EU Regulations on Food Supplements, Health Foods, Herbal MedicinesEU Regulations on Food Supplements
In an effort to harmonize the internal EU market for food supplements and similar products the European Union has adopted some key pieces of legislation. This report will provide a brief overview of the market for nutrition products in the EU and a look at the European Food Safety Authority (EFSA). This is followed by a summary of each piece of legislation related to:
Nutritional and functional claims
Traditional herbal medicinal products
Pet Food Supplements
The Market for Nutrition Products in Europe
In the European Union (EU), the vitamins and dietary supplements market totaled nearly €7 billion in 2009. According to the European Commission's 2008 Working Document, food supplement products containing vitamins and minerals have a 50% share of the market. Euromonitor International's 2009 research revealed that supplements taken to address digestive health, the immune system, joint health, beauty and heart health were the most popular products in Western Europe Western Europe
The countries of western Europe, especially those that are allied with the United States and Canada in the North Atlantic Treaty Organization (established 1949 and usually known as NATO). , accounting for more than 55% of value sales of all dietary supplements. A similar finding also applies to Eastern Europe.
The number of substances other than vitamins and minerals used in food supplements on the European market is estimated to be over 400. Some of the most commercially significant include fish oils, probiotics and herbal ingredients. Other substances include amino acids, enzymes, prebiotics, essential fatty acids, botanicals, other substances like lycopenes, and glucosamine.
Another issue to note is that significant national variations exist. For example, fish oils constitute over 50% of the market of other substances in Denmark, but under 3% in Spain and in Italy. Probiotics account for 44% of the market in Italy and only 0.3% in Denmark. Herbal products (ginkgo, ginseng, St John’s Wort, echinacea and garlic) make up 75% of the market in the Netherlands, 40% in France, and under 5% in Italy.
Until relatively recently, the market for vitamins and dietary supplements was underdeveloped in Eastern Europe but in the last couple of years, the demand for these products has grown very quickly, due to increasing disposable income of Eastern European countries and their growing concern for a healthy lifestyle and illness prevention.
The channels for distribution vary by country, with the majority of sales occurring in pharmacies. In the UK market, grocery stores and pharmacy chains are prevalent, while independent pharmacies dominate the markets in France, Germany, Denmark and Italy. Some other retail outlets including supermarkets are beginning to be developed in some countries such as Italy. Drugstores are gaining ground in countries such as Austria. Health food stores are also becoming more popular for example in Denmark.
Source: Euromonitor, European Commission
The European Food Safety Authority (EFSA)
The European Food Safety Authority (EFSA) was set up in January 2002 as an independent source of scientific advice that produces opinions which then are used by the European Commission to adopt legislation. Most relevant for companies in the food supplements sector, EFSA has been asked by the European Commission to evaluate proposals for the addition of vitamins and minerals to the Food Supplements Directive and to evaluate nutrition and health claims. EFSA has also worked with the European Commission on assessing how to establish maximum limits for vitamins and minerals in food supplements and fortified foods and provided opinions on substances other than vitamins and minerals. EFSA works in close collaboration with national authorities and in open consultation with its stakeholders.
Food Supplements Directive
The Food Supplements Directive (FSD) Directive 2002/46/EC, establishes a definition for food supplements, establishes a list of allowable vitamins and minerals, and sets labeling requirements. The Directive calls for the establishment of harmonized minimum and maximum dosage amounts however this has yet to be done and remains a competence of EU member states. Also, substances other than vitamins and minerals are not directly covered by the directive and rules regulating these substances are still governed by individual EU Member States.
Food supplements are "foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological function, alone or in combination, marketed in dose form, namely forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders designed to be taken in measured small unit quantities."
The scope of the FSD includes vitamins and minerals. Rules for nutrients other than vitamins and minerals should be developed in the future and for now are governed by Member State legislation.
List of allowable vitamins and minerals
The Directive establishes a positive list of allowable vitamins and minerals and their associated forms to be included in food supplements. The list as amended by Regulation 1170/2009 includes 13 vitamins with 45 allowable sources and 17 minerals with a total of 136 allowable sources.
