Greece’s National Medicines Organization (EOF) has announced a ban on the distribution and sale of ASEPTOMAN gel, an alcohol-based hand sanitizer made by Dr. Schumacher, on the Greek market.
The product is an alcohol-based gel sanitizer that had been widely available in the country through both pharmacies and online retail channels — including major e-commerce platforms. It was marketed as a fast-acting, fragrance-free hand disinfectant effective against bacteria, fungi, and viruses, including HBV, HIV, and HCV.
The EOF’s Decision
According to the EOF, the ban applies to ASEPTOMAN gel because the product was placed on the market before the evaluation process for its biocide marketing authorization had been completed. This constitutes a violation of Article 17, paragraph 1, of EU Regulation 528/2012, the EU’s Biocidal Products Regulation (BPR), which requires that all biocidal products must be formally authorized before they can be sold or distributed anywhere in the European Economic Area.
BOURNAS MEDICALS, which acts as the product’s distributor in Greece, is required to immediately notify all recipients and proceed with withdrawing the sanitizer from the market within a reasonable timeframe. The EOF’s decision will remain in effect until the relevant marketing authorization for the product is officially issued.
What Is the EU Biocidal Products Regulation?
The EU BPR, which has been in full force since September 2013, governs the sale and use of all biocidal products across member states, a category that includes hand sanitizers, surface disinfectants, insecticides, and preservatives, among others. The regulation requires that biocidal products and their active substances must be authorized before being used or sold on the European Union market.
For hand sanitizers specifically, they fall under Product Type 1, defined as disinfectants for personal hygiene, and must be assessed and authorized by the competent national authority of a member state or by the European Chemicals Agency (ECHA) before reaching consumers. The authorization process involves evaluating the product’s active substances for safety and effectiveness, a step that can be both time-consuming and costly.
The case of ASEPTOMAN gel is far from isolated. In a major enforcement sweep, national enforcement authorities across 29 countries checked over 3,500 biocidal products, and found that 37% were non-compliant with at least one legal requirement. Around 18% had fundamental deficiencies, either lacking product authorization entirely or containing non-allowed active substances. Most biocides with such major violations were disinfectants. All products lacking authorization or containing non-allowed substances were withdrawn from the market, and in some cases criminal complaints or fines were issued.
