Cosmetovigilance is the activity for the collection, assessment, and monitoring of information on the unwanted effects observed as a result of normal or reasonably foreseeable use of cosmetic products.
This system is coordinated by the Spanish Agency for Medicines and Medical Devices (AEMPS in Spanish) in the notification, collection, assessment, and monitoring of undesirable effects produced by cosmetic products and on any measures that may be taken on a case-by-case basis.
Market controls, in addition to focusing on the safety of marketed products, will also emphasize compliance with the principles of Good Manufacturing Practice.
The National Alert Network for Cosmetic Products, formed by EMPS (to be the coordinator) and the health authorities of the autonomous communities. Its activity focuses on the identification of cases of risks to human health or serious unwanted effects produced by cosmetic products, as well as recommendations, warnings, or any other information that is appropriate for the protection of the health and safe use of cosmetic products.
Practical cases and their consequences
A) ISDIN Fotoprotector Pediatrics Transparent Spray SPF 50+ y BABARIA Solar Infantil Spray Protector SPF 50+”.
Following further analysis, the “variability in results and inconsistency” was found in some studies with the Solar Protection Factor (FPS) for labeling, which required additional measures.
As a precautionary measure, ESMA informed that it had agreed with the responsible companies that it voluntarily withdrew these products from the market.
In addition, the following actions were carried out in order to ensure the effectiveness of solar protectors from ESMA:
– The Committee was again contacted with the Committee responsible for drawing up ISO 24444 for determining the PPS, with the European institutions responsible for the matter and industry in the sector, to transfer them the need for a reference method to the extent of solar protection that is reproducible for any product format.
– A solar protector market control campaign was launched, which will review its effectiveness studies, will be analyzed and checked if they correspond to the FPS labeling.
B) PRIMARK Prep & Perfect watermelon primer wáter y Prep & Perfect primer water charcoal
ESMA reported that the final user’s end-user withdrawal and recovery of all batches of cosmetic products because they are microbiologically contaminated. These products should not be used.
The most common causes of cosmetic and personal care alert in the RAPEX system (European Rapid Information Exchange System) are:
- Microbial contamination, presence of substances prohibited in cosmetics in accordance with Annex II.
- Presence of restricted substances outside the limits set out in Annex III.
- Presence of colors not included in Annex IV.
- Labeling and misleading appearance which may lead the consumer to confuse products with food.
The Commission publishes the RAPEX alerts on its website, which are public access. During the period October-December 2019, 26 cosmetic alerts and 13 personal care products were registered.
It is therefore essential to meet all the requirements of cosmetic legislation, in order to avoid the withdrawal of our products and its extensive economic consequences. The legislation to be taken into account is as follows:
– Royal Decree 85/2018 of 23 February, regulating cosmetic products.
– Regulation 1223/2009 of the European Union for the regulation of cosmetics.
From Zurko, our regulatory and consultancy department, continue to work day-to-day support in developing a wide range of services such as:
– Preparation and review of the product dossier (PIF)
– Preparation of technical files and all associated documentation for CE marking, approval FDA, LATAM, etc.
– Preparation of regulatory procedures for the placing on the market of biocidal products.
– Implementation and review of Quality Management Systems in accordance with ISO standards for cosmetics (22716) and health products (13485).
– Authorization of activities and facilities.
– And many more services …
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