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Emulsifying wax
Emulsifying wax
Emulsifying wax
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Emulsifying wax is a cosmetic emulsifying ingredient. The ingredient name is often followed by the initials NF, indicating that it conforms to the specifications of the National Formulary.

Emulsifying wax is created when a wax material (either a vegetable wax of some kind or a petroleum-based wax) is treated with a detergent (typically sodium dodecyl sulfate or polysorbates) to cause it to make oil and water bind together into a smooth emulsion. It is a white waxy solid with a low fatty alcohol odor.

According to the United States Pharmacopoeia - National Formulary (USP-NF), the ingredients for emulsifying wax NF are cetearyl alcohol and a polyoxyethylene derivative of a fatty acid ester of sorbitan (a polysorbate).[1]

In a cosmetic product, if the emulsifying wax used meets the standards for the National Formulary, it may be listed in the ingredient declaration by the term "emulsifying wax NF".[2] Otherwise, the emulsifier is considered a blended ingredient and the individual components must be listed individually in the ingredient declaration, placed appropriately in descending order of predominance in the whole.[3]

Safety

[edit]

The Cosmetic Ingredient Review Expert Panel reviewed the safety and use of Emulsifying Wax NF in 1984.[4] Their review of usage reported during the previous years found only 12 products using emulsifying wax; those all had usage rates under 10%. Over 35 animal and human studies were cited in the review; none showed more than minor irritation or reaction. The safety assessment found that Emulsifying Wax NF was safe to use as a cosmetic ingredient at the then-present practices and concentrations of use.

The Cosmetic Ingredient Review Expert Panel revisited Emulsifying Wax NF in 2003. They found that it was used in 102 cosmetic products in 2002 at a maximum use concentration of 21% (in hair straighteners). Based on the data available in 2003, the CIR determined not to open a new safety assessment.[5]

References

[edit]
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Emulsifying wax

View on Grokipedia
from Grokipedia
Emulsifying wax is a non-ionic, self-emulsifying waxy solid prepared from and a polyoxyethylene derivative of a of , commonly used to stabilize oil-in-water emulsions in cosmetic and pharmaceutical formulations. According to the National Formulary (NF), it meets specific standards including a range of 50–54°C, a pH of 5.5–7.0 in aqueous dispersion, and low values for iodine (≤3.5) and (≤14), ensuring its suitability for topical applications. In , emulsifying wax functions primarily as an emulsifier and stabilizer, binding and water phases to create smooth, consistent textures in products such as moisturizers, lotions, creams, and conditioners without leaving an oily residue on the skin. It is also employed in pharmaceutical preparations as an in topical creams and ointments, enhancing product stability and delivery of active ingredients for conditions like or . The ingredient is typically derived from plant-based sources like palm or , though petroleum-based variants exist, and it is listed under the INCI name as Cetearyl Alcohol (and) Polysorbate 60. Safety assessments by the Cosmetic Ingredient Review (CIR) Expert Panel have concluded that emulsifying wax NF is safe for use in at concentrations up to 21%, with no significant concerns for , , or systemic based on available animal and clinical data. The (EWG) rates it as low hazard overall, noting minimal risks for cancer, allergies, or , though it advises caution for potential mild skin or eye in sensitive individuals.

Overview

Definition

Emulsifying wax is a waxy, solid emulsifier derived from plant- or petroleum-based sources that facilitates the formation of stable oil-in- (O/W) emulsions by binding immiscible oil and phases together. This material functions primarily as a blend, either non-ionic or anionic, which reduces interfacial tension between the phases and creates a protective barrier around dispersed droplets to prevent coalescence and . In formulations, emulsifying wax stabilizes emulsions by promoting uniform dispersion and enhancing product texture, such as in creams and lotions where it ensures long-term homogeneity without separation. It typically appears as a white to off-white, waxy solid or flakes with a faint or negligible , and it becomes upon gentle warming. Emulsifying waxes compliant with pharmacopeial standards, such as USP-NF (non-ionic variant) or (anionic variant), are widely used in pharmaceutical and cosmetic applications due to their reliability in achieving consistent stability.

