Review of the standards of proof (of safety) for FDA regulated consumer products and how the generally recognized as safe criteria could be applied to cosmetics.

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) amends the Food, Drug and Cosmetic Act (FDCA), elevating the standard of proof of safety (better known as a "safety standard") for cosmetics to the standard of a "reasonable certainty … [of] … safe."a standard equal to that of food ingredients. The standards of the proof of safety differ for various classes of FDA-regulated product categories e.g., cosmetics, dietary supplements, food ingredients and food itself. This manuscript describes the various standards of proof, the essential differences between the standards, key elements required to achieve a particular standard and, compares the standards to more familiar legal terms such as "a preponderance of the evidence" or "beyond reasonable doubt." The standards of proof for these product categories are also ranked according to increasing threshold for achievement of "safe" status. Lastly, this manuscript suggests how the requirements for the high standard of a "reasonable certainty of safe" (or "reasonable certainty of no harm") might be met.

Cosmetic Contact Lenses in the United Kingdom: Assessment of Online Regulation and Quality of Consumer Health Information.

OBJECTIVES: To determine the compliance of online vendors to the UK Opticians Act 1989 Section 27 requirements and safety regulations for cosmetic contact lens (CCL) sales and the quality of online CCL health information. METHODS: The top 50 websites selling CCLs on each three search engines, namely Google, Yahoo, and Bing, were selected. Duplicates were removed, and the remaining websites were systematically analyzed in February 2023. UK legal authorization for CCL sales was assessed using the Opticians Act Section 27 and safety regulations determined by the presence of Conformité Européene (CE) marking. The quality and reliability of online information was graded using the DISCERN (16-80) and JAMA (0-4) scores by two independent reviewers. RESULTS: Forty-seven eligible websites were analyzed. Only six (12.7%) met the UK legal authorization for CCL sales. Forty-nine different brands of CCLs were sold on these websites, of which 13 (26.5%) had no CE marking. The mean DISCERN and JAMA benchmark scores were 26 ± 12.2 and 1.3 ± 0.6, respectively (intraclass correlation scores: 0.99 for both). CONCLUSIONS: A significant number of websites provide consumers with easy, unsafe, and unregulated access to CCLs. Most online stores do not meet the requirements set out in the Opticians Act for CCL sales in the United Kingdom. A significant number of CCLs lack CE marking, while the average quality of information on websites selling CCLs is poor. Together, these pose a risk to consumers purchasing CCLs from unregulated websites, and therefore, further stringent regulations on the online sales of these products are needed.

Paving the way for application of next generation risk assessment to safety decision-making for cosmetic ingredients.

Next generation risk assessment (NGRA) is an exposure-led, hypothesis-driven approach that has the potential to support animal-free safety decision-making. However, significant effort is needed to develop and test the in vitro and in silico (computational) approaches that underpin NGRA to enable confident application in a regulatory context. A workshop was held in Montreal in 2019 to discuss where effort needs to be focussed and to agree on the steps needed to ensure safety decisions made on cosmetic ingredients are robust and protective. Workshop participants explored whether NGRA for cosmetic ingredients can be protective of human health, and reviewed examples of NGRA for cosmetic ingredients. From the limited examples available, it is clear that NGRA is still in its infancy, and further case studies are needed to determine whether safety decisions are sufficiently protective and not overly conservative. Seven areas were identified to help progress application of NGRA, including further investments in case studies that elaborate on scenarios frequently encountered by industry and regulators, including those where a 'high risk' conclusion would be expected. These will provide confidence that the tools and approaches can reliably discern differing levels of risk. Furthermore, frameworks to guide performance and reporting should be developed.

The SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation, 11th revision, 30-31 March 2021, SCCS/1628/21.

The "SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation, 11 th Revision" (SCCS/1628/21) contains relevant and updated information on the different aspects of testing and safety evaluation of cosmetic substances in Europe. The emphasis is on cosmetic ingredients for which a concern has been expressed for human health. Indirectly, the Guidance also provides some advice on the safety of finished products. A general aim is to improve harmonised compliance with the current cosmetic EU legislation, Regulation (EC) No 1223/2009, for which animal testing and marketing bans fully apply from 2013 onwards. This means that no in vivo testing of ingredients or finished products is allowed in Europe for the purpose of cosmetics. For this reason, the SCCS has closely followed the progress made in regard to the development and validation of alternative replacement methods, also referred to as new approach methodology (NAM). The "SCCS Notes of Guidance" are regularly revised and updated in order to incorporate progress made and experience gained over time, in particular on the use of NAMs, and the new methods and data that became available since previous revision (SCCS/1602/18) formed the basis of the current (11 th) Revision.

