Advances in Regulatory and Technological Aspects of Cosmetics

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

Deadline for manuscript submissions: closed (25 December 2022) | Viewed by 53721

Special Issue Editors


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Guest Editor
Department of Pharmacy, Pharmacology and Health Technologies, Faculty of Pharmacy, University of Lisbon, 1649-003 Lisbon, Portugal
Interests: cosmetics; topical delivery systems; biocompatible excipients; rheology; in vitro characterization; in vivo studies; dermal availability; regulatory aspects; safety

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Guest Editor
Research Institute for Medicines (iMed.ULisboa), Universidade de Lisboa, 1649-003 Lisbon, Portugal
Interests: transdermal/topical systems; skin delivery; cosmetic formulations; 3D printing; quality-by-design
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Special Issue Information

Dear Colleagues,

In recent years, we have witnessed several changes in the regulatory framework of cosmetics. The demands around the quality, safety, and efficacy of these products have been increasing. However, there is a paradigm that is worth debating: taking into account the definition of a cosmetic product described in worldwide legislation, cosmetics only have to act at the level of the upper layers of the epidermis. However, cosmetic skin delivery has a very important impact on the action of cosmetics. Meanwhile, it also brings safety issues and the customization of national laws and regulations. Scientific and technology advances currently used by the cosmetic industry, namely nano-ingredients, nanoencapsulation techniques or even the presence of skin enhancers into formulations, can lead certain cosmetic ingredients to reach other layers of the skin, keeping them out the scope of the definition of cosmetics. Therefore, formulation development, efficacy, and safety studies as well as regulatory aspects should be updated and scienced based.

This Special Issue is of great relevance since it proposes to highlight the current problems of the regulations based on science and technology. We encourage submissions on formulation development and characterization, innovations in cosmetics ingredients, and analytical, in silico/in vitro/in vivo evaluation methods on delivery pathways available to cosmetic molecules. Papers on the laws and regulations of various countries on cosmetics are particularly welcome, as well as the prospect of novel permeation enhancement technologies.

It is our pleasure to invite you to submit a manuscript to this Special Issue. Full papers, communications, and reviews are welcome.

Dr. Helena Ribeiro
Dr. Joana Marques Marto
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 submissions that pass pre-check are 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 semimonthly 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 1800 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

  •  regulatory aspects
  •  topical delivery systems
  •  formulation and technologies in cosmetics development
  •  formulation characterization
  •  cosmetic nanosystems
  •  new ingredients
  •  safety studies
  •  sensory profiling
  •  dermal delivery
  •  borderline products
  •  analytical methods
  •  in silico/in vitro/in vivo safety and efficacy testing of cosmetics

Published Papers (7 papers)

