Table of Contents
- What standards govern cosmetics testing?
- How is microbiological safety tested?
- How are heavy metals and prohibited ingredients analyzed?
- How is the preservative system tested?
- What is the role of animal-testing alternatives?
- How is stability tested?
- How does the Chinese regulatory framework differ?
- FAQ
- Our cosmetics testing service
What standards govern cosmetics testing?
Cosmetics testing is governed by a regulatory framework that varies fundamentally by jurisdiction — unlike most other consumer products, there is no single international harmonisation that defines what a cosmetic must be tested against. The EU, the U.S., China and Japan each operate their own framework, with different definitions of "cosmetic", different prohibited-and-restricted ingredient lists, different microbiological limits, and different market-access regimes. A cosmetic destined for multiple markets must be tested against each market's framework, because the frameworks are not interchangeable.
The principal regulatory frameworks our laboratory works to are:
- EU Cosmetics Regulation (EC) No 1223/2009 (EUR-Lex) — the European framework, replacing the 1976 Cosmetics Directive. It defines the Responsible Person (the manufacturer, the retailer or the importer who holds the product dossier and is legally accountable), the Cosmetic Product Notification Portal (CPNP), the annexes of prohibited (Annex II), restricted (Annex III) and permitted substances, and the ban on animal testing for cosmetics that took full effect in 2013. The Scientific Committee on Consumer Safety (SCCS) issues the scientific opinions that the restriction levels are based on, and the regulation is enforced through the market-surveillance authorities of the EU member states.
- U.S. FD&C Act and MoCRA (Modernization of Cosmetics Regulation Act of 2022) (FDA) — the U.S. framework, where the FDA does not have the legal authority to approve cosmetic products before they go to market (with the exception of color additives, which require FDA approval for their specific intended use). MoCRA, enacted in 2022, added the mandatory cosmetic facility registration and the cosmetic product listing, the adverse-event reporting, the safety substantiation requirement and the FDA authority to recall — the most significant change to U.S. cosmetics regulation since 1938.
- China CSAR (Cosmetics Supervision and Administration Regulation), State Council Order No. 727 (NMPA) — the Chinese framework, effective from January 2021, replacing the 1990 regulation. It classifies cosmetics into the special cosmetics (染发、烫发、祛斑美白、防晒、防脱发 — hair dye, hair perming, whitening, sun protection, anti-hair-loss) that require registration (注册) with the National Medical Products Administration, and the ordinary cosmetics that require filing (备案). The supporting technical document is the Safety and Technical Standards for Cosmetics (《化妆品安全技术规范》2015), which sets the prohibited-and-restricted substances, the heavy-metal limits, the microbiological limits and the test methods.
- Japan Pharmaceuticals and Medical Devices Act (PMDA Act) and the JCIA self-standards — the Japanese framework, where cosmetics are regulated under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, supplemented by the self-standards of the Japan Cosmetic Industry Association. Japan defines the prohibited substances (hydrogen peroxide, formalin, methanol), the restricted substances (salicylic acid, phenoxyethanol, certain UV filters) and the microbiological limits in the JCIA self-standard.
- ISO 22716, Cosmetics — Good Manufacturing Practices (GMP) — the international GMP standard for cosmetics, covering the production, the control, the storage and the shipment. ISO 22716 is the GMP standard that the EU regulation references and that the major markets accept as the production-quality baseline.
- ISO 11930, Cosmetics — Antimicrobial Preservation — the international standard for the challenge test that qualifies the preservative system.
- OECD test guidelines (TG 439, 442, 437 and others) — the in-vitro alternative-test methods that have replaced the animal tests for skin irritation, skin sensitisation and eye irritation under the EU ban, and that are accepted under the major non-animal-testing regimes.
