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Ethanol Approval in Biocidal Products

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Ethanol in Biocides: Regulatory Developments Following ECHA BPC Opinion

On 24 February 2026 the European Chemicals Agency’s (ECHA) Biocidal Products Committee (BPC) adopted the opinions supporting the approval of Ethanol as active substance in the following biocidal product-types:

  • Product-type 1: Human hygiene products, such as hand disinfectants;
  • Product-type 2: Disinfectants and algaecides not intended for direct contact with humans or animals; and
  • Product-type 4: Products used in food and feed areas.

Following the BPC adoption, the European Commission will prepare a draft Implementing Regulation proposing either approval or non-approval of the substance. If supported by the EU Member States in the Standing Committee on Biocidal Products, the Commission will formally adopt the decision and it becomes legally binding.

If ethanol is approved as active substance for the above-mentioned product types:

According to EOF Circular No. 39102/10-5-2016, applications may be submitted to the National Organization for Medicines (EOF) for the authorisation of biocidal products containing ethanol as active substance, up to one year before the approval date that will be specified in the relevant Implementing Regulation. For variations that do not require evaluation, as well as for renewals, applications will be accepted up to six months before the specified approval date. Following the approval date, the provisions of the EU Regulation 528/2012 will apply and marketing authorisation holders will be required to take one of the following actions:

I) Submit an application for parallel mutual recognition of the biocidal product for the Greek market in accordance with Article 34 of Regulation (EU) No 528/2012.

II) Apply for Union authorisation of the biocidal product to the European Chemicals Agency (ECHA), in accordance with Articles 41 to 43 of Regulation (EU) No 528/2012.

III) Apply for a national authorisation of the biocidal product in Greece, in accordance with Article 29 of Regulation (EU) No 528/2012.

If ethanol is not approved as active substance for the above-mentioned product types:

Products containing the substance must be withdrawn from the EU market within the applicable transition periods.

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