How the Biocides Regulation will impact your Food Contact Surface Sanitizers

June 2025 is fast approaching!  This is the day that the new Biocides Regulations take effect.  And that means that this is day that the regulatory environment changes significantly for Food Contact Surface Sanitizers.   

The current environment 

Currently these products do not require specific registration.  They are regulated under the Foods Directorate as incidental additives and can be sold without registration.  Companies can request a voluntary Letter of No Objection (LONO) then proceed to market following Consumer Packaging and Labelling regulations and GHS.  

Incidental additives may be regarded as substances which are used in food producing facilities such as food processing plants, restaurants, kitchens and which may potentially cause residues in foods. With the exception of certain products, which are regulated under specific regulations, such as disinfectants, cosmetics, natural health products, etc., there are no sections of the Food and Drugs Act and Regulations, which specifically require the pre-clearance of incidental additives for use in food producing facilities.   

Below are some examples of incidental additives when they are used in food producing facilities: 

• Sanitizers 

• Cleaning agents for food equipment and food handling areas (including bacterial enzyme, drain, membrane and other cleaners) 

• Detergents (dish and laundry) 

• Hand products (cleaners, antiseptic, lotions, barrier creams, etc.) 

• Boiler water treatment compounds 

• Lubricants, release agents, solvents and related compounds 

• Antifoaming agents for incidental use with food contact 

What the future holds 

Registration will be required and Voluntary LONO’s will no longer be given 

The definition of a Biocide, under the new regulations, includes food contact surface sanitizers.  As of June 1, 2025 they will be subject to the same review pathways and application requirements as other biocides such as Disinfectants.  They will now require registration including evidence of safety, efficacy (claims must be supported with prescribed test data) and quality.  There will be new labelling requirements, incident reporting and safety monitoring, record retention and adherence to Health Canada’s Fabrication Standard (Guide 49).  Some of these things are also going to be new for current DIN Disinfectants. 

Products Excluded from the New Biocide Regulations 

• Sanitizers that do not meet the definition of a drug under the FDA (including algaecides, slimicides, material preservatives, and products for odor control). 

• Sanitizers and disinfectants that meet the definition of a drug but are for use in air or water (including pool and spa disinfectants, water sanitizers, and air sanitizers). 

• High-level disinfectant and sterilant solutions regulated as medical devices, and contact lens disinfectants. 

• Disinfectants and surface sanitizers exclusively for use directly on the surface of food, topical drugs with antimicrobial activity for use on humans or animals, and chemical cleaners. 

Just this month the Bureau of Chemical Safety (BCS) announced plans to transition out of the voluntary Letter of No Objection (LONO) service for incidental additives and food processing aids. Further stakeholder communication will be provided in the coming weeks regarding this however we do know that this will take effect to May 31, 2025, to align with the coming into force of the Biocides Regulations. 

Further answers regarding how BCS is engaging provincial and territorial counterparts on this change and management of submissions in queue have not been yet provided. 

Transition Period for the New Biocides Regulations 

The Transition Implementation period extends until May 31, 2029, with a mandatory registration deadline for food contact surface sanitizers by May 31, 2031. This process includes submitting efficacy data to substantiate any claims regarding these products. It is crucial to initiate preparations now to avoid delays in testing, as laboratories are anticipated to be busy in the coming years.   

Over the next 6 months, more online application and transition forms and more guidance documents will become available.  At that time, Dell Tech will be able to reach out to companies with more details on the best paths forward for your products.  Do you transition your DIN, submit a brand-new Biocides application, work with a lab to test your food contact surface sanitizers for efficacy, safety and quality support, develop a new label etc?   

Dell Tech is dedicated to facilitating your compliance journey. We offer expert consultations to discuss your products and develop an optimal timeline for transitions or registrations. Our team will guide you through the regulatory compliance process, including providing comprehensive details on the associated costs. Please contact us to schedule a meeting and ensure your products meet the new regulatory requirements efficiently.