HCF 2016: Erika Kunz

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Dr. Erika KunzGlobal Product StewardshipGlobal Registration and Evaluation of Chemicals20.04.2016

Global Data Sharing How can businesses and regulators make smarter use of data already available?

A REGISTRANTS VIEW

Dr. Erika Kunz, Global Product Stewardship, Global Registration and Evaluation of Chemicals, 20.04.20162

Table of Contents

Public, Global Data Sharing - how can businesses and regulators make smarter use of data already available?

– 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?


Clariant at a GlanceA 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

5 807 227 4

17 213

EBITDA 2015 (CHF m) before exceptionals

14.7 %853EBITDA margin 2015before exceptionals

110 in 53companies countries Employees 2015

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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


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.


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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


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



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



(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


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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


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


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”


Clariant contributes to achieve the 2020 goal: we implement intelligent tools for the evaluation of all chemicals- CompTox


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.


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 SUITEToxicology predictionIdentification of toxicological showstoppers

CSIR&D ASSESSMENTProprietary indexindicates relative sustainability of products; Definition of a regulatory roadmap

PORTFOLIO VALUE PROGRAMScreening 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


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


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Does the finalisation of negotiations on the TSCA reform legislation offer an opportunity to use data submitted under REACH?

Yes, but to which extent?


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


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Vielen Dank!LET’S DISCUSS

HCF 2016: Erika Kunz

Presentations & Public Speaking