AFTER-SALE MONITORING
After-sales supervision means the collection, evaluation and monitoring of reports arising from undesirable effects observed during or after normal use of the product. This activity, in the cosmetic field, is completely different from that applied in the pharmaceutical field, both for the amount of cosmetics used and for the type of reaction caused, which in most cases can be transient and reversible. Cosmetics, even if used correctly, can cause undesirable effects. The reporting of such effects by citizens, health professionals (doctors, dermatologists, hospital and local pharmacists...), cosmetic professionals (beauticians, hairdressers,...)companies and distributors is important to implement the market surveillance system.
The majority of reactions is caused by irritative contact dermatitis (DIC) and allergic contact dermatitis (DAC). Other pathologies related to the use of cosmetics are represented by comedogenesis, erythema, urticaroid dermatitis (characterized by the onset, in a short time, of ponfi in the cosmetic contact sites) and also allergic photodermatitis (e.g. triggered by bergamot essence and subsequent exposure to solar radiation).The person exhibiting the undesirable effect shall be the first person who may attribute the adverse effect on health caused the effect and then indicate whether the effect is serious according to the EIG definition and specify the severity criterion of the reaction between those possible.
It is also necessary to indicate if the consequence has been confirmed by a doctor or a specialist and if you have a medical certificate; in this case the report is more reliable because it is validated and confirmed objectively by a doctor.
However, undesirable effects may also be reported by the end-user or by a health professional who becomes aware of damage suffered by the patient and caused by a particular cosmetic product.
The Natieco with extreme duty makes available its resources in order to ensure maximum support to the competent authorities and actively participate in any reports, in order to determine the causes.
ACCORDING TO REGULATION EU NO. 1223/2009:
- the undesirable effects (UE) are defined as "adverse reactions to human health attributable to the normal or reasonably foreseeable conditions of use of a cosmetic product";
- the serious undesirable effects (EIG) are defined as "undesirable effects inducing temporary or permanent functional incapacity (understood as temporary or permanent physical damage affecting the quality of life and/or making it difficult for the consumer to carry out his normal occupations and/or activities, including work), disability, hospitalization (understood as hospitalization), congenital abnormalities, immediate death risks or death".
DOWNLOADABLE USEFUL DOCUMENTS BELOW:
The form (in italian), once completed, can be forwarded by fax to the number +39 06.59943776, to the e-mail box cosmetovigilance.italy@sanita.it or by certified mail dgfdm@postacert.sanita.it.
useful answers
Cosmetovigilance is the set of activities for the collection and management of reports of undesirable effects attributable to the use of a cosmetic, carried out with the aim of facilitating post-marketing surveillance and ensuring the protection of the health of citizens.
Serious Safet Event (SSE), "serious undesirable effects", are defined as undesirable effects that induce temporary or permanent functional incapacity, disability, hospitalization, congenital abnormalities, immediate death risks or death.
On the subject of surveillance, and always to protect health, Regulation (EC) no. 1223/2009 also deals with the problem of counterfeiting, as reported in recital 15 "The European cosmetics sector is one of the industrial activities victims of counterfeiting, with increasing risks to human health. Internal market controls are an efficient tool for identifying products that do not comply with requirements of this Regulation". Natieco collaborates with the bodies responsible for the control and ensures compliance of the brands and products it produces, in compliance with the undersigned code of ethics.
For products with a minimum shelf life of more than 30 months, an expiry date need not be indicated on the label, but an indication must be given of the period of time during which the product, once the container has been opened, can be used without harmful effects to the consumer, the PAO, depicted with the symbol of a jar indicating the number of months after opening.
Food supplements are products that fall within the scope of food and therefore must comply with all applicable food law provisions on safety, labelling and claims. Plant protection is mainly concerned with risk assessment and monitoring of the incidence of adverse effects (ADR), potentially associated with the "therapeutic" use of food supplements. Side effects caused by the use of phytotherapists are quite frequent, because often the final consumer uses them in an inadequate way, underestimating the advice of the doctor or manufacturer.
