Peter Berry Ottaway03.01.02
There are very great differences in the regulatory approach to the control of dietary supplements, nutraceuticals and functional foods between Europe and other major markets such as the U.S. Most of the differences are significant enough to require major changes to product formulations exported from other countries to countries in the European Union (EU).
As currently constituted, the EU consists of 15 countries in Western Europe (Table 1). Norway and Switzerland are not part of the EU as their citizens voted against joining. Within the next three years it is likely that the EU will be considerably expanded to include Hungary, Poland and the Czech Republic joining the community, bringing the membership to over 25 countries.
Since the first stages of the EU were established in the early 1960s, there has been a move to harmonize the laws so that all the 15 countries operate under the same food legislation. While about 90-95% of this pan-European legislation is currently in place, the areas not yet completed include dietary supplements and herbal products.
Until European-wide legislation is adopted, each member state of the EU is free to apply their national legislation to products marketed within their territorial boundaries. This means that there are still 15 different sets of legislation covering micronutrients and a similar number controlling the composition and sale of products containing herbs. As a result, a large number of products cannot be sold freely across the EU.
The harmonization of EU food law has been in progress for 40 years. From the early 1960s to 1985 most of the focus was on vertical legislation with "recipe" or compositional criteria established for product categories. Of the original program of over 30 "recipe" directives, only nine were agreed to and adopted during the first 20 years of the European community. In 1985 a White Paper from the European Commission to the European Council recommended a complete overhaul with respect to the approach to food legislation and that the original concept of restrictive vertical legislation be replaced by a system of horizontal legislation.
A new concept of European food law based on five horizontal framework directives was proposed and eventually adopted by the European Council and Parliament. The framework directives were developed to comply with identified requirements for public health and safety, consumer information and general food control measures. However, even with the more simplified and streamlined system introduced with the 1985 initiative, progress was slow and much of the proposed legislation was not in place by the introduction of the Single Market (a common term applied to the theoretical free trade between the 15 member states) in January 1993.
In January 2000 the European Commission published its White Paper on Food Safety, which included details and a timetable for 84 items of legislation that were still outstanding. Some of this outstanding legislation is of direct relevance to the nutraceutical, functional food and supplement industries, and much was still not completed by the end of 2001.
Labeling: There are very detailed pan-European labeling requirements for products, which include the declaration of all ingredients in descending order by weight, open expiry date coding and storage conditions, the name of the manufacturer, packer or importer established within the EU, a generic description of the product and usage instructions.
There are a number of rules governing both the format and calculations to be used for presenting nutrition information. The factors required to calculate energy from the energy nutrients and those used for vitamin activity differ significantly from those used in the U.S. and some other non-European countries. Additionally, there are rules for the labeling of ingredients and additives derived from genetically modified organisms (GMOs).
Food Additives: Within European food law there are very detailed requirements governing the use of food additives, colors, sweeteners, extraction solvents and flavors. Technological additives such as preservatives and antioxidants, for example, are controlled not only by the categories of food in which they are permitted, but also by upper limits on their input, which are specific to each permitted category. In some cases the additives are permitted for a number of food categories and in others may be allowed for only one or two. If the food category does not appear on the list for a particular additive, the additive cannot be used in the product. Since the legislation came into effect in March 1997, there have been a number of instances where the technological needs of a product could not be met by strict observance of the legislation.
The laws for colors and sweeteners follow the same format as that for the technological additives (i.e. defined permitted categories with maximum levels of use).
The directive on colors can be particularly confusing as there are a number of tables, which include those for products that are not permitted to be colored; those that can contain only certain colors and colors that can only be used in specified foods.
There are similar controls on the use of intense sweeteners and polyols (e.g. sorbitol, xylitol, etc). If an extraction solvent is used in the production of a food ingredient, both the solvent and its residue levels must comply with European legislation.
