Interim guide on the production of ethanol for use in alcohol-based hand sanitizers: Technical-grade ethanol

Published: July 9, 2020
Updated: July 30, 2021

On this page

• Overview
• General information about this temporary authorization
• Licensing and notification procedures
• Contact us

Overview

The COVID-19 pandemic has caused a shortage of ethanol that meets pharmacopoeial (for example, USP) and food-grade (for example, Food Chemical Codex) standards. These and other acceptable ethanol standards are in the interim guide on the production of ethanol for use in alcohol-based hand sanitizers.

To increase the supply of ethanol, Health Canada has temporarily authorized the use of technical-grade ethanol in hard-surface disinfectants and hand sanitizers. This authorization is on a short-term, case-by-case basis and granted under specific conditions.

We have assessed the risks and benefits of using specific sources of technical-grade ethanol in hand sanitizers. When used as directed and for a limited period, the public health benefit of using hand sanitizers with approved sources of technical-grade ethanol to limit the spread of COVID-19 outweighs the risk.

Ethanol that doesn't conform to USP standards (or to comparable standards and the acceptable deviations outlined in the interim guide) or that isn't on the list of approved suppliers of technical-grade ethanol can't be used in the manufacturing of hand sanitizer products.

The notice to industry, published on April 15, 2020, updated on June 26, 2020, and again in September 2020, outlines the conditions for producing hand sanitizers with technical-grade ethanol. It also:

• lists the requirements for companies that supply technical-grade ethanol
• includes specific instructions for current and potential product licence holders who may want to use technical-grade ethanol in the production of hand sanitizers

General information about this temporary authorization

As with all alcohol-based hand sanitizers, to manufacture and sell hand sanitizer with technical-grade ethanol, a company needs both a site licence and a product licence. The company also requires a no objection letter (NOL) granted by Health Canada to authorize the use of technical-grade ethanol. Companies that currently hold a NOL to use technical-grade ethanol are included in the list of approved manufacturers.

Only suppliers that have received temporary authorization may produce and sell technical-grade ethanol for use in hand sanitizers. Suppliers and the approved technical-grade ethanol products are included in the list of approved suppliers.

Authorized distributors may also distribute or resell Health Canada-approved technical-grade ethanol products from approved suppliers for use in the production of hand sanitizers. These authorized distributors are included in the list of approved distributors.

Technical-grade ethanol purchased for the manufacturing of hand sanitizers must be sourced from a Health Canada-approved supplier or distributor. Hand sanitizers containing technical-grade ethanol from unauthorized suppliers or distributors can't be sold, distributed or donated. Health Canada will take enforcement action on any case where this requirement hasn't been met.

The process to begin using technical-grade ethanol is outlined below. It is independent of the process to license the product with Health Canada. Health Canada won't be issuing or amending product licences to specifically include the use of technical-grade ethanol. New and previously authorized products must comply with the conditions outlined in their respective product licences.

Once the supply of USP or food-grade ethanol is stable, licence holders must go back to using the higher-quality grades of ethanol if they wish to continue to manufacture these products.

Manufacturers of hand sanitizers and/or hard-surface disinfectants containing technical-grade ethanol must discontinue production and distribution:

• by March 31, 2022, or
• when they are notified by Health Canada (whichever comes first)

Distributors of technical-grade ethanol must discontinue distribution:

• by February 15, 2022, or
• when they are notified by Health Canada (whichever comes first)

Suppliers of technical-grade ethanol must discontinue production and sale:

• by December 31, 2021, or
• when they are notified by Health Canada (whichever comes first)

We will notify you in advance if there is an extension on this deadline.

In health care and commercial settings, technical-grade hand sanitizers must be labelled for personal use only. This is because they have not met the evidence requirements for higher-risk uses (for example, as pre-surgical scrubs).

Licensing and notification procedures

To use technical-grade ethanol to manufacture and sell hand sanitizers in Canada, companies must follow the steps below.

If you're applying for a new product licence

1. Send in your application for a product licence as per the licensing approach to produce and distribute alcohol-based hand sanitizers
   • Wait to receive a product licence before proceeding to Step 2
2. After receiving a product licence (NPN), you will submit a notification on the use of technical grade ethanol form with a copy of your bilingual product label to hc.rmd.coordination-dgr.sc@canada.ca
   • Use the subject line Technical grade ethanol notification - <NPN> <company code>
3. Don't distribute your finished product until you receive an NOL from us
   • The NOL will indicate the conditions of this approval and the acceptable date of last sale for products containing technical- grade ethanol

If you have an existing product licence

If you are licensed to manufacture and sell a hand sanitizer, you may request to use technical-grade ethanol from an approved supplier in your product. The terms of your market authorization can't be changed.

