Key obligations

• Maintain ingredient dossiers with toxicology summaries, exposure calculations, and supporting studies.
• Document the tests run on finished products, such as preservative efficacy, stability, and micro.
• Track how supplier updates or new scientific findings trigger label or formulation changes.
• Store substantiation evidence in systems that can be shared quickly during inspections.

Evidence regulators expect to see

• Supplier attestations, specifications, and safety certificates.
• Laboratory reports covering micro limits, stability, and challenge studies.
• Risk assessments linking product categories to testing plans.
• Change-control log tying safety data updates to artwork or SOP revisions.

Intake sections that populate this section

• Suppliers & Testing
• Products
• Policies & References

Relevant SOP templates

• Safety Substantiation SOP
• Supplier Oversight SOP

Risk of non-compliance

• FDA can deem a product adulterated and request a recall.
• Civil lawsuits from consumers who suffer reactions without proof of safety work.
• Retailer quality teams may pause shipments until evidence is supplied.

Further reading

• 21 U.S.C. § 364d – Safety substantiation
• FDA: Product Testing of Cosmetics