Annex III

United Kingdom

Annex VI to Regulation (EC) No 1272/2008 is amended as follows:

(1)
Part 1 is amended as follows:
1. (a)
  
  in point 1.1.3.1, the following notes V and W are added:
  
  ‘Note V:
  
  If the substance is to be placed on the market as fibres (with diameter < 3 μm, length > 5 μm and aspect ratio ≥ 3:1) or particles of the substance fulfilling the WHO fibre criteria or as particles with modified surface chemistry, their hazardous properties must be evaluated in accordance with Title II of this Regulation, to assess whether a higher category (Carc. 1B or 1A) and/or additional routes of exposure (oral or dermal) should be applied.’
  
  Note W:
  
  ‘It has been observed that the carcinogenic hazard of this substance arises when respirable dust is inhaled in quantities leading to significant impairment of particle clearance mechanisms in the lung.
  
  This note aims to describe the particular toxicity of the substance; it does not constitute a criterion for classification according to this Regulation.’;
2. (b)
  
  in point 1.1.3.2, the following note 10 is added:
  
  ‘Note 10:
  
  The classification as a carcinogen by inhalation applies only to mixtures in powder form containing 1 % or more of titanium dioxide which is in the form of or incorporated in particles with aerodynamic diameter ≤ 10 μm.’;

(2)

in Part 3, Table 3 is amended as follows:

(a)

the rows with index numbers 604-083-00-X and 611-159-00-6 are deleted;

(b)

the rows corresponding to index numbers 015-189-00-5, 027-001-00-9, 028-018-00-4, 603-023-00-X, 605-005-00-7, 606-047-00-9, 607-232-00-7, 607-247-00-9, 608-039-00-0, 613-054-00-0, 616-018-00-2 and 648-055-00-5 are replaced by the following rows respectively:

Index No	Chemical name	EC No	CAS No	Classification		Labelling			Specific Conc. Limits, M-factors and ATEs	Notes
Index No	Chemical name	EC No	CAS No	Hazard Class and Category Code(s)	Hazard statement Code(s)	Pictogram, Signal Word Code(s)	Hazard statement Code(s)	Suppl. Hazard statement Code(s)	Specific Conc. Limits, M-factors and ATEs	Notes
‘015-189-00-5	phenyl bis(2,4,6-trimethylbenzoyl)-phosphine oxide	423-340-5	162881-26-7	Skin Sens. 1A Aquatic Chronic 4	H317 H413	GHS07 Wng	H317 H413’
