Global data sharing:

26 May 2016

The 8th Global Helsinki Chemicals Forum

Christel MussetDirector of RegistrationEuropean Chemicals Agency

ECHA’s perspective on the smarter useof data already available

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Chemicals legislations managed by ECHA

Data availability• Comprehensive datasets from industry• Evaluation & risk management intentions and opinions/decisions from the

European Competent Authorities as well as supporting documents• All information (except certain business confidential information) publicly

available on ECHA website

REACHRegistrationEvaluation

Authorisation

All chemicals >1 tpa

CLPClassification

Labelling Packaging

All chemicalsand mixtures

GHS

BPRBiocides

Active substances and biocidal

products

PICPrior Informed

Consent

Import/export ofcertain hazardous

chemicalsRotterdam

Convention

How we can benefit from the data

Can we speak about big data?

Substances of Very High Concern168

460 Risk management proposals

1 500 Dossiers for HPV chemicals checked for compliance

120 000 Substances classified with GHS

2 million Study summaries on propertiesand effects of chemicals

14 000 Substances registered under REACH

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Pre-requisites

EU: Harmonised legislations, no patchwork of national legislations International: CLP implements GHS criteria and rules

Mandatory data sharing in SIEFs; Contractual agreements established by registrantsRegulatory work distributed across ECHA, National Authorities and CommissionOECD-related work, Cooperation with peer-regulatory agencies

OECD standards: Guidelines, GLP, harmonised templates, controlled vocabularies, QSAR Toolbox IUCLID, data mining and algorithms

Legal requirement to make data publicly available Large volume of data already published e.g. ECHA website, OECD eChemPortal

1. Enabling regulatory environment

2. Collaboration

3. Common data formats and interoperability

4. Information disclosure

Opportunities

How the data can be shared…

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Some basic principles

• Use international standards and common formats (OECD-based) for supporting data generation and interoperability

• Provide standardised IT tools free of charge for all• IUCLID is the backbone: companies use it for REACH, Biocides

and CLP. Central repository for ECHA, EU National Authorities and Commission

• All data in digital format for ready access by humans and computers, automation and efficient data processing

• Data integration platform supporting data mining, valuable information extraction, and dissemination to the public

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How data are shared among Authorities

Data generation and interoperability: OECD harmonised templates, controlled

vocabularies Shared through IUCLID

REACH & CLP: Integrated European Regulatory Framework

knowledge

informationInformation extraction:

Data mining toolsData integration platform

Shared through Portal dashboard

Scientific knowledge: Identification of data patterns throughadvanced algorithms, QSAR Toolbox

Shared through Portal dashboard

External data adapted to standard formats

large-scale data

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How data are made available to the public

• ECHA website: One single point of access to all data• Infocards, Brief profiles, Full registration dossier• Data can be downloaded. Registration dossier subject to IPR

• Data synchronised with OECD eChemPortal: Advanced search on properties of chemicals

• Study results available in the OECD QSAR toolbox for data gap filling, trend analysis, modelling

• Available soon: • Web services to synchronise with ECHA website• Under investigation: how to provide study results to 3rd parties,

e.g. research, academia, in a format suitable for data processing and analysis

Global data sharing:Are we on our way?

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Our vision• Make best use of REACH & CLP data for ensuring safe use of

chemicals through better-informed risk management actions• Provide easy access to publicly available data • Share information and seek synergies with Authorities to

reduce duplication of effort and provide economies of scale for all parties

• Ensure that industry investment in REACH can be leveraged by re-using data and chemical assessments for other legislations in EU and worldwide

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The easiest. A lot achieved through OECDBut still a variety of formats for same type of data. How to best promote the OECD standards? Data are available! But can we share them?REACH data generated by companies. How to compensate their investment and solve IPR? Industry to work on global data sharing agreements? Reliability? Companies to take the challenge if they want that REACH datasets are accepted globally without full study report

A lot already achieved through OECD work and cooperation among peer regulatory agencies. Are we ready for more, also on the global scale? Up to basing our assessments on the same dataset? Accepting each other’s risk assessment results vs. sharing data?

Tools, standards, methodologies

Data

Harmonisation between regulators

Challenges to overcome…

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christel.musset@echa.europa.eu