I know we're supposed to be moving on to a new topic at this point, but I'd be remiss if I didn't publish Andreas Wolf's thorough European Union overview. It's not too often that we get an international perspective from someone NOT in the U.S. Plus, it's hard to quibble with Andreas' background: He is an attorney who advises U.S. supplement companies on entering the EU.
So without further the ado, here's Andreas, who will wrap up his post tomorrow. On Friday, we'll get started with weight management.
For businesses in the United States being active in the field of dietary and food supplements, the EU (with more than 500 million potential customers) might be an interesting spot when it comes to opening up new markets overseas.
However, to be successful in this endeavor there are a few things to be considered which are illuminated in the course of this essay.
The first part—the second half of which will run tomorrow—provides an overview on the EU market and its regulation for food supplements. This should tide you over for a while.
I. Historical development of the EU market
Unlike the U.S., the EU is made up of many individual national states, where the national governments still have rights of control where, for example, public health may be affected.
The internal market of the European Union, in general, is a single market in which the free movement of goods, services, capital and persons is ensured by the EU treaties and in which European citizens are free to live, work, study, and do business. Since it was created in 1993, the single market has opened more to competition, defined more affordable prices for consumers, and enabled businesses and citizens to benefit from a wide choice of goods and services.
The free movement of goods, with the objective of ensuring trade within the European Union, is one of the cornerstones of the internal market. Provided for by the Treaty establishing the European Community, it offers businesses the advantage of larger markets and European citizens a wider choice at lower prices in an open and competitive area. Free movement applies under the same conditions for all goods circulating within the EU, including those from third countries, with the exception of those posing risks to consumers, public health, or the environment. The ban on measures restricting imports and exports between Member States and the principle of mutual recognition ensure compliance under the monitoring of the Commission.
In order to guarantee the free movement of goods, the European Commission has established harmonized rules for many product categories. Let’s focus on those regulating the internal market of food supplements.
II. Definition of Food Supplements
Food supplements in the legal definition of the European Commission are concentrated sources of nutrients or other substances with a nutritional or physiological effect whose purpose is to supplement the normal diet. Such substances may include vitamins, minerals, and certain other categories of nutrients such as amino acids and other nitrogen-containing substances in foods for particular nutritional uses. At the moment, regarding food supplements, specific rules only on vitamins and minerals have been laid down.
They are marketed in dose form—e.g., pills, tablets, capsules, liquids in measured doses, etc.
III. Groups of Food
Food supplements may be added for nutritional purposes in foods for particular nutritional uses or as ingredients in food supplements. For the purposes of the addition of nutritional substances to foods, it is considered that food products will generally fall within one of three main categories of food:
a.) Food for particular nutritional uses, that might also be referred to as “dietetic food” or “dietary food” as covered by Directive 2009/39/EC of the European Parliament.
b.) Food covered by Regulation (EC) No 1925/2006 of the European Parliament and of the Council on the addition of vitamins and minerals and of certain other substances to food so called “fortified food.”
c.) Food supplements as covered by Directive 2002/46/EC of the European Parliament.
IV. Food Supplements Regulations in Detail
The Directive 2002/46/EC of the European Parliament and Council of 10 June 2002 on the approximation of the laws of Member States relating to food supplements established harmonized rules for the labelling of food supplements and introduced specific rules on vitamins and minerals in food supplements.
The aim was to harmonize the legislation and to ensure that these products are safe and appropriately labelled within the EU market, so that consumers can make informed choices.
Annex II of Directive 2002/46/EC provides an important list of permitted vitamin or mineral preparations that may be added for specific nutritional purposes in food supplements. It has been amended by Commission Directive 2006/37/EC, Commission Regulation 1170/2009, Commission Regulation No 1161/2011, and Commission Regulation No 119/2014 to include additional substances.
The trade of products containing vitamins and minerals not listed in Annex II has been prohibited from the 1st of August 2005.
In summary this means, nutritional substances that can be added are controlled through positive lists included in four directives and one regulation.
For completeness, it should be noted, that requests for the inclusion of a new nutritional substance in the Annexes of the Directives on foods for particular nutritional substances or food supplements, in general, is possible and can be submitted to the European Commission, Health and Consumers Directorate General. The fact that this might be a lengthy and costly procedure requires no elaboration.
The Commission is also responsible for establishing the purity criteria for substances contained in food supplements, and the maximum and minimum quantities authorized, with the assistance of the Standing Committee on the Food Chain and Animal Health.
V. National derogations and restrictions
However, specific provisions allow Member States to provide derogations for vitamins and minerals and their forms not included in these acts. This is due to the fact, mentioned in the beginning, that the EU is a conglomeration of individual, national States.
General Member States may not prohibit or restrict trade in food supplements that comply with this Directive 2002/46 EC except where they find that the products pose a public health risk. Where such a risk occurs, a Member State may temporarily suspend or restrict application of the provisions of the Directive. It shall immediately inform the other Member States and the European Commission thereof and give reasons for its decision. The Commission shall examine the grounds adduced by the Member State for temporarily suspending or restricting the trade in food supplements and shall consult the Standing Committee on the Food Chain and Animal Health before delivering its opinion and taking appropriate measures. This national caveat is frequently the endeavor for political objectives.
In assessing such national practices, the rulings that the European Court of Justice issued in the last few years concerning the use of PRI/RDI in some Member States must be also taken into consideration when preparing the opening of new EU markets.
For example, there were German and Austrian MoH practices, classifying nutritional supplements as pharmaceutical products that were lawfully produced or marketed as food supplements in other Member States. This was due to the fact that these products contained amounts of vitamins and minerals exceeding up to three times the national RDA/PRI values. The European Court of Justice ruled in the cases C-387/99 and C-150/00 that “the automatic nature of that practice does not make it possible to identify and assess a real risk to public health, which requires a detailed assessment on a case-by-case basis of the effects which the addition of the vitamins in question could entail” and therefore that these practices are disproportionate.
Andreas Wolf can be reached at [email protected].