The cosmetic industry was worth above $300 billion in 2024 and is projected to reach more than $500 billion by 2033. With millions of cosmetic products sold each year, manufacturers share a responsibility to protect consumer health on a grand scale. Mass spectrometry has made it possible to test cosmetics and identify harmful ingredients before they reach the market. 

The integration of MS into cosmetics allows researchers to detect trace elements and guarantee product safety and effectiveness. Modern ionization methods have improved detection sensitivity and expanded the range of detectable substances. Innovative techniques facilitate investigation into new ingredients, resulting in market differentiation and unique products. 

Consumer-Centric Mass Spectrometry

Access to reliable data allows companies to maintain transparency and build consumer trust in their products. Consumer preferences and feedback significantly influence innovation in cosmetic products, and market insights create new product developments, support customer satisfaction, and foster brand loyalty. 

Mass spectrometry tests the efficacy of cosmetic formulations by verifying active ingredients are present in measured concentrations. This helps companies refine formulations according to consumer demands and improve quality aspects, such as scent, texture, and product effectiveness. Additionally, mass spectrometry aids in detecting allergens and irritants. By accurately identifying and quantifying potentially harmful substances, this technology helps prevent the inclusion of toxic ingredients in consumer products.

Compliance and Safety Standards

With such a wide range of purposes, ingredient lists face many challenges and setbacks regarding health, many of which result from cost-cutting endeavors. The complex relationship between materials foreign to the body and their application ultimately makes the regulation of cosmetics as important as food or drugs.

The Food and Drug Administration (FDA) and the European Union (EU) set strict guidelines for cosmetics to ensure consumer safety, and guaranteeing compliance with regulatory standards is an important aspect of quality control. Mass spectrometry verifies that products adhere to these guidelines by detecting polluting substances and ensuring products are free from contamination. This industry constantly evaluates the presence of strictly controlled polluting substances by employing MS-based methods. It confirms the composition of ingredients to guarantee levels of active compounds fall within the stated concentrations and pollutants are below acceptable limits. These efforts ensure that the products meet legal requirements and provide transparency to consumers. Techniques discussed in cosmetic quality and safety testing facilitate compliance with these standards.

Cosmetic Lab Testing

Mass spectrometry is especially helpful when understanding cosmetic ingredients and the presence of preservatives. Although many help improve shelf life and prevent microbial growth, their toxicity, concentration, and effects on the body can widely vary. 

With MS – often specifically electrospray ionization tandem mass spectrometry (LC–ESI-MS-MS) – labs can accurately identify ingredient concentrations in formulations. Here are some ingredients and preservatives many labs test for:

  • Fragrances: perfume, cologne, aftershave, shampoo, lotion, creams, essential oils

  • Latex: natural rubber latex, hair bonding adhesives, face and body paints, eyeliner, and eyelash adhesives

  • Preservatives: methylparaben, ethylparaben, propylparaben, isopropyl paraben, benzyl paraben, butylparaben, triclosan, DL-α-tocopherol acetate, butylated hydroxyanisole (BHA), and butylated hydroxytoluene (BHT)

  • Dyes/Color Additives: coal tar, p-phenylenediamine (PPD), etc.

  • Heavy metals: chromium, cobalt, nickel, cadmium, mercury, lead, gold, antimony or arsenic

  • Alpha Hydroxy Acids (AHAs): skin smoothing agents, like glycolic acid or lactic acid

  • Beta Hydroxy Acids (BHAs): skin agents and exfoliants such as salicylic acid

  • Parabens: methylparaben, propylparaben, butylparaben, ethylparaben, and other preservatives that may protect from harmful bacteria and mold

  • Phthalates: plasticizers and non-binding plastics, such as dibutylphthalate (DBP), dimethylphthalate (DMP), and diethyl phthalate (DEP)

  • Talc: naturally occurring mineral composed of magnesium, silicon, oxygen, and hydrogen; chemically, talc is hydrous magnesium silicate (Mg3Si4O10(OH)2); used for absorbing moisture, preventing caking and making facial makeup opaque and texturized

  • Diethanolamine: emulsifiers or foaming agents, such as Cocamide DEA, Cocamide MEA, DEA-Cetyl Phosphate, DEA Oleth-3 Phosphate, Lauramide DEA, Myristamide DEA, TEA-Lauryl Sulfate, Triethanolamine

Identifying non-labeled components, such as synthetic additives, are equally as important for compliance and labeling requirements. By using mass spec, potentially harmful materials can be quickly identified and removed from formulations, including these prohibited ingredients:

  • Bithionol: Bithionol is prohibited because it may cause photo contact sensitization (21 CFR 700.11).

