EN Annexes 1 to 4 ANNEX I

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1 Ref. Ares(209)4469-0/0/209 EN Annexes to 4 ANNEX I In Annex II to Regulation (EC) No 272/2008, in Part 2, the following section 2.2 is inserted: 2.2. Mixtures containing titanium dioxide. The label on the packaging of liquid mixtures containing % or more of titanium dioxide particles with a diameter equal to or below 0 µm shall bear the following : EUH2: 'Warning! Dangerous droplets may be formed when sprayed. See information supplied by the manufacturer. Comply with the safety instructions.' The label on the packaging of solid mixtures containing % or more of titanium dioxide shall bear the following : EUH22: 'Warning! Dangerous dust may be formed when used. See information supplied by the manufacturer. Comply with the safety instructions.' The label on the packaging of liquid and solid mixtures not intended for the general public and not classified as hazardous which are labelled with EUH2 or EUH22, shall bear EUH20 in addition.

2 ANNEX II In Part 3 of Annex III to Regulation (EC) No 272/2008, in Table 2., the following rows EUH 2 and EUH 22 are inserted: EUH2 Language Warning! Dangerous droplets may be formed when sprayed. See information supplied by the manufacturer. Comply with the safety instructions. EUH22 Language Warning! Dangerous dust may be formed when used. See information supplied by the manufacturer. Comply with the safety instructions. 2

3 ANNEX III Annex VI to Regulation (EC) No 272/2008 is amended as follows: () Part is amended as follows: (a) in point..3., the following note V is added: Note V: If the substance is placed on the market as fibres (with diameter < 3 μm, length > 5 μm and aspect ratio 3:) 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 Regulation (EC) No 272/2008 to assess whether a higher category (Carc. B or A) and/or additional routes of exposure (oral or dermal) should be applied. ; (b) in point..3.2, the following note 0 is added: Note 0: The classification as a carcinogen by inhalation applies only to mixtures placed on the market in powder form containing % or more of titanium dioxide particles with diameter 0 µm. ; (2) in Part 3, Table 3 is amended as follows: (a) the rows corresponding to index numbers X and are deleted; (b) the rows corresponding to index numbers , , , X, , , , , , , and are replaced by the following rows respectively: 3

4 Index No Chemical name EC No CAS No Classification Labelling Specific Conc. Limits, M- Class and factors and Category ATEs phenyl bis(2,4,6-trimethylbenzoyl)- phosphine oxide Skin Sens. A 4 H43 Word H43 Suppl cobalt Carc. B Muta. 2 Repr. B Resp. Sens. Skin Sens. 4 H360F H334 H43 H360F H334 H nickel bis(sulfamidate); nickel sulfamate Carc. A Muta. 2 Repr. B Acute Tox. 4 STOT RE Resp. Sens. Skin Sens. Aquatic Acute i *** H372** H334 i *** H372** H334 oral: ATE = 853 mg/kg bw (anhydrate) oral: ATE = 098 mg/kg bw (tetrahydrate) STOT RE ; H372: C % STOT RE 2; : 0, % C < % Skin Sens. ; : C 0,0 % H M= X ethylene oxide; oxirane Flam. Gas Press. Gas Carc. B Muta. B Repr. B Acute Tox. 3 Acute Tox. 3 STOT SE 3 STOT SE 3 STOT RE Skin Corr. Eye Dam. H220 H340 H360Fd H33 H30 H335 H336 H372 (nervous system) H34 H38 GHS02 GHS06 GHS05 H220 H340 H360Fd H33 H30 H335 H336 H372 (nervous system) H34 inhalation: ATE = 700ppm (gases) oral: ATE = 00 mg/kg bw U 4

5 Index No Chemical name EC No CAS No Classification Labelling Specific Conc. Limits, M- Class and factors and Category ATEs metaldehyde (ISO); 2,4,6,8-tetramethyl-,3,5,7- tetraoxacyclooctane Flam. Sol. 2 Repr. 2 Acute Tox. 3 3 H228 H36f H30 H42 Word GHS02 GHS06 H228 H36f H30 H42 Suppl. oral: ATE = 283 mg/kg bw benzyl-2-dimethylamino-4'- morpholinobutyrophenone Repr. B Aquatic Acute pyridate (ISO); O-(6-chloro-3-phenylpyridazin-4- yl) S-octyl thiocarbonate Acute Tox. 4 Skin Irrit. 2 Skin Sens. Aquatic Acute H35 GSH07 H35 oral: ATE = 500 mg/kg bw M= M= dodecyl methacrylate STOT SE 3 H335 H335 STOT SE 3; H335: C 0% phenylhexanenitrile Acute Tox. 4 2 H4 H4 oral: ATE = 500 mg/kg bw thiabendazole (ISO); 2-(thiazol-4-yl)benzimidazole Aquatic Acute M= M= diethyltoluamide (ISO): N,N-diethyl-m-toluamide; [deet] Acute Tox. 4 Skin Irrit. 2 Eye Irrit. 2 H35 H39 H35 H39 oral: ATE = 892 mg/kg bw 5

