
Article 1 
Regulation (EC) No 1272/2008 is amended as follows:

((1)) Annex II is amended as set out in Annex I to this Regulation;
((2)) Annex III is amended as set out in Annex II to this Regulation;
((3)) Annex VI is amended as set out in Annex III to this Regulation.
Article 2 
Annex VI to Regulation (EC) No 1272/2008 is corrected as set out in Annex IV to this Regulation.
Article 3 
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 9 September 2021.
However, Article 2 shall apply from 1 December 2019.
Substances and mixtures may, before 9 September 2021, be classified, labelled and packaged in accordance with Regulation (EC) No 1272/2008 as amended by this Regulation.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 4 October 2019.
For the Commission
The President
Jean-Claude JUNCKER
ANNEX I

Part 2 of Annex II to Regulation (EC) No 1272/2008 is amended as follows:

((1)) The introductory paragraph is amended as follows:
'The statements set out in sections 2.1 to 2.10 and 2.12 shall be assigned to mixtures in accordance with Article 25(6).'
((2)) Section 2.12 is added:
'
2.12. 
The label on the packaging of liquid mixtures containing 1 % or more of titanium dioxide particles with aerodynamic diameter equal to or below 10 μm shall bear the following statement:

EUH211: ‘Warning! Hazardous respirable droplets may be formed when sprayed. Do not breathe spray or mist.’

The label on the packaging of solid mixtures containing 1 % or more of titanium dioxide shall bear the following statement:

EUH212: ‘Warning! Hazardous respirable dust may be formed when used. Do not breathe dust.’

In addition, 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 EUH211 or EUH212, shall bear statement EUH210.
'

