Cosmetics are defined by their intended use, as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance” [FD&C Act, sec. 201(i)]. The products covered under this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, cleansing shampoos, permanent waves, hair colors, and deodorants, or any other substance intended for use as a component of a cosmetic product.
According to Cosmetics Directive of European Union, “a ‘cosmetic product’ by definition is any substance or preparation intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odors and/or protecting them or keeping them in good condition.
Undesirable event (UE): An undesirable or adverse event is defined as any human adverse health event which is:
- Voluntarily reported by consumers, healthcare professionals, Competent Authorities, and any other individuals to have occurred during or after normal or reasonably foreseeable use (exclude misuse and abuse) of a cosmetic product.
- Not necessarily related to the product.
Undesirable Effect (UE)
‘Undesirable effect’ means an adverse reaction for human health attributable to the normal or reasonably foreseeable use of a cosmetic product.
Undesirable Effects include but are not limited to irritant or allergic reactions that can affect the skin, eyes or mouth. Undesirable effects caused by product misuse and abuse are not included in this definition.
Serious undesirable effect (SUE)
A serious undesirable effect is an undesirable effect which results in temporary or permanent functional incapacity, disability, hospitalisation, congenital anomalies or an immediate vital risk or death.
Reportable experience means an experience involving any allergic reaction, or other bodily injury, alleged to be the result of the use of a cosmetic product under the conditions of use prescribed in the labeling of the product, under such conditions of use as are customary or reasonably foreseeable for the product or under conditions of misuse, that has been reported to the manufacturer, packer, or distributor of the product by the affected person or any other person having factual knowledge of the incident, other than an alleged experience which has been determined to be unfounded or spurious when evaluated by a filed screening procedure.
Causality assessment is the analysis of the probability that a well identified product used by a consumer is responsible for a genuine undesirable event, i.e., whether the event is attributable to the use of a cosmetic product and should therefore be considered as an Undesirable Effect. A causality assessment is done for a specific use of the product by an individual consumer. It does not give an evaluation of the risk of a product to the general population.
Cosmetic product misuse: Misuse corresponds to an intentionally and inappropriately use of a cosmetic product not in accordance with its normal or reasonably foreseeable use or its special warnings and precautions for use.
Regulatory reporting Timelines:
Europe:
SUEs must be reported to the NCA of the country as soon as possible and in any case no later than 20 calendar days following the date of initial receipt of the SUE. Complementary information when obtained should be registered in the report file with the date of their receipt. If the collected information has significant impact, such as the nature of the event, on the outcome or the assessment of the case, it should be sent to the NCA as a follow up using the same SUE report form as the one initially used, with the addition of the complementary information obtained and within the 20 calendar days following their reception.
Association of Southeast Asian Nations (ASEAN) Cosmetic Directive:
Fatal or life threatening adverse events:
Fatal or life threatening adverse event qualify for very rapid reporting to the regulatory authority, which shall be notified (e.g. by telephone, facsimile transmission, email or in writing) as soon as possible but no later than 7 calendar days after first knowledge, followed by completing the Adverse Cosmetic Event Report Form within an additional 8 calendar days and providing any other information as may be requested by the regulatory authority.
Other serious adverse events
All other serious adverse events that are not fatal or life threatening must be reported as soon as possible, but no later than 15 calendar days after first knowledge.
FDA: These are voluntary reports. There is no required timeframe for submission.
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