Consumers' lack of understanding of customized cosmetics made on the spot and implications for regulations and controls.

Customized cosmetics immediately made on the spot are now in the market. The present study surveyed 1084 consumers to obtain general insights into their perceptions and perspectives on this novel type of cosmetic. Over half of the total respondents (57.2%) answered they were likely to purchase customized cosmetics; however, a large proportion of consumers also thought microbiological (59.2%)/chemical safety (69.4%) of cosmetics were not good. This reflects consumer anxiety regarding safety issues concerning the customized cosmetics. Even customized cosmetics are regulated by the cosmetic act in each country (i.e., the Cosmetic Act in the Republic of Korea, the Federal Food, Drug, and Cosmetic Act in the USA, and EC Cosmetic Regulation 1123/2009 in Europe), there have been no specific regulations for customized cosmetics made on the spot worldwide so far. To dispel consumer concerns and establish a principled market for the new cosmetics in the field, proper management plans should be established based on consumer surveys. This study indicated that consumers thought it was important to manage the facility/equipment and safety of raw materials (19.7%, each). We believe this study provides a valuable resource for understanding consumers' perceptions and requirements on customized cosmetics, which contributes to establishing future regulations and guidelines.

Beyond dermal exposure: The respiratory tract as a target organ in hazard assessments of cosmetic ingredients.

Dermal contact is the main route of exposure for most cosmetics; however, inhalation exposure could be significant for some formulations (e.g., aerosols, powders). Current cosmetic regulations do not require specific tests addressing respiratory irritation and sensitisation, and despite the prohibition of animal testing for cosmetics, no alternative methods have been validated to assess these endpoints to date. Inhalation hazard is mainly determined based on existing human and animal evidence, read-across, and extrapolation of data from different target organs or tissues, such as the skin. However, because of mechanistic differences, effects on the skin cannot predict effects on the respiratory tract, which indicates a substantial need for the development of new approach methodologies addressing respiratory endpoints for inhalable chemicals in general. Cosmetics might present a particularly significant need for risk assessments of inhalation exposure to provide a more accurate toxicological evaluation and ensure consumer safety. This review describes the differences in the mechanisms of irritation and sensitisation between the skin and the respiratory tract, the progress that has already been made, and what still needs to be done to fill the gap in the inhalation risk assessment of cosmetic ingredients.

Safety Assessment of Citrus Peel-Derived Ingredients as Used in Cosmetics.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 47 Citrus peel-derived ingredients, which are most frequently reported to function in cosmetics as skin conditioning agents. The Panel reviewed the available data to determine the safety of these ingredients. Because final product formulations may contain multiple botanical ingredients, each containing similar constituents of concern, formulators are advised to be aware of these constituents and to avoid reaching levels that may be hazardous to consumers. Industry should use good manufacturing practices to limit impurities that could be present in botanical ingredients. The Panel concluded that Citrus peel-derived ingredients are safe in the present practices of use and concentration in both rinse-off and leave-on cosmetic products when formulated to be non-sensitizing and non-irritating, provided that leave-on products do not contain more than 0.0015% (15 ppm) 5-methoxypsoralen (5-MOP).

Safety Assessment of Citrus Plant- and Seed-Derived Ingredients as Used in Cosmetics.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 30 Citrus plant- and seed-derived ingredients, which are most frequently reported to function in cosmetics as fragrances and/or skin conditioning agents. Because final product formulations may contain multiple botanicals, each containing similar constituents of concern, formulators are advised to be aware of these constituents and to avoid reaching levels that may be hazardous to consumers. With Citrus plant- and seed-derived ingredients, the Panel was concerned about the presence of the hydroperoxides of limonene and linalool in cosmetics. Industry should use good manufacturing practices to limit impurities. The Panel reviewed the available data presented and concluded that 18 of these ingredients are safe in the present practices of use and concentration when formulated to be non-irritating and non-sensitizing. The data for the remaining 12 ingredients are insufficient to determine safety.

