Authorisation of Hand Sanitizers in the EU
Hand disinfectants (gels, soaps and wipes) are considered biocides in Europe and must be authorised prior to being placed on the EU market (according to the Biocidal Products Regulation (EU) No. 528/2012).
- Active substance evaluation and approval
Active substances such as ethanol, propanol, chlorine, chlorhexidine, and/or quaternary ammonium compounds, which are used in a biocidal product or to treat an article must be assessed positively for safety and efficacy. The assessments are to be completed by the Evaluating Competent Authority of a Member State (MSCA) or the European Chemical Agency (ECHA) and will be approved by the European Commission for a specific Product Type (PT):
Product Type 1: Disinfectants for personal hygiene
Product Type 2: Disinfectants not intended for direct application on people or animals
In accordance with Article 95 of the Biocidal Products Regulation (BPR), companies who are placing the active substance on the market are obligated to ensure that either the “substance supplier” or “product supplier” is included in the list of approved active substances and suppliers published by ECHA.
- Authorisation of biocidal product containing the active substance
Biocidal products must be authorised by Competent Authorities (MSCA or ECHA) prior to being used or sold in the market, and the active substances contained in that product must be previously approved. There are two types of authorisation processes for biocidal products which depend on the approval status of the active substance contained in the product:
- Pending approval for active substance: Biocidal products containing active substances that are currently being reviewed in the Review Programme can be made available on the EU market and used, subject to national registration granted by the relevant Member State. An example of this type of product is an ethanol-based hand sanitizer.
- Approved active substance: When an active substance in the Review Programme is approved for a specific product type, the biocidal product must be authorised according to the requirements and procedures in the BPR. An example of these types of biocidal products are chlorine released from sodium hypochlorite-based hand sanitizers.
- the active substance is approved or under review for the relevant PT
- the use of the product is safe for human, animal and environmental health
- the product is proven to be effective for its intended use(s)
- efficacy claims must be supported by testing
- examples of efficacy claims:
- Fight germs
- Kills 99% bacteria
- Provide antibacterial protection
- examples of efficacy claims:
- Providing regulatory guidance and solutions
- Preparation of dossiers for the registration of biocidal products
- Creation of a testing strategy, study monitoring, risk assessments and preparation of supporting documents
- Liaising with Competent Authorities to discuss authorisation strategies, submitted dossiers , etc.
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