1. Download and complete the notification on the use of technical grade ethanol form
2. Send 1 form for each product, with a copy of the modified bilingual label (see below), by email to hc.rmd.coordination-dgr.sc@canada.ca
   • In your subject line include Technical grade ethanol notification - <NPN> <company code>
3. Make sure you have provided all the information requested in the notification form and that you meet all the requirements
   • You can't manufacture or distribute your product until you have received an NOL from Health Canada

Completing the Notification on the Use of Technical-Grade Ethanol Form

1. Review all information on the form before completing it
2. Fill in all fields related to your company and the affected product
3. Provide the name, address and contact information of the technical-grade ethanol supplier
   • also provide a copy of your contractual agreement between the hand sanitizer manufacturer and the technical-grade ethanol supplier
   • identify the acetaldehyde level of your technical-grade ethanol (this is identified on the Certificate of Analysis)
4. Provide a copy of the bilingual product label that meets the labelling requirements outlined below and specify if your product has an external packaging (for example, box) in addition to the primary container (labelling information must appear on both the primary container and the external packaging, if applicable)
   • depending on the impurity level of the technical-grade ethanol, complete section C or D (see the labelling requirements sections below for more information)
5. Specify what sector(s) the product is intended to supply (for example, hospitals and clinics, commercial, retail, domestic or personal use, or all of the above) and the area/region of distribution (for example, province or territory, city)
6. Ensure the senior official (chief executive officer or director) signs the form (electronic signatures are acceptable)

Labelling requirements

Existing labelling requirements for the antiseptic skin cleansers monograph and those outlined in the guidance document on the licensing approach to produce and distribute alcohol-based hand sanitizers must be followed for all hand sanitizer products. The product label must not include any false or misleading information.

As indicated in the recently updated risk assessment summary, additional warning statements aren't required for authorized products containing technical-grade ethanol that meets specified levels of impurities, including acetaldehyde levels equal or less than 75 ppm. However, authorization is still required from Health Canada to manufacture products containing technical-grade ethanol. For products using technical-grade ethanol containing acetaldehyde levels above 75 ppm, the following information must be added to the product label (on the product container and the external packaging, if applicable):

• in English:
  • under Medicinal Ingredients: "Ethanol XX% (technical grade)"
  • under Directions: "Adults only"
  • under Warnings:
    • "Do not use on broken or damaged skin";
    • "Not recommended for use by women who are pregnant or breastfeeding";
    • "Do not inhale"
  • include a statement for consumers to "Report any incident to Canada.ca/drug-device-reporting"
  • include "Questions?: Call 1-866-234-2345 to report any adverse reaction"
• in French:
  • sous « Ingrédients médicinaux », spécifiez « Éthanol XX% (qualité technique) »
  • sous « Mode d'emploi », spécifiez « Adultes seulement ».
  • sous « Mises en garde », spécifiez «
    • « Ne pas utiliser sur peau endommagée ou présentant des lésions »;
    • « Utilisation non recommandée pour les femmes enceintes ou qui allaitent »;
    • « Ne pas inhaler »
  • inclure une déclaration demandant aux consommateurs de « Signalez tout incident à Canada.ca/medicament-instrument-declaration »
  • inclure « Questions? Appelez le 1-866-234-2345 pour signaler tout effet indésirable »

End-of-interim measure

For suppliers

As indicated in the notice to industry, once the regular supply of USP or food-grade ethanol for hand sanitizers stabilizes, temporary authorization granted to technical-grade ethanol suppliers will end. Current authorizations are valid until December 31, 2021. We will provide authorized suppliers 2 weeks' notice to discontinue sales to manufacturers of hand sanitizers. Suppliers of technical-grade ethanol may choose to change from technical-grade to USP or food-grade ethanol before this interim measure expires. However, you must first inform Health Canada of this change. You may not advise your customers of this change until we confirm you have complied with the requirements of these standards.

For distributors

Authorized distributors of technical-grade ethanol have until until February 15, 2022, or earlier to distribute their stock and discontinue distribution. It is important to closely monitor your inventory.

For manufacturers

Manufacturers of hand sanitizers containing technical-grade ethanol have until March 31, 2022, or earlier to use up their stock and discontinue production and distribution. It is important to closely monitor your inventory.

When this interim measure ends, licence holders will be expected to return to USP or food-grade ethanol for manufacturing hand sanitizers and hard-surface disinfectants. All manufacturers using technical-grade ethanol will be asked to:

• provide information on their remaining stock
• indicate their final date of production using technical-grade ethanol
• sign a declaration that they will switch to USP or food-grade ethanol or cease production entirely

Manufacturers may choose to go back to using USP or food-grade ethanol before this interim measure ends.

You must keep records to demonstrate that testing has been conducted for each lot or batch of raw material in accordance with the Natural Health Products Regulations. Your records should demonstrate that the material is fit for this purpose and complies with the corresponding pharmacopoeial ingredient monograph.

We will take a risk-based approach to addressing any non-compliance.

Contact us

For questions about this annex or the use of technical-grade ethanol in hand sanitizers, you may contact our Natural and Non-prescription Health Products Directorate by email at nnhpd.consultation-dpsnso@hc-sc.gc.ca.