Food supplements

Food supplements

Legal framework

Harmonized rules

The EU rules relating to food supplements are laid down in Directive 2002/46/EC on the approximation of the laws of the Member States relating to food supplements.

 

Food supplements are defined in the Directive as foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of vitamins, minerals, or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, namely forms such as capsules, pastilles, tablets, pills, and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders, designed to be taken in measured small unit quantities.

 

The Directive contains lists of vitamins and minerals and the chemical substances in the form of which they may be added to food supplements. However, the Directive does not contain minimum or maximum amounts of vitamins and minerals that may be present in food supplements.

 

The Directive does not contain lists of other substances with a nutritional or physiological effect that may be added to food supplements. Such substances include but are not limited to amino acids, essential fatty acids, fibers, and botanical preparations.

 

The Directive also lays down specific rules for the labelling, presentation, and advertising of food supplements. These specific rules apply in addition to the rules laid down in horizontal EU legislation applicable to all foods.

 

Lastly, the Directive makes it possible for Member States to have a notification procedure in place within their territory, through which food business operators are required to notify the competent authorities of the placing on the market of their food supplements.

Non-harmonized rules

Considering that no minimum or maximum amounts of vitamins and minerals that may be present in food supplements have been laid down in EU law, Member States are free to lay down their own national rules in this respect. Some Member States have laid down mandatory minimum and/or maximum amounts in their national law, while some other Member States have adopted guidance documents or recommendations with minimum and/or maximum amounts. The rest of the Member States have not laid down any minimum or maximum amounts. Where national rules exist, food business operators must comply with them. In the absence of national rules, food business operators must ensure that the vitamins and minerals in their food supplement are present at least in significant amounts and are not present in amounts that are dangerous to health.

 

In the absence of EU lists of substances other than vitamins and minerals that may be added to food supplements, Member States are free to lay down their own national rules in this respect. Some Member States have laid down national rules, either in the form of positive or negative lists. Positive lists contain the substances that are permitted, while all substances that are not on the lists are prohibited. Negative lists contain the substances that are prohibited, while all substances that are not on the lists are permitted. The rest of the Member States have not laid down national rules. Where national rules exist, food business operators must comply with them. In the absence of national rules, food business operators must ensure that the substances other than vitamins and minerals that are added to their food supplements have the required nutritional or physiological effect and are not dangerous to health.

 

Member States may have specific national rules for the labelling, presentation, and advertising of food supplements, such as mandatory or recommended warning statements for certain ingredients.

 

Lastly, the majority of Member States have established a notification procedure within their territory, through which food business operators are required to notify the competent authorities of the placing on or withdrawal from the market of their food supplements or of any modifications made to them.

 

How we can assist

We can review the formulation of your product in line with EU and Member State laws.

• Our comprehensive report indicates the legal status of each ingredient, together with the underlying legal reasoning.

 

We can review the label of your product in line with EU and Member State laws.

• Our comprehensive report indicates the labelling requirements and the legal status of each particular on the label, including claims, together with the underlying legal reasoning. The report also includes the proposed legally compliant and translated label text.

 

We can review the marketing materials of your product in line with EU law.

• Our comprehensive report indicates the legal status of each marketing statement, together with the underlying legal reasoning. The report also includes the proposed legally compliant and translated marketing text.

 

We can notify the competent authorities of the Member States of the placing on or withdrawal from the market of your product or of any modifications made to it.

• We let you know which information and documentation is needed for the notification, compile and submit the notification file on your behalf, and follow up with the competent authorities where needed.