Interim guidance for producing ethanol for use in alcohol-based hand sanitizers: Use of denaturants and other non-medicinal ingredients
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- Use of denaturants in hand sanitizers
- Denaturant formulations
- Recognized denaturants
- Non-medicinal ingredients
Use of denaturants in hand sanitizers
Denaturants are chemicals that are added to ethanol to make it taste bad and therefore unfit for drinking. They are used in health products so people, especially children, do not accidentally ingest the product.
The use of denaturants in hand sanitizers in Canada is recommended but not mandatory. If manufacturers use denatured ethanol in their product, it must be safe and not:
- have any pharmacological effects
- have any effect contradictory to the product's recommended purpose
- exceed the minimum concentration required for the formulation
- adversely affect the bioavailability, pharmacological activity or safety of the medicinal ingredients
An ethanol grade may refer to the ethanol quality (for example, the USP grade) or the denatured ethanol formula (for example, specially denatured alcohol grades). As the denaturant formulations do not specify the quality of ethanol used, denaturants may be added to any quality grade of ethanol.
Before denaturants are added, the product licence holder is responsible for ensuring that the ethanol used in their product is of an acceptable quality grade.
Denaturants used in a denatured ethanol formulation must also:
- meet the quality standards outlined in the Quality of Natural Health Products Guide
- be identified in the Natural Health Products Ingredient Database (NHPID) as an acceptable non-medicinal ingredient (NMI) for this purpose
Denatured alcohols may be used for a variety of different purposes and industries. For this reason, some formulations may be dangerous or toxic when ingested or absorbed through the skin and therefore may not be appropriate for use in health products. (Note: A denaturant formulation is considered a denaturant grade. This is independent of the grade of ethanol to be used in the product.)
If ethanol is being denatured in order to be compliant with the Excise Act, it must be denatured with designated denaturant formulations that have specific ratios and are given an alpha-numeric designation. These formulations are defined in the Denatured and Specially Denatured Alcohol Regulations (made possible under the Excise Act). However, Health Canada has not reviewed the denaturant formulations outlined in these regulations for safety, efficacy and suitability for use in hand sanitizers. Some of the denaturant formulations listed in these regulations are not safe for use in health products.
Every ingredient added as part of a denaturant formulation must be listed on the product licence application form and labelled as an NMI. To be used in a hand sanitizer, the ingredient must first be listed, with a specific denaturant role, in the NHPID.
Please submit an NHPID Issue Form if:
- an ingredient in your proposed product is not in the NHPID or does not have a denaturant purpose associated with it and
- you would like Health Canada to consider this ingredient and/or purpose
Send your request to the Ingredient Support Unit at email@example.com.
For help in completing the form, please consult the NHPID Issues Form Guide.
Before adding a denaturant to ethanol that will be used in the production of alcohol-based hand sanitizers, the manufacturer or product licence holder must confirm that the ethanol and the ingredients within the denaturant formulation meet appropriate quality standards. Please consult the Quality of Natural Health Products Guide.
The following denaturant grades may be used in hand sanitizer formulations in Canada, provided the un-denatured ethanol meets acceptable quality standards.
- Canadian denatured ethanol designated formulations:
- SDAG-3:ethanol denatured with denatonium benzoate or sucrose octaacetate
- SDAG-6: ethanol denatured with denatonium benzoate and tert-Butyl alcohol or sucrose octaacetate and tert-Butyl alcohol
- SDAG-9: ethanol denatured with isopropyl alcohol
- American denatured ethanol designated formulations:
- Formula 3-C: ethanol denatured with isopropyl alcohol)
- Formula 40A: ethanol denatured with tert-butyl alcohol
- Formula 40B: ethanol denatured with denatonium benzoate and tert-butyl alcohol
- Alternative formula recognized for use by the U.S. Food and Drug Administration:
- Formula using 3% triethyl citrate (w/w)
A non-medicinal ingredient (NMI) must be listed in the Natural Health Products Ingredient Database (NHPID) to be included in a hand sanitizer product. The listing must also indicate an acceptable purpose. The NMI must also comply with all listed restrictions outlined in the NHPID as well as the requirements outlined in the Quality of Natural Health Products Guide.
Product licence holders should refrain from using priority food allergens in their products. This is particularly important for products that all Canadians will use in public.
For more information on priority food allergens, please see common food allergens.
For more information on restrictions to NMIs, please consult the guidance document on the licensing approach to produce and distribute alcohol-based hand sanitizers.
The table below also provides information on the quality requirements for specific NMIs used in ethanol-based hand sanitizers, based on guidance by the World Health Organization (WHO).
|Hydrogen peroxide||The low concentration of hydrogen peroxide in the finished product (0.125%) is intended to help eliminate contaminating spores in the bulk solutions and recipients. It is not an active substance for hand antisepsis.|
|Glycerol and other humectants or emollients||
Glycerol (also known as glycerine or 1,2,3-Propanetriol) is added as a humectant at a final concentration of 1.45%, to increase the acceptability of the product.
Other humectants or emollients at a similar concentration may be used for skin care, provided they are affordable, available locally, miscible (mixable) in water and alcohol, non-toxic and not likely to cause an allergic reaction. Glycerol has been chosen because it is safe and relatively inexpensive. Lowering the percentage of glycerol may be considered to further reduce the stickiness of the hand-rub.
|Use of proper
|While sterile distilled water is preferred, boiled and cooled tap water may also be used as long as it is free of visible particles.|
|Addition of other additives||
It is strongly recommended that no ingredients other than those specified in this document be added to the formulations. All NMIs, including denaturants, are to be listed in the product licence application.
If there are additions or substitutions of an NMI after the product licence is issued, a post-licence notification must be filed with the Natural and Non-prescription Health Products Directorate. (See the Natural Health Products Management of Applications Policy for details on post-licensing activities.) You must keep documentation on the safety of the additive and its compatibility with the other ingredients. These documents are to be available to Health Canada when requested.
Any substitutions should come from approved ingredients in the NHPID. If the NMI that you intend to use and/or its purpose is not found in NHPID, you can complete a Natural Health Products Ingredients Database Issue Form. Email the form to firstname.lastname@example.org. You may also email us to request the addition of the ingredient and/or its purpose, along with associated evidence to support the addition.
You must list all the ingredients (medicinal and non-medicinal) on the product label.
|Gelling agents||No data are available to assess the suitability of adding gelling agents to WHO-recommended liquid formulations. Any additives selected for this purpose must be listed in the NHPID and comply with listed restrictions. The addition of a gelling agent must be included in the list of ingredients on the product label.|
|Fragrances||Adding fragrances, while not prohibited, is not recommended because of the risk of potential allergic reactions. As with other ingredients, a fragrance is considered an NMI and must be included in the product licence application and on the product label.|
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