Global Guidelines: Can They Ever Work?

Confusion and controversy dog the role of Codex Alimentarius, the international body responsible for setting food standards. Here, Simon Pettman, executive director of IADSA, explains how Codex operates, and the challenges that lie ahead.

Codex has been under attack in the last few months in a way it has never before experienced. The cause is the draft guideline on vitamin and mineral supplements. Advocates for freedom of vitamin therapy have sent tens of thousands of emails, held demonstrations outside Codex meetings, and set up Web sites in an attempt to prevent a proposed Codex ruling. Is all this uproar justified, and will it create a more liberal regulatory environment for marketing dietary supplements and other natural health products?

Codex Alimentarius, established by the United Nations in 1961, links 165 member countries. Its primary purpose is to ensure a fair deal for consumers by improving the quality of food products and to ensure fair and free trade in food through common standards agreements. The member countries are represented in a range of committees that discuss and develop standards, guidelines and other measures that are eventually agreed upon by the Codex Alimentarius Commission.

Currently, four key Codex initiatives directly affect the dietary supplements sector, with key implications for the functional foods sector: the draft guideline on vitamin and mineral supplements; the draft standard on additives, including those that may be used in supplements; a draft guideline for health claims that can be used for foods, including supplements; and the principles for assessing and managing risks.

A key concern looms over the validity of such discussions at an international level. In light of the industry-at-large's desire to ensure that as many consumers as possible around the world have access to its products, the logical response is that any international guidance which supports this makes sense.

As an industry, we need to get better at clearly defining our product range, and its value to the consumer.

Another concern is whether the current draft Codex measures will contribute to this goal. The answer to this must be vague for now, since all measures are only drafts, some with elements of great concern to the industry. The answer, therefore, depends on the outcome of discussions and the success of lobbyists to garner an appropriate worldwide regulatory framework.

The third question is whether Codex will really make a difference in markets with a liberal regulatory environment. Most likely it will not. For example, the draft Codex guideline on vitamin and mineral supplements is but an advisory document to individual governments, which are not required to introduce it into law. Codex will not restrict vitamin therapy in the US as long as the US administration has not already taken that initiative. Codex also will not restrict vitamin therapy in Germany because it is already restricted under existing German law.

Reality Check
The reality is that Codex exists to help many countries, particularly developing countries, create their own legislation on food. If the Codex model is a good one, it will be enacted into law in many markets across the world. If Codex legislation is restrictive, those markets may be closed or difficult to access.

We need to ensure that regulators understand the substantial volume of data available which underpin our products.
Having been involved in Codex meetings since 1995, I believe the most significant problem is education. As an industry, we need to more clearly define our product range and its value to the consumer, both in industrialised and developing countries. The Stop Codex campaign is unfortunately closing people's minds to important messages. Through bombarding regulators with emails, and making wild claims about Codex day after day, the sympathy level that our industry enjoyed in the past is falling fast. The recent Codex Committee on Nutrition in Berlin was disappointing; the number of governments prepared to support our industry is dwindling.

For Codex Alimentarius to be successful, we need to see even greater international co-ordination on the development of positions and communication of messages relating to the benefits and safety of our products to regulators. This process has been initiated through IADSA as an accredited non-governmental organisation to Codex and should continue. Although Codex progresses slowly, the dietary supplements industry must move faster in those countries where greater education is required.

Simon Pettman is executive director of IADSA, the International Alliance of Dietary Supplements Associations, based in Brussels, Belgium. IADSA brings together 35 associations from 27 countries and is actively engaged in supporting the industry by communicating information, developing common positions and lobbying for an appropriate regulatory framework for dietary supplements. Tel: +32 2 209 11 55 Fax: +32 2 223 30 64

CODEX Guideline On Vitamin And Mineral Supplements

The draft guideline on vitamins and mineral supplements is discussed in the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU), which meets annually in Berlin. The key issues addressed in the draft guideline include labeling as well as calculating minimum and maximum levels of vitamins and minerals in supplements. The draft guideline has been on the table for nearly 10 years and is still only at step three of the eight-step Codex process.

HEALTH CLAIMS: The Codex Committee on Food Labeling (CCFL), which meets annually in Canada, is developing guidelines for health claims for foods, including food supplements. At present, health claims include disease-risk reduction.

ADDITIVES: The additives required to manufacture dietary supplements are a critical yet often forgotten element. Many different additives standards exist across the world, and Codex is developing a common list so that a dietary supplement containing an additive made in one country may be sold in the other 164 Codex member countries. IADSA has submitted to Codex a priority list of additives to be added to this draft list.

RISK ANALYSIS: Science must remain the mainstay of regulation for dietary supplements. The Codex Committee on General Principles is establishing basic principles for risk assessment. This committee is at the centre of a substantial debate on whether the 'precautionary principle' should be introduced into the Codex principles, raising the spectre of arbitrary government decisions on whether a product is safe or not. The precautionary principle may have been defeated for the time being, but our continued work ensures that science remains at the heart of risk analysis.

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