Declaration of food supplements

When a food supplement is first introduced on the market in Luxembourg, the manufacturer or the party responsible for placing it on the market must file a declaration with the National Health Directorate (Direction de la santé).

This declaration is not an authorisation to place the product on the market.

Operators in the food sector are responsible for the conformity of their products. Hence, they must make sure that, at every stage of production, processing and distribution, their food products are in conformity with the applicable legal requirements. No food product may be put on the market if it is dangerous.

 

Who is concerned

Any manufacturer of food supplements or any person wishing to place food supplements on the market must file a declaration with the National Health Directorate.

Prerequisites

Composition of food supplements

To be eligible to be put on the market, food supplements containing vitamins and minerals or other substances must be in conformity with the legal provisions.

The maximum quantities of vitamins and minerals in food supplements must not exceed the maximum daily intakes set out by Grand Ducal regulation.

However, the Minister for Health may grant a dispensation in respect of these quantities. To obtain such a dispensation, the interested party must file a reasoned application with the National Health Directorate which will issue its opinion on the matter within 3 months. If no opinion is issued by then, the opinion is deemed to be favourable.

Specific rules are applicable for so-called "Novel Foods", i.e. foods with no history of significant consumption in the European Union before 1997.

Labelling of food supplements

General information

To help consumers identify foodstuffs, use it in an appropriate manner, and choose foods which are suited to their needs, food supplements must comply with the regulation in force on the provision of food information to consumers.

Specific information

Food supplements may be sold only if they clearly state the wording "compléments alimentaires" or "Nahrungsergänzungsmittel".

The labelling must specify:

  • the name of the categories of nutrients or substances that characterise the product (or an indication of their nature);
  • the quantity of nutrients or other substances contained in the product, in numeric form and expressed as a percent of the recommended daily intake;
Information about vitamins and minerals must be expressed as percentages of the reference nutrient intake (RNI) values.
  • the recommended daily intake of the product;
  • a warning about exceeding the recommended daily intake;
  • a statement of the type "Not to be used as a substitute for a balanced diet" or similar;
  • a warning to "Keep out of reach of children" or similar.

Nutritional and health claims

There are specific rules which apply to nutritional claims and health claims.

Statements relating to foodstuffs must:

  • firstly, be clearly understood by consumers;
  • secondly, protect consumers from misleading statements (misleading advertising).
Any nutritional and health claims stated on the products must be clear, accurate, and be able to be scientifically proven.

Forbidden statements

The labelling, presentation and advertising of food supplements must, under no circumstances:

  • credit these products with properties that prevent, treat or cure diseases;
  • make any mention of such properties;
  • state or suggest that a healthy, varied and balanced diet is not a sufficient source of nutrients to cover a person's daily vitamin and mineral requirements.

Preliminary steps

Registration of businesses in the food sector

Any Luxembourg company wishing to place its products on the market must register with the competent authorities beforehand.

To do so, the Luxembourg company must file an online registration application via MyGuichet.lu.

Foreign businesses are not required to apply for registration.

 

How to proceed

Declaration of food supplements

The application for declaration of food supplements must be submitted using MyGuichet.lu or by email to the National Health Directorate and contain at least the following data:

  • the description of the product (name, brand, form, packaging, maximum daily intake/dose, producer);
  • the list of ingredients of the product, along with the quantity of each ingredient;
  • where applicable, the nutritional composition of the product;
  • information on active substances (per daily dose), and on the toxicity and stability of those substances;
  • the labelling of the product;
  • the data required to assess the product's nutritional value;
  • a clause in which the manufacturer commits to carry out frequent testing on the product at varying times and to make the results of those tests available to the Food Safety Unit.

Supporting documents

A copy of the labelling of the food supplement has to be attached to the application.

Dangers relating to food supplements

When the National Health Directorate establishes, on the basis of new data or a new evaluation of existing data, that the use of a food supplement presents a health hazard, the Minister for Health may temporarily suspend or restrict the use of the product in question.

The Minister will immediately apprise the other Member States and the European Commission of the measures, and the reason for their decision. The final decision on whether or not to authorise the use of the product is then aligned with the decision taken at EU-level.

Forms / Online services

Notification de compléments alimentaires

To complete your application, the information about you collected from this form needs to be processed by the public administration concerned.

