EU Data Requirements for Biocides

Biocides are regulated in the EU in a two stage authorisation process.  The active component (the “active substance”) is assessed at EU level in a process involving the EU Member States, ECHA and the Commission.  The formulation containing an EU approved active substances (i.e. the biocidal product) is assessed at national or union level.  The European Chemicals Agency, ECHA, coordinates and oversees a range of activities for the purpose of biocidal active substance approval and product authorisation.  In addition the Agency publishes a wide range of resources to assist applicants and inform the public:

Data requirements for assessing the safety of the active substance are presented in Regulation (EU) No 528/2012.  Annex II (Title 1/ Section 10 and Title 2/ Section 9) deals with the data requirements for assessing the Environmental fate and behaviour of the active substance.  The corresponding data requirements for assessing the safety and effectiveness of the products are specified in Annex III (Title 1 and 2/ Section 10).  ECHA has provided guidance on how to fulfil the information requirements set by the BPR and on how to perform the required risk assessments.  Volume IV deals with the Environment, please refer to the links below for further details

Quick Links

ECHA Guidance on How to Fulfil the Information Requirements Set by the BPR (EU) 528/2012 for the Environment and How to Perform the Required Risk Assessments

Environmental Emission Scenario Documents

EU Technical Agreements for Biocides (TAB)

EU Reference Tool for Environmental Exposure Assessments under the BPR (EUSES)


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