II 
(Non-legislative acts) 
REGUL ATIONS 
COMMISSION DELEGA TED REGUL ATION (EU) 2020/217 
of 4 Oct ober 2019 
amending, for the pur poses of its adaptation to technical and scientif ic prog ress, Regulation (EC) No 
1272/2008 of the European Parliament and of the Council on classif ication, labelling and packa ging 
of subst ances and mixtures and correcting that Regulation 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Havi ng regar d to the Treaty on the Functioning of the European Union, 
Havi ng regard to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on 
classificat ion, labelling and packag ing of substances and mixtures, amending and repealing Directives 67/548/EEC and 
1999/45/EC, and amending Regulation (EC) No 1907/2006 (1), and in particular Articles 37(5) and 53(1) thereof, 
Whereas: 
(1) Table 3 of Part 3 of Annex VI to Regulation (EC) No 1272/2008 contains the list of harmonised classification and 
labelling of hazardous substances based on the criteria set out in Parts 2 to 5 of Annex I to that Regulation. 
(2) Proposals to introduce harmonised classification and labelling of certain substances and to update or delet e the 
harmonised classification and labelling of certain other substances have been submitted to the European Chemicals 
Agen cy (‘Agen cy’) pursuant to Article 37 of Regulation (EC) No 1272/2008. Based on the opinions on those 
proposals issued by the Committ ee for Risk Assessment of the Agency (RAC), as well as on the comments received 
from the parties concer ned, it is appropr iate to introduce, updat e or delet e harmonised classif ication and labelling 
of certain substances. Those RAC opinions (2) are: 
— Opinion of 9 June 2017 concer ning 4,4’-sulf onyl bisphenol, polymer with ammonium chlor ide (NH 4Cl), 
pentachlorophosp horane and phenol 
— Opinion of 22 Sept ember 2017 concer ning disodium 4-amino-6-((4-((4-(2,4-diaminophenyl )azo) 
pheny lsulfamo yl)phenyl)azo)-5-h ydro xy-3-((4-nitrophen yl)azo)naphthalene- 2,7-disulf onat e 
— Opinion of 9 June 2017 concer ning Phenyl bis(2,4,6-tr imethylbenzo yl)-phosphine oxide; 
— Opinion of 22 Septembe r 2017 concer ning cobalt ; 
— Opinion of 22 Septembe r 2017 concer ning nick el bis(sulfamidat e); nick el sulfamate; 
— Opinion of 22 Septembe r 2017 concer ning ethylene oxide; oxirane; 
— Opinion of 22 Septembe r 2017 concer ning 2,4,6,8-tetrameth yl-1,3,5,7-tetrao xacy clooctane; metaldehyde; 
— Opinion of 15 Marc h 2017 concer ning 2-benzyl-2-dimethylamino-4’morph olinobutyrophenone; 
(1)OJ L 353, 31.12.2008, p. 1. 
