FORMULEY RESEARCH
COSMETIC PRODUCT-RECORD REQUIREMENTS MATRIX

Last reviewed: September 8, 2026

Purpose
Use this matrix to identify working records and owners before choosing software. It is a discovery tool, not a universal compliance checklist. Requirements depend on product, claims, market, organization role, current law, and professional judgment. Confirm applicability with qualified safety, regulatory, quality, legal, privacy, and security reviewers.

AREA: PRODUCT IDENTITY AND OWNERSHIP
Possible records: product and SKU identifiers; brand; market; responsible business role; project owner; intended use; target user; status; linked agreements.
Evidence question: Can the team identify the product, accountable organization, intended markets, and owner of each open decision?
Typical owners: Product, regulatory, legal, operations.

AREA: FORMULA AND PROCESS
Possible records: composition; ingredient percentages; units; phases; yield; processing instructions; rounding; version; change reason; approval.
Evidence question: Can the team identify the exact approved formula and distinguish intended process from experimental notes?
Typical owners: R&D, formulation, technical review.

AREA: RAW MATERIALS AND SUPPLIERS
Possible records: trade name; INCI name; supplier and manufacturer; internal code; specification; safety data; certificate or lot evidence; allergen, origin, or sourcing context; storage; document revision.
Evidence question: Can every material in the formula be traced to the source information used for review and to lots used in a batch?
Typical owners: R&D, procurement, quality, regulatory.

AREA: SAFETY AND TESTING
Possible records: safety assessment inputs; stability, microbiological, challenge, compatibility, consumer, and claim studies where applicable; protocols; samples; results; reviewer; limitations.
Evidence question: Is each result connected to the tested product version, package, method, date, and decision?
Typical owners: Safety assessor, R&D, quality, regulatory.

AREA: LABELING AND CLAIMS
Possible records: ingredient declaration inputs; identity statement; net contents; business details; warnings; directions; artwork version; claim wording; substantiation; approval; market differences.
Evidence question: Can the team show which sources and approvals supported the released label and claims?
Typical owners: Regulatory, legal, marketing, packaging.

AREA: MARKET AND REGULATORY RECORDS
Possible records: facility registration or product listing references where applicable; EU responsible-person, safety-report, product-information-file, and notification references where applicable; jurisdiction-specific tasks; correspondence; renewal dates.
Evidence question: Does the record distinguish submission or task status from a legal conclusion, and is applicability reviewed for the organization’s role?
Typical owners: Regulatory, legal, responsible person or designated business owner.

AREA: PACKAGING
Possible records: component identity; supplier; specification; artwork; bill of materials; compatibility evidence; status; change approval; packaging cost.
Evidence question: Can a package change be traced to affected testing, artwork, product versions, and batches?
Typical owners: Packaging, procurement, R&D, quality, marketing.

AREA: MANUFACTURING AND RELEASE
Possible records: master manufacturing instructions; executed batch record; material lots; actual quantities; equipment; operators; dates; in-process checks; deviations; investigation; disposition; retained sample; release approval.
Evidence question: Can a reviewer reconstruct what was made, compare it with the authorized instruction, and see why the batch was released or rejected?
Typical owners: Manufacturing, quality, technical operations.

AREA: POST-MARKET
Possible records: distribution or channel context; complaints; serious adverse events where applicable; returns; investigation; batch lookup; corrective action; recall readiness; reporting.
Evidence question: Can an incoming report be connected promptly to the relevant product version, package, and batch?
Typical owners: Quality, regulatory, customer operations, legal.

AREA: GOVERNANCE AND SYSTEM OPERATIONS
Possible records: roles; approvals; audit history; retention; backup; recovery; integrations; exports; AI data flow and review; incident response; training.
Evidence question: Are access, change, recovery, and exit controls proportionate to the record’s importance?
Typical owners: IT, security, privacy, system owner, quality.

Implementation notes
1. Label each row Required, Useful, Not Applicable, or Unresolved.
2. Name the accountable owner and authoritative system.
3. Link evidence rather than copying uncontrolled summaries.
4. Preserve historical versions when current sources change.
5. Test one difficult change across every affected record.
6. Export and reconcile before treating a migration as complete.

Sources:
- FDA, Modernization of Cosmetics Regulation Act of 2022:
  https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022-mocra
- FDA, Registration and listing of cosmetic product facilities and products:
  https://www.fda.gov/cosmetics/registration-listing-cosmetic-product-facilities-and-products
- FDA, Summary of cosmetics labeling requirements:
  https://www.fda.gov/cosmetics/cosmetics-labeling-regulations/summary-cosmetics-labeling-requirements
- European Union, Regulation (EC) No 1223/2009:
  https://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX%3A32009R1223
- European Commission, CosIng:
  https://single-market-economy.ec.europa.eu/sectors/cosmetics/cosmetic-ingredient-database_en
- Formuley Research methodology:
  https://formuley.com/blog/formuley-research-methodology