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Thymol

Thymol is a naturally occurring monoterpenoid phenol with the molecular formula C₁₀H₁₄O and a molecular weight of 150.22 g/mol, primarily extracted from the essential oils of plants such as (thyme), (oregano), and Trachyspermum ammi (ajwain). This white crystalline solid, chemically known as 2-isopropyl-5-methylphenol, exhibits a pleasant aromatic odor reminiscent of thyme and has been utilized for millennia in across Greek, Roman, and Egyptian cultures as an , , and remedy for respiratory ailments, digestive issues, and infections. Recognized as generally safe by the U.S. , thymol demonstrates low , with LD₅₀ values ranging from 88 mg/kg in guinea pigs to 1,200 mg/kg in mice, underscoring its broad applicability in both historical and contemporary contexts. Physically, thymol has a of 49–51 °C, a of 231–233 °C, and limited solubility of approximately 900 mg/L at 20 °C, though it dissolves readily in and other organic solvents. Its structure, featuring a ring substituted with a hydroxyl group, a methyl at position 5, and an isopropyl at position 2, contributes to its , volatility ( of 0.016 mm Hg), and bioactive profile. These make thymol a versatile in food flavoring, , and industrial preservatives, where it enhances shelf life and imparts antimicrobial effects against bacteria like Staphylococcus aureus and Escherichia coli. Thymol's pharmacological potential spans , , , and anticancer activities, supported by preclinical studies showing free radical scavenging, inhibition (e.g., TNF-α, IL-6), and induction of in tumor cells via ROS generation and activation. In modern uses, it features in oral care products like mouthwashes and dental varnishes for its properties against oral pathogens, as well as in pesticides for control in agriculture and apiculture. Ongoing research explores its therapeutic roles in , , and neurodegenerative disorders through mechanisms involving /MAPK pathway modulation and agonism, positioning thymol as a promising natural agent for pharmaceutical development.

Chemical Identity

Molecular Structure and Formula

Thymol is a monoterpenoid phenol with the molecular formula C10H14O. Its IUPAC name is 2-isopropyl-5-methylphenol, also expressed as 5-methyl-2-(propan-2-yl)phenol. The chemical structure of thymol consists of a benzene ring substituted with a hydroxyl group (-OH) at position 1, an isopropyl group (-CH(CH3)2) at position 2, and a methyl group (-CH3) at position 5. This arrangement features the phenolic -OH group ortho to the isopropyl substituent and meta to the methyl group (with the methyl group para to the isopropyl substituent), contributing to its characteristic reactivity as a phenol. The core phenolic -OH bond is central to its structural identity, enabling hydrogen bonding and influencing its chemical behavior. Thymol is a positional of , another monoterpenoid phenol found in essential oils; while thymol has the isopropyl group at position 2 and methyl at position 5 relative to the -OH at position 1, features the methyl at position 2 and isopropyl at position 5. The name "thymol" originates from its primary isolation from oil (), with "thyme" deriving from the Greek word thymos, meaning courage or strength, reflecting the plant's historical associations.

Physical and Chemical Properties

Thymol appears as a colorless to white crystalline solid at , often exhibiting a characteristic herbal odor reminiscent of . Its melting point ranges from 49.6 °C to 51.5 °C, while the boiling point is between 231 °C and 233 °C at standard . The is approximately 0.97 g/cm³ at 25 °C, and it demonstrates limited in , approximately 0.9 g/L at 20 °C, but high solubility in organic solvents such as , , and . Chemically, thymol behaves as a weak owing to its hydroxyl group, with a value of about 10.6 at 20 °C. This structural feature enables its activity through effective scavenging of free radicals, such as hydroxyl and peroxyl species, forming stable radicals in the process. Thymol also undergoes oxidation, particularly under catalytic conditions, to yield thymoquinone (C_{10}H_{12}O_2), involving dehydrogenation of the structure. It is incompatible with strong oxidizing agents and bases, which can promote unwanted reactions. Thymol remains stable under normal storage conditions in cool, dry, and well-ventilated areas, with no significant expected. However, prolonged exposure to or elevated temperatures can lead to degradation, primarily through or , reducing its concentration over time. In terms of spectroscopic properties, the () spectrum features a broad O-H stretching band at approximately 3176 cm^{-1}, indicative of the hydroxyl group, along with C-H stretches around 2957 cm^{-1} and 2926 cm^{-1}. (^1H NMR) in CDCl_3 shows characteristic signals for the aromatic protons and methyl groups, with the hydroxyl proton appearing around , while ^{13}C NMR reveals shifts for the phenolic carbon at about .

