Declaration of food supplements

Last update 03.03.2021

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 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 person responsible for placing food supplements on the market must file a declaration with the Health Directorate.

The manufacturer or the person responsible for placing the products on the market must be a business established in the European Union (EU).

Each business in the food sector must be known to the competent authorities before they can place their products on the market.

To do so, each Luxembourgish business must file an online registration application via MyGuichet.lu.

Foreign businesses are not required to apply for registration in Luxembourg. However, they must register with the competent authorities in their country of establishment.

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 of Health may grant a derogation in respect of these quantities. In order to obtain such a derogation, the interested party must send a reasoned request for derogation to the Minister of Health, by email or by post to the following address:

Ministre de la Santé
Allée Marconi – Villa Louvigny
L-2935 Luxembourg

The Health Directorate will give its opinion within 3 months. After this period, the opinion is deemed to be favourable.

Note: the application file concerning the derogation is a different file from the notification file for food supplements. There is no standard file for this application. The application can be submitted at the same time as the declaration of food supplements or after receipt of the acknowledgement of receipt.

In Luxembourg, there is no positive list for "plants" and "other substances" that can be used for the manufacture of food supplements. The lists drawn up in the other Member States serve as a reference for the competent authorities.

However, specific rules apply to the new foods referred to as Novel Food, i.e. foods whose human consumption was negligible in the EU 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.

The food business operator responsible for food information is:

  • the operator under whose name or business name the food is marketed; or
  • the importer on the EU market, if that operator is not established in the EU.

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; and
  • 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

Each Luxembourgish business that wishes to place its products on the market must register with the competent authorities beforehand.

To do so, each Luxembourgish business 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 file for the declaration of food supplements must 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.

Businesses located in Luxembourg

The file for the declaration of food supplements must be submitted in electronic form via MyGuichet.lu using a LuxTrust connection.

Businesses located in other European countries

The file for the declaration of food supplements must be submitted in electronic form via MyGuichet.lu using an eID connection.

Only countries that are not on the eID list can submit their request by email to the Food Safety Unit of the Health Directorate. Please note that the list of countries on the eID list is constantly expanding.

The notification file template is available on the website of the Food Safety Unit. Businesses that have already submitted a notification in another EU Member State can also send this file provided that it:

  • it is written in one of the 3 official languages of Luxembourg (Luxembourgish, French, German); and
  • includes all the information as requested in our notification file example.

Modification of a file

Any modification involving a change in the composition of a product (new ingredients, additives, different dosages, etc.) requires the sending of a new notification file with a reference to the previous file.

For all other changes (labelling, presentation, etc.), an email containing the changes made and the submission of the new label is sufficient.

For files submitted via MyGuichet.lu, changes will eventually be possible in the initial file. While waiting for this step, modifications can be communicated by email.

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 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

Declaration of food supplements

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 15, boulevard du Jazz L-4370 Belvaux.

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

Déclaration 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 15, boulevard du Jazz L-4370 Belvaux.

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

Anzeige von Nahrungsergänzungsmitteln

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, 15, boulevard du Jazz L-4370 Belvaux).

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

Declaration of food supplements for businesses based abroad

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 15, boulevard du Jazz L-4370 Belvaux.

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

Déclaration de compléments alimentaires pour les entreprises basées à l'étranger

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 15, boulevard du Jazz L-4370 Belvaux.

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

Anzeige von Nahrungsergänzungsmitteln für Unternehmen mit Sitz im Ausland

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, 15, boulevard du Jazz L-4370 Belvaux).

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

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