Nanotechnology in cosmetics

Nanomaterials are being used in cosmetic products for various effects. However, their use also raises potential safety concerns. Some of these concerns can be addressed by determining the type of nanomaterials used, as well as stability, potential for skin absorption, route of exposure, and how they are formulated in cosmetic products. There has been considerable effort internationally to harmonize approaches in order to address definitional issues and safety concerns related to the use of nanomaterials in cosmetic products.     

A review of quality surveillance projects on cosmetics in Taiwan

The Food and Drug Administration in Taiwan is responsible for the quality regulation and control of cosmetics. In order to have a clear understanding of the trends in the product quality monitoring outcomes and the regulatory control measures over the past years, this study has put together the reports of nine cosmetic surveillance projects conducted between 1982 and 2012. The findings can be used as a reference in developing a more solid quality monitoring plan and management system for cosmetic products. Results show that permanent wave products, hair dye products, and phthalate esters in cosmetic products have the highest average noncompliance rates at 39.2%, 14.2%, and 11.2%, respectively. These are followed by the average noncompliance rates of mercury in products, sunscreen products, and microorganisms in products, at 8.5%, 7.1%, and 5.5%, respectively, and the remaining three projects averaging below 4.1%. Since 1997, when new standards were announced and assistance to manufacturers was reinforced, the noncompliance rates of permanent wave products decreased annually, until 2007, when it was fully qualified for the standards. Overall, the study showed that the noncompliance rates of permanent wave products and for levels of phthalate esters, mercury, and hydroquinone in cosmetic products have all decreased in the previous years. The results of surveillance projects conducted after 2005 revealed only one noncompliance sample with lead, arsenic, and cadmium, whereas the surveillance projects on permanent wave products and chloroform- and 1,4-dioxane-containing products revealed full compliance with regulation standards. However, the noncompliance rates for microorganisms in cosmetics and the ingredients in hair dye products and sunscreen products were still high. These high-risk products must be monitored. These surveillance projects are conducted to ensure the safety of cosmetics in the market.     

超高效液相色谱法测定化妆品中15种防晒剂含量

目的 建立同时测定化妆品中各种防晒剂含量的方法.方法 2019年1—4月,采用超高效液相色谱法同时测定化妆品中15种防晒剂含量,样品使用四氢呋喃和混合溶液[V(甲醇):V(四氢呋喃):V(水):V(高氯酸)=250:450:300:0.2]提取后测定,以CORTECSTM UPLC?C18(1.6μm,2.1 mm×1...     

重组人皮肤模型在化妆品皮肤刺激性评价中的应用研究

目的 探讨重组人皮肤模型应用于化妆品体外皮肤刺激性评价的可行性.方法 以重组人皮肤模型(EpiSkinTM)为受试模型,在对10个已知刺激性分类的标准化学品进行方法验证的基础上,再根据化妆品的使用特性对23个产品进行皮肤刺激性分类评价,其中6个基础型化妆品和10个美容型化妆品暴露18 h、7个清洁型化妆品分别暴露18、...     

Assessment of embryotoxicity of compounds in cosmetics by the embryonic stem cell test

The new EU legislations for cosmetics (Seventh Amendment) have laid down deadlines for the replacement of animal tests in cosmetics. This policy stimulates the acceptance of in vitro approaches to test embryotoxic potentials of compounds in cosmetics products. The embryonic stem cell test (EST) designed by The European Centre for the Validation of Alternative Methods (ECVAM) is currently the most promising in vitro assay to predict the embryotoxic potential of compounds. In this study, six selected compounds (hydroquinone, eugenol, dibutyl phthalate, antimony (III) oxide, neodymium (III) nitrate hydrate, melamine) formerly involved in cosmetic products were selected to test their embryotoxic potentials by the EST. 5-Fluorouracil and penicillin G were separately set as positive and negative control. The embryotoxic potential was determined by the prediction model (PM), which was calculated from three endpoints, the IC₅₀ 3T3, IC₅₀ ES, and ID₅₀. Hydroquinone, eugenol, and antimony (III) oxide indicated with strong embryotoxicity, while dibutyl phthalate, neodymium (III) nitrate hydrate, and melamine exhibited a weak embryotoxicity. These results may provide a valuable attempt to expand the application of EST to the cosmetics field.     