Natural Occurrence and Biosynthesis

Biosynthesis in Plants

Thymol, a , is primarily biosynthesized in through the 2-C-methyl-D-erythritol-4-phosphate () pathway localized in plastids, which generates the universal isoprenoid precursors isopentenyl diphosphate () and dimethylallyl diphosphate (DMAPP) from glyceraldehyde-3-phosphate and pyruvate. These precursors condense via geranyl diphosphate to form geranyl diphosphate (GPP), the immediate precursor for monoterpenes. GPP then undergoes cyclization catalyzed by γ-terpinene to produce γ-terpinene, which serves as the key intermediate leading to thymol through subsequent oxidation steps. The conversion from γ-terpinene to thymol involves a series of oxidations primarily mediated by monooxygenases, such as CYP71D178 and CYP71D180, which hydroxylate γ-terpinene to form intermediates like and precursors, followed by methylation and further modifications via a short-chain /reductase. These enzymes are particularly prominent in the family, where thymol-specific pathways have evolved; the core pathway is conserved across plants, but specific synthases and oxidases may vary in other families such as . Genetic regulation of thymol biosynthesis is governed by terpene synthase genes, including those encoding γ-terpinene synthase (e.g., Ttps2 in ), whose expression correlates with thymol accumulation. Recent genomic studies in the 2020s, such as the chromosome-level assembly of the genome, have identified multiple γ-terpinene synthase genes and revealed their tissue-specific expression patterns linked to thymol production. Evolutionarily, thymol biosynthesis represents an adaptive trait in plants, enhancing defense against herbivores and pathogens through its potent and insect-repellent properties, which deter feeding and infection. Environmental factors, particularly abiotic stresses like , can upregulate thymol by inducing expression of pathway genes, thereby increasing thymol levels as a protective response to oxidative damage and herbivory pressure.

Plant Sources and Concentrations

Thymol is primarily found in various plants belonging to the family, with the highest concentrations occurring in s extracted from their aromatic leaves and flowers. The most prominent source is (common ), where thymol can constitute up to 50% of the essential oil composition, making it a key monoterpenoid in this herb. Other major sources include Origanum vulgare (oregano), which typically contains 5-20% thymol in its essential oil, and species of (such as or bee balm), where thymol levels vary widely from 10-60% depending on the and environmental conditions. Minor sources of thymol are also notable, particularly Trachyspermum ammi ( or carom seeds), which can yield approximately 50% thymol in its seed , and other members like Satureja species (), where concentrations range from 10-40%. Concentrations of thymol exhibit significant variability influenced by factors such as the plant part—leaves generally have the highest levels compared to stems or flowers—chemotype variations (e.g., thymol-dominant versus carvacrol-dominant phenotypes), and geographic origins, with Mediterranean regions producing the highest yields due to optimal climate and soil conditions. For instance, thymol content in Thymus vulgaris can drop to below 20% in non-Mediterranean cultivars. Thymol's global distribution reflects its native Mediterranean origins, primarily in and , but it is now cultivated worldwide in temperate climates, including , , and , to meet demand for . This widespread cultivation has led to diverse thymol profiles across regions, with higher concentrations often observed in wild Mediterranean populations compared to domesticated varieties elsewhere.
Plant SpeciesCommon NameThymol Content in Essential Oil (%)Primary Plant Part
Thymus vulgarisCommon thyme20-50Leaves
Origanum vulgare5-20Leaves/Flowers
Trachyspermum ammi40-50Seeds
Monarda fistulosa10-60 (variable)Leaves/Flowers
Satureja montana10-40Leaves

