Regulatory Amendments of the Food and Drug Regulations (Nutrition Labelling, Nutrition Claims and Health Claims)

Most of industry must meet the requirements under the new regulations by December 12, 2005. Small manufacturers, those with a gross revenue of $1 million (Canadian) or less from food sales in Canada for the period of December 12, 2001 to December 11, 2002 must meet the new regulations by December 12, 2007.

During the transition period, the CFIA will enforce both the current requirements of the Food and Drugs Act and Regulations (FDA & FDR) and the new requirements that were published in Canada Gazette, Part II on January 1, 2003. Manufacturers cannot label food with a combination of the two labelling systems, either the former or the new nutrition labelling requirements must be used.

At the end of the transition period (either December 12, 2005 or 2007, depending on the size of the manufacturer), all foods sold by a manufacturer must comply with the new regulations. "Sell" includes products that are offered for sale, exposed for sale, are in possession for sale and distributed, whether or not the distribution is made for consideration (Section 1, FDA). For further information, please see the CFIA's Enforcement and Compliance Information Letter

Transition Period

• the expression "nutrition facts", "valeur nutritive" or "valeurs nutritives" is used;
• the health claims in Column 1 of the table following Section B.01.603 are used;
• the nutrient content claims in Column 4 for items 15,16, and 22 to 26 of the table following Section B.01.513 regarding % fat-free, trans fatty acids, or omega fatty acids are used.
  If one of these claims or the words "nutrition facts" or "valeur(s) nutritive(s)" is used, then the label and advertisement of the food must comply with the new requirements immediately.

• the expression "nutrition facts", "valeur nutritive" or "valeurs nutritives";
• the health claims in Column 1 of the table following Section B.01.603;
• the nutrient content claims in Column 4 for items 15,16, and 22 to 26 of the table following section B.01.513 regarding % fat-free, trans fatty acids, or omega fatty acids.

The CFIA strongly encourages manufacturers to comply with the new regulations for any new packaging material in anticipation of the approaching compliance date. If the manufacturer choses to follow the former regulations during the transition period, the labels will need to be updated by the end of the applicable transition period.

For imported products, label compliance is expected as the product enters Canada. If the CFIA was notified of the importation of non-compliant foods, the label must be compliant when it leaves the importer's warehouse to enter the distribution chain or within three months after the importation of the food, whichever occurs first (A.01.044, FDR).

It is unlikely that the CFIA would immediately focus its resources on foods still on retail shelves that were purchased by the retailer before the end of the transition period, provided the labels comply with the former requirements. However, this would not prevent the CFIA from taking appropriate action at any level of the distribution chain, including retail, should circumstances warrant.

More information on the CFIA compliance and enforcement strategy can be found in our July 2004 Information Letter: Compliance and Enforcement Strategy – New Nutrition Labelling Regulations.

Imported Foods

Retailers, however, are also legally obligated to ensure that the products they sell are compliant with the appropriate regulations.

Nutrition Information Panels from Other Countries

The Food and Drug Regulations set out the manner in which energy and nutrient values must be declared, as well as the presentation and requirements for nutrient content claims and health claims. Subsection 5(2) of the Food and Drugs Act prohibits labelling that is contrary to the Regulations. Since the nutrition information requirements of other countries do not match the Canadian requirements, labels and advertisements with nutrition information other than that permitted by the Food and Drug Regulations are considered to be labelled or advertised contrary to Canadian legislation.

Language Requirements

Although other languages are not permitted within the Nutrition Facts table, they could appear separately outside the Nutrition Facts table, provided the Nutrition Facts table is already shown in English and French on the label and the information does not violate the Food and Drugs Act and Regulations, the Consumer Packaging and Labelling Act and Regulations, or any other federal legislation.

Advertising

Information on Other Food Components

Note: The aspartame content is required to be shown in mg per serving of stated size. The serving size should be consistent with the serving size shown in the Nutrition Facts table.

More information on product specific labelling requirements can be found in the 2003 Guide to Food Labelling and Advertising.

Lactose free means that there is no detectable lactose in the food using an acceptable analytical method.

Lactose reduced may be used to describe a product that has been reduced significantly in lactose. A significant reduction is considered to be a 25% reduction or more.