Physical and Chemical Properties

Emulsifying wax is a white to off-white, waxy solid with a characteristic faint , exhibiting a typically between 50°C and 54°C as specified in the United States Pharmacopeia (USP) monograph. Its density ranges from approximately 0.8 to 1.0 g/cm³ at 20°C, contributing to its ease of incorporation into formulations without significantly altering the overall . The material is practically insoluble in , forming emulsions upon dispersion, but it shows partial solubility in (96%) and good in oils and most organic solvents, which facilitates its role in binding disparate phases. Chemically, emulsifying wax NF is a non-ionic blend primarily composed of cetearyl alcohol and 60, resulting in a low ionic character that minimizes interactions with charged in formulations. In contrast, emulsifying wax BP is an anionic variant incorporating sodium lauryl , which introduces sulfate groups for enhanced emulsifying action in certain systems. The (HLB) value for non-ionic emulsifying wax NF is approximately 14.9 to 15, positioning it ideally for oil-in-water (O/W) emulsions by promoting stable micellar structures that encapsulate oil droplets. Stability is a key attribute, with emulsifying wax maintaining integrity across a pH range of 4.5 to 8, allowing compatibility in mildly acidic to neutral cosmetic and pharmaceutical products. Thermally, it exhibits robustness up to 80°C, beyond which degradation may occur, ensuring reliable performance during processing and storage. This and resilience supports the formation of durable micellar aggregates essential for long-term integrity. In end products, emulsifying wax imparts desirable sensory attributes, including a smooth, non-greasy texture and velvety after-feel, while minimally impacting to preserve product spreadability. These qualities enhance in creams and lotions without introducing tackiness or residue.

History and Development

Early Emulsifiers

The use of as an emulsifier dates back to ancient times, with the Greek physician (131–201 AD) employing it in lotions to create stable mixtures of oils and , most notably in his formulation of , a primitive oil-in-water that served as a protective and soothing cosmetic. 's natural ability to form a barrier between immiscible phases made it the oldest documented emulsifying agent, valued for its role in early dermatological preparations across Mediterranean civilizations. During the , the development of synthetic emulsifiers marked a significant shift from purely natural substances, with salts—commonly known as soaps—emerging as key agents for stabilizing emulsions in cleaning and cosmetic products. These soaps, produced through of animal and vegetable fats with alkalis, allowed for more controlled and reproducible blending of oils and aqueous components, as demonstrated in early industrial applications like floor polishes and rudimentary creams. Concurrently, the isolation of in 1846 by French chemist Théodore Gobley from egg yolks, which he named in 1850, introduced a phospholipid-based emulsifier that enhanced the stability of and pharmaceutical emulsions, preventing separation in mixtures such as medicinal ointments and early processed foods. In the early , experimentation with vegetable waxes like carnauba, harvested from the leaves of the Copernicia prunifera palm and first introduced to in , began to address limitations in cosmetic formulations by improving durability and resistance to environmental factors. Carnauba's high and hardness provided a stable base for oil-water blends in polishes and early beauty products, paving the way for hybrid wax systems that would evolve into modern emulsifying waxes.

Modern Formulation

The development of modern emulsifying wax began in the early , marking a shift toward standardized, synthetic emulsifiers for pharmaceutical and cosmetic applications. A pivotal advancement occurred in 1900 when chemist Isaac Lifschütz patented Eucerit, a lanolin-derived emulsifying agent that enabled the creation of stable oil-in-water emulsions for ointments and creams, revolutionizing topical formulations by improving homogeneity and spreadability. This innovation laid the groundwork for subsequent emulsifier technologies, building on rudimentary natural emulsifiers from antiquity. A key milestone influencing broader emulsifier development came in 1917 with Einar Viggo Schou's patent for the first commercial food emulsifier, Palsgaard Emulsion Oil, a fatty acid ester that demonstrated scalable emulsification principles applicable beyond food to cosmetic variants seeking consistent stability. Standardization followed in the mid-20th century, with the USP-NF monograph for Emulsifying Wax introduced to ensure pharmaceutical-grade quality, specifying a blend suitable for safe, effective topical products. Similarly, the British Pharmacopoeia formalized its Emulsifying Wax specification around 1963, adapting it for European markets to support reliable emulsion-based formulations. Post-World War II innovations further refined emulsifying wax by emphasizing blends of fatty alcohols and synthetic to replace variable natural waxes, driven by growing demand for durable, non-separating amid industrial-scale production. This era saw patents like US 4,468,254 (), which detailed enhanced wax emulsions combining waxes with liquid polymers for improved film-forming and stability in applied products. These developments prioritized consistency and efficacy, establishing emulsifying wax as a cornerstone of modern technology.

