Safety Of Cosmetic Products Research Articles

Evaluating the Efficacy of Cosmetic Product Safety Regulations in Malaysia: The Role of the National Pharmaceutical Regulatory Agency (NPRA) and Industry Compliance

Various legislative measures, such as the Sale of Drugs Act 1952, Control of Drugs and Cosmetics Regulations 1984, Poison Act 1952, Guidelines for Control of Cosmetic Products 2022, and other directives introduced by the NPRA in Malaysia, are intended to control the safety of cosmetic products. Despite these existing laws and directives, cosmetic products containing hazardous ingredients persist in the Malaysian market. NPRA reportedly received 1,041 complaints about cosmetic products in 2022, while its website also displays an annual increase in cases involving cosmetic products that contain hazardous ingredients. The persistent presence of harmful cosmetic products in the market highlights significant gaps in efforts to control hazardous cosmetic products. This study examined the efficacy of cosmetic product safety regulations in Malaysia, focusing on the role of the National Pharmaceutical Regulatory Agency (NPRA) and industry compliance. This qualitative study gathered data from library databases and conducted semi-structured interviews with NPRA officers, cosmetic manufacturers, and cosmetic industry experts. Findings suggest that despite the extensive nature of the regulatory framework, its implementation, which heavily relies on self-regulation and post-market surveillance, requires serious improvement. While some cosmetic producers adhere to Good Manufacturing Practice (GMP) standards, there are still persistent issues related to product notification, misuse of self-regulation, and inadequate penalties for non-compliance. Therefore, an intensive awareness campaign aimed at cosmetic manufacturers is necessary to ensure the production of safe cosmetic products. Consumers must play their role in helping the NPRA control the sale of hazardous cosmetic products by performing safety checks before purchasing them.

Evaluation of the Safety and Tolerability of Lumify Eye Illuminations Cosmetic Products.

Cosmetic products applied to the periocular area can cause skin sensitivity reactions, and manufacturers routinely test the safety and tolerability of products in development. This research was sponsored by Bausch + Lomb to evaluate three Lumify Eye Illuminations products: a lash and brow serum, a hydra-gel eye cream, and a micellar water eye makeup remover. A cumulative irritation test (CIT) study and a repeated insult patch test (RIPT) study enrolled adult males or females with no known sensitivities to cosmetic products. Three clinical safety studies enrolled adult females with self-reported characteristics targeted by each product, which was applied in a manner consistent with expected use for 8 or 12weeks. In CIT (n=34) and RIPT (n=201) studies, faint/minimal erythema reactions were observed in 0% to 2.9% of participants; there were no moderate or severe reactions. No safety signals were observed in participants who completed clinical safety studies for lash and brow serum (n=66 enrolled, n=55 completed [83%]), eye cream (n=61 enrolled, n=52 completed [85%]), or eye makeup remover (n=80 enrolled, n=68 completed [85%]). No clinically relevant changes in visual acuity or ophthalmologic slit-lamp examination findings were noted. No participants reported ocular sensations of burning/stinging, foreign-body sensation, or soreness. At the final clinical safety study assessment, mild cutaneous erythema (as graded by the investigator) was reported for one participant (eye cream study); no other prespecified signs of cutaneous irritation (eg, edema, dryness) were observed. A treatment-related adverse event that led to study discontinuation was experienced by one participant in the eye makeup remover study (bilateral periorbital swelling). Findings from rigorously conducted irritation testing and clinical safety studies indicated that these products were safe and well tolerated. Increased availability of data regarding ocular and cutaneous safety of cosmetic products can inform consumer decision-making and eye care provider recommendations.

Formulation and evaluation of medicated polyherbal tattoo ink

Transdermal tattoos offer a potential avenue for administering drugs externally into the dermis, resulting in the creation of a lasting mark. Analyzing complex samples is crucial to assess the presence of ingredients, ensuring the safety of cosmetic products that contribute to health protection. This investigation aims to formulate and assess tattoo ink for treating allergies and inflammation. The study proposes a comprehensive analytical approach, encompassing physical appearance, homogeneity, pH, spreadability, viscosity, and antibacterial evaluation to characterize samples of henna and annatto. Standardizing herbal formulations is imperative to evaluate drug quality based on the concentration of active principles. This paper focuses on the standardization of Henna (Lawsonia inermis Linn) from the Lythraceae family and Annatto from the plant Bixa Orellana. Annatto, known for its lower toxicity and improved biodegradability, can be extracted using water or organic solvents to obtain pigment, tocotrienol, and geranylgeraniol components. These compounds exhibit antibacterial activity, inhibit certain types of cancer, and demonstrate hypocholesterolemic effects, among other properties.