A point worth stating plainly because it affects every multi-market project: a cosmetic that complies with the EU framework does not automatically comply with the Chinese framework, and neither complies with the U.S. framework. The prohibited-and-restricted ingredient lists differ (a UV filter permitted in the EU at a defined level may be prohibited in Japan; a preservative permitted at 0.4 % in the EU may have a different limit in China), the microbiological limits differ (the Japanese JCIA standard sets the aerobic count at 1×10² CFU/g for eye-and-mucosa products against the Chinese 500 CFU/g for eye-and-lip-and-children products), and the market-access regime differs (the EU requires the CPNP notification, China requires the NMPA registration or filing, the U.S. now requires the MoCRA listing). We confirm the target market before quoting, because the test scope is driven by the regulatory framework the cosmetic will be sold under.
How is microbiological safety tested?
The microbiological testing answers the question: does the cosmetic contain harmful microorganisms, and is the total microbial load within the limit? Cosmetics are not required to be sterile (they cannot be, given the water activity, the natural ingredients and the repeated consumer use), but they must not contain harmful microorganisms, and the total aerobic count must be within the regulatory limit.
The microbiological test programme typically covers:
Total aerobic microbial count (TAMC). The cosmetic sample is prepared under defined conditions, plated on the defined growth medium, and the colony-forming units per gram or per millilitre are counted after incubation. The result is compared to the regulatory limit. The Chinese limits under the Safety and Technical Standards for Cosmetics (2015) are: ≤500 CFU/g (or mL) for eye, lip and children's cosmetics; ≤1000 CFU/g (or mL) for other cosmetics. The Japanese JCIA self-standard sets the limit at 1×10² CFU/g (100 CFU/g) for products used around the eye, on the mucous membrane, or for toddlers under 3 years, and 1×10³ CFU/g (1000 CFU/g) for other products. The USP <61> and the equivalent pharmacopoeial methods apply for the U.S. and the EU markets, with the count limits set in the pharmacopoeial chapters.
Total combined yeasts and moulds count (TYMC). The cosmetic sample is plated on the Sabouraud-dextrose agar (or equivalent fungal medium), and the colony count per gram or millilitre is reported. The Chinese limit is ≤100 CFU/g (or mL); the equivalent pharmacopoeial limit applies for the U.S. and the EU.
Specified microorganisms (the pathogenic-bacteria panel). The cosmetic must be free of the specified pathogens, which are detected by the enrichment-and-selective-medium methods and reported as detected / not detected per gram. The Chinese Safety and Technical Standards require the following to be not detected:
- Escherichia coli (and the faecal-coliform group)
- Pseudomonas aeruginosa
- Staphylococcus aureus
- Candida albicans
The Japanese JCIA standard adds Aspergillus brasiliensis to the challenge-test panel. The U.S. and EU pharmacopoeial methods cover the same core pathogens with the methods standardised in USP <62> and the equivalent chapters.
A practical point from the published microbiological methods: the limit is interpreted with a tolerance that accounts for the dispersion in the count. The Japanese JCIA standard specifies that a test result above 200 CFU/g (or 200 CFU/mL) for the eye-and-mucosa category is regarded as over the limit, because the count dispersion means that a true limit of 100 CFU/g would produce counts above 200 in some replicate plates by sampling variability alone. The same logic applies to the higher-count categories — a result above 2000 CFU/g is regarded as over the 1000 CFU/g limit. This tolerance is part of the microbiological interpretation, and a report that quotes the count without the tolerance interpretation leaves the conformity conclusion ambiguous.
The microbiological testing is the test that catches the contamination incidents — the manufacturing hygiene failure, the preservative-system failure, the consumer-use contamination that the product was supposed to prevent. A cosmetic that passes every chemical-safety test but fails the microbial count is a cosmetic that cannot be sold, and the microbial test is the one that the post-market surveillance authorities most frequently sample for.
How are heavy metals and prohibited ingredients analyzed?
The heavy-metal and the prohibited-ingredient analysis covers the toxic substances that are either intentionally added (and regulated) or present as contaminants (and limited). The analysis is performed by instrumental methods on the cosmetic sample, and the results are compared to the regulatory limits.