Composition and Production

Key Ingredients

Emulsifying wax primarily consists of cetearyl alcohol as the base component, a mixture of (C16) and (C18) derived from fatty acids, which acts as a waxy structurant to provide thickness, opacity, and long-term stability to . This alcohol blend forms the solid matrix that supports the emulsion structure, preventing while contributing emollient properties to the final product. The key emulsifying agents vary by formulation type; in non-ionic versions such as Emulsifying Wax NF, polysorbate 60 (polyoxyethylene sorbitan monostearate) serves as the , enabling the dispersion of and water phases through its (HLB) of approximately 14.9, which promotes stable -in-water emulsions without ionic interference. According to the , Emulsifying Wax NF is a containing not less than 90.0% and not more than 110.0% of the labeled amounts of cetearyl alcohol and polysorbate 60, with typical commercial formulations using 70–80% cetearyl alcohol and 20–30% polysorbate 60. In anionic versions like , sodium lauryl sulfate (SLS) provides stronger emulsification due to its charged sulfate group, enhancing foam formation and cleansing but potentially increasing sensitivity in sensitive skin applications. The specifies approximately 90% cetostearyl alcohol and 10% sodium lauryl sulfate. Optional additives may include ethylene oxide derivatives, such as additional ethoxylated fatty alcohols, to improve solubility and compatibility in aqueous systems. Eco-friendly or plant-based variants may use alternative self-emulsifying agents like glyceryl stearate combined with potassium stearate, though these are distinct from traditional emulsifying wax compositions. This balance allows the wax to melt and incorporate seamlessly during formulation, yielding robust emulsions suitable for and pharmaceuticals.

Manufacturing Process

The manufacturing process of emulsifying wax begins with the preparation of raw materials, primarily vegetable-derived fatty alcohols such as cetearyl alcohol sourced from sustainable palm or oils. These alcohols are produced through the of corresponding fatty acids to ensure purity and stability, removing impurities like unsaturated bonds. While petroleum-based waxes can be used as alternatives, vegetable sources predominate in modern production for their compatibility with cosmetic and pharmaceutical standards. For the anionic Emulsifying Wax BP, cetearyl alcohol is heated to approximately 95°C in a controlled environment to achieve a molten state. , in a 9:1 ratio to the alcohol, along with a small amount of (about 4% by weight), is then added to the melt. The mixture is further heated to 115°C and stirred vigorously until foaming ceases, ensuring even distribution of components. Cooling and solidification follow, with the mixture subjected to rapid cooling under controlled conditions to form a brittle, white solid, which is then broken into flakes or pellets. The product undergoes quality assessments to verify consistency in properties such as hydrophile-lipophile balance (HLB) value, generally around 15-16 for effective emulsification. For non-ionic variants like Emulsifying Wax NF, the process involves melting cetearyl alcohol and blending with polysorbate 60 at elevated temperatures, followed by cooling, without the addition of or SLS. On an industrial scale, production employs batch reactors capable of handling large volumes, with processes adhering to (GMP) standards to prevent contamination and ensure . Automated stirring and temperature controls maintain precision, and final products are packaged under inert conditions to preserve .