Safety Assessment of Citrus Fruit-Derived Ingredients as Used in Cosmetics.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 80 Citrus fruit-derived ingredients, which are most frequently reported to function in cosmetics as fragrances and/or skin-conditioning agents. The Panel reviewed the available data to determine the safety of these ingredients. Because final product formulations may contain multiple botanicals, each containing similar constituents of concern, formulators are advised to be aware of these constituents and to avoid reaching levels that may be hazardous to consumers. Industry should use good manufacturing practices to limit impurities that could be present in botanical ingredients. The Panel concluded that these ingredients are safe for use in both rinse-off and leave-on cosmetic products when formulated to be non-sensitizing and non-irritating, provided that leave-on products do not contain more than 0.0015% (15 ppm) 5-methoxypsoralen (5-MOP).

Safety Assessment of Citrus Flower- and Leaf-Derived Ingredients as Used in Cosmetics.

The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) assessed the safety of 33 Citrus flower- and leaf-derived ingredients, which are most frequently reported to function in cosmetics as fragrances and/or skin-conditioning agents. The Panel reviewed the available data to determine the safety of these ingredients. Because final product formulations may contain multiple botanicals, each containing similar constituents of concern, formulators are advised to be aware of these constituents and to avoid reaching levels that may be hazardous to consumers. With Citrus flower- and leaf-derived ingredients, the Panel was concerned about the presence of the hydroperoxides of limonene and linalool in cosmetics. Industry should use good manufacturing practices to limit impurities that could be present in botanical ingredients. The Panel concluded that these ingredients are safe in the present practices of use and concentration when formulated to be non-irritating and non-sensitizing.

Consumer Safety Considerations of Skin and Oral Microbiome Perturbation.

Microbiomes associated with human skin and the oral cavity are uniquely exposed to personal care regimes. Changes in the composition and activities of the microbial communities in these environments can be utilized to promote consumer health benefits, for example, by reducing the numbers, composition, or activities of microbes implicated in conditions such as acne, axillary odor, dandruff, and oral diseases. It is, however, important to ensure that innovative approaches for microbiome manipulation do not unsafely disrupt the microbiome or compromise health, and where major changes in the composition or activities of the microbiome may occur, these require evaluation to ensure that critical biological functions are unaffected. This article is based on a 2-day workshop held at SEAC Unilever, Sharnbrook, United Kingdom, involving 31 specialists in microbial risk assessment, skin and oral microbiome research, microbial ecology, bioinformatics, mathematical modeling, and immunology. The first day focused on understanding the potential implications of skin and oral microbiome perturbation, while approaches to characterize those perturbations were discussed during the second day. This article discusses the factors that the panel recommends be considered for personal care products that target the microbiomes of the skin and the oral cavity.

Risk communication for labeling all ingredients in consumer products.

The labeling of all ingredients contained in consumer products has been requested by consumers concerned regarding their safety. Consequently, regulatory agencies have set guidelines for industries on how to provide safety information regarding the ingredients in their products. However, discordant opinions were raised from stakeholders, resulting in the formation of a risk communication forum among industries, regulatory agencies, consumer groups, and academia. There are several methods that might be utilized to provide ingredient information to consumers: (1) listing all ingredients on the label of products, (2) providing major ingredients on the label of products, (3) presenting all ingredients on the websites of each manufacturer, and (4) listing major ingredients on the label of products and the remainder of ingredients (not on the label) on the websites. Each method might have its own advantages and disadvantages with respect to providing the information regarding the names of the ingredients used in consumer products to the consumers. A continuous risk communication forum might be an effective tool to facilitate an improved understanding of chemical information, toxicological science, regulatory guidelines, labeling methods, and consumers' concern. This study suggests that risk communication efforts may be helpful and a good opportunity for stakeholders to exchange opinions and reach a harmonious conclusion on labeling of consumer products ingredients.

Hispanic/Latinos and Skincare: Disparities in Product Development, Marketing, and Toxicity.

“Hispanic” and “Latino” (also known as Mestizo) describe a diverse racial and ethnic group, with a range of cultures, languages, and biological ancestry. It includes individuals of Mexican, Central-to-South American, and Spanish-Caribbean (eg, Cuban, Puerto Rican, and Dominican) descent.1 Individuals of Hispanic/Latino race and ethnicity represent a heterogenous group of people with different skin tones and Fitzpatrick phototypes. Hispanic/Latinos are the fastest growing population in the United States (US) - projected to increase from 55 million in 2014 to 119 million in 2060, an increase of 115%.2 By 2060, more than one-quarter (29%) of the US is projected to be Hispanic/Latino.2.

Fatty Acid Composition of Cosmetic Argan Oil: Provenience and Authenticity Criteria.

