News from AAFC’s Market Access Secretariat

The Hong Kong Special Administrative Region Government (HKSARG) has launched a public consultation process on proposed amendments to the Food Adulteration (Metallic Contamination) Regulations (Cap. 132V). The public consultation period will remain open until February 16, 2025.

The proposed amendments aim to update Hong Kong’s maximum levels (MLs) for metallic contaminants in food to align with international standards, including those set by the Codex Alimentarius Commission (Codex), as well as standards in mainland China and South Korea. Key proposed changes include:

• Increasing the total number of MLs from 144 to 177, with 27 new MLs for specific metals in designated food items and updates to 9 MLs for lead.
• Adding or updating MLs for lead, cadmium, and methylmercury in foods such as grape juice, edible fungi, fish, and sugar products.
• Introducing a new ML for methylmercury in fish balls/fish cakes, reflecting their high consumption in Hong Kong.
• Retaining the existing ML for lead in wine at 0.2 mg/kg, which differs from Codex standards.
• Setting a new ML for lead in maple syrups at 0.5mg/kg, with reference to mainland China and South Korea standards.

The Hong Kong Centre for Food Safety (CFS) has emphasized that these amendments are not expected to significantly impact food trade. However, Canadian stakeholders are encouraged to carefully review the proposed changes and how they might impact exports to Hong Kong.

For additional details, please refer to the Hong Kong Government Consultation Document.

We strongly encourage Canadian industry stakeholders to provide their comments and questions to the Market Access Secretariat (MAS) by February 7, 2025. Feedback can be sent to: aafc.mas-sam.aac@agr.gc.ca. MAS will work with our Canadian Consulate in Hong Kong to submit comments received from Canadian stakeholders to the Hong Kong CFS.

The FDA is revoking the authorization for the use of FD&C Red No. 3 as a matter of law, based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA is amending its color additive regulations to no longer allow for the use of FD&C Red No. 3 in food and ingested drugs in response to a 2022 color additive petition. The petition requested the agency review whether the Delaney Clause applied and cited, among other data and information, two studies that showed cancer in laboratory male rats exposed to high levels of FD&C Red No. 3 due to a rat specific hormonal mechanism. The way that FD&C Red No. 3 causes cancer in male rats does not occur in humans. Relevant exposure levels to FD&C Red No. 3 for humans are typically much lower than those that cause the effects shown in male rats. Studies in other animals and in humans did not show these effects; claims that the use of FD&C Red No. 3 in food and in ingested drugs puts people at risk are not supported by the available scientific information.

The Delaney Clause, enacted in 1960 as part of the Color Additives Amendment to the FD&C Act, prohibits FDA authorization of a food additive or color additive if it has been found to induce cancer in humans or animals. This is not the first time the agency revoked an authorization based on the Delaney Clause. For example, in 2018, the FDA revoked the authorization for certain synthetic flavors based on the Delaney Clause in response to a food additive petition.

FD&C Red No. 3 is a synthetic food dye that gives foods and drinks a bright, cherry-red color. The FDA estimates that FD&C Red No. 3 is not as widely used in food and drugs when compared to other certified colors based on information available in third-party food product labeling databases, food manufacturers’ websites and other public information, and the FDA’s certification data. FD&C Red No. 3 has been primarily used in certain food products, such as candy, cakes and cupcakes, cookies, frozen desserts, and frostings and icings, as well as certain ingested drugs.

Manufacturers who use FD&C Red No. 3 in food and ingested drugs will have until January 15, 2027 or January 18, 2028, respectively, to reformulate their products. Other countries still currently allow for certain uses of FD&C Red No. 3 (called erythrosine in other countries). However, foods imported to the U.S. must comply with U.S. requirements.

Additional Information

FD&C Red No. 3

Food Chemical Safety

The Canadian Food Inspection Agency (CFIA) has published amendments to the fish import inspection fees in Part 16 of the CFIA Fees Notice to introduce a single fee for all fish products. This single fee applies to all regulated parties who have a licence under the Safe Food for Canadians Regulations.

Consultations with stakeholders took place in Spring and Summer 2024, and no concerns were raised. These changes will not impact the service delivery to importers but will lower the cost for most businesses that import fish and seafood into Canada.

Beyond amendments to Part 16, the CFIA is also amending all table headers to increase clarity and is removing obsolete fees for services that the CFIA no longer delivers.

The amendments are part of a broader cost recovery modernization initiative that aims, among other objectives, to align the CFIA Fees Notice with modernized regulations such as the Safe Food for Canadians Regulations.

For more information on these and other recent amendments to the CFIA Fees Notice, please consult the Canada Gazette, Part I publication.

Related information

• Proposed amendments to fish import inspection fees in the CFIA Fees Notice: Closed consultation

The U.S. Food and Drug Administration issued a final rule to update the “healthy” nutrient content claim to help consumers identify foods that are particularly useful as the foundation of a diet that is consistent with dietary recommendations. Manufacturers can voluntarily use the claim on a food package if the product meets the updated criteria.