Production Methods

Natural Extraction

Thymol is primarily isolated from natural sources via of s derived from the leaves and flowering tops of () and related species like (). This method involves harvesting the aerial parts of the s, drying them to reduce moisture content, and then passing through the plant material in a apparatus, typically at temperatures around 100°C, to volatilize and carry over the volatile oil components. The resulting distillate is cooled and separated into the essential oil layer and hydrosol, with the oil then undergoing under reduced pressure to isolate thymol based on its of 232°C. yields from this process range from 0.5% to 2.5% by weight of the dried plant material, with thymol constituting 37–55% of the oil, depending on the plant variety and chemotype. Alternative extraction techniques include solvent using non-polar solvents like , which dissolves thymol from the plant matrix, followed by evaporation and purification to recover the compound; this method can achieve comparable yields to but often requires additional steps to remove solvent residues. Supercritical CO2 extraction represents a modern, solvent-free approach, where dried and ground leaves are subjected to CO2 under supercritical conditions (e.g., 300 bar and 40°C) in a high-pressure vessel, followed by depressurization in cascaded separators to fractionate the extract; this yields thymol-rich fractions with purities exceeding 70%, such as 75% from zygis, and is preferred for producing high-purity isolates (>95%) suitable for pharmaceutical applications. Yield optimization in natural extraction is influenced by factors such as timing, with maximum and thymol contents achieved during or immediately after full bloom, when peak; for instance, thymol levels can reach 69% in the at this stage compared to lower values pre-flowering. Plant density and practices also play a role, as higher densities can increase yield per , though excessive crowding may reduce quality. On an industrial scale, natural faces challenges like seasonal availability and variability in plant sourcing; the global natural thymol supply is estimated in the low thousands of tons annually as of 2025, primarily from Mediterranean regions where is cultivated, while total market (including synthetic) exceeds 10,000 tons.

Synthetic Production

Thymol can be synthesized industrially from , a petroleum-derived , through a classical multi-step process involving sulfonation followed by fusion. The process begins with the sulfonation of p-cymene using concentrated to form cymene-3-sulfonic acid, which is then converted to its sodium salt. This salt is subsequently fused with at elevated temperatures (280–310 °C) in a , leading to the rearrangement and formation of thymol via migration of the isopropyl group. This method achieves yields of approximately 40-60%, making it scalable for commercial production despite the high temperatures and corrosive conditions required. Modern synthetic routes have expanded beyond the classical pathway to include dehydrogenation of , a cyclic derived from oil or other , using catalysts such as nickel supported on and . In this approach, undergoes and dehydrogenation under controlled conditions to yield thymol, offering an alternative starting material that leverages abundant feedstocks. Additionally, alkylation of with isopropanol in the gas phase serves as another contemporary method, where the phenolic ring is functionalized to produce thymol directly. These routes maintain the key sulfonation-fusion step in some variants— reacts with H₂SO₄ to form the intermediate, followed by NaOH fusion—but incorporate milder conditions for improved efficiency. Recent advancements emphasize catalyzed methods for greener , such as -based for the or steps. For instance, zeolites with tailored acidity and , like H-BEA or H-MFI types, facilitate the selective of to thymol by promoting isopropyl group attachment while minimizing side products, operating under lower temperatures and pressures than traditional fusions. A 2022 study highlighted zeolite composites for related modifications, underscoring their role in sustainable , though direct thymol from cymene remains under exploration for reduced energy use. These catalytic approaches enhance scalability by enabling continuous flow processes and reducing waste. Emerging bio-based methods include microbial using engineered or to biosynthesize thymol from glucose or renewable feedstocks, achieving titers up to several grams per liter in lab-scale fermentations as of 2025. This approach offers a sustainable alternative to routes, with potential for industrial scaling to reduce environmental impact. Synthetic thymol typically achieves purity levels exceeding 99%, surpassing natural extracts due to controlled reaction conditions and purification steps like or . As of 2025, bulk synthetic thymol is priced at approximately $10-20 per kg, generally lower than natural thymol at $20-60 per kg depending on grade, driven by efficient feedstocks and large-scale . This cost advantage supports wider industrial adoption. The shift toward synthetic production addresses concerns by reducing reliance on harvesting, which can strain resources like fields, and offers a controlled process with minimal environmental footprint compared to extensive . However, dependence on petrochemical-derived raises issues of use and potential emissions, prompting ongoing research into bio-based precursors for fully renewable routes.

