The EC Regulation 1223/2009, which came fully into force on 11 July 2013, defines a “serious undesirable effect” as any adverse effects to human health arising from normal use or reasonably foreseeable use of a cosmetic product that causes temporary or permanent functional incapacity, disability, hospitalization, congenital anomalies, immediate mortal danger or death.
The same Regulation, Art. 23, specifies that any undesirable effect known to the Responsible Personor the Distributor of the cosmetic product must be promptly reported to the competent authority of the EU country in which the effects were observed.
At a moment when, through the reporting of a client, a doctor or a pharmacist, the Responsible Person is made aware of these adverse reactions, he/she must take action in order to recover as much useful information as possible to verify the existence of a causal link between the use of the product and the adverse reaction.
Once this preliminary investigation has been conducted, is necessary to assess the available evidence and express an opinion with regards to the event.
If there has been a serious undesirable effect, the communication to the Authority must be complete with all information in the possession of the company relative to the event, in order to allow officials to verify, in their turn, the causal link and issue an final judgment.
The Responsible Person must store all documentation relating undesired effect and report within the PIF (Product Information File), all cases of known undesirable effects. The constant updating of the information will be necessary to re-evaluate, if necessary, the safety of the cosmetic product, assuming, if necessary, a change in the formulation.
Di Renzo Regulatory Affairsis able tooffer its customers the following services:
- Gather information necessary for the evaluation of adverse reactions
- Evaluation of the causal link
- Management of the practice of communication of serious undesirable effect to the Authorities
- Updating the PIF
- Regulatory updates in the case of new restrictions or prohibitions in the use of cosmetic ingredients