UNDERSTANDING UNDESIRABLE EFFECTS, COSMETOVIGILANCE & RAPEX
There are 2 types of undesirable events according to Regulation (EC) No 1223/2009 on cosmetic products:
- “undesirable effects (UEs)” are defined as “adverse reactions to human health attributable to the normal or reasonably foreseeable conditions of use of a cosmetic product”;
- “serious undesirable effects (SUEs)” are defined as “undesirable effects that induce temporary or permanent functional incapacity (understood as temporary or permanent physical damage that impacts the quality of life and/or makes it difficult for the consumer to carry out his or her normal occupations and/or activities, including work), disability, hospitalization, congenital anomalies, immediate fatal risks or death”.
Once SUE happens SUE form (also called form A) should be filled out. It can be submitted directly by the final consumer, pharmacist, competent doctor, manufacturer, distributor, or Responsible Person (RP).
Under Regulation (EC) No 1223/2009, cosmetovigilance ensures that any adverse reactions to cosmetics are documented and addressed. Cosmetovigilance was created as a centralized European system to deliver early warnings across the EU in response to reports of adverse effects.
The RP must take corrective actions, such as reformulating or withdrawing a product if necessary, while national authorities oversee compliance and share safety data across the EU.
“RAPEX” (RAPid EXchange of information system) is the EU’s early warning system for potentially harmful consumer products, such as cosmetics.
Its goal is to quickly notify the European Commission and the national authorities of EU Member States about products and services that present serious risks to consumer health and safety.
Each week, the Commission compiles a report summarizing all received notifications. This report is available online, allowing the public to see which products have been removed from the market.
Give it a try and search: Safety Gate: the EU rapid alert system for dangerous non-food products