Contaminants: Over the last few years there has been increasing focus on contaminants in food. There are a number of European laws controlling the maximum levels of a large number of contaminants including pesticides, heavy metals, mycotoxins, 3-MCPD (3-monochloropropane-1, 2 diol) and dioxins and each ingredient must be checked for compliance. For example, from July, 1 2002 there could be a legal limit on dioxins in fish oils.
There are complex laws on flavorings that control the source materials. In addition, flavorings produced from natural botanical sources must comply with requirements that impose low limits on biologically active principles (BAPs), which occur naturally in plants. BAPs subject to strict control include coumarin, safrole and berberine. Companies hoping to export products to Europe are advised to ensure that their suppliers certify that the composition of the flavors is in conformance with European law.
Other Legislation: Legislation that must also be considered during the development of a product includes detailed requirements on materials and articles that come into contact with food, such as the inner surface of packaging, the requirements of the hygiene directive and the packaging waste directives.
The framework directive on foods for particular nutritional uses 89/398/EEC was adopted in 1989. This directive defined dietetic foods and laid down general requirements for their composition and labeling. It also required that detailed directives be developed for nine categories of dietetic foods. These categories included foods for infants and young children, meal replacement products for weight control, foods for special medical purposes and sports nutrition products.
A directive on sports nutrition products is still in the early stages of development. The European Commission's expectation of a first draft to be available by December 2001 was not met and is now slated for later this year and is expected to include supplements marketed as sports nutrition products.
In February 2001 Directive 2001/15/EC was adopted. This directive contains a positive list of nutrient sources for vitamins, minerals and amino acids. The directive will be applicable from April 1, 2004 and by that time all PARNUTS products(including sports nutrition products) can only be sold if they are using nutrient sources on the permitted list.
In January 1997 Regulation (EC) No258/97 on Novel Foods and Novel Food Ingredients was adopted and went into effect in all member states of the EU on May 15, 1997. This regulation requires that all foods, ingredients and some processes that had not been used for human consumption within the European Community to a significant degree before May 1997 be subject to official review and approval before being placed on the market in any EU country. Since its introduction, this law has had a very serious impact on product innovation in Europe and has particularly affected functional foods and nutraceuticals.
The regulation requires that a full dossier on the substance or process be reviewed by a competent authority in the EU country of intended first sale. In theory, the total time taken to review the application should be no longer than 150 days. In practice, however, it has been found that applications are, in effect, being reviewed in detail by the competent authorities in all or most of the member states, resulting in up to 15 reviews of the same data. By the end of 2001, only 35 applications had been submitted and only five of these had received approval. The costs of obtaining the data to support an application have been found to be substantial and are considered to be prohibitive by many of the small to medium sized innovative companies.
Experience with the Novel Foods Regulations based on the first four and a half years suggests that, unless there are radical changes in procedures, it is unlikely that more than two or three new nutraceutical ingredients will be approved each year.
Functional foods also face obstacles. Functional foods must obey not only the relevant European laws but also the individual national laws covering micronutrients and herbs. Consequently, the development of a pan-European product is in many cases almost impossible at present.
Within the EU, dietary supplements can be sold freely as food products in most countries provided they comply with very strict national rules. Unfortunately for the industry there is, as yet, no consistency in these rules between countries.
For regulatory purposes dietary supplements must be considered according to four categories: supplements containing as active ingredients only vitamins and minerals; supplements containing vitamins, minerals and other non-botanical actives (e.g. glucosamine); supplements containing herbals and non-herbal active ingredients and supplements containing only herbs/botanicals.
Depending upon the country, each of the above categories can be subject to specific and complex laws. For example, a product containing the herb echinacea, vitamin C and zinc (category 3) cannot be sold as a dietary supplement in a number of EU countries, including the U.K. In contrast to the U.S., most herbs that exhibit any pharmacological function are considered to be medicines in Europe and cannot be marketed as dietary supplements.
