Finally, ECHA have published the Competent Authority Report (CAR) for ethanol for Product Types 1, 2 and 4.
Earlier this year, The European Chemicals Agency (ECHA) Biocidal Products Committee (BPC) supported the approval of ethanol for use in disinfectants (PT1, PT2 and PT4).
So, what does this mean?
The publication of the CAR provides the details of the evaluating authority’s scientific and regulatory conclusions on ethanol and provides the endpoints required to complete the risk assessments required for product authorisation.
If you place ethanol-based disinfectants on the EU market, you can now begin the initial steps to ensure you will have a complete and compliant dossier. Something about assisting with regulatory strategy?
Data Gap Analysis
The CAR contains a reference list of studies submitted to support the evaluation and approval of ethanol. This list can be used to identify which studies you already have, new studies you need to generate for your product and AS studies you require a letter of access to. Based on this information, you can have a clearer picture of how much data is missing from your dossier and the potential costs for filling the data gaps.
Preliminary Risk Assessment
The list of endpoints are now available in the CAR to allow for preliminary risk assessments for human health and environmental emissions to be performed. This is a useful step to predict exposure to the end user and therefore verify if the intended use and application of your product will pass the required assessments ensuring safe use. Preliminary risk assessments provide early identification of potential issues and allow for risk mitigations and refinements to be determined.
Completing these steps early allows companies to plan costs more efficiently, especially around testing and data access. It is also a good time to review your product portfolio, determine the correct registration route and ensure transitional registrations are in place for continued market access whilst your BPR dossier is being evaluated.
If ethanol forms part of your product portfolio range, it may be worth taking some time now to understand your position and consider next steps.
Of course, this is not the end of the story for ethanol. The classification has not yet been finalised for CMR or ED, but restrictions/RMM for some indoor uses for PT2 and 4 could be expected. The final classification is expected later this year.
If you need support please contact our Head of Regulatory Affairs, Priya Patel at priya.patel@enviresearch.com