Wednesday, 27 January 2016

Biocidal Products Regulation


The European Chemical Agency has issued “Transitional Guidance on Efficacy Assessment for Product Types 1-5, Disinfectants”. This legislation will affect the number and types of disinfectants registered in the European Union.

The document states: “This Transitional Guidance deals with the evaluation methodology of efficacy tests for disinfectants for the national and Union authorisations of products under the EU Biocidal Products Regulation 528/2012 (BPR).”


The types of efficacy claims made for a disinfectant/ biocidal product depend upon, among other things, the types of micro-organisms the disinfectant targets (e.g. fungal spores, yeasts, mycobacteria, bacteria or bacterial spores) and the disinfectant’s intended use (e.g. in hospitals, in contact with food, in animal houses, in homes). Label claims and recommendations for use, including concentration and contact time, must be supported by the results of bactericidal, fungicidal, etc. tests appropriate to the area of application, which are normally performed on the basis of the specific standards. Complete instructions for use are an integral part of the label.

The document can be accessed via the ECA.

Posted by Dr. Tim Sandle

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