| 1 | Define the Product Category and Intended Use | Confirm whether the product is a body lotion, wash, scrub, deodorant, hand cream, massage oil, or another cosmetic category. Document the intended user, application area, frequency of use, and rinse-off or leave-on status. | Keep the formula consistent with the intended cosmetic function. Avoid therapeutic, disease-treatment, antimicrobial, or drug-like claims unless the product is legally classified and authorized for that purpose. | United States: Claims can affect whether a product is regulated as a cosmetic, drug, or both.
Australia: Therapeutic claims may bring the product under TGA requirements.
EU and UK: Claims must be supported and must not mislead consumers. | High if claims are not controlled |
| 2 | Review the Full INCI Ingredient List | Obtain the complete qualitative and quantitative formula, including ingredients below one percent, colorants, fragrance components, processing aids, and potential impurities. | Check ingredient names against the current regional inventories and restrictions. Pay particular attention to preservatives, colorants, UV filters, exfoliating acids, retinoids, essential oils, and restricted fragrance allergens. | EU/EEA: Use the current CosIng reference and Annex restrictions under Regulation (EC) No. 1223/2009.
UK: Check the UK cosmetics framework and UK-specific restrictions.
ASEAN: Review the ASEAN Cosmetic Directive and local notification rules. | High |
| 3 | Assess Preservative and Microbiological Safety | Request preservative challenge testing, microbiological specifications, stability data, and manufacturing hygiene controls. Verify that the formula is suitable for the intended packaging and usage pattern. | Evaluate the preservative system, pH, water activity, packaging protection, and contamination risk during repeated consumer use. Products containing water generally require stronger microbiological controls than anhydrous oils. | Microbiological safety evidence is important for the EU Product Information File, UK compliance documentation, ASEAN Product Information File, and safety substantiation in many other markets. | High for water-based products |
| 4 | Verify Stability and Packaging Compatibility | Review accelerated and real-time stability tests covering appearance, odor, color, viscosity, pH, microbial quality, and package integrity throughout the proposed shelf life. | Test compatibility between the formula and the container, closure, pump, liner, label adhesive, and decoration. Oils, solvents, acids, and essential oils may interact with plastics, elastomers, or printed materials. | Many jurisdictions expect evidence that the product remains safe and suitable during its stated shelf life. A period-after-opening symbol may be required or appropriate where product durability after opening is relevant. | Medium to high |
| 5 | Check Fragrance, Allergen, and Essential-Oil Controls | Request the fragrance composition declaration, allergen information, supplier documentation, and maximum use level for the finished product category. | Fragrance allergens may need separate label disclosure when thresholds are exceeded. Essential oils can contribute allergens, phototoxicity, sensitization, or irritation risks and should not be treated as automatically safe because they are natural. | EU/EEA: Review applicable fragrance-allergen disclosure thresholds and implementation dates.
UK: Apply the current UK allergen-labeling rules.
United States: Ensure fragrance labeling and safety substantiation meet applicable requirements. | High for fragranced leave-on products |
| 6 | Evaluate Claims and Substantiation | Build a claim matrix for statements such as “moisturizing,” “24-hour hydration,” “dermatologically tested,” “sensitive-skin suitable,” “vegan,” “natural,” or “recyclable.” Define the test method and acceptance criteria for each claim. | Use instrumental tests, consumer studies, expert assessments, or ingredient evidence as appropriate. Avoid absolute claims such as “chemical-free,” “non-toxic,” or “100% safe,” which can be scientifically misleading. | EU: Cosmetic claims should follow the common criteria under Regulation (EU) No. 655/2013.
UK: Claims must be truthful, supportable, and not misleading.
United States: Advertising and labeling claims may be reviewed under consumer-protection rules. | High for performance claims |
| 7 | Confirm Regional Labeling and Language Rules | Prepare a market-specific label master containing product identity, net contents, ingredient declaration, responsible business details, batch or lot code, durability information, warnings, and directions for use. | Use the legally accepted ingredient nomenclature and verify the order of ingredients. Confirm whether fragrance, allergens, colorants, allergens from botanicals, or precautionary statements require additional disclosure. | EU/EEA: A Responsible Person and required label particulars are generally needed.
UK: A UK Responsible Person and UK-compliant labeling are generally required.
Canada: Label information generally needs English and French treatment where applicable.
China: Imported products require China-compliant labeling and documentation. | High |
| 8 | Map Registration, Notification, and Responsible-Person Duties | Identify who owns the compliance file, who communicates with authorities, who manages adverse events, and who controls formula and label changes in every target market. | Maintain the final formula, specifications, raw-material documents, manufacturing records, safety evidence, artwork approvals, and change-control history in a traceable system. | EU/EEA: A Responsible Person, Product Information File, Cosmetic Product Safety Report, and CPNP notification are generally required before placing a cosmetic on the market.
UK: SCPN notification and a UK Responsible Person are generally required before sale.
United States: MoCRA introduced facility registration, product listing, safety substantiation, and serious adverse-event obligations, subject to applicable exemptions.
ASEAN: Cosmetic notification and a Product Information File are commonly required through the relevant national authority. | Very high |
| 9 | Check Market-Specific Ingredient and Product Rules | Do not assume that approval in one country permits sale in another. Compare prohibited, restricted, positive-list, colorant, preservative, UV-filter, animal-origin, and nanomaterial requirements. | Pay special attention to exfoliating acids, high-level salicylic acid, retinoid-related ingredients, hair-growth or slimming ingredients, antibacterial positioning, CBD or hemp-derived materials, and nano-sized materials. | China: Imported general cosmetics commonly require notification, while special cosmetics generally require registration; claims and ingredients can affect classification.
Japan: Products making quasi-drug claims may require a different authorization pathway than ordinary cosmetics.
Canada: Cosmetic ingredients must comply with the Canadian Cosmetic Ingredient Hotlist and notification requirements. | Very high for active-ingredient products |
| 10 | Audit Manufacturing, Supply Chain, and Post-Market Controls | Verify manufacturing quality systems, batch traceability, change control, complaint handling, recall readiness, testing laboratories, and supplier qualification before placing a private-label order. | Request certificates of analysis, raw-material specifications, allergen statements, contaminant testing, and evidence of good manufacturing practice. ISO 22716 is a widely used cosmetic GMP reference, but local legal requirements still apply. | Maintain procedures for adverse-event monitoring, regulatory updates, corrective actions, and product recalls. Under U.S. MoCRA, serious adverse events must generally be reported within the prescribed timeframe; other markets also impose post-market obligations. | Medium with strong controls; high without traceability |
