Product and active substance evaluation: results may vary
- Efficacy against target
organisms is particularly
important for products
An evaluation of a dossier on a biocidal product by the competent authority includes assessment of the evidence of the efficacy and of the risks arising from the use of the product. Before an evaluation, the applicant must make sure whether the use of data on the active substance(s) contained in the product is permissable. The applicant must prove that he/she holds the property rights of the studies already submitted for the evaluation of the active substance(s) under the EU Review Programme.
Also, the applicant needs to establish in how far, in scientific terms, the data obtained from the review of the active substance(s) are sufficient for the evaluation of the biocidal product. Therefore he must also establish the technical equivalence between the active substance contained in the product with the active substance listed in Annex I/IA of the Biocidal Products Directive. Often biocidal products are complex formulations with a large number of constituents. Thus not only active substances but also other components with dangerous properties are evaluated. For substances of concern the following information is required:
- chemical name of all substances of concern;
- compilation of all required data and studies (as specified in chapter 4 of the "TNsG on Data Requirements");
- risk assessment of all substances of concern contained in the BP.
Besides, one has to check - in individual cases - in how far the overall effect of the product can be determined on the basis of the effects from the individual constituents.
- Aquatic compartment
In those cases where a biocidal product may be applied directly in the environment and relevant exposure to the product (in its original composition) may be assumed, separate tests with the product have to be performed to establish the effects on non-target organisms. In other cases, the environmental risk is usually assessed on the basis of information on single (active) substances. The data and tests required are specified in Annex IIB and IIIB of the Biocidal Products Directive 98/8/EC (BPD), with further details in the Technical Notes for Guidance on Data Requirements.
In all cases, however, a summary of the efficacy assessment has to be provided, including an estimation, based on the realistic worst case, of the exposure to be expected for humans, animals and the environment under the intended uses of the biocidal product.