What is an undesirable effect?
An Undesirable Effect (UE) is defined by the Cosmetic Regulation as an “adverse reaction for human health attributable to the normal or reasonably foreseeable use of a cosmetic product.” The regulation differentiates Serious Undesirable Effect (SUE) that “causes (temporary or permanent) functional incapacity, disability, hospitalization, congenital anomalies or an immediate vital risk or death.”
NB: Seriousness is used to describe the patient/event outcome or action.
A small proportion of consumers will inevitably experience some undesirable effects, however the incriminated product is still considered safe if the percentage and the nature of the undesirable effect remains within acceptable limit.
All undesirable effects must be listed in part A of the Cosmetic Safety Report. Indeed, as mentioned in Annex I of the Cosmetic Regulation 1223/2009, all available data on UE and SUE relating to the cosmetic product or, where relevant other cosmetic products, must be reported. This includes statistical data.
What are my responsibilities?
Article 23 of Regulation 1223/2009 defines the scope of the communication of undesirable effects and serious undesirable effects.
As a Responsible Person or a distributor, you must notify to the concerned Member State’s competent authorities and provide:
- All serious undesirable effects known to them;
- The name of the cosmetic product concerned (for its identification);
- The corrective measures they have taken, if any.
The EU Cosmetic Regulation requires that existing data on UE and SUE must be made available to the public by any appropriate means, upon request.
NB: Before the notification or the transmission of Serious Undesirable Effects to the EU competent Authority, Responsible Persons, Distributors and Member State’s competent authority must ensure that the SUE meets the seriousness criteria and that the UE or SUE are imputable to the cosmetic product.
Be careful! When it comes to choosing your Responsible Person (RP), you must take into account his scientific and regulatory expertise. Indeed, the RP will be in direct contact with the competent authorities.
How to report Serious Undesirable Effects?
The EU Commission and Member States but also industry have developed a complete guidance on the reporting of SUE. You’ll find a template and assessment method to follow here.
Corrective action taken by authorities
Market surveillance is a regulatory obligation, which can be found in chapter VII of the EU Regulation 1223/2009.
In case of non-compliance, competent authorities can address corrective action against the Responsible Person and/or the Distributor. “The measures taken should be proportional to the nature and/or frequency of the SUE and be subject to the same rigorous risk assessment exercise conducted by competent authorities”.
Non-exhaustive list of corrective measures:
- Change in use instructions
- Labeling modification
- Add/modification of warnings
- Changes to the formula
- Recall the incriminated product
- Withdrawal of the product
As stated in articles 25, 26, 27 of EU Regulation 1223/2009., other measures can be taken by authorities.
All companies must set up a cosmetovigilance process after marketing their products by registering all events that occur during the marketing.
Cosmetovigilance also helps the industry define better standards and make cosmetics safer for the consumer.
To draft your own cosmetovigilance process you should always refer to the Cosmetic Regulation 1223/2009 particularly to:
- Chapter I “definitions”
- Chapter VI « consumer information »
- Chapter VII « Market surveillance »
- But also SUE guidelines
If Undesirable Effects (UE) must be recorded only, Serious Undesirable Effects (SUE) must be reported to the authorities without delay. A follow-up report must be implemented when new information is obtained.
Cosmetovigilance is an essential tool for decision-making in the risk management process.
Discover our European Cosmetics Regulation services
Please do not hesitate to contact us: [email protected], if you have any questions about cosmetic compliance or if you’re looking for specific services. EcoMundo acts as Responsible Person for Europe and can provide the following services:
- Regulation 1223/2009 services
- EU cosmetic compliance
- Responsible Person for Europe
- Formula review
- Claim review
- Cosmetic labeling services
- PIF creation
- Safety Assessment
- CPNP notification services
- Cosmetic certification for Europe
Contact us via phone: for North America please use + 1 (778) 231-1607 or for Europe +33 (0)1 83 64 20 54