
Article 1 
Annex VI to Regulation (EC) No 1223/2009 is amended in accordance with the Annex to this Regulation.
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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 20 June 2018.
For the Commission
The President
Jean-Claude JUNCKER
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 %  

((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 % 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. 