ANNEX II

In Part 3 of Annex III to Regulation (EC) No 1272/2008, the following rows EUH 211 and EUH 212 are inserted:
'
EUH211 Language 
 BG Внимание! При пулверизация могат да се образуват опасни респирабилни капки. Не вдишвайте пулверизираната струя или мъгла.
 ES ¡Atención! Al rociar pueden formarse gotas respirables peligrosas. No respirar el aerosol.
 CS Pozor! Při postřiku se mohou vytvářet nebezpečné respirabilní kapičky. Nevdechujte aerosoly nebo mlhu.
 DA Advarsel! Der kan danne sig farlige respirable dråber, når der sprayes. Undgå indånding af spray eller tåge.
 DE Achtung! Beim Sprühen können gefährliche lungengängige Tröpfchen entstehen. Aerosol oder Nebel nicht einatmen.
 ET Hoiatus! Pihustamisel võivad tekkida ohtlikud sissehingatavad piisad. Pihustatud ainet või udu mitte sisse hingata.
 EL Προσοχή! Κατά τον ψεκασμό μπορούν να σχηματιστούν επικίνδυνα εισπνεύσιμα σταγονίδια. Μην αναπνέετε το εκνέφωμα ή τα σταγονίδια.
 EN Warning! Hazardous respirable droplets may be formed when sprayed. Do not breathe spray or mist.
 FR Attention! Des gouttelettes respirables dangereuses peuvent se former lors de la pulvérisation. Ne pas respirer les aérosols ni les brouillards.
 GA Aire! D’fhéadfaí braoiníní guaiseacha inanálaithe a chruthú nuair a spraeáiltear an táirge seo. Ná hanálaigh sprae ná ceo.
 HR Upozorenje! Pri prskanju mogu nastati opasne respirabilne kapljice. Ne udisati aerosol ni maglicu.
 IT Attenzione! In caso di vaporizzazione possono formarsi goccioline respirabili pericolose. Non respirare i vapori o le nebbie.
 LV Uzmanību! Izsmidzinot var veidoties bīstami ieelpojami pilieni. Ne smidzinājumu, ne miglu neieelpot.
 LT Atsargiai! Purškiant gali susidaryti pavojingų įkvepiamų lašelių. Neįkvėpti rūko ar aerozolio.
 HU Figyelem! Permetezés közben veszélyes, belélegezhető cseppek képződhetnek. A permetet vagy a ködöt nem szabad belélegezni.
 MT Twissija! Jista’ jifforma qtar perikoluż li jinġibed man-nifs meta tisprejja minn dan. Tiġbidx l-isprej jew l-irxiex man-nifs.
 NL Let op! Bij verneveling kunnen gevaarlijke inhaleerbare druppels worden gevormd. Spuitnevel niet inademen.
 PL Uwaga! W przypadku rozpylania mogą się tworzyć niebezpieczne respirabilne kropelki. Nie wdychać rozpylonej cieczy lub mgły.
 PT Atenção! Podem formar-se gotículas inaláveis perigosas ao pulverizar. Não respirar a pulverização ou névoas.
 RO Avertizare! Se pot forma picături respirabile periculoase la pulverizare. Nu respirați prin pulverizare sau ceață.
 SK Pozor! Pri rozprašovaní sa môžu vytvárať nebezpečné respirabilné kvapôčky. Nevdychujte aerosóly ani hmlu.
 SL Pozor! Pri razprševanju lahko nastanejo nevarne vdihljive kapljice. Ne vdihavajte razpršila ali meglic.
 FI Varoitus! Vaarallisia keuhkorakkuloihin kulkeutuvia pisaroita saattaa muodostua suihkutuksen yhteydessä. Älä hengitä suihketta tai sumua.
 SV Varning! Farliga respirabla droppar kan bildas vid sprejning. Inandas inte sprej eller dimma.'
'
EUH212 Language 
 BG Внимание! При употреба може да се образува опасен респирабилен прах. Не вдишвайте праха.
 ES ¡Atención! Al utilizarse, puede formarse polvo respirable peligroso. No respirar el polvo.
 CS Pozor! Při použití se může vytvářet nebezpečný respirabilní prach. Nevdechujte prach.
 DA Advarsel! Der kan danne sig farligt respirabelt støv ved anvendelsen. Undgå indånding af støv.
 DE Achtung! Bei der Verwendung kann gefährlicher lungengängiger Staub entstehen. Staub nicht einatmen.
 ET Hoiatus! Kasutamisel võib tekkida ohtlik sissehingatav tolm. Tolmu mitte sisse hingata.
 EL Προσοχή! Κατά τη χρήση μπορεί να σχηματιστεί επικίνδυνη εισπνεύσιμη σκόνη. Μην αναπνέετε τη σκόνη.
 EN Warning! Hazardous respirable dust may be formed when used. Do not breathe dust.
 FR Attention! Une poussière respirable dangereuse peut se former lors de l’utilisation. Ne pas respirer cette poussière.
 GA Aire! D’fhéadfaí deannach guaiseach inanálaithe a chruthú nuair a úsáidtear an táirge seo. Ná hanálaigh deannach.
 HR Upozorenje! Pri prskanju može nastati opasna respirabilna prašina. Ne udisati prašinu.
 IT Attenzione! In caso di utilizzo possono formarsi polveri respirabili pericolose. Non respirare le polveri.
 LV Uzmanību! Izmantojot var veidoties bīstami ieelpojami putekļi. Putekļus neieelpot.
 LT Atsargiai! Naudojant gali susidaryti pavojingų įkvepiamų dulkių. Neįkvėpti dulkių.
 HU Figyelem! Használatkor veszélyes, belélegezhető por képződhet. A port nem szabad belélegezni.
 MT Twissija! Meta jintuża dan, jista’ jifforma trab perikoluż li jinġibed man-nifs. Tiġbidx it-trab man-nifs.
 NL Let op! Bij gebruik kunnen gevaarlijke inhaleerbare stofdeeltjes worden gevormd. Stof niet inademen.
 PL Uwaga! W przypadku stosowania może się tworzyć niebezpieczny pył respirabilny. Nie wdychać pyłu.
 PT Atenção! Podem formar-se poeiras inaláveis perigosas ao pulverizar. Não respirar as poeiras.
 RO Avertizare! Se poate forma pulbere respirabilă periculoasă în timpul utilizării. Nu inspirați pulberea.
 SK Pozor! Pri použití sa môže vytvárať nebezpečný respirabilný prach. Nevdychujte prach.
 SL Pozor! Pri uporabi lahko nastane nevaren vdihljiv prah. Prahu ne vdihavajte.
 FI Varoitus! Vaarallista keuhkorakkuloihin kulkeutuvaa pölyä saattaa muodostua käytön yhteydessä. Älä hengitä pölyä.
 SV Varning! Farligt respirabelt damm kan bildas vid användning. Inandas inte damm.'