(2)https://ec ha.europa.eu/registr y-of-clh-intentions-until-outcome/-/dislist/name/-/ecNumber/-/casNumber/-/dt e_receiptFrom/-/ 
dte_ receiptT o/-/prc_public_status/Opinion+Ado pted/dt e_withdrawnFrom/-/dt e_withdra wnTo/-/sbm_expected_submissionFrom/-/ 
sbm_expected _submission To/-/dt e_fin alise_deadlineFrom/-/dte_ finalise_deadlineT o/-/haz_addional_hazard/-/lec_submitter/-/ 
dte_ assessmentFrom/-/dte_assessmentT o/-/prc_regulatory_p rogramme/-/ EN Offi cial Jour nal of the European Union 18.2.2020                                                                                                                                            L 44/1   — Opinion of 5 December 2017 concer ning pyridate (ISO); O-(6-chlor o-3-phenylp yridazin-4-yl) S-octyl 
thiocarbonate; 
— Opinion of 22 Septembe r 2017 concer ning dodecyl methacr ylate; 
— Opinion of 5 December 2017 concer ning 2-phen ylhexanenitr ile; 
— Opinion of 15 Marc h 2017 concer ning thiabendazole (ISO); 2-(thiazol-4-yl)benzimidazole; 
— Opinion of 9 June 2017 concer ning N,N-diethyl-m-t oluamide; deet ; 
— Opinion of 14 Septembe r 2017 concer ning Titanium dioxide; 
— Opinion of 15 Marc h 2017 concer ning Methylmercur ic chlor ide; 
— Opinion of 9 June 2017 concer ning benzo[rst]pentaphene; 
— Opinion of 9 June 2017 concer ning Dibenzo[b,def]chry sene; Dibenzo[a,h]p yrene; 
— Opinion of 22 Sept ember 2017 concer ning Ethanol, 2,2’-iminobis-, N-(C13-15-branched and linear alkyl) 
derivs; 
— Opinion of 5 December 2017 concer ning cyflumetof en (ISO); 2-metho xyethyl (RS) -2-(4-t ert-butylphen yl)-2- 
cyano-3-o xo-3-(α,α,α- trifluoro-o-t olyl)propionate; 
— Opinion of 9 June 2017 concer ning Pentapotassium 2,2’,2’’ ,2’’’,2’’’’-(ethane-1,2-diylnitr ilo)pentaacetat e; 
— Opinion of 9 June 2017 concer ning N-carbo xymeth yliminobis (ethyl enenitr ilo)tetra(a cetic acid); 
— Opinion of 9 June 2017 concer ning pentasodium (carbo xylatom ethyl)iminobis(eth ylenenitr ilo) tetraacetate; 
— Opinion of 9 June 2017 concer ning diisohexyl phthalat e; 
— Opinion of 9 June 2017 concer ning fludio xonil (ISO); 4-(2,2-dif luoro-1,3-benzodio xol-4-yl)-1H-p yrrole-3- 
carbonitr ile; 
—Opinion of 22 Sept ember 2017 concer ning halosulfuron-methyl (ISO); meth yl 3-chloro-5{[(4,6-dimetho xy-
pyrimidin-2-yl)carbamo yl]sulf amo yl}-1-meth yl-1H-p yrazole4-carbo xylate; 
— Opinion of 5 December 2017 concer ning 2-meth ylimidazole; 
— Opinion of 15 Marc h 2017 concer ning (RS)-2-metho xy-N-methyl-2- [α-(2,5-xylylo xy)-o-to lyl]acetamide; 
mandestrobin; 
— Opinion of 5 December 2017 concer ning carbo xin (ISO); 2-methyl -N-phenyl-5,6-dih ydro-1,4-o xathiine-3- 
carbo xamide; 5,6-dih ydro-2-methyl-1,4-o xathiine-3-carbo xanilide; 
— Opinion of 5 December 2017 concer ning metaf lumizone (ISO); (EZ)-2’-[2-(4-cyanophenyl)- 1-(α,α,α -trifluoro- 
m-tol yl)ethylidene]-[4-(tri fluorometho xy)phenyl]carbaniloh ydrazide [E-isomer ≥ 90 %, Z-isomer≤ 10 % relative 
conte nt] [1] (E)-2’-[2-(4-cyanophen yl)-1-(α,α,α -trifluoro-m-to lyl)eth ylidene]-[4-(tr ifluorometho xy)phenyl] 
carbanilohydrazi de [2]; 
— Opinion of 5 December 2017 concer ning Dibutylbis(pentane-2,4-dionat o-O,O’)tin. 