Heavy metals (lead, arsenic, mercury, cadmium, antimony and others). The heavy-metal content is measured by inductively coupled plasma mass spectrometry (ICP-MS), the high-sensitivity multi-element method that detects and quantifies the metals from sub-ppb to ppm levels. The Chinese Safety and Technical Standards for Cosmetics set the heavy-metal limits at: lead ≤10 mg/kg, arsenic ≤2 mg/kg, mercury ≤1 mg/kg, cadmium ≤5 mg/kg. (The mercury limit is higher, at 1 mg/kg as the contaminant limit, with an exception for the eye-area products where mercury is used as a preservative — the use is being phased out globally under the Minamata Convention.) The EU and the U.S. operate on a similar contaminant-limit logic, with the heavy metals treated as unintended contaminants whose presence must be controlled through the raw-material specification and the production control.
Prohibited substances. Each jurisdiction maintains a list of substances that are prohibited from use in cosmetics. The Chinese prohibited list (the Annex to the Safety and Technical Standards) contains over a thousand substances, including the recognised toxic substances (the heavy metals above, the formaldehyde at the prohibited level, the methanol), the restricted pharmaceuticals (the hormones, the antibiotics), and the specific cosmetic ingredients that are prohibited for safety reasons. The EU Annex II prohibited list and the U.S. prohibited list operate on the same logic with jurisdiction-specific entries. The detection of a prohibited substance is an outright non-conformity — the cosmetic cannot be sold with the detected substance present.
Restricted substances. The restricted substances are those permitted at or below a defined maximum concentration, and the analysis quantifies the substance and compares it to the limit. Examples drawn from the SCCS opinions and the regulatory reviews include:
- Parabens — the historical review reduced the total maximum from 0.8 % (0.4 % of any single ester) to a combined maximum of 0.19 % for propylparaben and butylparaben, with no recommendation for isopropylparaben or isobutylparaben.
- Triclosan — approved at a maximum of 0.3 %, but only for some cosmetic products (not all product types).
- The UV filters (BP-3, 4-MBC, HS and others) — under ongoing SCCS review, with the permitted levels and the product-type scope adjusted per the scientific opinion.
- Phenoxyethanol, salicylic acid, the formaldehyde-releasers — each with a defined maximum concentration in the jurisdiction-specific restricted-substance list.
The analytical methods are HPLC for the organic substances (preservatives, UV filters, the formaldehyde-releasers), GC-MS for the volatile substances and the methanol, and ICP-MS for the heavy metals. A complete project reports the prohibited-substance screen (not detected), the restricted-substance quantification (at or below the limit), and the heavy-metal quantification (at or below the limit), with the methods and the detection limits named alongside the results.
A subtlety worth noting: the analytical result depends on the test method and the limit of quantitation, and a substance that is "not detected" under one method may be detected under a more sensitive method. The published Japanese-market observation is that some products may be determined to be non-compliant in Japanese-laboratory analytical tests due to the differences in the test methods and the lower limits of quantitation, even when the same products pass in the exporting country. This is why a multi-market project tests under the destination market's methods — a "not detected" under the exporting-country method does not guarantee a "not detected" under the importing-country method.
How is the preservative system tested?
The preservative system is what keeps the cosmetic free of microbial contamination through its shelf life and its in-use period, and the challenge test (also called the preservative-efficacy test, PET) is the test that qualifies the system. The test is run under ISO 11930 for the international market, under the pharmacopoeial methods (USP <51>) for the U.S. market, and under the methods specified in the Safety and Technical Standards for the Chinese market.
The challenge test works by inoculating the cosmetic sample with defined concentrations of a panel of representative microorganisms — the bacteria (Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus) and the fungi (Candida albicans, Aspergillus brasiliensis) — and measuring the log reduction in the microbial count over a defined time series (typically at 7 days, 14 days, 28 days after inoculation). The preservative system is qualified if the log reduction meets the criterion defined in the standard — typically a 3-log (99.9 %) reduction for the bacteria within 7 or 14 days and no increase thereafter, and a 1-log (90 %) reduction or no increase for the yeasts and moulds within 7 or 14 days and no increase thereafter.
