Biocidal active substances and biocidal products are subject to a complex approval/authorisation process.
Legislation in Europe foresees a two-step procedure for biocides, in which the biocidal active substances must first be approved. In a second step, authorisation can be sought for biocidal products which can only contain active substances that have already been approved – either Union-wide or in individual EU member states. Both procedures represent very complex processes in which specific use patterns and different product types may increase the regulatory requirements and thus the workload for dossier preparation enormously. Furthermore, approvals/authorisations are only valid for a limited period of time (e.g. 10 years) and need to be renewed before the end of the permitted period to keep them on the market, which usually means a complete re-evaluation.
However, exceptions apply to this principle. Active substances covered by the review program and biocidal products containing these active substances can already be placed on the market while a final decision on an active substance approval is still pending.
In most industrial countries worldwide, biocidal products must be listed in the corresponding national directories before they can be placed on the market. Additional regulations often apply to handling and application, which require the registration (approval/authorisation) of an active substance and/or product similar to the procedures applied in the EU.
Given that such a high level of knowledge, experience and efficiency is required, it is a major challenge to place products on the market in such a tightly regulated industry and, indeed, to keep them there (“renewal”).
We are your service partner for the successful approval, registration/authorisation of biocidal active substances and products and their renewal.
- Derivation of all regulatory obligations and data gap analysis in the framework of European and worldwide biocide legislation
- Compilation of active substance and product dossiers in accordance with the Biocidal Products Regulation (EU) No 528/2012 (BPR) and other national regulations across the world
- Support or entire takeover of all process steps – from your product idea, initial data gap analysis, dossier preparation and submission, via defence of submitted active substance and product dossiers, to final approval/authorisation
- Initiation and monitoring of studies on physico-chemical properties, physical hazards, (eco)toxicology, environmental behaviour and efficacy at eligible CROs/labs, if necessary
- Authorisation of single products, product families and in-situ systems
- Compliance checks according to applicable rules for treated articles