Assessment of undesirable events in cosmetic market surveillance: Background, description and use of a causality assessment method in cosmetovigilance

Bons, B.; Audebert, F.; Bitaudeau, C.; Cachin, N.; Colson, L.; Farr, Craig H.; Fix, L.A.; Gilmour, Nicola; Gorni, R.; Griffiths, Mark D.; Harris, Bridget; Holle, V.; Kirk, Sara; Meredith, Exie; Pari, C.; Poinsot, P.; Renner, Gerald

doi:10.1016/j.yrtph.2010.06.015

Cited by 13 publications

(11 citation statements)

References 10 publications

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“…Annex I of the SUE guidelines [17] specifies the comprehensive process of causality assessment on about 10 pages. To tackle the problem that this essential assessment is too complicated for several companies or authorities, a spreadsheet following the decision tree [18] from the Annex I was designed and is provided as assistance by the BVL [19]. The spreadsheet has a short assessment procedure that is useful if only rare information was provided about a case and it offers a comprehensive assessment procedure if substantial medical information is available.…”

Section: Discussionmentioning

confidence: 99%

Experiences and Statistical Evaluation of Serious Undesirable Effects of Cosmetic Products in the EU

et al. 2016

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The Council of Europe created an outline for a vigilant system of undesirable effects of cosmetic products in 2006. In 2013, some of those aspects were included in the European Cosmetics Regulation (EC) 1223/2009. Since then, serious undesirable effects (SUEs), which are the tip of the iceberg of all undesirable effects of cosmetic products, have to be reported to competent authorities. Neglecting the first phase of establishing the system, we have about two years of experience regarding the notification of SUEs. This notification system is based on a huge amount of cases that allow us to identify occurring problems at an early stage through a signal of increased reported cases for a certain product. It has already been shown that the system is able to identify products that have the potential to cause health risks even if they seem to comply with the legal requirements and the safeguard clause was applied. Until May 2016, 680 cases of SUEs were shared in the EU. The statistics of SUEs indicate that hair dyes and skin care products are the product types that cause the most SUEs. Almost 80% of all SUEs occurred in the head area, especially the skin of the face was affected.

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Section: Discussionmentioning

confidence: 99%

Experiences and Statistical Evaluation of Serious Undesirable Effects of Cosmetic Products in the EU

et al. 2016

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“…Post Launch Monitoring and Colipa guidelines aim to assess causality of undesirable effects of cosmetic products on human health. [192021] The time of onset, duration, and whether it is unexpected or reproducible with rechallenge are key determinants for assessment of causality. [192021]…”

Section: Resultsmentioning

confidence: 99%

Cosmetovigilance: A review of the current literature

Toklu

Antigua

Lewis

et al. 2019

J Family Med Prim Care

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The term “pharmacovigilance” defines the activities related to the collection, detection, assessment, monitoring, and prevention of adverse reactions occurring with medications. Recently, the spectrum of “-vigilance” has broadened to include safety of herbal products and cosmetic products as well. “Cosmetovigilance” was introduced as a new term used for defining surveillance carried out by industry to address the safety of cosmetic products. It was first used in literature by Vigan (1997) to refer to the monitoring of cosmetic product safety. Today, it is recognized globally as a concept of public health. For this systematic review, a PubMed search was conducted in July 2018 for the term “cosmetovigilance.”

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“…A standardized methodology should be employed. The cosmetic industry developed such a methodology in 2005 [13,14]. The current algorithm used is that developed within the frame of the European Commission SUE Reporting Guidelines (SUE reporting guidelines) [15].…”

Section: Causality Assessmentmentioning

confidence: 99%

“…The two causality assessment algorithms used for the two periods share the same criteria for classifying UEvs as "likely" and "very likely" [6,12,14]. Therefore, the aller- Table 4.…”

Section: Comparison Of Allergic Contact Dermatitis-type Response ("Limentioning

confidence: 99%

Contact allergy to hair-colouring products: a cosmetovigilance follow-up study by four companies in Europe from 2014 to 2017

Krasteva¹,

Caratas-Perifan²,

Kock³

et al. 2020

European Journal of Dermatology

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Background: A previous analysis of undesirable events (UEvs), reported to four major companies following the use of hair-colouring products in Europe, showed that the reporting rates were stable for both oxidative and direct hair-colouring products over the period 2003-2006. Objectives: In order to verify the impact of risk management measures implemented since 2006, as well as the impact of a new Commission Regulation (No 1223/2009), the same four companies analysed cosmetovigilance data collected over an additional four-year period (2014-2017). The objective was to determine whether there was any time effect, country effect, or product type effect, as well as identify risk factors. Materials and Methods: Each company collected reports of alleged UEvs, undesirable effects (UEfs) and serious undesirable effects (SUEs) for their products in their key European markets, and calculated the respective reporting rates (number of events/million units sold). A detailed analysis was performed on allergic contact dermatitis-type events. Results: The reporting rates for alleged UEvs and allergic-type UEfs associated with hair-colouring products remained stable over the four-year period, although a statistically significant decrease was observed for some companies. No time effect on SUEs was observed for three companies but a statistically significant decrease in SUEs was observed for one company. Black henna tattoos remained a major risk factor regarding SUEs due to hair dyes. Conclusion: The reporting rates of undesirable events, including contact allergy-type events, were stable over time. This was true for oxidative and direct hair dyes, for both home use and professional exposure scenarios.

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Assessment of undesirable events in cosmetic market surveillance: Background, description and use of a causality assessment method in cosmetovigilance

Cited by 13 publications

References 10 publications

Experiences and Statistical Evaluation of Serious Undesirable Effects of Cosmetic Products in the EU

Experiences and Statistical Evaluation of Serious Undesirable Effects of Cosmetic Products in the EU

Cosmetovigilance: A review of the current literature

Contact allergy to hair-colouring products: a cosmetovigilance follow-up study by four companies in Europe from 2014 to 2017

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