Two features of the challenge test make it the most informative single test of the cosmetic's in-use microbial safety:
The test simulates the in-use contamination. A cosmetic in a jar is contaminated every time the consumer dips a finger into it; a cosmetic in a pump bottle is contaminated only through the air that enters as the product is dispensed. The challenge test simulates the contamination event by deliberately inoculating the sample, and the pass criterion is that the preservative system kills or suppresses the inoculated microorganisms to the defined extent. A cosmetic that passes the microbiological count test (the as-manufactured count is below the limit) can still fail the challenge test (the preservative system does not adequately suppress a contamination event), and the challenge test is the one that predicts the in-use behaviour.
The test qualifies the preservation over the shelf life. The ISO 11930 standard distinguishes the "Criterion A" (the stricter log-reduction criterion, which qualifies the cosmetic for preservation without a specific in-use statement) and the "Criterion B" (the less strict criterion, which must be accompanied by the in-use information — for example, the period-after-opening, the single-use packaging, the specific consumer-use instructions). The choice of criterion affects the labelling and the in-use claim, and the test report states which criterion was applied.
The challenge test is therefore the test that connects the cosmetic's preservative formulation to its in-use safety, and it is the test that the GMP audit (ISO 22716) and the market-surveillance authority both expect to see evidence of. A cosmetic that passes the as-manufactured microbiological count but has not been challenge-tested is a cosmetic whose in-use microbial safety is unverified.
What is the role of animal-testing alternatives?
The animal-testing question is central to modern cosmetics testing because the major markets have moved at different speeds and in different directions, and the laboratory's testing regime must respect the destination market's rules.
The global landscape:
- EU ban (2013) — the EU prohibits both the testing of cosmetics on animals and the sale of cosmetics that have been tested on animals, with the testing ban implemented through the REACH framework's restrictions on the animal-test data for cosmetics ingredients.
- Bans in 45+ countries — Canada, India, Israel, Norway, Iceland, Switzerland, Mexico, the UK, South Korea, Taiwan, Turkey, Australia, Brazil, Colombia, Ecuador, Guatemala, New Zealand, Chile and others have prohibited cosmetics animal testing, with twelve U.S. states (California, Hawai'i, Illinois, Louisiana, Maine, Maryland, Nevada, New Jersey, New York, Oregon, Virginia, Washington) banning the sale of animal-tested cosmetics.
- China (transitioning) — historically the Chinese government required all cosmetics to be tested on animals. From 2014, China allowed companies manufacturing ordinary cosmetics within China to avoid animal tests. From 2021, China further amended the regulations to allow some imported ordinary cosmetics without animal testing. Special cosmetics (hair dye, sunscreens) and some product categories still require animal testing, and many non-animal test methods are not yet accepted by the Chinese regulators — the transition is partial and ongoing.
- U.S. (no requirement) — animal testing is not legally required for cosmetics sold in the U.S., and the Humane Cosmetics Act (federal legislation under consideration) would prohibit both the testing and the sale of animal-tested cosmetics.
The alternative-test methods that have replaced the animal tests are the OECD-validated in-vitro methods:
- Skin irritation — the reconstructed-human-epidermis (RhE) models (EpiDerm, SkinEthic), validated under OECD TG 439, replace the rabbit Draize skin test.
- Skin corrosion — the RhE models and the in-vitro membrane-barrier test, under OECD TG 430 / 431 / 435.
- Eye irritation — the bovine-corneal-opacity-and-permeability (BCOP) test, the isolated-chicken-eye (ICE) test, and the reconstructed-human-cornea models, under OECD TG 437 / 438 / 492. The HET-CAM test (the hen's egg test on the chorio-allantoic membrane), which applies the test material to the CAM of a chicken egg on day 9 of embryonation and assesses the haemorrhage, lysis and coagulation endpoints, is also used as an organotypic model — though it is not strictly in-vitro (the CAM is a living tissue), it avoids the use of live animals and is widely used in the European cosmetics industry for the eye-irritation screening.
