Labeling guidance for hydroalcoholic gels published by the Spanish Agency of Medicines and Medical Device (AEMPS)

The Spanish Agency of Medicines and Medical Device (AEMPS) has published guidance on labeling and safety instructions for the use and preservation of hydroalcoholic gels and solutions.

Hydroalcoholic gels/solutions are classified as biocides or cosmetics depending on the primary function of the product, claims and the content of alcohol.

When they are classified as biocides mostly due to the antimicrobial effect linked to the high concentration of ethanol, their labels should be compliant with the requirements set out by the “CLP” Regulation 1272/2008. This Regulation applies when some ingredients, or a mix of them, are classified as hazardous and lays down the indications and precautions to take to avoid risks.

Therefore, on the basis of the ‘’CLP’’ Regulation, biocidal products must be displayed on the label the appropriate hazard pictograms to visually inform the user that they are dangerous and flammable in an easily identifiable fashion, as well as indications about the nature of the risk and guidance on its use and preservation/mitigation? This is especially relevant due to the high concentration of alcohol in products that may cause serious eye irritation and are toxic in case of ingestion.

When gels and solutions are considered as cosmetic products, due to their main  cleaning  function and minimal percentage of alcohol they are not required to include all the mentioned information on the label However, the AEMPS recommends that they nevertheless follow the same precautions as the gels considered biocides, and they have elaborated some guidance and precautions to use and preserve them appropriately. Find more information on the following link.


María Nagore Corell & Floriana Dibitetto

VIP Department & R&D Department

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