Authorization of Biocidal Products / Biocidal Product Families
After the decision on the inclusion of a biocidal active substance in the Union's positive list, about 18 to 24 months usually remain to submit an application for authorization of a biocidal product - containing, generating or releasing an active substance to an authority in the EU member states (national authorization) or the ECHA (Union authorization).
As a novel feature, the regulation stipulates that not only individual products can be authorized, but also product families. Within these families, products that meet certain requirements can be combined and authorized in a single application.
The following criteria must be met within a family (BPR Article 3.1(s)):
- similar uses;
- identical active substance(s);
- similar composition with defined limits, similar hazard potential and effectiveness
For an application, data according to Annex III BPR must be generated for the product or products within a family. In addition, the application must contain either a letter of access or a complete data set for the active substance(s) contained. Based on this data, an assessment and summary of the product properties must be prepared.
We can guide you, tailored to your needs, through the complete process or just through individual steps and together with you we create and submit a successful application.
The following is a brief overview about the services we offer. These can be ordered as a full-service package or individually to complement your application efforts.
Our Services at a Glance
- Planning of a product family
- Weighing up the different authorization options
- Authority contacts
- "Data gap analysis" & test strategies
- Literature search
- Communication with data owners
- Commissioning and monitoring of studies
- Creation of the technical dossier (IUCLID 6 data set)
- Preparation of the endocrine disruptor (ED-) assessment
- Supervision/support during the approval process
Are You Affected by BREXIT?
Please do not hesitate to contact us if you have
any questions regarding our Authorization of biocidal products services.
We manage your
regulatory challenges.
Contact us with specific questions, a defined project or as a full-service partner for your regulatory needs.