Are your hand sanitizers compliant with the regulations?
Confronted by a lack of production capacity and extremely high demand for hand sanitizers, many companies and entrepreneurs want to do their bit to increase the supply of this human hygiene product during the COVID-19 pandemic. From cosmetic manufacturers to distilleries, the sugar industry and even the general public, the help is welcome but not all products are effective in killing viruses and/or bacteria.
Regulatory status of hand sanitizers
Hand sanitizers can fall under the scope of different regulations depending on their use, claims and composition. Products encompass hand sanitizers, rubs and antiseptic wipes.
Cosmetics are primarily used to clean and/or moisturise the skin but can also provide an antimicrobial effect. Biocides control organisms harmful to human health such as viruses, while medicines claim to control specific pathogens. However, the borderline between the three is also dependent on the country in which you are placing the product on the market.
The regulatory status will drive the labeling of the product and it may be confusing and difficult to get it right if you have not previously manufactured hand sanitizers. Depending on the product and jurisdiction, the product may need to comply with cosmetic labeling, OTC (Over-The-Counter) labeling, CLP (Classification, Labeling and Packaging) labeling, biocide labeling, medicine labeling and transport of dangerous goods labeling.
Placing hand sanitizers on the market
You may be following the WHO-recommended guidance for formulations using ethanol or isopropanol as the active substance/ingredient in your product, but that doesn’t mean your product can simply be placed on the market. Each country has implemented its own transitional rules for such products which need to be followed.
In the EU, there are 27 active substances in the review programme for human hygiene use (Product Type 1). Eleven substances are already approved while 16 are still under review. Not all active substances in Product Type 1 are appropriate for use in hand disinfection.
In the United States, there are only three active ingredients covered under the OTC monograph for consumers and six active ingredients for healthcare use. Otherwise a new drug submission is required with the FDA before the product can be marketed.
In Canada, active ingredients must be chosen from the current Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in that database, the Food and Drug Regulations (FDR), and the current Cosmetic Ingredient Hotlist, when relevant. Otherwise, a new drug submission is required.
Efficacy and safety of hand sanitizers
Of primary concern for any country is to ensure that products are safe for man and the environment, as well as being efficacious. This is especially important for products that are applied to human skin with the intention of disinfecting it. With some exceptions, including responding to the COVID-19 pandemic using the WHO alcohol-based formulations, manufacturers of hand sanitizers should be able to support their efficacy claims with data.
In addition, it is important that the active substance/ingredient, as well as its concentration, corresponds with its intended use. For example, 60% ethanol is the minimum level for certain uses of alcohol-based hand sanitizers; however such products may not meet the efficacy requirements for a medical environment.
TSG can help
TSG Consulting has many years’ experience in cosmetics and biocides regulations. We understand the country-specific guidelines for COVID-19 in Europe and North America and are working with many companies in this sector. We can help you choose the correct regulatory status for your product depending on the user and market, review your label, prepare the Safety Data Sheet when required and of course notify/register in Europe and North America in accordance with requirements.
It’s easy to assume that bringing a hand sanitizer to market will be simple; the opposite is true and it can be quite complex to navigate the regulations. Let TSG’s specialists bridge the knowledge gap and support you through the process, giving you the best chance of bringing your product to market to help during the current public health crisis.