December 11, 2020 By danny.carvalho@ymail.com Off

Hard surface disinfectants and hand sanitizers: Information for manufacturers

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Licensing approach

The COVID-19 pandemic has created an unprecedented demand and urgent need for disinfectants and hand sanitizers. But the manufacture and sale of disinfectants and hand sanitizers require authorization from Health Canada before they can start.

To increase access to these products in Canada, we have taken the following interim measures:

  • published an interim step-by-step guide to obtaining a licence to manufacture and sell an alcohol-based hand sanitizer, an interim guide on the production of ethanol and an interim guide on the production of isopropyl alcohol
  • providing administrative flexibilities to companies on site licence renewal applications, such as:
    • site licence holders can submit applications for renewal less than 30 days before the site licence expiry date
    • site licences with an expiry date between March 10, 2020, and November 30, 2020, have been extended to December 1, 2020
  • prioritizing the review of applications for disinfectants that can demonstrate efficacy against the COVID-19 virus
  • facilitating access to products that may not fully meet current regulatory requirements
  • allowing licensed pharmacists to compound and sell hand sanitizers

For more information on our interim measures, please contact us:

How to obtain authorization to produce and sell hand sanitizers

Manufacturers of alcoholic beverages and other alcohol producers may apply for authorization to manufacture and sell alcohol-based hand sanitizers through the step-by-step guide.

To obtain authorization, manufacturers must submit a:

  • product licence application to support the safety, efficacy and quality of their alcohol-based hand sanitizer
  • site licence application to support that the site being used to manufacture, package and/or import their alcohol-based hand sanitizer meets good manufacturing practices

Interested companies should follow the instructions outlined in the guide on the licensing approach for the production and distribution of alcohol-based hand sanitizers. Please also see the interim guide on the production of ethanol for use in alcohol-based hand sanitizers.

Once hand sanitizers are authorized through this process, they are added to the list of approved hand sanitizers. We are updating the list regularly.

Companies are required to maintain records to facilitate product recalls if needed.
If you have any questions on the application process, please contact us at hc.nnhpd-dpnso.sc@canada.ca.

Expedited access for importers

The expedited access measure allows importers to supply sanitizers or disinfectants that:

  • do not fully meet Health Canada requirements or
  • are authorized or registered in other jurisdictions where the regulatory frameworks and quality assurances are similar

Under this measure, importers must:

  • notify Health Canada prior to importing
  • keep records in the event of a product recall

Contact us by email at hc.covid19healthproducts-produitsdesante.sc@canada.ca for an attestation form.

This attestation form helps us work with the Canada Border Services Agency to facilitate importation. The information provided helps authorities take necessary action if the product is considered to pose a health risk.

Distribution to hospitals and clinics

We are facilitating access to products that may not fully meet current regulatory requirements to address the urgent need for products by hospitals and clinics.

As part of this interim measure, an alcohol-based hand sanitizer product authorized for personal use can also be distributed to hospitals and clinics once we are notified.

You must notify us by email at hc.nnhpd-dpsnso.sc@canada.ca. Your email should include:

  • COVID-19 product notification in the subject line
  • information on the product in the body of the email (for instance, NPN) and its intended distribution

Please note: The existing label referencing personal use should continue to be used. Any changes to the label will need to be reviewed by us.

You do not need to wait for a reply or confirmation from us that we have received the notification email before distributing the product to hospitals and clinics.

For more information, please contact us by email: hc.nnhpd-dpsnso.sc@canada.ca

Disinfectant claims for COVID-19

Manufacturers and distributors of hard-surface disinfectants can make indirect efficacy claims for SARS-CoV-2, the virus that causes COVID-19, if these authorized products are already:

  • labelled as a broad-spectrum virucide
  • carry a specific claim against non-enveloped viruses of the picornaviridae, caliciviridae, astroviridae, reoviridae or papillomaviridae families or
  • carry a specific claim against a specific coronavirus, such as:
  • MERS-CoV
  • SARS-CoV
  • human coronavirus strain 229E

Alternate sources of active ingredients for disinfectants and non-alcohol-based hand sanitizers

Alternate sources of active ingredients for disinfectants and hand sanitizers may be accessed.

Hard-surface disinfectants

When there are active ingredient shortages for hard-surface disinfectants, manufacturers may change suppliers for their active ingredients if the Chemical Abstracts Service (CAS) numbers and concentrations are identical.

Non-alcohol-based hand sanitizers

When there are shortages of active ingredients manufactured under Good Manufacturing Practice (GMP) compliant conditions, manufacturers may use non-GMP active ingredients. These ingredients are listed in the antiseptic skin cleansers monograph. The non-GMP active ingredients must meet a quality standard.

Where there is a pharmacopoeial standard (schedule B, Food and Drugs Act) for the active ingredient, the ingredient should be manufactured and tested against that standard. However, other quality standards such as ISO (International Organization for Standardization) and HACCP (Hazard Analysis and Critical Control Point Approach) are also acceptable.

