European consumer exposure to cosmetic products, a framework for conducting population exposure assessments

Hall, Barbara; Tozer, S.; Safford, Bob; Coroama, M.; Steiling, W.; Leneveu-Duchemin, M.C.; McNamara, C.; Gibney, Michael J.

doi:10.1016/j.fct.2007.06.017

Cited by 135 publications

(72 citation statements)

References 8 publications

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“…Daily exposure levels for different cosmetic product types (toothpaste and mouthwash) were taken from the distribution of measured values (Hall et al, 2007(Hall et al, , 2011. The data reported by EHIA show similar levels of l-carvone in dry leaves of Mentha spicata (9000 mg/kg) as those described by Ravid et al in 1987 (7000 mg/kg;see Table 3).…”

Section: Interpretation Of the Terms Of Referencementioning

confidence: 72%

“…For personal care products i.e mouthwash and toothpaste, the estimated adult daily exposure levels have been calculated by the Scientific Committee using the daily amounts applied in average and at a 95th percentile from the distribution of measured values (Hall et al, 2007(Hall et al, , 2011 with the average concentration data of d and l-carvone. The Scientific Committee also looked at different non-food sources of carvone, such as dermal exposure from cosmetics and personal care products.…”

Section: Exposure Assessmentmentioning

confidence: 99%

“…The adult daily exposure levels for different cosmetic product types have been estimated by the EC Scientific Committee on Consumer Safety (EC SCCS, 2012) using data provided for several product types including toothpaste in 2005 and mouthwash in 2009 (Hall et al 2007(Hall et al , 2011. These values take into account the daily amount resulting from oral exposure.…”

Section: Estimated Exposure To D-and L-carvone From Orally-used Persomentioning

confidence: 99%

“…In order to provide a pertinent prediction for the European population, the exposure data for these types of products were generated using probabilistic analysis. The daily amounts applied in average and at a 95th percentile were taken from the distribution of measured values (Hall et al, 2007(Hall et al, , 2011. For toothpaste, the estimated daily exposure is 1.5 mg/kg bw/day in average and 2.4 mg/kg bw/d at the 95th percentile.…”

Section: Estimated Exposure To D-and L-carvone From Orally-used Persomentioning

confidence: 99%

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Scientific Opinion on the safety assessment of carvone, considering all sources of exposure

2014

EFSA Journal

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Carvone occurs naturally as dextrorotatory (d-) and levorotatory (l-) enantiomers in several food items; these may also be used as a pesticide, food flavouring, feed flavouring, in feed additive, in personal care products and as (veterinary) medicine. In order to improve coherence regarding the risk assessment of carvone in the different food and feed sector areas, EFSA asked its Scientific Committee to establish a single ADI for carvone, estimate the overall exposure of European consumers, and quantify the contribution for each source of exposure to the overall exposure of carvone. Having reviewed the information available the Scientific Committee decided to address dcarvone and l-carvone separately and limit its assessment to the oral intake of d-and l-carvone. The Scientific Committee established an ADI of 0.6 mg/kg bw/day for d-carvone, based on the BMDL10 of 60 mg/kg bw/day for an increase in relative liver weight in the rat 90-day studies and an uncertainty factor of 100. The Scientific Committee could not establish an ADI for l-carvone because of a lack of toxicological data for this enantiomer. The highest level of aggregated exposure to d-carvone is estimated to be 0.60 mg/kg bw/day, i.e. is at the level of the ADI established for d-carvone. The highest level of aggregated exposure to l-carvone is three-fold that of d-carvone. In view of key uncertainties 1) on the toxicity of l-carvone, 2) on the biological relevance of the endpoint selected to establish the ADI for d-carvone and its use as a surrogate for the observed lethality in tested animals, 3) whether d-and l-carvone should be considered together for possible combined effects and 4) in the aggregated exposure assessments to d-and to l-carvone, the Scientific Committee recommended generating additional data to refine the current risk assessment. In order to improve coherence regarding the risk assessment of carvone in the different food and feed sector areas of the European Food Safety Authority, EFSA asked its Scientific Committee to 1) establish a single ADI for carvone to be used at European level, regardless of the food sector area, and considering all previous evaluations, 2) estimate the overall exposure of European consumers to the carvone resulting from its various uses, and 3) quantify the contribution for each source of exposure to the overall exposure of carvone. Having reviewed the data available and the previous assessments done, the Scientific Committee decided to address d-carvone and l-carvone separately and limit its assessment to the oral intake of d-and l-carvone. In view of an expected request for extending the application of d-carvone as an anti-sprouting agent to ware and starch potatoes; the Scientific Committee decided to include also this use in its assessment.The Scientific Committee considered the data available for d-carvone and selected the liver effects as the most likely relevant endpoint to be used as the basis for risk assessment. The Scientific Committee established an ADI of 0.6 mg/kg bw/day for d-carvo...

