Guidance on the Use of Incidental Additives in Food Processing Establishments

On this page

• Introduction
• Definition of incidental additives
• Compliance with Food and Drugs Act
  • Air treatment agents
  • Boiler water additives
  • Cleaning agents not defined as biocides under Biocides Regulations
  • Lubricants with incidental food contact
  • Process water treatment
• Incidental additives that are regulated by other governmental organizations
  • Food-contact Surface disinfectants and surface sanitizers (Biocides)
  • Human-use antiseptic products
  • Cosmetics
• The National Sanitation Foundation (NSF) International and Other Third-Party Organizations
• Inquiries about this guidance
• References

Introduction

Effective January 1, 2025, Health Canada’s Food and Nutrition Directorate (FND) discontinued the non-mandatory pre-market safety assessment of incidental additives for use in food processing establishments, and therefore is no longer issuing letters of no objections (LONOs) for these products. There are no regulatory requirements for pre-market review of incidental additives in Canada, and historically these reviews were considered a service to industry. 

In general, FND considers incidental additives to be low risk because they are to be used in a manner that results in no or negligible residues in food.  The following information is to assist the food industry to ensure that the use of incidental additives complies with the requirements of the Section 4(1)(a) of the Food and Drugs Act, which states, "No person shall sell an article of food that has in or upon it any poisonous or harmful substance".

Note that sanitizers or disinfectants for use on hard food-contact surfaces in food establishments are regulated as biocides under the new Biocides Regulations which came into force on May 31, 2025. As biocides, these products will require premarket authorization by the Natural and Non-prescription Health Products Directorate (NNHPD).  Existing LONOs for these biocides are valid until May 31, 2031.

Definition of incidental additives

While not defined under the Food and Drugs Act (FDA), incidental additives may be regarded, for administrative purposes, as those substances which are used in food processing establishments and often not intended to come into direct contact with food but which may potentially become adventitious residues in foods. 

The following products are examples of incidental additives when they are used in food processing establishments:

• Cleaners/degreasers to remove dirt and impurities from food processing equipment that are not defined as biocides under Biocides Regulations
• Detergents (for dish and laundry)
• Hand products (cleaners, antiseptic, lotions, barrier creams, etc.)
• Odour control agents
• Boiler water treatment compounds
• Lubricants
• Air treatment compounds

Although Health Canada ceased to issue LONOs for incidental additives, the food industry is expected to ensure that products they are using do not pose a health concern and complies with the requirements of the FDA. If these products are misused, resulting in contamination of food and a potential health risk to consumers, the sale of that food would be in violation of Section 4(1)(a) of the Food and Drugs Act.

Compliance with Food and Drugs Act

Incidental additives are typically not intended to come into direct contact with food and they are deemed low risk because they are intended to be used in a way that leaves no or minimal residues in food. In most cases, their use is followed by a thorough potable water rinse. The following information provides more details on how to use specific incidental additives in order to comply with the requirements of the Section 4(1)(a) of the Food and Drugs Act.

In addition, for any new active and non-active ingredient used in the formulation of a incidental additive product, the actual amount of residues that remain on the food contact surfaces that may incidentally be transferred to food must not result in dietary exposure that exceeds the threshold of concern (TOC) value of 0.025 µg per kg body-weight per day, which is considered to represent an exposure below which it is unlikely that a substance would represent any more than a negligible risk via food.  This value is consistent with the approach used by the US Food Drug Administration^{Footnote 1Footnote 2}.

Air treatment agents

The use of air treatment agents to control the air quality in food processing establishments, may be subject to occupational health and safety standards administered by provincial or territorial authorities. Food facility operators are encouraged to contact the appropriate authority to ensure compliance with the standards.

Please note that gaseous antimicrobial treatments used directly on food to control the microbial load in or on the food, may be either food additives or food processing aids. Food processing aids are also not subject to pre-market authorization, so in such cases, companies are advised to be aware of how to differentiate food additives from food processing aids to ensure compliance with regulations of food additives.

Boiler water additives

Boiler water additives (BWAs), such as oxygen scavengers and corrosion inhibitors, are used to maintain the efficiency and longevity of boiler water systems in food processing establishments. Whether these additives are used in systems where the steam produced does not contact food or in systems where the steam produced may come into contact with food, the recommended usage conditions, including dosage rates, must ensure that food contamination does not occur.

For certain boiler water additives, which are intended for use in boiler water systems where the treated steam may come into contact with food, concentration limitations have been set by the U.S. Food and Drug Administration (US-FDA)^{Footnote 3}. These limits may also apply to BWAs used in the Canadian market. Other non-volatile chemicals are commonly used for the treatment of boiler water in food premises. Although no specific maximum concentrations have been established for these chemicals, their use in food premises must also be subject to the following requirements:

1. the amount of the product used is not in excess of that required for its functional purpose; and
2. the amount of steam in contact with food does not exceed that required to produce the intended effect in or on the food.

Cleaning agents not defined as biocides under Biocides Regulations

The use of cleaning agents on food contact surfaces or equipment should always be followed by a thorough potable water rinse. For companies to comply with Canadian Regulations, it is recommended that cleaners (e.g., metal polish), which cannot be effectively removed by rinsing with potable water, not be used on food contact surfaces. If, however, such a cleaner is required, its use should not result in dietary exposure that exceeds the threshold of concern (TOC) value of 0.025 µg per kg body-weight per day.

