Special Issue "Cosmetic Safety: Ingredients, Type of Reactions, Undesirable Effects, Cosmetovigilance"

A special issue of Cosmetics (ISSN 2079-9284).

Deadline for manuscript submissions: closed (31 May 2016)

Special Issue Editors

Guest Editor
Prof. Dr. Lidia Sautebin

Department of Pharmacy, University of Naples Federico II, Via Montesano 49, 80131 Naples, Italy
Website | E-Mail
Phone: +39 081678427
Interests: cosmetic safety, undesirable effects, cosmetovigilance, gender-dependent inflammation
Guest Editor
Dr. Immacolata Caputo

Department of Pharmacy, University of Naples Federico II, Via Montesano 49, 80131 Naples, Italy
E-Mail
Phone: +39 081678426

Special Issue Information

Dear Colleagues,

Cosmetic products are very popular and their use continues to increase because consumers consider physical appearance important and, at the same time, they consider cosmetics as safe products. However, in spite of safety and tolerability of cosmetics, we have become aware that undesirable effects can occur. Although cosmetic undesirable effects are generally of mild to moderate severity and seriousness involving primarily the skin, recent studies have described more severe and serious reactions. In particular, an increase of allergic reactions, potentially related to the use of cosmetics, has been recently observed. Therefore the field of application of a Cosmetovigilance system is also to identify the causative ingredients/products which can represent a risk for consumer’s health through the collection, evaluation and monitoring of spontaneous reports of undesirable events observed during or after normal or reasonably foreseeable use of a cosmetic product. The final aim is the adoption of appropriate corrective measures in order to maintain the protection of health and safety of cosmetic users by reducing the likelihood of recurrence of serious undesirable effects. Therefore, the aim of this Special Issue is to provide an overview on Cosmetic safety with particular regard to ingredients, type of reactions and undesirable effects (cosmetovigilance).

Prof. Dr. Lidia Sautebin
Dr. Immacolata Caputo
Guest Editors

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All papers will be peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Cosmetics is an international peer-reviewed open access quarterly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 350 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • allergens
  • cosmetic ingredients
  • cosmetic products
  • cosmetic safety
  • cosmetovigilance
  • skin reactions
  • systemic reactions
  • serious undesirable effects
  • undesirable effects

Published Papers (8 papers)

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Editorial

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Open AccessEditorial Editorial on Special Issue “Cosmetic Safety: Ingredients, Type of Reactions Undesirable Effects, Cosmetovigilance”
Received: 7 February 2017 / Revised: 7 February 2017 / Accepted: 7 February 2017 / Published: 8 February 2017
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Abstract
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

Research

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Open AccessFeature PaperCommunication Cosmetics Europe Guidelines on the Management of Undesirable Effects and Reporting of Serious Undesirable Effects from Cosmetics in the European Union
Received: 6 October 2016 / Revised: 17 November 2016 / Accepted: 28 November 2016 / Published: 3 January 2017
Cited by 1 | PDF Full-text (382 KB) | HTML Full-text | XML Full-text
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
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Open AccessArticle Packaging Evaluation Approach to Improve Cosmetic Product Safety
Received: 17 June 2016 / Revised: 31 August 2016 / Accepted: 31 August 2016 / Published: 5 September 2016
Cited by 2 | PDF Full-text (2296 KB) | HTML Full-text | XML Full-text
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
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Open AccessArticle Experiences and Statistical Evaluation of Serious Undesirable Effects of Cosmetic Products in the EU
Received: 30 May 2016 / Revised: 29 June 2016 / Accepted: 7 July 2016 / Published: 18 July 2016
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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
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Open AccessArticle An Overview of Trials´Accreditation and Recognition of Brazilian Tests Used for the Safety Evaluation of Cosmetic Products
Received: 8 April 2016 / Revised: 8 June 2016 / Accepted: 13 June 2016 / Published: 21 June 2016
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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
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Open AccessArticle High Performance Liquid Chromatography Tandem Mass Spectrometry Measurement of Bimatoprost, Latanoprost and Travoprost in Eyelash Enhancing Cosmetic Serums
Received: 11 December 2015 / Accepted: 4 February 2016 / Published: 6 February 2016
Cited by 1 | PDF Full-text (497 KB) | HTML Full-text | XML Full-text
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
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Open AccessArticle Microbiologically Contaminated and Over-Preserved Cosmetic Products According Rapex 2008–2014
Received: 25 December 2015 / Revised: 21 January 2016 / Accepted: 25 January 2016 / Published: 30 January 2016
Cited by 10 | PDF Full-text (190 KB) | HTML Full-text | XML Full-text
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

Other

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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
Received: 31 March 2016 / Revised: 21 June 2016 / Accepted: 2 July 2016 / Published: 11 July 2016
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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
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