In this work, fatty-acid profiles, including trans fatty acids, in combination with chemometric tools, were applied as a determinant of purity (i.e., adulteration) and provenance (i.e., geographical origin) of cosmetic grade argan oil collected from different regions of Morocco in 2017. The fatty acid profiles obtained by gas chromatography (GC) showed that oleic acid (C18:1) is the most abundant fatty acid, followed by linoleic acid (C18:2) and palmitic acid (C16:0). The content of trans-oleic and trans-linoleic isomers was between 0.02% and 0.03%, while trans-linolenic isomers were between 0.06% and 0.09%. Discriminant analysis (DA) and orthogonal projection to latent structure-discriminant analysis (OPLS-DA) were performed to discriminate between argan oils from Essaouira, Taroudant, Tiznit, Chtouka-Aït Baha and Sidi Ifni. The correct classification rate was highest for argan oil from the Chtouka-Aït Baha province (90.0%) and the lowest for oils from the Sidi Ifni province (14.3%), with an overall correct classification rate of 51.6%. Pairwise comparison using OPLS-DA could predictably differentiate (≥0.92) between the geographical regions with the levels of stearic (C18:0) and arachidic (C20:0) fatty acids accounting for most of the variance. This study shows the feasibility of implementing authenticity criteria for argan oils by including limit values for trans-fatty acids and the ability to discern provenance using fatty acid profiling.

A systematic review of global legal regulations on the permissible level of heavy metals in cosmetics with particular emphasis on skin lightening products.

BACKGROUND: There is an urgent need to address the safety problems caused by the use of skin lightening cosmetics. Evidence suggests that some of them may contain heavy metals. OBJECTIVES: We conducted a systematic review of global legal regulations regarding the permissible level of mercury, lead, arsenic, and cadmium in cosmetic products, with particular emphasis on skin lightening preparations. METHODS: The systematic search of documents was a two-stage process. First, official websites of 17 regional organizations and subsequently regulations for countries with a population over 100 million were searched. RESULTS: Fifteen legislative acts, encompassing more than 67·2% of the global population were reviewed. Regulations were identified for 44/59 high income countries, 16/55 upper middle income countries, 9/45 lower income countries, 0/34 low income countries. The median adult literacy rate was 91·4% and 64·2% in countries with and without regulations, respectively. The use of mercury, lead, arsenic, and cadmium has been banned in 67, 67, 65, and 65 out of 69 countries, respectively. CONCLUSIONS: While regulations exist in most of the high income countries, in low income countries there is a lack of similar standards. In most countries for which these legal regulations have been identified, restrictions on the permissible level of heavy metals are strict. There is a need for enforcement of existing rules, and rigorous assessment of the effectiveness of these regulations.

Health hazards of nanoparticles: understanding the toxicity mechanism of nanosized ZnO in cosmetic products.

In recent years, nanoparticles are being used extensively in personal healthcare products such as cosmetics, sunscreens, soaps, and shampoos. Particularly, metal oxide nanoparticles are gaining competence as key industrial constituents, progressing toward a remarkable rise in their applications. Zinc oxide and titanium oxide nanoparticles are the most commonly employed metal oxide nanoparticles in sunscreens, ointments, foot care, and over the counter topical products. Dermal exposure to these metal oxides predominantly occurs through explicit use of cosmetic products and airway exposure to nanoparticle dusts is primarily mediated via occupational exposure. There is a compelling need to understand the toxicity effects of nanoparticles which can easily enter the cells and induce oxidative stress. Consequently, these products have become a direct source of pollution in the environment and thereby greatly impact our ecosystem. A complete understanding of the toxicity mechanism of nano-ZnO is intended to resolve whether and to what extent such nanoparticles may pose a threat to the environment and to human beings. In this review article, we have discussed the characteristics of metal oxide nanoparticles and its applications in the cosmetic industry. We have also highlighted about their toxicity effects and their impact on human health.

Analysis of phthalate esters in two different baby care products available in United Arab Emirates.