  • Chlorofluorocarbon propellants: The use of chlorofluorocarbon propellants in cosmetic aerosol products for domestic consumption is prohibited (21 CFR 700.23).

  • Chloroform: The use of chloroform in cosmetic products is prohibited because it causes cancer in animals and is likely to harm human health. The regulation makes an exception for residual amounts from its use as a processing solvent during manufacturing or as a byproduct from the synthesis of an ingredient (21 CFR 700.18).

  • Halogenated salicylanilides (di-, tri-, metabromsalan and tetrachlorosalicylanilide). These are prohibited in cosmetic products because they may cause severe skin disorders (21 CFR 700.15).

  • Hexachlorophene: Because of its toxic effect and ability to penetrate human skin, hexachlorophene (HCP) may be used only when no other preservative is as effective. The HCP concentration in a cosmetic may not exceed 0.1 percent and may not be used in cosmetics that are applied to mucous membranes, such as the lips (21 CFR 250.250).

  • Mercury compounds: Mercury compounds are readily absorbed through the skin on topical application and tend to accumulate in the body. They may cause allergic reactions, skin irritation, or neurotoxic problems. The use of mercury compounds in cosmetics is limited to eye area products at no more than 65 parts per million (0.0065 percent) of mercury calculated as the metal. It is permitted only if no other effective and safe preservative is available. All other cosmetics containing mercury are adulterated and subject to regulatory action unless it occurs in a trace amount of less than 1 part per million (0.0001 percent), calculated as the metal and its presence is unavoidable under conditions of good manufacturing practice (21 CFR 700.13).

  • Methylene chloride: It causes cancer in animals and is likely to be harmful to human health, too (21 CFR 700.19).

  • Prohibited cattle materials: To protect against bovine spongiform encephalopathy (BSE), also known as "mad cow disease," cosmetics may not be manufactured from, processed with, or otherwise contain prohibited cattle materials. These materials include specified risk materials, material from nonambulatory cattle, material from cattle not inspected and passed, or mechanically separated beef. Prohibited cattle materials do not include tallow that contains no more than 0.15 percent insoluble impurities, tallow derivatives, hides and hide-derived products, and milk and milk products (21 CFR 700.27).

  • Sunscreens in cosmetics: The term "sunscreen" or similar sun protection wording in a product's labeling generally causes the product to be regulated as a drug or a drug/cosmetic, depending on the claims. However, sunscreen ingredients may also be used in some cosmetic products to protect the products’ color. The labeling must also state why the sunscreen ingredient is used, for example, "Contains a sunscreen to protect product color." If this explanation isn’t present, the product may be subject to regulation as a drug (21 CFR 700.35). For more information on sunscreens, refer to Tanning Products.

  • Vinyl chloride: Vinyl chloride is prohibited as an ingredient in aerosol products because it causes cancer and other health problems (21 CFR 700.14).

  • Zirconium-containing complexes: The use of zirconium-containing complexes in aerosol cosmetic products is prohibited because of their toxic effect on animals' lungs and the formation of granulomas in human skin (21 CFR 700.16).

Note that color additives are permitted in cosmetics only if FDA has approved them for the intended use. In addition, some may be used only from batches that the FDA has tested and certified. To learn more, see “Color Additives and Cosmetics.”

Allergen Testing

Allergens in consumable products have profound implications, especially cosmetics, due to their interaction with skin, hair, nails, and eyes. Many companies strive for allergen-free cosmetics free of silicones, parabens, preservatives, formaldehyde, and nanomaterials while promoting cruelty-free (no animal testing) claims. However, whether these claims are stated, all cosmetic companies require proof of their products’ components through rigorous lab testing.

