国内外合成生物学化妆品原料的研究进展与监管

doi:10.3969/j.issn.2097-2806.2025.03.013

Abstract

Abstract:

The use of synthetic biology technology to develop cosmetic ingredients is attracting widespread attention due to its effectiveness, safety, and environmental friendliness. This article explains the concept of synthetic biology and its key technologies and current status in the production of cosmetic ingredients. It also briefly analyzes the regulatory approaches to synthetic biology-based cosmetic ingredients in different countries and regions, providing guidance for the management of this field in China. The goal is to ensure product safety, enhance consumer trust, and promote the healthy development of the industry.

Key words: synthetic biology, cosmetic ingredients, regulatory policies

CLC Number:

TQ658

Yunping Lan, Zhijie Xie, Chujie Zhao, Xiaochun Liu, Shiqiong Wang, Qiuxing He. The research progress and regulation of cosmetic ingredients produced by synthetic biology at home and abroad[J].China Surfactant Detergent & Cosmetics, 2025, 55(3): 367-380.

Figures/Tables 5

Tab. 1

Application, advantages and disadvantages of four production technologies of cosmetic raw materials"

Production technology	Principle	Merit	Defect
Chemical synthesis technology	Compounds are synthesized by oxidation, reduction, alkylation, acylation and other chemical reactions	1. High stability and strong functionality: The chemical synthesis production process of the anti-aging component Pro-xylane is relatively controllable, which can ensure the purity and quality stability of the product^[1]. 2. Diversified and efficient production: Some commonly used preservatives, surfactants, etc., can achieve low-cost, high-efficiency and diversified production through chemical synthesis technology	1. Pollute the environment: Some synthetic volatile organic compounds （VOCs） can cause air pollution. For example, during the production of nail polish, hair dye and phenylenediamine oxidative dyes^[2]. 2. Have a relatively high safety risk: Cocamide DEA is used rather frequently in cosmetics. However, under certain conditions, it may form N-nitrosamine compounds, which pose certain safety risks^[3]
Phytoextraction technique	The extraction of effective components from natural plants includes traditional technologies such as water extraction, alcohol extraction, organic solvent extraction, steam distillation and modern technologies such as supercritical CO₂extraction technology	1. Natural, mild and multi-functional: Artemisia annua oil extracted from Artemisia annua has the effects of anti-inflammatory, soothing, regulating microecology and repairing skin barrier in skin care products^[4]. 2. High efficiency and environmental protection: mild fermentation conditions, reduce energy consumption^[5]. 3. Sustainability and environmental protection: The technology of plant extraction is relatively more sustainable	1. Enrichment toxicity of chemical components: For example, Sophora flavescens is originally non-toxic, but after extraction, when alkaloids are enriched, it may become toxic. In addition, attention should also be paid to the transformation process of chemical components in the body. For instance, oxymatrine can be converted into matrine in the body^[6]. 2. Risk of impurity residue introduction: Physical pressing extraction may have pesticide residues. There may be solvent residues in the extraction. Extraction with resin materials may introduce monomers, porogens or cross-linking agents^[7]. 3. Resource and cost constraints: limited resources and complex extraction. For example, the extraction of paclitaxel from yew trees and the extraction of wild ginseng
Bio-fermentation technology	Using enzyme engineering, microbial metabolic engineering and biochemical engineering, as well as cell growth characteristics and biocatalytic systems to react with organic substrates	1. Enrich functional substances: The content of polysaccharides, flavonoids and peptides in Ganoderma lucidum fermentation broth is higher than that of Ganoderma lucidum aqueous extract^[8]. 2. Reduce toxicity: Microbial fermentation of ginkgo leaves increased the content of active components such as flavonoids and lactones, while the toxic component ginkgolic acid was decomposed and transformed^[9]	1. Complexity in product purification: In the fermentation process, it is necessary to purify and dispose of the harmful substances that may be produced, increasing the complexity and cost of the production process. For example, in the bio-fermentation expression of collagen, there are drawbacks such as the difficulty in resolubilizing inclusion bodies and incorrect folding^[10]. 2. Strict production conditions: The fermentation system is extremely sensitive to the growth environment, such as temperature, nutrient concentration, pH, dissolved oxygen concentration and other factors^[11]
Synthetic biology	Converging multiple disciplines, by writing DNA to guide organic reactions and constructing synthetic components with predictable and controllable properties	1. Renewable and sustainable raw materials: Hyaluronic acid is produced by fermentation through synthetic biology technology to reduce the dependence on animal resource extraction. β-Farnesene is produced by fermenting sucrose with yeast engineering cells, and then high-purity squalene products are prepared by chemical reaction and purification^[12]. 2. High product quality and purity: Tetrahydropyrimidine is developed by synthetic biology technology, and the purity of the product can reach over 98%^[13,23]. 3. Directional design and diversification: Construction of recombinant collagen with different molecular weight. The production of hyaluronic acid with different molecular weights is achieved by modifying microbial chassis cells^[14]	1. Technical sophistication: The exploration of metabolic pathways has always been a difficult point in synthetic biology, such as the synthesis of aromatic natural products and terpenoids. 2. Product safety verification and long-term monitoring: Some cosmetic raw materials produced by synthetic biotechnology on the market lack long-term human safety data. For example, although certain new bioactive substances have shown good effects in short-term laboratory tests and animal experiments, they may have potential adverse effects during long-term use by humans, such as allergic reactions and immune reactions. 3. Complex intellectual property rights and regulatory issues: The intellectual property system and standard system play a vital role in the process of technology research and development, product access and application development^[15]. How to strike a balance between regulation and the innovation of synthetic biology remains a problem yet to be solved

