May 2023: Post-market surveillance refers to a surveillance system registering undesirable effects, serious or not, linked to the use of a cosmetic product. The issue generally occurs within the scope of a normal or reasonably foreseeable utilisation of a cosmetic, or in the case of a potential misuse. In Europe and the USA, this process is mandatory by law in many areas including cosmetics.
This article aims at explaining your duties as a cosmetic brand after putting cosmetic products on the European and American markets. Also called “Cosmetovigilance”, post-market surveillance in the cosmetics industry is an important part of compliance requirements and should be taken care of by experts in regulations.
1) Cosmetics post-market surveillance in Europe
In order to ensure the protection of human health as well as the functioning of the European market, the European Commission established in 2009 the EU Cosmetics Regulation EC No 1223/2009 pertaining to the cosmetics industry. On the other side, following the Brexit, the UK enforced its own cosmetics legislation, known asThe Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019, Schedule 34 ».
USEFUL DEFINITIONS
- Withdrawal: any measure aimed at preventing the making available on the market of a cosmetic product in the supply chain.
- Recall: Any measure aimed at achieving the return of a cosmetic product that has already been made available to the end user.
- Undesirable effect: An adverse reaction for human health attributable to the normal or reasonably foreseeable use of a cosmetic.
- Serious undesirable effect: An undesirable effect which results in temporary or permanent functional incapacity, hospitalisation, congenital anomalies or an immediate vital risk or death.
According to the above regulations, “For reasons of effective market surveillance, the competent authorities should be notified of certain information about the cosmetic product placed on the market”. Moreover, “In order to allow for rapid and appropriate medical treatment in the event of difficulties, the necessary information about the product formulation should be submitted to poison control centers and assimilated entities, where such centers have been established by Member States to that end ». “In order to keep administrative burdens to a minimum, the notified information for competent authorities, poison control centers and assimilated entities should be submitted centrally for the Community by way of an electronic interface ».
As explained in our dedicated article on the Responsible Person, handling post-market surveillance issues (undesirable effects) in Europe is the duty of the EU/UK Responsible Person. For a reminder, the RP must have an address in the EU and the UK. If a customer complains after the use of a cosmetic and that an undesirable effect or serious undesirable effect occurs, the Responsible Person must follow-up with the brand and the authorities to ensure the best course of action. If the situation requires it, the Responsible Person has to take all appropriate measures, including corrective actions in order to bring the cosmetic into compliance. A withdrawal or a recall of the cosmetic from the market, depending on the nature of the risk, can be required by the authorities. Recalls of products will be needed if a raised issue can lead to a danger for the consumer. For instance, an allergen labelling mistake could lead to such a decision even if the product itself is not problematic. This kind of procedure is decided on with the authorities to ensure the best course of action.
In the event of serious undesirable effects, the Responsible Person and distributors must notify the issue to the competent authorities of the right member state. If the end user is declaring the serious undesirable effect, the Responsible Person will be notified. If the Responsible or the distributor are not taking all appropriate measures, including corrective actions bringing the cosmetic product into conformity, the withdrawal or the recall, competent authorities will take the lead. As a result, cosmetics post-market surveillance in Europe falls under the Responsible Person’s obligations, which is why choosing a competent one is a must.
2) Cosmetics post-market surveillance in the USA
As you may know by now, the MoCRA’s publication in 2022 has changed the former regulation in place. You can check this article to understand its consequences on the American cosmetics market. The MoCRA does not replace the former regulation but brings additional rules on the table. For instance, there is no cosmetic definition in the MoCRA because amending it was not necessary. Thus, pre-existing rules on post market surveillance still apply unless the MOCRA specifies the contrary. Cosmetics post-market surveillance is the duty of the Responsible Person (must be located in the USA), which has to:
- Receive and take care of the adverse reactions, including reporting to the FDA when needed. In case of Serious Adverse Events, the Responsible Person must submit a report within 15 business days after the report is received by the Responsible Person.
- Keep and maintain up to date a cosmetovigilance dossier, as well as maintain records of Adverse Events reports.
- Organize a market recall when needed/requested by the FDA
The MoCRA mentions that “The Responsible Person shall submit to the Secretary any report received of a serious adverse event associated with the use, in the United States, of a cosmetic product manufactured, packed, or distributed by such person”. It must submit a report of the situation to the FDA and follow-up on the incident.
How can BIORIUS help you
Our experts in American law have been helping hundreds of brands so sell in the USA. We can check the compliance of your formulae and labels, on top of making the mandatory Toxicological Risk Assessment. In case your USA Responsible Person is not qualified to handle cosmetics post-market surveillance, BIORIUS can help on some points.
In the EU and the UK, BIORIUS is a trusted Responsible Person able to lead cosmetovigilance procedures required by a Responsible Person. For more information, do not hesitate to contact your CRM (Customer Relationship Manager), if you are already a Biorius’ client or to contact us at info@biorius.com.