‘027-001-00-9	cobalt	231-158-0	7440-48-4	Carc. 1B Muta. 2 Repr. 1B Resp. Sens. 1 Skin Sens. 1 Aquatic Chronic 4	H350 H341 H360F H334 H317 H413	GHS08 Dgr	H350 H341 H360F H334 H317 H413’
‘028-018-00-4	nickel bis(sulfamidate); nickel sulfamate	237-396-1	13770-89-3	Carc. 1A Muta. 2 Repr. 1B Acute Tox. 4 STOT RE 1 Resp. Sens. 1 Skin Sens. 1 Aquatic Acute 1 Aquatic Chronic 1	H350i H341 H360D* H302 H372 H334 H317 H400 H410	_GHS08 GHS07 GHS09 Dgr	H350i H341 H360D* H302 H372 H334 H317 H410		oral: ATE = 853 mg/kg bw (anhydrate) oral: ATE = 1098 mg/kg bw (tetrahydrate) STOT RE 1; H372: C ≥ 1 % STOT RE 2; H373: 0,1 % ≤ C < 1 % Skin Sens. 1; H317: C ≥ 0,01 % M = 1’
‘603-023-00-X	ethylene oxide; oxirane	200-849-9	75-21-8	Flam. Gas 1 Press. Gas Carc. 1B Muta. 1B Repr. 1B Acute Tox. 3 Acute Tox. 3 STOT SE 3 STOT SE 3 STOT RE 1 Skin Corr. 1 Eye Dam. 1	H220 H350 H340 H360Fd H331 H301 H335 H336 H372 (nervous system) H314 H318	GHS02 GHS08 GHS06 GHS05 Dgr	H220 H350 H340 H360Fd H331 H301 H335 H336 H372 (nervous system) H314		inhalation: ATE = 700ppm (gases) oral: ATE = 100 mg/kg bw’	U
‘605-005-00-7	metaldehyde (ISO); 2,4,6,8-tetramethyl-1,3,5,7-tetraoxacyclooctane	203-600-2	108-62-3	Flam. Sol. 2 Repr. 2 Acute Tox. 3 Aquatic Chronic 3	H228 H361f H301 H412	GHS02 GHS08 GHS06 Dgr	H228 H361f H301 H412		oral: ATE = 283 mg/kg bw’
‘606-047-00-9	2-benzyl-2-dimethylamino-4'-morpholinobutyrophenone	404-360-3	119313-12-1	Repr. 1B Aquatic Acute 1 Aquatic Chronic 1	H360D H400 H410	GHS08 GHS09 Dgr	H360D H410’
‘607-232-00-7	pyridate (ISO); O-(6-chloro-3-phenylpyridazin-4-yl) S-octyl thiocarbonate	259-686-7	55512-33-9	Acute Tox. 4 Skin Irrit. 2 Skin Sens. 1 Aquatic Acute 1 Aquatic Chronic 1	H302 H315 H317 H400 H410	GHS07 GHS09 Wng	H302 H315 H317 H410		oral: ATE = 500 mg/kg bw M = 1 M = 10’
‘607-247-00-9	dodecyl methacrylate	205-570-6	142-90-5	STOT SE 3	H335	GHS07 Wng	H335		STOT SE 3; H335: C ≥ 10 %’
‘608-039-00-0	2-phenylhexanenitrile	423-460-8	3508-98-3	Acute Tox. 4 Aquatic Chronic 2	H302 H411	GHS07 GHS09 Wng	H302 H411		oral: ATE = 500 mg/kg bw’
‘613-054-00-0	thiabendazole (ISO); 2-(thiazol-4-yl)benzimidazole	205-725-8	148-79-8	Aquatic Acute 1 Aquatic Chronic 1	H400 H410	GHS09 Wng	H410		M = 1 M = 1’
‘616-018-00-2	diethyltoluamide (ISO): N,N-diethyl-m-toluamide; [deet]	205-149-7	134-62-3	Acute Tox. 4 Skin Irrit. 2 Eye Irrit. 2	H302 H315 H319	GHS07 Wng	H302 H315 H319		oral: ATE = 1892 mg/kg bw’