Cell based models for validation of safety of cosmetic products and ingredients

The use of cosmetic products has grown many folds in recent years. The consumer and regulatory bodies are more concerned about the hazardous outcome of these products on skin health. The development of alternative and effective safety assessment methodologies to avoid animal testing is an urgent need due to restrictions and ethical considerations set by various regulatory bodies such as OECD, COLIPA, and BIS. The new integrated approaches like in-vitro assays (Cell-based and Cell-free assays) are indispensable for assessing the safety of cosmetic products. In-vitro testing systems provide advantages over animal testing as they are more cost-effective, and less time-consuming. In this article, we present the details of some of the important invitro assays that are routinely used by different laboratories for validation of the safety of cosmetic ingredients.

Cosmetic Surveillance: An update and comprehensive Review

Surveillance has recently been expanded to include the safety of herbal and cosmetic products. A new phrase has emerged characterizing industry monitoring known as “Kosmetonadzor” to ensure the safety of cosmetic products. Wigan (1997) was the first in the literature to use the term to refer to the safety management of cosmetic products. It is now recognized as a public health concept worldwide. 
 As there is no systematic reporting system, side effects or side effects of cosmetics are relatively insignificant or overlooked. There is a follow-up management system for preparation. In India, market surveillance is usually focused on drug side effects. As a result, more emphasis has been placed on medical devices, blood products, biologics, natural products, and special diets, and less on related side effects. To sum up, Cosmetology refers to the monitoring of cosmetic products that have recently entered the market.
 Conclusions
 Cosmetic surveillance is a new approach to regulating the safety of cosmetic products. It is an important component of public health initiatives. As post-sale surveillance of cosmetics becomes more and more common worldwide, malfunctions in these items can be detected and corrected, so safety can be achieved. Physicians Family doctors and general practitioners play an important role in detecting ADRs caused by cosmetic items and, as a result, urge patients to report ADRs. Raising awareness of this new notion will be an important contribution to global public health. 
 In general, the Cosmetovigilance system can avoid both significant and minor adverse effects. Because the notification procedure is critical to the system, healthcare workers must be taught and supported as part of the Cosmetovigilance feedback system. Some regulation modifications are required to keep up with Turkey's developing cosmetics business.
 In general, cosmetic monitoring systems can prevent both serious and minor side effects. As the reporting process is a key element of the system, medical professionals must be educated and supported in terms of cosmetic oversight within the feedback system. Some regulatory updates are needed to keep pace with the changing Turkish cosmetics market.

Entrapment of magnetic nanoparticles into poly(divinylbenzene-co-N-vinylpyrrolidone) copolymer for the determination of prohibited and restricted fragrance ingredients in cosmetic products

In this work, a magnetic composite made by cobalt ferrite (CoFe2O4) magnetic nanoparticles entrapped into a poly(divinylbenzene-co-N-vinylpyrrolidone) copolymer is used to determine recently prohibited and restricted fragrances (i.e., Lilial, Lyral, and methyl-N-methylanthranilate) in cosmetics. This hydrophilic-lipophilic balance type material was characterized by magnetism measurements, scanning electron microscopy, nitrogen adsorption–desorption isotherms, and thermogravimetric analysis. The proposed method is based on stir bar sorptive dispersive microextraction (SBSDME) followed by gas chromatography coupled to mass spectrometry (GC–MS). The main quantitative parameters involved in the SBSDME were optimized by using a Box-Behnken design, whereas the desorption solvent was optimized by using a Simplex-Centroid design. Under the optimized conditions, good analytical features were obtained, showing good linearity (at least up to 200 ng mL−1), enrichment factors from 18 to 26, method limits of detection in the low µg/g range (0.01–0.1 µg g−1), and good intra- and inter-day repeatability (relative standard deviations below 10 %). Matrix effects were negligible as long as no more than 0.1 and 0.25 g of fat- and water-soluble samples, respectively, were weighed and diluted to 25 mL. Finally, the proposed method was successfully applied to three commercial cosmetic samples of different formulation, and quantitative relative recovery values (76–108 %) were obtained by external calibration. This work expands the analytical potential of SBSDME to the use of new magnetic polymer-based sorbents. In addition, it contributes to the availability of methods to ensure the safety of cosmetic products through quality control by means of a green methodology.

