Annex

United Kingdom

Annex VI to Regulation (EC) No 1223/2009 is amended as follows:

(1)

entry 23 is replaced by the following entry:

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.’;

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 %^f1

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.’;
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 %^f1

(2)

entry 23a is inserted:

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.’.

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 %^f2
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.

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.’.
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 %^f2	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.

Annotations

Footnotes

f1: 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.’;
f2: 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.’.