Toxic metals contained in cosmetics: A status report

The persistence of metals in the environment and their natural occurrence in rocks, soil and water cause them to be present in the manufacture of pigments and other raw materials used in the cosmetic industry. Thus, people can be exposed to metals as trace contaminants in cosmetic products they daily use. Cosmetics may have multiple forms, uses and exposure scenarios, and metals contained in them can cause skin local problems but also systemic effects after their absorption via the skin or ingestion. Even this, cosmetics companies are not obliged to report on this kind of impurities and so consumers have no way of knowing about their own risk. This paper reviewed both the concentration of metals in different types of cosmetics manufactured and sold worldwide and the data on metals’ dermal penetration and systemic toxicology. The eight metals of concern for this review were antimony (Sb), arsenic (As), cadmium (Cd), chromium (Cr), cobalt (Co), mercury (Hg), nickel (Ni) and lead (Pb). This was because they are banned as intentional ingredients in cosmetics, have draft limits as potential impurities in cosmetics and are known as toxic.     

Mercury content in marketed cosmetics: analytical survey in Shijiazhuang,China

Context: Mercury is one of the skin-lightening ingredients in cosmetics as mercury ions are thought to inhibit the synthesis of the skin pigment melanin in melanocyte cells.

Objective: The objective of this study was to evaluate the mercury levels of cosmetics currently marketed in Shijiazhuang, a northern city in China.

Methods: We collected 146 random cosmetic samples and analyzed for mercury concentrations or levels by cold vapor atomic absorption spectrometry.

Results: Among the 146 samples, 134 (91.8%) were positive for mercury, and the concentrations of mercury ranged from not detectable to 592?ng/g. Cosmetic samples for children and babies had the highest detection rate (100%), followed by shampoo and hair conditioner (92.3%) and skin-lightening cream (92.0%). All of them were lower than the acceptable limit (1?μg/g) in China.

Discussion and conclusions: Cosmetics for skin had the highest mean mercury content (45?ng/g), followed by hair products (42.1?ng/g). The concentrations of mercury detected in samples were lower than the current legal limit in China, indicating it may not pose a risk to consumers.     

HPLC法测定祛痘类化妆品中的过氧化苯甲酰

目的建立高效液相色谱法测定祛痘除螨类化妆品中的过氧化苯甲酰的方法。方法采用ZORBAX C18柱,4．6×250mm．5μm;以甲醇-0．02mol·L^-1的醋酸铵溶液（80：20）为流动相;检测波长为230nm。结果过氧化苯甲酰在0．224μg·mL^-1～44．8μg·mL^-1范围内呈良好线性关系,r=0．9996．过氧化苯甲酰的平均回收率为95．94％．RSD％为2．5％。结论上述建立的方法简便易行、准确、重现性好,可用于祛痘类化妆品中禁用物质过氧化苯甲酰的检测。     

A tiered approach to the use of alternatives to animal testing for the safety assessment of cosmetics: Eye irritation

The need for alternative approaches to replace the in vivo rabbit Draize eye test for evaluation of eye irritation of cosmetic ingredients has been recognised by the cosmetics industry for many years. Extensive research has lead to the development of several assays, some of which have undergone formal validation. Even though, to date, no single in vitro assay has been validated as a full replacement for the rabbit Draize eye test, organotypic assays are accepted for specific and limited regulatory purposes. Although not formally validated, several other in vitro models have been used for over a decade by the cosmetics industry as valuable tools in a weight of evidence approach for the safety assessment of ingredients and finished products. In light of the deadlines established in the EU Cosmetics Directive for cessation of animal testing for cosmetic ingredients, a COLIPA scientific meeting was held in Brussels on 30th January, 2008 to review the use of alternative approaches and to set up a decision-tree approach for their integration into tiered testing strategies for hazard and safety assessment of cosmetic ingredients and their use in products. Furthermore, recommendations are given on how remaining data gaps and research needs can be addressed.     

山东省国产非特殊用途化妆品网上备案情况分析

目的：分析山东省国产非特殊用途化妆品网上备案情况,为化妆品监管工作提供技术参考。方法对2014年7月至2015年12月国产非特殊用途化妆品网上备案申请及完成数量进行统计,归纳备案主要问题,并提出相应建议。结果与结论加大备案政策法规的宣贯力度,加强事后监管,规范备案工作,促进企业自律发展。     

综合护理干预在皮肤激光美容治疗中的应用效果

目的：探讨综合护理干预在皮肤激光美容治疗中的应用效果。方法选取2012年6月~2014年6月在本院接受激光美容手术的96例患者作为研究对象,随机分为两组。对照组给予常规护理,观察组给予综合护理干预。比较两组的焦虑评分、不良反应发生率、患者满意度评分、半年复发率。结果两组护理后的焦虑评分显著低于护理前,差异有统计学意义(P<0.05)。观察组护理后的焦虑评分显著低于对照组护理后,差异有统计学意义(P<0.05)。观察组的患者满意度评分显著高于对照组,差异有统计学意义(P<0.05)。观察组的不良反应发生率、半年复发率显著低于对照组,差异有统计学意义(P<0.05)。结论综合护理干预在激光美容治疗中的应用效果显著,可显著缓解患者的焦虑情绪,降低不良反应发生率及复发率,提高护理满意度。     

