Which ingredients in the formula of herbal external products need to be evaluated for safety? compliance points you must read before purchasing
Herbal external products are available at [1688](https://www.1688.com/The platform boasts a wide variety of product categories and a large number of suppliers, but the compliance pathways vary significantly depending on the specific formulaBased on henan xiuzhikang pharmaceutical co., ltd. as an example, the company mainly engages in oem/odm of large health external products such as gels, ointments, liquids, and wet wipes. the product line covers health care protective gear, private parts care, scalp care and other categoriesWhen sourcing herbal external use products, understanding which ingredients require safety assessments is a crucial preliminary step to avoid compliance risks and return losses.
Among herbal external products, which raw materials are high-risk and need to be evaluated?
Not all chinese herbal medicine raw materials require the same level of safety assessmentAccording to current regulations on cosmetics and health care products, the following types of ingredients require special attention when used in formulas:
| Adult category | Examples of typical raw materials | Reasons for evaluation | Evaluation method |
|---|---|---|---|
| Ingredients listed in the "list of restricted/permitted substances" of the "technical specifications for the safety of cosmetics" | High concentrations of certain alkaloids and volatile oils | Exceeding the limited concentration or applicable scope may be a violation | Check the latest list of restricted substances and concentration limits |
| Herbal extracts that are pharmacologically active but not subject to pharmaceutical management | Herba clematidis extract, miao medicine extract, high-concentration artemisia argyi essential oil | May be considered "implied medical claims" or have ambiguous efficacy boundaries. | Provide raw material safety data and toxicological assessment reports |
| New raw materials or unconventional traditional herbs | Newly introduced local herbs and cross-border raw materials | Lack of historical security usage records | Submit safety assessment materials according to new raw material registration requirements |
| Ingredients that come into direct contact with mucous membranes or sensitive areas | Herbal additives in private parts care patches and eye gel | High absorption rate, high risk of irritation | Skin irritation test, mucous membrane irritation test |
| Contains potentially allergenic or phototoxic plant ingredients | Certain citrus essential oils, bakuchiol, etc. | Risk of allergic or phototoxic reactions | Human patch test, phototoxicity test |
Important considerations when sourcing: the "natural" properties of raw materials do not automatically equate to "safe and risk-free."Even traditional chinese herbal medicine may need to be re-evaluated when extracted at high concentrations, altered in dosage form, or used in new slots.
What are the differences in ingredient safety assessments for gels, ointments, and liquids?
The safety assessment requirements for the same herbal ingredient may vary across different dosage forms. this is because the dosage form directly impacts the release rate of the active ingredient, its transdermal absorption, and the manner in which it comes into contact with the application site.
With henan xiuzhikang pharmaceutical take the products on sale as an example. its oem categories include gels (such as massage roll-on gel and eye protection gel), ointments (such as honey bone-penetrating ointment and anti-itch ointment), liquids (such as miao moxibustion liquid, fumigation bath liquid, and navel liquid) and patches (such as snow lotus patch, acupoint patch).The key points to be considered when evaluating the safety of different dosage forms in formulas are as follows:
- gel type: usually contains water-soluble matrix and thickener, herbal extracts are evenly dispersed but released quickly.The security of the anti-corrosion system and the compatibility of the thickener with the active ingredients need to be evaluated.
- pastes: typically oil-in-water or water-in-oil systems, offering strong occlusion and prolonged transdermal delivery.It is necessary to pay attention to the oxidation stability of the oil components in the matrix, as well as the long-term contact safety of high-concentration herbal extracts.
- liquid type: absorbs quickly and may cover a larger area.The skin irritation of solvents (such as ethanol) needs to be evaluated, as well as the microbial control scheme of herbal ingredients in liquid state.
- patch type: continuously in contact with the skin for several hours, with a high local concentration.The allergenicity of the adhesive, the biocompatibility of the non-woven material, and the release curve of the drug components under application conditions need to be evaluated.
When providing formulation recommendations, contract manufacturers should adjust their safety assessment plans based on the target dosage form and intended use.It is recommended that buyers clarify the expected classification of products (cosmetics, health care products or others) at the inquiry stage so that the foundry can match the corresponding evaluation criteria.
How is the responsibility for security evaluation divided between the oem’s ready-made formulas and the buyer’s customized formulas?