Analysis of Prohibited and Restricted Ingredients in Cosmetics

The general public uses cosmetics daily. Cosmetic products contain substances (ingredients) with various functions, from skincare to enhancing appearance, as well as ingredients that preserve the cosmetic products. Some cosmetic ingredients are prohibited or restricted in certain geographical regions, such as the European Union and the United States of America, due to their potential to cause adverse effects such as cancer, birth defects, and/or developmental and reproductive disorders. However, the ingredients may be used in other regions, and, hence, the monitoring of the cosmetic ingredients actually used is important to ensure the safety of cosmetic products. This review provides an overview of recent analytical methods that have been developed for detecting certain ingredients that are restricted or prohibited by the U.S. Food and Drug Administration (FDA) and/or EU legislation on cosmetic products.

Understanding the chemical and mineralogical composition of commercial henna and jagua tattoos and dyes—a multi-analytical approach

Temporary tattoos and dyes constitute a great analytical challenge in relation to the regulatory control of their ingredients. Most of these commercial products are not labeled according to their content and their chemical nature is highly diverse. Therefore, it is necessary to analyze these complex samples to evaluate the potential presence of metallic impurities, to ensure the safety of cosmetic products contributing to health protection. This study proposes a multi-analytical methodology, which includes handheld X-ray fluorescence (h-XRF) and X‐ray diffraction (XRD), complemented by variable pressure scanning electron microscopy coupled with energy-dispersive X‐ray spectrometry (VP-SEM–EDS) to fully characterize 34 commercial samples of jagua and henna tattoos and dyes. The approach allowed the identification of the main constituents providing complementary compositional data and differences between sample types were established. In addition, information on the degree of natural pigments homogeneity was also obtained. The results’ discussion considering the current European cosmetics regulation may be useful to support the drafting of safety requirements and specific regulation.

Innovative approaches in cosmetic testing, in compliance with European regulations

This collection includes the abstracts presented at the theoretical practical course “Innovative approaches in cosmetics in compliance with the European regulation” (Genoa, 22-23 June 2022). The course aims to provide an update on alternative methods to animal experimentation, in the context of risk assessment in the European cosmetology field, based on the new regulations establishing the total ban on animal experimentation for cosmetic purposes (EC Regulation No. 1223/2009). Such regulation improves the safety of cosmetic products in the EU by strengthening safety requirements, simplifies procedures for companies and competent authorities in the sector, updates the rules to take into account the latest technological developments such as the use of nanomaterials, and keeps the ban on animal testing in place. From this point of view, it is essential to offer the scientific basis of these regulations and updated information to students of scientific degrees, to contribute to the training of technicians/cosmetic industry, with interest to eco-sustainability. The course promotes the interdisciplinary collaboration between biologists, chemists and ecologists. The course has been organized by Centro3R, Interuniversity Center for the Promotion of the 3Rs Principles in Teaching and Research.

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.

TUPOKSI APOTEKER DALAM PENJAMINAN MUTU PRODUK KOSMETIK SESUAI KETENTUAN CPKB DI INDUSTRI FARMASI KOSMETIK

Cosmetics are a preparation or product for women and men that are used on the outside of the human body. The cosmetic industry implements an operational system in producing cosmetics by ensuring the quality and safety of cosmetic products to be produced. A cosmetic industry in producing cosmetics must comply with the standard requirements for the quality of cosmetic products that have been determined in accordance with the CPKB (Good C Manufacturing Practices). CPKB is a basic feasibility guideline according to the requirements aimed at making a cosmetic industry produce safe, useful and quality products. Pharmacists who work as QA (Quality Assurance) in the pharmaceutical industry for quality assurance of cosmetic products. The benefit of this article is the role of pharmacists in quality assurance of cosmetic products according to GCMP provisions in the cosmetic pharmaceutical industry. The purpose of this article is to determine the role of pharmacists in the quality assurance of cosmetic products contained in the GCMP. The method in this article is literature study using sources, guidelines, references regarding the main duties and functions of a pharmacist. Quality Assurance (QA) functions to ensure that product quality remains during the shelf-life to distribution processes, ensures that self-inspection or quality audits are in accordance with procedures, ensures suppliers of the starting materials used and the packaging are evaluated in accordance with the provisions in order to meet quality requirements. The task of pharmacists as quality assurance is to regulate the design, manufacture and development of products in accordance with applicable regulations, implement the product manufacturing process to comply with the provisions, ensure that the supply of materials, use of starting materials, manufacture and packaging are correct.

