From The June 2001 Issue of Nutrition Science News

Going Global: What Manufacturers Need To Know About Navigating The European Regulatory Maze

By Peter Berry Ottaway

One European dietary supplements expert said the United States market is "like being in heaven every day." As a general rule, European governments take a more restricted approach to supplements. Most do not even allow formulas containing both herbs and vitamins—and some forbid herbs entirely except those that have undergone an expensive review and registration process.

The United States and Europe have divergent approaches to regulatory control of dietary supplements, nutraceuticals and functional foods. Most differences are significant enough to require major changes to product formulations exported from the United States to countries in the European Union (EU). Two major issues are Europe's view that herbs and botanicals are considered medicines, not supplements, and the 1997 Novel Food and Novel Food Ingredient Regulation that has essentially eliminated product innovation across the Continent.

Within the EU, dietary supplements can be sold freely as food products in most countries, provided they comply with strict national rules. Since the mid-1960s, the EU has attempted to harmonize the laws so that eventually all 15 countries will operate under the same rules. Although about 90 percent of this pan-European legislation is in place, the areas not yet completed include dietary supplements and herbal products.

Until European-wide legislation is adopted—some estimate by 2004—each EU member state can apply its own national legislation to products marketed within its boundaries. This means 15 different sets of legislation govern dietary supplements, and a similar number control the composition and sale of herbal products. For regulatory purposes across Europe, dietary supplements have to fit one of four categories.

1. Supplements containing only vitamins and minerals as active ingredients. Products in this category, such as vitamin C or zinc, are subject to various national rules. Historically, many European countries have considered products containing high levels of vitamins and minerals to be drugs, and a number of these countries have laws with strict upper intake limits. For example, in Ireland and Spain, products must not contain more than the Recommended Daily Allowance (RDA) of each vitamin and mineral per serving. In Germany, vitamin A as retinol and vitamin D are not permitted in supplements. Other vitamins may be added at up to three times the RDA per day, while a number of minerals are permitted at only less than half of the RDA. Italy allows most micronutrients up to 1.5 times the RDA, and Belgium allows some at three times the RDA. Other countries restrict content to one or two times the RDA. One proposed law would implement consistent upper limits for vitamins and minerals across Europe.
   
   
2. Supplements containing vitamins, minerals, and other non-botanicals as active ingredients. Products in this category, such as glucosamine or Co-Q10, have to be considered on a state-by-state basis because many EU countries have either maximum intake levels or do not permit the nutrients at all. The vitamin and mineral levels in such combinations must comply with category one rules.
   
   
3. Supplements containing both herbal and nonherbal active ingredients. In many EU countries, most products in this category—such as echinacea (Echinacea spp.), vitamin C, and zinc formulas—cannot be sold as dietary supplements; rather, they must be registered as medicines. The legislation on herbs sold under food law is far more strict across Europe than in the United States since the Dietary Supplements Health and Education Act (DSHEA) of 1994. In contrast to the United States, in Europe most herbs that exhibit any pharmacological function are considered medicines and cannot be marketed as dietary supplements. The requirements for each country are so complex that each product is subjected to expert regulatory review.
   
   
4. Supplements containing only herbs or botanicals. Marketing herbal products in Europe is incredibly complex. There is considerable confusion and misunderstanding about the status of herbal products in the EU. Traditionally, herbs sold in unit dose form have been considered medicines in Europe, even in England where, until the end of the 1980s, most products on the market were licensed as medicines. At present it is impossible to produce an herbal dietary supplement that can be sold as a food in a pan-European market. Companies hoping to launch an herbal supplement face 15 different sets of laws corresponding to each of the EU members. These laws range from the U.K.'s relatively liberal approach, to the strict requirements of Ireland, which requires any product containing an herbal compound to be registered as a medicine.

Depending on the country, each of the four categories can be subject to specific and complex laws. The EU is attempting to harmonize the rules for dietary supplements; however, these laws are unlikely to be reconciled and enforced for several years. Until then, the present situation will continue, whereby many products have to be specifically formulated for each country.

European Food Law
At present, there is no European-wide legislation specifically for dietary supplements, but it is generally a requirement that supplements not registered as medicines comply with all aspects of relevant food law. There already are pan-European food laws in place covering most aspects of composition, labeling, manufacture (good manufacturing practices or GMPs), contamination and control. Dietary supplements must meet the requirements of all these food laws.

Manufacturers must not assume that ingredients and additives commonly used in American products are automatically acceptable under European law. Every product intended for export to Europe should be subject to expert scrutiny to ensure compliance.

