Cosmétiques

Cosmetics: how can we better protect consumer health?

The composition of cosmetic products means that we can routinely be exposed to potentially harmful chemicals. What are their possible effects on health? Why is it important to report adverse effects? Since early 2024, ANSES has been responsible for vigilance and expert appraisals relating to cosmetics and tattoo products. Our experts on the subject tell you everything you need to know about cosmetics and protecting health.

What is a cosmetic product?

Céline Druet: Although we immediately think of skin creams or make-up, cosmetics actually cover a wide variety of very different products. They include for example toothpastes, shampoos and soaps, sunscreens, nail varnishes, perfumes, deodorants, hair-removal creams and hair dyes.

According to the European regulations, a cosmetic product is "any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours".

On the other hand, creams, ointments or gels for therapeutic use (antibiotics, anti-inflammatories, for example) are medicines or medical devices, not cosmetics. Cosmetic products are not intended for healing.

What are the potential health effects of cosmetic products?

Juliette Bloch: A cosmetic product contains numerous chemicals that can cause adverse effects in the short or long term. A product's safety must therefore have been demonstrated by the company that placed it on the European market. The most toxic substances are banned and must not be found in products, while others must not exceed a certain concentration, or are reserved for particular uses or populations.

The vast majority of adverse effects concern allergic reactions, even when all the ingredients in the product comply with the regulations, due to certain people being particularly sensitive.

Other harmful effects may be identified. For example, glyoxylic acid is a chemical used in certain cosmetic products for its straightening properties. As part of its cosmetovigilance mission, in 2024 ANSES received reports of acute kidney failure following the application of "Brazilian hair straightening" treatments containing this chemical.

What precautions should be taken when applying a cosmetic product?

Élodie Lontsi: To ensure the safe use of cosmetic products, here are the essential precautions to follow:

Above all, it is important to read the labels carefully

  • Follow the instructions: comply with the conditions of use indicated on the product, such as the area and duration of application, or the frequency of use. Be sure to comply with the expiry date and the shelf life after opening the product. Allergy sufferers should check whether or not the product is suitable for them. Certain products should not be used on children.  

For specific products, such as hot wax for hair removal, the instructions must be strictly followed, particularly the heating time, etc.

>> Read our Vigil'Anses article on hair removal wax

Pay attention to specific warnings: for example, avoid applying a deodorant to irritated or damaged skin, or using a product on a child when the manufacturer advises against it.

  • Check the product's composition:

Read the list of ingredients to identify any allergens to which you may be sensitive.

In the event of an adverse effect:

Why and how should you report an adverse effect?

Élodie Lontsi: Reporting is essential if we are to better understand the risks and protect consumers.

According to the French Public Health Code: distributors of cosmetic products or the "responsible person" for the product, i.e. manufacturers, representatives or importers working within the European Union, have an obligation to report any serious undesirable effects occurring in humans under normal or reasonably foreseeable conditions of use of a cosmetic product: an effect leading to hospitalisation, permanent or temporary functional incapacity, disability, congenital anomalies, an immediate vital risk or death.

Healthcare professionals or users, hairdressers or beauticians can also report adverse effects associated with cosmetic products.

> Find out more about reporting an adverse effect

Since January 2024, ANSES has been responsible for monitoring adverse effects associated with the use of cosmetic products. 
Once they have been analysed by ANSES, these reports are invaluable for strengthening consumer health protection. In particular, they are used to adjust the conditions of use, identify non-compliant products on the market, or detect toxic substances so that they can be more effectively regulated, or even, in some cases, banned at European level.

Between 1 January 2024 and 31 December 2024, we received 378 reports, including 129 serious cases.

Users submitted 51% of the reports, including two from beauty professionals.

What happens after an adverse effect has been reported?

Élodie Lontsi: When ANSES receives a report relating to a cosmetic product, regardless of how it was submitted, it verifies that the incriminated product is registered in the European CPNP database, as required by the regulations. This enables it to determine the product's composition and the precautions for use that must appear on the packaging.

ANSES then assesses the causality of all serious adverse effects, i.e. a possible link between the product and the serious adverse effects reported, based on various information provided (for example, the symptoms, the time taken for them to appear, the results of tests to screen for allergies, etc.). For the purposes of this assessment, ANSES may seek the opinion of its "Vigilance for chemical products" expert group, which includes toxicologists from the poison control centres and dermatologists.

ANSES reports serious cases on the European Information and Communication System for Market Surveillance (ICSMS) portal, except in the case of misuse or when the causality of the product has been ruled out. This enables all the European competent authorities for cosmetovigilance to be informed.

When a product is implicated in several cases of adverse effects, particularly if they are serious, ANSES will contact the manufacturer and ask them to forward any reports they may have received, along with the precise composition of the product, its current packaging, advice on use and sales volumes.

Any breaches of the regulations noted by the Agency are reported to the Directorate General for Competition, Consumer Affairs and Fraud Control (DGCCRF), the French authority responsible for monitoring the safety of products placed on the market and withdrawing them in the event of fraud.

If a substance is suspected of causing adverse effects, even if it is not subject to regulatory prohibitions or restrictions on use, ANSES can initiate an expert appraisal in order to study more specifically the risks associated with exposure to this substance.

How can users of cosmetics be better protected?

Sandrine Charles: If an ingredient used in a cosmetic product gives rise to any safety concerns, a Member State may ask the European Commission to instruct the Scientific Committee on Consumer Safety (SCCS) to assess or reassess the safety of using this ingredient. On this basis, the European Commission can then regulate the use of this ingredient. In practical terms, this means amending the annexes to the Cosmetics Regulation, which set out the lists of prohibited, restricted and authorised substances.

Within this framework, ANSES can therefore carry out expert appraisals in order to submit proposals to the European Commission regarding substances to be assessed when safety concerns are raised. For example, in response to reports of acute kidney failure following the application of "Brazilian hair straightening" products containing glyoxylic acid, ANSES undertook an expert appraisal on the renal toxicity of this substance. In its opinion, it recommended conducting a risk assessment in order to rule on the need for a restriction or even a ban on the use of this substance in hair care products, under the European Cosmetics Regulation.

ANSES may also be asked by its supervisory ministries to provide scientific support on specific subjects, as was the case with the revision of the European Commission's 2006 recommendation on safety and efficacy claims for sunscreen products. In its opinion, the Agency called for the recommendation to be made clearer and more restrictive, in order to provide better information and protection for users of sunscreen products.

Is titanium dioxide (TiO2) authorised in cosmetics?

Céline Druet TiO2 is a cosmetic ingredient authorised as a colorant and UV filter. Its uses are governed by Annexes IV and VI (lists of ingredients allowed as colorants and UV filters respectively) of the European Cosmetics Regulation (Regulation (EC) No 1223/2009).

Following concerns raised by the European Food Safety Authority (EFSA) about its potential genotoxicity, the European Commission gave the SCCS a mandate to reassess the safety of TiO2 in cosmetics, focusing on inhalation and oral exposure of consumers and the substance's potential genotoxicity. It concluded that it was not possible to rule out a potential genotoxic effect of most forms of TiO2 used in cosmetics.

In response to the SCCS's assessment, in May 2024 a group of manufacturers shared a roadmap with the Member States and the European Commission, proposing an approach for providing additional data, which ANSES analysed.

This article was based on interviews with Céline Druet, Deputy Director of the Risk Assessment Department, Juliette Bloch, Director of Health Alerts and Vigilance, Élodie Lontsi, Cosmetovigilance and Tattoo Vigilance Project Manager and Sandrine Charles, Cosmetic and Tattoo Products Project Manager.