European Union: Food Supplements Directive Upheld

Last Updated: 22 February 2006
Article by Debra Hueting

On 12 July 2005 the European Court of Justice (ECJ) upheld the validity of Directive 2002/46/EC on the approximation of the laws of the Member States relating to food supplements. In particular it upheld the internal market legal base and the positive list of vitamins and minerals that can be used in supplements.

BACKGROUND

In June 2002 the European Parliament and Council adopted Directive 2002/46/EC on the approximation of the laws of Member States relating to food supplements ("the Directive"). The Directive is based on Article 95 EC which allows measures to be taken to ensure the functioning of the internal market.

Food supplements are defined by the Directive as "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 effect, 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 liquid, drop dispensing bottles, and other similar forms or liquids and powders designed to be taken in measured small unit quantities". Nutrients are defined as vitamins and minerals, which means that the scope of the Directive is limited to vitamins and minerals.

The Directive aims to approximate the laws of the Member States on the use of vitamins and minerals in food supplements. This should allow these products to move freely throughout the Community. At the same time it aims to achieve a high level of consumer protection. The Directive establishes a positive list whereby only products containing the vitamins and minerals included in the lists in the annexes to the Directive can be marketed in the Community. There is a mechanism by which nutrients can be added to the positive list. The legislation will also set maximum and minimum dosage levels for the vitamins and minerals. Labelling requirements are set out in the Directive.

THE UK ACTIONS AND THE ARGUMENTS OF THE APPLICANTS

In the UK, the National Association of Health Stores and Health Food Manufacturers Ltd (trade associations representing around 580 companies, the majority of which are small firms which distribute dietary products in the UK); the Alliance for Natural Health (a Europe-wide association of manufacturers, wholesalers, distributors, retailers and consumers of food supplements) and Nutri-Link Ltd (a small distributor and retailer) (together "the applicants") applied to judicially review the national implementing measures: the Food Supplements (England) Regulations 2003 and the Food Supplements (Wales) Regulations 2003. The UK court referred a number of questions to the ECJ.

The national court asked the ECJ to consider the validity of certain articles1 of the Directive for several reasons but including questioning if Article 95 EC is the correct legal base. The applicants argued that the Directive does not contribute to improving the conditions for the establishment and functioning of the single market and that some articles are contrary to the principle of the free movement of goods. In particular they argued that the provisions that prohibited trade in products which do not comply with the Directive infringed a number of EU principles and were adopted on the wrong legal base.

THE OPINION OF THE ADVOCATE-GENERAL

In April 2005 Advocate General Geelhoed argued that the Directive infringes the principle of proportionality, because basic principles of Community law, such as the requirements of legal protection, of legal certainty and of sound administration have not been properly taken into account. However the opinion of an Advocate General is merely persuasive and the final decision was to be taken by the ECJ.

THE JUDGMENT

On 12 July 2005 the European Court of Justice (ECJ) upheld the validity of Directive 2002/46/EC on the approximation of the laws of the Member States relating to food supplements.

The ECJ noted that before the Directive was adopted food supplements were regulated by a variety of different national rules. The discrepancies between the national rules were likely to impede the free movement of goods and the functioning of the internal market. In particular before the proposal for the Directive was brought forward by the Commission, the ECJ noted that there had been a substantial number of complaints from economic operators on account of the differences between national rules which the application of the principle of mutual recognition did not succeed in overcoming. Therefore the Court took the view that the Directive was correctly founded on the internal market legal base, Article 95 EC.

The applicants argued that the Directive was incompatible with the principle of the free movement of goods. However the ECJ took the view that the restrictions imposed by the Directive, particularly the use of the positive list of vitamins and minerals, were justified by the protection of public health and considered the measures to be necessary and appropriate for the purpose of achieving that objective, in other words the ECJ considered the Directive to be proportionate.

The ECJ found that a negative list might not be sufficient to achieve the same objective as the positive list. The Court took the view that a negative list could allow a substance to be used in food supplements even though it had not been subject to any scientific assessment proving that it posed no risk to human health.

The ECJ added that the positive list should be accompanied by a procedure to allow substances to be added to the list. The procedure should be consistent with the general principles of Community law, including, the principles of sound administration and legal certainty. It should also be accessible and must be completed in a reasonable time. Any refusal should be based on a full risk assessment and should be open to challenge before the courts. Whilst there are no provisions to ensure that the procedure is timely and transparent the Court is of the view that it is for the Commission to ensure that it is.

The ECJ found that the Directive does not breach the principle of subsidiarity2. The ECJ took the view that action by the Member States cannot satisfactorily achieve the objective of removing the barriers resulting from the differences between the national rules on vitamins and minerals in food supplements whilst ensuring a high level of health protection. The objective could be best achieved at Community level.

In summary the ECJ found:

  • the Directive is correctly based on the internal market legal base Article 95 EC
  • the restrictions that exist in the Directive are justified on the basis of the protection of public health and the measures in question are necessary and appropriate for their purpose
  • the system of a positive list of vitamins and minerals is upheld.

CONCLUSION

As a consequence of this judgment upholding the Directive in its entirety, Member States were obliged to prohibit trade in products which did not comply with the Directive from 1 August 2005.

Reaction to the judgment has been mixed. Some take the view that the Directive will help to ensure that all such products on the market are safe. Others believe the new legislation is too restrictive, effectively banning safe products.

Several Member States, in particular the UK, have well developed markets in food supplements. Some products that are currently on the market (and that have been on the market for a considerable period of time) may not be compatible with the new legislation in the future.

Minerals that are not currently on the positive list include tin, silicon, nickel, boron, cobalt and vanadium. Under the Directive these minerals will not be able to be included in new products. Member States may provide derogations for products already on the market until December 2009 in certain circumstances.

Now that the ECJ has upheld this Directive relating to vitamins and minerals it may be that other nutrients are more likely to be regulated at Community level in the foreseeable future. Indeed under the Directive the Commission is required to report to the European Parliament and Council on the situation relating to these other nutrients by 12 July 2007.

Footnotes

1 Articles 3, 4(1), and 15(b).

2 The principle of subsidiarity provides that the Community, in areas which do not fall within its exclusive competence, is to take action only if and insofar as the objectives of the proposed action cannot be sufficiently achieved by the Member States and the proposed action can therefore, by reason of the scale or effects, be better achieved by the Community

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
 
In association with
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
 
Email Address
Company Name
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement

Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of www.mondaq.com

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.

Disclaimer

Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.

Registration

Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.

Cookies

A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.

Links

This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.

Mail-A-Friend

If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.

Security

This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at enquiries@mondaq.com.

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.