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Hydroxypropyl cellulose
Hydroxypropyl cellulose
Hydroxypropyl cellulose
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Hydroxypropyl cellulose
Names
Other names
Cellulose, 2-hydroxypropyl ether; oxypropylated cellulose; E463; hyprolose
Identifiers
ChEMBL
ChemSpider
  • none
DrugBank
ECHA InfoCard 100.116.338 Edit this at Wikidata
E number E463 (thickeners, ...)
UNII
Properties
variable
Molar mass variable
Except where otherwise noted, data are given for materials in their standard state (at 25 °C [77 °F], 100 kPa).
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Hydroxypropyl cellulose (HPC) is a derivative of cellulose with both water solubility and organic solubility. It is used as an excipient; a topical ophthalmic protectant and lubricant; a thickener, emulsifier, and stabilizer in cosmetic formulations; a sieving matrix for DNA separations by capillary and microchip electrophoresis; a leather consolidant used in book preservation; and a wood consolidant.

Chemistry

[edit]

HPC is an ether of cellulose in which some of the hydroxyl groups in the repeating glucose units have been hydroxypropylated forming -OCH2CH(OH)CH3 groups using propylene oxide. The average number of substituted hydroxyl groups per glucose unit is referred to as the degree of substitution (DS). Complete substitution would provide a DS of 3. Because the hydroxypropyl group added contains a hydroxyl group, this can also be etherified during preparation of HPC. When this occurs, the number of moles of hydroxypropyl groups per glucose ring, moles of substitution (MS), can be higher than 3.

Because cellulose is very crystalline, HPC must have an MS about 4 in order to reach a good solubility in water. HPC has a combination of hydrophobic and hydrophilic groups, so it has a lower critical solution temperature (LCST) at 45 °C. At temperatures below the LCST, HPC is readily soluble in water; above the LCST, HPC is not soluble.

At the right concentrations, HPC forms liquid crystals and many mesophases. Such mesophases include isotropic, anisotropic, nematic and cholesteric. The last one gives many colors such as violet, green and red.[1] These colors are structural colors by nature and are also mechanochromic, meaning the HPC mesophase changes color when stress is applied.[2]

Red, green, and blue samples of cholesteric HPC water (left) and HPC gel (right) mixtures corresponding to 36, 34, and 32 weight percentage water, respectively. At the top of the image are samples contained within twenty millimetre diameter rubber O rings (six millimetres thick), sealed between glass slides with epoxy glue. In the middle are samples in tubes placed upside down for 48 hours showing the HPC gel doesn't flow, and at the bottom are free standing samples placed between two glass slides spelling out H P and C.
Cholesteric HPC water and HPC gel at different concentrations i.e. colors in various arrangements.[1]

Uses

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HPC is well established in the medical, pharmaceutical, and food industries as a widely applicable non-toxic, and cost-effective raw material.[2] It is commonly used as a thickener, emulsifier, stabilizer, binder and anti-caking agent. It has E number E463.

Mechanochromic HPC changing color in response to stress in different design configurations.[2] The top left shows HPC at rest (red) and at progressively higher stresses moving from red through to green to blue (circles 1 mm diameter). The top middle and right shows HPC in two different pixel arrangements (middle = 10 × 10 array with 1 mm pixel spacing; right = 19 × 19 array with 250 µm pixel spacing); both 500 µm2 pixels. The bottom shows a mechanochromic rainbow effect.