Tab. 1

Fig. 1

Fig. 2

Tab. 2

Synthetic pathways of cosmetic raw materials in synthetic biology and non-synthetic biology in recent years"

Component	Main efficacy	Synthetic biology pathway	Non-synthetic biological pathways
Hyaluronic acid （HA）	Moisturizing, skin repair, and anti-oxidation	By applying synthetic biology techniques, HA production can be enhanced through constructing heterologous HA synthesis pathways, strengthening precursor synthesis gene expression, reducing carbon flux in competitive metabolic branches, modifying HA synthase, and optimizing fermentation conditions^[21]	HAS catalyzes the polymerization of HA chains using Mg²⁺ and two precursor substrates, GlcA-UDP and GlcNAc-UDP^[22]. Synthesis of HA by Streptococcus metabolic pathway
Collagen	Moisturizing, promoting skin repair and regeneration, maintaining skin elasticity	By applying synthetic biology techniques, recombinant collagen production is achieved through constructing engineered cell banks, building expression systems, precisely controlling fermentation, and purifying cell expression systems^[23]	Mainly through animal and plant extraction
Niacinamide	Whitening, anti-acne, anti-aging, and anti-inflammatory	By modifying redox enzyme coenzyme preferences for NAD and NADP, target compound yields can be increased; engineering yeast cell surfaces to alter nicotinamide riboside kinase enables whole-cell catalysis of β-nicotinamide mononucleotide production^[24,25]	This can be prepared by dehydrating the salt formed from niacin and ammonia. Additionally, it can be extracted from natural biomaterials that contain niacinamide or its precursors
Astaxanthin	Antioxidant, anti-inflammatory, moisturizing, whitening, and anti-wrinkle	By establishing CRISPR/Cas9 technology, genes involved in the biosynthetic pathway of astaxanthin have been integrated into three chromosomal loci of Pichia pastoris, thereby creating a cell factory for astaxanthin production^[26]	Haematococcus pluvialis and Chlorella zofingiensis are key strains for astaxanthin production Haematococcus pluvialis and Chlorella zofingiensis are key strains for astaxanthin production^[27]
Ergothioneine （ERG）	Antioxidant, whitening, and anti-aging	By modifying the key enzymes Nc Egt1 and Egt D in an ergothionein-producing strain, the yield of ergothionein is improved^[28]	Extraction methods include biological extraction （using raw materials like fruiting bodies of edible fungi, plant seeds, and animal tissues）, chemical synthesis, and biosynthesis （through microbial liquid fermentation and bioconversion）^[29]
Ceramide	Moisturizing, skin repair, anti-inflammatory, and anti-aging	By strengthening precursor pathways （e.g., regulating palmitoyl-CoA and L-serine levels）, weakening competitive pathways （e.g., knocking out kinases）, and relieving feedback inhibition （e.g., deleting ORM1 and ORM2 genes）, ceramide production can be enhanced^[30]	Among the plant sources for natural extraction are konjac, rice bran, potatoes and so on. Ceramide is extracted by yeast fermentation. Chemical synthesis: using 2, 4-O-benzylidene-D-threose as the starting material, ceramide is synthesized through a series of chemical reactions^[31]
Sialic acid	Moisturizing, and antioxidant	By utilizing whole cells, Neu5Ac can be produced from GlcNAc and pyruvate or directly from unrelated carbon sources via microbial fermentation^[32]	Extraction can be performed from plants, animals, and microorganisms