(3) Acute Toxicity Estimate s (ATE) are mainly used to deter mine the classification for human health acute toxicity of 
mixtures containing substances classified for acute toxicity . The inclusion of harmonised ATE values in the entr ies 
liste d in Annex VI to Regulation (EC) No 1272/2008 facilitat es the harmonisation of the classification of mixtures 
and provid es suppor t for enforcement author ities. Follo wing further scientific assessments of some substances, ATE 
values have been calculat ed for methylmercur ic chlor ide, pentapotassium 2,2’, 2’’,2’’’ ,2’’’’-(ethane-1,2-diylnitr ilo) 
pentaacetat e, N-carbo xymeth yliminobis(ethylenenitr ilo)te tra(acetic acid), pentasodium (carbo xylatometh yl)iminobis 
(ethyl enenitr ilo)tetraacetat e (DTP A), ethylen e oxide, oxirane and metaldeh yde (ISO), 2,4,6,8-tetrameth yl-1,3,5,7- 
tetraoxacy clooctane, in addition to those proposed in the RAC opinions. Those ATE values should be inser ted in the 
penultimat e column of Table 3 of Part 3 of Annex VI to Regulation (EC) No 1272/2008. 
(4) In its scientific opinion of 22 Sept ember 2017 on the substance cobalt, RAC proposed to classify that substance as 
carcinog en cate gory 1B with a specifi c concentration limit of ≥ 0,01 %. Howe ver, the methodology used to 
determine a specifi c concentration limit required further assessment, in particular of its applicability to metal 
compo unds. It is theref ore appropr iate not to introduce, for the time being, any specifi c concentration limit in Table 
3 of Part 3 of Annex VI to Regulation (EC) No 1272/2008 for cobalt, in whic h case the general concentration limit of 
≥ 0,1 % applies, in accordance with Table 3.6.2 of Annex I to that Regulation. EN Offi cial Jour nal of the European Union L 44/2                                                                                                                                            18.2.2020   (5) In its scientifi c opinion of 14 September 2017 on the substance titanium dioxide, RAC proposed to classify that 
substance as carcinogen cate gory 2 by inhalation. As titanium dioxide-induced lung carcinog enicity is associated 
with inhalation of respirable titanium dioxide particles, retention and poor solubility of the particles in the lung, it 
is appropr iate to define respirable titanium dioxide particles in the titanium dioxide entr y. The deposited particles, 
but not solutes of titanium dioxide, are assumed to be responsible for the obser ved toxicity in the lung and 
subsequent tumour development. In order to avoid unjustifi ed classification of non-hazardous forms of the 
substance, specific notes should be laid down for the classification and labelling of the substance and mixtures 
containing it. In addition, as some hazardous dust or droplets could be formed during the use of mixtures 
containing titanium dioxide, it is necessar y to inform the users of the precautionar y measures that need to be taken 
to minimise the hazard for human health. 
(6) With regard to the substances pentapotassium 2,2’,2’’ ,2’’’,2’’’’-(ethane-1,2-diylnitri lo)pentaacetate , N-carbo xymethy­
liminobis(eth ylenenitr ilo)tet ra(acetic acid) and pentasodium (carbo xylatometh yl)iminobis(ethylenenitr ilo) 
tetraacetate (DTP A), the classif ication as acute toxicant catego ry 4 and specific target organ toxicant -repeated 
exposure (categor y 2) recommended in the RAC opinions of 9 June 2017 should be included in Annex VI to 
Regulation (EC) No 1272/2008, since suffi cient scientific evidence is available justifying those new classifications. 
With regard to the substances pentapotassium 2,2’,2’’,2’’’ ,2’’’’-(ethane-1,2-diylnitr ilo)pentaacetate and N- 
carbo xymethyl iminobis(ethylenenitr ilo)tetra( acetic acid), the classif ication as eye irritant catego ry 2, recommended 
in the RAC opinions of 9 June 2017, should be included in Annex VI to Regulation (EC) No 1272/2008, since 
suffi cient scientific evidence is available justifying those new classificat ions. Howe ver, the classif ication of the 
substances pentapotassium 2,2’,2’’,2’’’ ,2’’’’’-(ethane-1,2-diylnitr ilo)pentaacetat e, N-carbo xymethyl iminobis 
(ethyl enenitr ilo)tetra( acetic acid) and pentasodium (carbo xylatometh yl)iminobis(ethylenenitr ilo)tet raacetate (DTP A), 
as toxic for reproduction categor y 1B should not be included, since it requires further assessment by RAC in view of 
new scientific data on toxicity for reproduction present ed by the industr y after the RAC opinions were forwarded to 
the Commission. 