When considering a supplement for the European market, the combination of the active ingredients is critical. As previously stated, supplements can fall into four categories.
1. Supplements containing only vitamins and minerals. Products in this category are subject to diverse 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 national laws with strict upper limits of addition. For example, in Ireland and Spain products must not contain more than 1 x Recommended Daily Allowance (RDA) of each vitamin and mineral per recommended daily intake. In Germany, vitamins A (as retinol) and D are not permitted in supplements. Other vitamins may be added up to 3 x RDA per day, while a number of minerals are only permitted at less than half of the RDA. Italy allows most micronutrients at up to 1.5 x RDA and Belgium allows some at 3 x RDA while others are restricted to 1 or 2 x RDA.
There are proposed laws to harmonize the rules for vitamin and mineral supplements across the EU. These laws reached political agreement in September 2001 but still have to pass the second reading in the European Parliament and are unlikely to come into force for two to three years. Until they come into force, the situation whereby many products have to be specifically formulated for each country will continue.
2. Supplements containing vitamins, minerals and other non-botanical actives. In this category non-botanical actives include ingredients such as glucosamine and CoQ10. Such products have to be considered on a state-by-state basis because in many countries of the EU a number of such ingredients are not legal in supplements and in others there are maximum levels of input. The vitamin and mineral levels in such combinations still have to comply with the same rules as category 1.
3. Supplements containing herbs and non-herbal active ingredients, including vitamins and minerals. The legislation on herbs sold under food law is very strict across Europe. In many EU countries most products in this category cannot be sold as dietary supplements under food law and can only be sold as registered medicines. The requirements for each country are so complex that every product is subjected to expert regulatory review. Even in the U.K., which has generally been regarded as the most liberal of EU countries with regard to supplements, it is illegal to market a product that combines echinacea or St. John's Wort with a vitamin or mineral.
4. Supplements containing only herbs or botanicals. The marketing of herbal products in Europe is incredibly complex because there is considerable confusion and misunderstanding regarding the status of herbal products in the EU. At present it is impossible to produce an herbal supplement that can be sold in a pan-European market. Companies hoping to launch an herbal supplement are faced with 15 different sets of laws, ranging from the relatively liberal approach in the U.K. to the very strict requirements of its near neighbor, Ireland, where any product containing an herbal compound must be registered as a medicine. Traditionally, herbs sold in unit dose form are considered medicines in Europe.
All the member states have different laws and, at present, no two countries have the same approach to the regulation of herbs. Even in the U.K. there are complex inconsistencies. Some herbs such as ginseng and garlic can be sold in the U.K. under food law and can be marketed in combination with non-herbal actives such as vitamins and minerals. However, there are a number of herbs such as St. John's Wort, echinacea and valerian, which are regarded by the British authorities as being medicinal herbs, which cannot be mixed with non-herbal actives.
The problems with herbal products have been recognized by the European Commission, who is currently working on new laws to produce a "level playing field" for these products across the whole of Europe. A proposal is under consultation that would allow a simpler form of registration for traditional herbal remedies that can demonstrate a continuous use of 30 years in the same product form. There is a concession that the 30 years can be made up of 15 years in an EU country and 15 years in a non-EU country. The emphasis of the approval system will be on Good Manufacturing Practices (GMPs) and product safety. Discussions on the new proposals are progressing very slowly and it is unlikely that new laws will be in place within the next one to two years. Until then companies must ensure that each product obeys the laws of the European country in which it is intended to be sold.
This article outlines some of the issues that have created a wide disparity in the way supplements, nutraceuticals and functional foods can be legally marketed across the EU. It is likely to be at least three years before there are common rules for these products across Europe and until then companies will have to continue to adjust their products to the requirements of each European country.NW
About the author: Peter Berry Ottaway is founder and president of Berry Ottaway & Associates, a scientific and technical consultancy specializing in food science technology, nutrition and food law. He can be reached at 44-1432-270886; E-mail: berry.ottaway@dial.pipex.com.
