses calculated for each means of


Employee commuting 1,421 1,473 819 transportation(calculated based on the number of
employees until FY 2015)

Disposal of sold products 889 924 850 Amount used by type as classified under the
Containers and Packaging Recycling Act

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.

16
4. Results

■ Accolades
Ranked“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 opportunities


Rising 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

 4-2 Resource Conservation and Waste Treatment

■ Waste Treatment
As 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.

Amount of waste generated and productivity Amount of waste reused/


(sales/amount generated) recycled and recycling rate

Waste generated Sales/waste generated Waste reused/recycled Recycling rate


(tons) (tons)
5,000 5,000
88.7

78.1 78.6 77 79
76
71 71
67.8
62.0

2,500 2,500

4,564 4,275 3,509 3,944 3,820 4,671 4,177 3,129 3,436 3,929

0 0
2012 2013 2014 2015 2016(FY) 2012 2013 2014 2015 2016(FY)

Amount of waste put to landfill Breakdown of waste generated


and landfill rate (FY 2016 actual)
(tons)
150
Waste put to landfill Landfill rate Other
Paper 8%
2.5
6%
2.0 2.0
1.4 1.3
Waste plastic
8%

75
Waste oil
Sludge 63%
15%
124 77 89 123 65

0
2012 2013 2014 2015 2016(FY)

18
4. Results

■ Prevention of illegal dumping


To 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 materials


In 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.

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


FY 2016 results (tons)

Amount consigned for


Amount used
reuse/recycling

Plastic 929 197

Paper 638 17

Glass (transparent) 38 8

Glass (brown) 7 2

■ In-house reuse/recycling of resources


Organic 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.

19
4. Results

 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.

Testing the activity of an antibiotic Water consumption and productivity

Water use Sales/water use


(1,000 m3)
2,000

222
198

167 173
151
1,000

Before inactivation After inactivation


(inhibition circle formed) (inhibition circle not formed)
1,874 1,735 1,583 1,567 1,528

0
2012 2013 2014 2015 2016(FY)

Water consumption Drainage

Tap water Industrial water Underground water Sewers Public waters

(1,000 m3) (1,000 m3)


2,000 2,000
8
8
1 0 0

1,000 1,453 1,351 1,251 1,264 1,239 1,000 1,185 1,098 1,021 985 998

412 376 332 303 289 499 474 433 348 335

0 0
2012 2013 2014 2015 2016(FY) 2012 2013 2014 2015 2016(FY)

20
4. Results

 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.

■ PRTR
In 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.

Type 1 chemicals designated under the PRTR Act

(tons) Amount used of Type 1 chemicals designated under the PRTR Act
500 Amount released Amount transferred
451

400 377
345

300 279 289

235
209
200
168 170
148
110
100 74 61 63
50

0
2012 2013 2014 2015 2016 (FY)

Substances to be registered under the PRTR Act (kg)

Amount released Amount transferred


Substance name Amount used
Atmosphere Public waters Soil Outside operating sites Sewers

Acetonitrile 69,638 3,396 0 0 60,287 0

Chloroform 9,849 241 0 0 9,608 0

Dichloromethane (methylene chloride) 157,157 59,404 3 0 60,102 0

N,N-dimethylacetamide 2,590 0 0 0 2,590 0

N,N-dimethylformamide 18,972 130 0 0 5 0

Tributylamine 8,516 0 0 0 0 0

Pyridine 11,122 26 0 0 5,526 0

N-hexane 9,243 224 0 0 9,019 0

Benzene 677 0 0 0 0 0

Formaldehyde 906 0 0 0 906 0

21
4. Results

VOC use and release into the atmosphere

(tons)
2,000 Amount of VOC used Release into the atmosphere
1,844

1,353
1,196

987
1,000

755

131 149 116


88 77
0
2012 2013 2014 2015 2016 (FY)

■ PCB
Polychlorinated 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.

■ AMR
AMR 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

22
4. Results

■ Safety assessment of chemical processes


To 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.

 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.

Workshop for primary school students

23
4. Results

 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 Front view Side view
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.

24
4. Results

 4-7 Environmental Protection

■ Prevention of Air pollution, water and soil contamination


To 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.