In pharmaceuticals it is used as a binder[3] in tablets, and is used variously within cosmetic formulations such as shampoos, conditioners, and lotions.[4] Lacrisert, manufactured by Aton Pharma, is a formulation of HPC used for artificial tears. It is used to treat medical conditions characterized by insufficient tear production such as keratoconjunctivitis sicca, recurrent corneal erosions, decreased corneal sensitivity, exposure and neuroparalytic keratitis. HPC is also used as a lubricant for artificial eyes.[5][6][7]

HPC is used as a sieving matrix for DNA separations by capillary and microchip electrophoresis.[8]

HPC is the main ingredient in Cellugel, described as a "safe, penetrating consolidant for leather book covers affected by red rot" by Preservation Solutions, and used in book conservation.[9]

Due to its ability for structural color and mechanochromism at the right concentrations, it can also be utilised as an optical strain sensor,[10] or as a more environmentally responsible color display technology driven mechanically.[2]

HPC was used by conservators at the Firearms Museum at the Buffalo Bill Center of the West on the Forgotten Winchester, a Winchester Model 1873 lever-action centerfire rifle discovered in 2014 leaning against a tree in Great Basin National Park, Nevada.[11]

See also

[edit]

Notes and references

[edit]
Revisions and contributorsEdit on WikipediaRead on Wikipedia

Hydroxypropyl cellulose

View on Grokipedia
from Grokipedia
Hydroxypropyl cellulose (HPC) is a non-ionic, water-soluble of , consisting of polymers of anhydroglucose units partially substituted with hydroxypropyl groups (-OCH₂CH(OH)CH₃) at the hydroxyl positions of the glucose ring, with the general formula C₆H₇O₂(OR₁)(OR₂)(OR₃) where R₁, R₂, and R₃ are hydrogen or hydroxypropyl. It appears as a white to slightly off-white, odorless, and tasteless hygroscopic powder that swells in water to form clear, viscous colloidal solutions, with a range of 5.0–8.0 in a 1% , and is also soluble in but insoluble in and hydrocarbons. HPC is commercially available in various grades differing in and degree of substitution (molar substitution typically 2.5–10), enabling tailored applications across industries. HPC is produced industrially by treating purified fibrous plant , such as wood pulp or linters, with under alkaline conditions, where the ring-opening etherification reaction attaches hydroxypropyl groups to the cellulose backbone, followed by purification to remove byproducts and control the substitution level. This process yields a versatile with thermoplastic properties, including a temperature around 10–20°C and thermal gelation behavior at elevated temperatures, distinguishing it from other cellulose ethers like . In pharmaceuticals, HPC serves as a binder in tablet formulations, a film-coating agent for controlled release, an extrusion aid in hot-melt processes, and a in ocular inserts for treating dry eye conditions like keratoconjunctivitis sicca by forming a protective lubricating on the eye surface. In the , it functions as a thickener, stabilizer, and emulsifier (E 463 or INS 463) in products such as salad dressings, baked goods, and low-fat spreads, enhancing texture without altering flavor. For and personal care, HPC acts as a film-former, thickener, and emulsifier in shampoos, lotions, and hair styling products, providing water retention and smooth application. Additionally, it finds use in industrial applications like ceramics binding, coatings, and as an inert in pesticides. HPC is for these uses, with low oral absorption (primarily excreted unchanged in ), no , and approval by regulatory bodies including the FDA and EU for direct food contact and pharmaceutical excipients, though high doses may cause mild gastrointestinal effects in animal studies.

Overview

Definition and General Properties

Hydroxypropyl cellulose (HPC) is a non-ionic, water-soluble ether derived from natural sources such as wood pulp or linters. It is produced by reacting with under alkaline conditions, resulting in the substitution of hydroxyl groups on the anhydroglucose units with hydroxypropyl groups (-OCH₂CH(OH)CH₃). This semisynthetic polymer is widely recognized for its versatility in forming clear, viscous solutions in water and many organic solvents. HPC possesses key general properties that enhance its utility across industries, including its nature, which allows it to be processed via molding or without degradation. It demonstrates low , as it is not significantly absorbed orally and is considered safe for use in , , and pharmaceuticals, with no identified hazards under normal conditions. Additionally, HPC exhibits and physiological inertness, making it suitable for direct contact with biological tissues without adverse reactions. Commercially, HPC is available in various grades categorized by —such as low (e.g., 150–600 mPa·s), medium (e.g., 1,500–6,500 mPa·s), and high—and corresponding molecular weights typically ranging from 50,000 to 1,300,000 Da, enabling tailored applications based on solution . The basic chemical is [\ceC6H7O2(OH)3−x−m(OCH2CH(OH)CH3)m]n[ \ce{C6H7O2(OH)_{3-x-m}(OCH2CH(OH)CH3)_m} ]_n, where xx represents the degree of substitution (DS, ranging from 0 to 3, indicating substituted hydroxyls per glucose unit) and mm the molar substitution (MS, which can exceed 3 due to potential side-chain etherification).