Countries in the EU
As currently constituted, the EU consists of 15 countries in Western Europe (Table 1). Norway and Switzerland are not part of the EU as their citizens voted against joining. Within the next three years it is likely that the EU will be considerably expanded to include Hungary, Poland and the Czech Republic joining the community, bringing the membership to over 25 countries.
Since the first stages of the EU were established in the early 1960s, there has been a move to harmonize the laws so that all the 15 countries operate under the same food legislation. While about 90-95% of this pan-European legislation is currently in place, the areas not yet completed include dietary supplements and herbal products.
Until European-wide legislation is adopted, each member state of the EU is free to apply their national legislation to products marketed within their territorial boundaries. This means that there are still 15 different sets of legislation covering micronutrients and a similar number controlling the composition and sale of products containing herbs. As a result, a large number of products cannot be sold freely across the EU.
Background to European Food Law
The harmonization of EU food law has been in progress for 40 years. From the early 1960s to 1985 most of the focus was on vertical legislation with "recipe" or compositional criteria established for product categories. Of the original program of over 30 "recipe" directives, only nine were agreed to and adopted during the first 20 years of the European community. In 1985 a White Paper from the European Commission to the European Council recommended a complete overhaul with respect to the approach to food legislation and that the original concept of restrictive vertical legislation be replaced by a system of horizontal legislation.
A new concept of European food law based on five horizontal framework directives was proposed and eventually adopted by the European Council and Parliament. The framework directives were developed to comply with identified requirements for public health and safety, consumer information and general food control measures. However, even with the more simplified and streamlined system introduced with the 1985 initiative, progress was slow and much of the proposed legislation was not in place by the introduction of the Single Market (a common term applied to the theoretical free trade between the 15 member states) in January 1993.
In January 2000 the European Commission published its White Paper on Food Safety, which included details and a timetable for 84 items of legislation that were still outstanding. Some of this outstanding legislation is of direct relevance to the nutraceutical, functional food and supplement industries, and much was still not completed by the end of 2001.
Labeling: There are very detailed pan-European labeling requirements for products, which include the declaration of all ingredients in descending order by weight, open expiry date coding and storage conditions, the name of the manufacturer, packer or importer established within the EU, a generic description of the product and usage instructions.
There are a number of rules governing both the format and calculations to be used for presenting nutrition information. The factors required to calculate energy from the energy nutrients and those used for vitamin activity differ significantly from those used in the U.S. and some other non-European countries. Additionally, there are rules for the labeling of ingredients and additives derived from genetically modified organisms (GMOs).
Food Additives: Within European food law there are very detailed requirements governing the use of food additives, colors, sweeteners, extraction solvents and flavors. Technological additives such as preservatives and antioxidants, for example, are controlled not only by the categories of food in which they are permitted, but also by upper limits on their input, which are specific to each permitted category. In some cases the additives are permitted for a number of food categories and in others may be allowed for only one or two. If the food category does not appear on the list for a particular additive, the additive cannot be used in the product. Since the legislation came into effect in March 1997, there have been a number of instances where the technological needs of a product could not be met by strict observance of the legislation.
The laws for colors and sweeteners follow the same format as that for the technological additives (i.e. defined permitted categories with maximum levels of use).
The directive on colors can be particularly confusing as there are a number of tables, which include those for products that are not permitted to be colored; those that can contain only certain colors and colors that can only be used in specified foods.
There are similar controls on the use of intense sweeteners and polyols (e.g. sorbitol, xylitol, etc). If an extraction solvent is used in the production of a food ingredient, both the solvent and its residue levels must comply with European legislation.
Contaminants: Over the last few years there has been increasing focus on contaminants in food. There are a number of European laws controlling the maximum levels of a large number of contaminants including pesticides, heavy metals, mycotoxins, 3-MCPD (3-monochloropropane-1, 2 diol) and dioxins and each ingredient must be checked for compliance. For example, from July, 1 2002 there could be a legal limit on dioxins in fish oils.
