To combat SARS-CoV-2, it is important that healthcare professionals and European citizens have access to disinfectants.
ECHA supports EU/EEA countries and companies to ensure that disinfectants can be placed on the market quickly.
Several Member States have already granted exemptions under BPR Article 55(1) for various active substances. Possibilities are also being explored to give more flexibility to companies. There are certain requirements concerning the composition of disinfectants.
We can support you in the following areas:
- Information on the daily updated status of exemptions according to BPR Article 55(1) for biocidal products with active substances requiring authorisation (e.g. isopropanol, propan-1-ol, sodium hypochlorite, hydrogen peroxide, peracetic acid, iodine, lactic acid, citric acid etc.)
- Notification and registration of disinfectants based on e.g. ethanol, active chlorine, ADBAC, DDAC, formic acid etc.
- Distinction between medicinal product, biocide and medical device
- Application for regular admission for sale at a later date
- Advice on virucidal efficacy, areas of application, restrictions, listings
- Review of labels according to the requirements of the BPR and CLP
- Review of advertising and wording for compliance with the provisions of Article 72 of the BPR
- Questions about safety data sheets and poison centre notifications
Regarding active chlorine, please note: Product type 1, human hygiene or skin disinfection, is NOT marketable for the active ingredient “Active chlorine released from hypochlorous acid”.
Get in touch with us: <email@example.com>: We will be pleased to provide you with a non-binding quotation.