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Cosmetovigilance: protecting consumers in the world of cosmetics


To ensure the safety and quality of a cosmetic product, a special system was created to regulate this: what is known as “cosmetovigilance”.

Cosmetovigilance refers to the control and monitoring of the safety of cosmetic products on the market. It is a surveillance system with a very special purpose: to detect, evaluate and prevent possible adverse effects or risks associated with the use of cosmetics.

This guarantees, in a way, the safety of consumers in the world of cosmetics.

Cosmetovigilance involves the collection and analysis of information related to cosmetics, such as allergic reactions, skin irritation, unexpected side effects or any other skin health and safety issues. This information may come from consumers, health professionals, manufacturers, distributors or regulatory authorities.

What does the cosmetovigilance process consist of in Spain?

Considering that cosmetics are products that have a very direct and profound impact on the health and well-being of the person who consumes them, it is very important to keep them as regulated and supervised as possible.

Therefore, the cosmetovigilance process is methodical and quite thorough. This includes:

  • Data collection: the first step is to collect and aggregate information on possible adverse events related to the use of cosmetics. This may include reports from consumers, health professionals or manufacturer notifications.
  • Risk assessmentThe data collected are analyzed and evaluated to determine the severity and frequency of adverse events, also known as undesirable effects (these are adverse reactions to human health directly related to the normal or reasonably foreseeable use of a cosmetic product. Considering serious cases such as functional, temporary or permanent incapacity, disability, hospitalization, congenital anomalies, immediate vital risk or death). The aim is to establish possible causes and determine whether there is a real risk to public health. A key aspect of this assessment is the identification of toxic ingredients in cosmetics.
    toxic ingredients in cosmetics
    .Cosmetovigilance: protecting consumers in the world of cosmetics 1
  • Preventive actions: depending on the results of the risk assessment, measures can be taken to prevent or minimize adverse effects. These measures may include warnings, changes in product formulations, recalls or recommendations for safe use.
  • Communication: findings and actions taken are communicated to relevant stakeholders, such as manufacturers, health professionals and consumers. This is done to inform about identified risks and promote safety in the use of cosmetics.

All this is done through the cosmetovigilance form, also known as cosmetic adverse event reporting form. This document compiles the problems that can occur during the use of cosmetic products.

Cosmetovigilance Data Collection

What does the cosmetovigilance form contain in Spain?

As we have seen above, this sheet is used in the context of cosmetovigilance systems to collect standardized data on undesirable effects experienced by cosmetic users.

The cosmetovigilance form usually includes the following sections:

  • Notifier information: personal or contact details of the notifier, such as name, address and telephone number.
  • Product information: details of the cosmetic in question, such as product name, brand, lot or serial number and date of purchase.
  • Description of the adverse event: information on the adversity experienced with the use of the cosmetic product, such as the nature of the undesirable effect (irritation, allergy, burns, etc.), areas of the body affected and specific symptoms.
  • Details of product use: information on frequency of use, duration of use and any other relevant details on the use of the cosmetic prior to the adverse event.
  • Medical information: if the reporter sought medical attention, details of diagnosis and medical treatment received may be included.
  • Additional information: any other relevant information, such as the existence of pre-existing conditions, the concurrent use of other cosmetic products or medications, or any changes in the consumer’s general health status.cosmetovigilance laboratory

How can an adverse event be reported in relation to a cosmetic product?

The AEMPS (Spanish Agency of Medicines and Health Products) offers health professionals the NotificaCS portal. It contains the electronic forms corresponding to the different types of notifier, which can be used to notify quickly and easily.

Once the notification is sent, the AEMPS receives it and registers it in the national database. It is then that he evaluates it and carries out an exhaustive follow-up of the same.

Upon completion of its investigation, it contacts the physician who reported the case to inform him/her of the conclusions it has reached and, if necessary, to request additional information.

As part of the investigation, the person responsible for the product is also contacted in order to make him/her aware of the effect and request the necessary technical information.

In addition, in the event that the undesired effect is serious, it is transmitted to the other competent authorities of the Member States and recorded in the European database.

In short, cosmetovigilance is vital to protect and ensure the health and well-being of consumers of any type of cosmetics. It helps to identify and address potential problems with such products, which can result in improvements in formulation, labeling and overall safety.

It also enables the early detection of emerging risks and the implementation of appropriate preventive measures. appropriate preventive measures.

About the author
Picture of Victoria Sánchez
Victoria Sánchez
Soy una apasionada de la cosmética natural y ecológica, y creadora de la marca Saper Organic Skincare en 2011. Máster en Cosmetología y experta en evaluación y seguridad del producto cosmético. Mi objetivo es la belleza, la salud y la sostenibilidad del planeta. Para ello busco siempre los mejores ingredientes e investigo formulaciones de cosmética vegana, obteniendo los mejores resultados para la piel, cuidando siempre del medio ambiente.
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