Harmonization of the National Legislation on Cosmetic Products in the Context of the Standardization of the European Legislation in the Field

Considering the concern of the European Union to implement an internal market for cosmetic products which also ensures a high level of human health protection and that cosmetics is one of the industrial activities in the EU affected by counterfeiting, which may increase the risks to human health, this article examines how European horizontal legislation is implemented in national law. This article aims to present the legal instruments created at EU level to consolidate the safety of cosmetic products and to strengthen the surveillance of the cosmetic products introduced on the market, but also to protect consumers, taking into account that in order to ensure an effective control of the market it is necessary to have a high degree of administrative cooperation between the competent authorities of the Member States. Moreover, the article aims to present the active role undertaken by the cosmetics industry in developing alternative testing methods within the Horizon 2020 Programme.

Profiling 58 compounds including cosmetic-relevant chemicals using ToxRefDB and ToxCast

Safety assessment for cosmetic-relevant chemicals (CRCs) in the European Union has been reshaped by restrictions on animal testing, and new approach methodologies (NAMs) for predicting toxicity are critical to ensure new cosmetic product safety. To demonstrate NAMs for safety assessment, we surveyed in vitro bioactivity and in vivo systemic toxicity data in the US Environmental Protection Agency's (EPA's) Toxicity Forecaster (ToxCast) and Toxicity Reference databases (ToxRefDB), respectively, for 58 chemicals identified as CRCs, including cosmetic ingredients as well as trace contaminants. CRCs were diverse in use types as suggested by broad chemical use categories. In terms of both target organ effects and study type, the median of the lowest effect level (LEL) doses in ToxRefDB for CRCs tended to be slightly higher than the median for the remaining 928 chemicals with study data in ToxRefDB, though the ranges of LELs were similar. For 17 of the 58 CRCs, high-throughput toxicokinetic data were used to calculate administered equivalent doses (AEDs) in mg/kg/day units for the in vitro bioactivity observed, and these AEDs served as conservative estimators of the systemic LELs observed in vivo. This work suggests that NAMs for bioactivity may inform a conservative point-of-departure estimate for diverse CRCs.

The efficacy of skin care products containing glutathione in delivering skin lightening in Indonesian women

Glutathione is a potent antioxidant, which is widely used in skin care products for skin lightening especially in the Asian market. Presently, there was only one study of topical 2% oxidized glutathione (GSSG) in Philipino women, further study is needed to evaluate the efficacy and safety of cosmetic products containing glutathione. A double blind randomized clinical trial study was conducted in Yogyakarta, Indonesia, in 74 healthy Indonesian women, with average age 33.3 ± 5.9 years when subjects participated in the study. Each subject received supervised applications of Facial Wash twice a day, Day Cream with sunscreen and Night Cream. The subjects were divided into 3 groups based on the active ingredients of the tested products, which included glutathione reduced (GSH) 0.1%, GSH 0.5%, and without GSH. The effects of the tested products in lightening skin color and pigmentation were measured colorimetry with Chromameter Minolta for L*. Compared to a baseline, there were significant increases of L* (lightness) or ΔL* detected as early as week 2 in which group of GSH 0.1% were significantly higher compared to group of GSH 0.5% and group without GSH. Hyperpigmented lesions also improved, where GSH 0.5% group showed its superiority compared to others groups in week 8. The undesired effect were few minutes mild tingling sensation after night cream, and worsening of acne in all tested products. Conclusion skin care products containing GSH 0.1% and 0.5% were effective in facial skin lightening.

Cosmetovigilance: A review of the current literature.

The term “pharmacovigilance” defines the activities related to the collection, detection, assessment, monitoring, and prevention of adverse reactions occurring with medications. Recently, the spectrum of “-vigilance” has broadened to include safety of herbal products and cosmetic products as well. “Cosmetovigilance” was introduced as a new term used for defining surveillance carried out by industry to address the safety of cosmetic products. It was first used in literature by Vigan (1997) to refer to the monitoring of cosmetic product safety. Today, it is recognized globally as a concept of public health. For this systematic review, a PubMed search was conducted in July 2018 for the term “cosmetovigilance.”

