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Biocides data dissemination
How will the biocides pages change? 23 November 2018 Anita Rynkänen Computational Assessment and Dissemination Unit Directorate of Registration
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What will change? Greater compliance with Article 67
Information shall be made publicly available Centralised access to the biocides data Alignment with other pages on ECHA website New ways to present data Extended search functionalities Visual elements Comparison tool
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Active substances Viewing active substance information in two ways
Extended search functionalities (candidate for substitution, regulatory definition, assessment step in the active substance approval) Publication of non-confidential documents such as assessment reports, study summaries and BPC opinions
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Active substance Search
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Summary
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Active substance factsheet
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Biocidal products Overview of products on the EU market
Publication of the trade names under which a product are marketed Possibility to compare products
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Comparison tool
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Product factsheet Map to visualize market area and authorisation status of the product Publication of Summary of product characteristics (SPC) documents Assessment history
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Products – what will be disseminated
Documents subject to dissemination Decision documents PAR SPC Opinion (only for union authorisations) Expired and cancelled authorisations: Expiry or cancellation before 27/11/2018: no document disseminated Expiry or cancellation after 27/11/2018: documents previously disseminated will continue to be available
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Ensuring Confidentiality
Applicants: identify CBI and make justified confidentiality claims Dossiers (IUCLID, Document IIIA) Assessment Reports MSCAs: attribute the correct access level to the documents Public, restricted or restricted to authorities Document IIIA, AR, Opinion and Decisions Corrections managed by MSCAs: on valid assets only asset validity SPC and other documents access levels of documents
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Conclusions More information on active substances and biocidal products will be made available on 27 November.
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Questions? anita.rynkanen@echa.europa.eu
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