There are complex laws on flavorings that control the source materials. In addition, flavorings produced from natural botanical sources must comply with requirements that impose low limits on biologically active principles (BAPs), which occur naturally in plants. BAPs subject to strict control include coumarin, safrole and berberine. Companies hoping to export products to Europe are advised to ensure that their suppliers certify that the composition of the flavors is in conformance with European law.
Other Legislation: Legislation that must also be considered during the development of a product includes detailed requirements on materials and articles that come into contact with food, such as the inner surface of packaging, the requirements of the hygiene directive and the packaging waste directives.
Foods for Particular Nutritional Uses (PARNUTS)
The framework directive on foods for particular nutritional uses 89/398/EEC was adopted in 1989. This directive defined dietetic foods and laid down general requirements for their composition and labeling. It also required that detailed directives be developed for nine categories of dietetic foods. These categories included foods for infants and young children, meal replacement products for weight control, foods for special medical purposes and sports nutrition products.
A directive on sports nutrition products is still in the early stages of development. The European Commission's expectation of a first draft to be available by December 2001 was not met and is now slated for later this year and is expected to include supplements marketed as sports nutrition products.
In February 2001 Directive 2001/15/EC was adopted. This directive contains a positive list of nutrient sources for vitamins, minerals and amino acids. The directive will be applicable from April 1, 2004 and by that time all PARNUTS products(including sports nutrition products) can only be sold if they are using nutrient sources on the permitted list.
European Regulation on Novel Foods/Ingredients
In January 1997 Regulation (EC) No258/97 on Novel Foods and Novel Food Ingredients was adopted and went into effect in all member states of the EU on May 15, 1997. This regulation requires that all foods, ingredients and some processes that had not been used for human consumption within the European Community to a significant degree before May 1997 be subject to official review and approval before being placed on the market in any EU country. Since its introduction, this law has had a very serious impact on product innovation in Europe and has particularly affected functional foods and nutraceuticals.
The regulation requires that a full dossier on the substance or process be reviewed by a competent authority in the EU country of intended first sale. In theory, the total time taken to review the application should be no longer than 150 days. In practice, however, it has been found that applications are, in effect, being reviewed in detail by the competent authorities in all or most of the member states, resulting in up to 15 reviews of the same data. By the end of 2001, only 35 applications had been submitted and only five of these had received approval. The costs of obtaining the data to support an application have been found to be substantial and are considered to be prohibitive by many of the small to medium sized innovative companies.
Experience with the Novel Foods Regulations based on the first four and a half years suggests that, unless there are radical changes in procedures, it is unlikely that more than two or three new nutraceutical ingredients will be approved each year.
Functional foods also face obstacles. Functional foods must obey not only the relevant European laws but also the individual national laws covering micronutrients and herbs. Consequently, the development of a pan-European product is in many cases almost impossible at present.
Classification and Legal Status of Dietary Supplements in Europe
Within the EU, dietary supplements can be sold freely as food products in most countries provided they comply with very strict national rules. Unfortunately for the industry there is, as yet, no consistency in these rules between countries.
For regulatory purposes dietary supplements must be considered according to four categories: supplements containing as active ingredients only vitamins and minerals; supplements containing vitamins, minerals and other non-botanical actives (e.g. glucosamine); supplements containing herbals and non-herbal active ingredients and supplements containing only herbs/botanicals.
Depending upon the country, each of the above categories can be subject to specific and complex laws. For example, a product containing the herb echinacea, vitamin C and zinc (category 3) cannot be sold as a dietary supplement in a number of EU countries, including the U.K. In contrast to the U.S., most herbs that exhibit any pharmacological function are considered to be medicines in Europe and cannot be marketed as dietary supplements.
When considering a supplement for the European market, the combination of the active ingredients is critical. As previously stated, supplements can fall into four categories.
