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- Guest Column: EUCLEF – helping companies navigate through the legislative maze in the EU
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Article related to: REACH
Working towards one global IUCLID
Over the past decade, a considerable amount of information on chemicals available on the EU market has been submitted by companies to ECHA. The data is used to assess the safety of the chemicals and to find appropriate ways to manage their risks. Most of it has also been published on ECHA’s website, but there are plans to make the data and our knowledge around it available for even broader use in the future.
The data has been collected in a tool called IUCLID which allows users to record, store, submit and exchange data on chemicals in an internationally agreed format. IUCLID has become essential for anyone managing scientific data on chemicals in a regulatory context.
The information collected through REACH registrations, classification and labelling notifications and biocide applications, to mention some, forms the largest regulatory database on chemicals in the world.
Maximising the use of data
Given the amount and complexity of the information collected in IUCLID, ECHA has developed additional tools to help companies, authorities and researchers make the best use of it. For example, in December 2019, ECHA published a text analytics tool that allows information in all IUCLID fields to be searched. Text analytics can be downloaded free of charge and connected to the users’ own IUCLID.
Already since 2017, the REACH study results have been available for IUCLID users as a downloadable file. This file contains all non-confidential substance data that has been submitted to ECHA under REACH and reports study results for physical-chemical properties, environmental fate and pathways, and (eco)toxicological information. The data is useful for researchers and companies, for example, when generating safety data sheets or developing alternative methods such as QSAR models.
Breaking the ground outside Europe
Although Europe has been a forerunner in collecting chemical data for regulatory purposes in IUCLID format, interest from other parts of the world has increased.
Some authorities, for example in Switzerland and the US, have also started to accept data in IUCLID format for some parts of their chemical legislation. Other countries, such as Australia and New Zealand, will start using IUCLID once the tool is fully configured to fit their regulatory contexts. In general, we see that more and more authorities are using IUCLID as their chemical information database.
The more widely the IUCLID format is accepted globally, the better the news for industry, authorities and animal welfare. Needing to maintain only one dataset for a particular chemical would significantly reduce the administrative burden for companies with regulatory obligations in more than one region. It would also contribute to avoiding duplicate testing, supporting international harmonisation of chemical data and reducing trade barriers.
Using a universal format based on IUCLID would, in particular, support the mutual acceptance of test data since all authorities would ultimately have the same basis for their assessments. In the long run, this would improve the efficiency of the work and also increase the reliability of data.
However, even though a common database is not yet a reality, authorities do already exchange data for assessment purposes. For example, ECHA has supported both the United States Environmental Protection Agency and Health Canada in projects where the EU was able to provide more comprehensive information and knowledge on certain chemicals.
Future – IUCLID platform
To really maximise the use of existing data, ECHA’s future vision is to support setting up one international IUCLID platform. This would mean that all parties involved, whether authorities or industry, would be able to contribute by generating and entering data in the system.
Mutual acceptance of chemical safety data is already a reality and having one harmonised IT format for it might not be that far away. And if and when this happens, IUCLID has the potential to become the platform where chemical safety data can be uploaded and viewed, but also managed, exchanged and improved by all parties.
The future platform would integrate the functionalities and options from other tools and databases. For instance, in the coming years, the OECD QSAR Toolbox will be further developed so that some of its key functionalities, like chemical similarity searches and predicting hazard properties, could be made available in the future platform.
Having one international IUCLID platform would further support international cooperation on the management of chemicals, improve their safe use, support sustainable chemistry by making data available on the hazards of possible alternatives and contribute to a circular economy.
In practice this could lead to higher quality of classification and labelling throughout the supply chain and more appropriate and effective risk management, as well as making it easier to create more accurate and more widely applicable QSAR models.
Currently this is still a vision. ECHA will continue working towards this goal together with the OECD, which has recently agreed to further develop its Global Chemicals Knowledge Base in which IUCLID will play a central role. Short term, the aim remains to make the data and knowledge gathered in the framework of European chemicals legislation easier to access and use.
Case study: sharing data for developing alternative test methods
The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) is part of the United States Department of Health and Human Services, with representatives from sixteen US regulatory and research agencies. ICCVAM coordinates the efforts of improving alternative testing methods in the US.
One of their priority projects has been to develop alternative methods for the “six-pack” tests – these contain acute oral, dermal and inhalation systemic toxicity tests and tests to determine eye and skin irritation and skin sensitisation. Despite the shift towards in vitro methods – which are studies performed in test tubes instead of living organisms – several of the above mentioned tests are still performed partially or exclusively on animals to fulfil all regulatory requirements.
|"The data provided by ECHA were invaluable for helping us truly evaluate the predictivity of this model. ECHA's assistance and participation in similar projects in the future would be extremely helpful."|
- Dr Warren Casey, ICCVAM -
While developing their models, ICCVAM contacted ECHA to ask if the REACH data could be used to extend their training and test sets. ECHA supported ICCVAM by:
- investigating what acute oral toxicity data could be used for this purpose;
- extracting and filtering the data from ECHA’s database to provide data of adequate quality for model development and validation; and
- giving advice to the model developers on the best possible use and interpretation of the data.
Data exchange for the remaining endpoints is ongoing.
When the models are finalised, they will be publicly available for all companies and researchers to use free of charge. Discussions are ongoing if these models could also be included in the QSAR Toolbox.
Text by Päivi Jokiniemi
Published on: 13 February 2020
Top image: © Pixabay/Gerd Altmann
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