| 1 | Cosmetics GMP and manufacturing controls | Current GMP procedures, internal audit records, training records, and any third-party audit or certificate with its scope and validity dates. | ISO 22716:2007 provides guidelines for the production, control, storage, and shipment of cosmetic products. It is a GMP guideline; verify the scope of any claimed certification. | Confirm the documents cover the actual manufacturing site and relevant cosmetic activities; do not treat a certificate alone as proof of product compliance. |
| 2 | EU market access documentation | EU Responsible Person details, Cosmetic Product Safety Report (CPSR), Product Information File (PIF) availability, and evidence of CPNP notification before market placement. | Regulation (EC) No 1223/2009 sets EU cosmetics requirements, including safety assessment, PIF, Responsible Person, and notification obligations. | Confirm the documentation matches the final formula, product type, packaging, and intended markets. CPNP notification is not an EU approval or endorsement. |
| 3 | US MoCRA readiness | Applicable facility-registration and product-listing information, designated U.S. responsible-person details, and processes for adverse-event records and reporting. | MoCRA establishes FDA requirements that include facility registration and cosmetic product listing, subject to statutory exemptions and applicable deadlines. Serious adverse events must be reported to FDA within 15 business days. | Determine which party is legally responsible for each obligation and check whether an exemption applies; do not assume every facility or product has identical requirements. |
| 4 | Formula and ingredient review | Full ingredient list using appropriate ingredient names, ingredient specifications, supplier documentation, and a market-specific restricted/prohibited ingredient review. | EU Regulation 1223/2009 includes ingredient prohibitions and restrictions in its annexes. U.S. cosmetics must comply with applicable federal requirements. | Review the exact final formula for each destination market. A trade name or marketing description is not a substitute for full ingredient disclosure. |
| 5 | Safety assessment for lip-area use | Product safety substantiation, exposure assumptions, ingredient safety data, and the qualified safety assessor’s report where required. | EU cosmetics require a safety assessment and CPSR before being placed on the market under Regulation 1223/2009. | Ensure the assessment covers the intended application area, directions, foreseeable use, and final formula; do not rely solely on ingredient-level assurances. |
| 6 | Plumping-effect claims and substantiation | Claim wording, supporting test reports or other substantiation, and review of product directions and warnings. | Cosmetic claims should be truthful and appropriately substantiated; applicable rules differ by destination market and claim type. | Check that claims such as “plumping,” “volume,” or “long-lasting” are supported and do not imply drug-like effects without appropriate regulatory review. |
| 7 | Microbiological quality and preservation | Risk-based microbiological specifications, test results, preservation-system rationale, and water-quality controls where relevant. | ISO 22716 describes cosmetic GMP controls; product testing and specifications should be appropriate to the product and its risk profile. | Review methods, acceptance criteria, sample identity, and test timing. Request evidence tied to the relevant formula and production batch. |
| 8 | Stability, compatibility, and shelf-life support | Stability protocol and results, packaging-compatibility assessment, storage conditions, and substantiation for any stated shelf life or period-after-opening information. | EU safety documentation must support the product’s safety; stability evidence helps substantiate product quality over its intended life. | Check that testing uses the final formula and intended packaging, and that conclusions are supported by the data supplied. |
| 9 | Batch traceability and change control | Batch records, raw-material and packaging traceability, release criteria, deviation handling, and written change-notification procedures. | ISO 22716 addresses cosmetic GMP practices, including production and control. EU PIF information must remain available to competent authorities as required. | Confirm the supplier can link finished-product lots to relevant inputs and promptly notify the buyer of formula, site, or process changes. |
| 10 | Label review and post-market support | Market-specific artwork review, ingredient declaration, required product particulars, complaint handling, adverse-event escalation, and record-retention procedures. | EU Regulation 1223/2009 sets labeling requirements. Under MoCRA, the U.S. responsible person has serious adverse-event reporting duties and must keep related records for the applicable statutory period. | Approve final artwork for each market and agree in writing on complaint escalation, cooperation, and records access before production. |