Addition of substances
Additional vitamin and mineral substances may be considered for inclusion in the lists following the evaluation of an appropriate scientific dossier concerning the safety and bioavailability of the individual substance by EFSA. Companies wishing to market a substance not included in the permitted list need to submit an application to the European Commission. Guidance document
The directive sets forth labeling requirements for foodstuffs to include:
the names of the categories of the nutrients or substances that characterize the product or an indication of the nature of those nutrients or substances;
the portion of the product recommended for daily consumption and a warning of the risks to health if this is exceeded;
a declaration to the effect that the supplement is not a substitute for a varied diet;
a warning to the effect that the product should be stored out of the reach of young children.
The labeling of food supplements must not contain:
any statement attributing to the product properties of preventing, treating or curing a human disease;
any mention stating or implying that a balanced and varied diet cannot provide appropriate quantities of nutrients in general.
Minimum and maximum levels
The Directive calls for the establishment of minimum dosage amounts for a product to be considered a nutritional supplement as well as upper safe limits to protect the consumer. However the European Commission and the European Food Safety Authority have not made progress on establishing these limits and this competence remains up to the Member states.
Substances other than vitamins and minerals
The European Commission prepared a report on the use of substances other than vitamins and minerals in food supplements and concluded that it was not feasible or necessary to lay down specific EU rules, given already existing EU legislation that regulate their use and member state legislation which should be mutually recognized throughout the EU.
The scope of the directive encompasses all food supplements and it does not cover the use of natural ingredients in food supplements. Accordingly, a natural food source of vitamins or minerals (e.g. cod liver oil) may be included in nutritional supplements as an ingredient even though the substance “cod liver oil” is not included in any of the annexes to the directive.
Nutrition and Health Claims
On July 1, 2007, a regulation on nutrition and health claims entered into force. Regulation 1924/2006 sets EU-wide conditions for the use of nutrition claims such as “low fat” or “high in vitamin C” and health claims such as “helps lower cholesterol”. The regulation applies to any food or drink product produced for human consumption that is marketed on the EU market. Only foods that fit a certain nutrient profile (below certain salt, sugar and/or fat levels) will be allowed to carry claims. Nutrition and health claims will only be allowed on food labels if they are included in one of the EU positive lists. Food products carrying claims must comply with the provisions of nutritional labeling Directive 90/496/EC and its amended version Directive 1169/2011 on information to consumers mentioned further below.
In December 2012, a list of approved functional health claims went into effect. The list includes generic claims for substances other than botanicals which will be evaluated at a later date. Disease risk reduction claims and claims referring to the health and development of children require an authorization on a case-by-case basis, following the submission of a scientific dossier to the European Food Safety Authority (EFSA). Health claims based on new scientific data will have to be submitted to EFSA for evaluation but a simplified authorization procedure has been established.
The development of nutrient profiles, originally scheduled for January 2009, has been delayed. Nutrition claims can fail one criterion, i.e. if only one nutrient (salt, sugar or fat) exceeds the limit of the profile, a claim can still be made provided the high level of that particular nutrient is clearly marked on the label. For example, a yogurt can make a low-fat claim even if it has high sugar content but only if the label clearly states “high sugar content”. A European Union Register of nutrition claims has been established and is updated regularly. Health claims cannot fail any criteria.
Food supplements from botanicals and derived preparations made from plants, algae, fungi or lichens have become widely available on the EU market. Examples include ginkgo, garlic, St. John’s Wort and ginseng. Such products are typically labeled as natural foods and a variety of claims are made regarding possible health benefits. They can be bought over the counter in pharmacies, supermarkets, specialist shops and via the Internet.
There is currently no EU legislation specifically for botanicals other than the general EU food legislation Regulation 178/2002. EFSA is currently discussing what the permitted types of botanical ingredients and how their safety should be assessed. EFSA is also discussing which health claims should be permitted and on which levels and types of evidence they should be based.
Marketing of botanicals in foods and food supplements in the EU is subject to several provisions of food law, which cover aspects of safety, production, labelling and product composition, including the use of additives and maximum levels of contaminants and residues. However, due to limited harmonization at the EU level, specific national regulations adopted at a Member State level also apply and mutual recognition is the mechanism through which such products can be marketed in EU countries other than those of origin.