- Skin sensitisation — the in chemico Direct Peptide Reactivity Assay (DPRA, OECD TG 442C), the in vitro KeratinoSens and LuSens assays (OECD TG 442D) and the human-cell-line-activation test (h-CLAT, OECD TG 442E), which together replace the guinea-pig maximisation test and the local-lymph-node-assay.
- Phototoxicity — the 3T3 neutral-red-uptake phototoxicity test (OECD TG 432).
The challenge for a multi-market cosmetic is that the non-animal-method acceptance is not uniform. A cosmetic tested under the EU-accepted non-animal methods will satisfy the EU and the markets that follow the EU, but it may not satisfy the Chinese regulator if the Chinese framework still requires the animal-test data for the product category. The laboratory's role is to confirm which methods are accepted in the destination market and to run the testing under those methods, because a result from an unaccepted method does not satisfy the destination regulator regardless of its scientific validity.
How is stability tested?
The stability testing qualifies the cosmetic's behaviour over its shelf life — that the colour, the fragrance, the pH, the viscosity, the emulsion stability and the packaging integrity all remain within specification through the declared shelf life and the period-after-opening. The stability testing is run on the finished product (not on the individual ingredients), and it is run under accelerated and long-term conditions.
The stability test programme, drawn from the published industry practice (including the Japanese BOKEN protocol), typically covers:
Accelerated test. The sample is held at 40 °C ± 2 °C and 75 % RH ± 5 % for 6 months, with the sample evaluated at defined intervals (typically 1 month, 2 months, 3 months, 6 months). The accelerated test predicts the shelf-life behaviour under the normal storage conditions, on the empirical correspondence that 3 months at 40 °C approximates 12 months at 25 °C and 6 months at 40 °C approximates 24 months at 25 °C.
Long-term storage test. The sample is held at 25 °C ± 2 °C and 60 % RH ± 5 % for 12 months (often extended to 36 months for the full shelf-life qualification), with the sample evaluated at defined intervals. The long-term test is the real-time confirmation of the accelerated-test prediction, and it is the data the shelf-life claim is based on.
Severe test (the cycling and the freeze-thaw). The sample is subjected to temperature cycling (e.g. -5 °C to 40 °C with defined holds), freeze-thaw cycling, and the high-temperature-and-high-humidity conditions, to qualify the cosmetic against the transport-and-storage extremes it may encounter. The severe test is particularly important for the emulsions, which can break under thermal cycling, and for the packaging, which can crack, break or lose seal under the thermal stress.
The measurement items at each interval include:
- Physical and chemical stability — the change in colour, the change in fragrance, the pH value, the weight loss, the viscosity change, and the emulsion stability (the separation of the product ingredients).
- Microbiological stability — the contamination by bacteria, mould and yeast over the storage period, which qualifies the preservative system's performance over the shelf life.
- Packaging stability — the effects the packaging has on the contained product (cracking, breaking, sealing, migration of packaging components into the product) and the effects the product has on the packaging (swelling, corrosion, label degradation).
The stability testing is the test that qualifies the cosmetic's shelf life and its period-after-opening, and it is the test that the GMP audit and the market-surveillance authority both expect to see evidence of. A cosmetic launched without the stability data has an unverified shelf life, and the shelf-life claim on the label is unsubstantiated.
How does the Chinese regulatory framework differ?
The Chinese cosmetics framework is the most distinctive of the major markets, and a cosmetic intended for China must be tested and registered under the Chinese-specific requirements. The framework has evolved significantly since 2021, and the evolution is ongoing.
The Chinese framework is built on two documents:
CSAR (Cosmetics Supervision and Administration Regulation, State Council Order No. 727), effective from January 2021, replaced the 1990 regulation. It classifies cosmetics into:
- Special cosmetics (特殊化妆品) — the product categories with higher risk: hair dye (染发), hair perming (烫发), skin whitening (祛斑美白), sun protection (防晒), anti-hair-loss (防脱发), and the products claiming new efficacy. Special cosmetics require registration (注册) with the NMPA before they can be manufactured or imported.
- Ordinary cosmetics (普通化妆品) — all other cosmetics. Ordinary cosmetics require filing (备案) with the NMPA before they can be sold or imported. The filing is a lighter-touch regime than the registration, but it still requires the full product dossier.