Air pollutant (SOx and NOx) emissions Drainage load (BOD, COD)

(tons) (tons)
NOx(Nitrogen oxides) BOD(Biochemical oxygen demand)
150 143 15
SOx(Sulfur oxides) 13.7 COD(Chemical oxygen demand)

11.5

100 10

80 8.4
8.0
7.2

50 43 5
4.0 3.9 3.7 3.8
26 28 26
21 1.8
6
1 0
0 0
2012 2013 2014 2015 2016(FY) 2012 2013 2014 2015 2016(FY)

25
4. Results

 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 scope
Accounting 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


Investment Cost
Category Key activities
(in 1,000 yen) (in 1,000 yen)

(1) Business area cost 13,697 698,678

・ Maintenance and management of exhaust gas


Breakdown treatment equipment
・ Maintenance and management of waste water
① Pollution prevention cost 0 377,945
treatment facilities
・ Dichloromethane-processing equipment
・ Measurement and analysis cost for the above

・ Renewal of air-conditioning system, refrigerators,


② Global environment transformers, and lighting fixtures
13,697 98,017
protection cost ・ Operational improvement of manufacturing and
air-conditioning facilities

・ Recycling and treatment of waste solvents


・ Recycling and treatment of general waste materials
③ Resource circulation cost 0 222,715
・ Recycling and treatment of industrial waste
・ Treatment and disposal of RI waste

(2) Upstream/downstream cost Consignment of reuse of containers and packaging 0 9,094

・ Maintenance and operation of environment


(3) Administration cost management systems 0 332,263
・ Development and maintenance of green zones

(4) R&D cost 0 0

・ Contribution to environment organizations


(5) Social activity cost 0 660
・ Communication with local communities

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

Total 13,697 1,040,884

Environmental protection benefit (actual positive effects)


Description Amount of money (in 1,000 yen)

Benefit Business income from recycling of waste 15,728

Cost reduction Reduction in energy and water expenses 10,776

Total 26,504

26
4. Results

 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.
(Cases)

FY 2014 2015 2016


Occupational accidents 23 14 17
Those resulting in worktime loss 5 0 5

FY 2014 2015 2016


Frequency rate 0.54 0.00 0.57
Severity rate 0.00 0.00 0.00

※ 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.

27
4. Results

 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 company
In 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 events
To increase opportunities for physical activities, we organize walking events.

● Data use and collaboration for employee health enhancement


The 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 health
Measures 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.

28
5. Site Report

■ Kuise Site

Energy and resource consumption (FY)

Item Unit 2012 2013 2014 2015 2016


Electricity 1,000 kWh 10,502 10,814 10,239 9,958 10,359
Gasoline kL 0 0 0 0 0
Kerosene kL 0 0 0 0 0
Light oil kL 0 0 0 0 0
Heavy oil A kL 0 0 0 0 0
Propane gas (LPG) tons 0 0 0 0 0
Liquefied natural gas (LNG) tons 0 0 0 0 0
Town gas 1,000 m 3
1,091 1,075 970 986 1,006
Water 1,000 m 3
115 100 100 89 81

Impact released (emissions) (FY)

Item Unit 2012 2013 2014 2015 2016


CO2 emissions tons-CO2 5,589 5,645 5,238 5,191 5,354
Waste generated tons 208 342 237 180 192
Waste put to landfill tons 0.6 1.2 0.2 0.2 0.0
Drainage (sewers) 1,000 m3 105 89 77 73 57
Drainage (public waters) 1,000 m3 0 0 0 0 0
NOx tons 1 0 0 0 0
SOx tons 0 0 0 0 0
BOD tons 1 0 0 0 0
COD tons − − − − −

Substances to be registered under the PRTR Act (kg)

Amount Amount released Amount transferred


Substance name
used Atmosphere Public waters Soil Outside operating sites Sewers
Acetonitrile 8,810 44 0 0 8,765 0

29
5. Site Report

■ Settsu Plant

Energy and resource consumption (FY)

Item Unit 2012 2013 2014 2015 2016


Electricity 1,000 kWh 30,187 26,606 21,165 20,864 19,549
Gasoline kL 3 2 2 1 1
Kerosene kL 0 0 0 0 0
Light oil kL 1 0 1 1 1
Heavy oil A kL 0 0 0 0 0
Propane gas(LPG) tons 0 0 0 0 0
Liquefied natural gas(LNG) tons 0 0 0 0 0
Town gas 1,000 m 3
4,045 3,784 2,933 3,036 2,899
Water 1,000 m 3
223 224 193 173 152

