Mike Rasenberg discussed the quality and access to chemical data collected under REACH and CLP regulations. Over 22,000 substances and 148,000 notifications have provided 4.5 million webpages of substance information. IUCLID format standardizes the data and maximizes sharing. While lack of compliance is an issue, other challenges include the data volume, requirement complexity, and balancing data protection and access. ECHA focuses on basic data access through their website and search tools, and plans to further streamline access through pilots with other agencies and transforming data to develop alternatives to animal testing. Global data sharing is expected to increase through IUCLID harmonization, though quality remains a challenge as well as fully accessing the knowledge potential in

1. Mike Rasenberg
Head of Unit
Computational Assessment
European Chemicals Agency
Helsinki Chemicals Forum - Panel 5
Messukeskus Conference Centre
23-24 May 2019 Helsinki - Finland
The quality of and access to
data on chemicals – a story
of goldmining

2. 2
The success of REACH and CLP…
In numbers:
• REACH Registration: 22 000 substances covered
• CLP Notifications: 148 000 substances
• 4.5 Million webpages with substance information, describing over
240.000 ‘substances’, refreshed as new information arrived
• 24.000 views per day

3. 3
…with IUCLID as the foundation
All data in ECHA is in IUCLID/OECD Harmonised Templates format:
- Maximises the value of the data in terms of improved sharing
possibilities, improved efficiency of (human) assessments and only
way for utilisation by machines
- Global uptake of IUCLID is an extremely positive trend
?

4. 4
“Quality issues”
Lack of compliance is an issue,

5. 5
“Quality issues” or rather, the
challenges
Lack of compliance is an issue, but not the only one, e.g.
- The amount of data represents a success but also a challenge,
especially in sharing and exchanging globally
- Complexity of requirements makes understanding and utilisation of
data challenging
- Ownership of data needs to be respected and can be complex: e.g.
industry wants to protect their data for “Registration” but at the
same time wants to use everybody’s data for other purposes, e.g.
SDS
- Users have different levels of needs and expertise
Mining is complex,
but there is still a lot of gold

6. 6
Availability
ECHA focussed on the basics first:
- Handle Confidential Information in a safe and responsible manner
- Make data available on our website to view: ensure transparency
(ongoing activity)
- Make data searchable available combined with other sources
globally: OECD eChemPortal (ongoing activity)
- Integrate selected data into the OECD QSAR Toolbox for predicting
toxicity (ongoing activity)
- Make key data available for download while respecting ownership
(project): alternatives to animals developments, safety datasheets,
input to chemical impact or risk assessments, substitution
- Make some data available for automatic processing (limited scale
pilot)
The basis is there, now it is about further streamlining and developing
the access to the gold (or the mine)?

7. 7
Future trends
Some observations/expectations:
- More use of IUCLID globally leads to
more sharing between industries
and authorities, more development
and sharing of data-tools that sit on
top of IUCLID
- Ownership/re-use policies and approaches will evolve, for instance in terms
of use for research and development in the EU, while data requirements and
reporting formats will evolve globally.
- ECHA is being approached by data holders, seeking support in making their
data available

8. 8
Future visions
ECHA is exploring the possibilities of IUCLID as a global data platform, a place to
view, use, download and upload data on chemicals, closely integrated with
IUCLID as a cloud platform, Chesar, OECD QSAR Toolbox and others IUCLID
based tools
- a first step is a pilot between US EPA, Canada and ECHA
- a sustainable resourcing model is needed
We will transform/curate data into a form that enables and accelerates the use of
the data for developing alternatives to animal testing, chemical pressure
indicators and informed substitution
The challenge remains to give access to the mine – in a sound and meaningful
manner

9. 9
Global data sharing will increase between all parties.
Data structure and harmonisation are key and IUCLID is the enabler.
In terms of exploring the wealth of data, quality is not the (only) issue, there are
more challenges.
Access to the mine doesn’t necessarily provide you with the gold, but there is still
a lot of knowledge to be created from the mine…
… including on where the gold is missing

10. Thank you!
mike.rasenberg@echa.europa.eu