(7) Regulation (EC) No 1272/2008 should theref ore be amended according ly. 
(8) Regulation (EC) No 1272/2008 contains the harmonised classif ication, labelling and packag ing for the substance 
pitch , coal tar, high temp. The Commission amended the harmonised classificat ion, labelling and packag ing of that 
substance by Commission Regulation (EU) No 944/2013 (3) with effect from 1 Apr il 2016. Commission Regulation 
(EU) 2018/669 (4) further amended Regulation (EC) No 1272/2008. However , due to an administrative oversight, 
certain amendments – the validity of which was not affected by the judgment of the General Cour t in Case T- 
689/13 (5) as upheld by the judgment of the Cour t of Justice in Case C-691/15 P(6) – introduced by Regulation (EU) 
No 944/2013 were not reflected in Regulation (EU) 2018/669. That Regulation will become applicable as of 1 
December 2019. Regulation (EC) No 1272/2008 should theref ore be corrected, with effect from the same date. 
(9) To ensure that suppliers of substances and mixtures have time to adapt to the new classificat ion and labelling 
provisions , the application of this Regulation should be defe rred. 
(10) In order to be consist ent with the approac h under pinning Article 61(2) of Regulation (EC) No 1272/2008, suppliers 
should have the possibility of applying the classificat ion, labelling and packa ging provis ions introduced by this 
Regulation on a voluntar y basis before its date of application, 
HAS ADOPTED THIS REGUL ATION: 
Article 1 
Amendments to Regulation (EC) No 1272/2008 
Regulation (EC) No 1272/2008 is amended as follows : 
(1) Annex II is amended as set out in Annex I to this Regulation; 
(3)Commission Regulation (EU) No 944/2013 of 2 October 2013 amending, for the purposes of its adaptation to technical and scientif ic 
progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of 
substances and mixtures (OJ L 261, 3.10.2013, p. 5). 
(4)Commission Regulation (EU) 2018/669 of 16 Apr il 2018 amending, for the purposes of its adaptation to technical and scientific 
progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of 
substances and mixtures (OJ L 115, 4.5.2018, p. 1). 
(5)Judgment of the General Cour t of 7 October 2015, Bilbaína de Alquitr anes and Others v Commission, T-689/13, EU:T :2015:767. 
(6)Judgment of the Cour t of 22 November 2017, Commission v Bilbaína de Alquitr anes and Others, C-691/15 P, EU:C:2017:882. EN Offi cial Jour nal of the European Union 18.2.2020                                                                                                                                            L 44/3   (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 
Cor rection to Regulation (EC) No 1272/2008 
Annex VI to Regulation (EC) No 1272/2008 is corrected as set out in Annex IV to this Regulation. 
Article 3 
Entr y into force and application 
This Regulation shall enter into force on the twentieth day followi ng that of its publication in the Official Journal of the 
European Union. 
It shall apply from 9 Sept ember 2021. 
However , Article 2 shall apply from 1 December 2019. 
Substances and mixtures may, before 9 September 2021, be classified, labelled and packag ed 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     EN Offi cial Jour nal of the European Union L 44/4                                                                                                                                            18.2.2020   ANNEX I 
Part 2 of Annex II to Regulation (EC) No 1272/2008 is amended as follows: 
(1) The introduct ory 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. Mixtures cont aining titanium dioxide 
The label on the packaging of liquid mixtures containing 1 % or more of titanium dioxide particles with aerodynamic 
diamete r equal to or below 10 μm shall bear the follo wing statement: 
EUH211: ‘Warning! Hazardous respirable droplets may be formed when spra yed. Do not breathe spra y or mist.’ 
