SODIUM PERBORATE

Sodium Perborate is the inorganic salt that conforms to the formula:

Prohibido

ASEAN · Japón · Reino Unido · Taiwán · Unión Europea

Restringido o prohibido

ASEAN · China · Corea del Sur · Japón · Taiwán · Unión Europea

Fuente: Directiva cosmética de la ASEAN · Reglamento de cosméticos de la UE · Normas de cosméticos de Japón · Ingredientes cosméticos de la FDA de Taiwán · Normativa cosmética del Reino Unido (OPSS) · Información regulatoria cosmética del MFDS (Corea)

Argentina · Brasil

• Field of application and/or use : (a)Talc (b) Products for oral hygiene (c) Other products (excluding bath products and hair undulation)
• Maximum concentration permitted at final product : (a) 5% (m/m calculated as boric acid) (b) 0,1% (m/m calculated as boric acid) (c) 3% (m/m calculated as boric acid)
• Other limitations and requirements : a) No use in products for children under 3 years. Do not use on broken or irritated skin if the tenor of soluble free borates exceed 1,5% (calculated as boric acid, m / m) b) No use in products for children under 3 years. c) No use in products for children under 3 years. Do not use on broken or irritated skin if the concentration of soluble borates exceed 1,5% (calculated as boric acid, m / m)
• Use conditions and warnings that must appear on the label : a), b) and c) For products for adult use: "Do not use in children" For products aimed at children: "Do not use in children under 3 years" a) Do not use on broken or irritated skin b) Do not ingest c) Do not use on broken or irritated skin
• Field of application and/or use : (a) Products for hair care (b) Products for skin care (c) Products to toughen nails d) Products for oral hygiene
• Maximum concentration permitted at final product : (a) 12% H2O2 (40 volumes) present or released (b) 4% H2O2 present or released (c) 2% H2O2 present or released d) 0,1% H2O2 present or released
• Use conditions and warnings that must appear on the label : a) Contains hydrogen peroxide - Avoid contact with eyes. In case of contact with eyes thoroughly rinse with water - Use suitable gloves b) and c) - Contains hydrogen peroxide - Avoid contact with eyes. In case of contact with eyes thoroughly rinse with water

Canadá

• Conditions of Use by product type : Oral products containing peroxides or peroxide-generating compounds: Manufacturers should have the following information on hand as it may be requested by Health Canada: 1. A laboratory report providing pH of the product as applied to tooth or teeth. Section 13 of the Cosmetic Regulations requires that the pH is greater than or equal to 4.0 2. Product labelling indicating the directions of use and cautionary statements. 3. If an oral cosmetic contains more than 3% hydrogen peroxide (or equivalent), notifiers must submit a clinical study to demonstrate the salivary peroxide levels do not exceed 3% during the use of the product as per the directions of use. NB: Be aware of the conversion factor between hydrogen peroxide and other peroxide‐generating compounds. For example, 10% carbamide (ure(a) peroxide is approximately equivalent to 3% hydrogen peroxide.
• Warnings and Cautionary Statements: (to the effect of) : “If irritation (such as redness, swelling, soreness) of the gums or the mouth occurs, discontinue use and consult an oral health professional.” “Products containing peroxides are not recommended for use by children under 12 years ofage.” “Consult your oral health professional before prolonged use of this product.” “Avoid swallowing the cosmetic or part thereof.” “Avoid contact of the product with the eye.” “Avoid direct contact of the active surface of the tooth whitening product with the gums and/or salivary flow."

Restriction II/1397 · SCCS opinion: Opinion on Sodium Perborate and Perboric Acid

Fuente: Lista de ingredientes CosIng (UE)