Efficacy evaluation

Studies of the efficacy of biocidal product are a fundamental part of the risk assessment carried out in connection with the authorisation of a biocidal product.

The Danish Environmental Protection Agency often uses external specialists to assess efficacy

The information and efficacy data submitted in connection with an application for a product will often be assessed by a consultation party. Consultation partners are specialists who carry out efficacy evaluations of data and assess whether the claim corresponds with the results of the efficacy studies. Consultation partners for the individual product-types are shown in the table below.

The claims made for the product must correspond with the efficacy data

"Claim" is the term used for the use of the biocidal product for which authorisation is being sought. A distinction can be drawn between general and more specific claims. When a general claim is made, it is expected that the product is effective against a number of commonly occurring organisms/pests. It is however not certain that the product is sufficiently effective against or-ganisms/pests that:

• are difficult to control
• can only be controlled under certain specific conditions

The efficacy guidelines

The efficacy guidelines describe the tests that are required depending on the specificity of the claim.
The label must also clearly state which areas of use the product can be used for and give guidelines for such use. The following must therefore be included (where relevant):

• Purpose (including product-type) and function (e.g. preventive, curative, maintenance)
• Groups that use the product (e.g. industrial, professional, private use)
• Places where the product must/must not be used (e.g. in and around buildings, inside, outside, hard surfaces, soft surfaces, no contact with water/soil)
• How the product acts in purely biological terms on the target organism and, if applicable, on the target organism during the development stage
• Methods and technical details concerning the use (e.g. vacuum impregnation, pressure impregnation, brushing, spraying, dipping, flow coat, evaporation, feeding trays, in boxes)
• Procedures to be followed in connection with mixing, use and disposal of the product
• Describe the application rate/dosage and the treatment time/treatment frequency
• Other information/restrictions for the product's efficacy

More information

The information and efficacy data required for an active substance and a biocidal product respectively in an application (after inclusion of the active substance in Annex I) are described in" TNsG-Data-requirements " on the European Commission Website.

A description of the types of efficacy test required depending on the intended use of the product is given in " TNsG-Product-Evaluation " on the European Commission Website.

The table below presents an overview of other efficacy guidelines for the individual product-types (after the active substance's inclusion in Annex l).
Guidance Consultation party

* Under preparation
** Is under preparation after conclusion of the consultation period