From 1 May 2021, the new registration-and-filing information platform replaced the legacy system, and the regulatory workflow moved to the new platform. From 1 January 2022, the Efficacy Claim Substantiation Specification (《化妆品功效宣称评价规范》) requires the registrant or the filer to substantiate every efficacy claim on the product, with the substantiation evidence retained in the dossier and made available to the NMPA on request.
The Safety and Technical Standards for Cosmetics (《化妆品安全技术规范》2015) is the supporting technical document, and it is the Chinese counterpart of the EU Annexes and the SCCS opinions. It sets:
- The prohibited substances (over a thousand entries) — including the heavy metals (lead, arsenic, mercury, cadmium), the formaldehyde at the prohibited level, the methanol, the hormones, the antibiotics, and the specific cosmetic ingredients prohibited for safety reasons.
- The restricted substances — the substances permitted at or below a defined maximum concentration, with the per-substance limit set on the basis of the Chinese risk assessment.
- The heavy-metal limits — lead ≤10 mg/kg, arsenic ≤2 mg/kg, mercury ≤1 mg/kg, cadmium ≤5 mg/kg.
- The microbiological limits — total aerobic count ≤500 CFU/g (eye, lip, children) / ≤1000 CFU/g (others), moulds and yeasts ≤100 CFU/g, the four specified pathogens (E. coli, P. aeruginosa, S. aureus, C. albicans) not detected.
- The test methods — the chemical, the microbiological and the toxicological methods that the conformity testing must use, standardised in the Safety and Technical Standards.
Three points about the Chinese framework affect every project:
The animal-testing rule is partial. The 2021 amendment allowed some imported ordinary cosmetics to be filed without animal testing, and the domestic ordinary cosmetics can avoid animal tests under defined conditions. But the special cosmetics (the hair dye, the sunscreens, the whitening products) still require animal-test data for the registration, and the Chinese regulator does not yet accept the full range of the OECD-validated non-animal methods. A cosmetic that is cruelty-free in the EU may not be cruelty-free in the Chinese registration, and the testing plan for China must respect the current acceptance status of the non-animal methods.
The efficacy-claim substantiation is mandatory. Since 1 January 2022, every efficacy claim on the product must be substantiated by the evidence in the dossier — the moisturising claim, the anti-wrinkle claim, the whitening claim, the sun-protection claim. The substantiation can be the laboratory test, the consumer-use test, the published literature, or the ingredient-supplier data, but it must exist and it must support the specific claim. A claim that is not substantiated is a non-conformity, and the NMPA can order the claim removed or the product withdrawn.
The children's and the eye-and-lip cosmetics are the重点监管品类 (priority-supervised categories). The children's cosmetics carry the stricter microbiological limit (500 CFU/g), the additional safety-assessment requirements, and the prohibition on certain functional ingredients. The eye-and-lip cosmetics carry the stricter microbiological limit and the ingredient restrictions specific to the application site. A project for a children's or an eye-and-lip cosmetic must scope the additional requirements at the start, because they affect the test scope and the dossier.
A multi-market project tests against the Chinese framework alongside the EU and the U.S. frameworks, with the report explicitly naming the regulatory document, the test method and the limit for each measured value. The Chinese registration or filing requires the full test report in Chinese, against the Safety and Technical Standards, and a report issued against the EU or the U.S. framework will not be accepted by the NMPA without the Chinese-specific testing.
FAQ
Which standard should my cosmetic be tested to?
It depends on the target market and the product category. For the EU market, Regulation (EC) 1223/2009 and the SCCS opinions apply, with the CPNP notification and the Responsible Person status. For the U.S. market, the FD&C Act and MoCRA apply, with the facility registration and the product listing. For the Chinese market, CSAR (Order No. 727) and the Safety and Technical Standards (2015) apply, with the NMPA registration (special cosmetics) or filing (ordinary cosmetics). For the Japanese market, the PMDA Act and the JCIA self-standards apply. We confirm the target market and the product category before quoting, because the framework sets the test scope.
