Department of Pharmaceutical Analysis, Raghu College of Pharmacy, Dakamarri – 531162, Visakhapatnam, Andhra Pradesh, India.
"The cosmetics and personal care products industry has witnessed unprecedented growth. However, beneath the glamour and allure of these products lies a web of toxic chemicals that pose significant risks to human health and the environment. Through a critical examination of existing literature, regulatory frameworks, and industry practices, this study aims to raise awareness about the potential dangers impending in everyday cosmetics and personal care products, using different evaluation techniques such as physical, chemical, microbiological testing, and several advanced instrumentation techniques such as spectroscopic and chromatographic methods for identification of moisture, volatile matter, heavy metals content, powder fineness, density, viscosity, toxic chemicals or carcinogens which are crucial for both raw materials and formulations, highlighting the importance of proper sample preparation and analytical techniques for accurate evaluation and compliance with regulatory standards. By shedding light on these issues, this review intends to promote awareness and evaluate the safety, efficacy, and quality of cosmetic products which is crucial to protect consumer health and prevent adverse reactions, ultimately advocating for stricter regulations, safer alternatives, and a more sustainable future.
Cosmetics derived from the term "Cosmetikos" meaning "the skill to decorate," are products applied to the body for beautifying, cleansing, or altering appearance. As per the Drugs and Cosmetics (D&C Act), cosmetics include makeup (lipstick, mascara, foundation), baby care products, skin care, dental products, personal hygiene items, shampoos, conditioners, and perfumes. Cosmetics like lipsticks, lip balms, and creams may contain heavy metals, either as colorants or impurities. These metals pose health risks through ingestion or skin absorption, often due to inadequate purification during manufacturing (1). Continuous use of cosmetics with high heavy metal concentrations can pose serious health risks, as metals like Zinc(Zn), Iron(Fe), Copper(Cu), Chromium(Cr), Cadmium(Cd), and Lead(Pb) may permeate the skin. These metals can cause conditions ranging from organ failure and cancer to developmental issues, dermatitis, and damage to kidneys and bones their presence in cosmetics raises significant safety and health concerns (2).
2.Toxicological Studies on Cosmetics:
Here are some case reports and studies related to toxicology concerns with herbal or artificial dyes in cosmetic products:
2.1 Artificial Dyes
Paraphenylenediamine (PPD) in Hair Dyes: PPD, a common ingredient in hair dyes, has been linked to skin irritation, allergic reactions, and even cancer. (3) Toluene-2,5-Diamine (PTD) in Hair Dyes: PTD, another common hair dye ingredient, has been associated with skin and eye irritation, as well as potential carcinogenic effects. (4) Red 3 (Erythrosine) in Cosmetics: Red 3, a synthetic dye used in some cosmetics, has been linked to thyroid tumors in animal studies. (5)
2.2 Herbal Dyes
Lawsonia inermis (Henna) Allergic Reactions: While henna is generally considered safe, some individuals may experience allergic reactions, including skin irritation and anaphylaxis. (6)
Indigofera tinctoria (Indigo) Toxicity: Indigo, a plant-based dye, has been associated with skin and eye irritation, as well as potential neurotoxic effects. (7) Berberis aristata (Berberine) Skin Irritation: Berberine, a plant-based dye, has been linked to skin irritation and allergic reactions in some individuals. (8)
2.3 Baby care products
Johnson & Johnson's Talcum Powder Lawsuits: Johnson & Johnson faced numerous lawsuits alleging that their talcum powder contained asbestos, which caused ovarian cancer and other health issues. Although the company denied the allegations, it announced the discontinuation of talc-based baby powder worldwide in 2022. (9)
Skin Irritation and Allergic Reactions: Some baby care products, such as those containing fragrances, dyes, or preservatives, can cause skin irritation and allergic reactions in infants. For instance, a study found that baby wipes containing certain chemicals can cause skin irritation and increase the risk of eczema (6). These cases highlight the importance of parents and caregivers being vigilant about the products they use on their babies. It's essential to choose products with natural ingredients, follow instructions carefully, and monitor for any signs of adverse reactions (9).
