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).
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.
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.
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
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.
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
Statements relating to foodstuffs must:
- firstly, be clearly understood by consumers;
- secondly, protect consumers from misleading statements (misleading advertising).
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.
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.
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.
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.