Editorial

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Open AccessEditorial

Editorial on Special Issue “Cosmetic Safety: Ingredients, Type of Reactions Undesirable Effects, Cosmetovigilance”

by Immacolata Caputo and Lidia Sautebin

Cosmetics 2017, 4(1), 8; https://doi.org/10.3390/cosmetics4010008 - 08 Feb 2017

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Regulation (EC) No 1223/2009 on cosmetic products (“Cosmetics Regulation”) [1] is the existing regulatory framework for finished cosmetic products placed on the European Union (EU) market.[...] Full article

(This article belongs to the Special Issue Cosmetic Safety: Ingredients, Type of Reactions, Undesirable Effects, Cosmetovigilance)

Research

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382 KiB

Open AccessCommunication

Cosmetics Europe Guidelines on the Management of Undesirable Effects and Reporting of Serious Undesirable Effects from Cosmetics in the European Union

by Gerald Renner, Francoise Audebert, Jens Burfeindt, Bénédicte Calvet, Madalina Caratas-Perifan, Martha Elena Leal, Roberto Gorni, Amanda Long, Emma Meredith, Úna O’Sullivan, Marc Paye, Clémentine Perriere and Kordula Schlotmann

Cosmetics 2017, 4(1), 1; https://doi.org/10.3390/cosmetics4010001 - 03 Jan 2017

Cited by 17 | Viewed by 16240

Abstract

The European Union (EU) Cosmetics Regulation (EC) No. 1223/2009 requires companies to collect and assess reports of adverse health effects from the cosmetic products (undesirable effects) they market. Furthermore, undesirable effects that are considered as serious need to be reported to the national [...] Read more.

The European Union (EU) Cosmetics Regulation (EC) No. 1223/2009 requires companies to collect and assess reports of adverse health effects from the cosmetic products (undesirable effects) they market. Furthermore, undesirable effects that are considered as serious need to be reported to the national competent authorities. Cosmetics Europe, representing the European cosmetics industry, has developed these guidelines to promote a consistent practical approach for the management of undesirable effects and the notification of serious undesirable effects. Following these guidelines allows companies concerned to demonstrate due diligence and compliance with the legal requirements. Full article

(This article belongs to the Special Issue Cosmetic Safety: Ingredients, Type of Reactions, Undesirable Effects, Cosmetovigilance)

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2296 KiB

Open AccessArticle

Packaging Evaluation Approach to Improve Cosmetic Product Safety

by Benedetta Briasco, Priscilla Capra, Arianna Cecilia Cozzi, Barbara Mannucci and Paola Perugini

Cosmetics 2016, 3(3), 32; https://doi.org/10.3390/cosmetics3030032 - 05 Sep 2016

Cited by 10 | Viewed by 11545

Abstract

In the Regulation 1223/2009, evaluation of packaging has become mandatory to assure cosmetic product safety. In fact, the safety assessment of a cosmetic product can be successfully carried out only if the hazard deriving from the use of the designed packaging for the [...] Read more.

In the Regulation 1223/2009, evaluation of packaging has become mandatory to assure cosmetic product safety. In fact, the safety assessment of a cosmetic product can be successfully carried out only if the hazard deriving from the use of the designed packaging for the specific product is correctly evaluated. Despite the law requirement, there is too little information about the chemical-physical characteristics of finished packaging and the possible interactions between formulation and packaging; furthermore, different from food packaging, the cosmetic packaging is not regulated and, to date, appropriate guidelines are still missing. The aim of this work was to propose a practical approach to investigate commercial polymeric containers used in cosmetic field, especially through mechanical properties’ evaluation, from a safety point of view. First of all, it is essential to obtain complete information about raw materials. Subsequently, using an appropriate full factorial experimental design, it is possible to investigate the variables, like polymeric density, treatment, or type of formulation involved in changes to packaging properties or in formulation-packaging interaction. The variation of these properties can greatly affect cosmetic safety. In particular, mechanical properties can be used as an indicator of pack performances and safety. As an example, containers made of two types of polyethylene with different density, low-density polyethylene (LDPE) and high-density polyethylene (HDPE), are investigated. Regarding the substances potentially extractable from the packaging, in this work the headspace solid-phase microextraction method (HSSPME) was used because this technique was reported in the literature as suitable to detect extractables from the polymeric material here employed. Full article

