Operators, i.e. any company involved in the product chain from manufacture to availability to the consumer (manufacturers, distributors, retailers, etc.) is responsible for the products it places on the market and is legally obliged to report any undesirable effects reported to it via the Nutrivigilance portal based on the Royal Decree of 03/12/2023 on the notification of undesirable effects linked to the use of foodstuffs. Cases of misuse, i.e. those linked to the improper use of the product, must also be reported.
As an operator, you are required to report all undesirable effects of which you are aware or of which you may reasonably be expected to be aware to our services within ten working days.
The operator is not required to carry out any prior assessment of cases. The severity of the effects is not taken into account in the declaration.
The company responsible for the product must keep a register of undesirable effects for each of its products and make it available to the competent authorities.
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. If the company responsible is not the declarant, FPS Public Health immediately notifies the declarant by email. Additional information may be requested from the operator to obtain accurate and verifiable information for the scientific evaluation. 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. No follow-up report will be provided to the operator.
All the information provided in the undesirable effects report is treated as confidential.
Monitoring undesirable effects is as much a part of quality control as any other complaint. The operator is responsible for the safety of their product and must make every effort to ensure its correct and safe use. Depending on the investigations carried out, the company responsible for the product may be contacted again to implement corrective and remedial measures (e.g. changes to labelling or composition). When adopting these measures, the company responsible must immediately inform the Nutrivigilance unit, and update its notification file if necessary.
Depending on the results of the medical 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, for example. It will then contact the company responsible to obtain more precise information on the raw materials used, and/or contact professional associations in the food sector to send relevant data to the assessment bodies (such as the Superior Health Council).
FPS Public Health, as risk manager, will determine the follow-up required, for example, a change in legislation.