Historical Development

Early Discovery and Traditional Uses

Thymol, primarily known through its presence in , featured prominently in ancient practices for mummified bodies, with chemical analyses of remains from the New Kingdom (c. 1570–1069 BCE) suggesting the possible use of for its preservative and terpenoids. This application leveraged 's natural antibacterial properties to inhibit decay, as was among the resins and plant materials applied during the ritual process to ensure long-term preservation. In and , thyme gained recognition for its medicinal value, particularly in addressing respiratory ailments. (c. 460–370 BCE), often regarded as the father of Western medicine, prescribed thyme preparations to treat coughs, , and other pulmonary conditions, emphasizing its expectorant and soothing effects. Similarly, the Greek physician Dioscorides, in his first-century AD text , detailed thyme's antiseptic qualities and recommended it for respiratory infections, , and as a remedy to clear congestion, influencing herbal traditions across the Mediterranean. The isolation of pure thymol marked a significant milestone in its history, first achieved in 1719 by German chemist Caspar Neumann, who extracted it from oil, though its full chemical characterization awaited later advancements. The structure of thymol was later elucidated by Wallach in the 1880s. By 1853, French chemist Alexandre Lallemand had purified the compound and formally named it thymol, deriving the term from its origins while determining its . Traditional uses of thymol-rich extended into the in , where it served as an antiseptic in ointments for wounds, burns, and skin afflictions, as noted by (12th century) for purifying unhealthy flesh and treating . In both and the , thyme acted as a natural for meats and foods, valued for its heating and drying properties that warded off spoilage and bacterial growth during storage and trade. Via ancient spice routes, these practices influenced Ayurvedic traditions in , where ajwain seeds—abundant in thymol—were employed for digestive relief, including , , and , by stimulating gastric secretions and easing intestinal contractions. Before 20th-century developments, thymol's applications remained constrained by the absence of pure isolation techniques, relying instead on crude distillations from plants like , which limited potency and standardization in remedies across cultures.

Modern Research and Commercialization

In the early 20th century, thymol gained prominence in commercial products like , which was first marketed over-the-counter in 1914 and became widely used by 1916 for its properties derived from including thymol. During the 1930s, initial scientific investigations into thymol's antimicrobial effects emerged alongside the pre-antibiotic era focus on natural antiseptics, laying groundwork for its validation as an antibacterial agent. More recently, in the , studies have examined thymol-containing for antiviral activity against , demonstrating reductions in in through assays on commercial formulations with . Commercialization of thymol accelerated post-World War II, with patents in the 1950s developing pesticide formulations leveraging its insecticidal and fungicidal properties, such as in botanical-based crop protection products. The global thymol market has grown steadily, reaching approximately USD 108 million in 2024 and USD 115 million in 2025, primarily driven by demand for natural preservatives in food, cosmetics, and pharmaceuticals amid consumer preference for clean-label ingredients. Recent research from 2023 to 2025 has focused on nano-encapsulation techniques to improve thymol's and controlled release for , such as chitosan-based nanoparticles that enhance and stability in oral applications. Similarly, studies have highlighted thymol's anti-biofilm efficacy against (MRSA), with nanoformulations showing synergistic effects in disrupting mature biofilms and reducing bacterial virulence in post-2020 contexts. Thymol received FDA (GRAS) status in the 1960s through the Flavor and Extract Manufacturers Association (FEMA) evaluations for use as a flavoring agent and in and drugs. In the , 2024 approvals expanded its use as a sensory additive in , authorizing thymol up to specified levels in premixtures for and pigs. A key commercialization challenge remains standardizing natural versus synthetic thymol, as natural extracts vary in purity due to plant sourcing inconsistencies, while synthetics ensure reproducibility but face higher production costs and regulatory scrutiny for equivalence.

