In any part of the world, the marketing of nutraceuticals requires overcoming several regulatory hurdles. This is also certainly the case for those looking at benefiting from the new market opportunities opening up in Eastern and Central European (ECE) countries. Companies must understand the regulatory situation in the "Wild East" to be able to meet the regulatory challenge of marketing nu-traceuticals in this part of the world.
After decades of Communist rule, ECE countries are on their way to catching up with the European Union (EU) and, more generally, the global economy. For that purpose, they are required to adapt their legislation to modern standards and are looking towards the EU for guidance in this area. However, the lack of coherent EU legislation on nutraceuticals makes it particularly difficult for these countries to find the appropriate track. De-pending upon their history and relative openness, each country has developed its own practice with respect to allowing entry of modern food products, including nutraceuticals. In turn, this requires companies to develop a separate regulatory approach for each ECE country.
The Eastward Enlargement Of The EU
Since the collapse of the Soviet Empire, and despite their economical and political difficulties, ECE countries are gradually becoming an integral part of the global economy. Forty or more years of socialist ruling have been replaced by democratically elected governments introducing self-regulating market economies. More specifically, the collapse of the Soviet empire led most ECE countries to look for closer ties with Western Europe as the condition for the maintenance of their sovereignty and future political and economical development. The EU has also been looking to integrate ECE countries within the West European sphere of influence as a pledge of stability.
In November 1998, the road to a new EU enlargement, eastward, took a more direct course with the EU opening accession negotiations with a first tier of ECE "applicant countries," namely, Poland, Hungary, the Czech Republic, Slovenia and Estonia. As we went to press, it was expected that the EU will invite the remaining ECE applicants (Latvia, Lithuania, the Slovak Republic, Romania and Bulgaria) to join the first tier countries in negotiations, beginning in the year 2000. The former Yugoslavian Republics and those of the former USSR have not yet decided to seek accession to the EU membership.
For traders, one obvious direct benefit of the EU enlargement will be the enlargement of the "single market," the area now confined to Western Europe where goods and services can freely circulate. Obviously, this requires the enlargement of the EU Customs Union and the elimination of all barriers to trade between the EU and ECE countries. Towards that end, the new members are asked to adopt legislation compatible with that in place in the EU, the so-called "Acquis Communautaire." This process started years ago and should be completed prior to the accession of the first ECE countries into the EU membership, an event that is generally not scheduled before 2002-2003.
The Nutraceuticals Situation
Much remains to be completed, however, before products can enjoy a single market from the Atlantic to the Russian Urals. This is true for many sectors, including the foodstuffs area. This is true even more so for nutraceuticals, which have a different profile than "regular" foodstuffs or medicinal products on the radar screen of the ECE regulator. Indeed, while EU food and drug legislation is largely aligned, there is still no "harmonized" EU legislation on food supplements, fortified foods or herbal products that could serve as a "model" for ECE countries. Also, the absence of regulatory history for nutraceuticals in ECE countries differentiates this specific field from other sectors where EU model legislation is not available.
One essential element from the food legislation in place in the Communist era remains, however, that plays an important role in the ECE countries' approach to nutraceuticals: the traditional ECE pre-market approval mechanisms and certification processes still in place in these countries. These processes are often overly burdensome and complex to be applied by foreign food producers. With respect to nutraceuticals, however, and in the absence of other guidances, these traditional processes can play their full role and offer practical ways to gain market access.
This is true in most ECE countries, as further described below, regardless of their profile as potential or prospective EU members. Interestingly, (but not surprisingly in view of the above), Russia-the ECE country that is most independent from the EU model and accession process-is where the most developed legislation on nutraceuticals came to life.
Russian Legislation On Nutraceuticals
Russia has the distinction of having specific legislation covering nutraceuticals. Three regulations are indeed in place in that country governing, respectively, (i) the evaluation and certification, (ii) registration, and (iii) safety of "biologically active dietary supplements" or "BAD's." These regulations were adopted from 1995 to 1998.
BAD's are defined as "compositions of natural, or identical to natural, biologically active substances designed for the intake with food or for adding to foods with a view to fortifying the diet with certain nutrients or biologically active substances or complexes thereof." More specifically, however, the legislation distinguishes BAD's used to adjust the chemical composition of the diet by the addition of nutrients ("nu-traceuticals") and those used for prophylaxis, auxiliary therapy or the maintenance of human functions ("parapharmaceuticals") and subjects them to different requirements.
