Hand Gel Regulatory Requirements

Ensure safety products are compliant with local regulations and notify/register the products properly.

March 12, 2020

Due to the outbreak of coronavirus (COVID-19) in Europe, there is a high demand for human hygiene products in the European market. Before exporting products to Europe, manufacturers should ensure the products are compliant with local regulations and notify/register the products properly.

An alcohol rub or hand gel can be considered as a cosmetic product in Europe if it does not make any biocidal claims, for example, "anti-bacterial," "anti-virus," "kills 99.9% germs." To market a cosmetic product in Europe, you must comply with the EU Cosmetic Regulation (EU) 1223/2009. A Cosmetic Product Safety Report (PCSR), label review, Product Information File (PIF), Cosmetic Product Notification Portal (CPNP), and Responsible Person (RP) will be needed.

If the products make biocidal claims on the packaging and in advertising, the product is within the scope of the Biocides Product Regulation (BRP) (EU) 528/2012 and is considered as a Product Type 1 (PT1) — human hygiene biocidal product. Currently, ethanol is under evaluation as an active substance in Europe, and, therefore, the national legislation under transitional measures applies, meaning that the products may require notification or registration in each of the EU member states. Once ethanol is approved, the BPR will apply across Europe.

In the United States, these products are over-the-counter drugs that must comply with the requirements set out in the 1974 monograph for hand sanitizers. The products do not require registration provided they do not deviate from the provisions set up by the FDA for that product category. An alcohol hand sanitizer needs to contain ethyl alcohol or ethanol at a level of 60 to 95 percent or isopropyl alcohol at a level of 70 to 91.3 percent. It must also be made under GMP (Good Manufacturing Practices) requirements, and the production facility must be listed with the FDA.

How Exponent Can Help

Exponent can provide safety assessments and regulatory compliance services for cosmetics and biocidal products worldwide. We can help to review your product and plan a compliance strategy for the markets where you intend to distribute and sell.