History

The foundations of hydroxypropyl cellulose trace back to the isolation of in 1838 by French chemist Anselme Payen, who identified it as a key structural component of cell walls resistant to common solvents. This breakthrough enabled later advancements in modifying to create derivatives with enhanced solubility and functionality. In the early , the development of cellulose ethers emerged, beginning with the first reported etherification of in 1905 using , followed by patents for compositions by 1912 that laid the groundwork for industrial production starting in the . Hydroxypropyl cellulose itself was developed in the late 1940s by Eugene D. Klug and coworkers at Hercules Powder Company (now part of Ashland Inc.), focusing on creating a water-soluble variant through hydroxypropylation of cellulose. This innovation culminated in a pivotal U.S. Patent 2,572,039 granted in 1951, with a further U.S. Patent 3,278,521 granted in 1966, detailing the synthesis process and highlighting its unique thermoplastic and solubility properties. Commercial production of hydroxypropyl cellulose began in the 1960s under the trade name Klucel™, initially targeting industrial applications such as adhesives and coatings due to its film-forming and binding capabilities. By the , its adoption expanded into pharmaceuticals, where it has been recognized as a safe for oral drug formulations. A significant in the 1970s was the recognition of hydroxypropyl cellulose's ability to form cholesteric liquid crystalline phases in concentrated aqueous solutions (above 30 wt%), which exhibit iridescent colors from selective light reflection and opened avenues for advanced material applications. In the and , regulatory growth accelerated, including its approval as a (E463) in the in 1989 under Directive 89/107/EEC, supporting uses in emulsification and stabilization. Since 2000, developments have emphasized sustainable sourcing from renewable feedstocks and biodegradable formulations, aligning with environmental demands in packaging and biomedical fields. Pharmaceutical sector demand has driven market expansion, with a projected (CAGR) of 5.6% from 2025 to 2035.

Chemical Structure and Synthesis

Molecular Structure

Hydroxypropyl cellulose (HPC) is a semisynthetic of , consisting of a linear chain composed of β-1,4-linked anhydroglucose units. In this structure, each anhydroglucose unit features three hydroxyl groups at the C2, C3, and C6 positions, which are available for substitution. The hydroxypropyl groups, with the -OCH₂CH(OH)CH₃, are attached to these hydroxyl groups through linkages, forming a nonionic that modifies the native backbone. The degree of substitution (DS) quantifies the average number of hydroxyl groups per anhydroglucose unit that have been replaced by hydroxypropyl groups, with a theoretical maximum of 3 (one per available position). In contrast, the molar substitution (MS) measures the total number of hydroxypropyl groups per anhydroglucose unit, which can exceed 3 because the terminal hydroxyl on the hydroxypropyl side chain (-CH(OH)CH₃) can undergo further etherification, creating branched substituents. Commercial HPC typically has an MS of around 4 to achieve sufficient solubility, while DS values are generally lower due to this branching. The repeating unit of HPC can be represented as: C6H7O2(OH)3−x(OCH2CH(OH)CH3)x\mathrm{C_6H_7O_2(OH)_{3-x}(OCH_2CH(OH)CH_3)_x} where xx corresponds to the DS for that unit, though actual polymers exhibit heterogeneous substitution patterns across the chain. Structural variations in substitution uniformity and density significantly influence the polymer's conformational properties. Higher degrees of hydroxypropylation disrupt the extensive inter- and intramolecular hydrogen bonding characteristic of crystalline cellulose, reducing chain rigidity and promoting greater flexibility. This leads to predominantly amorphous morphologies in HPC, as opposed to the semi-crystalline structure of unmodified cellulose, with the ether and secondary hydroxyl groups further hindering ordered packing.

