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Commission Regulation (EU) 2016/1143 of 13 July 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) 2016/1143 of 13 July 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)

Regulation (EU) 2016/1143 · Regulation · 3 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Article 1

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Annex VI to Regulation (EC) No 1223/2009 is amended in accordance with the Annex to this Regulation.

Article 2

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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

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ANNEX Annex VI to Regulation (EC) No 1223/2009 is amended as follows: (1) entry 27 is replaced by the following entry:   Substance Identification Conditions   Reference number Chemical name/INN/XAN Name of Common Ingredients Glossary CAS number EC number Product type, Body parts Maximum concentration in ready for use preparation Other Wording of conditions of use and warnings a b c d e f g h i ‘27 Titanium dioxide  ( *1 ) Titanium Dioxide 13463-67-7/ 1317-70-0/ 1317-80-2 236-675-5/ 215-280-1/ 215-282-2   25 %  ( *2 )     (2) entry 27a is inserted:   Substance Identification Conditions   Reference number Chemical name/INN/XAN Name of Common Ingredients Glossary CAS number EC number Product type, Body parts Maximum concentration in ready for use preparation Other Wording of conditions of use and warnings a b c d e f g h i ‘27a Titanium dioxide  ( *3 ) Titanium Dioxide (nano) 13463-67-7/ 1317-70-0/ 1317-80-2 236-675-5/ 215-280-1/ 215-282-2   25 %  ( *4 ) 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 ≥ 99 %, — rutile form, or rutile with up to 5 % anatase, with crystalline structure and physical appearance as clusters of spherical, needle, or lanceolate shapes, — median particle size based on number size distribution ≥ 30 nm, — aspect ratio from 1 to 4,5, and volume specific surface area ≤ 460 m 2 /cm 3 , — coated with Silica, Hydrated Silica, Alumina, Aluminium Hydroxide, Aluminium Stearate, Stearic Acid, Trimethoxycaprylylsilane, Glycerin, Dimethicone, Hydrogen Dimethicone, Simethicone; — photocatalytic activity ≤ 10 % compared to corresponding non-coated or non-doped reference, — nanoparticles are photostable in the final formulation.   ( *1 )   For use as a colorant, see Annex IV, No 143. ( *2 )   In case of combined use of Titanium Dioxide and Titanium Dioxide (nano), the sum shall not exceed the limit given in column g.’; ( *3 )   For use as a colorant, see Annex IV, No 143. ( *4 )   In case of combined use of Titanium Dioxide and Titanium Dioxide (nano), the sum shall not exceed the limit given in column g.’

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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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