The public perception of allergens may be milder than the actual repercussions of a reaction. Typically, symptoms include itchy skin, rash, flaking skin, peeling skin, irritation, hives or swelling. Yet, at times, allergic reactions may be so intense they lead to irreversible health damage and even death. For these reasons, consumers expect the listed claims and ingredients on products they choose to purchase to be truthful.

Cosmetic formulations incorporate an impressive variety of different types of ingredients but are typically grouped into classifications, such as:

 

ingredients for product form

water, oils, silicones, surfactants, polymers, polyhydric alcohols, inorganic and organic powders

ingredients for stabilizing

antimicrobial agents, pH control chemicals, antioxidants, and chelating agents

ingredients for efficacies, effects, and concepts

plant extracts and herbal medicine components, microbial-derived ingredients, proteins and amino acids, ceramides, and vitamins

ingredients acting on the senses of users

coloring and scenting agents, such as essential oils, extracts, and fragrances (natural or synthetic)

MS techniques can screen for multiple allergens simultaneously. Nowadays, mass spectrometry's precision in allergen analysis is indispensable for protecting consumers and mitigating risks related to product usage. Access more about allergen detection with mass spectrometry here.

Microbial Testing

Mass spectrometry provides a rapid and accurate alternative to traditional culture-based methods in microbial testing. Detecting microbial contamination requires complex measures, but it is necessary for consumers' safety and the quality of cosmetics.

MALDI-TOF MS helps prevent spoilage, extend shelf life, and guarantee product safety by rapidly detecting contamination. Although it does not fully replace genome sequencing for microbial or fungal identification, its speed and accuracy are invaluable in reducing the risk of product recalls and maintaining hygiene standards in production environments.

Stability Testing

Stability testing with mass spectrometry allows for the evaluation of cosmetic product lifespan. It examines how ingredients interact over time, assessing the effects of temperature, light, and other environmental factors on composition. Maintaining formulation stability is necessary to deliver consistent efficacy and safety.

Mass spectrometry can reveal degradation products, indicating changes that impact product effectiveness. This information helps you optimize formulations, extending the product’s usability. By monitoring the chemical integrity of cosmetics throughout their shelf life, you can ensure long-term stability and customer satisfaction. Accelerated stability testing using mass spectrometry aids in predicting product performance, providing insights that inform better packaging and storage solutions.

Mass Spec Methods for Cosmetics

Mass spectrometry is widely used to elucidate the chemical structure of unknown compounds. By measuring the mass-to-charge ratio (m/z) of ionized molecules, mass spectrometry provides accurate molecular weight information. Isotopic patterns in the mass spectrum further disclose molecular formulas, while the distribution of detected ions gives insights into a compound's elemental composition. This guarantees a comprehensive evaluation of cosmetic ingredients and any unwanted impurities or chemical changes that could impact product performance.

Analysis of Complex Mixtures

Mass spectrometry serves the cosmetic industry by precisely identifying ingredients, allergens, contaminants, product stability, and biomarkers that could indicate microbial contamination. Microbial contaminations are typically complex mixtures that require detailed analysis. With its high sensitivity and specificity, MS can isolate and quantify trace compounds simultaneously. Detecting contaminants using MS often involves advanced techniques like high-performance liquid chromatography-mass spectrometry (HPLC-MS) and multiple reaction monitoring (MRM) modes. These methods help separate specific compounds accurately while minimizing interference from other analytes.

Primary Mass Analyzers and Ion Sources

Standard mass analyzers include quadrupole, time-of-flight (TOF), and ion trap analyzers. Each serves various analytical needs, such as high sensitivity or resolution. The quadrupole analyzer is commonly used because it efficiently scans a wide mass range. TOF analyzers excel at obtaining the mass of ions with high accuracy.

The ion source significantly influences the quality of the data. Electrospray ionization is frequently used in cosmetic analysis because it can handle various substances. Other important ion sources include matrix-assisted laser desorption/ionization (MALDI) for larger molecules, which enhances the analytical process's robustness.

Liquid Chromatography-Mass Spectrometry (LC-MS)

LC-MS allows the analysis of a broader range of compounds, including thermally unstable and large molecules. The process involves dissolving the sample in a liquid mobile phase and moving it through the stationary phase, which separates the constituents based on polarity. 

