Information

May 2003

Moving forward with food fortification

What is food fortification?

Adding vitamins and minerals to food plays a valuable role in maintaining and improving the nutritional quality of the Canadian food supply as well as preventing nutrient deficiency diseases. Yet, like all chemicals, these nutrients can produce both acute and chronic adverse health effects if consumed in excess.

Most Canadians recognize the valuable role that adding vitamins and minerals to food can have on their health. And most also understand that regulating the amounts of fortification in our foods is the way to ensure that Canadians are exposed to levels that are neither dangerously high nor so low as to be ineffective.

The federal government regulates both the mandatory fortification of some nutrients - to make sure Canadians receive adequate amounts of the nutrient - and the upper limits of fortification of nutrients - to make sure Canadians do not consume a dangerous amount of them.

The addition of vitamins and minerals nutrients to food in Canada is controlled by the Food and Drug Regulations. Foods fortified to levels other than those approved under the Food and Drug Regulations may not be sold in Canada.

The new food fortification policy

Health Canada initiated a review of its food fortification policy in 1998 in response to concerns from some sectors of the food industry and consumers that our current regulations are overly restrictive The new policy, and the updated regulations that will follow it, will strike a balance between giving Canadians more choices in the foods they buy and government's responsibility to ensure that the food supply is both nutritious and safe. The new policy, and the regulations that will follow, will confirm the use of fortification to address public health issues and maintain the nutritional quality of the food supply. When implemented, it is anticipated that the new policy will also establish a new category of discretionary fortification and an expanded category of special purpose foods.

This will give Canadians more choices in the foods they buy while maintaining the government's responsibility to ensure that the food supply is both nutritious and safe.

While the policy is not yet completed, we anticipate it will recommend that Canada:

• retain food fortification as a way to maintain and improve the nutritional quality of the food supply chain;
• continue to use mandatory food fortification to correct or prevent nutritional problems of public health significance that cannot be adequately addressed through voluntary means;
• allow a wider range of fortified products; and
• establish a new category of discretionary fortification and propose the expansion of the special purpose foods category.

Setting limits

Just as too little of a vitamin or mineral can lead to deficiency symptoms, too much of many vitamins and minerals can also cause problems. For example, high amounts of vitamin A can lead to birth defects; too much folic acid can mask the symptoms of vitamin B12 deficiency which can result in irreversible neurological damage; and too much calcium can lead to kidney problems.

When making food fortification decisions Health Canada conducts a scientific assessment to determine how much of a specific nutrient Canadians are likely to consume by eating various foods during a typical day. We conduct surveys to gather consumers' eating habits and then, once we know the cumulative amount of the nutrient being consumed, we can do a risk assessment to determine the advisability of fortifying foods with that nutrient.

A new reference value, the Tolerable Upper Level of Intake (UL) is now being used to set a ceiling for nutrients. Amounts of nutrients taken in excess of the UL pose a risk of adverse health effects - the higher the excess, the higher the risk. The ULs were established by the U.S. Institute of Medicine (IOM) in a study that was jointly funded by Canada and the U.S. The Institute of Medicine (IOM) is one of four distinguished organizations that comprises the century-old U. S. National Academy of Sciences. The IOM brings together volunteer scientific experts to study and address critical issues and then give their unbiased advice to governments and the public.

What happens next with food fortification?

Before we can finalize our policy revision, we need further information on how to apply the new Upper Levels. Together with our counterparts at the U.S. Food and Drug Administration and the U.S. Department of Agriculture, we have asked the IOM for advice on how to use the ULs in determining nutrition policy and regulations. Their advice is due by the end of September 2003.

The timelines for finalizing the revised policy are:

• late Spring 2003: continue to define the criteria for the proposed category of discretionary fortification and the expanded category of special purpose foods;
• June 23, 2003: stakeholder meeting to discuss issues related to discretionary fortification and the applicability of exclusion criteria for certain foods;
• October 2003: analyse the advice from IOM and, if necessary, adjust the revised policy accordingly;
• Late Fall 2003: release a report on the proposed revised policy for final input from stakeholders prior to preparing the regulatory proposal; and
• January 2004: publish the proposed regulations in Canada Gazette Part I.

What are other countries doing regarding food fortification?

Like Canada, other countries are becoming concerned that too much of a good thing can be a risk to health:

• The United Kingdom's Food Standards Agency recently published a warning that vitamins and minerals could have harmful effects if taken in too high a dose
• The European Community proposes to take ULs into account when setting the maximum levels of vitamins and minerals for voluntary addition to foods.
• The U. S. Food and Drug Administration's policy emphasizes that widespread fortification of food is unnecessary and urges manufacturers to follow set guidelines.
• In Australia and New Zealand, the addition of vitamins and minerals is generally not allowed unless permission is given to add a specific vitamin or mineral to a food product; the ULs are a factor in the decision-making.

Countries vary in their approaches to, and controls on the addition of vitamins and minerals to foods. Some like Australia are similar to Canada; others like the United States are more permissive. Some countries, including the U. S., take the approach of regulating the amount of nutrients on a food-by-food basis, without taking into account the cumulative effect.

Pending requests to fortify foods

During the policy revision process, Health Canada received a number of expressions of interest from several companies in several sectors of the food industry, wanting to add nutrients to their food products at levels greater than are currently permitted in Canada. One of their objectives was to enable the harmonization of their production across Canada and the U.S.

We believe a precautionary approach is appropriate and are therefore deferring any decisions on specific requests until we receive advice from the IOM. Awaiting all available, scientific evidence before finalizing our policy supports our ongoing commitment to making decisions based on sound science and a thorough analysis of the benefits and risks of food fortification. Health Canada will consider pending requests once we have analysed the forthcoming report from the IOM.

More information on food fortification