Applications and Uses

Medical and Antimicrobial Applications

Thymol serves as a key antiseptic agent in oral care products, particularly mouthwashes like , where it is included at concentrations of 0.05-0.1% as part of an blend (eucalyptol, , , and thymol). This formulation demonstrates significant reductions in plaque and , with clinical studies showing up to 32.4% improvement in gingival index and 56.2% in plaque index after 3-6 months of adjunctive use alongside mechanical . The antimicrobial mechanism involves disruption of bacterial cell membranes, inhibiting growth and attachment of periodontal pathogens such as and . In pharmaceutical applications, thymol, as a component of thyme preparations, functions as an expectorant in cough syrups and lozenges, aiding in the relief of respiratory symptoms by promoting mucus clearance and reducing cough irritation. It also exhibits potent antifungal properties against Candida species, with minimum inhibitory concentrations (MICs) ranging from 39-78 μg/mL for C. albicans, C. tropicalis, and C. krusei, achieved through binding to ergosterol in fungal membranes, which increases permeability and induces cell death. Synergistic effects with nystatin reduce the MIC of both agents by approximately 87%, enhancing efficacy against oral candidiasis via a fractional inhibitory concentration index of 0.25. Emerging research highlights thymol's potential in wound healing, with recent studies (2023-2024) evaluating thymol-loaded biopolymer scaffolds, such as isabgol/konjac glucomannan gels, that promote tissue regeneration through antioxidant and antibacterial actions in in vitro models of skin wounds. These formulations accelerate healing by reducing inflammation via inhibition of the NF-κB signaling pathway, which downregulates pro-inflammatory cytokines like TNF-α and IL-6. Additionally, thymol-chitosan gels at 5% concentration have shown promise in treating cutaneous leishmaniasis wounds by enhancing epithelialization and reducing parasite load in a pilot clinical study in patients. In , thymol is incorporated into poultry feed additives, authorized by the in 2023 (extending prior approvals) as part of preparations with and other compounds to support gut health and control in chickens for fattening and laying. studies confirm thymol's anticoccidial activity, inhibiting Eimeria sporozoite invasion and oocyst sporulation at concentrations ≥2%. Thymol's antimicrobial efficacy is evidenced by MIC values of 200-400 μg/mL (0.02-0.04%) against , primarily through membrane permeabilization and inhibition. It exhibits synergies with antibiotics, such as reducing the MIC of by over 4-fold against multidrug-resistant E. coli strains and enhancing activity against via fractional inhibitory concentration indices <0.5. These interactions restore susceptibility in resistant isolates without promoting further resistance development.

Industrial and Other Applications

Thymol serves as a , leveraging its properties to inhibit oxidation and extend in various products. In the United States, it is recognized as (GRAS) by the (FDA) for use as a synthetic agent under 21 CFR 172.515 and as a or indirect under 21 CFR 175.105, allowing its incorporation into foods such as meats and to prevent spoilage. Studies have demonstrated its efficacy in reducing oxidative rancidity in meat products when applied via essential oils or direct addition. In the cosmetics industry, thymol is incorporated into perfumes, deodorants, and personal formulations at low concentrations, typically below 1%, to provide fragrance with , notes and benefits that help preserve product integrity. Its soothing and anti-aging properties make it suitable for and oral applications, where it acts as a without the volatility of . Agriculturally, thymol functions as a , with the U.S. Environmental Protection Agency (EPA) granting exemptions from tolerance requirements for its residues in commodities since 2003 and reaffirmed in subsequent decisions, enabling its use in insect control. It is particularly valued in for formulations targeting mites, such as thymol-based gels that disrupt mite reproduction without harming bee colonies when applied correctly. Beyond these sectors, thymol is utilized as an antioxidant additive in polymers, enhancing the stability of biodegradable and packaging materials by scavenging free radicals and preventing degradation. It also appears as a component in products and certain e-liquids, contributing spicy, undertones to mimic natural profiles. The global thymol market, driven by demand for natural alternatives, allocates a substantial portion—with a size of approximately USD 0.11 billion in 2024 and projected to reach USD 0.16 billion by 2033—to and agricultural applications, with increasing emphasis on sustainable sourcing from extracts to meet eco-friendly standards.

