The importance of cosmetovigilance
Regulations don’t stop once your new cosmetic product is launched onto the market – cosmetovigilance is required so you can assess your product’s performance and rule out any potentially hazardous ingredients which may be present, whilst it also enables you to evaluate the public’s response to the product.
In this article, we provide more detail on what cosmetovigilance is, what undesirable effects (UE) and serious undesirable effects (SUE) are, the role of a responsible person (RP), and how a causality assessment is performed.
What is cosmetovigilance?
Cosmetovigilance is the post-marketing surveillance of cosmetic products and involves collecting, analyzing, and assessing adverse reactions which occur in users of cosmetic products, to identify any potential health risks. The continued surveillance is considered to reduce the likelihood of both UE and SUE, therefore making products safer for the public.
Regulation EC No 1223/2009 states that “ensuring traceability of a cosmetic product throughout the whole supply chain helps to make market surveillance simpler and more efficient”.
An undesirable effect (UE) is any adverse health effect which differs from that expected from normal and reasonably foreseeable use of a cosmetic product. In most cases, UE’s do not end in medical intervention as they are typically mild and completely reversible. Common adverse reactions involving cosmetics include bleeding, urogenital reactions, dermatitis, infection, vomiting, tissue damage, flammability-induced death, respiratory system reactions, discoloration, nervousness, and diarrhea.
For an issue to be classed as an UE, it must be voluntarily reported, have occurred during/after normal use of a product, but does not necessarily have to be related to product use. A reaction that occurs following misuse or abuse of a cosmetic product is excluded from being classed as an UE, as this wouldn’t be under normal circumstances. A ‘genuine’ UE requires;
- an identifiable reporter (initials, age, gender)
- consumer (date of birth, age, gender, initials)
- cosmetic product (commercial name, brand name, category, batch number, CPNP number)
- description of the reaction
The event of an UE is only considered to become “genuine” once this evidence is gathered and the criteria are met.
Serious undesirable effects
In rare cases, an UE could be more serious, which would result in the effect being escalated to a serious undesirable effect (SUE).
A SUE is defined as an undesirable effect that results in temporary or permanent functional incapacity, disability, hospitalization, congenital anomalies, or immediate/vital risk or death. Temporary or functional incapacity refers to a significant disruption in the consumer’s ability to carry out normal occupational or physical life functions for a significant time frame.
To report a SUE, you must have;
- an identifiable reporter
- the nature of the alleged event
- the date of reaction onset
- the chronology
- an identifiable cosmetic product.
The role of a responsible person (RP)
The responsible person is answerable for establishing and maintaining adequate post-marketing surveillance regarding suspected UE’s, and for communicating any SUE’s with the relevant authorities, along with carrying out a causality assessment if necessary.
Inter Scientific provides a RP service for products both in the UK and Europe, in which we ensure that cosmetic products are compliant on the market and also have the power to make corrective actions to ensure regulatory compliance.
A causality assessment is the systematic evaluation of the relationship between reaction and product to determine the probability that the use of a product caused an undesirable event.
This evaluation is based on symptom likelihood, chronological criteria, and further investigation. Symptom likelihood involves considering whether it is plausible that a reaction could be caused by the specific product, in that manner and in that time frame for example; the reaction should usually involve the site of application. With regards to chronology, experts say that skin reactions usually occur within 24 hours and skin reactions that occur after this time may not be compatible. This time frame is extended when considering reactions from other products, such as hair dye reactions.
Investigation usually involves any additional examination or re-exposure. The outcome of this assessment is the likelihood of an association between the product and the reaction, which can include one of five options: very likely, likely, not clearly attributable, unlikely, and excluded.
We can help
Inter Scientific can use a fast and targeted cosmetovigilance system for your products to; record UE’s & determine their genuineness, progress cases to relevant authorities, store the reports, evaluate each case in terms of medical significance, frequency & causes, conduct a causality assessment, and answer any questions from relevant authorities on your behalf.
In a SUE case, Inter Scientific can implement the necessary corrective measures, including formula modifications, changes to the instructions, or warnings on the product label.