6 (c) the following rows are inserted: Index No Chemical Name EC No CAS No Classification Labelling Specific Conc. Limits, M-factors and ATEs titanium dioxide; [in a powder form containing % or more of particles with diameter 0 µm] Class and Category Carc. 2 H35 Word H35 Suppl. V, methylmercuric chloride Carc. 2 Repr. A Lact. Acute Tox. 2 Acute Tox. 2 Acute Tox. 2 STOT RE Aquatic Acute X benzo[rst]pentaphene Carc. B Muta. 2 H35 f H362 H330 H30 H300 H372 (nervous system, kidneys) GHS06 H35 f H362 H330 H30 H300 H372 (nervous system, kidneys) inhalation: ATE = 0,05 mg/l (dusts or mists) dermal: ATE = 50 mg/kg bw oral: ATE = 5 mg/kg bw dibenzo[b,def]chrysene; dibenzo[a,h]pyrene Carc. B Muta ethanol, 2,2'-iminobis-, N-(C3-5-branched and linear alkyl) derivs Repr. B cyflumetofen (ISO); 2-methoxyethyl (RS)-2-(4-tert- butylphenyl)-2-cyano-3-oxo-3- (α,α,α-trifluoro-o-tolyl)propionate Carc. 2 Skin Sens. A H35 H35 6

7 Index No Chemical Name EC No CAS No Classification Labelling Specific Conc. Limits, M-factors and ATEs pentapotassium 2,2,2,2,2 - (ethane-,2- diylnitrilo)pentaacetate Class and Category Repr. B Acute Tox. 4 STOT RE 2 Eye Irrit. 2 H39 Word H39 Suppl. inhalation: ATE =,5 mg/l (dusts or mists) N- carboxymethyliminobis(ethylene nitrilo)tetra(acetic acid) Repr. B Acute Tox. 4 STOT RE 2 Eye Irrit. 2 H39 H39 inhalation: ATE =,5 mg/l (dusts or mists) pentasodium (carboxylatomethyl)iminobis(eth ylenenitrilo)tetraacetate Repr. B Acute Tox. 4 STOT RE 2 inhalation: ATE =,5 mg/l (dusts or mists) diisohexyl phthalate Repr. B H360FD H360FD fludioxonil (ISO); 4-(2,2- difluoro-,3-benzodioxol-4-yl)- H-pyrrole-3-carbonitrile Aquatic Acute M= M= halosulfuron-methyl (ISO); methyl 3-chloro-5-{[(4,6- dimethoxypyrimidin-2- yl)carbamoyl]sulfamoyl}-- methyl-h-pyrazole-4- carboxylate Repr. B Aquatic Acute methylimidazole Repr. B f M=000 M=000 f 7

8 Index No Chemical Name EC No CAS No Classification Labelling Specific Conc. Limits, M-factors and ATEs (RS)-2-methoxy-N-methyl-2-[α- (2,5-xylyloxy)-o-tolyl]acetamide; mandestrobin Class and Category Aquatic Acute Word Suppl. M= M= carboxin (ISO); 2-methyl-N-phenyl-5,6-dihydro-,4-oxathiine-3-carboxamide; 5,6-dihydro-2-methyl-,4- oxathiine-3-carboxanilide STOT RE 2 Skin Sens. Aquatic Acute (kidneys) (kidneys) M= M= metaflumizone (ISO); (EZ)-2'-[2-(4-cyanophenyl)-- (α,α,α-trifluoro-m- tolyl)ethylidene]-[4- (trifluoromethoxy)phenyl]carbani lohydrazide [E-isomer > 90%, Z- isomer <0% relative content]; [] (E)-2'-[2-(4-cyanophenyl)-- (α,α,α-trifluoro-m- tolyl)ethylidene]-[4- (trifluoromethoxy)phenyl]carbani lohydrazide [2] dibutylbis(pentane-2,4-dionato- O,O')tin [] [2] Repr. 2 Lact. STOT RE Repr. B STOT RE H36fd H362 H360FD H372 (immune system) H36fd H362 H360FD H372 (immune system) 8

9 ANNEX IV In the Annex to Commission Regulation (EU) 208/669, the row with Index No is replaced by the following: pitch, coal tar, high-temp.; [The residue from the distillation of high temperature coal tar. A black solid with an approximate softening point from 30 C to 80 C (86 F to 356 F). Composed primarily of a complex mixture of three or more membered condensed ring aromatic hydrocarbons.] Carc. A Muta. B Repr. B H340 H360FD H340 H360FD 9

COMMISSION REGULATION (EU) / of XXX

Ref. Ares(2019)141469-10/01/2019 EUROPEAN COMMISSION Brussels, XXX [ ](2018) XXX draft COMMISSION REGULATION (EU) / of XXX amending, for the purposes of its adaptation to technical and scientific progress,