Ammonium Hydroxide

EU Annex III restricted ingredient under Regulation (EC) No 1223/2009 with maximum 6% as NH3 in finished product and mandatory label declaration of Contains Ammonia above 2% as NH3. CIR (2018): safe as used in hair dyes/colors and safe in cosmetics applied to skin when formulated to be non-irritating. FDA GRAS as direct food ingredient per 21 CFR 184.1139 but inadequate data for OTC skin protectant GRASE. Primary function is pH adjustment and denaturant. Used in 1,354 products per 2017 VCRP data with 81.5% in hair coloring. Safety is conditional on finished-product pH and free ammonia concentration control.

FDA GRAS as direct food ingredient per 21 CFR 184.1139. Classified as skin protectant under OTC drug framework but FDA determined inadequate data to establish GRASE for that indication. Not a UV filter; no sunscreen relevance. VCRP 2017 data: 1,354 cosmetic products; highest concentration 12.5% in rinse-off hair dyes, 1.5% in leave-on face/neck products. CIR 2018 final conclusion: safe as used in hair dyes/colors and safe in cosmetics applied directly to skin at present practices of use and concentration when formulated to be non-irritating.