Article 1
Annex VI to Regulation (EC) No 1223/2009 is amended in accordance with the Annex to this Regulation.
Commission Regulation (EU) 2016/621 of 21 April 2016 amending Annex VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance)
Commission Regulation (EU) 2016/621 of 21 April 2016 amending Annex VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance)
Data as of 2026-07-04 Β· Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. Β· Read the official text β
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
Supplementary provisions
ANNEXSupplementary provisions
ANNEX The following entries are added to Annex VI to Regulation (EC) No 1223/2009 as reference numbers 30 and 30a: Reference number Substance identification Conditions Wording of conditions of use and warnings Chemical name/INN Name of Common Ingredients Glossary CAS number EC number Product type, body parts Maximum concentration in ready for use preparation Other a b c d e f g h i β30 Zinc oxide Zinc Oxide 1314-13-2 215-222-5 Β 25 % Β ( *1 ) Not to be used in applications that may lead to exposure of the end-user's lungs by inhalation. Β 30a Zinc oxide Zinc Oxide (nano) 1314-13-2 215-222-5 Β 25 % Β ( *1 ) 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: β purity β₯Β 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, β median diameter of the particle number size distribution D50 (50 % of the number below this diameter) >Β 30 nm and D1 (1 % below this size) >Β 20 nm, β water solubility <Β 50 mg/L β uncoated, or coated with triethoxycaprylylsilane, dimethicone, dimethoxydiphenylsilanetriethoxycaprylylsilane cross-polymer, or octyl triethoxy silane. Β ( *1 ) Β Β In case of combined use of zinc oxide and zinc oxide (nano), the sum shall not exceed the limit given in column g.β
Source: EUR-Lex (Publications Office of the EU), Β© European Union, reuse permitted under Commission Decision 2011/833/EU.
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