Squalane	Sebum regulation, and antioxidation	By enhancing precursor supply, knocking out competitive pathways, modifying enzymes, expressing heterologous genes, regulating central carbon metabolism, enabling coenzyme regeneration, and utilizing promoter engineering, squalene production can be increased^[33]	Extract from shark liver
Arbutin	Melanogenesis inhibition, antibacterial and anti-inflammatory activity	By introducing 4-hydroxybenzoic acid hydroxylase from Candida parapsilosis CBS604 into Escherichia coli, catechol production is catalyzed^[34]	β-Arbutin can be extracted from sources such as bearberry leaves, pears, wheat, coffee, and tea. Additionally, plant cell culture techniques can be used to convert exogenous catechol into β-arbutin
Succinic acid	pH regulator, anti-oxidation, and promoting blood circulation	By expressing malate dehydrogenase derived from Corynebacterium glutamicum in Mannheimia succiniciproducens, the production of malate can be enhanced^[35]	Initially, succinic acid is extracted from natural amber, and later, it began to be produced through chemical synthesis and biological fermentation
γ-polyglutamic acid	Tyrosinase activity inhibition, and melanin production reduction	By applying CRISPR-Cas9n technology to modify Bacillus amyloliquefaciens, the yield of γ-polyglutamic acid is enhanced^[18]	It is primarily found in microorganisms such as Bacillus anthracis, Bacillus licheniformis, and Bacillus subtilis
Malic acid	pH regulator	By modifying metabolic pathways and applying genetic engineering in Aspergillus niger, citric acid accumulation is reduced, with enhanced glycolysis flux, and increased malic acid yield; in Escherichia coli, overexpressing PEPC and MDH redirects metabolic flux toward L-malic acid synthesis^[19,36]	Malic acid can be produced using various microorganisms, including Aspergillus, Escherichia coli, Saccharomyces cerevisiae, and Pichia pastoris

Tab. 2

Tab. 3

References 65

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Country / Region	Supervisory body	Supervision laws	Regulatory focus	Supervision characteristics	Reference
USA	Food and Drug Administration （FDA）	Federal Food, Drug, and Cosmetic Act （FDCA）	Safety, and innovation encouragement	State-level supervision is the main way. FDA guarantees overall safety and encourages innovation	[50]
EU	European Commission （EU）, Scientific Committee on Consumer Safety （SCCS）	EU Cosmetics Regulation （EC） 1223 / 2009	Safety, and risk assessment	Negative List Management （Disabled and Restricted Substances List）, and SCCS Safety Assessment	[51]
Japan	Ministry of Health Labor	Cosmetics safety standards and other relevant provisions	Safety, and compliance	Negative list system, and industry independent standard auxiliary management	[52]
Korea	Ministry of Food and Drug Safety （MFDS）	Cosmetics Law and its implementation order, implementation rules, etc.	Safety, and functional review	Prohibited component management, functional cosmetics review, and focus on safety supervision	[53]
China	State Food and Drug Administration （NMPA）	Cosmetics supervision and management regulations, etc.	Safety, and effectiveness	Classified management, new raw materials need to register or record, strict technical review and safety assessment	[54]

The research progress and regulation of cosmetic ingredients produced by synthetic biology at home and abroad

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