Under Graduate Scholar, Pravara Rural College of Pharmacy Pravaranagar, Loni
Most of the products are synthetic, but herbal-based cosmetics become a part of attention at the global level due to their natural benefits and?fewer side effects. While this extraterrestrial promise?continues to exist, and the regulations are in place, ensuring safety, efficacy, and consistency of quality continues to be the main hurdle. Standardization is a key step in achieving uniformity in batches of herbal cosmetics but is challenging due to the variability in phytochemical?constituents of plant-based ingredients determined by species and environmental and cultivation factors.This review highlights current methodologies and challenges in standardizing herbal cosmetics. Key aspects discussed include Good Manufacturing Practices (GMP), phytochemical profiling, marker-based standardization, and the role of regional regulatory guidelines. Additionally, advanced analytical techniques such as chromatography, spectroscopy, and molecular fingerprinting are examined for their role in improving quality consistency.This review focuses on the regulatory frameworks, and collaboration with the industries to uphold some standard protocols on an urgent basis as the demand for natural herbal products is rising day to day. This will ensure safety, efficacy, and consumer satisfaction in the growing market.
As per the Drugs and Cosmetic Act, Cosmetic is defined as the articles intended to be rubbed, poured, sprinkled or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance [1]. The term cosmetic is derived from the Greek word "Kosmeticos," which means the art of arranging or decorating [2] [5]. Natural and herbal products have driven and expanded very rapidly in the global cosmetic industry. Due to this challenge for the standardization enhancement mainly involve variability in plant-based products, and therefore the trend highlights the need for clear regulations [5]. Many herbal cosmetics have the source of new ingredients particularly giving the traditional medicinal value in the regions of natural products. In developed countries like India, US, and Europe there is an increase in demand for plant extracts containing new ingredients that are highly required for depigmentation, anti-wrinkling, and cosmaceutical applications. Industreis also works on formulating agents that enhance collagen synthesis, melanogenesis, and reduce skin inflammation [14]
Fig.1.1 Herbal Cosmetics
The products are classified as drugs or cosmetics or both under the FDA, Drugs and Cosmetic Act according to U.S. Food and Drug Administration (FDA), however the “Cosmaceuticals” lacks the legal definition [1]. Herbal cosmetics come under key categories, including facial care, hair care, severe issues related to acne, and depigmentation. Another category surrounds the formulations like herbal shampoos, soaps, powders, and fragrances [2]. The standardization process is critical in providing consistent quality, safety, and efficacy, in herbal preparations. Compliance with regulatory bodies not only ensures safety, and defined labeling but also promotes market growth by trade errors [5] [6]. The various current challenges in standardizing herbal cosmetics and methodologies are covered in this review. This review aims to develop consumer trust, market expansion, and quality of the herbal products.
Challenges in Standardisation:
Major challenges in standardizing herbal cosmetics come from the variability of plant-based raw materials, that mainly influenced by differences in species category, cultivation processes, and harvesting techniques [17]. Furthermore, differences in phytochemical constituents which are often due to climate conditions, and soil variations, along with complications like adulteration, and substitution of raw materials present significant challenges [18]. However, processing variations including drying, extraction, as well as storage criteria, can crucially impact the quality and potency of the final herbal product. Therefore consistency in herbal cosmetics makes become difficult to achieve compliance with their safety and efficacy without standardizing procedures [17]. Also, herbal cosmetics are difficult in certain cases such as delayed action in skin conditions due to their holistic character. Some of them do not meet the quality control measures which again affect their efficacy and reliability. Additionally, they fail to fulfill the outlook of scientific data to maintain their effectiveness, leading to the development of further research and evaluation [10]. Formulating remedial products for complex diseases is difficult due to customer expectations for plant-based products. These products further need various actual active ingredients with their safety, efficacy, and therapeutic activity which should examined through appropriate trials by an official review board, and dermatologists for compliance with the FDA [8]. Identification, purity, and quality of herbal products are surrounded by holding ethical standards and carrying out modern analytical quality control techniques. The authentication process is strengthened by employing advanced quality control techniques, including phytochemical evaluation, and morphological appearance. In addition regulatory frameworks such as WHO regulation for standardization that essential for worldwide traditional herbal practices. As a result, a vigorous standardization process will satisfy consumers and support the uprightness of herbal remedies in the growing market [18]
Analytical Approaches for Standardization:
Phytochemical analysis provides standards for herbal cosmetics by giving techniques to identify and quantify active constituent’s quality and purity for efficacy. Following methods provides techniques for detection of adulteration and identify its purity such as chromatography and spectroscopy. This analytical approach help to enhance customer trust and safety analysis.
