With the onslaught of COVID-19, a warrior has come to the forefront in public health protection – the humble hand sanitizer. Companies, from huge distilleries to small health and beauty firms, want to sell sanitizers to a public eager to be armed with the best protection possible. But this common product, which in pre-virus days was treated as an afterthought, is actually a regulated “drug” according to both Health Canada and the US Food and Drug Administration. Creating a hand sanitizer is more complicated than dishing up a mix of alcohol and gelling agents. Fortunately, Health Canada is assisting suppliers to do it the right way with a new interim measure to expedite access to disinfectants and hand sanitizers.
Alcohol-based sanitizers (the typical type of hand sanitizer) are regulated by Health Canada under the “Natural Health Products Regulations” (NHPR). These sanitizers contain either ethanol (found in beverage alcohol, which is why distilleries and breweries are capable of making it) or isopropanol (found in rubbing alcohol). The NHPR has strict requirements for quality control and proof of effectiveness – we don’t want hand sanitizer coming on the market that doesn’t actually protect people. This will, in normal times, require that the manufacturer obtain a Site License and a Product License before selling the sanitizer.
However, we’re not in normal times, and Health Canada has relaxed the rules in order to increase the supply of sanitizers for the personal use of the public. (Note this doesn’t apply to products specifically for use in medical facilities.) These new rules apply to products that meet Health Canada’s Antiseptic Skin Cleaners (Personal Domestic Use) monograph, which lays out known safety and effectiveness data for standard concentrations of ethanol and isopropanol cleaners, so suppliers don’t have to provide data on products already well-known to be safe.
Health Canada’s goals are, as they explain:
“While these products are typically subject to regulatory requirements, such as licensing and bilingual labelling, Health Canada will allow certain products to be sold in Canada under this interim measure, including:
- products that are already authorized for sale in Canada but are not fully compliant with Health Canada requirements (e.g., English-only labelling, different packaging from what was authorized); and
- products that are not authorized for sale in Canada, but are authorized or registered in other jurisdictions with similar regulatory frameworks and quality assurances.”
In addition, Health Canada is streamlining and speeding up the process of approvals for both products and facilities.
For those who want to import hand sanitizers, or start manufacturing them in Canada, Health Canada has two main points.
First, if you’re an importer who already has a Drug Establishment Licence (DEL) or Site Licence (SL) – to conduct activities related to hand sanitizers and disinfectants that are covered by this measure, you must notify Health Canada in advance at firstname.lastname@example.org and give them details regarding the new product you’re importing. Furthermore, you’ll have to maintain records that will allow Health Canada to issue a product recall, in the event there are any problems with the product. However, you may be exempted from requirements such as bilingual labelling for the duration of the emergency period.
Second, if you’re a Canadian company that does not currently have a DEL (Drug Establishment License) or SL (Site License) to conduct activities related to hand sanitizers and disinfectants – You may submit an application for expedited review to Health Canada. Authorization will be granted normally on attestation that your site complies to the requirements, and should be granted within 24 to 48 hours. (Yes, when they say they’ll expedite things, they’re not joking.)
Domestic companies that do not currently have a DIN or NPN for a disinfectant or hand sanitizer they wish to sell at this time may also submit an application for expedited review to Health Canada, and be generated a number.
It appears that Health Canada inspectors are looking out for unauthorized sales of sanitizers, because when not manufactured properly they can be ineffective or even dangerous. However, as this article indicates, they appear willing to work with companies who may have been confused by the original requirements but do have a safe and much-needed product to provide to the Canadian public.
By the way, if you’re planning on manufacturing hand sanitizer, or supplying the companies who do, you may want to engage with the Hand-Sanitizer Manufacturing Exchange. Health Canada and concerned industry groups have collaborated on this site that allows companies to exchange information to locate available materials, services or manufacturing capacity needed for production.
Of course, the US has also created provisions, which are summarized at https://www.fda.gov/media/136289/download. We’ll address these in another blog entry.
Did you know ICC the Compliance Center is an “essential business”? We remain open to provide needed support to the transport industry. You can order any supplies on our website, or call us here at 888-442-9628 (U.S.) or 888-977-4834 (Canada). We can take your order and ship it to you safely and quickly. And of course, our regulatory staff is still on the job, ready to assist with any questions you may have about transportation or labelling requirements.
We have all the products you need to ensure you’re complying with regulations around the transportation of hand sanitizers:
Limited Quantity ‘Y’ Label, 4″ x 4″, Gloss Paper, 500/Roll
Hazard Class 9 – Miscellaneous Hazardous Material, 4″ x 4″, Gloss Paper, Non-Worded, 500/Roll
Hazard Class 3 – Flammable Liquid, 4″ x 4.75″, Gloss Paper, Non-Worded Proper Shipping Name Label, Blank, 500/Roll
Limited Quantity Label, 4″ x 4″, Gloss Paper, 500/Roll