Safety in Cosmetics and Cosmetovigilance

Cosmetovigilance is the monitoring of the safety of cosmetics in terms of human health. How is it managed ?

What is cosmetovigilance ?

Over the past decades, consumer protection in the health and beauty sectors has been significantly strengthened due to increased awareness of the potential risks arising from the evolution of cosmetic formulations and the expansion of product ranges.

At the heart of this protection approach is the implementation of cosmetovigilance, a system dedicated to monitoring and recording adverse effects of cosmetics on humans after they have been marketed.
This form of public health surveillance is distinct from industrial initiatives aimed at ensuring the safety of products for commercial purposes and from peer review for medical purposes (Revidal-Gerda).

Let's find out how this system of cosmetic product safety surveillance ensures that each product is safe for all consumers and inspires confidence in products marketed within the European Economic Area.

Cosmetovigilance : definition

The importance of cosmetovigilance


Cosmetics can pose risks due to new ingredients used for preservation or to enhance dispersion, and interactions between components. While safety studies are conducted by manufacturers before commercialization, these cannot foresee all risks. Thus, post-market surveillance, known as cosmetovigilance, is essential.

Established in 2004, this system relies on monitoring, reporting, and evaluating any adverse effects or misuse of cosmetics to protect consumer health.  It enables the identification of trends and anomalies. If necessary, corrective actions can be taken. These could include modifying product compositions, issuing usage recommendations, or even banning harmful products or ingredients.


ANSES's role in cosmetic product safety


In France, ANSES assumed responsibility for cosmetovigilance as of January 1, 2024, replacing ANSM. This move allows ANSES to reinforce its expertise in assessing risks related to chemical substances to which populations are exposed daily. 

ANSES operates across four main areas :
  1. Cosmetovigilance : The evaluation of the hazards and risks of substances used is carried out in accordance with the European regulation on cosmetic products.
  2. Expertise in support of the Directorate General for Competition, Consumer Affairs, and Fraud Control (DGCCRF) : Providing expertise to support market surveillance and health policing missions for these products.
  3. Conducting exposure studies : Leading studies on exposure to these products and their substances.
  4. Adaptation to regulatory changes : Responding to changes in the European regulation governing the marketing of cosmetics.
These actions help guarantee the safety of cosmetic products and meet the increasing consumer demand for safer, high-quality products.

Procedure and management of reports in cosmetovigilance

Reporting and data collection process


Consumers and beauty professionals are invited to report any adverse effects that may occur during or after the use of cosmetic products. The primary risks associated with these products include skin reactions such as irritation, allergies, and photosensitivity. Less frequently, effects may also be observed on the eyes and hair. In rare instances, certain products may result in significant systemic effects due to the absorption of active ingredients through the skin or mucous membranes, manifesting as symptoms such as nausea, headaches, or multi-organ reactions.

It is the responsibility of healthcare professionals, the cosmetics industry and distributors to immediately report to the competent authorities any adverse effects that may occur during the normal use of their products. There are several reporting methods, including online forms, mobile applications and paper declarations. These reports must include information on the product, the symptoms observed, the conditions of use, as well as chronological and semiological information. Anses receives and records all these alerts for later evaluation.


Management of adverse events


A specialized team at ANSES is responsible for analyzing all alerts received in order to assess the severity and frequency of the adverse effects reported. This analysis includes verifying the information, assessing possible causes and identifying trends or safety signals.

There are 3 types of adverse effects:
  • Adverse effect (AE): this is a harmful reaction to human health attributable to the normal or reasonably foreseeable consumption of a cosmetic product.
  • Serious adverse effect (SAE): This is an adverse effect that leads to a serious effect such as disability, hospitalization, immediate risk to life or death, to name just a few examples.
  • Misuse: As its name suggests, misuse corresponds to non-compliant use of the cosmetic product by the consumer, whether in relation to its normal use, its instructions for use or the special precautions for use, for example.

In response, corrective actions may be taken, such as reformulating the product, updating warning labels, communicating to regulatory authorities, or even withdrawing the product from the market if necessary, to protect consumers.

Cosmetovigilance has led, for example, to the banning of vitamin K3 in cosmetics, following increased awareness of the risks associated with paraphenylenediamine in temporary black tattoos, or to the detection of sensitization to octocrylene due to photosensitization by ketoprofen gel.


Legal obligations of manufacturers in cosmetovigilance


The legal obligations of manufacturers in the field of cosmetovigilance are defined by Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products. The provisions of article 23 and also articles L.5131-5, L.5431-8 and R.5131-6 to R.5131-15 of the French Public Health Code (Code de la santé publique, CSP) must be complied with. In the event of serious adverse reactions, manufacturers must immediately inform the competent authorities.

In addition, manufacturers must implement practices that are not only compliant but also proactive in managing and ensuring the safety of their products. This includes :
  • Continuous monitoring of potential adverse effects of products once they are on the market.
  • Evaluating the safety of all new products, taking into account data and new scientific research.
  • Communicating transparently with consumers through responsible customer service.
  • Active cooperation with distributors and authorities to ensure the safety and compliance of cosmetic products on the market.
  • Taking a proactive approach by implementing preventive measures based on cosmetovigilance data to enhance product safety.
  • Establish effective systems for collecting, managing and analyzing adverse effect data. This includes the use of specialized databases and software.


Conclusion

Cosmetovigilance aims to identify and understand adverse effects related to cosmetic products. This approach is essential to protect consumers and ensure the safety of products available on the market. By reducing the risks associated with their use, cosmetovigilance plays a key role in the continuous improvement of the quality of cosmetics. It places consumer safety at the heart of its priorities, allowing them to use these products with confidence.

PLM software and the management of cosmetovigilance

Product lifecycle management (PLM) software improves cosmetovigilance management by centralizing essential cosmetic product data and automating the monitoring of regulated and banned substances. It promotes proactive risk management and ensures compliance with regulatory standards, thereby improving product safety and quality throughout their lifecycle.