Abstract
Regulatory bodies perform risk assessments of chemicals and produce regulatory outcomes: evaluations and decisions on chemicals and conditions of their use. Access to scientifically proven and already regulated information becomes crucial for their efficient work and consistent decisions. Exchanging and reusing information relies on common understanding of the main concepts. Here is the challenge: even if the regulations and industry standards provide definitions of chemical substance, the interpretation poses some issues. This paper introduces a concept of Regulated Substance and aims to highlight the complexity of implementing semantic interoperability on regulated information between different parties.
The regulatory activities of European Chemicals Agency (ECHA) overlap, follow or trigger activities performed by other authorities. Capabilities to exchange the information and having access to shared databases can increase regulatory benefits. The common initiative of European Commission, Publication Office, and EU agencies is looking into possibilities to exchange the information. One of the tools promoted by Publication Office – Core Vocabularies – is meant to facilitate interoperability between authorities. The initiative will build foundations for access to the public repositories of the regulated information and non-confidential scientific data for academia and researchers via Open Linked Data.
The above represents the opinion of the author and is not an official position of the European Chemicals Agency.
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Notes
- 1.
IUPAC International Union of Pure and Applied Chemistry.
- 2.
EC Regulation No. 1907/2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals.
- 3.
EC Regulation No. 1272/2008 on the Classification, Labelling and Packaging of substances and mixtures.
- 4.
EU Regulation No. 528/2012 concerning the making available on the market and use of biocidal products.
- 5.
Regulation (EU) 649/2012 concerning the export and import of hazardous chemicals.
- 6.
The symbol of ‘arrow’ implies a change of location and not a succession of events.
- 7.
OECD - The Organisation for Economic Co-operation and Development.
- 8.
Identifier assigned to substances for regulatory purposes by the European Commission.
- 9.
EFSA - European Food Safety Agency; EMA - European Medicines Agency; ECDC - European Centre for Disease Prevention and Control.
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Dys, A.A. (2019). Identification and Exchange of Regulated Information on Chemicals: From Metadata to Core Vocabulary. In: Garoufallou, E., Sartori, F., Siatri, R., Zervas, M. (eds) Metadata and Semantic Research. MTSR 2018. Communications in Computer and Information Science, vol 846. Springer, Cham. https://doi.org/10.1007/978-3-030-14401-2_31
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