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Reporting Undesirable Effects of cosmetics

What is an undesirable effect (UE)?

An undesirable effect is an adverse reaction for human health attributable to the normal or reasonably foreseeable use of a cosmetic product.

What is a serious undesirable effect (SUE)?

A serious undesirable effect is an undesirable effect which results in temporary or permanent functional incapacity, dis­ability, hospitalisation, congenital anomalies or an imedi­ate vital risk or death.

What is a cosmetic product misuse?

Misuse corresponds to an intentionally and inappropriately use of a cosmetic product not in accordance with its normal or reasonably foreseeable use or its special warnings and precautions for use.

Reporting of undesirable effects by the Responsible Person of cosmetic products

Upon receipt of a serious undesirable effect, the cosmetic company placing a cosmetic product on the EU market (i.e. the Responsible Person) has to report it to the National Competent Authority (NCA) of the country where the undesirable effect occurred.

The reporting of undesirable effects contributes to the detection of signals and to post marketing surveillance of cosmetic products, therefore, to the improvement of the safety of all consumers.

When necessary, preventive or corrective actions are undertaken by the Responsible Person and/or by the authorities following the assessment of the serious undesirable effects or the validation of a trend or signal.

Some of those corrective or preventive measures include a change in usage instructions, labeling, warnings or in the composition of the cosmetic product. 

Cosmetic Product Safety Report (CPSR)

The cosmetics products Regulation (EC) No 1223/2009 establishes that, in order to demonstrate that a cosmetic product complies with general safety requirements, the Responsible Person shall, prior to placing a cos­metic product on the market, ensure that the cosmetic product has undergone a safety assessment on the basis of the relevant information.

The cosmetic product safety report is a critical scientific review of the safety of the cosmetic product conducted by a suitably qualified person (safety assessor). The safety assessor works closely together with the Responsible Person to ensure that the safety of the product is properly assessed, documented and kept up-to-date. 

The Cosmetic Product Safety Report is part of the product information file (PIF).

What must be include in the Cosmetic Product Report?

The Cosmetic Product Report must be established in accordance with Annex I of the Cosmetics Regulation and shall, as a minimum, contain the following:

PART A – Cosmetic product safety information

1. Quantitative and qualitative composition of the cosmetic product
2. Physical / chemical characteristics and stability of the cosmetic product
   
3. Microbiological quality
4. Impurities, traces, information about the packaging material
   
5. Normal and reasonably foreseeable use
   
6. Exposure to the cosmetic product
7. Exposure to the substances
8. Toxicological profile of the substances
9. Undesirable effects and serious undesirable effects
10. Information on the cosmetic product

PART B – Cosmetic product safety assessment

1. Assessment conclusion
   
2. Labelled warnings and instructions of use
   
3. Reasoning
4. Assessor’s credentials and approval of part B

Cosmetovigilance in the European Union

Cosmetovigilance in the EU is under the scope of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products. This regulation was published in the Official Journal of the European Union on 22 December 2009 and applies from 11 July 2013.

The aim of the cosmetics regulation is to ensure a high level of protec­tion of human health and harmonise the rules in the Community in order to achieve an internal market for cosmetic products with due regard to the welfare of animals.

Cosmetovigilance concerns all cosmetic products placed on the market.

Cosmetovigilance relies on: 

• the notification of undesirable effects and the gathering of the corespondent information.
• document, investigate, validate and evaluate undesirable effects cases within a context of prevention.
• performing studies and preparing reports concerning the safety use of cosmetic products.
• performing and follow-up corrective actions, if needed.

Cosmetovigilance allows the identification of undesirable effects that were not observed during the safety studies performed before the cosmetic product was placed on the market.

Cosmetovigilance in France

In France, cosmetovigilance follows also articles L.5131-5, L.5431-8 and R.5131-6 - R.5131-15 of the French Health Code (CSP) and is under the scope of ANSM (French National Agency for Medicines and Health Products).

Who can report undesirable effects?

Industry

The Responsible Person of the cosmetic company placing a cosmetic product on the EU market must report all serious undesirable effects which are known to him or which may reasonably be expected to be known to him.

Health professionals 

Doctors, pharmacists, nurses, dentists, etc., must inform ANSM, without delay, of all serious undesirable effects attributable to the normal or reasonably foreseeable use of a cosmetic product.

They can also notify other undesirable effects including undesirable effects caused by product misuse.

Consumers and beauty professionals

Consumers and beauty professionals (hairdressers, aesthetician, etc.) can notify all undesirable effects (serious and non serious) including undesirable effects caused by product misuse.

How to notify undesirable effects in France?

Since the 13th of March 2017, undesirable effects attributable to the use of cosmetics can be notified on-line through the portal for reporting adverse health events in France.

Cosmetic products Responsible Person

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