Synthesis Methods

Hydroxypropyl cellulose is produced starting from purified , primarily α-cellulose obtained from wood pulp or linters with a purity exceeding 95%. The process begins with the alkalization of this using (NaOH) to form alkali cellulose, which activates the hydroxyl groups for subsequent reaction. This is followed by etherification, where the alkali cellulose reacts with (PO) in a system, often employing water or inert organic diluents such as or to facilitate dispersion and control the reaction. The etherification step occurs under elevated temperatures ranging from 40–120°C and autogenous pressures for durations of 2–16 hours, enabling the to open its ring and attach hydroxypropyl groups to the backbone via alkali . A simplified representation of the reaction is: \text{Cellulose-OH} + n \ \ce{(CH3)CH-CH2O} \rightarrow \text{Cellulose-O-[CH2CH(OH)CH3]_n} + \frac{n}{2} \ \ce{H2O} This process yields hydroxypropyl cellulose with a molar substitution (MS) typically greater than 2 for in . Synthesis variations include one-step methods, where alkalization and etherification occur sequentially in a single vessel, and two-step approaches that involve pre-swelling the before staged addition of to achieve higher uniformity and MS values. The degree of substitution (DS) and MS are precisely controlled by the molar ratio of to anhydroglucose units (AGU), with ratios typically ranging from 5–20 moles PO per AGU (varying by process and desired substitution), commonly used to produce water-soluble grades exhibiting MS values around 2.5–4.5. Following etherification, the reaction mixture undergoes neutralization with a weak acid such as acetic acid to halt the process and remove excess , followed by repeated washing with hot water to eliminate salts, unreacted , and byproducts. The purified product is then dried to form a fine or granules, achieving yields typically in the range of 90–95%. On a commercial scale, production employs batch s for precise control, though continuous reactor systems are increasingly adopted to enhance and minimize usage in modern facilities.

Physical and Chemical Properties

Solubility and Thermal Behavior

Hydroxypropyl cellulose (HPC) exhibits high solubility in at , achieving concentrations up to approximately 40% w/v, as well as in cold and various organic solvents such as , acetone, and . However, it becomes insoluble in hot above its (LCST), typically around 40–45°C, where occurs reversibly upon cooling. In terms of phase behavior, HPC solutions above the LCST undergo due to chain aggregation. Concentrated aqueous solutions exceeding 40% w/w exhibit liquid crystalline phases, transitioning from isotropic below 30% concentration to nematic or cholesteric structures at higher levels; this phenomenon was first observed in the 1970s. The thermal properties of HPC include a glass transition temperature (Tg) typically ranging from -5 to 20°C, varying with the molar substitution (MS) level and grade. It demonstrates thermal stability up to about 200°C, beyond which decomposition proceeds via , and no distinct melting point is observed owing to its polymeric nature. Solubility and phase transitions in HPC are influenced by the degree of substitution (DS); higher DS enhances in organic solvents by increasing hydrophobicity. The LCST-induced collapse of the hydration shell is primarily entropy-driven, arising from strengthened hydrophobic interactions that release structured molecules.

