Declaration of food supplements

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Summary:

When you market a food supplement in Luxembourg for the 1st time, you must declare it online via MyGuichet.lu to the Luxembourg Veterinary and Food Administration (Administration vétérinaire et alimentaire luxembourgeoise - ALVA).

Declaration of food supplements

In Luxembourg, all food supplements marketed for the 1st time, must be declared to the Luxembourg Veterinary and Food Administration (ALVA).

You must submit the declaration electronically via MyGuichet.lu.

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

You are responsible for the conformity of your products. Hence, you must make sure that, at every stage of production, processing and distribution, the 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 responsible for placing food supplements on the market.

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

Any Luxembourgish business in the food sector that wishes to place its products on the market must be known beforehand to the competent authorities. To do so, it is necessary to submit an online application for registration using 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

In order to be eligible to be put on the market, food supplements containing vitamins and minerals or other substances must be compliant 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.

You may, however, apply for a derogation in respect of these quantities. In order to obtain such a derogation, you must send a reasoned request for derogation by email to complalim@alva.etat.lu.

The ALVA director will issue an opinion within 3 months. You will then get the answer from the Ministry of Agriculture, Food and Viticulture in the form of either a decree, or a letter of refusal.

The application file concerning the derogation is a different file from the notification file for food supplements. There is no standard template for this application. You can submit the application 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

Food supplements must comply with the regulation in force on the provision of food information to consumers in order to enable the latter:

  • to identify the food product;
  • to use it in an appropriate manner; and
  • to choose foods which are suited to their needs.

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'.

Their 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 also 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:

  • be comprehensible for consumers; and
  • protect all 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.

How to proceed

Declaration of food supplements

You must declare the food supplements electronically via MyGuichet.lu. You can file the procedure:

  • with authentication using:
    • a LuxTrust product;
    • an electronic identity card (eID); or
    • an eIDAS device from another European country;
  • without authentication.

How to create a business eSpace on MyGuichet.lu

There are 2 possible scenarios:

  1. You are a new user of MyGuichet.lu. You must:
    • first register on MyGuichet.lu; and
    • then create a business eSpace.
  2. You already have a private eSpace on MyGuichet.lu. You can directly create a business eSpace without having to register again.

Further information as well as tutorials in relation with the business eSpace are available in our dedicated help page.

The procedure with authentication has several advantages, in particular:

  • the auto-fill feature using data held by the administrations;
  • the possibility to put the procedure on hold at any time and resume it later;
  • tracking the status of the procedure and consulting the electronic messages you have received in your business eSpace;
  • duplicating the procedure with all the information entered.

Searching ingredients

When declaring food supplements, you must in particular indicate all the ingredients in the product. To effectively search for a nutrient in the ALVA database, simply:

  • type a few letters from any part of the word; and
  • select the ingredient in question from the drop-down menu that is displayed.

Use the 'Other ingredient (inactive)' type only if the ingredient in question does not appear in any of the databases available for the other types.

See our tutorial which uses screenshots to guide you, step by step, through the online procedure:

Supporting documents

You must attach a copy of the labelling of the food supplement to the file.

Modification of a file

For any modification involving a change in the composition of a product (new ingredients, additives, different dosages, etc.), you must complete and send a new file via MyGuichet.lu. In this case, you must indicate the reference number in the top left-hand corner of the previous acknowledgement of receipt in the 'Comments' field.

You can duplicate declarations on MyGuichet.lu by clicking on the icon in the top right-hand corner. This creates a new declaration with the status 'In preparation', which already contains all the data entered in the initial declaration (attachments are not included). You can then modify this data to reflect any changes you make to the product.

For all other changes (labelling, presentation, etc.), simply send an email to complalim@alva.etat.lu including:

  • a description of the changes made; and
  • the new label.

Tutorials

Online services and forms

Online services

Declaration of food supplements

Other language(s)

Who to contact

  • Luxembourg Veterinary and Food Administration (ALVA)

    Address:
    7, rue Thomas Edison L-1445 Strassen Luxembourg
    Email address:
    info@alva.etat.lu

Related procedures and links

Procedures

Food

Links

Further information

Legal references

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