The label on the packag ing of solid mixtures containing 1 % or more of titanium dioxide shall bear the followi ng 
state ment : 
EUH212: ‘Warning! Hazardous respirable dust may be formed when used. Do not breathe dust.’ 
In addition, the label on the packag ing of liquid and solid mixtures not intended for the general public and not classified 
as hazardous whic h are labelled with EUH211 or EUH212, shall bear statement EUH210.’   EN Offi cial Jour nal of the European Union 18.2.2020                                                                                                                                            L 44/5   ANNEX II 
In Part 3 of Annex III to Regulation (EC) No 1272/2008, the followi ng rows EUH 211 and EUH 212 are inser ted:                                                                 
‘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 . Nevdechujt e 
aerosoly nebo mlhu.  
DA Advarsel! Der kan danne sig farlige respirable dråber , når der spra yes. Undgå indånding af 
spra y eller tåge.  
DE Achtung! Beim Sprühen können gefährliche lung engängig e Tröpfche n entstehen. Aerosol 
oder Nebel nicht einatmen.  
ET Hoiatus! Pihustamisel võivad tekkida ohtlikud sissehingat avad piisad. Pihustatud ainet või 
udu mitte sisse hinga ta.  
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 spra yed. Do not breathe spra y 
or mist.  
FR Attention! Des goutt elette s respirables dangereuses peuvent se former lors de la 
pulvér isation. Ne pas respirer les aérosols ni les brouillards.  
GA Aire! D’fhéadfaí braoiníní guaiseac ha inanálaithe a chruthú nuair a spraeáilt ear an táirge seo. 
Ná hanálaigh sprae ná ceo.  
HR Upozorenje! Pri prskanju mogu nastati opasne respirabilne kapljice. Ne udisati aerosol ni 
mag licu.  
IT Attenzione! In caso di vapor izzazione possono formarsi goccioline respirabili pericolose. 
Non respirare i vapor i o le nebbie.  
LV Uzmanību! Izsmidzinot var veidoties bīstami ieelpojami pilieni. Ne smidzinājumu, ne miglu 
neieelpot.  
LT Atsargiai! Purškiant gali susidar yti pavojingų įkvepiamų lašelių. Neįkvėp ti rūko ar aerozolio.  
HU Figy elem! Permetezés közben veszély es, belélegezhető cseppek képz ődhetnek. 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-irx iex man-nifs.  
NL Let op! Bij verneveling kunnen gevaarlijk e inhaleerbare druppels worden gevor md. 
Spuitnevel niet inademen.  
PL Uwaga! W przypadku rozp ylania mogą się tworz yć niebezpieczne respirabilne kropelki. Nie 
wdy chać rozp ylonej cieczy lub mgły .  
PT Atenção! Podem formar -se gotículas inaláveis perigosas ao pulver izar. Não respirar a 
pulver ização ou névoas.  
RO Avertizare! Se pot forma picătur i respirabile periculoase la pulver izare. Nu respirați prin 
pulver izare sau ceață.  
SK Pozor! Pri rozprašova ní sa môžu vytvárať nebezpečné respirabilné kvapôčky . Nevdy chujte 
aerosóly ani hmlu.  
SL Pozor! Pri razprševanju lahk o nastanejo nevar ne vdihljive kapljice. Ne vdihava jte razpršila ali 
meg lic. EN Offi cial Jour nal of the European Union L 44/6                                                                                                                                            18.2.2020   ‘EUH211 Language   
FI Varoitus! Vaarallisia keuhk orakkuloihin kulkeut uvia pisaroita saattaa muodostua 
suihkutuksen yhte ydessä. Älä hengitä suihketta tai sumua.  
SV Varning! Farli ga 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 prac h. Nevdec hujte prach .  
DA Advarsel! Der kan danne sig farligt respirabelt støv ved anvendelsen. Undgå indånding af 
støv .  
DE Achtung! Bei der Verwendung kann gefährlic her lung engängig er Staub entsteh en. Staub 
nicht einatmen.  