Rheological Properties

Hydroxypropyl cellulose (HPC) solutions in water display shear-thinning non-Newtonian behavior, where decreases with increasing , making them suitable for processing applications requiring flow under stress. Commercial grades of HPC exhibit a wide range, typically measured at 1–10% aqueous solutions at 25°C, with low-viscosity grades like SL and SSL around 3–10 mPa·s (10%) and high-viscosity grades like HF or MF up to 1,500–3,000 mPa·s (1%) or 4,500–7,500 mPa·s (2%), determined by molecular weight and substitution degree. This profile arises from the polymer's flexible chains and hydrophobic propyl groups, which promote chain entanglement under shear. The rheological response of HPC is highly concentration-dependent. At low concentrations below 5 wt%, solutions behave as Newtonian fluids with constant , reflecting unentangled chain dynamics in dilute regimes. Above this threshold, particularly in semi-dilute solutions exceeding 10 wt%, chains form entangled networks that exhibit pseudoplastic flow and, in gel-like states, a yield stress on the order of 1–10 Pa, requiring an initial stress to initiate flow. These transitions are quantified through critical overlap concentration models, where entanglement density increases exponentially with concentration. In the melt state, HPC demonstrates low conducive to thermoplastic processing, typically 100–1,000 Pa·s at 180°C and shear rates of 10–100 s⁻¹, allowing and molding without excessive . The flow is approximately 50–70 kJ/mol, following Arrhenius dependence, such that halves for every 10–15°C increase above the . As a non-ionic , HPC melt and solution viscosities are minimally influenced by salts or variations (stable from pH 2–12), unlike ionic celluloses, due to the absence of charge interactions. Intrinsic viscosity [η][\eta] of HPC, a key measure of hydrodynamic volume, is determined using the Mark-Houwink equation: [η]=KMa[\eta] = K M^a where MM is molecular weight, and constants KK and aa (typically K≈10−4K \approx 10^{-4} to 10−310^{-3} mL/g and a≈0.6–0.8a \approx 0.6–0.8) are solvent- and temperature-dependent for HPC in or organic media. This relation enables molecular weight estimation from viscometric data, with values ranging from 100–1,000 mL/g for commercial grades.

Applications

Pharmaceutical Applications

Hydroxypropyl cellulose (HPC) serves as a versatile in pharmaceutical formulations, primarily functioning as a binder in tablet production. In wet granulation processes, HPC is incorporated at concentrations of 2–5% w/w to enhance granule cohesion and tablet integrity without compromising disintegration. As a film-former, HPC is applied in tablet coatings, often blended with hydroxypropyl methylcellulose (HPMC) to achieve controlled drug release profiles by forming semi-permeable barriers that regulate and . Additionally, low concentrations of HPC act as a suspending agent in liquid oral formulations, maintaining uniform dispersion of insoluble active pharmaceutical ingredients through its viscosity-modifying properties. In ophthalmic applications, HPC is utilized in Lacrisert inserts, sterile rod-shaped devices containing 5 mg of the polymer, designed for insertion into the inferior cul-de-sac to treat moderate to severe dry eye syndromes such as keratoconjunctivitis sicca. These inserts soften within 1 hour and most dissolve completely within 14 to 18 hours, stabilizing the precorneal tear film, prolonging breakup time, and alleviating symptoms like and burning. HPC also functions as a in artificial tear solutions, enhancing ocular surface hydration and comfort by thickening the tear film without causing . HPC plays a key role in controlled-release systems as a matrix former in hydrophilic gels for oral , where it swells upon hydration to form a layer that modulates and for sustained release over extended periods. Its mucoadhesive properties further improve , particularly in buccal films, by promoting prolonged contact with mucosal surfaces and facilitating direct absorption, bypassing first-pass —for instance, in formulations for poorly soluble drugs. HPC is featured as an in numerous FDA-approved products, including antiretrovirals and antineoplastics, and has seen expanded use in the 2020s for stabilizing nanoparticles in targeted delivery systems and as a in 3D-printed personalized , such as extrusion-based implants for hydrophobic drugs. These applications leverage HPC's and chemical inertness, ensuring no adverse interactions with active ingredients while providing reliable performance .

