FDA cosmetic + EU EC 1223/2009 ingredient regulation, how do you handle?
Skincare ingredient regulation is the most under-built piece of every DTC skincare build I audit. The basics:
- FDA cosmetic (US), cosmetic regulation is light. MoCRA (Modernization of Cosmetics Regulation Act, 2022) tightened it: facility registration, adverse-event reporting, safety substantiation file required. Comply by Dec 2024.
- EU EC 1223/2009, banned-ingredients list (~1,300 substances), restricted-use list, mandatory CPSR (Cosmetic Product Safety Report) per SKU, EU Responsible Person required. The CPSR is the time-sink, $300, $1,500 per SKU from a contract toxicologist.
- California Prop 65, warning-label required for ~900 substances. Different ingredient list from EU EC 1223. Plenty of K-beauty SKUs sold in Korea are Prop 65 flagged in California.
- FDA drug (US), SPF is a drug, not a cosmetic. OTC Monograph compliance: specific actives, specific concentrations, specific labeling. SPF SKUs need separate workflow from cosmetic SKUs.
- UK / Australia / Canada / Japan / Korea, each has its own ingredient list. Korea’s KFDA is closest to Japan’s; UK post-Brexit diverged slightly from EU; Canada (Health Canada) has its own Cosmetic Ingredient Hotlist.
Magento implementation: per-region SKU visibility rules. The same product hides in California if a Prop 65 ingredient is flagged. Custom attribute region_blocklist drives the rule. Mismatching is how you get a CARB letter or a class action. Worth getting right.