Safe Foods for Canadians Regulations and Licensing Requirements

The most significant change in the history of Canadian Food and Drug Regulations is about to take effect.

The Safe Food for Canadians Act was passed in November 2012, but the regulations and guidance documents are expected to be published in Canada Gazette I as early as January 2015.

In order to ensure a stronger Food Safety System, CFIA will now require both importers and manufacturers of all foods in Canada to obtain a license and establish baseline food safety requirements that reflect CODEX.

Written Preventative Control Plans (PCPs) will be required covering safety, labelling and trade requirements and active management of food risks.

These plans will be inspected by CFIA before a license will be issued, and the importer or manufacturer will need to demonstrate that their food safety program has been properly implemented and documented. This will not be a onetime event. The preventative control program is expected to demonstrate that procedures are in place to ensure ongoing monitoring.

Importers and manufacturers are expected to identify a "Responsible Person" in the organization that has been appropriately trained in addition to the person who conducts the monitoring. This ensures that the organization is accountable at the highest level. Traceability procedures are also expected to be in place in the event that a food recall is initiated.

To learn more click here

As of September 2, 2013, Health Canada is transferring the responsibility of International Trade Certificates issuance to independent 3rd parties. 
 
An International Trade Certificate is a document which speaks to the regulatory status of a natural health product (NHP) in Canada and/or the Canadian manufacturing, packaging, and/or labeling site.

On May 31st, 2013 the NHPD issued a message to Natural Health Product Stakeholders regarding the issuance of International Trade Certificates to consult on transferring this practice from the NHPD to independent 3rd parties. Up until that time the NHPD voluntarily issued these certificates as a service. However, following the close of the consultation on August 29, 2013 the NHPD has confirmed that they are transferring the responsibility of International Trade Certificates issuance to independent 3rd parties.
  
At the present time, there are 3 organizations that have been authorized by Health Canada to issue International Trade Certificates:

Canadian Cosmetic, Toiletry and Fragrance Association (CCFTA)
Canadian Health Food Association (CHFA)
Consumer Health Products (CHP Canada)
 
While additional organizations can apply to Health Canada to become a 3rd party issuer of International Trade Certificates, Health Canada will not be managing a publicly available list of 3rd parties that are authorized to perform this function.
 
International Trade Certificates: How can we help?
 
It is standard practice amongst many countries to require an International Trade Certificate to accompany any NHP imported into their jurisdiction. Our NHP regulatory consultant company can prepare the application for your International Trade Certificate for NHPs or for Good Manufacturing Practices (GMP) Compliance to submit to the approved 3rd parties for issuance of the International Trade Certificates. We are available to facilitate the process of receiving your International Trade Certificate with 3rd party issuers.

For further information contact us at This email address is being protected from spambots. You need JavaScript enabled to view it. or This email address is being protected from spambots. You need JavaScript enabled to view it.

- Special Alert -

Phase I of the NHP Compliance and Enforcement transition period is ending December 1, 2013.  Companies have been advised to ensure that they are familiar with and in compliance with the Regulations.

In order to legally sell natural health products (NHPs) in Canada, you must have a Natural product Number (NPN), or product license from Health Canada.  However, there is currently an NHP compliance and enforcement "transition period" that allows products that have not received their market authorizations to be sold without being subject to enforcement actions.

From now until December 1, 2013 the Inspectorate will allow manufacturers, packagers, labellers, and importers of NHPs to sell their products without taking enforcement action if it meets the following criteria:

•The product has a submission number (indicating that you filed a product license application)

•The product is manufactured and/or imported through a Site Licensed facility

•The product is not considered high risk (examples of high risk products are those indicated for children or pregnant women, or products that contain ingredients that have been the subject of recalls in the past)

As of December 1, 2013, all manufactured and imported products should have their NPNs and may be subject to enforcement action if they do not.  From December 1, 2013 to September 1, 2014, products without an NPN can continue to be distributed and/or sold at retail without an NPN if they meet the above criteria.  After September 2014, all products on the market must have an NPN in order to be legally sold.

As we are nearing the December 1 deadline it is advisable to manufacture, package, label and import your NHPs such that they meet the above criteria.  While the Inspectorate has assured the industry that there has been no change in their NHP Compliance and Enforcement Policy and enforcement will continue to be risk based, they have indicated that actions will be focused on all activities including the supply chain.  Additionally, enforcement will be based on whether a company has tried to come into compliance (i.e. do they have an application in queue for assessment).

Source: dicentra

dicentra can assist you with filing your product license applications, site license applications and conduct label reviews to ensure you are in compliance with the regulations.  Additionally, to help ensure a smooth process at the border dicentra offers importation services through their site license.

dicentra provides sought-after regulatory and scientific guidance on product and marketing compliance, quality assurance, research and development, new ingredient assessments and overall regulatory strategies for health-related products sold in North American marketplaces.  They can be reached at 1-866-647-3279 or This email address is being protected from spambots. You need JavaScript enabled to view it..