Blog

What the 1% EU cap does and does not tell you about phenoxyethanol safety, how the US regulates it, and which questions a formulator should ask before raising the dose.

The EU limits kojic acid to 1% and only in face and hand products (Annex III No 375). Body lotions and neck-below products cannot use it. The US bans it from cosmetics nowhere — but skin-lightening claims change the product's category.

In the EU, limonene (Annex III No 88) and linalool (No 84) must be individually named in the ingredient list above 0.001% in leave-on and 0.01% in rinse-off products; limonene also needs a peroxide value below 20 mmol/L. The US allows them under “fragrance”.

The EU allows methylisothiazolinone only in rinse-off products at up to 0.0015% (15 ppm) — Annex V No 57 — and bans it from leave-on products entirely. The US sets no federal cosmetic limit.

Manufacturers and processors of cosmetics distributed in the US must register each facility with FDA and renew every two years from the initial registration date. Small businesses can be exempt, with four product carve-outs. How Cosmetics Direct, FEI numbers and renewals work.

What MoCRA puts on a US cosmetic label, what it puts in a filing instead, and which parts are still waiting on FDA regulations. Responsible person, professional-use statement, adverse-event contact, registration and listing.