Kozmetički proizvodi i neinvazivne estetske procedure - bezbednost primene i preporuke za izbor tokom trudnoće i laktacije

Changes of the skin and skin appendages, which occur during pregnancy, are often the cause of discontentment and the reason why pregnant and breastfeeding women use numerous cosmetic products on the daily basis and show the interest for the different aesthetic procedures. Although safety of cosmetic products must be confirmed before the product is placed on the market, the fact is that their safety, as well as the safety of aesthetic procedures, is not estimated on pregnant or breastfeeding women. The selection of an appropriate product is further complicated by the absence of the list of allowed raw materials which should be considered during pregnancy and lactation, especially for substances that are known or potential endocrine disruptors or substances which are (potentially) toxic for the reproduction. Additionally, there are no official recommendations issued by the regulatory bodies or any healthcare associations, which would facilitate the selection of cosmetic products during pregnancy and breastfeeding and reduce the possible fear regarding the exposure of fetus/baby to unsafe ingredients. The paper provides an overview of the safety data of the specified cosmetic ingredients, different categories of cosmetic products and non-invasive aesthetic procedures, with an attempt to consolidate those data into the specific recommendations regarding selection and their usage during pregnancy and lactation.

DETERMINATION OF ZINC AND CADMIUM IN ANTI-DANDRUFF SHAMPOOS AVAILABLE AT THE LIBYAN MARKET BY ATOMIC ABSORPTION

The present study is carried out to measure zinc and cadmium in twenty samples of anti-dandruff shampoo products commercially available in the localcosmetic markets in Libya. Detection of zinc and cadmium were done by Flame Atomic Absorption Spectrophotometry (FAAS) method. The results showed that cadmium concentration ranged between 0.017 and 9.37 mg.kg−1 while zinc concentration ranged between 25.9mg kg−1and 8300mg.kg−1. These measurements indicated that cadmium and zinc contents in the investigated samples were higher than WHO limits; suggesting that chronological use of these shampoo products would impose serious health risks to human users. Therefore, quality control and concentration optimism should be implemented to assure the safety of cosmetic products. This also can be achieved by improving the processing and manufacturing practices in the industry.

Zašto je potrebna toksikološka procena rizika za kozmetički proizvod?

Bearing in mind that cosmetic products are applied throughout the lifetime and that they can contain potentially harmful and toxic substances, valid EU regulation in this area has set strict requirements regarding their safety. Manufacturers are required to provide a cosmetic product safety report containing a toxicological assessment made by experts. Toxicological assessment is based on existing in vivo toxicological data, and in particular in silico and in vitro, since EU regulations in the field of cosmetic products prohibit new animal studies. Although sporadic cases of serious poisoning after the application of cosmetic products have been recorded, adverse effects after normal and reasonably foreseeable use of cosmetic products are usually mild (allergic reactions and skin irritation) and completely reversible. EU regulations require mandatory reporting of serious adverse effects (functional incapacity, hospitalization, disability, etc.) in order to detect ingredients of cosmetic products that potentially endanger human health and prevent similar effects from recurred. The paper describes the procedure of toxicological risk assessment for cosmetic ingredients because the assessment of the safety of the cosmetic product is based on the assessment of the safety of its ingredients.

Mikrobiološka bezbednost kozmetičkih proizvoda i potencijalni rizici za potrošače

The European regulatory framework in the field of cosmetic products requires of manufacturers to provide an assessment of microbial limits tests and results of preservation challenge test, as well as microbiological stability data which should be documented in the cosmetic product safety report. During the development of a cosmetic product, it is necessary to consider the risk of microbiological contamination in the selection of starting cosmetic ingredients and packaging, manufacturing process, alongside with conditions of storage and use. The deviation of the microbiological quality of the cosmetic product from the manufacturer's specification presents a risk for consumers, especially if it is used around the eyes, on mucous membranes in general, on damaged skin or it is intented for use in specific groups of consumers (children under the age of 3, elderly people and immunocompromised persons).

Packaging Evaluation Approach to Improve Cosmetic Product Safety

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.