Currently the nature of the commercial botanical products made available to consumers as traditional medicinal products or food supplements, depends largely on the EU Member State under consideration as a consequence of how competent National Authorities and manufacturing companies interpret and apply current regulations rather than on the intrinsic properties of the botanical products and their constituents
Food supplements also need to comply with the EU Novel Foods Regulation, which lays down rules for novel foods that were not used before 1997. According to the Regulation, novel foods and food ingredients must not present a danger for the consumer or mislead him and should not differ from the ingredients that they are intended to replace to such an extent that normal consumption would represent a nutritional disadvantage for the consumer
In order for food and supplements containing novel ingredients to be allowed on the EU market, an application for authorization must be submitted to the competent authorities. The Novel Food Regulation 258/97 lays down detailed rules for the authorization of novel foods and novel food ingredients. The EU is currently revising the rules on novel foods which will cover foods produced by new techniques/technologies such as cloning, nanotechnology and foods with a history of safe use in other countries such as noni juice. The proposal that was under discussion failed to be approved because the European Parliament and Council did not manage to agree on how to handle food from clones and their offspring. Until the review is adopted, the current regulation 258/97 remains in force. More information can be found on the Commission's website.
Unlike food additives and vitamins and minerals, a positive list of novel foods and ingredients does not yet exist. A Novel Foods Catalog is available on the website of the European Commission but is not exhaustive. U.S. exporters are advised to check the legal status of novel food ingredients before exporting to the EU.
Dietetic/ PARNUTS Foods
There are a series of directives related to foodstuffs intended to satisfy particular nutritional requirements of specific groups of the populations. Directive 2009/39/EC sets out a framework of rules for the composition, marketing and labeling requirements of these "dietetic foods". Regulation 953/2009 lists the substances (vitamins, minerals and amino acids) that may be added for specific nutritional purposes in foodstuffs for particular nutritional uses.
The framework directive lists the following four groups of dietary foods for which specific rules are to be set out:
Directive 2006/125/EC on processed cereal-based foods and baby foods for infants and young children.
Directive 96/8/EC on foods intended for use in energy-restricted diets for weight reduction.
Directive 1999/21/EC on dietary foods for special medical purposes.
Regulation 41/2009 lays down new EU harmonized rules for the composition and labeling of foodstuffs suitable for people who are intolerant to gluten. This regulation sets conditions for the use of the terms “very low gluten” and “gluten-free”.
Traditional Herbal medicines
All medicinal products, including herbal medicinal products, need a marketing authorization to be placed on the EU market. The Herbal Directive 2004/24/EC was adopted to facilitate the placing on the EU market of traditional herbal medicinal products through a simplified procedure. As of May 1, 2011, applicants must submit the corresponding application to the competent authorities in the Member States where they want to market.
For registration as a traditional herbal medicinal product, the applicant must provide sufficient evidence of the medicinal use of the product throughout a period of at least 30 years, including at least 15 years in the European Union.
The European Medicines Agency (EMA) does not have a role in the registration of traditional herbal medicinal products. This means that applications for registration need to be submitted in each Member State where the product is to be marketed. These applications are handled by the competent authority in each Member State. The European Commission shall establish an EU list of herbal preparations or herbal substances so that Member States shall recognize registration of traditional herbal medicinal products granted by another Member State whenever it is based on the EU list.
Herbal products may be classified and placed on the market as food provided that they do not fulfill the definition of medicinal products and that they comply with the applicable food law. In particular, herbal products marketed in the form of food supplements should comply with Directive 2002/46/EC on food supplements and Regulation 1924/2006 on nutrition and health claims made on foods.
All unlicensed herbal medicinal products must either be marketed as medicines, or they must be ‘withdrawn’ from the market. They could be launched correctly labeled as food supplements, carrying no claims unless those claims have been approved according to the Nutrition and Health Claims Regulation.
Marketing of traditional herbal medicinal products is regulated by an ad hoc Directive (i.e. Directive 2004/24/EC) covering in detail all the relevant aspects of these products, including a facilitated registration procedure at national level. However, by distinguishing traditional herbal medicinal products from plant food supplements and establishing selective marketing modalities for these two product categories, the EU has been confronted with implementation difficulties for traditional herbal medicinal products and a lack of homogeneity in the regulatory approaches adopted in different EU Member States.