Safety, Toxicology, and Environmental Effects

Human Health and Toxicology

Thymol demonstrates low acute oral , with a reported LD50 of 980 mg/kg body weight in rats. Acute dermal exposure also indicates low , classified as practically non-toxic, due to limited absorption through . In terms of chronic effects, thymol is generally safe for human use at concentrations below 1% in consumer products, such as and oral care formulations, where exposure levels remain low. However, higher concentrations can cause to and eyes, manifesting as redness or burning sensations, and rare cases of have been documented, particularly in sensitive individuals. Thymol is metabolized rapidly in the liver through conjugation with and , forming and metabolites that are primarily excreted in the , with approximately 16% of the dose recovered within 24 hours. Reproductive toxicity studies in animals show no adverse effects up to a NOAEL of 200 mg/kg/day, suggesting low risk during , though human data is limited. High doses are not recommended for children due to potential irritation and limited safety data in . Recent assessments, including a 2024 fragrance , confirm thymol's lack of , with negative results in the Ames bacterial reverse test and other assays. A (NOAEL) of 13.33 mg/kg/day has been established from repeated-dose studies, supporting its at typical exposure levels.

Environmental Fate and Pesticidal Uses

Thymol undergoes rapid in environmental compartments such as and , primarily through microbial oxidation processes. Studies indicate that it is readily biodegradable, with dissipation half-lives (DT50) conservatively estimated at 1 day in and ranging from 1 to 5 days in under aerobic conditions. Its potential for is low, as evidenced by an (log Kow) of 3.3, which limits significant uptake and magnification in food chains. These properties contribute to thymol's minimal persistence in the , reducing long-term ecological risks. Regarding ecotoxicity, thymol demonstrates low acute toxicity to bees, with a topical LD50 exceeding 100 µg/bee, making it suitable for applications in apiculture. In aquatic systems, it exhibits moderate toxicity, with a 96-hour LC50 of approximately 3.2 mg/L for fish species such as . The U.S. Environmental Protection Agency (EPA) classifies thymol as a low-risk biochemical , reflecting its favorable environmental profile when used according to guidelines. Thymol's pesticidal applications leverage its natural and repellent properties. It serves as an effective miticide, notably in products like Apiguard, which contains 25% thymol and is EPA-registered for controlling mites in hives without requiring supers to be removed. Additionally, thymol is incorporated into EPA-registered insect repellents targeting pests such as mosquitoes and ticks, with formulations from the 2020s enhancing its efficacy through optimized delivery systems like gels and emulsions. As a biobased compound extracted from plants like , thymol offers a sustainable alternative to synthetic s, aligning with Green Deal goals to reduce chemical pesticide use by 50% by 2030, supporting strategies.