1.1 Chromatography: Chromatography and Its Types Chromatography is an essential analytical method for separating components in herbal mixtures, enabling their identification and bioactivity evaluation. Key types include:
TLC, especially high-performance TLC (HPTLC), generates detailed chromatographic profiles, aiding in the quality assessment of herbal drugs [3].
1.2 Mass Spectroscopy: Inductively Coupled Plasma Mass Spectroscopy (ICP-MS) is a key analytical technique for determining the elemental composition of medicinal plants. This is crucial for understanding their biological roles and ensuring the safety of trace elements in human diets. ICP-MS detects both ionic and non-ionic forms of elements, which can affect toxicity and bioavailability. Elements like chromium, copper, and zinc can be toxic in excess, while cadmium, lead, and mercury are harmful even at low levels. The concentration of these elements varies based on geographical factors such as rainfall, soil type, pH, and temperature, which impact the quality of herbal products. ICP-MS, along with Particle Induced X-ray Emission (PIXE), facilitates studies that link elemental content to the therapeutic effects of medicinal plants [18].
1.3 HPLC Technique: The presence of microorganisms in herbal products lacks the standards of herbals. Identifications of toxic contaminants help to enhance quality in production. Analysis of heavy metals identifies harmful elements that sometimes aggregate in formulations for consumers' safety. Several tests done on herbals, such as pesticide screening, help to ensure the absence of toxic substances in the raw material collected. All these analyses are necessary to ensure safety profiles [20].
Fig.1.2 High Performance Liquid Chromatography (HPLC)
2. Quality Control Measures:
Quality control of herbal products enhances standards and consumer trust by ensuring consistent production quality, which requires adhering to Good Manufacturing Practices. It provides stability and ensures that maintained products retain their efficacy, safety, and consistent product quality for consumers [1].
2.1 Good Manufacturing Practices (GMP): Good Manufacturing Practices (GMP) are required in all production and manufacturing areas that ensure product safety and quality. GMP applies practices from the very beginning process such as Good Agriculture Practices (GAP) for raw material integrity i.e. from cultivation to harvesting for further requirements in herbal preparations. Once herb material is harvested by appropriate technique it is stored in warehouses and preserved for their active constituents to avoid contamination. For extraction purposes, there are different methods like Supercritical Fluid Extraction (SFE), high-pressure water extraction, Microwave Assisted Extraction (MAE) which enhance the yield in the extraction process. These extracts are then used in production and then packed and marketed under GMP guidelines [1]. FDA doesn’t have regulations for herbal cosmetics, all the manufacturers are still expected to follow the GMP guidelines, but in “Cosmetic GMP Guidelines/Inspection Checklist” by the FDA, offers rules for herbal standards preparation [5].
2.2 Stability Testing: Stability studies help to maintain its shelf life during storage and use over time. Stability analysis is important during production and post-marketing as it critical for ensuring customers safety and to provide therapeutic efficacy consistently. The World Health Organisation has given importance to further studies on herbal products' safety and efficacy, assuring compliance with regulations. Furthermore, regulatory agencies like EMA and the US Food And Drug Administration provide comprehensive standards for conducting studies on the stability and safety of herbal products [9].
2.3 Microbial and Contaminant Testing: The presence of microorganisms in herbal products lacks the standards of herbals. Identifications of toxic contaminants help to enhance quality in production. Analysis of heavy metals identifies harmful elements that sometimes remain in formulations for consumers' safety. Several tests carried out on herbals, such as pesticide screening, help to ensure the absence of toxic substances in the raw material collected. All these analyses are necessary to ensure safety profiles [20].
3. Regulatory Frameworks:
3.1 Global Standards and Guidelines: Regulatory frameworks Ensure safety standards of herbal drugs. In many countries regulatory frameworks exist in developing countries like India, Bangladesh, USA, Brazil, and Australia, however, these regulations are not uniform across all these countries. In India, according to the Drugs And Cosmetic Acts 1940 and its Rules 1945 herbal drugs are supervised. For Ayurveda, Siddha, and Unani medicine the outline for Good Manufacturing Practices (GMP) is described in Schedule T and Rule 157 [9].