European Regulation 1925/2006 establishes an EU-wide regulatory framework concerning the addition of vitamins, minerals and certain other substances such as herbal extracts to foods. This regulation harmonizes the different rules in force in Member States by establishing a list of vitamins and minerals which are authorized to be added to foods. Only vitamins and minerals from these positive lists can be used. The regulation sets minimum amounts based on the notion of "significant amount" as defined in the Annex to Council Directive 90/496/EEC on nutrition labeling.
Although originally scheduled for January 2009, the Commission is still working on a proposal to set maximum permitted levels of vitamins and minerals in foods and food supplements. Minimum amounts are linked to the notion of “significant amount” as defined in the Annex to Council Directive 90/496/EEC on nutrition labeling
Directive 2000/13/EC on the Labeling, Presentation and Advertising of Foodstuffs is the main EU directive on food labeling. It ensures that the consumer gets all the essential information regarding the composition of a product, its manufacturer, the method of storage and preparation. Directive 90/496/EEC on Nutrition Labeling for Foodstuffs lays down harmonized rules on the presentation and content of nutritional information for pre-packed foods. But the inclusion of nutrition information is voluntary unless a nutrition-related claim is made on the package. The nutrition labeling rules do not apply to food supplements and natural mineral waters.
"Nutrition labeling" means any information on the label that relates to energy value and to the following nutrients: protein, carbohydrate, fat, fiber, sodium, vitamins and minerals present in significant amounts as defined in the Annex to Directive 90/496/EC.
As a general rule, labeling has to be in a language easily understood by consumers; this is in practice the official language(s) of the member state. As an exception to the general rule, it is also allowed to use other means depicting the content (pictures) or an easily understood language by consumers. Multi-language labeling is allowed throughout the EU.
In 2011, the EU adopted a new regulation on the provision of food information to consumers (1169/2011). The new EU labeling requirements do not apply for the mandatory nutrition declaration which will apply from December 13, 2016. Some of the key changes of the new labeling rules are: Improved legibility of information (minimum font size for mandatory information); Mandatory allergen information for non-prepacked food, including in restaurants and cafes; Requirement of certain nutrition information for majority of pre-packed processed foods; Mandatory origin information for fresh meat from pigs, sheep, goats and poultry; Same labelling requirements for online, distance-selling or buying in a shop among others.
Other regulations and requirements
Generally, there is no EU requirement to register imported foods except for the introduction of novel foods. The person/company introducing a novel food has to submit a request to the authorities in the Member States where the product will be marketed and a copy of this request has to be sent to the Commission’s Health and Consumer Protection Directorate. Importers of organic products are required to notify the competent regulatory authority of the Member State of their activity. The introduction of foodstuffs with particular nutritional uses needs to be notified to the Member State where the food is sold. Exporters of vitamin-enriched foods or nutritional supplements are especially advised to check for the existence of specific Member State registration or notification requirements.
Regulation 764/2008, adopted in July 2008, sets out the procedural requirements for denying mutual recognition and defines the rights and obligations of national authorities on the one hand and enterprises on the other. Free movement can only be guaranteed when all aspects are covered by harmonized legislation: e.g. a foodstuff may comply with the general labeling directive but may carry a health claim for which harmonized rules have not yet been finalized. Imported products must meet existing Member State requirements in cases where EU regulatory harmonization is not yet complete.
Other useful links
USDA Food and Agricultural Import Regulations and Standards EU 28 2014: https://gain.fas.usda.gov/Recent%20GAIN%20Publications/Food%20and%20Agricultural%20Import%20Regulations%20and%20Standards%20-%20Narrative_Brussels%20USEU_EU-28_12-9-2016.pdf
European Commission Directorate General for Health and Food Safety:
European Food Safety Authority
For More Information:
The U.S. Commercial Service at the U.S. Mission to the European Union is located at Boulevard du Regent 27, Brussels BE-1000, Belgium, and can be contacted via e-mail at: email@example.com; or by visiting the website: http://2016.export.gov/europeanunion/ .
One can locate the nearest U.S. Export Assistance Center or Commercial Service offices throughout Europe by visiting www.buyusa.gov and http://2016.export.gov/europeanunion/
To the best of our knowledge, the information contained in this report is accurate as of the date published. However, The Department of Commerce does not take responsibility for actions readers may take based on the information contained herein. Readers should always conduct their own due diligence before entering into business ventures or other commercial arrangements. The Department of Commerce can assist companies in these endeavors.
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