Regulatory and Compendial Status

Pharmacopeial Standards

The (USP) and National Formulary (NF) define thymol as containing not less than 99.0% and not more than 101.0% of C₁₀H₁₄O, calculated on the dried basis, to ensure its suitability for pharmaceutical use. Identification is established through infrared absorption spectrophotometry, comparing the spectrum to that of a USP Thymol Reference Standard, and by range determination between 48°C and 51°C. Impurity limits include nonvolatile residue not exceeding 0.05% and residue on ignition not more than 0.1%, with the assay conducted via to quantify the thymol content accurately. The (EP) and (BP), which are harmonized, specify thymol as 5-methyl-2-(1-methylethyl)phenol (C₁₀H₁₄O; Mᵣ 150.2), with a content of 97.0% to 102.0% determined by . Identification methods include infrared absorption matching the reference spectrum, between 48°C and 52°C, and color reactions producing violet in with dilute or bluish-green with a mixture of anhydrous acetic acid, , and . Purity tests limit related substances to a total of not more than 1.0% via (disregarding peaks below 0.05%), with residue on evaporation not exceeding 0.05% and no or color beyond specified references; storage is required in airtight containers protected from light. The Japanese Pharmacopeia (JP) requires thymol to be white to pale yellow crystals or powder, with a purity of 97.0% to 102.0% assayed by , and a melting point of 49°C to 51°C. Identification confirms compliance through clarity, color, (≤20 ppm), (≤2 ppm), and related substances (≤1.0%), alongside residue on ignition not more than 0.10%. For herbal medicinal products, the (WHO) references specifications in monographs for L. herba and aetheroleum, where thymol is a key component; these require essential oil content of at least 1.2% (v/w) in the herb, with thymol and comprising not less than 40% of the oil, verified by to support traditional uses in and remedies. Common pharmacopeial testing methods for thymol emphasize chromatographic techniques for purity and , such as with flame ionization detection to separate and quantify thymol from impurities like (limited to <0.5% in some specifications) and other related . serves for structural identification by matching absorption bands characteristic of the phenolic and isopropyl groups, while residue tests involve ignition or evaporation to assess inorganic or nonvolatile contaminants below 0.1%. In the United States, thymol is classified as (GRAS) for use as a synthetic substance and in foods under 21 CFR 172.515, permitting its addition to various food products at levels not exceeding good manufacturing practices. It is also approved by the (FDA) for incorporation into over-the-counter (OTC) drug formulations as an antibacterial and agent in products such as mouthwashes and topical antiseptics. Additionally, thymol has been granted exemptions from tolerance requirements for residues in food commodities when used in biochemical applications, such as mite control in hives. In the , thymol is authorized as a substance under (EC) No 1334/2008, designated with the FL No. 04.006, allowing its use in foodstuffs provided it complies with purity criteria and maximum levels specified in Annex I. The substance is registered under the REACH (EC) No 1907/2006, with the (ECHA) overseeing its dossier for chemical safety assessments and risk management. Thymol is approved as an active substance for plant protection products under (EC) No 1107/2009 via Commission Implementing (EU) No 568/2013, and it holds approval under the Biocidal Products (EU) No 528/2012 for specific product types, including repellents and insecticides, subject to efficacy and safety evaluations by member states. In , thymol is recognized as a medicinal ingredient in natural health products (NHPs) under Schedule 1, item 2, of the Natural Health Products Regulations, enabling its use in licensed formulations such as throat lozenges and antimicrobial supplements after review by for safety and efficacy. The Pest Management Regulatory Agency (PMRA) has also issued registration decisions approving thymol-based products for pesticidal uses, including varroa mite control in apiculture, with established maximum residue limits where applicable. Regarding international restrictions, thymol faces no specific concentration bans in EU cosmetics under Annex III of Regulation (EC) No 1223/2009, though its inclusion must adhere to general safety assessments for skin sensitization and irritation potential. High-purity thymol does not appear subject to specialized export controls under frameworks like the or dual-use regulations, facilitating global trade primarily under standard hazardous materials shipping guidelines. As of 2025, regulatory landscapes continue to evolve; for instance, the , post-Brexit, regulates thymol under the UK REACH framework, mirroring EU standards for registration and authorization while introducing independent notifications via the . In the region, harmonization efforts under the updated ASEAN Cosmetic Directive (version 2024-2, effective December 2024) streamline import notifications for cosmetic ingredients like thymol, reducing variability across member states and aligning with international safety norms, though product-specific assessments remain mandatory.

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