Food and Cosmetic Uses

Hydroxypropyl cellulose (HPC), designated as E463 in the , functions as a thickener, stabilizer, and emulsifier in food applications, enhancing texture and preventing in various products. In gluten-free baked goods, it is incorporated at levels of 1–2% to mimic the viscoelastic properties of , improving structure and final product crumb softness. For low-fat sauces and dressings, HPC acts as a fat replacer, providing and while maintaining emulsion stability during storage. In beverages, it serves as a stabilizer to prevent of particles, ensuring uniform consistency in products like fruit juices and drinks. In frozen desserts such as ice creams, HPC contributes to freeze-thaw stability by controlling formation and preserving smoothness after repeated temperature cycles. This additive also improves overall in dairy-based items like yogurts and creams, where it enhances creaminess without altering flavor. According to standards, HPC usage in foods follows good manufacturing practices (GMP), with no specified upper limit beyond functional efficacy, though typical concentrations range up to 5% in select formulations. Its water supports these roles by enabling easy dispersion in aqueous systems. In cosmetics, HPC acts as a film-former, particularly in hair sprays, where it provides flexible hold and styling without the stiffness associated with traditional resins. As a thickener in lotions and creams, it is used at 0.5–3% to increase and improve product spreadability on the skin. In nail polishes, HPC functions as a suspending agent, preventing settling and ensuring even application. These properties enhance resistance in formulations like sunscreens and lotions, while maintaining a non-greasy feel. HPC's benefits in extend to performance, with assessments confirming it is nonirritating and nonsensitizing for skin contact at typical use levels. Recent trends since 2015 highlight its role in clean-label, plant-derived formulations for natural , driven by consumer demand for bio-based stabilizers amid growing focus.

Industrial Applications

Hydroxypropyl cellulose (HPC) serves as a versatile binder in polymer processing applications, particularly in and inks, where it enhances green strength and facilitates uniform particle dispersion during fabrication. In manufacturing, HPC acts as a binder for injection molding processes, enabling the production of complex components such as bio- and parts like turbine blades by providing temporary cohesion before . Its rheological properties support smooth flow in molding, contributing to defect-free green bodies with improved handling. Additionally, HPC is employed as a solid binder in binder-jet of high-density , where it promotes between powder particles during layer deposition. In cultural heritage conservation, HPC functions as an effective consolidant for fragile artifacts, stabilizing deteriorated materials without altering their appearance. Products like Cellugel, a formulation of HPC dissolved in isopropanol, are widely used to treat red rot in leather, paper, and wood, penetrating deeply to restore cohesion while drying to a flexible, non-tacky film. For instance, in 2015, conservators at the Buffalo Bill Center of the West applied a 2% Klucel G (HPC) solution in water and ethanol to preserve the flaking wooden stock of a historic Winchester Model 1873 rifle discovered in Great Basin National Park, halting further degradation and maintaining structural integrity. This approach is also common in book restoration, where HPC adhesives like Klucel G consolidate leather bindings and historical textiles by reactivating dried coatings with solvents for targeted repairs. Advanced applications leverage HPC's film-forming and gelation capabilities in technical fields. As a sieving matrix in capillary gel electrophoresis, HPC provides an adsorptive coating that enables efficient separation of DNA fragments up to several kilobases, with optimized conditions yielding high-resolution peaks through artificial neural network modeling. In 3D printing, HPC serves as a hydrogel precursor for direct ink writing and photocrosslinking, producing stable, high-fidelity structures suitable for sensors and scaffolds; for example, composite films incorporating silver nanowires exhibit motion-sensing functionality with conductivities exceeding 10^4 S/m. HPC finds utility in finishing, adhesives, and coatings, where it imparts durability and flexibility to surfaces. In conservation and finishing, HPC-based adhesives enhance tensile strength and prevent cracking in historical fabrics and hides, often applied via reactivation for seamless integration. For textiles, it acts as a agent in conservation treatments, stabilizing weakened fibers while allowing . Recent developments in the highlight HPC's role in sustainable materials, including biodegradable films derived from upcycled sources like giant reed , which achieve optical over 90% and tensile strengths above 10 MPa for eco-friendly barriers. Similarly, HPC contributes to drug-free dressings as a biocompatible matrix in nanofibrous composites with , promoting moisture retention and effects without active pharmaceuticals. These applications underscore HPC's strengths exceeding 10 MPa in composites, ensuring robust performance in demanding industrial contexts.

