Alcohol Task Force

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Ethanol, Propan-1-ol and Propan-2-ol: Biocidal Active Substances

Beside many other applications in industry and the household, Ethanol, Propan-1-ol and Propan-2-ol are globally available, highly effective antimicrobial substances. Alcohols have a very rapid onset of activity, and a broad range of efficacy covering as well bacteria (including mycobacteria), fungi, and (especially in case of Ethanol) viruses. There are no indications that disinfection with alcohols leads to the selection of resistant strains. On the contrary, alcohols are effective against bacterial strains, which became multi-resistant against antibiotics. The use of alcohols for disinfection is vital in the fight against the spread of multi-resistant germs in hospitals.

Most important fields of the biocidal application of alcohols are hand and skin disinfection and disinfection of hard surfaces.


Authorisation of Ethanol, Propan-1-ol and Propan-2-ol as Biocidal Active Substances according to BPD 98/8/EC resp. BPR 528/2012

The European rules about placing biocidal products on the market require that a biocidal product can only be marketed, if the biocidal active substances on which it is based have been evaluated in an elaborate authorisation process for a positive risk-benefit relation.

However, in case of the Ethanol, Propan-1-ol and Propan-2-ol, the biocidal use of the substances represents only a small portion of the overall business. Therefore, the substance manufacturers at the time were not in a position to invest significant sums of money in the authorisation of the alcohols as biocidal active substances acc. to BPD/BPR.

In this situation, a small group of companies manufacturing disinfectant products with alcohols, decided to jointly support the authorisation of Ethanol, Propan-1-ol and Propan-2-ol for Product Types 1, 2 and 4 on their own, and formed the Alcohol Task Force (ATF).

In the following years, the ATF undertook all necessary efforts to enable the authorisation of the alcohols as biocidal active substances:

  • Establishing complete authorization dossiers and paying the fees for the evaluation
  • Fulfilling additional data requests after submission
  • Defending the substances in the risk evaluation process

Currently,

Propan-2-ol and Propan-1-ol have has been successfully authorised

For Ethanol, the discussion of the Competent Authority Report (CAR) has been finalised. The authorisation process is still ongoing.

As a result, the ATF is the owner of fully evaluated and assessed dossiers, on which the substance authorisations are (resp. will be) based on. The dossiers are unique to this respect and the endpoints, the substance quality, the exposure scenarios and the included risk assessment are benchmark for the authorisation process of biocidal products. For this purpose, the ATF offers Letters of Access to its dossiers, containing all endpoints. In addition, Letters of Access to the complete dossiers (needed for Article 95 listing) are also available to all interested parties. The conditions for LoAs are based on the REACH principles for data sharing.

Regarding the substance Propan-1-ol, which was approved by Regulation 2017/2001 with date of entry into force of 1 May 2019, the ATF (Sub-Group Propan-1-ol) would like to inform applicants and competent authorities that the ATF dossier that was used to support the approval of Propan-1-ol under the BPR includes two key vertebrate studies (as confirmed by the final RMS Assessment Report), which are therefore both required for authorisation of products containing 1-propanol, and that, at present, the ATF dossier is the only dossier which includes these two studies (or access to these studies).