Impact released (emissions) (FY)

Item Unit 2012 2013 2014 2015 2016


CO2 emissions tons-CO2 18,113 16,454 12,919 13,055 12,356
Waste generated tons 688 462 373 459 390
Waste put to landfill tons 0.6 1.3 1.3 1.7 1.0
Drainage (sewers) 1,000 m 3
156 158 190 126 108
Drainage (public waters) 1,000 m3 0 0 0 0 0
NOx tons 3 4 2 4 3
SOx tons 0 0 0 0 0
BOD tons 3 2 3 2 1
COD tons 3 3 3 3 1

Substances to be registered under the PRTR Act (kg)

Amount Amount released Amount transferred


Substance name
used Atmosphere Public waters Soil Outside operating sites Sewers
Acetonitrile 2,067 0 0 0 2,067 0

30
5. Site Report

■ Kanegasaki Plant

Energy and resource consumption (FY)

Item Unit 2012 2013 2014 2015 2016


Electricity 1,000 kWh 38,002 38,146 28,232 17,115 14,900
Gasoline kL 6 5 0 5 5
Kerosene kL 0 0 0 0 0
Light oil kL 2 2 0 0 0
Heavy oil A kL 10,733 6,640 989 233 325
Propane gas(LPG) tons 14 14 14 13 14
Liquefied natural gas(LNG) tons 0 2,531 6,361 8,970 8,530
Town gas 1,000 m3 0 0 0 0 0
Water 1,000 m 3
1,063 951 906 990 938

Impact released (emissions) (FY)

Item Unit 2012 2013 2014 2015 2016


CO2 emissions tons-CO2 42,062 37,862 29,512 30,747 29,055
Waste generated tons 2,720 2,606 1,920 2,360 2,261
Waste put to landfill tons 95 50 53 98 43
Drainage (sewers) 1,000 m 3
0 0 0 0 0
Drainage (public waters) 1,000 m3 958 864 807 829 818
NOx tons 134 71 37 20 18
SOx tons 25 21 6 1 0
BOD tons 3 2 2 2 3
COD tons − − − − −

Substances to be registered under the PRTR Act (kg)

Amount Amount released Amount transferred


Substance name used
Atmosphere Public waters Soil Outside operating sites Sewers
N,
N−dimethylacetamide 1,070 0 0 0 1,070 0
N,
N−dimethylformamide 18,972 130 0 0 5 0
Acetonitrile 40,488 3,054 0 0 31,479 0
Dichloromethane (methylene chloride) 155,256 59,149 3 0 58,455 0
Tributylamine 8,516 0 0 0 0 0
Pyridine 11,122 26 0 0 5,526 0
Benzene 677 0 0 0 0 0

31
5. Site Report

■ Pharmaceutical Research Center

Energy and resource consumption (FY)

Item Unit 2012 2013 2014 2015 2016


Electricity 1,000 kWh 27,152 27,611 27,577 28,224 28,647
Gasoline kL 0 0 0 0 0
Kerosene kL 0 0 0 0 0
Light oil kL 0 0 0 0 0
Heavy oil A kL 3 1 2 1 3
Propane gas(LPG) tons 0 0 0 0 0
Liquefied natural gas(LNG) tons 0 0 0 0 0
Town gas 1,000 m 3
3,126 3,573 2,670 2,522 2,625
Water 1,000 m 3
200 195 149 134 157

Impact released (emissions) (FY)

Item Unit 2012 2013 2014 2015 2016


CO2 emissions tons-CO2 15,142 16,274 14,243 14,099 14,464
Waste generated tons 476 464 451 464 466
Waste put to landfill tons 16 17 16 15 16
Drainage (sewers) 1,000 m 3
200 195 149 134 157
Drainage (public waters) 1,000 m3 0 0 0 0 0
NOx tons 2 2 2 2 2
SOx tons − − − − −
BOD tons 6 6 3 3 3
COD tons − − − − −

Substances to be registered under the PRTR Act (kg)