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Section: Interpretation Of the Terms Of Referencementioning

confidence: 72%

Section: Exposure Assessmentmentioning

confidence: 99%

Section: Estimated Exposure To D-and L-carvone From Orally-used Persomentioning

confidence: 99%

Section: Estimated Exposure To D-and L-carvone From Orally-used Persomentioning

confidence: 99%

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Scientific Opinion on the safety assessment of carvone, considering all sources of exposure

2014

EFSA Journal

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“…Since the beginning of civilization, cosmetics have been included in daily body care, not only by the upper class of society, but also by the middle and lower classes [1].…”

Section: Brief History Of the Use Of Cosmetic Productsmentioning

confidence: 99%

An Overview of Trials´Accreditation and Recognition of Brazilian Tests Used for the Safety Evaluation of Cosmetic Products

Almeida

2016

Cosmetics

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For some time, Brazil has been appointed as one of the greatest consumers of cosmetic products in the world. Although cosmetics may seem harmless, destined exclusively to enhance personal appearance or to clean and protect the skin, hair and nails, new studies and events are highlighting the need to evaluate the safety of such products. The present work interrelated the lifecycle of a cosmetic product with the safety trials and tests applicable to some cycle phases. From this information, a survey was made of accredited Conformity Assessment Bodies (CAB) and test facilities recognized by the General Coordination for Accreditation (CGCRE) which are competent respectively to carry out safety trials and tests of cosmetics. Twenty five competent laboratories were identified to carry out chemical and/or biological trials of cosmetics, according to the legislation ABNT ISO IEC 17025:2005, and 10 test facilities recognized by the Compliance Monitoring Program that can carry out tests of the development of a product for register purposes, aiming at human health and safety. It is interesting to notice that Brazil has accredited laboratories to carry out trials that are critical for the health of the population, such as the levels of heavy metals and the presence of pathogens. On the other hand, CGCRE does not have a program to recognize safety clinical trials. The importance of this kind of study is understood, considering the world history of adverse reactions and the great consumption of cosmetics in the country.

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Toxicology of Cosmetics

Santamaria,

Hirani,

Kozal

et al. 2023

Patty's Toxicology

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Cosmetics are personal care products that are designed to be applied to the body for the purpose of cleaning, protecting, beautifying, and producing a healthy appearance or altering appearance without changing the body's physiology. The seven categories of cosmetics include oral, skin, sun, hair, and body care products, as well as decorative cosmetics and perfumes. There are millions of cosmetic products in the marketplace, and new products are constantly introduced. Cosmetic products are not subjected to premarket evaluation and approval like food or drug products by the federal government in the United States (US). However, some states are implementing laws and regulations that are specific to cosmetic products. For example, California is the first state to ban specific ingredients from being included in any cosmetic product manufactured or sold in the state. Further, unlike in the US, preregistration of cosmetics is required in the European Union (EU). Specifically, before cosmetic products are placed or made available on the EU market, responsible persons must submit specific product information to the Cosmetic Product Notification Portal (CPNP), which then makes this information available to EU authorities and poison control centers. This chapter reviews the history of cosmetics, types of cosmetics and ingredients, contaminants in cosmetics, cosmetic ingredients of concern and prohibited ingredients, exposure assessment approaches, regulation of cosmetics in the US and in the EU, global approaches to nonanimal testing for cosmetic products, and the development and application of new approach methods (NAMs) for next generation risk assessment (NGRA) of cosmetic ingredients.

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European consumer exposure to cosmetic products, a framework for conducting population exposure assessments

Cited by 135 publications

References 8 publications

Scientific Opinion on the safety assessment of carvone, considering all sources of exposure

Scientific Opinion on the safety assessment of carvone, considering all sources of exposure

An Overview of Trials´Accreditation and Recognition of Brazilian Tests Used for the Safety Evaluation of Cosmetic Products

Toxicology of Cosmetics

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