Regulatory Guide

Compliance, automated

Navigate FDA, EU, and international regulations with confidence. Our AI checks every formulation against 50+ regulatory frameworks before production begins.

United States

FDA

Cosmetics

FDA 21 CFR Parts 700-740

  • Ingredient safety substantiation
  • Proper labeling per FPLA
  • Good Manufacturing Practices (GMP)
  • Allergen and colorant declarations
  • MoCRA registration (2024+)

Dietary Supplements

FDA 21 CFR Part 111

  • cGMP compliance for manufacturing
  • New Dietary Ingredient (NDI) notifications
  • Structure/function claim substantiation
  • Supplement Facts panel accuracy
  • Adverse event reporting (DSHEA)

Beverages

FDA 21 CFR Parts 100-169

  • GRAS or food additive approval for ingredients
  • Nutrition Facts labeling
  • Allergen declarations (FALCPA)
  • Facility registration with FDA
  • HACCP and Preventive Controls compliance

European Union

EC / ECHA

Cosmetics

EU Regulation 1223/2009

  • Cosmetic Product Safety Report (CPSR)
  • Product Information File (PIF)
  • CPNP notification prior to market
  • Banned/restricted substance compliance
  • Responsible Person designation

Food Supplements

Directive 2002/46/EC

  • Positive list ingredient compliance
  • Maximum permitted levels adherence
  • National competent authority notification
  • Labeling per EU FIC 1169/2011
  • Novel Food authorization if applicable

Beverages

EU FIC Regulation 1169/2011

  • Nutrition declaration compliance
  • Allergen emphasis labeling
  • Health claims per EC 1924/2006
  • Traceability per EC 178/2002
  • HACCP implementation

Canada

Health Canada

Cosmetics

Cosmetic Regulations (C.R.C., c. 869)

  • Cosmetic Notification Form (CNF)
  • Hotlist restricted ingredient compliance
  • Bilingual labeling (EN/FR)
  • Ingredient listing per INCI

Natural Health Products

NHP Regulations (SOR/2003-196)

  • Natural Product Number (NPN) licensing
  • Site License for manufacturing
  • Evidence for health claims
  • GMP per NHP Regulations Part 3

How CPGFactory.ai automates compliance

Real-Time Ingredient Screening

Every ingredient is automatically checked against banned/restricted lists across all target markets during formulation.

Label Compliance Engine

Auto-generates compliant ingredient lists, nutrition panels, allergen warnings, and claim language per jurisdiction.

Pre-Submission Audit

Before any batch runs, our AI performs a full regulatory audit and flags issues with suggested corrections.

Certificate of Analysis

Automated CoA generation with batch-specific test results, meeting retailer and distributor requirements.

Market-Specific Packaging

Generates packaging specs per market -- bilingual labels for Canada, CPNP-ready files for EU, FDA-compliant for US.

Change Impact Analysis

When you modify a formulation, the system instantly shows which markets are affected and what re-approvals are needed.

Ready to get started?

Upload your formulation and invoice. We'll handle the rest — from quoting to manufacturing to your door.

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