Description
Annex III/12 — HYDROGEN PEROXIDE
HYDROGEN PEROXIDE is an inorganic peroxide, identified in its chemical description as the inorganic oxide corresponding to that formula. In pharmaceutical nomenclature it appears as hydrogen peroxide (INN) and hydrogenii peroxidum in the European Pharmacopoeia. Under this name, other compounds or mixtures that release hydrogen peroxide are grouped, including carbamide peroxide and zinc peroxide. Its declared technical functions are antimicrobial, oral care and oxidizing. Oxidizing agents act as reagents capable of releasing oxygen within the formulation; antimicrobial ingredients limit the growth of microorganisms; oral care ingredients are intended for oral hygiene preparations.
It is regulated in Annex III, reference 12. The maximum concentrations of H2O2, present or released, are set by product type: "(a) 12 % of H2O2 (40 volumes), present or released" in hair products; "(b) 4 % of H2O2, present or released" in skin products; "(c) 2 % of H2O2, present or released" in nail hardeners; "(d) ≤ 0,1 % of H2O2, present or released" in oral products, including mouth rinses, toothpastes and bleaching products; "(e) > 0,1 % ≤ 6 % of H2O2, present or released" in tooth-whitening products; and "(f) 2 % of H2O2, present or released" in eyelash products. For (e) the entry lays down "To be only sold to dental practitioners" and "Not to be used on a person under 18 years of age"; for (f) "For professional use only" applies. The mandatory labelling includes "Contains hydrogen peroxide", "Avoid contact with eyes" and "Rinse immediately if product comes into contact with them"; for (a) and (f), "Wear suitable gloves" is added.
In cosmetic formulation, oxidizing agents take part in chemical processes that modify structures within the product; antimicrobial ingredients are used to control the microbial load; and oral care ingredients appear in preparations intended for oral hygiene. The applicable cosmetic restriction is III/12. The information presented is for technical reference only and does not constitute a recommendation for use or an efficacy claim.