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Research

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15 pages, 3015 KiB  
Article
Compounds in Indonesian Ginger Rhizome Extracts and Their Potential for Anti-Skin Aging Based on Molecular Docking
by Shadila F. Asoka, Irmanida Batubara, Ayu Rahmania Lestari, Wulan Tri Wahyuni and Setyanto Tri Wahyudi
Cosmetics 2022, 9(6), 128; https://0-doi-org.brum.beds.ac.uk/10.3390/cosmetics9060128 - 01 Dec 2022
Cited by 2 | Viewed by 2912
Abstract
Skin aging is a condition caused by reactive oxygen species (ROS) and advanced glycation end products (AGEs). Indonesian gingers (Zingiber officinale), which consists of Gajah (GG), Red (MM), and Emprit (EE) ginger, are thought to produce anti-skin aging compounds through enzyme [...] Read more.
Skin aging is a condition caused by reactive oxygen species (ROS) and advanced glycation end products (AGEs). Indonesian gingers (Zingiber officinale), which consists of Gajah (GG), Red (MM), and Emprit (EE) ginger, are thought to produce anti-skin aging compounds through enzyme inhibition. The enzymes used in the molecular docking study were collagenase, hyaluronidase, elastase, and tyrosinase. This study aimed to determine the compounds contained in Indonesian ginger rhizome ethanolic extracts using liquid chromatography–mass spectrometry/mass spectrometry to differentiate metabolites contained in the different Indonesian ginger rhizome extracts. A principal component analysis (PCA) and a heat map analysis were used in order to determine which compounds and extracts contained potential anti-skin aging properties based on a molecular docking study. Ascorbic acid was used as a control ligand in the molecular docking study. Ninety-eight compounds were identified in three different ginger rhizomes extracts and were grouped into three separate quadrants. The most potent compound for anti-skin aging in the Indonesian ginger rhizome extracts was octinoxate. Octinoxate showed a high abundance in the EE ginger rhizome extract. Therefore, the EE ginger extract was the Indonesian ginger rhizome extract with the greatest potential for anti-skin aging. Full article
(This article belongs to the Special Issue Advances in Regulatory and Technological Aspects of Cosmetics)
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11 pages, 290 KiB  
Article
Study Design on the Presence of Metals in Moisturisers, and Compliance with Regulation (EC) No. 1223/2009 of the European Parliament and of the Council of the European Union, on Cosmetic Products
by Iria Rujido-Santos, Paloma Herbello-Hermelo, María Carmen Barciela-Alonso, Pilar Bermejo-Barrera and Antonio Moreda-Piñeiro
Cosmetics 2022, 9(4), 82; https://0-doi-org.brum.beds.ac.uk/10.3390/cosmetics9040082 - 04 Aug 2022
Cited by 2 | Viewed by 2393
Abstract
Metals are present in cosmetics due to deliberate addition by the manufacturers, contamination of raw materials, and/or contamination during their manufacture or storage. The objective of this work was to explore the metal content in the most-consumed moisturising creams on the Spanish market, [...] Read more.
Metals are present in cosmetics due to deliberate addition by the manufacturers, contamination of raw materials, and/or contamination during their manufacture or storage. The objective of this work was to explore the metal content in the most-consumed moisturising creams on the Spanish market, to verify their degree of compliance with Regulation (EC) No. 1223/2009 of the European Parliament and of the Council of the European Union, regarding the presence of metals in cosmetics. The moisturisers were digested (microwave-assisted acid digestion) and analysed by inductively coupled plasma-mass spectrometry (ICP-MS), for metal assessment. The ICP-MS measurements were successfully validated (RSDs lower than 5% and analytical recoveries within the 91–110% range). Metals banned in cosmetics were found at very low concentrations in some of the moisturisers, as inevitable traces of pollutants. This was the case with beryllium (found in only two samples, at concentrations lower than 0.10 µg g−1), cadmium (found at 0.075 µg g−1 in one sample), mercury (found in four samples at concentrations within the 0.10–0.18 µg g−1 range), and lead (also found in four samples at concentrations from 0.03 to 0.44 µg g−1). Furthermore, nickel (0.16–0.56 µg g−1, six samples), chromium (0.09–0.30 µg g−1, three samples), and cobalt (lower than 0.13 µg g−1, two samples) were also found in the analysed creams. Full article
(This article belongs to the Special Issue Advances in Regulatory and Technological Aspects of Cosmetics)
10 pages, 3102 KiB  
Article
