Global Data Sharing. Erika Kunz, Head of Global Registration and Evaluation of Chemicals, Clariant Produkte, Germany.

1. Public
Dr. Erika Kunz
Global Product Stewardship
Global Registration and Evaluation of Chemicals
20.04.2016
Global Data Sharing
How can businesses and
regulators make smarter
use of data already
available?
A REGISTRANTS VIEW

2. Dr. Erika Kunz, Global Product Stewardship, Global Registration and Evaluation of Chemicals, 20.04.2016
Table of Contents
Public, Global Data Sharing - how can businesses and regulators make smarter use of data already available?2
– Clariant at a Glance
– What has been done by regulators over the past few years to reduce
barriers to data sharing and acceptance?
– Are there unsurmountable barriers of cost, data protection, language
and culture that mean we should aim for a common minimum standard
of data sharing rather than anything more ambitious?
– Can we ever achieve the aims of the 2020 goal without more
progress on data sharing given what UNEP describes as the trend
of “chemicals intensification” of economies?
– Does the finalization of negotiations on the TSCA reform legislation
offer an opportunity to use data submitted under REACH?

3. Dr. Erika Kunz, Global Product Stewardship, Global Registration and Evaluation of Chemicals, 20.04.2016
Clariant at a Glance
A GLOBALLY LEADING COMPANY
IN SPECIALTY CHEMICALS
Corporate Presentation 20163
Business AreasNet result 2015 (CHF m)
from continuing operations
Sales 2015 (CHF m)
from continuing operations
5807 227 4
17213
EBITDA 2015 (CHF m)
before exceptionals
14.7%853
EBITDA margin 2015
before exceptionals
110in 53
companies countries Employees 2015

4. Public
Dr. Erika Kunz
Global Product Stewardship
Global Registration and Evaluation of Chemicals
20.04.2016
What has been done by
regulators over the past few
years to reduce barriers to
data sharing and
acceptance?
Enhanced availability of
data-Data ownership needs
to be considered

5. Dr. Erika Kunz, Global Product Stewardship, Global Registration and Evaluation of Chemicals, 20.04.2016
Increased awareness of existing data, transparency on
sharing mechanisms and data flows is key for data sharing
– Regulators:
- Dissemination of registration data by regulatory bodies – a lot has been done
- Implementing GHS
- OECD Harmonized Templates have been further developed
- The Navigator requested by chemical industry from COM is still in a nascent status
– Guidance for data sharing between registrants has been issued:
- K-REACH, ECHA, the data sharing implementing act was recently published-
– Industry:
- Global Product Strategy is provided by chemical industry on ICCA’s portal
- Improved transparency within supply chain communication
Data ownership always needs to be considered.
Public, Global Data Sharing - how can businesses and regulators make smarter use of data already available?5

6. Public
Dr. Erika Kunz
Global Product Stewardship
Global Registration and Evaluation of Chemicals
20.04.2016
Are there unsurmountable
barriers of cost, data
protection, language and
culture that mean we
should aim for a common
minimum standard of data
sharing rather than
anything more ambitious?
Our vision:
One substance - one data set

7. Dr. Erika Kunz, Global Product Stewardship, Global Registration and Evaluation of Chemicals, 20.04.2016
Minimum standard for data sharing – One common
standard for datasets and approaches for substances
– Mutual Acceptance of Data (MAD) - also for non OECD countries
– Compliance with Principles of Good Laboratory Practice - also for non
OECD countries
– OECD Guidelines for the testing of chemicals being understood as
agreed testing methods to asses the safety of chemical products
globally
– Implementation of the Replacement, Reduction and Refinement
Principles (3R)
– Common understanding and acceptance of QSAR and Read across
Public, Global Data Sharing - how can businesses and regulators make smarter use of data already available?7

8. Dr. Erika Kunz, Global Product Stewardship, Global Registration and Evaluation of Chemicals, 20.04.2016
Practical example: Clariant’s approach for the
evaluation of chemicals - data sharing is key
search
• a worldwide in depth search inside and outside Clariant on properties and effects of chemical
substance
group
• Identification and grouping of substances into chemical categories based on common and
comparable structures, properties and (expected) effects
evaluate
• Use of alternative (in silico/in chemico and/or in vitro) test methods to close existing data gaps
without using animals to the greatest degree possible
test
• where absolutely necessary to protect people or the environment or when required by legal
regulations, studies involving animal testing are contracted by Clariant – according to our
Animal Welfare Policy
report
• If possible one single dataset is created for the evaluation of our substances for submission to
regulatory bodies
Public, Global Data Sharing - how can businesses and regulators make smarter use of data already available?8