Types and Variants

Emulsifying Wax NF

Emulsifying Wax NF refers to the grade of emulsifying wax that complies with the standards outlined in the United States Pharmacopeia-National Formulary (USP-NF), serving as a non-ionic, self-emulsifying agent essential for formulating stable oil-in-water emulsions in and pharmaceuticals. It is prepared as a waxy solid from (also known as cetearyl alcohol) that incorporates a polyoxyethylene derivative of a ester of , specifically polysorbate 60, and is free of anionic to ensure compatibility with sensitive ingredients. Commercially, it typically consists of a blend of approximately 90% cetearyl alcohol and 10% polysorbate 60 to meet these requirements. The USP-NF specifications for Emulsifying Wax NF emphasize its purity and consistency, including a melting range of 50–54°C, a between 178 and 192, an not exceeding 3.5, a of 14 or less, and a of 5.5–7.0 when dispersed in water. Additionally, it must comply with residual solvent limits under USP <467>, which includes residues below 1 ppm to minimize potential contaminants. These criteria ensure its suitability for pharmaceutical-grade applications, confirming high purity and stability across a broad range. Performance-wise, Emulsifying Wax NF excels in providing mild emulsification for products intended for sensitive , owing to its non-ionic composition that avoids harsh interactions. Its hydrophilic-lipophilic balance (HLB) value of approximately 15.5 positions it ideally for oil-in-water systems, such as lotions, where it is used at concentrations of 3–6% to achieve smooth, stable textures without excessive thickening. This makes it particularly effective for lightweight formulations like serums and thin creams, contributing to excellent stability even under varying storage conditions. Key advantages of Emulsifying Wax NF include its reduced potential for skin irritation compared to ionic alternatives, broad compatibility with active ingredients, and certification for pharmaceutical-grade purity, which supports its prevalent use in U.S.-based and over-the-counter products. It is widely available through established brands such as Polawax, which adheres to these NF standards and undergoes rigorous testing for limits to ensure safety and efficacy.

Emulsifying Wax BP

Emulsifying Wax BP refers to the anionic emulsifying wax defined in the , consisting of and sodium lauryl , prepared extemporaneously by melting 90 g of at 95°C, adding 10 g of sodium lauryl , mixing thoroughly, incorporating 4 mL of , heating to 115°C while stirring until translucent, and cooling rapidly to form a waxy solid. This formulation includes sodium salts from the sulfate component, which contribute to enhanced foaming properties in emulsions. The wax appears as an almost white or pale yellow, waxy solid or flakes, practically insoluble in water but capable of forming emulsions, and it meets pharmacopoeial tests including a minimum of 8.7% sodium alkyl sulfates (as C12H25SO4Na), water content not exceeding 4.0% w/w, and an iodine value of ≤3.0. This BP-compliant wax exhibits stronger emulsifying power, particularly suited for formulating thicker creams, with a (HLB) value of approximately 16 that supports oil-in-water emulsions. It is typically used at concentrations of 5–8% to achieve robust stability in formulations with high content, enabling the creation of stable, self-bodying systems without additional stabilizers. Key advantages of Emulsifying Wax BP include its suitability for rinse-off products, where the sodium lauryl sulfate provides inherent cleansing properties that aid in removal during washing. It also holds European regulatory approval through alignment with the (which incorporates Ph. Eur. standards), making it appropriate for medicinal creams and ointments in pharmaceutical applications. In contrast to the non-ionic Emulsifying Wax NF, the BP variant has a higher irritancy potential due to the sodium lauryl sulfate content but offers superior performance in acidic environments, providing greater stability against weak acids such as boric, carbolic, and .

Applications

In Cosmetics

Emulsifying wax plays a primary role in stabilizing oil-in-water (O/W) emulsions within cosmetic formulations, enabling the uniform dispersion of and phases in products such as creams, lotions, and conditioners. By forming a protective interface around oil droplets, it prevents and enhances overall product stability during storage and application. Additionally, it improves spreadability on the skin, allowing for smoother application, while reducing greasiness to provide a lightweight, non-residue feel. In specific product examples, emulsifying wax is commonly incorporated into moisturizers at concentrations up to 12%, where it contributes to a creamy texture that absorbs quickly without leaving an oily film. It is also used in hair straighteners at levels up to 21%, aiding in the even distribution of active ingredients for effective conditioning and straightening effects. Foundations similarly benefit from its inclusion to achieve a blendable consistency that enhances coverage while maintaining a matte finish. These applications leverage its ability to enhance texture and sensory attributes without compromising the product's aesthetic appeal. Formulation guidelines recommend using emulsifying at 2–10% of the total formulation to achieve optimal , balancing thickness for lotions (around 3–5%) and richer creams (5–10%). It pairs effectively with humectants like glycerin to boost moisture retention and integrity, promoting a hydrated feel in the final product. As of , emulsifying wax was reported in over 100 cosmetic products, with its adoption continuing to grow in and plant-derived formulations due to the availability of vegetable-based variants that align with clean beauty trends.