ET Hoiatus! Kasutamisel võib tekkida ohtlik sissehingata v tolm. Tolmu mitte sisse hinga ta.  
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 dang ereuse peut se former lors de l’utilisation. Ne pas 
respirer cette poussière.  
GA Aire! D’fhéadf aí deannach guaiseach inanálaithe a chruthú nuair a úsáidte ar 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 polver i respirabili pericolose. Non respirare 
le polver i.  
LV Uzmanību! Izmantojot var veidoties bīstami ieelpojami putekļi. Putekļus neieelpot.  
LT Atsargiai! Naudojant gali susidar yti pavojingų įkvepiamų dulkių. Neįkvėp ti dulkių.  
HU Figy elem! Használatk or veszély es, belélegez hető por képz ődhet. 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 gevaarlijk e inhaleerbare stofdeeltjes worden gevormd. Stof niet 
inademen.  
PL Uwaga! W przypadku stoso wania może się tworzyć niebezpieczny pył respirabiln y. Nie 
wdy chać pyłu.  
PT Atenção! Podem formar -se poeiras inaláv eis perigosas ao pulver izar. Não respirar as poeiras.  
RO Avertizare! Se poate forma pulbere respirabilă periculoasă în timpul utilizăr ii. Nu inspirați 
pulberea.  
SK Pozor! Pri použití sa môže vytvárať nebezpečný respirabilný prach . Nevdy chujt e prach.  
SL Pozor! Pri uporabi lahk o nastane nevaren vdihljiv prah. Prahu ne vdiha vajte.  
FI Varoitus! Vaarallista keuh korakkuloihin kulkeutuvaa pölyä saattaa muodostua käytön 
yhte ydessä. Älä hengitä pölyä.  
SV Varning! Farli gt respirabelt damm kan bildas vid användning. Inandas inte damm.’   EN Offi cial Jour nal of the European Union 18.2.2020                                                                                                                                            L 44/7   ANNEX III 
Annex VI to Regulation (EC) No 1272/2008 is amended as follo ws: 
(1) Part 1 is amended as follo ws: 
(a) in point 1.1.3.1, the following note s V and W are added: 
‘Note V: 
If the substance is to be placed on the mark et as fibres (with diamet er < 3 μm, length > 5 μm and aspect ratio ≥ 3:1) or particles of the substance fulfilling the WHO fibre criteria or as 
particles with modifi ed surface chemistr y, their hazardous proper ties must be evaluated in accordance with Title II of this Regulation, to assess whether a higher cate gory (Carc. 1B or 
1A) and/or additional route s of exposure (oral or dermal) should be applied.’ 
Note W: 
‘It has been obser ved that the carcinog enic hazard of this substance arises when respirable dust is inhaled in quantities leading to signif icant impair ment of particle clearance 
mechani sms in the lung. 
This note aims to descr ibe the particular toxicity of the substance; it does not constitut e a criterion for classif ication according to this Regulation.’; 
(b) in point 1.1.3.2, the follo wing note 10 is added: 
‘Note 10: 
The classification as a carcinog en by inhalation applies only to mixtures in powder form containing 1 % or more of titanium dioxide which is in the form of or incor porated 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 delet ed; 
(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 Classif ication Labelling 
Specif ic Conc. 
Limits, M-factors 
and ATEs Notes Hazard Class and 
Categor y Code(s) Hazard 
statement 
Code(s) Pictogram, 
Signal Word 
Code(s) Hazard 
statement 
Code(s) Suppl. 
Hazard 
statement 
Code(s) 
‘015-189-00-5 pheny l bis(2,4,6-tr i­
meth ylbenzo yl)-phos­
phine oxide 423-340-5 162881-26-7 Skin Sens. 1A 
Aquatic Chronic 4 H317 
H413 GHS07 
Wng H317 
H413’    EN Offi cial Jour nal of the European Union L 44/8                                                                                                                                            18.2.2020   Index No Chemical name EC No CAS No Classif ication Labelling 
Specif ic Conc. 
