The positive opinion is a relevant development for companies working with ethanol based biocidal products. At the same time, it does not remove all uncertainty. Safe use and efficacy have been demonstrated for uses within these product types. The BPC did not reach a definitive conclusion on a possible classification of ethanol as a carcinogenic or reprotoxic substance. This means the discussion within the EU CLP framework remains complex, and ethanol continues to carry regulatory risk.
The active substance dossier has now moved to the European Commission for final and legally binding decision making. Once the implementing regulation enters into force, national transitional laws will expire. From that moment, companies must obtain formal Union authorizations or national product authorizations under the Biocidal Products Regulation in order to keep their products on the market.
Do not wait until the deadline is finalized. Protect your EU market position by preparing your ethanol based biocide portfolio in time.
Contact isabel.vanlaanen@triskelion for a quick scan of your product portfolio.
For companies placing ethanol based biocidal products on the EU market, the next phase concerns formal authorization under the BPR. The positive BPC opinion marks a relevant step in the regulatory process. The final legal decision still lies with the European Commission.
Once the implementing regulation enters into force, the current national transitional framework will no longer apply. Companies will then need the appropriate authorization route in place to maintain market access for relevant products.
This becomes relevant if your organization places ethanol based biocidal products on the EU market within PT01, PT02 or PT04.
It is particularly relevant if your current market position depends on national transitional rules, or if your product portfolio still needs to be assessed against the future authorization route under the BPR.
The period before the final deadline is fixed can be used to prepare. Failure to submit the correct dossiers in time may result in products being withdrawn from the European market.
The coming period can be used to take strategic action for ethanol based biocidal products. Triskelion supports the chemical industry in ensuring a seamless transition.
This support includes strategic BPR consultancy to determine the fastest route to market authorization, whether national or Union based. It also includes dossier compilation and validation in line with ECHA guidelines, exposure and risk assessment for intended ethanol containing products and their uses, and efficacy testing support focused on the performance of specific ethanol formulations against bacteria, fungi and enveloped viruses.
Triskelion supports companies with strategic BPR consultancy on authorization route selection, dossier compilation and validation in line with ECHA guidelines, exposure and risk assessment for ethanol containing products and intended uses, and efficacy testing support for specific ethanol formulations.
No. The active substance dossier has moved to the European Commission for final and legally binding decision making.
No. The BPC did not reach a definitive conclusion on possible CMR classification, which means the discussion within the EU CLP framework remains complex and ethanol continues to carry regulatory risk.
The coming period can be used to take strategic action. Failure to submit the correct dossiers in time may result in products being withdrawn from the European market.
Do not wait until the deadline is finalized. Protect your EU market position by preparing your ethanol based biocide portfolio in time.
Contact isabel.vanlaanen@triskelion for a quick scan of your product portfolio.
