Global Data Shiring: Christel Musset, Director of Registration, ECHA

1. Global data sharing:
26 May 2016
The 8th Global
Helsinki Chemicals Forum
Christel Musset
Director of Registration
European Chemicals Agency
ECHA’s perspective on the smarter use
of data already available

2. 2
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
REACH
Registration
Evaluation
Authorisation
All chemicals
>1 tpa
CLP
Classification
Labelling
Packaging
All chemicals
and mixtures
GHS
BPR
Biocides
Active substances
and biocidal
products
PIC
Prior Informed
Consent
Import/export of
certain hazardous
chemicals
Rotterdam
Convention

3. How we can benefit from the data

4. Can we speak about big data?
Substances of Very High Concern
168
460 Risk management proposals
1 500
Dossiers for HPV chemicals checked for
compliance
120 000 Substances classified with GHS
2 million Study summaries on properties
and effects of chemicals
14 000 Substances registered under REACH

5. 5
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 registrants
Regulatory work distributed across ECHA, National
Authorities and Commission
OECD-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…

6. 6
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

7. 7
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
information
Information extraction:
Data mining tools
Data integration platform
Shared through Portal dashboard
Scientific knowledge:
Identification of data patterns through
advanced algorithms, QSAR Toolbox
Shared through Portal dashboard
External data
adapted to
standard formats
large-scale data

8. 8
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

9. Global data sharing:
Are we on our way?

10. 10
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

11. 11
The easiest. A lot achieved through OECD
But 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