ANNEX III

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

((1)) Part 1 is amended as follows:

((a)) in point 1.1.3.1, the following notes V and W are added:
'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.'
‘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.’;
((b)) in point 1.1.3.2, the following note 10 is added:
'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
Hazard Class and Category Code(s) Hazard statement Code(s) Pictogram, Signal Word Code(s) Hazard statement Code(s) Suppl. Hazard statement Code(s)
‘015-189-00-5 phenyl bis(2,4,6-trimethylbenzoyl)-phosphine oxide 423-340-5 162881-26-7 Skin Sens. 1AAquatic Chronic 4 H317H413 GHS07Wng H317H413’   
‘027-001-00-9 cobalt 231-158-0 7440-48-4 Carc. 1BMuta. 2Repr. 1BResp. Sens. 1Skin Sens. 1Aquatic Chronic 4 H350H341H360FH334H317H413 GHS08Dgr H350H341H360FH334H317H413’   
‘028-018-00-4 nickel bis(sulfamidate);nickel sulfamate 237-396-1 13770-89-3 Carc. 1AMuta. 2Repr. 1BAcute Tox. 4STOT RE 1Resp. Sens. 1Skin Sens. 1Aquatic Acute 1Aquatic Chronic 1 H350iH341H360D***H302H372**H334H317H400H410 GHS08GHS07GHS09Dgr H350iH341H360D***H302H372**H334H317H410  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 1Press. GasCarc. 1BMuta. 1BRepr. 1BAcute Tox. 3Acute Tox. 3STOT SE 3STOT SE 3STOT RE 1Skin Corr. 1Eye Dam. 1 H220H350H340H360FdH331H301H335H336H372 (nervous system)H314H318 GHS02GHS08GHS06GHS05Dgr H220H350H340H360FdH331H301H335H336H372 (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. 2Repr. 2Acute Tox. 3Aquatic Chronic 3 H228H361fH301H412 GHS02GHS08GHS06Dgr H228H361fH301H412  oral: ATE = 283 mg/kg bw’ 
‘606-047-00-9 2-benzyl-2-dimethylamino-4'-morpholinobutyrophenone 404-360-3 119313-12-1 Repr. 1BAquatic Acute 1Aquatic Chronic 1 H360DH400H410 GHS08GHS09Dgr H360DH410’   
‘607-232-00-7 pyridate (ISO);O-(6-chloro-3-phenylpyridazin-4-yl) S-octyl thiocarbonate 259-686-7 55512-33-9 Acute Tox. 4Skin Irrit. 2Skin Sens. 1Aquatic Acute 1Aquatic Chronic 1 H302H315H317H400H410 GHS07GHS09Wng H302H315H317H410  oral: ATE = 500 mg/kg bwM = 1M = 10’ 
‘607-247-00-9 dodecyl methacrylate 205-570-6 142-90-5 STOT SE 3 H335 GHS07Wng H335  STOT SE 3; H335: C ≥ 10 %’ 
‘608-039-00-0 2-phenylhexanenitrile 423-460-8 3508-98-3 Acute Tox. 4Aquatic Chronic 2 H302H411 GHS07GHS09Wng H302H411  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 H400H410 GHS09Wng H410  M = 1M = 1’ 
‘616-018-00-2 diethyltoluamide (ISO): N,N-diethyl-m-toluamide; [deet] 205-149-7 134-62-3 Acute Tox. 4Skin Irrit. 2Eye Irrit. 2 H302H315H319 GHS07Wng H302H315H319  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
Hazard Class and Category Code(s) Hazard statement Code(s) Pictogram, Signal Word Code(s) Hazard statement Code(s) Suppl. Hazard statement Code(s)
‘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) GHS08Wng H351 (inhalation)   V, W, 10’