Toxic Ingredients in Cosmetics
One notable lawsuit was filed in 2013, which alleged that nearly 100 hair care and personal care products contained cocamide diethanolamine (cocamide DEA), a known carcinogen. The lawsuit targeted major retailers like Walmart, Target, and Babies R Us (10)
Chemicals and Toxic Cosmetics
Certain chemicals used in cosmetics, such as phthalates, imidazolidinyl urea, and parabens, have raised health concerns. These chemicals have been linked to hormonal issues, allergic reactions, and other health problems (11,12).
3. Regulatory Guidelines for Cosmetics:
These evaluation procedures help ensure the safety and efficacy of chemicals in cosmetics, protecting human health and the environment.
OECD guidelines: Following guidelines set by the Organisation for Economic Co-operation and Development (OECD) for testing chemicals (13).
FDA guidelines: Adhering to guidelines set by the US Food and Drug Administration (FDA) for cosmetic testing.
ISO standards: Complying with International Organization for Standardization (ISO) standards for cosmetic testing(14).
GLP standards: Following Good Laboratory Practice (GLP) standards for laboratory testing (15).
Specific BIS Standards for Cosmetic Products:
The Bureau of Indian Standards (BIS) sets quality and safety standards for cosmetics in India under Indian Standards (IS).
The study of quality and analysis methods for raw materials in cosmetic manufacturing, as per the Bureau of Indian Standards (BIS), focuses on ensuring the safety and efficacy of ingredients. It includes various analytical techniques and quality control measures to assess the suitability of raw materials used in cosmetic products.
Types of raw materials used in cosmetic manufacture
Water: The most widely used raw material, serving as a solvent for many ingredients.
Preservatives: Essential for preventing microbial growth and extending shelf life
Humectants: Help retain moisture in products.
Surfactants: Used for cleansing and emulsifying properties.
Oils, Fats & Waxes: Provide texture and moisturizing benefits.
Perfumes: Added for fragrance.
Colors: Used to enhance the visual appeal of products(18).
Evaluation Of Cosmetic Products:
Figure 1: Flow chart showing different evaluation tests for cosmetic products
4.1 General Method of Analysis:
4.1.1 Physical Testing:
Determination of Moisture:
Determining moisture content in cosmetic raw materials is vital for product quality and stability. Moisture affects shelf life, texture, and microbial stability. Ovens provided a lower moisture content value when compared to drying in the sun. However, mechanical dryers provide a more beneficial drying effect in terms of moisture content and better functional properties when compared to drying using sunlight (19). Below are the commonly used methods for determining moisture content:
Moisture Content (%) or % LOD = (weight before drying - weight after drying) / weight before drying × 100. Chemical Method-Kal Fischer Titration: This accurate method measures low moisture content by reacting water with Karl Fischer reagent, which contains iodine and a buffering agent in methanol. The reaction quantifies water content based on iodine concentration. The water content is determined by measuring the amount of iodine consumed as a result of a reaction with water in a sample (21).
Determination of Ash content:
Ash content in cosmetic raw materials indicates the presence of inorganic impurities, fillers, or minerals. It is essential for quality control and regulatory compliance (24).
Determination of Volatile Matter:
Volatile matter content is the total amount of all types of volatile matter combined in the sample. This depends upon the composition of the cosmetic product under study for determination.
It is usually carried out by using a simple gravimetric LOD (loss on drying) method and sample does not require any preparations in this method and can be used as such.
Test 1: Dry the sample at a lower temperature (e.g., 50°C to 60°C) for a shorter period (e.g., 1-2 hours). This will help to remove only the moisture content.
Test 2: Dry the sample at a higher temperature (e.g., 105°C to 110°C) for a longer period (e.g., 2-3 hours). This will help to remove both moisture and volatile content. The LOD result from Test 1 (lower temperature) represents the moisture content in the sample. By subtracting the moisture content from the LOD result of Test 2 (higher temperature) to obtain the volatile content (27).
Determination of heavy metals:
Weigh 1g of the sample and perform wet digestion using 65% nitric acid and 60% hydrochloric acid (3:2 ratio), neutralizing with 4% hydrogen peroxide after each digestion. Heavy metals are analyzed in the digest using a flame atomic absorption spectrophotometer with air-acetylene and nitrous oxide flames. Lead- 10ppm, Cadmium – 0.3ppm, Arsenic – 3ppm, Mercury – 1ppm, Cr 1.73–416.31 ppm, Fe 14.72–24,882 ppm, Mn 0.20–1211.92 ppm, Ni 0.91–95.66 ppm and Zn 0.13–2649.04 ppm. (28).