Amount Amount released Amount transferred


Substance name
used Atmosphere Public waters Soil Outside operating sites Sewers
Acetonitrile 13,496 249 0 0 13,247 0
Chloroform 8,836 221 0 0 8,615 0
Dichloromethane (methylene chloride) 1,902 255 0 0 1,647 0
N-hexane 9,243 224 0 0 9,019 0
Formaldehyde 906 0 0 0 906 0

Pharmaceutical Research Center

32
5. Site Report

■ Aburahi Facilities

Energy and resource consumption (FY)

Item Unit 2012 2013 2014 2015 2016


Electricity 1,000 kWh 2,611 2,832 2,941 2,340 2,485
Gasoline kL 3 5 5 5 5
Kerosene kL 7 7 7 4 1
Light oil kL 0 0 0 0 0
Heavy oil A kL 616 590 32 0 0
Propane gas(LPG) tons 3 23 326 301 327
Liquefied natural gas(LNG) tons 0 0 0 0 0
Town gas 1,000 m 3
0 0 0 0 0
Water 1,000 m 3
38 30 25 16 15

Impact released (emissions) (FY)

Item Unit 2012 2013 2014 2015 2016


CO2 emissions tons-CO2 2,483 2,543 1,973 1,626 1,738
Waste generated tons 83 43 167 43 41
Waste put to landfill tons 3 2 13 2 1
Drainage (sewers) 1,000 m3 0 0 0 0 0
Drainage (public waters) 1,000 m3 30 29 20 12 8
NOx tons 2 1 2 2 2
SOx tons 1 0 0 0 0
BOD tons 0 0 0 0 0
COD tons 0 0 0 0 0

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

33
5. Site Report

■ Shionogi Pharma Chemicals Co., Ltd.

Energy and resource consumption (FY)

Item Unit 2012 2013 2014 2015 2016


Electricity 1,000 kWh 2,037 3,214 2,895 3,811 4,455
Gasoline kL 0 0 0 0 0
Kerosene kL 0 0 0 0 0
Light oil kL 0 0 0 0 0
Heavy oil A kL 101 32 14 0 0
Propane gas(LPG) tons 0 0 0 0 0
Liquefied natural gas(LNG) tons 0 0 0 0 0
Town gas 1,000 m 3
114 260 254 359 366
Water 1,000 m 3
197 204 194 150 172

Impact released (emissions) (FY)

Item Unit 2012 2013 2014 2015 2016


CO2 emissions tons-CO2 1,197 1,732 1,566 2,067 2,292
Waste generated tons 92 152 203 261 313
Waste put to landfill tons 0.0 0.3 0.0 0.6 1.2
Drainage (sewers) 1,000 m3 0 0 0 0 0
Drainage (public waters) 1,000 m3 197 204 194 145 172
NOx tons 0 0 0 − −
SOx tons 1 0 0 − −
BOD tons 1 1 0 1 1
COD tons 1 1 0 1 0

Substances to be registered under the PRTR Act (kg)

Amount Amount released Amount transferred


Substance name
used Atmosphere Public waters Soil Outside operating sites Sewers
N,
N−dimethylacetamide 1,520 0 0 0 1,520 0
Acetonitrile 4,777 48 0 0 4,729 0
Chloroform 1,013 20 0 0 993 0

34
5. Site Report

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

Energy and resource consumption (FY)

Item Unit 2012 2013 2014 2015 2016


Electricity 1,000 kWh 4,455 3,900 8,017 7,044 9,004
Coal tons 1,585 1,574 242 0 0
Propane gas (LPG) tons − − 449 302 534
Water 1,000 m3 141 161 201 180 236

Impact released (emissions) (FY)

Item Unit 2012 2013 2014 2015 2016


CO2 emissions tons-CO2 7,213 6,748 8,243 6,470 10,012
Waste generated tons 491 288 76 53 153
Waste put to landfill tons 0 0 0 11 19
Drainage (sewers) 1,000 m3
− − − 63 74
Drainage (public waters) 1,000 m3
− − − 0 0

35
EHS Management
EHS経営評価意見書 Assessment

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.

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

36
EHS Management
2.EHSマネジメント
Assessment

EHS Management Assessment

An outline of the objectives and executed actions


As 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.

Assessment
Shionogi & 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, 2017


Institute 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

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