Transitional Guidance

These Transitional Guidance documents have been discussed and supported by the working groups/adhoc working groups of the Biocidal Products Committee (BPC). The majority of these documents undergo a "transitional" consultation with the Biocidal competent authorities and accredited stakeholder organisations, however some may not have had this consultation and, this will be addressed when the document is incorporated into the new Biocidal Products Regulation guidance structure.

A "Transitional Guidance" is a document that has been initiated under the "old" Biocidal Products Directive and because it has been finalised before the relevant new Biocidal Products Regulation guidance document has been fully developed, it is being made available as a Transitional Guidance document until such time as the relevant new document is ready for publication.

All the documents here are to be considered as Transitional Guidance documents.

Exceptionally, there may be some documents that have had a Public Consultation by the Commission and have been passed to ECHA for publication. These documents are essentially finalised and are awaiting inclusion into the appropriate volume of the new Biocidal Products Regulation guidance structure. There will be no further formal consultation on these documents, unless updates have been identified, and they will be added by a corrigendum when the relevant volume is available.

Transitional Guidance on Efficacy Assessment for Product Type 18, Insecticide, Acaricides & other Biocidal Products against Arthropods and Product Type 19, Repellents & Attractants
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Transitional Guidance on Efficacy Assessment for Product Types 18+19
Description:
This guidance document deals with the methodology for the evaluation of efficacy tests for Insecticide, Acaricides & other Biocidal Products against Arthropods (Product Type 18) and Repellents & Attractants (Product Type 19), that is applicable for the authorisation of products under the EU Biocidal Products Regulation (BPR, Regulation (EU) 528/2012).
 
download full PDF document (16/09/2016)
Transitional Guidance on Efficacy Assessment for Disinfectants Product Types 1-5
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Transitional Guidance on Efficacy Assessment for Disinfectants Product Types 1-5
Description:
This guidance document deals with the methodology for the evaluation of efficacy tests for disinfectant products (Product Types 1-5) that is applicable for the authorisation of products under the EU Biocidal Products Regulation (BPR, Regulation (EU) 528/2012).
 
download full PDF document (31/05/2016)
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Transitional Guidance on Efficacy Assessment for Product Type 8 Wood Preservatives
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Transitional Guidance on Efficacy Assessment for Product Type 8 Wood Preservatives
Description:
This guidance document deals with the methodology for the evaluation of efficacy tests for wood preservatives (Product Type 8) that is applicable for the authorisation of products under the EU Biocidal Products Regulation (BPR, Regulation (EU) 528/2012).
 
download full PDF document (31/03/2015)
Transitional Guidance on Evaluation of Environmental RMM for Disinfectants Product Type 1-5
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Transitional Guidance on Evaluation of Environmental RMM for Disinfectants PT 1-5
Description:
This is a set of 5 documents addressing the evaluation of environmental risk mitigation measures (RMM). The aim of this set of Guidance documents is to gather and to harmonise possible RMM for disinfectants, product type (PT) 1-5. The Guidance documents present a set of possible RMM that can be used for all authorisations in Europe.
 
Disinfectants PT 1 (Human hygiene)
download full PDF document (13/11/2014)
 
Disinfectants PT 2 (Disinfectants and algaecides not intended for direct application to humans or animals)
download full PDF document (13/11/2014)
 
Disinfectants PT 3 (Veterinary hygiene)
download full PDF document (13/11/2014)
 
Disinfectants PT 4 (Food and feed area)
download full PDF document (13/11/2014)
 
Disinfectants PT 5 (Drinking water)
download full PDF document (13/11/2014)
 
Transitional Guidance on Efficacy Assessment for Product Type 22 Embalming Products
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Transitional Guidance on Efficacy Assessment for Product Type 22 Embalming Products
Description:
This guidance document deals with the methodology for the evaluation of efficacy tests for embalming products that is applicable for the authorisation of products under the EU Biocidal Products Regulation (BPR, Regulation (EU) 528/2012).
 
download full PDF document (12/08/2014)
 
Transitional Guidance on Efficacy Assessment for Product Type 21 Antifouling Products
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Transitional Guidance on Efficacy Assessment for Product Type 21 Antifouling Products
Description:
This guidance document deals with the methodology for the evaluation of efficacy tests for antifouling products that is applicable for the authorisation of products under the EU Biocidal Products Regulation (BPR, Regulation (EU) 528/2012).
 
download full PDF document (28/05/2014)
 
Transitional Guidance on Efficacy Assessment of Preservatives
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Transitional Guidance on Efficacy Assessment of Preservatives
Description:
The aim of this guidance document is to help with the practical aspects of designing and performing laboratory trials for testing the efficacy of preservatives. It is the intention of this guidance to make the general testing principles understood so that they can then be applied in all types of preservative testing.
 
download full PDF document (28/05/2014)
 
Transitional Guidance on mixture toxicity assessment for biocidal products for the environment
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Transitional Guidance on mixture toxicity assessment for biocidal products for the environment
Description:
This guidance document addresses the assessment of the mixture toxicity of products as well as synergistic effects by applying a tiered scheme for the adequate consideration of mixture effects during the environmental risk assessment of biocidal products.
 
download full PDF document (28/05/2014)