Strategy to Avoid Skin Sensitization: Application to Botanical Cosmetic Ingredients
by Mickaël Puginier, Alicia Roso, Hervé Groux, Cédric Gerbeix and Françoise Cottrez
Cosmetics 2022, 9(2), 40; https://0-doi-org.brum.beds.ac.uk/10.3390/cosmetics9020040 - 05 Apr 2022
Cited by 2 | Viewed by 3772
Abstract
Assessment of skin sensitization potential is mandatory for ingredients dedicated to topical applications. A battery of in vitro tests covering the key steps of the Adverse Outcome Pathway (AOP) for skin sensitization has been recommended to replace animal testing. However, despite international guidelines [...] Read more.
Assessment of skin sensitization potential is mandatory for ingredients dedicated to topical applications. A battery of in vitro tests covering the key steps of the Adverse Outcome Pathway (AOP) for skin sensitization has been recommended to replace animal testing. However, despite international guidelines on in vitro methods, there is no universal approach defining their combination. The purpose of this work was to assess skin sensitization of botanical ingredients relying on a previously developed in vitro testing strategy. This tool focused on complex and poorly water-soluble substances, which were not already covered. Sixteen botanical extracts were tested in a sequential approach, starting with Sens-Is, supplemented by Organization for Economic Cooperation and Development (OECD) in vitro methods when necessary. The results on the selected well-known botanical sensitizers complemented the relevance of the strategy. Testing on experimental botanicals could detect skin sensitizers. In addition, phytochemistry was a determining support to identify and remove the components at the origin of the effect. Altogether, these results enlarged the scope of the methodology to various ingredient categories and chemical natures, contributing to place on the market new ingredients, safe for workers and end-users. Full article
(This article belongs to the Special Issue Advances in Regulatory and Technological Aspects of Cosmetics)
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12 pages, 275 KiB  
Article
Analysis of Fluoride Concentration in Toothpastes in the United Arab Emirates: Closing the Gap between Local Regulation and Practice
by Ammar Abdulrahman Jairoun, Sabaa Saleh Al-Hemyari, Moyad Shahwan, Obaida Jairoun and Sa’ed H. Zyoud
Cosmetics 2021, 8(4), 113; https://0-doi-org.brum.beds.ac.uk/10.3390/cosmetics8040113 - 30 Nov 2021
Cited by 4 | Viewed by 4500
Abstract
Background: While there is much scientific evidence supporting the benefits of fluoride for oral health, the concentration of fluoride in over-the-counter fluoride toothpaste should meet United Arab Emirates (UAE) regulations of a fluoride concentration not exceeding 0.15%. Objectives: The current study examines the [...] Read more.
Background: While there is much scientific evidence supporting the benefits of fluoride for oral health, the concentration of fluoride in over-the-counter fluoride toothpaste should meet United Arab Emirates (UAE) regulations of a fluoride concentration not exceeding 0.15%. Objectives: The current study examines the fluoridated toothpaste products available on the UAE market and aims to quantify their total fluoride content. Methods: A total of 50 toothpaste products were collected and analyzed in this study. Ion Chromatography (IC) conductivity analysis was performed to determine the total fluoride content. Results: Among the 50 products tested, 10 exceeded the recommended concentration of total fluoride of less than 0.15%, while 12 had a total fluoride concentration that was less than was declared on their labels. Moreover, this study has revealed that 22 of the sampled products had a total fluoride concentration below 1000 ppm fluoride. An increased risk of higher total fluoride content was observed in the toothpaste products with monofluorophosphate active ingredients than in products with potassium nitrate/sodium fluoride and sodium fluoride (p = 0.011). Conclusions: There is a need to reassess the effectiveness of current regulations in the UAE to ensure that all fluoridated toothpastes available on the market are safe and effective for the consumer. Specifically, appropriate guidelines should be established on the basis of the risks and benefits inherent in fluoride exposure. Moreover, fluoridated toothpastes need to be subject to stricter monitoring and control regarding their safety and quality through good manufacturing practices (GMPs), education, research, and adverse event reporting. Full article
(This article belongs to the Special Issue Advances in Regulatory and Technological Aspects of Cosmetics)