The “healthy” claim can empower consumers by providing a quick signal on food package labels to help consumers identify foundational foods for building healthy dietary patterns. The claim could be especially helpful for those who may be less familiar with nutritional information. Today’s action is part of the FDA’s broader commitment to make food a vehicle for health and wellness, reduce diet-related chronic diseases, and promote health equity. This initiative, and others such as front-of-package nutrition labeling and sodium reduction, are featured in the White House National Strategy on Hunger, Nutrition, and Health.

Diet-related chronic diseases in the U.S. are the leading causes of death and disability and many of these chronic diseases are experienced at higher rates by certain racial and ethnic minority groups and those with lower socioeconomic status, compared to the overall average. Healthy eating patterns, which include foundational foods like fruits, vegetables, fat-free and low-fat dairy, and whole grains, are associated with improved health, such as reduced risk of cardiovascular disease, type 2 diabetes, certain types of cancers, and being overweight or obese. Providing informative and accessible food labeling empowers consumers and may help foster a healthier food supply for all if some manufacturers voluntarily reformulate food products to meet the updated criteria.

The updated criteria for the “healthy” claim are aligned with current nutrition science, the Dietary Guidelines for Americans, and the updated Nutrition Facts label, which requires the declaration of added sugars. The updated criteria for the “healthy” claim include nutrients to limit and identifies foods that help consumers to build a diet consistent with current recommendations.

To bear the “healthy” claim, a food product needs to:

• Contain a certain amount of food (food group equivalent) from at least one of the food groups or subgroups (such as fruits, vegetables, fat-free and low-fat dairy etc.) recommended by the Dietary Guidelines.
• Adhere to specified limits for the following nutrients: saturated fat, sodium, and added sugars.

As an example, to include the “healthy” claim on the package, a cereal needs to contain a certain amount of whole grains and adhere to limits for saturated fat, sodium, and added sugars. Nuts and seeds, higher fat fish, such as salmon, certain oils, and water are examples of foods that did not qualify for the “healthy” claim before but are foundational to a healthy eating pattern and recommended by the Dietary Guidelines. These foods now qualify to bear the “healthy” claim. Many foods that fit into a range of budgets such as some peanut butters and canned fruits and vegetables also qualify.

Manufacturers who choose to use the “healthy” claim have three years to conform but can use the new criteria sooner.

On a separate but related track, the FDA is also continuing to explore development of a symbol that manufacturers could use on food labeling to show that a product meets the criteria for the “healthy” claim. Having a standardized graphic to show that a food meets the criteria for the “healthy” claim would further support the FDA’s goal of helping consumers to identify food products that can be the foundation of healthy eating patterns.

The FDA will host a stakeholder webinar to provide an overview of the final rule and address questions. More information on the webinar will be released shortly.

Additional Information

Final Rule: Food Labeling: Nutrient Content Claims; Definition of Term “Healthy”

Use of the Term Healthy on Food Labeling

Consumer Update: A Fresh Take on What “Healthy” Means on Food Packages

FDA’s Nutrition Initiatives

Dietary Guidelines for Americans, 2020-2025

Press Release

Education Materials

Updated “Healthy” Claim – Factsheet

Updated “Healthy” Claim – Infographic

Updated “Healthy” Claim & What it Means for You – Infographic

Updated “Healthy” Claim & What it Means for You – Factsheet

On January 1, 2025, the U.S. Food and Drug Administration (FDA) will open the Voluntary Qualified Importer Program (VQIP) application portal for fiscal year (FY) 2026.

VQIP is a voluntary fee-based program that provides importers, who achieve and maintain control over the safety and security of their supply chains, the benefits of expedited review and importation of human and animal foods into the United States.

To participate in VQIP, food importers must meet certain eligibility requirements, including ensuring that the facilities of their foreign suppliers are certified through the FDA’s Accredited Third-Party Certification Program. Certification bodies conduct food safety audits of foreign facilities and farms, and issue the certifications that importers need to participate in VQIP.

Important Update: The VQIP application portal will remain open until September 1, 2025, allowing food importers ample time to apply for FY26 VQIP benefits.

Additional Information

Voluntary Qualified Importer Program

Fact Sheet: Preparing for the FDA Voluntary Qualified Importer Program

Submission of VQIP Application User Guide

Public Registry of Accredited Third-Party Certification Bodies

Questions may be submitted to the VQIP Importers’ Help Desk via 1-301-796-8745 or via email; to FSMAVQIP@fda.hhs.gov.

VQIP supports the FDA Strategy for the Safety of Imported Food by incentivizing importers to use certified suppliers and robust processes and procedures to help ensure imported food is meeting U.S. food safety requirements.