As healthcare professionals (doctors, pharmacists, dieticians, nurses, speech therapists, physiotherapists, etc.), you are in contact with patients or consumers and are therefore likely to identify undesirable effects among them. That is why we strongly encourage you to notify any undesirable effects reported to you. We also invite you to complete the report with as much information as possible and to attach any useful and relevant case-related documents (blood tests, photo of the undesirable effects (e.g. redness, eczema, rash)) that you can obtain from the complainant. Cases of misuse, i.e. those linked to the improper use of the product, must also be submitted.

You can report your undesirable effects online or in downloadable PDF format.

By reporting undesirable effects, you play an essential role in advancing our knowledge of products covered by Nutrivigilance and, consequently, improving consumer health. So ask your patients about their use of dietary supplements and other food products, and guide them in their choices if necessary. undesirable effects can also be linked to concomitant medication: Nutrivigilance works in collaboration with Pharmacovigilance.

What happens after I submit my report?

Reports are received by FPS Public Health, which carries out a preliminary assessment of the dossiers. FPS may contact the declarant again if important information is missing.  Sufficiently documented reports are examined by a specialised medical expert and the Nutrivigilance Commission, which brings together a range of experts, doctors and health professionals. Their main objective is to assess imputability, i.e. determine whether the undesirable effects observed are indeed linked to the consumption of the suspected product.

Depending on the results of the assessments, the observed effects and the number of cases received, FPS Public Health can determine whether it is necessary to carry out a safety study on a specific ingredient and whether measures need to be taken regarding a product or ingredient to guarantee the safety of the products placed on the market in Belgium.

All the information provided in the undesirable effects report will be treated as confidential. For reasons of data confidentiality, it is not possible to follow-up the case with the declarant.

Some information to pass on to patients:

  • Dietary supplements are not medicines and are not intended to prevent or treat disease.

  • Remember that it is best to seek the advice of a doctor or healthcare professional before consuming these food products.

  • Be wary of miracle products and advertisements that try to convince you that a dietary supplement or other food product can cure or prevent an illness.

  • Observe the quantity, conditions of use, recommendations and warnings given on the label.

  • Patients should be advised against combining dietary supplements with medication or other food supplements.

  • Prolonged or repeated use should not be recommended.

  • Remember that it is better to buy dietary supplements or any other food products in physical shops rather than from abroad via the internet.