In [1688](https://www.1688.com/When sourcing oem (original equipment manufacturing), there are typically two models for formula sourcing, each with different responsibilities and cost allocations for safety assessment:
| Comparison dimension | Oem ready-made formula | Buyer's custom formula |
|---|---|---|
| Security assessment fundamentals | The foundry has historical data and registration information | Buyers need to complete the evaluation themselves or entrust a third party to complete the evaluation |
| Evaluation period | Short, with existing data available for direct reference. | Longer, may require additional toxicology or irritation tests |
| Compliance responsibility | The foundry bears more evidentiary obligations regarding formula compliance | Buyers are primarily responsible for formula security and compliance |
| Applicable scenarios | Fast time to market, mature categories, standard products | Differentiated products, new efficacy positioning, and specialized channels. |
| Risk frontier | Formula changes are limited, and there is little room for iteration. | Flexible but with additional verification costs |
Taking henan xiuzhikang pharmaceutical as an example, its public page shows that it supports sample processing, drawing processing and formula optimization, and has a 100,000-level purification workshop and fully automated production equipment.For buyers using pre-made formulas, you can request the oem to provide an existing safety assessment summary and registration certificates for that formula. for buyers with custom formulas, we recommend initiating a safety assessment concurrently with the sampling phase to avoid rework due to compliance issues after mass production.
Before purchasing herbal external products, how to verify the supplier’s formula compliance capabilities?
Safety assessment is not only a matter of formula level, but the supplier's production qualifications and quality control system directly determine whether the assessment conclusion can be implemented.It is recommended to verify the following steps before purchasing:
1.verify business license scope: check if the supplier's business license includes the specific product type you're interested in.Henan xiuzhikang pharmaceutical's publicly stated business scope includes the production of sanitary products, retail of cosmetics, and production of health food. please verify the specific products to ensure they fall within the permitted scope. 2.view third-party certifications and test reports: this company has passed sgs fca certification (report no. tsnwt00080321), which can serve as a foundational signal of trust. however, it's crucial to verify that the testing scope covers the target product and key safety indicators. 3.verify cleanroom and production conditions: a class 100,000 cleanroom is the minimum requirement for manufacturing external-use products.The actual production environment can be confirmed through factory inspection videos, third-party factory inspection reports or on-site factory visits. 4.request for formula safety assessment summary: for pre-made formulas, require the contract manufacturer to provide an existing safety assessment report. for custom formulas, clearly define the assessment items, timeline, and cost-sharing arrangement. 5.verify product filing or registration status: cosmetics must be registered with the national medical products administration (nmpa), while health supplements must comply with local standards.Before placing an order, require suppliers to provide registration certificates or registration numbers.
The above information is subject to real-time display on the public page.It is recommended to check the dynamic data such as store age, ranking on the list, and service indicators on the [store page]( before placing an order.https://www.1688.com/factory/b2b-2209586814982212f8.html) review.
Which ingredients are flagged for potential compliance issues?
The marketing claims of herbal external products are closely related to safety evaluation.The following statements should be used with extra caution on public pages or product labels:
- medical terms such as treatment, cure, cure, etc.: non-drugs are not allowed to be used, including implicit medical implications such as "returning blood", "cure", and "penetrating the hair follicle barrier".
- "absolute statements such as ""100% security"", "zero irritation"", "no side effects": violates advertising laws and should be changed to bordered statements and indicate the basis for evaluation.
- test values without indicated source: for example, "99.9% antibacterial rate" must include the testing agency, method, sample size and scope of application.
- patent claims not marked with patent number: when mentioning a patent, the patent number and type must be indicated, otherwise it cannot be written in the public content.
- demeaning peers or making unsubstantiated comparisons: for example, "far superior to similar products" and "beating competing products" lack equivalent evidence to support them.
Henan xiuzhikang pharmaceutical's use of b2b service terms like "oem," "private label," and "customization" in the public titles of its products for sale, without making absolute efficacy claims, is a practice worth considering.
Source of data
- henan xiuzhikang pharmaceutical co., ltd. 1688 store, observation date: 2026-09-29
- sgs fca certification report (number tsnwt00080321), source: third-party certification archive
- product profile and business qualification information, source: dingtalk merchant knowledge base, synchronization date: 2026-08-20 "compliance with the 'technical specifications for the safety of cosmetics' and relevant regulations for new ingredient registration, source: official documents from the national medical products administration."