1. Supplements containing only vitamins and minerals. Products in this category are subject to diverse 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 national laws with strict upper limits of addition. For example, in Ireland and Spain products must not contain more than 1 x Recommended Daily Allowance (RDA) of each vitamin and mineral per recommended daily intake. In Germany, vitamins A (as retinol) and D are not permitted in supplements. Other vitamins may be added up to 3 x RDA per day, while a number of minerals are only permitted at less than half of the RDA. Italy allows most micronutrients at up to 1.5 x RDA and Belgium allows some at 3 x RDA while others are restricted to 1 or 2 x RDA.
There are proposed laws to harmonize the rules for vitamin and mineral supplements across the EU. These laws reached political agreement in September 2001 but still have to pass the second reading in the European Parliament and are unlikely to come into force for two to three years. Until they come into force, the situation whereby many products have to be specifically formulated for each country will continue.
2. Supplements containing vitamins, minerals and other non-botanical actives. In this category non-botanical actives include ingredients such as glucosamine and CoQ10. Such products have to be considered on a state-by-state basis because in many countries of the EU a number of such ingredients are not legal in supplements and in others there are maximum levels of input. The vitamin and mineral levels in such combinations still have to comply with the same rules as category 1.
3. Supplements containing herbs and non-herbal active ingredients, including vitamins and minerals. The legislation on herbs sold under food law is very strict across Europe. In many EU countries most products in this category cannot be sold as dietary supplements under food law and can only be sold as registered medicines. The requirements for each country are so complex that every product is subjected to expert regulatory review. Even in the U.K., which has generally been regarded as the most liberal of EU countries with regard to supplements, it is illegal to market a product that combines echinacea or St. John's Wort with a vitamin or mineral.
4. Supplements containing only herbs or botanicals. The marketing of herbal products in Europe is incredibly complex because there is considerable confusion and misunderstanding regarding the status of herbal products in the EU. At present it is impossible to produce an herbal supplement that can be sold in a pan-European market. Companies hoping to launch an herbal supplement are faced with 15 different sets of laws, ranging from the relatively liberal approach in the U.K. to the very strict requirements of its near neighbor, Ireland, where any product containing an herbal compound must be registered as a medicine. Traditionally, herbs sold in unit dose form are considered medicines in Europe.
All the member states have different laws and, at present, no two countries have the same approach to the regulation of herbs. Even in the U.K. there are complex inconsistencies. Some herbs such as ginseng and garlic can be sold in the U.K. under food law and can be marketed in combination with non-herbal actives such as vitamins and minerals. However, there are a number of herbs such as St. John's Wort, echinacea and valerian, which are regarded by the British authorities as being medicinal herbs, which cannot be mixed with non-herbal actives.
The problems with herbal products have been recognized by the European Commission, who is currently working on new laws to produce a "level playing field" for these products across the whole of Europe. A proposal is under consultation that would allow a simpler form of registration for traditional herbal remedies that can demonstrate a continuous use of 30 years in the same product form. There is a concession that the 30 years can be made up of 15 years in an EU country and 15 years in a non-EU country. The emphasis of the approval system will be on Good Manufacturing Practices (GMPs) and product safety. Discussions on the new proposals are progressing very slowly and it is unlikely that new laws will be in place within the next one to two years. Until then companies must ensure that each product obeys the laws of the European country in which it is intended to be sold.
Conclusion
This article outlines some of the issues that have created a wide disparity in the way supplements, nutraceuticals and functional foods can be legally marketed across the EU. It is likely to be at least three years before there are common rules for these products across Europe and until then companies will have to continue to adjust their products to the requirements of each European country.NW
About the author: Peter Berry Ottaway is founder and president of Berry Ottaway & Associates, a scientific and technical consultancy specializing in food science technology, nutrition and food law. He can be reached at 44-1432-270886; E-mail: berry.ottaway@dial.pipex.com.