Analysis of preservatives and fragrances in topical medical devices: The need for more stringent regulation.

INTRODUCTION: Medical devices (MDs) have a long history of use, and come with regulatory frameworks to ensure user safety. Although topically applied MDs in the form of gels and creams might be used on damaged skin, their composition is often similar to that of cosmetic products applicable to intact skin, especially in terms of preservatives and fragrances. However, unlike cosmetics, these products are not subject to compound-specific restrictions when used in MDs. OBJECTIVE: This study aimed to identify and quantify preservatives and fragrances in topically applied MDs and assess their safety towards the Cosmetic Regulation (EC) 1223/2009. METHOD: Sixty-nine MDs available on the EU market were subjected to previously validated liquid chromatography tandem mass spectrometry (LC-MS/MS) and gas chromatography-mass spectrometry (GC-MS) methods to identify and quantify occurring preservatives and fragrances. RESULTS: Findings revealed that 32% of the examined MDs did not provide comprehensive ingredient lists, leaving users uninformed about potential risks associated with product use. Furthermore, 30% of these MDs would not meet safety standards for cosmetic products and, most significantly, 13% of the analysed samples contained ingredients that are prohibited in leave-on cosmetics. CONCLUSION: Results highlight the pressing demand for more stringent requirements regarding the labelling and composition of MDs to enhance patient safety. Improved regulation and transparency can mitigate potential risks associated with the use of topically applied MDs.

Herbal nanocosmecuticals: A review on cosmeceutical innovation.

BACKGROUND: Cosmeceuticals are drugs, cosmetics, or a combination of both. Cosmeceuticals are personal care products that not only beautify but also need to have healing, therapeutic, and disease-fighting characteristics. For decades, phytocompounds have been employed in cosmeceuticals and have shown potential in applications such as moisturizing, sunscreen, antiaging, and hair-based therapy. The inability of phytocompounds to easily penetrate through the skin and their instability limit their usage in cosmetic products. This can be overcome by incorporating nanotechnology into cosmetic products for a more stable and long-lasting release. Nanotechnology's substantial impact on the cosmetics industry is due to the improved properties attained by particles at the nano scale, such as color, solubility, and transparency. Liposomes, solid lipid nanoparticles, niosomes, and many varieties of nanoparticulate systems are commonly used in cosmetics. Safety concerns for the usage of nanomaterials in cosmeceuticals have been raised lately, hence causing the restriction on the use of nanomaterials by cosmetic companies and enforcing laws demanding thorough safety testing prior to market entry. AIM: This review focuses on the types of nanomaterials used in phytocosmetics, along with the potential hazards they pose to human life and the environment, and what legislation has been enacted or can be enacted to address them. METHODS: For relevant literature, a literature search was conducted using PubMed, ScienceDirect, and Google Scholar. Nanotechnology, cosmeceuticals, herbal cosmetics, and other related topics were researched and evaluated in articles published between 2016 and 2022. RESULTS: Herbal drugs provide a tremendous range of therapeutic benefits. And when nanoparticles were introduced to the personal care industry, the quality of the final product containing phyto-compounds continued to rise. Unfortunately, because these nano components can permeate intact skin barriers and create unwanted consequences, this revolution comes with a slew of health risks. CONCLUSION: The cosmeceutical industry's expansion and growth in the application of herbal compounds, as well as the entrance of nanotechnology into the cosmeceuticals business, entail the urgent need for scientific research into their efficacy, safety profile, and use.

Continuing animal tests on cosmetic ingredients for REACH in the EU

EU cosmetic ingredients are governed by two regulations that conflict. Regulation EC 1223/2009, the Cosmetic Regulation, bans in vivo (animal) testing for cosmetic product safety assessments, including both final products and ingredients. At the same time, the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation can impose in vivo testing of those same ingredients under its chemical testing requirements. Here, we examined REACH dossiers for chemicals for which the only reported use is cosmetics to determine the extent of new in vivo testing caused by REACH. We found the REACH database has 3,206 chemical dossiers with cosmetics as a reported use. Of these, 419 report cosmetics as the only use, and 63 of these have in vivo tests completed after the Cosmetic Regulation ban on in vivo testing. Registrants largely used alternative, non-animal methods to evaluate ingredients for REACH, but some still conducted new in vivo tests to comply with REACH requirements for toxicity data and worker safety assessments. In some cases, ECHA, the agency that evaluates REACH dossiers, rejected registrants' alternative methods as insufficient and required new in vivo tests. As ECHA continues to evaluate dossiers, more requests for in vivo tests are likely. REACH tests on cosmetic ingredients appear only as "industrial chemicals legislation" tests in EU reports. Given the importance to consumers and the cosmetic industry of having cosmetics free of animal testing, the public should be made aware of REACH testing until the conflict between the regulations is resolved.

Safety evaluation of traces of nickel and chrome in cosmetics: The case of Dead Sea mud.

BACKGROUND: Metal impurities such as nickel and chrome are present in natural ingredients-containing cosmetic products. These traces are unavoidable due to the ubiquitous nature of these elements. Dead Sea mud is a popular natural ingredient of cosmetic products in which nickel and chrome residues are likely to occur. OBJECTIVE: To analyze the potential systemic and local toxicity of Dead Sea mud taking into consideration Dead Sea muds' natural content of nickel and chrome. METHODS: The following endpoints were evaluated: (Regulation No. 1223/20, 21/12/2009) systemic and (SCCS's Notes of Guidance) local toxicity of topical application of Dead Sea mud; health reports during the last five years of commercial marketing of Dead Sea mud. RESULTS AND CONCLUSIONS: Following exposure to Dead Sea mud, MoS (margin of safety) calculations for nickel and chrome indicate no toxicological concern for systemic toxicity. Skin sensitization is also not to be expected by exposure of normal healthy skin to Dead Sea mud. Topical application, however, is not recommended for already nickel-or chrome-sensitized persons. As risk assessment of impurities present in cosmetics may be a difficult exercise, the case of Dead Sea mud is taken here as an example of a natural material that may contain traces of unavoidable metals.