(This article belongs to the Special Issue Cosmetic Safety: Ingredients, Type of Reactions, Undesirable Effects, Cosmetovigilance)

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1064 KiB

Open AccessArticle

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

by Andreas Butschke, Astrid Droß, Katja Dünnebier, Ines Laube and Ariane Weiler

Cosmetics 2016, 3(3), 25; https://doi.org/10.3390/cosmetics3030025 - 18 Jul 2016

Cited by 6 | Viewed by 9562

Abstract

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 [...] Read more.

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. Full article

(This article belongs to the Special Issue Cosmetic Safety: Ingredients, Type of Reactions, Undesirable Effects, Cosmetovigilance)

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408 KiB

Open AccessArticle

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

by Luciana Dos Santos Almeida

Cosmetics 2016, 3(2), 20; https://doi.org/10.3390/cosmetics3020020 - 21 Jun 2016

Cited by 1 | Viewed by 9386

Abstract

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 [...] Read more.

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. Full article

(This article belongs to the Special Issue Cosmetic Safety: Ingredients, Type of Reactions, Undesirable Effects, Cosmetovigilance)

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497 KiB

Open AccessArticle

High Performance Liquid Chromatography Tandem Mass Spectrometry Measurement of Bimatoprost, Latanoprost and Travoprost in Eyelash Enhancing Cosmetic Serums

by Emilia Marchei, Daniela De Orsi, Carmine Guarino, Maria Concetta Rotolo, Silvia Graziano and Simona Pichini

Cosmetics 2016, 3(1), 4; https://doi.org/10.3390/cosmetics3010004 - 06 Feb 2016

Cited by 8 | Viewed by 9328

Abstract

Most common prostaglandin analogs, bimatoprost, latanoprost and travoprost, are licensed for the reduction of elevated intraocular pressure in patients with open angle glaucoma and ocular hypertension, but their non approved use as eyelash enhancers is becoming popular, especially in patients with eyelashes hypotrichosis. [...] Read more.

Most common prostaglandin analogs, bimatoprost, latanoprost and travoprost, are licensed for the reduction of elevated intraocular pressure in patients with open angle glaucoma and ocular hypertension, but their non approved use as eyelash enhancers is becoming popular, especially in patients with eyelashes hypotrichosis. A fast and sensitive high performance liquid chromatography tandem mass spectrometry method was developed for the measurement of bimatoprost, latanoprost and travoprost in cosmetic serums freely web-sold to increase eyelash length, thickness and darkness. The analytes and the internal standard (reserpine) were separated by reversed phase chromatography with 5 mM ammonium acetate with 0.02% formic acid (mobile phase A) and 5 mM ammonium acetate in acetonitrile/water (95/5; v/v) with 0.02% formic acid (mobile phase B) by gradient elution and detected with tandem mass spectrometry operated in multiple reaction monitoring mode. Linearity between 1 and 500 μg/g shows good correlation coefficients (r² = 0.99) for all substances. Analytical recovery of analytes under investigation were always higher than 90% and intra-assay and inter-assay precision and accuracy always better than 11%. This method was successfully applied to analyze cosmetic serums freely sold on the Internet websites. Full article

(This article belongs to the Special Issue Cosmetic Safety: Ingredients, Type of Reactions, Undesirable Effects, Cosmetovigilance)

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190 KiB

Open AccessArticle

Microbiologically Contaminated and Over-Preserved Cosmetic Products According Rapex 2008–2014

by Edlira Neza and Marisanna Centini

Cosmetics 2016, 3(1), 3; https://doi.org/10.3390/cosmetics3010003 - 30 Jan 2016

Cited by 56 | Viewed by 27928

Abstract

We investigated the Rapid Alert System (RAPEX) database from January 2008 until week 26 of 2014 to give information to consumers about microbiologically contaminated cosmetics and over-preserved cosmetic products. Chemical risk was the leading cause of the recalls (87.47%). Sixty-two cosmetic products (11.76%) [...] Read more.

