Ethanol - Prepare your EU BPR Product Authorisation
Ethanol (CAS No 64-17-5) is a popular biocidal active substance used in disinfectant products that is due to come to a conclusion soon.
Companies that have biocidal products containing Ethanol in Product Types 1,2 and 4 must submit an application for Product Authorization by the Approval Start date to ensure continuity on the market. This Approval Start date deadline could be as small a window as a year to compile this application making it important to plan now.
In March 2024, Greece submitted a revised assessment report for Ethanol to ECHA for Product type 1,2 and 4 uses examining ethanol hazard properties, evaluating its risks for using it as a biocidal product and assessing the related efficacy data.
This report is now undergoing peer review by experts from all of the EEA countries and Switzerland within the BPC and its working groups. The BPC has mentioned that it is likely an opinion will be adopted in the second half of this year. Therefore, potential product authorisation strategies should be considered.
Availability of contract laboratories to carry out testing will only be more pressured once ethanol is approved. Being prepared for Product Authorisation whether that be single product or product families is extremely important, you should start preparing your product authorisation applications now.
This is important so businesses can maximise the time to prepare for product authorisation.
What falls under the scope of Product-types 1, 2 and 4?
Product Type 1: covers products used for human hygiene purposes, applied on or in contact with human skin for the primary purpose of disinfecting the skin or scalp.
Product Type 2: covers products used for the disinfection of surface, materials, equipment and furniture which are not used for direct application to humans or animals. Usage areas include swimming pools, aquariums, bathing and other waters; air conditioning systems; and walls and floors in private, public, and industrial areas as well as in other areas of professional activities.
Product-type 4: covers the products used to disinfect equipment, containers, and surfaces needed in the production, transport, storage, or consumption of food or feed for people and animals
How can Yordas help?
Rosalinda Gioia, Principal Science (UK) said:
“We have supported clients with Product Authorisation applications under EU BPR for the last 10 years. Throughout our work, we have forged excellent working relationships with several EU Member States Competent Authorities, and have developed a network of service providers such as test laboratories and legal advisers to contribute at all stages of the application process.”
We can help you comply with BPR requirements and provide companies with insight, strategic advice, help preparing the required Product Authorisation dossiers, submission, and follow-up with the authorities. In addition we can help with classification of your products, commissioning of efficacy studies to support your product claims, risk assessments and more.
Get in touch today by clicking here.
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