Phthalates are used as plasticizers in a wide range of products and are known to affect the human health adversely. Hence, the present study was carried out to identify and quantify the presence of four phthalates namely dimethyl phthalate (DMP), dibutyl phthalate (DBP), and diethyl phthalate (DEP), di (2-ethylhexyl) phthalate (DEHP) in the two baby products i.e. baby oils and baby lotions. The daily exposure levels and hazard index of each phthalate were also calculated. It was an analytical study where two different brands of samples of baby oil and baby lotion each, from the date of manufacturing of 3, 10, and 20 months were collected. The extraction of phthalates from different samples was done and analyzed using HPTLC. Results showed the presence of all four phthalates, although some phthalates were not present in 3 M samples. The maximum concentration of all the phthalates was found in 20 M samples. Their concentration increased with the storage time indicating the possibility of leaching and migration of phthalates from the container into the product. The hazard indices for phthalates estimated for baby oil and baby lotion were found below 1, which denotes that the daily phthalate exposures are within the regulatory limits. It is important to consider that the exposure to phthalates can occur not only by dermal contact of these baby products but also through other routes. Hence, the study signifies the importance of phthalates concentration in such regularly used products.

[Mandatory regulations and standards regarding cosmetic botanic ingredients in major countries and regions].

Cosmetics containing botanic ingredients have been used from thousands of years up to now in China. Because of the consumers' demand for health and beauty,the number of products about " botanic" have been growing rapidly in the cosmetics market,which has played an important role in upgrading the industry and enhancing the international competitiveness nowadays. Therefore,to strengthen the management about used botanic raw materials in cosmetics products and revise the application regulation of new raw materials has become an important work to ensure product quality,promote the healthy and stable development of cosmetic business. The article summarizes the related mandatory regulations and standards about botanic ingredients which used as activity function in major cosmetic business countries or regions. Furthermore,the information of botanic ingredients commonly used in non-special cosmetics notification and special cosmetic registration system were described to expect the better application and development.

Cosmetic Versus Medicine: How Does Your Country Define Sunscreen?

Skin cancer (melanoma and non-melanoma) is the most commonly diagnosed cancer in the United States of America, and non-melanoma skin cancer is the most common cause of Australian hospitalisations with cancer as the principle diagnosis, having a huge cost to the country's health care system. Primary and secondary skin cancer prevention is globally inadequate, with only 3 in 10 American adults using sun protection routinely. Evidence suggests that regular sunscreen use in Australians prevents both melanoma and non-melanoma skin cancers, and American research has found that daily sunscreen use reduced the incidence of melanoma - the most skin cancer deaths - by half. Despite this, in many countries and regions around the world, a major ongoing divergence remains on the classification of sunscreen as either a cosmetic product or a form of medical therapy, which in turn affects the consumers' attitudes towards the use of sunscreen. This is also affected by the increasing use of the internet, which has made the purchasing of products internationally convenient and easy for consumers worldwide, including sunscreen products, which are frequently marketed online. There is variation between each country or region and their regulations of sunscreen affect the consequent labelling claims of sunscreen products. This affects the unsuspecting consumer's choices in purchasing sun protection, which may be misinformed. Australia, Canada, and the US are the only countries to classify sunscreen as a form of medical therapy. This paper explores the current classification of sunscreen products in countries and regions around the world and discusses the impact of these discrepancies and similarities on the attitudes of consumers towards sunscreen use. Finally, we make suggestions on changes that can be made to encourage sunscreen use and safe sunscreen purchasing. J Drugs Dermatol. 2018;17(8):899-904.

Application of Check-All-That-Apply (CATA) Questions for Sensory Characterization of Cosmetic Emulsions by Untrained Consumers.

The sales potential of cosmetic products is greatly determined by skin feel and skin sensory performance. To please the target audience, it is important to gather information about consumers' perception of products' sensory characteristics. In this study, six different emulsions were formulated. Samples represented three different types of emulsions, including steric-stabilized oil-in-water (O/W), liquid crystal-stabilized O/W, and water-in-oil emulsions, providing different skin feel and aesthetics. Emulsions within the same group differed in the emollients, providing similar sensory attributes. The aim was to have 50 consumers evaluate the emulsions' sensory characteristics. Using a check-all-that-apply (CATA) survey, consumers provided information about their perception of appearance, rub-out, pick-up, and afterfeel. Consumers effectively discriminated between the emulsions. Statistical analysis showed significant differences for 15 sensory attributes in the before, during, and after phases. Our findings suggest that emulsifiers, and not emollients, have the dominant role in determining the aesthetics of a skin care emulsion, similar to previous findings. The fact that untrained consumers provided similar results as trained panelists suggests the validity of the CATA survey and its reliability as a screening tool in the product development process. CATA questions may serve as a viable complimentary to descriptive sensory analysis performed by trained panelists.