In general, Russian legislation requires all BAD's to undergo a sanitary expert evaluation carried out by the State Sanitary and Epidemiological Service. It also prohibits the use of genetically modified ingredients in BAD's as well as the use of specified risk materials of animal origin that risk transmitting BSE.
With regards to vitamin and mineral content, the legislation provides for BAD's not to contain more than three times their Recommended Daily Allowance (RDA) for vitamins A, D, B1, B2, B6, B12, niacin, pantothenic acid and biotin, and not more than 10 times their RDA for vitamins E and C. Levels are set down as well for a range of other vitamins, minerals and other trace elements. The legislation also contains recommended intakes for essential fatty acids, energy, protein, fat, carbohydrates and dietary fiber. Regarding the plants used in the manufacture of "parapharmaceuticals," they must comply with the Russian or foreign Pharmacopeias and/or other applicable international requirements.
Finally, mandatory labeling particulars for BAD's are also laid down. However, there are no specific provisions applicable to the use of specific health or functional claims for BAD's. Rather, proposed claims are reviewed on a case by case basis in the product approval process. In addition, certain advertising restrictions are laid down to prevent misleading advertising.
Legislation In Other ECE Countries
Contrary to Russia, Hungary, Poland, the Czech Republic, the Slovak Republic, Slovenia, Romania, Bulgaria, Estonia, Latvia and Lithuania have no specific legislation in place on nutraceuticals. However, the food legislation of some ECE countries does contain general provisions that apply to these products. Also specific references and/or provisions governing food supplements, herbal products, fortified foods and the claims that can be made exist in the local legislation, as described below:
Food supplements. Food and dietary supplements are recognized and regulated in ECE countries as "food" or "medicinal products" depending upon their low or high content in nutrients compared to the respective RDA of each nutrient. There are important variations from one country to the other, however, with respect to the multiple of the RDA that serves as the trigger point to call on the application of the food or drug legislation. Also, other specific provisions in place in some ECE countries may be highlighted.
The specificity of Hungarian legislation is to contain a separate regulatory category for "substances and preparations of natural origin that have therapeutic effect but are not considered as normal medicines." These are referred to as "para-medicines" and are subject to a simplified registration procedure when compared to regular medicinal products. This category includes supplements containing vitamins and minerals at above one time their RDA per recommended dose, as well as some other supplements, depending upon their therapeutical effects. By contrast, food supplements containing vitamins and minerals at up to one time their RDA per recommended dose are re-garded as "normal" foodstuffs.
The Polish legislation considers food supplements as "dietetic foods" and defines them as "a set of nutrients intended to be consumed in amount not exceeding their recommended daily dose." From this definition, it is apparent that one time the RDA is also the trigger point in Poland for deciding which food supplements are regulated as foodstuffs (up to one time the RDA) or as another regulatory category (here, medicinal products, at above one time the RDA).
One time the RDA is also a decisive factor in some but not all other ECE countries. In particular, the Czech legislation defines "food supplements" as "vitamins, mineral substances, amino acids, special fatty acids and other substances with significant biological effects." For that purpose, the Czech Ministry of Health maintains a list of vitamins and minerals with their maximum permitted levels in food or food supplements, ranging from five to 10 times their RDA for vitamins and from one to 1.5 times their RDA for minerals. Approval of supplements with higher doses of vitamins and minerals require registration as medicinal products.
In the Slovak Republic, where food supplements are generally regulated under the provisions applicable to "foodstuffs for special nutrition purposes," recommended levels are laid down for vitamins and minerals for food supplements per population groups, with higher amounts requiring the Ministry of Health's approval.
As a last example, the legislation in place in Estonia distinguishes "regular" food supplements that "are used in addition to foods to satisfy the nutritional requirements of the human body" from those that are considered as "semi-medicinal products" if they contain high levels of vitamins, minerals, plant extracts or extracts of animal origin and other similar substances.