Human health safety evaluation of cosmetics in the EU: A legally imposed challenge to science

As stated in the European legislation, cosmetic products present on the European market must be safe for the consumer. Safety evaluation of the products is carried out by a qualified safety assessor who needs to consider potential exposure scenarios next to the physicochemical and toxicological profiles of all composing ingredients. Whereas, until recently, the tools to determine the toxicological profile of cosmetic ingredients mainly consisted of animal experiments, they have now been narrowed down substantially by the legally imposed animal testing ban on cosmetic ingredients, taken up in the Cosmetic Products Directive (76/768/EEC). This Directive, however, is not a stand-alone piece of European legislation, since as well directly as indirectly it is influenced by a complex web of related legislations. Vertical legislations deal with different categories of chemicals, including dangerous substances, biocides, plant protection products, food additives, medicinal products, and of course also cosmetics. Horizontal legislative texts, on the contrary, cover more general fields such as protection of experimental animals, consumer product safety, misleading of consumers, specific provisions for aerosols, and others. Experience has learnt that having a general overview of these related legislations is necessary to understand their impact on the cosmetic world in general terms and on cosmetic safety evaluation in particular. This goes for a variety of concerned parties, including national and European regulators/agencies, contract laboratories, raw material suppliers, cosmetic companies, research and educational centers. They all deal with a number of aspects important for the quality and toxicity of cosmetics and their ingredients.This review summarises the most relevant points of the legislative texts of different types of product categories and emphasises their impact on the safety evaluation of cosmetics.     

A simple capture-release strategy based on an instantly formed mixed metal hydroxide sorbent for determination of salicylic acid in cosmetics

We present a simple eco-friendly extraction-release strategy for enhancing the assessment of salicylic acid (SA) in cosmetic samples. Given that the extraction and the formation of mixed metal hydroxides (MMHs) acting as sorbent occurred at the same time, the in situ solid phase extraction (is-SPE) of SA was achieved by mixing magnesium and aluminium ions in an alkaline sample solution. After the is-SPE, the MMHs precipitates were isolated by centrifugation and dissolved completely in sulfuric acid. Subsequently, the released SA was quantified by spectrophotometry at 237 nm. The is-SPE parameters including the amount of hydroxide ions, amount of metal ions, extraction time, and centrifugation time were studied thoroughly. Under the optimized conditions, this method provided the linear range of 0.15–2 mg L^?1 with the relative standard deviations of less than 7.20% and the limit of detection of 45 μg L^?1. In addition, the proposed method was successfully applied for SA analysis in toner, foam, and serum samples with reasonable relative recoveries in the range of 76.3–100.3%. This method eliminated the use of organic solvents and avoided the synthesis step of sorbents as well as their characterization, thus saving time, chemicals, and energy.     

Are natural compounds used in personal care products toxic for the aquatic environment?

Natural substances are frequently used ingredients in personal care products. As the discharge of rinse-off products, like shampoos or soap, is mainly via the aquatic environment, the question is, whether these natural substances pose an environmental risk. More than a quarter of the natural substances which are listed in the “Inventory …… of ingredients employed in cosmetic products” (INCI list) are classified as dangerous for the environment with long lasting effects according to the European regulation on classification and labelling, e.g. various Citrus preparations, Cupressus sempervirens extract, Picea excelsa extract or Pinus sylvestris leaf extract. Some of the components responsible for the classification of natural substances as dangerous for the environment are e.g. limonene, pinenes or benzyl benzoate. Classification and labelling is a trigger for the registration requirements for natural substances according to the European regulation on chemicals (REACH), but so far only 5% of natural substances classified are registered. It must be assumed that there are more substances that should undergo the REACH process among the 703 natural substances that do not yet turn up in the data base of substances classified and labelled as hazardous (C&L inventory). Natural substances and personal care products receive special treatments in the European chemical legislation. The compilation of the classifications might question whether this special treatment is justified.     

化妆品新分类方法在行政许可检验结果分析中的应用

目的 探索《化妆品分类规范》中的分层分类方法在化妆品检验结果分析中的提示作用。方法 按《化妆品分类规范》对2012年至2017年企业委托的行政许可检验化妆品进行分层分类,并对不同类别化妆品检验结果进行分析。结果 滋养类和膏霜剂型产品送检量最多,宣称修复功能、油剂类产品的不合格率最高,膏霜剂型、保湿功能产品不合格批次最多。微生物不合格产品水剂较多,毒理学不合格主要是油剂类和膏霜乳液类产品。结论 新分层分类方法更利于追溯化妆品的安全风险点,在化妆品监管过程中,可根据不同剂型、功能宣称、使用部位、适用人群化妆品的不合格风险差别,指导监管重点以及监督检验项目的制定。     

