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 competent authorities. The Luxembourg Veterinary and Food Administration (Administration luxembourgeoise vétérinaire et alimentaire - ALVA) is responsible for managing the administrative formalities of the procedure.

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.

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

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.

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, either by email or by post to the following address:

Ministre de la Santé
L-2935 Luxembourg

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

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;

• 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).

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.

How to proceed

Declaration of food supplements

The food supplements declaration must be submitted electronically via MyGuichet.lu.

Businesses can carry out the procedure:

• with authentication using a LuxTrust product or an electronic identity card (eID); or
• without authentication.

The procedure with authentication has many advantages over the procedure without authentication. In particular, it allows the temporary saving of the data entered so that the company can access them later.

Contents of the declaration file

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;
• any data required to assess the product's nutritional value;
• the manufacturer's written commitment to:
  • conduct product analyses frequently and at varying times; and
  • make the results available to the Luxembourg Veterinary and Food Administration (ALVA).

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 using authentication, it will eventually be possible to make changes to the initial file.

In the meantime, 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

Who to contact