That information is kept by the administration in question for as long as it is required to achieve the purpose of the processing operation(s).

Your data will be shared with other public administrations that are necessary for the processing of your application. For details on which departments will have access to the data on this form, please contact the public administration you are filing your application with.

Under the terms of Regulation (EU) 2016/679 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, you have the right to access, rectify or, where applicable, remove any information relating to you. You are also entitled to withdraw your consent at any time.

Additionally, unless the processing of your personal data is compulsory, you may, with legitimate reasons, oppose the processing of such data.

If you wish to exercise these rights and/or obtain a record of the information held about you, please contact the administration in question using the contact details provided on the form. You are also entitled to file a claim with the National Commission for Data Protection (Commission nationale pour la protection des données), headquartered at 1, Avenue du Rock'n'Roll, L-4361 Esch-sur-Alzette.

By submitting your application, you agree that your personal data may be processed as part of the application process.

Notification de compléments alimentaires

Les informations qui vous concernent recueillies sur ce formulaire font l’objet d’un traitement par l’administration concernée afin de mener à bien votre demande.

Ces informations sont conservées pour la durée nécessaire par l’administration à la réalisation de la finalité du traitement

Les destinataires de vos données sont les administrations compétentes dans le cadre du traitement de votre demande. Veuillez-vous adresser à l’administration concernée par votre demande pour connaître les destinataires des données figurant sur ce formulaire. Conformément au règlement (UE) 2016/679 relatif à la protection des personnes physiques à l'égard du traitement des données à caractère personnel et à la libre circulation de ces données, vous bénéficiez d’un droit d’accès, de rectification et le cas échéant d’effacement des informations vous concernant. Vous disposez également du droit de retirer votre consentement à tout moment.

En outre et excepté le cas où le traitement de vos données présente un caractère obligatoire, vous pouvez, pour des motifs légitimes, vous y opposer.

Si vous souhaitez exercer ces droits et/ou obtenir communication de vos informations, veuillez-vous adresser à l’administration concernée suivant les coordonnées indiquées dans le formulaire. Vous avez également la possibilité d’introduire une réclamation auprès de la Commission nationale pour la protection des données ayant son siège à 1 Avenue du Rock'n'Roll, L-4361 Esch-sur-Alzette.

En poursuivant votre démarche, vous acceptez que vos données personnelles soient traitées dans le cadre de votre demande.

Notification de compléments alimentaires

Ihre in diesem Formular erfassten personenbezogenen Informationen werden von der zuständigen Verwaltungsbehörde verarbeitet, um Ihren Antrag erfolgreich abzuschließen.

Diese Informationen werden von der Behörde für den zur Verarbeitung erforderlichen Zeitraum gespeichert.

Die Empfänger Ihrer Daten sind die im Rahmen Ihres Antrags zuständigen Verwaltungsbehörden. Um die Empfänger der in diesem Formular erfassten Daten zu erfahren, wenden Sie sich bitte an die für Ihren Antrag zuständige Behörde.

Gemäß der Verordnung (EU) 2016/679 zum Schutz natürlicher Personen bei der Verarbeitung personenbezogener Daten und zum freien Datenverkehr haben Sie das Recht auf Zugang, Berichtigung und gegebenenfalls Löschung Ihrer personenbezogenen Informationen. Sie haben zudem das Recht, Ihre erteilte Einwilligung jederzeit zu widerrufen.

Weiterhin können Sie, außer in Fällen, in denen die Verarbeitung Ihrer Daten verpflichtend ist, Widerspruch einlegen, wenn dieser rechtmäßig begründet ist.

Wenn Sie diese Rechte ausüben und/oder Einsicht in Ihre Informationen nehmen möchten, können Sie sich unter den im Formular angegebenen Kontaktdaten an die zuständige Verwaltungsbehörde wenden. Sie haben außerdem die Möglichkeit, bei der Nationalen Kommission für den Datenschutz Beschwerde einzulegen (Commission nationale pour la protection des données, 1, Avenue du Rock'n'Roll, L-4361 Esch-sur-Alzette).

Wenn Sie Ihren Vorgang fortsetzen, akzeptieren Sie damit, dass Ihre personenbezogenen Daten im Rahmen Ihres Antrags verarbeitet werden.

Who to contact

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