Ethanol officially approved as an active substance in biocidal products (BPR)
The European Commission has taken a decisive step in regulating some of the most widely used disinfectant solutions on the market. Through a new Implementing Regulation, ethanol has been formally approved as an existing active substance for use in biocidal products. This decision aligns with the directives of Regulation (EU) No 528/2012 of the European Parliament and of the Council, commonly known as the BPR.
This publication initiates a mandatory transitional period for manufacturing and distributing companies to adapt their registrations and meet new safety requirements before the established deadlines.
Ethanol officially approved: the timeline.
The entry into force of this regulation establishes a clear chronological roadmap for the sector, defining the exact start of enforcement and the validity period of the approval:
- Official approval date: Ethanol will be effectively regulated starting 1 May 2028.
- Approval expiry date: The validity of this measure will span a decade, concluding on 30 April 2038.
Scope of application and purity standards
The new European directive does not affect all uses of the substance equally; instead, it targets three critical areas of hygiene and disinfection:
- Product-Type 1 (PT1): Biocidal products used for human hygiene (such as hand sanitizers).
- Product-Type 2 (PT2): Disinfectants and algaecides not intended for direct application to humans or animals (surfaces, healthcare environments, etc.).
- Product-Type 4 (PT4): Disinfectants for food and feed areas (surfaces in contact with food).
Regarding technical parameters, the regulation stipulates that the minimum degree of purity of the evaluated active substance is 92.6% by weight (equivalent to 95.1% by volume). However, the commercialization of substances with different purities will be permitted provided they are proven to be technically equivalent to the active substance evaluated by the European Union.
Specific conditions and new safety restrictions
The approval comes with stringent conditions. Competent authorities of the Member States and the European Commission will apply rigorous evaluation criteria when granting final product authorisations.
Special attention to toddlers and exposure risks
For products classified under PT2 and PT4, European guidelines require product risk assessments to pay particular attention to the exposure and risks regarding children (toddlers). Any formulation must strictly demonstrate its efficacy and risk reduction in environments where young children are present.
Strict labeling requirements for treated articles
Companies placing treated articles on the market—either treated with or incorporating ethanol—must comply with Article 58(3) of Regulation (EU) No 528/2012. This means that the label of the treated article must provide clear instructions for use and relevant precautions, which must be explicitly detailed in the summary of biocidal product characteristics.
Furthermore, national evaluations will closely scrutinize any specific uses or exposure scenarios that were not covered or addressed in the initial Union-level assessment of the active substance.
How does this impact your business?
The publication of this legal text activates a countdown for manufacturers, importers, and distributors of disinfectant solutions in Europe. Preparing product authorisation dossiers and initiating technical equivalence processes well ahead of the 2028 deadline is essential to prevent product withdrawals from the market.
At Nordiik, we closely monitor regulatory developments to provide you with the technical support needed to market your ethanol-based biocidal products safely. Contact us!
Source: EC
Download the draft approval document here: 26_04975_00_e