Allergens

Foods Derived from Biotechnology

Label Reviews and Mandatory Label Registration

Mandatory Label Registration: Mandatory label registration is required for meat products governed under the Meat Inspection Act and Regulations and certain domestically produced processed fruit and vegetable products, covered by the Processed Products Regulations.

The CFIA's Label Registration Unit, which registers labels for all processed meat and processed fruit and vegetable products produced in federally registered establishments, will process registration requests for entirely new products in the usual manner. As in the past, new product label registration requests are to be submitted with the CFIA form 1478 (www.inspection.gc.ca/english/for/mpppe.shtml), accompanied by the appropriate copies of the label and formulation, as well as the specified fee.

When labelling changes are made to a previously registered label in order to comply with the new nutrition labelling regulations, the amended label must be re-registered. When the only changes made are with respect to nutrition labelling, and no other label or recipe modifications are made, the company is to submit three copies of the proposed new label and three copies of the most recent final registration form for that label, to the CFIA's Label Registration Unit. The new label will be reviewed to determine if the requirements of the nutrition labelling regulations have been met. Once completed, a re-registered stamped final registration form will be sent back to the company.

In view of the large volume of labels that will require re-registration, it is recommended that industry stagger re-registration submissions in order to allow the Label Registration Unit to register revised labels in a timely manner. In order to expedite the process, companies should provide information such as the available display surface of the package, the area taken up by the UPC, the die-lines on label proofs where necessary, the figure used for the Nutrition Facts table, and any relevant calculations.

The label submission procedure for the products requiring mandatory label registration is available from the CFIA web site. The label must be accompanied by the registration of label, markings and containers form 1478 found on the CFIA web site.

Please note that labels which have not been registered or updated according to these procedures cannot be applied to products until a stamped final registration form 1478 has been received by the company.

Voluntary Pre-Market Label Review: Labels for voluntary pre-market label reviews are provided as a courtesy to the industry based on available resources. They should be submitted to the local CFIA inspection office for the commodity involved. Currently, the CFIA is not assessing labels with respect to the new nutrition labelling regulations as part of the voluntary label review program.

Voluntary Pre-Market Label Review: The Voluntary Pre-Market Label Review is not an approval process. The CFIA provides comments to assist and educate the industry and assist them with producing labels that meet regulatory requirements. Currently, the CFIA is not assessing labels with respect to the new nutrition labelling regulations as part of the voluntary pre-market label review program.

The CFIA reminds industry of their responsibility to comply with the Canadian regulations and to ensure that all labels meet the requirements of the appropriate legislation.

Clerk
Process, Formulation and Label Registration Unit
Canadian Food Inspection Agency
159 Cleopatra Drive
Nepean, Ontario
K1A 0Y9

Telephone: (613) 221-7115

Voluntary Pre-Market Label Review: If a company feels that the label review is unclear or does not agree with the CFIA's interpretation, a request can be made to the inspector to have the issue submitted to the Area or National program specialist for further clarification. Decisions will be provided back to the company by the inspector. The 2003 Guide to Food Labelling and Advertising can also help clarify the requirements of the regulations and it is suggested that industry thoroughly consult the 2003 Guide prior to making changes to labels.

Voluntary Pre-Market Label Review: There is no requirement for other labels to be submitted to the CFIA for review. Due to resource limitations, the CFIA is not presently conducting reviews of the new requirements when applied to labels.

It is the industry's responsibility to ensure compliance with the Food and Drug Regulations. Resources are available through Health Canada's and CFIA's web sites, as outlined in Question 1 of Where Can I Get More Information section.

Enforcement of New Regulations

The CFIA enforcement policy with respect to non-compliance issues has been developed. It takes into consideration the gravity of the violation, a company's past history, and its willingness to comply with the new requirements.

For the new nutrition labelling regulations, a staged compliance program is being developed with appropriate compliance action to be taken based on risk. The CFIA will work with industry so that the industry understands and corrects violations. Health Canada will provide the CFIA with an assessment of food categories and nutrients to assist in setting risk-based inspection and sampling priorities.