9. Dr. Erika Kunz, Global Product Stewardship, Global Registration and Evaluation of Chemicals, 20.04.2016
(Unsurmountable) barriers for data sharing today
– Currently there is not in all highly regulated countries a mechanism or platform set up
by the authorities for data and cost sharing
– Tests have to be there performed according to specific national guidelines or follow
OECD methods or ISO standards, but
- Some eco tox studies have to be performed with national test systems – although
the respective OECD studies are already available
- For joint registrations sharing of the registered tonnages is required
- Acceptance of QSARs/read across is limited
Vision: One data set accepted by all chemicals management systems avoiding
duplication of vertebrate studies and enabling data sharing without commercial
impact and a globally consistent approach to the evaluation of chemicals
Public, Global Data Sharing - how can businesses and regulators make smarter use of data already available?9

10. Public
Dr. Erika Kunz
Global Product Stewardship
Global Registration and Evaluation of Chemicals
20.04.2016
Can we ever achieve the
aims of the 2020 goal
without more progress on
data sharing given what
UNEP describes as the
trend of “chemicals
intensification” of
economies?
All stakeholders have to
commit – we do

11. Dr. Erika Kunz, Global Product Stewardship, Global Registration and Evaluation of Chemicals, 20.04.2016
Chemicals Intensification – shift and increase of chemical
production from OECD to non OECD countries
The global chemicals
industry is growing steadily
with the clear trend towards
Asia
Data sharing is one aspect
of the 2020 goal – sound
waste management and
circular economy are
among others very
important topics
Public, Global Data Sharing - how can businesses and regulators make smarter use of data already available?11
Source: HIS 2014, McKinsey
2020 goal: “…that chemicals are used and produced in ways that lead to the
minimization of significant adverse effects on human health and the environment”

12. Dr. Erika Kunz, Global Product Stewardship, Global Registration and Evaluation of Chemicals, 20.04.2016
Clariant contributes to achieve the 2020 goal: we implement
intelligent tools for the evaluation of all chemicals- CompTox
Public, Global Data Sharing - how can businesses and regulators make smarter use of data already available?12
The CompTox Suite is a system that simultaneously accesses data from different sources
and allows tox properties to be predicted by calculation using Ambit as one single platform.
The CompTox Suite makes it easier to find suitable comparative data of already registered or
tested substances.
– The following data can be searched:
- Similar chemical structures
- Structures with comparable functional groups
- Structures with comparable substructures
- Substance data already recorded for all these substances
– Quantitative structure-effect relationships are another method of gathering data in
CompTox.

13. Dr. Erika Kunz, Global Product Stewardship, Global Registration and Evaluation of Chemicals, 20.04.2016
Clariant contributes to achieve the 2020 goal…. Ensuring safer
and more sustainable products and solutions by the systematic
application of several in-house developed Clariant tools
COMPTOX SUITE
Toxicology prediction
Identification of
toxicological
showstoppers
CSIR&D ASSESSMENT
Proprietary index
indicates relative
sustainability of
products;
Definition of a
regulatory roadmap
PORTFOLIO VALUE PROGRAM
Screening of product and solutions
before commercialization to ensure
continuous high sustainability
performance of product portfolio and
allow for EcoTain branding
SCOPESCOUT EXECUTE COMMERCIALIZE
SUBSTANCE EVALUATION
CompTox Suite/
Testing/Dossiers

14. Dr. Erika Kunz, Global Product Stewardship, Global Registration and Evaluation of Chemicals, 20.04.2016
Clariant contributes to achieve the 2020 goal:… we communicate
in a transparent way to internal and external stakeholders
– Information on products is made available to
employees, distributors, customers and
authorities according to legal requirements and
industry standards as required in Clariant ESHA
Guideline 26.
– All available data are entered into and
maintained in a globally rolled out Substance
Data Management System
– Safety Data Sheets (SDS) are created taking
into account the local laws and regulations.
– Clariant is committed to the Global Product
Strategy and is making available GPS summary
reports of substances it places on the market
Public, Global Data Sharing - how can businesses and regulators make smarter use of data already available?14

15. Public
Dr. Erika Kunz
Global Product Stewardship
Global Registration and Evaluation of Chemicals
20.04.2016
Does the finalisation of
negotiations on the TSCA
reform legislation offer an
opportunity to use data
submitted under REACH?
Yes, but to which extent?

16. Dr. Erika Kunz, Global Product Stewardship, Global Registration and Evaluation of Chemicals, 20.04.2016
Data for TSCA reform require chemicals to be
reviewed by EPA
– based on sound science and reflect risk-based criteria protective of human
health and the environment
– Based on information provided by manufacturers which allow to conclude that
new and existing chemicals are safe and do not endanger public health or the
environment
Seeing these principles we expect that the data created for REACH – full study
reports- will be helpful also for TSCA reform.
Still open:
Acceptance of robust study summaries used for REACH
Public, Global Data Sharing - how can businesses and regulators make smarter use of data already available?16

17. Public
Dr. Erika Kunz
Global Product Stewardship
Global Registration and Evaluation of Chemicals
20.04.2016
Vielen Dank!
LET’S DISCUSS