Determination of Density:
It ensures formulation accuracy such as proper ingredient proportioning, product stability, packaging efficiency & quality control ensuring batch consistency and compliance. There are various factors affecting density such as ingredients (oils vs water-based components), temperature, air content, and viscosity (29). Different methods for measuring density are a pycnometer, hydrometer, digital density meter (U–tube), and density cups. The regulatory & quality assurance standards should be as per ISO 2811, ASTM D1475 (30).
Determination of Viscosity:
Measures a fluid’s resistance to flow, expressed in poise. Higher viscosity means greater thickness. It is important to evaluate the texture and feel (affects spreadability), stability, packaging, and performance. There are various factors affecting viscosity such as temperature, shear rate, ingredients (polymers & surfactants), and pH. Different methods for measuring viscosity are rotational viscometer, capillary viscometer, rheometer, flow cup viscometer, and penetrometer. The quality assurance standards should be as ISO 2555, and ISO 3219 (31).
Determination of Fineness of Powder:
Relates to particle size, affecting bulkiness and flow properties. Smaller particles improve flow. Sieve analysis (mechanical sieving), microscopic analysis (optical/scanning electron microscope, stage micrometer), laser diffraction are used for the determination of the above (32).
Table 1: Classification of Powders by Fineness
|
Descriptive Terms |
Particle size range |
|
Coarse |
>355 |
|
Moderately fine |
180-349 |
|
Fine |
125-179 |
|
Very fine |
<125> |
4.1.2 Chemical Testing:
Acid Value:
Indicates the amount of free fatty acids in oils. Acid value is generally determined for oily materials used in the cosmetic preparation and for the finished products. Oily materials are used in creams, sunscreen products, and other cosmetic preparations where they are convenient to use and have a good level of water resistance. Acid value can be defined as the number of milligrams of potassium hydroxide required to neutralize the free fatty acids present in one gram of fat.
Determination of Acid value in creams and in oils used in the formulation of creams:
Dissolve 10g of sample in 50 ml alcohol-ether mix, heat until dissolved using reflux, add 1ml phenolphthalein, and titrate with 0.1N NaOH until a faint pink color remains for 30 seconds.
Acid value = n x 5.61/w
Where, n = number of ml of NaOH required;
w = the weight of the substance taken (33).
Saponification Value:
Saponification value measures the alkali needed to saponify fats in oils used in cosmetics like creams and sunscreens for water resistance.
The saponification value is defined as the number of mg of KOH required to neutralize the free and combined fatty acids formed by the complete hydrolysis of 1gm of fat/oil.
It is a measure of the average molecular weight of the triacylglycerides in a sample.
Determination of Saponification value in the formulation of creams:
Introduce about 2gm of substance (cream/oil) refluxed with 25 ml of 0.5N alcoholic KOH for 30 minutes, to 1 ml of phenolphthalein is added and titrated immediately, with 0.5N HCl, and Saponification value is determined by
Saponification value = (b-a) x 28.05 /w
Where, a = the volume of HCl utilized;
b = ml of substance being examined (KOH);
W = Weight in grams of the substance (34).
Iodine Value:
Indicates the degree of unsaturation in fats and oils. The iodine value is generally determined for oily materials used in the cosmetic preparation and for the finished products. Oily materials are used in creams, sunscreen products, and other cosmetic formulations where they are convenient to use and have a good level of water resistance.
? Iodine value is defined as the no of grams of iodine that would add to carbon-carbon unsaturated double bonds present in 100 grams of oil/lipid material.
? Iodine value gives a measure of the degree of unsaturation of lipids.
Determination of Iodine value in the formulation of creams:
Dissolve 1g of oil/cream in carbon tetrachloride, add pyridine bromide, let stand for 10 min, then add potassium iodide and titrate with sodium thiosulfate using starch indicator. Perform a blank titration.
Iodine value = (b-a) x 0.01269 x actual molarity/ wt of sample in grams
Where, b= blank value; a = acid value (35).
Ester value:
Ester value is determined for oily materials in cosmetics like creams and sunscreens, ensuring convenience and water resistance.
