Cosmetovigilance is the activity of collecting, assessing, and monitoring undesirable effects observed as a consequence of the normal use of cosmetic products, as well as taking measures and disseminating information related to these effects.

These activities are regulated in each Member State by a National Cosmetovigilance System, involving a National Agency, health authorities, health professionals and any consumer or professional using or applying cosmetic products, that is, the whole population is involved.

But how can I, as manufacturer, act in case of an adverse event of my product?

If I am a manufacturer located outside the European Union (EU), I must contact my Responsible Person (RP) there, as it will be responsible to the European authorities.

If I am a manufacturer located within the EU, I can also be a RP or my RP can be another company located in the EU. The first case will be explained later in this article; and if I am in the second situation, I must contact my RP in the same way as if I were a manufacturer outside the EU.

In addition, in all cases, I must make any necessary changes to the product as instructed by my RP to be reassessed as safe for the consumer.

What if I am the distributor of the product?

In this case, I can be both a distributor and a RP, for which I must act as a RP, which we are going to explain later in this article.

If I am only a distributor, then I must report the adverse event to the competent authorities and in parallel contact the RP of the product for its information.

But what if I am the RP of the product?

Then I am responsible for everything that happens to the product. In other words, I will have to contact the relevant authorities (if the notification has not reached me directly through them) and carry out a Causality Assessment which I will have to send to these authorities. And the competent authorities will notify other competent authorities in Member States where the product in question is also marketed.

I case the Causality Assessment concludes that the adverse event has been caused by the product under the correct conditions of use, the RP should make all appropriate modifications to render the product safe again. To do so, it must contact the manufacturer, who will reformulate or make the changes.

For any of these situations, Sigillum KS will be happy to help you in the process. Please, be free to contact us!