In Pharmaceuticals

Emulsifying wax serves as a key base in pharmaceutical topical formulations, particularly ointments and creams, where it facilitates the uniform dispersion of active pharmaceutical ingredients (APIs) such as steroids by stabilizing oil-in-water emulsions and reducing interfacial tension between phases. This ensures consistent drug release and enhances the delivery of therapeutics across the skin barrier. In creams, such as Cream USP (0.1%), emulsifying wax is incorporated into the base alongside components like to create a stable vehicle for the , promoting effective action. Similarly, it appears in antibiotic and antifungal topical preparations, including Nystatin Cream USP, where it supports the even distribution of the active agent in or forms for treating skin infections. The NF variant of emulsifying wax is preferred in these applications due to its compliance with (USP) standards, ensuring pharmaceutical-grade purity and performance. The use of emulsifying wax improves the of lipophilic drugs by enhancing their within the matrix, allowing better skin penetration and therapeutic efficacy. It remains stable in sterile formulations at concentrations up to 6%, contributing to the longevity and reliability of medicinal preparations without requiring additional stabilizers. Furthermore, as a listed in the FDA's Inactive Ingredient Database, emulsifying wax is approved for extemporaneous in pharmacies, enabling customized topical therapies while meeting regulatory requirements.

Safety and Regulations

Safety Assessments

The Cosmetic Ingredient Review (CIR) Expert Panel conducted an initial safety assessment of emulsifying wax in as part of its evaluation of and synthetic waxes, concluding that it is safe for use as a in present practices and concentrations, specifically at levels up to 10% in preparations. This assessment incorporated animal and clinical data demonstrating no significant adverse effects under typical exposure conditions. In 2003, the CIR Expert Panel revisited emulsifying wax through its annual of cosmetic ingredient safety assessments, reaffirming the conclusion and deeming it safe for use at concentrations up to 21% in 102 products, including hair straighteners, with only minor observed in relevant studies. The panel determined that no further was necessary, as patterns of exposure and use had remained largely unchanged since the prior . In 2024, the CIR Expert Panel reaffirmed the safety of emulsifying wax NF for use in at current practices and concentrations (up to 25%), based on updated data including decreased reported use (5 products in 2023), though noting insufficient information for potential incidental exposure. Toxicological evaluations supporting these conclusions indicate low acute oral toxicity, with an LD50 exceeding 5 g/kg in rats. Ocular and dermal irritation studies in rabbits yielded minimal scores, showing no severe reactions. Regarding allergenicity, is rare, as evidenced by repeated insult patch tests, and available data reveal no reproductive or carcinogenic effects.

Potential Concerns and Regulations

One potential concern with ethoxylated variants of emulsifying wax is the possible contamination with or its byproduct , both of which are known carcinogens that can persist as trace impurities from the process involving . As of 2025, the EU maintains that levels in should be as low as reasonably achievable under good practices, with no specific regulatory limit but industry targets below 10 ppm. The Emulsifying Wax BP variant may exhibit higher irritancy potential due to its inclusion of sodium lauryl sulfate (SLS), which can cause reactions such as burning, stinging, itching, and redness, particularly in individuals with sensitive or conditions like eczema. Petroleum-derived sources of emulsifying wax contribute to sustainability challenges, as they rely on non-renewable fuels and may include non-biodegradable components that persist in the environment during production and disposal. Industry recommendations advocate shifting to plant-based alternatives, such as those derived from vegetable oils, to mitigate these impacts and promote biodegradability. In the United States, the (FDA) permits the use of emulsifying wax in , provided the product is not adulterated and adheres to good manufacturing practices. Under the European Union's REACH and regulations, impurities such as and in emulsifying wax must be minimized through good manufacturing practices to ensure safety. The Cosmetic Ingredient Review (CIR) Expert Panel has reaffirmed the safety of emulsifying wax in at current use levels but concluded that data are insufficient for evaluating risks associated with exposure in products such as sprays. To address these concerns, manufacturers are encouraged to use purified grades of emulsifying wax that minimize contaminant levels, while consumers with surfactant sensitivities should perform patch testing prior to widespread application.

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