4.1.3 Microbiological Testing:
Ensures products are free from harmful microorganisms. This is done for most of the raw materials like calcium carbonate, zinc oxide, magnesium carbonate and many others. Microbiological testing involves using various chemicals and media to detect and identify microorganisms. Here are some common chemicals and media used in microbiological testing Culture Media: Agar, Broth, Nutrient Agar, Macconkey Agar, Sabouraud Dextrose Agar. Stains and Dyes: Gram Stain, Crystal Violet, Safranin, Methylene Blue, Acridine Orange. Disinfectants and Sterilants: Ethanol, Isopropanol, Sodium Hypochlorite, Hydrogen Peroxide, Autoclave (37).
Chemicals: buffer solutions, enzyme substrates, antibiotics, detergents, surfactants.
4.2 Instrumental Methods of Analysis for Cosmetic Products
4.2.1 Chromatographic Analysis:
Different types of chromatographic techniques such as column chromatography, thin layer chromatography, ion exchange chromatography, gas chromatography, high-performance liquid chromatography can be utilized to determine the quality of raw materials used in cosmetic manufacture by their characteristic retention time and retardation factor The values of retention time and retardation factor of one compound is specific when a particular type of chromatographic method is employed which varies for another compound and when different chromatographic method is followed (38).
4.2.2 Spectroscopic Analysis:
4.2.3 Hyphenated Techniques:
It is a laboratory analytical method that combines two or more different techniques to achieve a more comprehensive analysis of a sample. The term "hyphenated" refers to the fact that the techniques are linked or coupled together, often through a shared interface or data acquisition system (40). Examples of hyphenated techniques include:
GC-MS (Gas Chromatography-Mass Spectrometry): combines gas chromatography for separating and identifying compounds with mass spectrometry for structural analysis. It is used for ingredient identification, allergen detection, and contaminant detection.
LC-MS (Liquid Chromatography-Mass Spectrometry): combines liquid chromatography for separating and identifying compounds with mass spectrometry for structural analysis. It is used for the detection of peptide analysis and protein analysis.
GC-IR (Gas Chromatography-Infrared Spectroscopy): combines gas chromatography for separating and identifying compounds with infrared spectroscopy for structural analysis. It is used for Essential oil analysis, moisturizer analysis, and fragrance analysis. HPLC-UV (High-Performance Liquid Chromatography-Ultraviolet Spectroscopy): combines high-performance liquid chromatography for separating and identifying compounds with ultraviolet spectroscopy for detecting and quantifying compounds. It is used to test finished products by performing stability testing, shelf-life testing, and comparative analysis (41). Hyphenated techniques have several advantages such as improving sensitivity and selectivity, enhancing structural information, increasing accuracy and precision, reducing analysis time, and improving sample throughout (42).
5. CONCLUSION:
The exploratory analysis of toxic chemicals in cosmetics and personal care products has revealed a complex web of health and environmental risks. The widespread use of toxic ingredients, regulatory loopholes, and inadequate labeling practices have created a perfect storm that puts human health and the environment at risk. From stability and microbiological tests to dermatological assessments and regulatory compliance, each parameter ensures that products meet the highest standards for consumer use. As the cosmetic industry continues to evolve, incorporating innovative testing methods and adhering to global safety regulations will remain crucial. Ultimately, rigorous testing not only safeguards consumer health but also enhances product credibility and brand trust in an increasingly competitive market. Cosmetics industry relies heavily on advanced instrumental techniques to ensure the quality, safety, and efficacy of their products. Techniques such as chromatography, spectroscopy play a crucial role in analyzing the chemical composition of cosmetics, detecting contaminants and adulterants and verifying the presence of active ingredients. The use of advanced instrumental techniques enables cosmetics manufacturers to organize with regulatory requirements. Ultimately, the pursuit of beauty and wellness should not come at the cost of human health and the environment. As consumers, policymakers, and industry stakeholders, we must work together to create a future where cosmetics and personal care products are safe, sustainable, and responsible.
REFRENCES
Harini Upppada*, Tanusree Muvvala, Moni Prasanna Mandalapu, Naveena Koyya, Evaluating The Safety and Sustainability of Cosmetics and Personal Care Products, Int. J. of Pharm. Sci., 2025, Vol 3, Issue 2, 1539-1547. https://doi.org/10.5281/zenodo.14887890
10.5281/zenodo.14887890