Manufacturers of hard-surface disinfectants and non-alcohol-based hand sanitizers are responsible for conducting a risk assessment to ensure that a change in ingredient source will not affect the product’s safety, efficacy and quality. For example, you should conduct stability testing using representative batches of the new sources of active ingredients to ensure that the product’s shelf life remains the same. The dosage form fabricator and the DIN holder continue to be responsible for ensuring all applicable requirements of division 2 (GMP) of the Food and Drug Regulations are met.

When the interim measures expire once the regular supply stabilizes, production using the original active ingredient source must resume. However, the existing product stock can be used up.

Compounding information for pharmacists

During the COVID-19 pandemic, we are allowing licensed pharmacists to compound and sell hand sanitizers in their province or territory of practice. We recommend pharmacists follow a reputable formula, such as the one published by the World Health Organization.

Should a pharmacist wish to distribute their product for resale by a third party, they would be required to obtain a valid site and product licence through the process listed above.

For more information, please contact us by email: hc.nnhpd-dpsnso.sc@canada.ca.

Hand-Sanitizers Manufacturing Exchange

To help expand production, we have facilitated a dialogue between the hand sanitizer industry and other industries that are able to provide ingredients and materials. As a result, Cosmetics Alliance Canada (CAC), Spirits Canada/Association of Canadian Distillers (ACS) and the Canadian Consumer Specialty Products Association (CCSPA) have created the Hand-Sanitizers Manufacturing Exchange. Through this exchange, manufacturing capacity will be matched with suppliers of raw materials.

You are strongly encouraged to join this exchange and help contribute to the fight against COVID-19 if you:

  • are a supplier of ingredients and/or materials entering into the production of hand sanitizer or
  • have the capability to manufacture hand sanitizers

Due to shortages in rheology modifiers being experienced by hand sanitizer manufacturers, Health Canada and the National Research Council have collaborated with experts and stakeholders to develop a list of alternatives.

Hand sanitizer packaging and reusing containers

We are providing additional flexibilities to industry on acceptable packaging materials and sizes. We are also allowing hand sanitizer packaging that has been disinfected to be reused. Both strategies will ensure the continued availability of these products during the COVID-19 pandemic.

Product packaging is an important factor in ensuring the proper use of the product. If a hand sanitizer container, its format or its appearance looks similar to that of other products intended to be handled differently, errors may occur and harm may result.

Packaging of hand sanitizers

The flexibilities for packaging are outlined below.

  • Any food or pharmaceutical grade packaging can be used to package hand sanitizers (for instance, bottles or bags/pouches for use in dispensers), provided that it is chemically resistant to the hand sanitizer.
  • Although hand sanitizers are generally packed in clear (see-through) containers, appropriately graded packaging that is opaque (for example, white, coloured) can also be used.
  • Health Canada does not regulate the size of hand sanitizer packaging:
  • As long as the formulation is identical to what has been authorized by us, any size of packaging that ensures appropriate shelf-life will suffice.
  • The same Natural Product Number (NPN) can be used for different container sizes.

Also:

  • keep the size of the opening on the container small to prevent evaporation (for instance, no wide-mouth containers)
  • large openings increase the surface area where alcohol and other ingredients can evaporate, lessening the effectiveness of the product
  • label large-format containers used for bulk packaging as refill containers
  • use only lids designed for use with the container to prevent contamination and evaporation
  • use packaging that is not re-sealable only once, as this may be prone to contamination and evaporation once opened
  • make refill formats compatible with existing pump or lid components
  • Suppliers are encouraged to facilitate or advise users to continue to recycle used containers in accordance with the recommended practices and waste management systems available locally

    Reusing hand sanitizer containers

    In commercial and institutional settings where there is a shortage of packaging for hand sanitizers, it is possible to clean or disinfect hand sanitizer containers. To do so:

    • clean containers thoroughly with detergent and tap water to eliminate any residual product
    • disinfect containers by boiling in water if heat-resistant
    • this is the preferred method for disinfecting containers
  • use chemical disinfection for containers that are not heat-resistant
    • soaking the bottles in a solution containing 1000 ppm of chlorine (for example, add 35 mL of 3% sodium hypochlorite solution (bleach) to 965 mL of water, to obtain a 1 L solution) for a minimum of 15 minutes
    • rinse with cooled boiled water in a covered container to prevent re-contamination
  • after disinfection, leave containers to dry completely upside-down in a bottle rack
  • store dry containers with a lid and store, protected from dust, until use
  • Hospitals may have their own procedures for contamination control. Re-introducing refillable containers into these settings may defeat the purpose of their contamination controls.

    Refill bags intended to replace box-in-bag dispenser units should be compatible with the specific dispenser units. These refill bags are single-use and cannot be reused.

    End of interim measures

    Health Canada will lift the interim measures when the regular supply stabilizes.

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