The benefits of the 3T3 NRU test in the safety assessment of cosmetics: long-term experience from pre-marketing testing in the Czech Republic

We have introduced the 3T3 NRU cytotoxicity test for methodological, economical and ethical reasons as a regular part of tier pre-marketing testing to assess local tolerance of raw materials for cosmetics, household chemicals and final cosmetic products. Using the 3T3 cell line according to the standard INVITTOX protocol No.64 (NRU Assay) the borderline concentration, relevant to the highest tolerated dose, is determined for each material. The toxic effect is reached at different concentration levels specific for individual cosmetics categories, depending on their chemical characteristics. Typical ranges of cytotoxicity for specific categories of cosmetics were established after testing of hundreds of materials. The range lies between 1 μg/ml (anti-dandruff shampoos), up to 2000 μg/ml (toothpastes and mouthwashes). The 3T3 NRU cytotoxicity test is a sensitive tool able to identify more agressive products, that are also more likely to evoke irritation in human skin. It was even possible to detect protective effects of one natural herbal ingredient. The comparative study of cytotoxicity test results and human patch test results from a group of essential oils is presented. Cytotoxicity tests represent a highly ethical approach for estimation of irritancy. On the basis of in vitro test results suggesting low risk we can proceed to confirmatory tests in human volunteers.     

A tiered approach to the use of alternatives to animal testing for the safety assessment of cosmetics: Skin irritation

Evaluation of the skin irritancy and corrosivity potential of an ingredient is a necessity in the safety assessment of cosmetic ingredients. To date, there are two formally validated alternatives to the rabbit Draize test for skin corrosivity in place, namely the rat skin transcutaneous electrical resistance (TER) assay and the Human Skin Model Test using EpiSkin™, EpiDerm™ and SkinEthic™ reconstructed human epidermal equivalents. For skin irritation, EpiSkin™, EpiDerm™ and SkinEthic™ are validated as stand-alone test replacements for the rabbit Draize test. Data from these tests are rarely considered in isolation and are evaluated in combination with other factors to establish the overall irritating or corrosive potential of an ingredient. In light of the deadlines established in the Cosmetics Directive for cessation of animal testing for cosmetic ingredients, a COLIPA scientific meeting was held in Brussels on 30th January, 2008 to review the use of alternative approaches and to set up a decision tree approach for their integration into tiered testing strategies for hazard and safety assessment of cosmetic ingredients and their use in products. In conclusion, the safety assessments for skin irritation/corrosion of new chemicals for use in cosmetics can be confidently accomplished using exclusively alternative methods.     

2021年山东省委托生产的化妆品注册人、备案人检查发现的问题及建议

《化妆品监督管理条例》颁布实施后,明确了化妆品注册人、备案人的概念,化妆品注册人、备案人组织化妆品生产的重要形式为委托生产。本文以我省开展的化妆品注册人、备案人检查情况为数据支撑,就《条例》实施新背景下,对委托生产的化妆品注册人、备案人在制度执行中存在的问题进行了统计分析,并就如何做好风险管控提出了建议。     

Quantitative analysis of fragrance allergens in various matrixes of cosmetics by liquid–liquid extraction and GC–MS

Fragrances are the most common chemicals in cosmetics to which people expose every day. However, the unwanted allergic reactions such as contact dermatitis caused by direct contact with fragrances may happen. In Directive 2003/15/EC of the EU, cosmetic product containing one or more of 26 fragrance allergens must be declared on the package label. In addition, commission regulation (EU) 2017/1410 amending Annexes II and III of cosmetic regulation 1223/2009 restricted fragrance chemical of methyl eugenol, and prohibited Lyral, atranol, chloroatranol to be used in cosmetic. In this study, an efficient and sensitive GC–MS method for 3 banned fragrances, 26 fragrance allergens along with restricted methyl eugenol in cosmetics was established. Sample preparation by liquid–liquid extraction was developed by testing various solvent systems to simplify traditional complex extraction methodologies. Validation of the proposed method showed good linearities in a wide concentration ranges of 0.1–10 μg/mL. The intra-day and inter-day recoveries were between 84.4 and 119% with coefficient of variation (CV) below 13.5%. The limit of quantifications (LOQs) of 27 fragrance allergens were in the range of 2–20 μg/g. A surveillance study consisted with 82 cosmetics was conducted, among which 31 products claimed fragrance-free. The results showed some fragrance-free claims were false. In the other hand, there were seven cosmetics labeled containing Lyral, but only four were detected. The top fragrance allergens detected in the samples were linalool, limonene, and geraniol. The analysis of fragrance allergens in cosmetics indicated that potential contact allergy related to these products should be considered, even though some fragrance allergens were from natural extracts, such as oak moss absolute.