Methodology & Data Provenance

How we collect, normalize, and present regulatory data.

1. Hard Rules vs Evidence vs Confidence

We separate three types of information in every report:

  • Hard Rules: Codified regulatory restrictions (bans, concentration limits, conditions of use) with official citations. These come directly from government rulebooks and annexes.
  • Evidence: Enforcement events, warning letters, import alerts, and adverse-event reports that mention an ingredient. These are factual occurrences but do not prove causation.
  • Confidence: Our assessment of how reliable a given piece of information is. Stable = direct from official source. Provisional = legacy or heuristic. Contextual = suggested guidance.

A rule with high confidence but zero evidence may still be actionable. An ingredient with many enforcement events but no hard rule may still be risky for marketing claims. We present all three so you can make informed tradeoffs.

2. Data Collection

We ingest data directly from official government sources and regulatory databases. Our current sources include:

  • U.S. FDA warning letters and import alerts
  • FDA/openFDA cosmetic adverse event reports
  • Health Canada Cosmetic Ingredient Hotlist
  • EU CosIng Annex II-VI restrictions

We do not scrape retailer sites, brand pages, or unofficial databases. All data comes from primary regulatory authority publications.

2. Normalization

Each source uses different naming conventions, classifications, and rule formats. We normalize these into a single schema:

  • Ingredient identity: Canonical names mapped to CAS numbers where available
  • Market: US, EU, JP, KR, CA, ASEAN
  • Status: allowed, restricted, prohibited, disclosure_required, drug_boundary
  • Rule type: ban, restriction, preservative, uv_filter, colorant, allergen

Normalization is performed by our ingestion pipeline. If you spot a mapping error, contact us with the ingredient name and expected correction.

3. Update Cadence

Sources are refreshed on a rolling schedule:

  • FDA warning letters: daily
  • Import alerts: weekly
  • Adverse events: weekly
  • Health Canada Hotlist: monthly
  • EU CosIng: monthly

Each source page shows the last successful refresh timestamp. Sources marked "Stale" have not refreshed within 7 days.

4. Limitations

Our data has known limitations:

  • Enforcement events are matched by keyword similarity, not confirmed ingredient-level causation
  • Adverse event reports are matched by product name, not confirmed ingredient causation
  • Cross-market rules may not cover all product types or special-use categories
  • Concentration limits are source-specific and may differ between leave-on and rinse-off products

This tool is for informational and planning purposes. It does not constitute legal or regulatory advice. Always consult a qualified regulatory professional before launching a product.

5. Independence

IngredientCompliance is operated by Gerim-Sterling LLC. We are not affiliated with the FDA, Health Canada, the European Commission, or any other regulatory body. We republish public regulatory data with normalization and commentary.

Legal Disclaimer

This service is provided "AS IS" without warranties of any kind. Regulatory data is for reference only and does not constitute legal or regulatory advice. Always consult a qualified attorney or regulatory consultant before making compliance decisions. Not affiliated with the U.S. Food and Drug Administration (FDA) or any government agency. IngredientCompliance is an independent tool operated by Gerim-Sterling LLC. © 2026 Gerim-Sterling LLC.