LC-MS can evaluate non-volatile components in particularly complex mixtures. With its capacity to handle diverse sample types, this method is indispensable for quality assurance and safety evaluations in the cosmetic industry. Its versatility makes it ideal for both routine analysis and in-depth research applications.

Gas Chromatography-Mass Spectrometry (GC-MS)

GC-MS can evaluate both volatile and semi-volatile compounds in cosmetics, identifying compounds after vaporization. The mobile phase is typically an inert gas, allowing the separation of components based on boiling points and column affinity. GC-MS is widely used for quality control and authenticity verification due to its high sensitivity and specificity in detecting trace elements in cosmetic formulations. This technique is particularly effective for analyzing essential oils and fragrance components.

Inductively Coupled Plasma-Mass Spectrometry (ICP-MS)

ICP-MS can detect trace metals in cosmetics. Unlike other methods, an inductively coupled plasma ionizes and atomizes the sample before analysis, allowing for highly accurate detection of even minute concentrations at the parts-per-trillion scale. This method's precision aids in compliance with health standards and keeps harmful metals below regulatory limits before cosmetic products reach the market. 

FDA Classifications of Cosmetics and Drugs

The cosmetic industry needs to maintain top regulations and health safety standards because millions of consumers rely on these protections every year. Many people mistakenly believe that the FDA lacks any regulatory control over cosmetic products. Because these products get applied to and absorbed through the skin, they become subject to FDA regulations, which cover chemicals used on the skin, hair, nails, teeth, and oral and ocular mucous membranes. The Federal Food, Drug, and Cosmetic Act (FD&C Act) of 1938 gave the FDA the authority to create strict standards for manufacturers, defining a cosmetic as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance."

If health claims are marketed, many products may be defined as a cosmetic and a drug. The FDA classifies drug products as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or any function of the body of man or other animals." An example of this may be a makeup product with sun protection claims due to the health qualities of applying the makeup, the manufacturer must follow drug regulations. Another example would be anti-dandruff shampoo: despite being a cosmetic due to the cleansing virtues for hair, it may also be classified under drugs due to its dermatology claims.

Because of these implications, the FDA provides Guidance for Industry: Cosmetic Good Manufacturing Practices (GMP) for companies that create products under their jurisdiction. This document defines GMP as "that part of quality assurance aimed at ensuring that products are consistently manufactured to a quality appropriate to their intended use. It is thus concerned with both manufacturing and quality control procedures." Manufactures should readily be available to provide the following:

  • Documentation of all ingredients (name, code, lot number, batch volume, quantity, etc.)

  • Documentation of all production steps (processing, handling, transferring, holding, and filling)

  • In-process sampling, controlling, and adjusting steps

  • Batch and finished product lot or control numbers

  • The finished products control status- accepted or rejected

Further regulation by the FDA includes the quality of buildings, facilities, equipment, and personnel. Products have prohibited ingredient lists and water quality standards that must be strictly followed. Protocols must be closely followed in case of adverse events and recalls, with systematic audits and laboratory testing.

Addressing Environmental Concerns

Due to the numerous ingredients from a breadth of sources, cosmetic companies now share a new burden of environmental safety, especially when dealing with hazardous waste and byproducts. With the help of mass spec, cosmetic testing can help identify harmful contaminants and evaluate the biodegradability of compounds, which ultimately reduces the ecological footprint of their industry.

Testing for Environmental Contaminants

By identifying microplastics and other pollutants, companies can ensure their products are safe for use and environmentally friendly. For instance, MS can detect microplastics in cosmetics, which are a significant environmental issue. Such insights help adhere to regulatory standards and pave the way for meaningful discussions on sustainability.

Specific protocols involve collecting samples from products and analyzing them through advanced mass spectrometric techniques at various stages of production. This process allows for the early detection of substances that may pose risks to users and the ecosystem. By efficiently utilizing these methods, lab testing can significantly minimize cosmetics' environmental impact.

Assessing the Biodegradability of Compounds

Mass spectrometry helps assess how quickly and effectively ingredients break down in biological and soil environments. This process involves tracking the degradation pathways and identifying by-products that may arise during decomposition. Manufacturers can then choose high-quality biodegradability ingredients, reducing long-term environmental impact.

