Q&A info

• 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”). 

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).

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.

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.

• 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 III-A
  • Active substance / Union authorisation Opinion

When you notice that certain published information from your active substance/authorisation is inaccurate, incorrect or 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.

For other reasons, contact ECHA.

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.

The extended search functionalities allows you to search for products based on trade names, uses of the product (target organisms, application method, etc.) or authorisation type. You can also compare different biocidal products based on the data in the summary of product characteristics, such as the active substances in the product, their concentrations, product use information, and hazard and precautionary statements.

When more than one SPC is provided in the same biocidal product authorisation, i.e., different language versions, the “Information on chemicals” website will aggregate this information and provide – as search results – any possible different information available in different language versions. If certain information from the SPC is missing or invalid in a simplified authorisation or national authorisation, you may contact your national authorities to modify the information available in these SPCs.

The search results available in the “Search for chemicals” entry available in the ECHA homepage displays results derived from notifications, registrations or applications submitted from different regulatory context such as REACH, CLP, BPR or PIC. ECHA displays information on chemicals following an aggregation process that considers the substance identification, as provided by data submitters, in different regulatory context.

In order to ensure that the information on a specific active substance relates only to the BPR, click on the Biocidal active substances to ensure that the substance identity and related data refers solely to the BPR.

Alternatively, you may search directly using the Biocidal active substances section of the “Information on chemicals” portal.

The following options can be found under the “Approval/Assessment status” of a specific active substance and product-type combination:

FINAL DECISIONS

• “Approved”: positive decision on approval adopted by the European Commission.
• “Not approved”: decision not to approve adopted by the European Commission.
• “No longer supported”: the Commission issues a non-approval decision of an active substance/PT initially included in the review programme.
• “Cancelled”: application where the assessment of the evaluating Competent Authority is not continued any longer.
• “Expired”: the active substance/PT is no longer valid, nor an application for renewal has been submitted.

APPLICATIONS IN PROGRESS

• “Initial application for approval in progress”: depending on the status of the application, the application can be pending the evaluation of the appointed competent authority, the opinion of the Biocidal Product Committee (BPC) or the Commission decision.
  Other scenarios may apply, such as an invitation to take over the role of participant in the review programme or a decision made by participants in the review programme not to support an active substance/PT pending the Commission decision. 
• “Renewal in progress”: while the initial application for approval has already been completed with a positive decision by the European Commission, a renewal application to extend the validity period of the relevant active substance/PT combination is in progress.
• “Other updates in progress”: the Commission reviews the conditions for approval of an active substance/PT combination according to Art. 15 of the BPR or there is a need to further submit additional data in accordance with the BPC opinion.

Additional information on the main steps can be found in the existing active substance process and new active substance process.