General principles

The purpose of the evaluation is to establish whether or not the product complies with the criteria set down in point (b) of Article 19(1). The evaluating body shall reach its conclusion as a result of the integration of the risks arising from each active substance together with the risks from each substance of concern present in the biocidal product, based on the assessment carried out in accordance with points 13 to 54 of this Annex. In establishing compliance with the criteria set out in point (b) of Article 19(1), the evaluating body shall arrive at one of the following conclusions for each product-type and each area of use of the biocidal product for which application has been made: that the biocidal product complies with the criteria; that, subject to specific conditions/restrictions, the biocidal product can comply with the criteria; that it is not possible, without additional data, to establish if the biocidal product complies with the criteria; that the biocidal product does not comply with the criteria. The evaluating body shall, when seeking to establish whether a biocidal product complies with the criteria in point (b) of Article 19(1), take into account uncertainty arising from the variability in the data used in the evaluation process. If the conclusion arrived at by the evaluating body is that additional information or data are required, then the evaluating body shall justify the need for any such information or data. This additional information or data shall be the minimum necessary to carry out a further appropriate risk assessment.

← CONCLUSIONS · All articles · 55. →

Source: EUR-Lex (Cellar) · retrieved 2026-10-29 · Text as adopted (Official Journal); later amendments are not incorporated in this text.