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Commission Regulation (EU) 2018/885 of 20 June 2018 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) 2018/885 of 20 June 2018 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) 2018/885 · 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 23 is replaced by the following entry: Reference Number Substance identification Conditions Wording of conditions of use and warnings 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   a b c d e f g h i ‘23 2,2′-Methylene- bis(6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol)/Bisoctrizole Methylene Bis-Benzotriazolyl Tetramethylbutylphenol 103597-45-1 403-800-1   10 %  ( *1 )     (2) entry 23a is inserted: Reference Number Substance identification Conditions Wording of conditions of use and warnings 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   a b c d e f g h i ‘23a 2,2′-Methylene- bis(6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol)/Bisoctrizole Methylene Bis-Benzotriazolyl Tetramethylbutylphenol (nano) 103597-45-1 403-800-1   10 %  ( *2 ) 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 ≥ 98,5 %, with 2,2′-methylene-bis-(6(2H-benzotriazol-2-yl)-4-(isooctyl)phenol) isomer fraction not exceeding 1,5 %; — Solubility < 5 ng/L in water at 25 °C; — Partition coefficient (Log Pow): 12,7 at 25 °C; — Uncoated; — Median particle size D50 (50 % of the number below this diameter): ≥ 120 nm of mass distribution and/or ≥ 60 nm of number size distribution.   ( *1 )   In case of combined use of Methylene Bis-Benzotriazolyl Tetramethylbutylphenol and Methylene Bis-Benzotriazolyl Tetramethylbutylphenol (nano), the sum shall not exceed the limit given in column g.’; ( *2 )   In case of combined use of Methylene Bis-Benzotriazolyl Tetramethylbutylphenol and Methylene Bis-Benzotriazolyl Tetramethylbutylphenol (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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