The Competent Authority Report (CAR) for the active substance ethanol under the Biocidal Products Regulation (BPR) has finally been published for Product Types (PT) 1, 2 and 4.
This publication represents a major milestone in the EU active substance review programme and provides the first comprehensive regulatory assessment that will shape the future authorisation of ethanol-based biocidal products.
The CAR offers valuable insight into the evaluating authority’s scientific and regulatory conclusions, allowing companies to conduct a dedicated risk assessment with the reference values of ethanol.
Now it is time to proceed with important tasks like:
- Identify any data gaps or regulatory considerations that may affect future product authorization.
- Define a proactive strategy for the next stages of the BPR product authorisation process, based on increasingly clear regulatory endpoints.
Have you already assessed what the Ethanol CAR means for your products and your regulatory strategy?
TEAM mastery can support you throughout the entire product authorisation process, starting today with a preliminary assessment of your formulations of interest and the currently available technical documentation and test data.