In all ECE countries, however, ap-proval mechanisms are in place and these must be followed to obtain the authorization to market a food supplement on the local market. The approval processes usually vary depending upon the classification of the supplement as a food, a medicinal product or another category, as in many other parts of the world, and the criteria to use one or the other process is not always transparent. The specificity of ECE countries is that approvals can sometimes be obtained for products that do not comply with existing requirements and that products that do comply with applicable requirements sometimes do require, in addition, the completion of an approval or registration process. This is the case in Romania, for example.
Herbal products. Also, none of the ECE countries we reviewed has specific legislation on herbal products. Much like food supplements, these products are regulated as foodstuffs or medicinal products or an intermediary category, if any, depending upon several varying criteria and national experiences, as re-viewed on a case by case basis. In the absence of established RDA's, other factors are used, however.
In Hungary, herbal products are considered to be "para-medicines" and must be registered as such. This is also the case in Estonia where some herbal products are classified as "semi-medicinal products" according to the rules elaborated by the Ministry of Social Affairs. In Latvia and Romania, certain herb products may be regulated as drugs if covered by a monograph. Under most other ECE countries' regulatory regime, however, herbal products are classified depending upon their therapeutic properties and subjected to the registration requirements applicable to the category under which they fall, much like other food supplements.
Fortified foods. Generally, fortified foods are judged under the same criteria and procedures as food supplements. However, there are some exceptions. For example, in Hungary, the fortification of foodstuffs is subject to some specific rules, including the requirement to be enriched with vitamins and minerals in quantities higher than one third of their RDA's and the requirement to allow the addition of vitamins A and D only in food consumed in substitution of food containing them, such as margarine, as well as in baby foods.
In the Czech Republic, the fortification of foodstuffs with vitamins and minerals is covered by the legislation on food additives. More specifically, Czech legislation authorizes the addition of five vitamins ( B1, B2, C, E and beta carotene) and six minerals (potassium, magnesium, calcium, zinc, copper and iodine) without pre-market approval. The use of other vitamins and minerals for fortification purposes requires ap-proval by the Ministry of Health.
Health And Functional Claims In The ECE
Health and functional claims are key to the marketing of nutraceuticals. Much like in the EU, however, and due to the absence of specific legislation on nutraceuticals, the use of claims on nutraceutical products is usually subject only to the general labeling requirements applicable in each ECE country, as applicable to foodstuffs or medicinal products, depending upon the regulatory regime under which a given product falls. In addition, however, the pre-market approval systems in place for these products are also used for the review and approval of the proposed labeling language, including a review of the proposed health and functional claims.
Regarding general labeling provisions applicable to those nutraceuticals regulated as foodstuffs, it should also be noted that most ECE countries have adopted legislation containing provisions similar to those of the EU labeling Directive 79/112/EEC which, inter alia, prohibits misleading claims as well as claims that "attribute to any foodstuff the property of preventing, treating or curing a human disease, or refer to such properties."
In the Czech Republic, for instance, the legislation in place prohibits claims that the food or food supplement (i) has an increased or special nutritive value without this being scientifically assessed, (ii) is suitable for the treatment, prevention or cure of a disease or for removing a specific physiological state, and (iii) is designed for special nutrition, unless approved by the Ministry of Health.
In addition to these general provisions, some ECE legislation also includes more specific labeling requirements. In particular, the current food labeling provisions in place in Hungary allow the use of medicinal claims provided they are scientifically justified. Also, in Hungary, a food can be marketed as "enriched with multivitamins" if at least four vitamins are added, of which two are at levels above 1/3 of their RDA's.
As another example of specific labeling requirements, the Slovak Food Codex requires the labeling of nutraceuticals to contain indication of the RDA of the nutrients they contain and, in addition to prohibiting medicinal claims and unless approved by the competent authorities, prohibits claims that the food or food supplement (i) is a source of all essential nutrients, and (ii) as part of a balanced diet, provides the body with all necessary nutrients.
From the above, and with the exception of Russian legislation, it is apparent the legislation in place in ECE countries contains relatively few substantive provisions specific to nutraceutical products. When these requirements exist, they do mainly serve to identify the approval process that the products will be required to follow, as a food, a drug or a product falling under another category. These processes will be key to market access but also to the determination of the potential claims that the authorized products will be able to bear. For food companies, therefore, the marketing of nutraceuticals in ECE countries requires a country by country regulatory approach, where knowledge of the processes in place, of the countries' regulatory background and suitable contacts become the keys to gain market access.