RegulatedAnx. VIRef. VI/30a

Zinc oxide (nano)

CAS
1314-13-2
IUPAC
Zinc oxide (nano)
Reference
VI/30a
Max conc.
25% - In case of combined use of zinc oxide and zinc oxide (nano), the sum shall not exceed the limit of 25%

Last CosIng update

1 March 2019

Description

ZINC OXIDE (NANO) es la forma nanoparticulada del óxido de zinc, un compuesto inorgánico perteneciente a la clase de los óxidos metálicos, obtenido mediante procesos controlados de síntesis que generan partículas de tamaño nanométrico con estructura cristalina definida. En cosmética, los óxidos metálicos en escala nano se emplean habitualmente como ingredientes de origen mineral en formulaciones destinadas a la protección frente a la radiación ultravioleta, formando parte de la categoría de filtros solares inorgánicos autorizados en la Unión Europea.

El ingrediente se encuentra listado en el Anexo VI, referencia 30a, del Reglamento (CE) 1223/2009. La concentración máxima autorizada es del 25%, con la precisión literal: "In case of combined use of zinc oxide and zinc oxide (nano), the sum shall not exceed the limit of 25%". Las condiciones de uso incluyen las advertencias de etiquetado obligatorias: "Not to be used in applications that may lead to exposure of the end-user's lungs by inhalation. Only nanomaterials having the following characteristics are allowed: — purity ≥ 96 %, with wurtzite crystalline structure and physical appearance as clusters that are rod-like, star-like and/or isometric shapes, with impurities consisting only of carbon dioxide and water, whilst any other impurities are less than 1 % in total, — median diameter of the particle number size distribution D50 (50 % of the number below this diameter) > 30 nm and D1 (1 % below this size) > 20 nm, — water solubility < 50 mg/L —uncoated, or coated with triethoxycaprylylsilane, dimethicone, dimethoxydiphenylsilanetriethoxycaprylylsilane cross-polymer, or octyl triethoxy silane."

Los filtros solares inorgánicos en forma nanoparticulada se incorporan habitualmente en emulsiones fotoprotectoras, cremas faciales con factor de protección solar, productos para uso infantil y formulaciones destinadas a pieles sensibles, actuando por mecanismos físicos sobre la radiación ultravioleta. La selección de recubrimientos superficiales autorizados condiciona la compatibilidad con la fase oleosa del vehículo cosmético. La información presentada es de referencia técnica y no constituye recomendación de uso ni claim de eficacia.

Detailed EU regulation

%

Maximum permitted concentration

25% - In case of combined use of zinc oxide and zinc oxide (nano), the sum shall not exceed the limit of 25%

§

Regulatory framework

Regulation (EC) No 1223/2009 — Annex VI, ref. 30a

Last update reflected in the database: 1 March 2019

Labelling warnings

Not to be used in applications that may lead to exposure of the end-user's lungs by inhalation. Only nanomaterials having the following characteristics are allowed: — purity ≥ 96 %, with wurtzite crystalline structure and physical appearance as clusters that are rod-like, star-like and/or isometric shapes, with impurities consisting only of carbon dioxide and water, whilst any other impurities are less than 1 % in total, — median diameter of the particle number size distribution D50 (50 % of the number below this diameter) > 30 nm and D1 (1 % below this size) > 20 nm, — water solubility < 50 mg/L —uncoated, or coated with triethoxycaprylylsilane, dimethicone, dimethoxydiphenylsilanetriethoxycaprylylsilane cross- polymer, or octyl triethoxy silane.

Recent analyses mentioning this substance

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Data source: Official CosIng from the European Commission, updated on 1 March 2019. Learn more →