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R4BP 3

Information on chemicals

What information is available for biocides since November 2018?

The following information is available in the “Information on chemicals” section for Biocides:

  • The list of biocidal active substances for which an application for approval has been submitted, approval has been granted or refused. The published information includes also documents such as the assessment report, study summaries (Document IIIA), opinion and a link to the related legal text approving or not approving substance to be used as a biocidal active substance.
  • The list of union, simplified and national biocidal product authorisations. The published information includes also documents such as the assessment report, summary of product characteristics, decision or authorisation document, and in case of union authorisations also the Opinion and link to the related legal text.
  • The list of active substances and suppliers (“Article 95 list”).
What information is available in the biocidal product factsheet?

The biocidal product factsheet contains detailed information on the biocidal product’s authorisation as available in R4BP 3. The factsheet also includes a map with the authorisation status of a product, authorisation details of all mutually recognised applications and historical data on previous assessments.

A biocidal product factsheet also contains the:

  • Summary of product characteristics (finalised or updated after 1 January 2016 in R4BP 3).
  • Product assessment report.
  • Product authorisation/decision documents.
  • Biocidal product committee opinion (for Union authorisations).
How does ECHA guarantee the reliability of Biocides data publicly available?

The biocides data available in the “Information on chemicals” section on the ECHA’s website originates from the information provided by applicants and verified by the evaluating competent authority. ECHA does not verify the adequacy or the correctness of information provided that falls under the responsibility of the national authorities. For confidential data assessed by your evaluating competent authority, you will need to ensure the adequacy of the information published with your national authorities.

For further information on this topic, see Q&A 1554 and Q&A 1555.

When will the information from my application be published on ECHA’s website?

Information on biocidal product authorisations will be published in the “Information on chemicals” section on ECHA’s website when a product asset is created in R4BP 3. Information on active substances will be published when the evaluation is started by the evaluating Member State authority.

How can I ensure that confidential information will not be published?

During the approval/authorisation process for active substance or biocidal product, the applicant has to provide comments within 30 days to ensure that documents subject to dissemination according to Article 67 of the BPR (the SPC, assessment report, Document III-A, Decisions/authorisation document and Opinion) do not contain confidential information. Once an authorisation, a renewal or a change on request is approved in R4BP 3, you can verify the correctness of the following R4BP 3 information disseminated on the ECHA website as available in your asset:

  • The summary of product characteristics (SPC) in XML format. Note: information on the function of other substances or of substances of concern will not be made publicly available.
  • Documents under the “Documents” tab with access level ‘Public’:
    • Active substance/product assessment report.
    • Product authorisation/decision documents.
    • Active substance Document IIIA.
    • Active substance/Union authorisation Opinion.
Certain information from my published approval/authorisation is incorrect/missing. What shall I do?

When you notice that certain published information from your active substance/authorisation is incorrect or is missing please contact the Member State responsible for evaluating your application. ECHA will publish the updated information as soon as the changes are applied in R4BP 3.

When data is inaccurate or incorrect as provided by your national authorities, you will need to contact your national authorities so they will be able to apply the necessary actions.

For other reasons, contact ECHA.

I cannot find information from an application on ECHA’s website. Why?

The most common reasons are:

  • Data from active substance or biocidal product applications must be available in R4BP 3, i.e., new applications or updates must be authorised by your authorities in R4BP 3.
  • For biocidal products, the information is derived from assets available in R4BP 3. Information from pending cases is not published.
  • Due to technical limitations only a limited number of cancelled and expired authorisations are currently disseminated. They will be progressively published.

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