(c)

the following rows are inserted:

Index No	Chemical Name	EC No	CAS No	Classification		Labelling			Specific Conc. Limits, M-factors and ATEs	Notes
Index No	Chemical Name	EC No	CAS No	Hazard Class and Category Code(s)	Hazard statement Code(s)	Pictogram, Signal Word Code(s)	Hazard statement Code(s)	Suppl. Hazard statement Code(s)	Specific Conc. Limits, M-factors and ATEs	Notes
‘022-006-002	titanium dioxide; [in powder form containing 1 % or more of particles with aerodynamic diameter ≤ 10 μm]	236-675-5	13463-67-7	Carc. 2	H351 (inhalation)	GHS08 Wng	H351 (inhalation)			V, W, 10’
‘080-012-00-0	methylmercuric chloride	204-064-2	115-09-3	Carc. 2 Repr. 1A Lact. Acute Tox. 2 Acute Tox. 2 Acute Tox. 2 STOT RE 1 Aquatic Acute 1 Aquatic Chronic 1	H351 H360Df H362 H330 H310 H300 H372 (nervous system, kidneys) H400 H410	GHS08 GHS06 GHS09 Dgr	H351 H360Df H362 H330 H310 H300 H372 (nervous system, kidneys) H410		inhalation: ATE = 0,05 mg/l (dusts or mists) dermal: ATE = 50 mg/kg bw oral: ATE = 5 mg/kg bw	1’
‘601-090-00-X	benzo[rst]pentaphene	205-877-5	189-55-9	Carc. 1B Muta. 2	H350 H341	GHS08 Dgr	H350 H341’
‘601-091-00-5	dibenzo[b,def]chrysene; dibenzo[a,h]pyrene	205-878-0	189-64-0	Carc. 1B Muta. 2	H350 H341	GHS08 Dgr	H350 H341’
‘603-236-00-8	ethanol, 2,2’-iminobis-, N-(C13-15-branched and linear alkyl) derivs.	308-208-6	97925-95-6	Repr. 1B	H360D	GHS08 Dgr	H360D’
‘607-733-00-0	cyflumetofen (ISO); 2-methoxyethyl (RS)-2-(4-tert-butylphenyl)-2-cyano-3-oxo-3-(α,α,α-trifluoro-o-tolyl)propionate	—	400882-07-7	Carc. 2 Skin Sens. 1A	H351 H317	GHS08 GHS07 Wng	H351 H317’
‘607-734-00-6	pentapotassium 2,2’,2’’,2’’’,2’’’’-(ethane-1,2-diylnitrilo)pentaacetate	404-290-3	7216-95-7	Acute Tox. 4 STOT RE 2 Eye Irrit. 2	H332 H373 (inhalation) H319	GHS08 GHS07 Dgr	H332 H373 (inhalation) H319		inhalation: ATE = 1,5 mg/l (dusts or mists)’
‘607-735-00-1	N-carboxymethyliminobis(ethylenenitrilo)tetra(acetic acid)	200-652-8	67-43-6	Acute Tox. 4 STOT RE 2 Eye Irrit. 2	H332 H373 (inhalation) H319	GHS08 GHS07 Dgr	H332 H373 (inhalation) H319		inhalation: ATE = 1,5 mg/l (dusts or mists)’
‘607-736-00-7	pentasodium (carboxylatomethyl)iminobis(ethylenenitrilo)tetraacetate	205-391-3	140-01-2	Acute Tox. 4 STOT RE 2	H332 H373 (inhalation)	GHS08 GHS07 Dgr	H332 H373 (inhalation)		inhalation: ATE = 1,5 mg/l (dusts or mists)’
‘607-737-00-2	diisohexyl phthalate	276-090-2	71850-09-4	Repr. 1B	H360FD	GHS08 Dgr	H360FD’
‘608-069-00-4	fludioxonil (ISO); 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile	—	131341-86-1	Aquatic Acute 1 Aquatic Chronic 1	H400 H410	GHS09 Wng	H410		M = 1 M = 10’
‘613-329-00-5	halosulfuron-methyl (ISO); methyl 3-chloro-5-{[(4,6-dimethoxypyrimidin-2-yl)carbamoyl]sulfamoyl}-1-methyl-1H-pyrazole-4-carboxylate	—	100784-20-1	Repr. 1B Aquatic Acute 1 Aquatic Chronic 1	H360D H400 H410	GHS08 GHS09 Dgr	H360D H410		M = 1000 M = 1000’
613-330-00-0	2-methylimidazole	211-765-7	693-98-1	Repr. 1B	H360Df	GHS08 Dgr	H360Df
‘616-225-00-8	(RS)-2-methoxy-N-methyl-2-[α-(2,5-xylyloxy)-o-tolyl]acetamide; mandestrobin	—	173662-97-0	Aquatic Acute 1 Aquatic Chronic 1	H400 H410	GHS09 Wng	H410		M = 1 M = 10’
‘616-226-00-3	carboxin (ISO); 2-methyl-N-phenyl-5,6-dihydro-1,4-oxathiine-3-carboxamide; 5,6-dihydro-2-methyl-1,4-oxathiine-3-carboxanilide	226-031-1	5234-68-4	STOT RE 2 Skin Sens. 1 Aquatic Acute 1 Aquatic Chronic 1	H373 (kidneys) H317 H400 H410	GHS08 GHS07 GHS09 Wng	H373 (kidneys) H317 H410		M = 1 M = 1’
‘616-227-00-9	metaflumizone (ISO); (EZ)-2’-[2-(4-cyanophenyl)-1-(α,α,α -trifluoro-m-tolyl)ethylidene]-[4-(trifluoromethoxy)phenyl]carbanilohydrazide [E-isomer ≥ 90 %, Z-isomer ≤ 10 % relative content]; [1] (E)-2’-[2-(4-cyanophenyl)-1-(α,α,α -trifluoro-m-tolyl)ethylidene]-[4-(trifluoromethoxy)phenyl]carbanilohydrazide [2]	—	139968-49-3 [1] 852403-68-0 [2]	Repr. 2 Lact. STOT RE 2	H361fd H362 H373	GHS08 Wng	H361fd H362 H373’
‘650-056-00-0	dibutylbis(pentane-2,4-dionato-O,O’)tin	245-152-0	22673-19-4	Repr. 1B STOT RE 1	H360FD H372 (immune system)	GHS08 Dgr	H360FD H372 (immune system)’.