Our Methodology — How We Rate Food Additives
Additive Facts is built on publicly available, government-published data. This page explains exactly where our data comes from, how our safety ratings are determined, and what the limitations of this approach are. We believe complete transparency on methodology is non-negotiable for health information sites.
1. Primary Data Sources
FDA Substances Added to Food (EAFUS)
Primary additive database — 3,971 substances
The Everything Added to Food in the United States (EAFUS) database is maintained by FDA's Center for Food Safety and Applied Nutrition (CFSAN). It lists all substances intentionally added to food in the US, including their technical function, regulatory basis (GRAS, approved food additive, prior sanctioned), CAS registry number, and relevant 21 CFR regulatory citation.
This database is the foundation of our additive catalog. Every additive in our database was initially sourced from EAFUS. We use the EAFUS name, CAS number, and functional class as the canonical identifier.
FDA EAFUS databaseEFSA OpenFoodTox
EU regulatory status and toxicological opinions — 5,700+ substances
OpenFoodTox is the European Food Safety Authority's database of hazard characterisations for substances evaluated in EFSA's scientific outputs. We use it to determine EU regulatory status, available ADI (Acceptable Daily Intake), and EFSA safety opinions for substances in our database.
EU approval status is cross-referenced with the EU Food Additive Portal (Regulation (EC) No 1333/2008), which is the authoritative list of additives approved for use in food in the European Union.
EFSA OpenFoodToxOpenFDA API — CAERS & Food Recalls
Adverse events and recalls — 148,459 adverse events, 28,679 recalls
The CFSAN Adverse Event Reporting System (CAERS) is a voluntary reporting database for adverse events associated with foods, dietary supplements, and cosmetics. Adverse event reports are submitted by consumers, healthcare providers, and manufacturers. We query OpenFDA's CAERS endpoint to count adverse events mentioning each additive or products containing it.
Food recall data is sourced from the OpenFDA food enforcement endpoint, which mirrors FDA's enforcement actions database. Recall counts are associated with additives through product name matching.
Open Food Facts
Product ingredient data — 3M+ products, ODbL license
Open Food Facts is a collaborative open database of food products from around the world. We use it to determine which commercial products commonly contain each additive, populating the "commonly found in" fields on additive pages. Data is used under the Open Database License (ODbL) and remains attributed to the Open Food Facts project.
Open Food Facts2. The Four-Tier Safety Rating System
Each additive in our database is assigned one of four safety ratings. Ratings are based on a combination of: regulatory status in major jurisdictions, EFSA/FDA scientific opinions, IARC carcinogen classifications, available ADI data, and adverse event signal volume. Ratings are editorial determinations — not official regulatory findings.
- Approved in both the US (FDA) and EU (EFSA)
- No significant adverse event signal in CAERS relative to usage prevalence
- No active regulatory review or revocation proceedings
- No EFSA or FDA scientific opinion identifying significant concerns
- Not on any IARC carcinogen list (Groups 1, 2A, 2B)
Examples: Ascorbic acid (Vitamin C), Pectin, Citric Acid
- Restricted in one or more major markets (not fully banned)
- OR: EFSA or FDA opinion identifies concerns at higher doses
- OR: Emerging peer-reviewed literature with significant findings (not yet reflected in regulation)
- OR: Requires warning labeling in at least one major jurisdiction
- OR: Moderate adverse event signal inconsistent with usage prevalence
Examples: Carrageenan, BHT, Sodium Benzoate, Yellow 5 (Tartrazine)
- Banned or not approved for food use in the EU, UK, Canada, or Australia
- OR: Listed by IARC as Group 1 (carcinogenic) or Group 2A (probably carcinogenic)
- OR: FDA has issued a formal revocation, warning letter, or recall related to this substance
- OR: High adverse event count that cannot be explained by usage prevalence alone
- OR: Multiple independent regulatory bodies have restricted use pending further review
Examples: Potassium Bromate, Azodicarbonamide, Red 3, Titanium Dioxide
- Fewer than 3 independent peer-reviewed studies on safety
- AND: No major regulatory opinion (FDA or EFSA) has been issued
- AND: Adverse event data is too sparse to draw conclusions
Examples: Many GRAS-notified flavoring agents with limited public safety data
3. Regulatory Status Determination
Country regulatory status is determined from the following primary sources for each jurisdiction:
United States
FDA EAFUS, 21 CFR Part 172/173/184/186
Status values: approved, gras, not_approved
European Union
EU Food Additive Portal (Reg. EC 1333/2008), EFSA opinions
Status values: approved, banned, restricted, not_approved
United Kingdom
UK Food Standards Agency (post-Brexit retained EU law)
Status values: approved, restricted, not_approved
Canada
Health Canada Food Additives Database
Status values: approved, restricted, not_approved
Australia
Food Standards Australia New Zealand (FSANZ)
Status values: approved, restricted, not_approved
Japan
Ministry of Health, Labour and Welfare (MHLW) Food Additives list
Status values: approved, restricted, not_approved
4. Editorial Independence Statement
No conflicts of interest
Additive Facts does not accept payments from food manufacturers, ingredient suppliers, trade associations, or any entity with a financial interest in food additive regulation. Safety ratings are not for sale. No additive receives a more favorable rating because of sponsorship, advertising, or any commercial relationship.
Monetization policy
When this site monetizes, it will be through display advertising (Google, Mediavine) and affiliate links to clean-label food products and supplement retailers. Affiliate relationships will be fully disclosed. No affiliate partner can influence safety ratings. All affiliate links will be marked with a disclosure notice.
Corrections policy
If a safety rating or regulatory status is incorrect, we want to know. Contact us at corrections@additivefacts.com with the substance name, the error, and the primary source citation that contradicts our data. We will review and correct within 5 business days, with a dated correction notice on the affected page.
5. Limitations & Disclaimers
Not medical advice
Nothing on Additive Facts constitutes medical or dietary advice. Individuals with specific health conditions, allergies, or dietary requirements should consult qualified healthcare professionals.
Regulatory data has latency
Regulatory status changes. Our database is updated when significant regulatory actions are taken, but there may be a lag between an official regulatory change and our database reflecting it. Always cross-reference critical decisions with the primary regulatory source.
GRAS determination complexity
The FDA GRAS (Generally Recognized as Safe) designation is a legal status, not a scientific quality rating. Approximately 10,000 substances are estimated to be self-affirmed GRAS without formal FDA notification or review. Our database covers only the 3,971 substances in EAFUS — the universe of additives with formal FDA documentation.
Adverse event counts are not causation
CAERS adverse event reports are unverified submissions. They indicate signal volume, not confirmed causation. Products consumed by larger populations generate more reports by volume alone.
Safety thresholds are dose-dependent
All safety determinations are dose-dependent. An AVOID rating does not mean that consuming one product with that additive once will cause harm. It means the evidence base warrants reducing chronic exposure. Context matters.
Individual variation
Safety ratings represent population-level assessments. Individual responses to food additives vary based on genetics, gut microbiome composition, concurrent exposures, and underlying health conditions. A substance rated SAFE may cause reactions in sensitive individuals.
6. Update Cadence
Adverse event counts
Monthly
OpenFDA CAERS is queried monthly to refresh adverse event counts.
Regulatory status
On event
Updated within 5 business days of a significant FDA, EFSA, or equivalent agency action.
Safety ratings
Quarterly review
Editorial review of ratings against new peer-reviewed literature each quarter.