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) is the nanoparticulate form of zinc oxide, an inorganic compound belonging to the class of metal oxides.

The ingredient is listed in Annex VI, reference 30a, of Regulation (EC) No 1223/2009. The maximum authorized concentration is 25%, with the literal clarification: "In case of combined use of zinc oxide and zinc oxide (nano), the sum shall not exceed the limit of 25%". The conditions of use include the mandatory 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."

The information presented is for technical reference only and does not constitute a recommendation for use or an efficacy claim.

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%

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Regulatory framework

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

Last update reflected in the database: 1 March 2019

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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

No analyses published yet for this substance. This section will be filled with regulatory blog articles as they are published.

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