A life cycle assessment can provide valuable insights into a product's lifespan, from production to disposal, and highlight areas for improvement. You can implement the findings to enhance the eco-friendliness of your product formulations, aligning with new regulations and consumer expectations for environmentally responsible cosmetics.

 

Want to learn more about our solvents? Read more of our articles or visit us at Birch Biotech. 

 

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Disclaimer: The content provided on the Birch Biotech blog is for educational and entertainment purposes only. The information offered here is designed to provide helpful insights and advice related to laboratory practices and supplies.

Readers are advised to refer to our product-specific quality data sheets and Certificates of Analysis (COAs) available on our website for detailed information on product specifications. It is essential to handle and store all materials according to the safety guidelines and regulatory requirements applicable to your area.

While we endeavor to ensure the accuracy and relevance of the information published, it should not be used as a substitute for professional advice or official protocols. We encourage all our readers to consult their institution's guidelines, local regulations, and professional standards before implementing any practices discussed here.

Birch Biotech does not accept liability for any actions undertaken based on the information provided in this blog nor for the misuse of our products. Furthermore, Birch Biotech does not guarantee the completeness, reliability, or timeliness of the information contained on this website.

This disclaimer is subject to change at any time without notifications.

 

[1] ADA Cosmetics. (2024, December 23). Allergens in cosmetics - what you need to know. https://ada-cosmetics.com/expert-stories/allergens-in-cosmetics/

[2] Giustra, M., Sinesi, G., Spena, F., De Santes, B., Morelli, L., Barbieri, L., Garbujo, S., Galli, P., Prosperi, D., & Colombo, M. (2024). Microplastics in cosmetics: Open questions and sustainable opportunities. ChemSusChem. https://doi.org/10.1002/cssc.202401065

[3] Motoyama, A., & Kihara, K. (2017). Mass spectrometry in cosmetic science: advanced ionization techniques for detecting trace molecules in or on human skin. Mass Spectrometry, 6(3), S0071. https://doi.org/10.5702/massspectrometry.s0071

[4] Office of the Commissioner. (2018, March 29). Federal Food, Drug, and Cosmetic Act (FD&C Act). U.S. Food And Drug Administration. https://www.fda.gov/regulatory-information/laws-enforced-fda/federal-food-drug-and-cosmetic-act-fdc-act

[5] Office of the Commissioner. (2022, March 2). FDA Authority over cosmetics: How cosmetics are not FDA-Approved, but are FDA-Regulated. U.S. Food And Drug Administration. https://www.fda.gov/cosmetics/cosmetics-laws-regulations/fda-authority-over-cosmetics-how-cosmetics-are-not-fda-approved-are-fda-regulated

[6] Program, H. F. (2022, June 28). Color Additives and Cosmetics: Fact sheet. U.S. Food And Drug Administration. https://www.fda.gov/industry/color-additives/color-additives-and-cosmetics-fact-sheet

[7] Pritchett, T. H., Myers, E. A., & Brettell, T. A. (2020, November 12). Determination of preservatives in cosmetics and personal care products by LC–MS-MS. Chromatography Online. https://www.chromatographyonline.com/view/determination-preservatives-cosmetics-and-personal-care-products-lc-ms-ms

[8] Research, S. (n.d.). Cosmetics Market Size, Trends, Growth & Forecast Report by 2033. https://straitsresearch.com/report/cosmetic-market

[9] Shang, Y., Meng, X., Liu, J., Song, N., Zheng, H., Han, C., & Ma, Q. (2023). Applications of mass spectrometry in cosmetic analysis: An overview. Journal of Chromatography A, 1705, 464175.

[10] Serb, A. F., Georgescu, M., Onulov, R., Novaconi, C. R., Sisu, E., Bolocan, A., & Sandu, R. E. (2024). Mass-Spectrometry-Based research of cosmetic ingredients. Molecules, 29(6), 1336. https://doi.org/10.3390/molecules29061336

[11] Statista. (2024, February 22). Global value of the cosmetics market 2018-2025. https://www.statista.com/statistics/585522/global-value-cosmetics-market/#:~:text=Global%20value%20of%20the%20cosmetics%20market%202018%2D2025&t

 

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