The authorisation of biocidal products involves considerable efforts in terms of product testing and dossier preparation, which – in combination with the associated fees – generates significant costs. The Biocidal Products Regulation (Regulation (EU) 528/2012) implements concepts such as the biocidal product family (BPF) and the same biocidal product (SBP) authorisation, allowing interested companies to join forces and work together on the authorisation of biocidal products.

SCC has gained a wealth of experience in the management of task forces for active substance approvals, and currently supports two consortia in the authorisation of biocidal products based on four different active substances.

We are currently planning to form consortia for biocidal products based on the following active substances:

• Hydrogen peroxide (CAS No. 7722-84-1), PT 11 & 12
• Sodiumdichloroisocyanurate dehydrate (CAS No. 51580-86-0 ), PT 2-5
• Troclosene sodium (CAS No. 2893-78-9), PT 2-5
• Symclosene (CAS No. 87-90-1), PT 2-5

If you are interested in joining one of these biocidal product consortia, we kindly ask you to express your interest as soon as possible. You can do so by following the link below and filling in the contact form.

We aim to initiate the consortium phase to coincide with the BPC meeting for the respective active substance at the very latest, and we will keep you updated on the progress of consortium formation.
For more information on biocidal product consortia, please contact  This email address is being protected from spambots. You need JavaScript enabled to view it. or This email address is being protected from spambots. You need JavaScript enabled to view it..

Biocidal Product Authorisation

In line with the Biocidal Products Regulation (BPR), product dossiers for existing products must be submitted at the latest by the date of approval of the respective active substance(s) contained in the product. If this requirement is not met, the products lose their marketing licence for the European market. The exact dates by which product dossiers must be submitted are provided in the active-substance-specific implementing regulations.

Dossier strategy

We help you define the appropriate dossier strategy:

• Is the biocidal product family concept applicable?
• Is Union authorisation or a mutual recognition application more suitable?
• Which member state should be approached for the role of the reference member state?

Dossier preparation

We support you throughout the compilation of your dossier, from the initial preparatory work through to submission:

• Review of available data on your biocidal product: Are there any gaps in the data? Is read-across or a non-submission justification possible?
• Planning and monitoring of required product studies
• Identification of substances of concern and definition of necessary regulatory activities
• Definition of intended uses
• Performance of exposure and risk assessments for human health, animal health and the environment
• Identification of possible critical issues and clarification of a way forward with the selected reference member state in a pre-submission meeting
• Preparation of the dossier (product assessment report, IUCLID file and SPC document)
• Dossier submission via R4BP3

Follow-up & defence

We assist you in the defence of your dossier:

• Timely and competent response to questions raised by the authorities
• Representation and support of the applicant in ECHA working group meetings in Union authorisation cases

Biocidal product consortia

SCC helps consortia of interested companies obtain joint authorisation for biocidal products. For more information, please refer to our website on consortia management.

We provide tailor-made solutions to offer the exact level of support that you need: Whether you require assistance with a few specific questions or want us to take overall responsibility for the preparation of entire product dossiers.

Don’t hesitate to contact us to discuss the best solution for your biocidal product dossier.

Thank you very much for your interest!

We have received your message and will contact you as soon as possible.

Approval of Biocidal Active Substances

Review of Biocidal Active Substances Under Regulation (EU) No. 528/2012

Active substance and product-type combinations for which an application for approval has been submitted under BPD or BPR are listed on the ECHA webpage. The ECHA List of Biocidal Active Substances contains "existing" active substances and "new" active substances. For approved active substances, the list provides a link to the corresponding legal act. There is also a link to a factsheet that refers to the Assessment Report and further non-confidential data, where available.

Active substance with outstanding approval have the status "under review".

Our Expertise at Your Service

Our Biocides team has submitted numerous BPD dossiers on more than 25 existing biocidal active substances, including substances of key importance for the biocide sector.

Since the dossier deadline for the fourth and last list was in October 2008, the current focus of our work on active substances is on the defense of submitted dossiers. This also includes dossiers which have not been prepared by us.

Do not hesitate to contact us if, during the evaluation of your dossiers, critical issues are raised by the Rapporteur Member State or if a refinement of your exposure and risk assessments is required.

For new active substances, we can help you on any aspect of dossier preparation, from data gap analysis through planning and monitoring of studies to dossier writing, including the performance of risk assessments.