Safety, Toxicity, and Regulations

Safety Profile

Hydroxypropyl cellulose demonstrates low acute oral , with an LD50 exceeding 10 g/kg in rats. It is generally non-irritating to and eyes at concentrations below 5%, though mechanical irritation from dust may occur upon direct contact. According to evaluations by the (EFSA), hydroxypropyl cellulose shows no genotoxic potential and is non-carcinogenic based on available toxicological data aligned with guidelines. Inhalation of hydroxypropyl cellulose dust may irritate the , with occupational exposure limits recommended at 10 mg/m³ for total dust to minimize risks. Dermal exposure is typically non-sensitizing, but protective measures are advised during handling. Environmentally, hydroxypropyl cellulose is biodegradable through microbial , though specific degradation rates vary by conditions. reactions to hydroxypropyl cellulose are rare, rendering it safe for the majority of users; however, monitoring for localized irritation is advised in ocular applications. It exhibits low potential due to its high molecular weight as a (log Kow not applicable, but equivalent to <1 for similar non-accumulating profiles). Production byproducts such as are recognized as (GRAS) by the FDA. Handling precautions in manufacturing include the use of (PPE) like gloves, , and respirators to avoid dust inhalation or contact; hydroxypropyl cellulose carries no biohazard classification.

Regulatory Status

Hydroxypropyl cellulose is recognized as a permitted by the U.S. (FDA) under 21 CFR 172.870, allowing its safe use in various foods except those standardized otherwise, with specifications for molecular weight and hydroxypropoxy content. In the , it is authorized as E463 under Regulation (EC) No 1333/2008, with detailed specifications outlined in Commission Regulation (EU) No 231/2012, permitting unlimited use in most food categories as a thickener, stabilizer, or emulsifier; as of 2025, specifications were amended under EU Regulation 2025/666. The Joint FAO/WHO Expert Committee on Food Additives (JECFA) established an (ADI) of "not specified" for hydroxypropyl cellulose in 2006, indicating low toxicity and no need for numerical limits based on available data. In the pharmaceutical sector, hydroxypropyl cellulose is included in the United States Pharmacopeia/National Formulary (USP/NF) monographs for both standard and low-substituted grades, specifying purity, identification, and performance tests to ensure suitability as an in tablets, films, and controlled-release formulations. The (EMA) approves it as an under the (Ph. Eur.) 12th Edition monograph (as of 2025), which harmonizes standards for hydroxypropoxy substitution levels and microbial limits across member states. For cosmetics, the Cosmetic Ingredient Review (CIR) Expert Panel assessed hydroxypropyl cellulose and related cellulose derivatives as safe for use in cosmetic formulations at concentrations up to 10% in 2009, confirming its role as a binder and film-former without significant irritation or sensitization risks. Its International Nomenclature of Cosmetic Ingredients (INCI) name is "Hydroxypropylcellulose," facilitating global labeling consistency. On the industrial and environmental front, hydroxypropyl cellulose is registered under the EU's REACH regulation (EC 1907/2006), with the (ECHA) overseeing its chemical safety assessment for non-food uses, including polymer production and emissions control. In the United States, the Agency (EPA) regulates manufacturing emissions through the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Cellulose Products Manufacturing (40 CFR Part 63, Subpart UUUU), originally listed in 1997 and promulgated in 2005, with updates including minor amendments finalized in February 2025 targeting hazardous air pollutants like from etherification processes. Global harmonization efforts include adherence to ICH Q7 guidelines on (GMP) for the production of pharmaceutical ingredients, which extend to excipients like hydroxypropyl cellulose to ensure consistent quality and traceability in international supply chains. Additionally, the EU's 2023 Chemicals Strategy for Sustainability under the Green Deal emphasizes sustainable sourcing for bio-based polymers such as cellulose derivatives, promoting reduced environmental impact through principles and verified supply chains.

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