In general, from an enforcement perspective, the CFIA will initially consider the following priorities: that the Nutrition Facts table has been applied where required, the mandatory information and format is given, and the claims are compliant. The initial approach during the transition period will be educational. Verification of the accuracy of nutrient values and claims will be done later by assessing industry control measures. Analytical verification by the CFIA of nutrient levels will be done on a complaint and investigative basis.

For more information, please consult the CFIA Information Letter on Compliance and Enforcement Policy.

The Nutrition Labelling Compliance Test describes how the CFIA will assess the information in the Nutrition Facts table.

Compliance Sampling

Values Declared in the Nutrition Facts Table

• where the first number discarded is less than 5, the last digit retained should not be changed, e.g. 4.3 rounded to 4. • where the first number discarded is more than 5, the last digit retained should be increased by 1, e.g. 4.7 rounded to 5. • rounding a given number in more than one stage by the above rules may lead to error therefore it is recommended that rounding be done in one step, e.g. 12.51 rounded to 13.

• if the product meets the conditions set out in column 2 of item 27 in the table following B.01.513 for "free of cholesterol" round to 0 mg.
• if the amount of cholesterol is 2.49 mg or less, round to 0 mg.
• in all other cases, to the nearest multiple of 5 mg.

It is the manufacturer's responsibility to ensure that the nutrient values presented in the Nutrition Facts table are accurate.

Retailer-Responsible Foods

• a fresh vegetable or fruit or any combination of fresh vegetables or fruits without any added ingredients, and with or without a protective coating;
• raw single ingredient meat, meat by-products, poultry meat, or poultry meat by-products, except if ground;
• raw single ingredient marine or fresh water animal products;
• food sold only in the retail establishment where they are made from its ingredients, including from premixes if an ingredient other than water is added during the preparation and processing;
• food sold only at a road-side stand, craft show, flea market, fair, farmers' market, or sugar bush by the individual who prepared and processed the product;
• an individual serving that is sold for immediate consumption and that has not been subjected to a process to extend its durable life, including special packaging; and
• sold only in the retail establishment where the product is packaged, if the product is labelled by means of a sticker and has an available display surface of less than 200 cm2.

A number of retail-packaged foods are required to show a Nutrition Facts table including, but not limited to:

• foods that are repackaged from bulk by the retailer in packages with an available display surface (ADS) greater than 200 cm2, such as deli meats, cheeses, candies, nuts, cookies, imitation seafood, etc.;
• foods carrying a nutrient content claim such as reduced fat cheese, low fat ham, reduced sodium turkey breast, lean chicken breasts, etc.;
• all ground meats and poultry meats;
• foods prepared by the retailer but contain no added ingredients other than water such as pre-frozen breads which are proofed and baked on the premises, muffins made from a premix where only water is added, etc.;
• foods containing the artificial sweeteners: aspartame, acesulfame potassium and sucralose such as candies and confectionary products;
• foods repackaged from bulk with added vitamins and minerals such as flour, skim milk powder, etc.;
• packages that use nutrient content claims or health claims.

For more exemptions and when exemptions no longer apply see Section B.01.401, FDR.

Note: Some retailers may only qualify for the three year transition period and should start looking at options for providing the required information by December 12, 2005.

Restaurants

However, with the exception of items that accompany meals such as salad dressings, crackers, creamers, etc. and prepackaged individual servings that have not been subjected to a process to extend their durable life, prepackaged foods sold in restaurants must carry a Nutrition Facts table in accordance with the requirements of the Food and Drug Regulations.

Prepackaged products, such as bottled BBQ sauce and salad dressings available for purchase by customers in the restaurant are required to show an appropriate Nutrition Facts table and comply with any applicable legislation.

Where Can I Get More Information?

Health Canada and the CFIA are proposing to jointly produce a guidance document dealing with the development and use of data bases by industry, to facilitate the generation of accurate nutrient values.

Food and nutrition labelling decisions are posted on the CFIA web site. You can subscribe to "Labelling Updates" listserv to receive e-mail notification of these decisions.

To assist with the design of your new label, you can request by e-mail the Compendium of Templates for "Nutrition Facts" Tables, which sets out full-size graphic illustrations of the various permitted versions of the Nutrition Facts table.

For more information, industry can contact the CFIA at: