Food and Beverage Services for Canada

Any food or beverage products sold in Canada must meet Health Canada’s standards for safety and nutritional quality. Canada also has strict regulations for food labeling.

Food & Beverage Safety Regulations in Canada Set by the Canadian Food Inspection Agency (CFIA)

The Canadian Food Inspection Agency enforces these regulations. Failure to meet safety and quality standards, or failure to correctly label food and beverage products will mean that these products cannot be sold in the Canadian market and could lead to legal action.

The Safe Food for Canadians Act (SFCA) was created to consolidate the regulations from different sub-sections of food and beverage into one overall regulation. Some important changes in these new regulations are increased traceability of ingredients for food products and ensuring that imported products meet domestic requirements for food safety. Cosmereg can support your business in preparing for these changes.

Health Canada required producers of food products to keep a close eye on their supply chain, in order to reduce the risk of fraudulent ingredients being used in their production. Cosmereg can help your business to develop a program to protect your products against food fraud.

The Global Food Safety Initiative (GFSI) is a multi-country collaboration that aims to improve the safety and quality of food globally. Food safety certification programs (CPOs) must reach high standards in order to be GFSI certified. Cosmereg can help your business to select a GFSI certified food safety management system.

To market food and beverage products as Halal, Organic, GMO-free or Gluten-free each product must be produced and processed in a specific way, using certified ingredients. Correct labelling of these products is also extremely important. Cosmereg can assist you in the applying for certification and ensuring that your food labelling complies with Health Canada’s regulations.

In order to market certain products in Canada, food and beverage producers must register with the Canadian Food Inspection Agency (CFIA). Federally registered establishments must meet high standards of food safety. Cosmereg can help your business to meet the requirements for registration.

In 2016, changes were made to Canadian food labelling regulations. Food and beverage products must now include information about the standard serving size, along with nutrition information per serving. Cosmereg can help your company to ensure that all food and beverage products comply with the updated regulations.
Temporary Market Authorizations (TMAs) are a way for products that have not yet been granted approval to gain access to the market. Many NHPs were first sold in Canada under TMAs. Cosmereg can support your business in applying for TMAs, to help get your products on to the market as quickly as possible.

Before a new product or a product containing a new ingredient can be marketed in Canada, a Novel Food Notification must be submitted to Health Canada. Cosmereg can help you to complete Novel Food Notifications, ensuring that your business complies with Canadian regulation.

In Canada, special GMPs apply for all infant formula. Before any infant food or formula can be marketed in Canada, it must undergo a detailed safety assessment and nutritional quality evaluation by Health Canada. Cosmereg can assist in this process, to ensure that your product meets Health Canada’s high standards.

Food packaging is also closely monitored in Canada. Any material intended to be used in the packaging must be voluntarily submitted to Health Canada for a pre-market assessment. Cosmereg can support your business in this process.

Audits are an essential part of maintaining food safety. Health Canada stipulates the need for regular audits in its GMPs for food and beverage providers. Cosmereg offers a complete Food Safety and Quality Systems Audit service.

According to government regulations, food labels on products sold in Canada must be accurate and available in both English and French. Cosmereg can assist you in this process through our food labelling consultancy service.

Regulatory strategic planning and product classification

The first step towards authorization of Medical Devices in Canada is classification based on their level of risk. Class I devices do not require a license. However, producers of these devices require an Establishment License. Cosmereg can help your business to determine which category your medical devices fit into, and support you in applying for the appropriate license.

Organize and manage meeting with the Therapeutic Products Directorate (TPD)

Medical Devices are regulated by the Therapeutic Products Directorate (TPD). Cosmereg can assist your company by organizing and managing meetings with the TPD, for pre-market approval of Medical Devices.

Prepare and file CTA’s (Clinical Trial Applications)

In order to market a Medical Device in Canada for use in a Medical Trial, a Clinical Trial Application (CTA) must first be submitted, just as in pharmaceutical trials. Cosmereg can assist your company with this application process.

Prepare and file Class II, III and IV applications

Class II, III and IV medical devices require a license to be sold in Canada. In order to obtain a license, a Medical Device License Application must be submitted to the TPD. The amount of information required for this application varies according to the device. Cosmereg provides a full Medical Device License Application service.

Provide application support during TPD review

Sometimes, applications are not immediately approved by the TPD – this may be due to a lack of information included in the application documents. Manufacturers of Medical Devices have the right to appeal decisions and re-submit their applications. Cosmereg can assist your business in ensuring that all the required information is included in your application, before it is reviewed by the TPD.

Perform Quality System audits

Manufacturers of Medical Devices must submit a Quality System Certificate to Health Canada. This is to prove that the device complies with industry regulations for its manufacture. Audits of product manufacture and quality are an essential component in ensuring that Medical Devices meet Health Canada standards. Cosmereg can assist your business in designing and conducting these audits.

Provide label and advertising review

Just as with food products or cosmetics, Health Canada stipulates that Medical Devices must be appropriately labelled. Medical Devices must not be sold or advertised in a manner that is misleading to the public. Cosmereg can assist your company to ensure that labels and promotional materials comply with Health Canada regulations.

Resolve regulatory compliance issues

Compliance with Canadian Medical Device regulations can sometimes be a complicated process. Cosmereg provides a full service for regulatory compliance and can assist your business in every step of the process.

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FAQ

In accordance with the Bioterrorism Act (2002), facilities that are involved in manufacturing, processing, packing or storing food intended for human or animal consumption must register with the FDA.

 
The Role of the US FDA Agent for Cosmetics, OTC and Drug Products

WE OFFER OTHER CANADA SERVICES

Cosmetic Regulations

COSMEREG CAN ASSIST YOU WITH ALL OF CANADIAN’S COSMETIC REGULATIONS AND REQUIREMENTS, WHETHER YOU’RE MANUFACTURING IN CANADA OR IMPORTING PRODUCTS INTO CANADA.

Natural Health Product (NHP)

IN CANADA, NATURAL HEALTH PRODUCTS (NHPS) ARE PRODUCTS SUCH AS VITAMINS AND MINERALS, PROBIOTICS AND TRADITIONAL MEDICINES.

Medical Devices

ALL MEDICAL DEVICES ARE REVIEWED BY HEALTH CANADA BEFORE AUTHORIZATION FOR THEIR SALE IN CANADA IS GRANTED.

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