Biocides Efficacy

Efficacy data are a fundamental component in the regulatory management and decision making process for active substances and biocidal products. This data is required to establish the benefit arising from the use of the active substance in biocidal products and must be balanced against the risks their uses pose to humans and the environment.

A comprehensive guidance document describing what must be included in the dossier is available from the European Chemicals Agency ( requirements_en.pdf).

This guidance provides technical scientific advice on how to fulfil the information requirements set by the Biocidal Products Regulation (BPR – Regulation (EU) No 528/2012) (

Authorisation of a Biocidal Product (BP) by the Irish Competent Authority, DAFM, will only be granted according to Article 19 (1) of the BPR if that product is shown to be sufficiently effective.

The data provided must show the efficacy of an active substance used in BPs and must be sufficient to permit an evaluation of a representative product containing that active substance.

The applicant must demonstrate that the BP is effective and suitable for its intended use when applied according to its instructions of use. This can be confirmed by provision of data that may include laboratory studies, simulated use or semi-field test data or other relevant study data, provided that the test conditions reflect the instructed conditions of use. For field studies the extent of the information required will vary depending on the biocidal product-type (PT) and proposed use pattern.

The test should be based on sound scientific principles and practices. Although Good Laboratory Practice (GLP) is not required for efficacy studies, it is recommended and testing should be carried out in accordance with a relevant quality standard, e.g. ISO17025 or ISO9001. More detailed PT specific guidance and test methods are provided in Volume ll Efficacy Parts B+C of the Guidance on the BPR (

The intended function and the given use conditions must be reflected in the efficacy test and the effects on the target organism required for the claimed efficacy should be described and specified for each use. Tests on storage stability must also be performed to show that the active substance content remains at a high enough level throughout the shelf life of the product to maintain efficacy. Storage stability at ambient temperature must be performed in accordance with the claimed shelf life of the product. Accelerated storage stability at elevated temperature should also be considered if the product is likely to be stored at higher temperatures.

If no such guidance exists for a particular PT the applicant should contact DAFM (Email: ) for advice on what studies to perform and include in the application.

The applicant must also provide information on the possible occurrence of the development of resistance and appropriate management strategies, including cross-resistance.