We investigated the Rapid Alert System (RAPEX) database from January 2008 until week 26 of 2014 to give information to consumers about microbiologically contaminated cosmetics and over-preserved cosmetic products. Chemical risk was the leading cause of the recalls (87.47%). Sixty-two cosmetic products (11.76%) were recalled because they were contaminated with pathogenic or potentially pathogenic microorganisms. Pseudomonas aeruginosa was the most frequently found microorganism. Other microorganisms found were: Mesophilic aerobic microorganisms, Staphylococcus aureus, Candida albicans, Enterococcus spp., Enterobacter cloacae, Enterococcus faecium, Enterobacter gergoviae, Rhizobium radiobacter, Burkholderia cepacia, Serratia marcescens, Achromabacter xylosoxidans, Klebsiella oxytoca, Bacillus firmus, Pantoea agglomerans, Pseudomonas putida, Klebsiella pneumoniae and Citrobacter freundii. Nine cosmetic products were recalled because they contained methylisothiazolinone (0.025%–0.36%), benzalkonium chloride (1%), triclosan (0.4%) in concentrations higher than the limits allowed by European Regulation 1223/2009. Fifteen products were recalled for the presence of methyldibromo glutaronitrile, a preservative banned for use in cosmetics. Thirty-two hair treatment products were recalled because they contained high concentrations of formaldehyde (0.3%–25%). Full article

(This article belongs to the Special Issue Cosmetic Safety: Ingredients, Type of Reactions, Undesirable Effects, Cosmetovigilance)

Other

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205 KiB

Open AccessCase Report

Sensitization and Clinically Relevant Allergy to Hair Dyes and Clothes from Black Henna Tattoos: Do People Know the Risk? An Uncommon Serious Case and a Review of the Literature

by Paola A. Moro, Marco Morina, Fabrizia Milani, Marco Pandolfi, Francesca Guerriero and Luca Bernardo

Cosmetics 2016, 3(3), 23; https://doi.org/10.3390/cosmetics3030023 - 11 Jul 2016

Cited by 1 | Viewed by 8744

Abstract

Henna (Lawsonia inermis L.) tattooing has been used in Egypt and India since ancient times. Today this temporary body art is becoming increasingly popular among young people. Various chemicals are added to henna to darken and enhance the definition of tattoos, especially [...] Read more.

Henna (Lawsonia inermis L.) tattooing has been used in Egypt and India since ancient times. Today this temporary body art is becoming increasingly popular among young people. Various chemicals are added to henna to darken and enhance the definition of tattoos, especially para-phenylenediamine (PPD), which is a strong sensitizer known to cause cross sensitive reactions to azoic dyes and other para-amino compounds. We present the case of an 18-year-old girl who became clinically sensitive to textile dyes after having showed a serious reaction both to her first hair dying when she was 16 years old and following the application of a temporary henna tattoo when she was a kid. The evidence from our literature review showed 33 cases of manifest sensitization to hair dye and only one of observable contact allergy to both hair and textile dyes from henna tattoos. The sensitization of children may have long-life lasting consequences, because of cross-reaction to dyes and other chemicals contained in hair colourants, clothes and drugs. Since tattoos are very popular and globalization has increased the circulation of unauthorized products we point out the need for informative campaigns about the risk of sensitization caused by temporary tattoos. Full article

(This article belongs to the Special Issue Cosmetic Safety: Ingredients, Type of Reactions, Undesirable Effects, Cosmetovigilance)

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