‘080-012-00-0 methylmercuric chloride 204-064-2 115-09-3 Carc. 2Repr. 1ALact.Acute Tox. 2Acute Tox. 2Acute Tox. 2STOT RE 1Aquatic Acute 1Aquatic Chronic 1 H351H360DfH362H330H310H300H372 (nervous system, kidneys)H400H410 GHS08GHS06GHS09Dgr H351H360DfH362H330H310H300H372 (nervous system, kidneys)H410  inhalation: ATE = 0,05 mg/l (dusts or mists)dermal: ATE = 50 mg/kg bworal: ATE = 5 mg/kg bw 1’
‘601-090-00-X benzo[rst]pentaphene 205-877-5 189-55-9 Carc. 1BMuta. 2 H350H341 GHS08Dgr H350H341’   
‘601-091-00-5 dibenzo[b,def]chrysene;dibenzo[a,h]pyrene 205-878-0 189-64-0 Carc. 1BMuta. 2 H350H341 GHS08Dgr H350H341’   
‘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 GHS08Dgr 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. 2Skin Sens. 1A H351H317 GHS08GHS07Wng H351H317’   
‘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 2Eye Irrit. 2 H332H373 (inhalation)H319 GHS08GHS07Dgr H332H373 (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 2Eye Irrit. 2 H332H373 (inhalation)H319 GHS08GHS07Dgr H332H373 (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. 4STOT RE 2 H332H373 (inhalation) GHS08GHS07Dgr H332H373 (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 GHS08Dgr 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 1Aquatic Chronic 1 H400H410 GHS09Wng H410  M = 1M = 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. 1BAquatic Acute 1Aquatic Chronic 1 H360DH400H410 GHS08GHS09Dgr H360DH410  M = 1000M = 1000’ 
613-330-00-0 2-methylimidazole 211-765-7 693-98-1 Repr. 1B H360Df GHS08Dgr 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 H400H410 GHS09Wng H410  M = 1M = 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 2Skin Sens. 1Aquatic Acute 1Aquatic Chronic 1 H373 (kidneys)H317H400H410 GHS08GHS07GHS09Wng H373 (kidneys)H317H410  M = 1M = 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. 2Lact.STOT RE 2 H361fdH362H373 GHS08Wng H361fdH362H373’   
‘650-056-00-0 dibutylbis(pentane-2,4-dionato-O,O’)tin 245-152-0 22673-19-4 Repr. 1BSTOT RE 1 H360FDH372 (immune system) GHS08Dgr H360FDH372 (immune system)’.   

ANNEX IV

In Annex VI to Regulation (EC) No 1272/2008, in table 3, the row with Index No ‘648-055-00-5’ is replaced by the following:

Index No Chemical name EC No Cas No Classification Labelling Specific Conc. Limits, M-factors and ATEs Notes
Hazard Class and Category Code(s) Hazard statement Code(s) Pictogram, Signal Word Code(s) Hazard statement Code(s) Suppl. Hazard statement Code(s)
‘648-055-00-5 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 180 °C (86 °F to 356 °F). Composed primarily of a complex mixture of three or more membered condensed ring aromatic hydrocarbons.] 266-028-2 65996-93-2 Carc. 1AMuta. 1BRepr. 1B H350H340H360FD GHS08Dgr H350H340H360FD’.   