Review

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22 pages, 1102 KiB  
Review
Cell-Based Model Systems for Validation of Various Efficacy-Based Claims for Cosmetic Ingredients
by Prachi Singh, Shruthi S. Bhat, Nikhil Singh, Babu U. Venkanna, Rafiq Mohamed and Raghavendra P. Rao
Cosmetics 2022, 9(5), 107; https://0-doi-org.brum.beds.ac.uk/10.3390/cosmetics9050107 - 18 Oct 2022
Cited by 5 | Viewed by 5322
Abstract
Cosmetic formulations have evolved significantly over the years. These are no longer viewed merely as beauty-enhancing products. Rather, they are expected to deliver additional benefits to the skin that positively affect the skin health. There is a renewed interest in using herbal extracts [...] Read more.
Cosmetic formulations have evolved significantly over the years. These are no longer viewed merely as beauty-enhancing products. Rather, they are expected to deliver additional benefits to the skin that positively affect the skin health. There is a renewed interest in using herbal extracts and herbal ingredients in cosmetic products since they offer several advantages over synthetic ingredients. Evaluating the cosmetic ingredients for their efficacy and safety is critical during product development. Several regulatory bodies impose restrictions on using animals for testing these ingredients in cosmetic products. This has increased the need for developing novel cell-based or cell-free biological assays. The current article systematically presents in-vitro/cell-based and/or cell-free strategies for validating the efficacies of cosmetic ingredients for skin health and hair growth. The article focuses on details about various assays for the anti-acne effects, hair-growth-promoting activities, anti-aging activities, skin-rejuvenating properties, wound-healing effects, and skin-depigmentation activities of natural ingredients in cosmetic formulations. Full article
(This article belongs to the Special Issue Advances in Regulatory and Technological Aspects of Cosmetics)
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27 pages, 1302 KiB  
Review
A State-of-the-Art Review on the Alternatives to Animal Testing for the Safety Assessment of Cosmetics
by Rita José Silva and Slobodanka Tamburic
Cosmetics 2022, 9(5), 90; https://0-doi-org.brum.beds.ac.uk/10.3390/cosmetics9050090 - 29 Aug 2022
Cited by 14 | Viewed by 16507
Abstract
Almost a decade after the stipulated deadline in the 7th amendment to the EU Cosmetics Directive, which bans the marketing of animal-tested cosmetics in the EU from 2013, animal experimentation for cosmetic-related purposes remains a topic of animated debate. Cosmetic industry continues to [...] Read more.
Almost a decade after the stipulated deadline in the 7th amendment to the EU Cosmetics Directive, which bans the marketing of animal-tested cosmetics in the EU from 2013, animal experimentation for cosmetic-related purposes remains a topic of animated debate. Cosmetic industry continues to be scrutinised for the practice, despite its leading role in funding and adopting innovation in this field. This paper aims to provide a state-of-the-art review of the field on alternative testing methods, also known as New Approach Methodologies (NAMs), with the focus on assessing the safety of cosmetic ingredients and products. It starts with innovation drivers and global regulatory responses, followed by an extensive, endpoint-specific overview of accepted/prospective NAMs. The overview covers main developments in acute toxicity, skin corrosion/irritation, serious eye damage/irritation, skin sensitisation, repeated dose toxicity, reproductive toxicity/endocrine disruption, mutagenicity/genotoxicity, carcinogenicity, photo-induced toxicity, and toxicokinetics. Specific attention was paid to the emerging in silico methodology. This paper also provides a brief overview of the studies on public perception of animal testing in cosmetics. It concludes with a view that educating consumers and inviting them to take part in advocacy could be an effective tool to achieve policy changes, regulatory acceptance, and investment in innovation. Full article
(This article belongs to the Special Issue Advances in Regulatory and Technological Aspects of Cosmetics)
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15 pages, 295 KiB  
Review
Overview of Cosmetic Regulatory Frameworks around the World
by Mariana Ferreira, Ana Matos, Ana Couras, Joana Marto and Helena Ribeiro
Cosmetics 2022, 9(4), 72; https://0-doi-org.brum.beds.ac.uk/10.3390/cosmetics9040072 - 30 Jun 2022
Cited by 13 | Viewed by 16873
Abstract
To ensure safety and efficacy, cosmetic products are regulated and controlled worldwide. However, the regulatory approaches of each country may be significantly different and impact the competitiveness and economic viability of the industry. This work presents an updated review and comparison of regulatory [...] Read more.
To ensure safety and efficacy, cosmetic products are regulated and controlled worldwide. However, the regulatory approaches of each country may be significantly different and impact the competitiveness and economic viability of the industry. This work presents an updated review and comparison of regulatory requirements from the European Union, United States of America, Canada, Japan, People’s Republic of China and Brazil. It outlines contents such as the definition, classification and categorization of cosmetics, pre-market requirements, ingredients management, general labelling requirements, regulation of claims concerning advertisement and commercial practices, increase of animal testing and marketing bans on cosmetic products. Furthermore, it weighs the impact of regulatory differences on the safety and accessibility of these products in the mentioned regions. Full article
(This article belongs to the Special Issue Advances in Regulatory and Technological Aspects of Cosmetics)
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