What are the microbiological limits for a cosmetic sold in China?
The Safety and Technical Standards (2015) set the total aerobic count at ≤500 CFU/g (or mL) for eye, lip and children's cosmetics, ≤1000 CFU/g for other cosmetics; the moulds and yeasts at ≤100 CFU/g; and the four specified pathogens (E. coli, P. aeruginosa, S. aureus, C. albicans) must not be detected. The children's and the eye-and-lip cosmetics are the priority-supervised categories with the stricter limit.
Is the animal-testing ban the same in all markets?
No. The EU bans both the testing and the sale of animal-tested cosmetics. Over 45 countries have similar bans. The U.S. does not require animal testing for cosmetics. China is transitioning — some imported ordinary cosmetics can now be filed without animal testing, but the special cosmetics (hair dye, sunscreens, whitening products) still require animal-test data for the registration, and the full range of non-animal methods is not yet accepted. The testing plan for a cosmetic must respect the destination market's current animal-testing rules.
What is the challenge test, and why is it important?
The challenge test (preservative-efficacy test, ISO 11930) is the test that qualifies the cosmetic's preservative system by deliberately inoculating the sample with a panel of bacteria and fungi and measuring the log reduction over a defined time series. It is the test that predicts the in-use microbial safety — whether the preservative system can suppress the contamination that occurs when the consumer uses the product. A cosmetic that passes the as-manufactured microbiological count can still fail the challenge test if the preservative system is inadequate, and the challenge test is the one that predicts the in-use behaviour.
What does the efficacy-claim substantiation require for the Chinese market?
Since 1 January 2022, every efficacy claim on a Chinese-market cosmetic must be substantiated by the evidence in the product dossier — the laboratory test, the consumer-use test, the published literature or the ingredient-supplier data. The substantiation must support the specific claim, and the NMPA can request the evidence. A claim that is not substantiated is a non-conformity. We help scope the substantiation evidence alongside the regulatory testing.
Our cosmetics testing service
Our laboratory provides cosmetics testing across the full regulatory framework stack — the EU Cosmetics Regulation (EC) 1223/2009 and the SCCS opinions, the U.S. FD&C Act and MoCRA, the Chinese CSAR (Order No. 727) and the Safety and Technical Standards for Cosmetics (2015), and the Japanese PMDA Act and the JCIA self-standards. Each project begins with a scoping step that confirms the target market, the product category (skin care, make-up, hair care, sun care, oral care, children's, special cosmetics) and the corresponding regulatory framework, so the report you receive answers the question your regulator, your retailer or your quality system will actually ask.
We run the microbiological tests (total aerobic count, yeasts and moulds, the specified-pathogen panel) under the Chinese Safety and Technical Standards, the pharmacopoeial methods and the ISO methods; the heavy-metal analysis (lead, arsenic, mercury, cadmium, antimony) by ICP-MS; the prohibited-substance screen and the restricted-substance quantification by HPLC, GC-MS and ICP-MS; the challenge test under ISO 11930 with the Criterion A / B selection; the stability testing under the accelerated, long-term and severe conditions with the physical, chemical, microbiological and packaging-stability measurement items; and the OECD-validated non-animal alternative methods for the skin and eye irritation, the skin sensitisation and the phototoxicity. For the Chinese market, we test against the Safety and Technical Standards and support the efficacy-claim substantiation dossier. Reports are issued with the regulatory framework, the test method, the measured value, the limit and the conformity conclusion explicitly stated, with the chromatograms, the ICP-MS spectra and the microbial plates included where the result depends on them, in a format suitable for regulatory submission, market notification, retailer qualification or batch acceptance.
To start a project, send us the product type and the ingredient list, the target market, the product category (ordinary or special, in the Chinese classification), the efficacy claims (for the Chinese substantiation), and whether the project is regulatory conformity, shelf-life qualification, preservative-system qualification, batch acceptance or claim substantiation. We will return a project scope, sample requirement, schedule and quotation, and begin testing on your confirmation.