Biocides control harmful or unwanted organisms chemically or biologically. This broad definition refers to a wide variety of applications which are crucial to our daily lives, including those that improve our quality of life in many ways. At the same time, we must ensure that biocidal products are used without any concern for public health and the environment.
As laid down in the Biocidal Products Regulation (Regulation (EU) 528/2012, BPR), two steps are required to gain EU market access. First, biocidal active substances must be approved EU-wide. All individual products containing such approved substances must then be authorized in the countries in which they will be marketed.
The development of new active substances and the related product authorization is a long and costly trajectory. We have experience with both and have successfully achieved various substance approvals and product authorizations.
Biocidal active approval
Following the identification of an eﬃcacious new molecule, a crucial next step is the setting up of a registration strategy. It’s also important to get in touch with the evaluating Competent Authority in order to create common ground and understanding for the subsequent dossier submission and evaluation process.
We can assist you with all aspects of the regulatory process, including:
- Developing a (cost-)eﬃcient strategy for dossier set-up and substance registration
- Developing the testing strategy for physicochemical, human and environmental hazards as well as eﬃcacy
- Sub-contracting the required test work and taking care of the study monitoring
- Preparing the IUCLID ﬁle and the draft Risk Assessment Report
- Performing hazard, exposure and risk assessments for human health, non-target organisms and environment, both for active substances and for substances of concern
- Assessing the endocrine disrupting properties according to the relevant guidance
- Submitting the dossier via R4BP and interacting with the Member State Authorities and ECHA
- Representing your company in registrant consortia or task forces and interacting with Competent Authorities
Biocidal product authorization
For biocidal products with approved active substances, transitional national admissions (which we can also take care of) no longer apply. You need to ensure that these products are authorized in every member state in which you market them.
If several EU countries need to be covered, national authorization and mutual recognition (in parallel or in sequence) can be applied for. Alternatively, EU-wide market access for most product types can be obtained via a Union Authorization.
For active substances listed in Annex I of the BPR, a simpliﬁed authorization procedure applies.
We can identify the regulatory status of your biocidal products, having developed a quick scan for that purpose. We can also advise you on the best way forward, e.g. the setting up of Biocidal Product Families (BPF) that lead to successful and cost-eﬃcient product authorization under the BPR. We can prepare and submit the dossier(s) on your behalf, in line with the chosen authorization strategy.
The types of activities listed above for active substances approval are also relevant to product authorization. For biocidal product authorization, the preparation of SPC (Summary of Product Characteristics) products may also be relevant. We are well-prepared to perform all of these activities for you.