Additive and excipient use is strictly governed. Many colors and flavors have upper limits for use in supplements. For example, cross-linked sodium carboxy-methyl cellulose (croscarmellose) can be used only up to 30 g/kg of final tablet weight. The FD and C colors permitted in Europe (some are not) are, in general, permitted only up to 300 mg/kg (300 parts per million) in dietary supplements. In addition, many excipients and colors commonly used in the United States are prohibited in Europe, such as sodium starch glycollate in tablets and annatto color in soft-gel capsules. Such limits apply to a wide range of additives and excipients.

Detailed labeling rules are pan-European and strictly enforced. Manufacturers must declare every component used in the product, including excipients, on each pack. Further, each package must include open expiration date coding and European-specific warning statements. There also are special rules and factors for calculating nutrition information. Surprisingly, these rules differ considerably between the United States and Europe.

Vivé la Difference... For Now
The United Kingdom and the Netherlands are the most liberal countries in Europe in terms of product diversity and availability. Meanwhile, in Germany, despite centuries of traditional herbal medicine use, every product is an official over-the-counter medicine, and as such, herbal supplements cannot be sold without some form of government oversight. U.S. manufacturers invariably choose one or two countries in which to market their products, basing their decision on population, income and propensity to buy supplements.

Across Europe, the best-selling products tend to be multivitamins and weight-loss products, although anomalies exist. For instance, fish oils, cod liver oil and evening primrose oil continue to be strong sellers in the United Kingdom. Meanwhile, Germans buy a lot of magnesium supplements because manufacturers are allowed to put 300 mg in tablets. In this way, the market tends to mold itself around what it can do.

Not many American products come to Europe without at least some formulation or labeling changes. Here is a sampling of the regulatory vagaries inherent in the five largest EU countries.

• FRANCE Under French law, there is a "positive list" of 34 herbs that can be sold as foods. Products containing herbs not on this list require registration. Unfortunately, only a few of the 34 herbs on the list are commercially important to the herbal supplements industry.
  
  
• GERMANY Herbs sold here in tablet or capsule form must adhere to a rule reinforced in 1995 when a court judgment concluded that garlic capsules were medicines requiring registration. Garlic cloves, powder and oil sold for culinary purposes, however, are considered food.
  
  
• ITALY The Italians have proposed a law dividing herbal products into two lists. The first contains herbs that may be sold only from pharmacies. Herbs on the second and longer list can be sold outside pharmacies but only under the control of a graduate herbalist. The proposed law defines the qualifications required of the herbalist—essentially a university degree in herbal medicine from a three-year program. Provisions in the law would grant herbalists already in business but without the required qualifications a transition period for upgrading their credentials.
  
  
• SPAIN Spaniards also restrict herbs. Twenty-three herbs on a positive list can be used for "infusates," and another list of herbs considered traditional medicinal plants can be sold freely provided no therapeutic or preventive claims are made. These herbs cannot be combined with other active substances, such as vitamins or minerals. Selling herbs outside business premises is prohibited.
  
  
• UNITED KINGDOM There are complex regulatory inconsistencies here. Some herbs, such as ginseng (Panax spp.) and garlic (Allium sativum), can be sold under food law and can be marketed in combination with nonherbal actives, such as vitamins and minerals. However, a number of herbs such as St. John's wort (Hypericum perforatum), echinacea (Echinacea spp.), and valerian (Valeriana officinalis) are regarded as medicinal herbs and cannot be mixed with nonherbal actives. Technically, those herbs deemed medicinal should be licensed as medicines, which is an expensive process. The British herbal products industry is currently regulating under legislation known as the "Section 12" exemption. This refers to Section 12 of the British Medicines Act of 1968, which confers exemption from licensing for certain herbal remedies provided a number of conditions are met. Many conditions cannot be met by most commercial operations, but the authorities are tolerating noncompliance.

Functional foods are not recognized as a separate category in European law, meaning they must comply with all European and national food regulations. Functional foods containing vitamins and minerals have to comply with the same national laws as supplements. The laws outlined above for herbs also apply to this category.

The British Department of Health contends that the current situation requires a European-wide rather than a national solution, and the British government has been encouraging the European Commission to introduce legislation for herbal medicines. Until pan-European legislation is established, companies must ensure that each product obeys the laws of the European country where it will be sold.

In the next few years, many new raw ingredients products will be introduced in the United States; most will likely come and go. Manufacturers of those few that succeed in the American market will then have the capital available to make an easier decision about whether to go through the formal application process to break into the European market. Being established in European stores before harmonized rules come into effect could be a powerful marketing advantage for those companies able to make that investment.

Sidebars:
The Law That Crushed Innovation
One Company's European Attempt

Peter Berry Ottaway is president of Berry Ottaway and Associates, an England-based consultancy specializing in food science, technology, nutrition and law. He has been in the industry since 1967.