Lubricants with incidental food contact

The quantity of lubricants used on equipment and machine parts where there is a possibility of incidental food contact should be the minimum quantity required to achieve the intended technical effect. When the lubricant is used as anti-rust film, it must be effectively washed or otherwise removed from the surfaces prior to re-use of the equipment or machine parts.

For lubricants with incidental food contact, based on their chemical compositions and conditions of use, certain restriction and concentration limitation may apply for ingredients of concern.

Process water treatment

Process water is potable water which is used in food processing plants and which may or may not directly contact food items and/or may be incorporated into food products (e.g., water used for general cleaning, cooking, blanching, fuming, washing foods, etc.).

The chemical ingredients used in the formulation of treatment compounds for water intended for food contact application should meet the specifications set out by the Food Chemicals Codex, Food Chemicals Codex (FCC) | FCC | Online, in order to avoid or minimize unwanted impurities.

The process water so treated must meet standards set out in the latest Guidelines for Canadian Drinking Water Quality. Drinking water is primarily an area of provincial and territorial jurisdiction in Canada, but Health Canada's role is critical in all Canadian jurisdictions. Health Canada's Water Air and Climate Change Bureau works in collaboration with the provinces and territories to develop the Canadian Drinking Water Guidelines - Canada.ca. For products used in the treatment of drinking water, Health Canada recommends the use of products that have been certified as meeting the appropriate health-based standard by an accredited certification body. A complete list of accredited certification bodies can be found on the website of the accreditation organization, the Standards Council of Canada.

Incidental additives that are regulated by other governmental organizations

The following describes products that will continue requiring notification or pre-market clearance by other organizations within Health Canada. 

Food-contact Surface disinfectants and surface sanitizers (Biocides)

Health Canada has introduced a new set of regulations under the FDA that provide Canadians with improved access to safe and effective surface sanitizers and surface disinfectants, while minimizing costs and burden on industry. Under the Biocides Regulations, substances or mixtures of substances that sanitize or disinfect non-living and non-liquid surfaces, collectively are referred to as biocides and will be regulated under the Biocides Regulations due to:

• their use in mitigating or preventing the transmission of human or animal disease; or
• their use in disinfection or sanitation in premises where food is manufactured, prepared, or kept.

Under Biocides Regulations, biocides require a pre-market assessment and the issuance of a market authorization before they can be sold in Canada. Biocides include surface sanitizers and surface disinfectants that are currently regulated in Canada under the Pest Control Products Regulations (PCPR) and the FDR. As biocides, these products will require premarket authorization by the Natural and Non-prescription Health Products Directorate (NNHPD).  Existing LONOs for these biocides are valid until May 31, 2031.

For more information on Biocides Regulations and guidelines, companies must contact NNHPD at nnhpd-dpsnso@hc-sc.gc.ca .

Human-use antiseptic products

An antiseptic product that is intended for use by food handlers to reduce transient organisms on the skin in a commercial or institutional setting including food processing plants, restaurants, retail supermarkets, and fast-food outlets, also require pre-market assessment. They are drugs or natural health products under the FDA and Natural health Products Regulations (NHPR). Therefore, before their use in food processing facilities as a hand sanitizer, they need to have an active Drug Identification Number (DIN) or Natural Health Product Number (NPN).

The NNHPD is responsible for the mandatory pre-market assessment of human-use antiseptic products. Hence, for products containing ingredients that meet the definition of Schedule 1 of the NHPR, sponsors are required to apply for a NPN with the NNHPD of Health Canada as per Section 5 of the NHPR. Sponsors of antiseptic products for human use containing ingredients other than those that meet the definition of Schedule 1 of the NHPR are required to file an application for a DIN with the NNHPD as per Section C.01.014 of the FDR. For more information on Human-Use antiseptic drugs, you can visit the NNHPD website. Contact information can be found in Appendix I.

Cosmetics

Cosmetic products, such as hand cleansers or lotions, intended for use in food processing establishments must meet all applicable requirements of the Cosmetic Regulations to ensure that they do not pose any health risk to consumers and are properly labelled. For more information on requirements for cosmetics, company should contact the Cosmetic Division, Consumer Product Safety Bureau of Health Canada at hc.cps-spc.sc@hc-sc.gc.ca.

The National Sanitation Foundation (NSF) International and Other Third-Party Organizations

To comply with section 4(1)(a) of the Food and Drugs Act (FDA), companies are encouraged to consult with the National Sanitation Foundation (NSF) or other specialized organizations to ensure they are not only complying with the FDA but also implementing best practices for food safety, which help to prevent potential contamination.

The National Sanitation Foundation (NSF) International is a World Health Organization (WHO) Collaborating Center on Food Safety and manages the Non-food Compounds Registration Program. This program certifies and registers non-food compounds (NFC) used in food processing and handling facilities. Registered products display an NSF Registration Mark and category code, indicating they meet established criteria for safety, toxicology, odor potential, and intended use.

Inquiries about this guidance

Comments, questions or concerns about this guidance can be addressed to the Bureau of Chemical Safety at bcs-bipc@hc-sc.gc.ca.

References

• CFIA - Guidance for Food Establishments Concerning Construction Materials and Packaging Materials and Non-Food Chemicals
• HC - Reference Listing of Accepted Construction Materials, Packaging Materials and Non-Food Chemical Products Database

Footnotes