3.2 Regulatory Agencies: As regulatory frameworks vary across global countries; herbal products may face challenges due to differences in regulatory standards. Harmonization of regulatory standards undertaken by numerous attempts, especially in European regions, where uniformity of cosmetics is influenced by Regulation (EC) No. 1223/2009 across the state members. Diversions can noticed in Canada and the USA that follow the earlier regulatory frameworks, like FD & C and Drugs and cosmetic regulations, lacks the maximum updates, moreover in Japan, the previous rules for herbal regulation were revised in 2014 under the Pharmaceutical and Medical Devices Law, and the Cosmetic Supervision and Administration Regulation (CSAR) was introduced in 2021 and holds strict regulations for control of errors in herbal products. In Brazil, cosmetics are regulated through the Ministry of Health and ANVISA, with continuously updated amendments [6]. For the need for particular regulation demands for the formulation and marketing of herbal medicines, later amendments in the Drugs and Cosmetic Rules of 2015 were received, which were imposed by state and central; authorities. To ensure herbal medicine quality Indian pharmacopeia (IP) plays an important role in consistently producing quality products. Values of standardization, quality control measures, and further research on the Indian system of medicines are maintained by the National Policy on Indian Systems of Medicine and Homeopathy (2002) and the National Health Policy (2017). After all these challenges, GOOD Manufacturing Practices are not adhered to across most industries [9].
3.3 Challenges in Harmonization: Compliance with herbal cosmetics and products is challenging due to different regulations across countries. To fulfill overall international harmony on quality standards is difficult, due to the uneven traditional practices. That’s why harmonizing the regulations is quite difficult [13].
4. Consumer Safety and Efficacy:
The primary focus is on customer well-being. Safety measurements are calculated using an evaluated toxicological data approach. Herbal cosmetics are often considered safe but also come with a complex nature, such as variability in plant-based materials. Safety concerns are mostly related to harmful chemical substances, microbes, and physical instability, including chemicals that contain pesticides and heavy metals. The safety evaluations can be carried out by making compliance with regulatory authorities, such as the EU Cosmetic Regulation (1223/2009), through safety parameters that can be effectively measured [13].
4.1 Safety Evaluation: During standardization, several steps are involved in the safety assessments.
4.2 Efficacy Testing: Cosmetic products' efficacy enhances customer confidence, the product holds different properties that can't be neglected by consumers such as anti-aging, and skin refinement. Efficacy evaluation guidelines are mentioned by The Scientific Committee on Consumer Safety (SCCS) has published several revisions of their Notes of Guidance (NoG) for the testing of cosmetic ingredients and their safety evaluation using clinical trials and in vitro studies [28]. Clinical trials followed by human assessments and in vitro involve the study of ingredients or formulations in verified aseptic labs [21].
5. Future Directions in Standardization:
5.1 Emerging Technologies: Nanotechnology and advanced AI techniques are growing in implementing standards in herbal formulations. Processing formulations and controlling quality can be optimized by AI, and at the same time ingredients ingredient conveyance and efficacy enhanced by nanotechnology [24]
5.2 Sustainable Sourcing: The local areas can be affected by changes in biodiversity, and release pollution from plant material which can figured out by implementing Good Agriculture Practices (GAP) and, RIO Convention [25].
5.3 Unified Global Frameworks: Regulatory frameworks and ethical standards are important for improving herbal cosmetics integrity. The International Control for Harmonisation (ICH) regulates countries across the world in consideration of consumer safety, however, both manufacturers and consumers get benefits from ICH. The World Health Organisation (WHO), and the European Medicine Agency (EMA) provide standards for the stability testing of herbal cosmetics [26].
CONCLUSION:
Herbal cosmetic nowadays lacks the adherence to standardization that becomes critical in ensuring safety, efficacy, and quality which requires consistency. Certain challenges in herbal cosmetic standardization should be overcome by applying techniques like phytochemical assessments including chromatography, and spectroscopy, furthermore implementing Good Manufacturing Practices (GMP) for variability in plant materials, and adherence to regulatory frameworks gives a strong impact. Looking consistently to advance standardization, the safety of consumers depends on adhering to standardized guidelines and testing protocols provided by higher regulatory authorities. Industrial collaboration is one of the comprehensive practices for ensuring a database by joining different organizations and building quality standards for herbal cosmetics. Herbal products gain the consumer's trust because natural plants are more effective and have fewer or no adverse reactions. Standardization gives the assurance that the product is of required quality and follows the ethical standards which produce consumer confidence and stronger market integrity.
REFERENCES
Dr. Sunayana Vikhe*, Sakshi Kape, Rina Gaikwad, Mansi Jamdhade, Standardizing Herbal Cosmetics: Analytical Approaches, Regulatory Complexities, and Emerging Trends, Int. J. of Pharm. Sci., 2025, Vol 3, Issue 4, 604-611. https://doi.org/10.5281/zenodo.15152062
10.5281/zenodo.15152062
