In order to market your product in the best conditions, you will have to define its regulatory status. This status will allow you to take note of the requirements for marketing the product using a coherent set of regulatory and mandatory texts.

What is a regulatory status?

A regulatory status is a set of mandatory texts that define the procedure to follow in order to obtain the marketing of a health product. The regulatory status therefore determines the legal framework surrounding the specific characteristics of each category of health products. These include drugs, medical devices, food supplements, cosmetics, biocides, etc. A certain number of rules and constraints must therefore be respected. In addition, these may be associated with standards, consensus “guidelines”, which are on a voluntary basis.


Advances in science and the creativity of marketing teams now make it possible to develop all kinds of products. However, as previously mentioned, regulations are retrospective. As a result, there are products that do not have a defined regulatory framework, and are therefore not attached to any status.

Your product does not fit into any category?

When a product does not fit into any category, there are two options:

  • Create a new product category
  • Modify it to fit into an existing category

In fact, the border status does not exist!

Which regulatory status to choose?

Here are some statuses and the key points that define them:


A cosmetic product is a “substance or mixture intended to be placed in contact with the superficial parts of the human body (the epidermis, the hair and capillary systems, the nails, the lips and the external genital organs) or with the teeth and the oral mucous membranes, with a view, exclusively or mainly, to cleaning them, perfuming them, modifying their appearance, protecting them, maintaining them in good condition or correcting body odours”.


“Food supplements are defined as “foodstuffs whose purpose is to supplement a normal diet and which constitute a concentrated source of nutrients or other substances with a nutritional or physiological effect. These products are intended to be taken orally and are packaged in doses in the form of tablets, capsules, lozenges, ampoules”


“Any instrument, apparatus, equipment, material, product, except products of human origin, or other article used singly or in combination, including accessories and software necessary for its proper functioning, intended by the manufacturer to be used in humans for medical purposes and whose principal intended action is not obtained by pharmacological or immunological means or by metabolism, but whose function may be assisted by such means.”


“Products intended to destroy, repel, render harmless, prevent the action of or control harmful organisms by chemical or biological action. Although targeted at pests, biocides are by definition active products that may have effects on humans, animals or the environment.”

Informing the consumer without misleading him must remain the main objective to be respected, especially when it comes to drafting product claims.

To ensure this, the competent authorities may review the regulatory status of the product on the basis of all the relevant elements available.

 You wish to be accompanied by experts for the definition of the status of your product, and the applicable regulatory obligations for its marketing (claims, customs constraints …..)?