Amendments to the Food and Drugs Act (Bill C-38)

Tools to Better Implement Safety Decisions

Under the current food safety system, once Health Canada scientists have made a safety decision - be it around the safety of a new food additive, setting a limit for a chemical contaminant or approving a new health claim on a food, it can take many months and sometimes even years to implement that decision through a change in the regulations.

Not only do these delays limit access to innovative and safe products for Canadians, they also limit the department's ability to respond to new scientific information that might have an impact on the health and safety of Canadians.

On April 26, 2012, as part of  Bill C-38, the Government of Canada brought forward two targeted changes to the Food and Drugs Act. The new tools, called "Marketing Authorizations" and "Incorporation by Reference", will reduce these delays, cut red tape and make the food regulatory system more efficient and flexible.

The amendments received Royal Assent on June 29, 2012, and the new authorities have since been formally adopted into the Food and Drugs Act (sections 30.2 to 30.4 for Marketing Authorizations and sections 30.5 and 30.6 for Incorporation by Reference)

About Marketing Authorizations

Amendments to the Food and Drugs Act (FDA) include a new Marketing Authorization (MA) framework. With the MA, the Minister of Health has an improved ability to act on certain food safety decisions. This will simplify and accelerate the approval of certain new or modified health claims for foods as well as setting safe levels of acceptable substances for foods, such as food additives.

The Marketing Authorization also enables the Minister to apply specific conditions on the approval of a product or substance, allowing more flexibility to address any particular risks. At the same time, the MA is subject to the same Department of Justice oversight as other regulations, and the principles of good regulation making (including consultation, transparency and the use of modern approaches) would still apply.

By using Marketing Authorizations for these decisions, the government will be able to continue to focus its efforts on safety, while reducing delays in implementing those safety decisions once they are made.

About Incorporation by Reference

The new Incorporation by Reference authority under the Food and Drugs Act explicitly enables Health Canada to incorporate by reference technical and non-technical standards, methods, guidelines or any other documents, regardless of their source, into the Food and Drug Regulations or an MA, including documents developed by the Government of Canada. It also allows for the incorporation of documents that may change from time to time (known as "ambulatory" incorporation).

Currently, lists are explicitly included, item by item, within the regulations. This is true for food additives, vitamins and minerals being added to foods, certain health claims, and maximum limits for chemical contaminants. This means any time any of these lists need to be changed, a lengthy regulatory amendment process is required.

Under the new law, these lists may be managed as publically available documents that are incorporated by reference into the Food and Drug Regulations and/or Marketing Authorizations issued by the Minister of Health.

Having lists incorporated by reference makes it much simpler and less time-consuming to add to, or change, these lists after appropriate consultations and notifications have taken place. This approach will reduce red tape and allow the department to focus resources where they will have the greatest impact on the health and safety of Canadians.

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