Mexico Cosmetics Post-Market Quality Management: NOM-259

Turn post-market controls into records and ownership

NOM-259 addresses good manufacturing practices at establishments that process and/or import cosmetics. Post-market quality management should cover lot identification, quality control, complaints and returns, recalls, deviations and documentation so the business can explain how products are made/imported, tested, released and handled when issues arise.

PLATIICA lists NOM-259 as current. It applies to establishments processing and/or importing cosmetics marketed in Mexico and includes sections on production, quality control, finished products, complaints/returns/recalls, deviations and documentation. The 2022 amendment changed transition periods only. The COFEPRIS self-inspection guide can support inspection preparation but does not replace the standard. [MX-NOM-259][MX-PLATIICA-NOM-259][MX-NOM-259-AMENDMENT-2022][MX-COFEPRIS-SELF-INSPECTION]

Maintain traceable quality records

Bring product changes into quality review

1. Formula, ingredient concentration, supplier or material specification changes.
2. Changes to use, target users, directions, claims or labeling.
3. Changes to packaging, storage/transport, manufacturing/import, labeling or repacking processes.
4. Complaints, deviations or quality trends indicate a need to reassess controls.

Article 270 requires applicable safety and efficacy studies to be held and provided when requested by the authority. Post-market records should be traceable to products and lots; the absence of a universal SKU registration/notification does not remove record-keeping duties. [MX-LGS]

• Product records trace to formula, lot and label versions.
• Complaints, returns, recalls and deviations have owners and closure records.
• Supplier, product and process changes receive quality and regulatory impact review.
• Use the current NOM-259 text as the quality-system reference.