EU Regulation 528/2012 (EU-BPR, the “Biocides Regulation”) replaced Directive 98/8/ EC, the “Biocides Directive” and came into force on 1 September 2013. It is expected to be applied in full in 2021/2022.
Biocidal products, such as disinfectants, wood preservatives, insecticides, insect repellents and rodenticides, are products designed and used for the purpose of destroying or controlling dangerous or unwanted organisms that can have harmful effects on the environment, on animals, people, economic activities or economic assets. Biocidal products are used in a wide variety of situations in the industrial, professional and domestic sectors.
The purpose of the Biocides Regulation is to facilitate the functioning of the European market while ensuring a high level of protection of human health and animals and the protection of the environment.
The authorisation scheme for Biocidal Products is based on a two-step process: the first is that a biocidal product’s active substance must be approved at European level after an assessment of its dangerous properties and of the possible risks attached to its use; the second is that must be authorised at European or Member State level.
In fact the approach is reversed for active substances which were already present on the European market at the time of the entry into force of the Biocides Directive (98/8). This Directive laid down a transition period for the evaluation (examination/review) of active substances, during which the products containing the active substance under investigation can still be placed on the market in accordance with the practices (legislation) current in individual Member States at the time.