Limits, M-factors 
and ATEs Notes Hazard Class and 
Categor y Code(s) Hazard 
statement 
Code(s) Pictogram, 
Signal Word 
Code(s) Hazard 
statement 
Code(s) Suppl. 
Hazard 
statement 
Code(s) 
‘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 nick el bis(sulfam idate); 
nick el 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 
Aquati c 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 (anh y­
drate) 
oral: ATE = 1098 
mg/kg bw (tetra­
hydrate) 
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 ethylen e 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 (ner­
vous system) 
H314 
H318 GHS02 
GHS08 
GHS06 
GHS05 
Dgr H220 
H350 
H340 
H360Fd 
H331 
H301 
H335 
H336 
H372 (ner­
vous system) 
H314  inhalation: ATE = 
700ppm (gase s) 
oral: ATE = 100 
mg/kg bw’ U EN Offi cial Jour nal of the European Union 18.2.2020                                                                                                                                            L 44/9   Index No Chemical name EC No CAS No Classif ication Labelling 
Specif ic Conc. 
Limits, M-factors 
and ATEs Notes Hazard Class and 
Categor y Code(s) Hazard 
statement 
Code(s) Pictogram, 
Signal Word 
Code(s) Hazard 
statement 
Code(s) Suppl. 
Hazard 
statement 
Code(s) 
‘605-005-00-7 metaldehyde (ISO); 
2,4,6,8-t etramethyl- 
1,3,5,7-t etrao xacy clooc­
tane 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-dimethy lami­
no-4'-mor pholinobutyro­
phenone 404-360-3 119313-12-1 Repr . 1B 
Aquati c Acute 1 
Aquatic Chronic 1 H360D 
H400 
H410 GHS08 
GHS09 
Dgr H360D 
H410’    
‘607-232-00-7 pyridate (ISO); 
O-(6-chloro-3- phenylp yri­
dazin-4-yl) S-octyl thiocar­
bonat e 259-686-7 55512-33-9 Acute Tox. 4 
Skin Irrit. 2 
Skin Sens. 1 
Aquati c 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 methacr ylate 205-570-6 142-90-5 STOT SE 3 H335 GHS07 
Wng H335  STOT SE 3; H335: 
C ≥ 10 %’  
‘608-039-00-0 2-phenylhexanenit rile 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)benzimida­
zole 205-725-8 148-79-8 Aquati c Acute 1 
Aquatic Chronic 1 H400 
H410 GHS09 
Wng H410  M = 1 
M = 1’  
‘616-018-00-2 diethylt oluamide (ISO): N, 
N-diethy l-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’    EN Offi cial Jour nal of the European Union L 44/10                                                                                                                                           18.2.2020   (c) the follo wing rows are inser ted: 
Index No Chemical Name EC No CAS No Classif ication Labelling 
Specif ic Conc. 
Limits, M-factors 
and ATEs Notes Hazard Class and 
Categor y 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 contain­
ing 1 % or more of particles 
with aerodynamic dia­
mete r ≤ 10 μm] 236-675-5 13463-67-7 Carc. 2 H351 (inhala­
tion) GHS08 
Wng H351 (inhala­
tion)   V, W, 
10’ 
‘080-012-00-0 meth ylmercur ic chlor ide 204-064-2 115-09-3 Carc. 2 
Repr . 1A 
Lact. 
Acute Tox. 2 
Acute Tox. 2 
Acute Tox. 2 
STOT RE 1 
Aquati c Acute 1 
Aquatic Chronic 1 H351 
H360Df 
H362 
H330 
H310 
H300 
H372 (ner­
vous system, 
kidne ys) 
H400 
H410 GHS08 
GHS06 
GHS09 
Dgr H351 
H360Df 
H362 
H330 
H310 
H300 
H372 (ner­
vous system, 
kidne ys) 
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]p yrene 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 cyflumetof en (ISO); 
2-metho xyet hyl (RS)-2- 
(4-ter t-butylphen yl)-2-cya­
no-3-o xo-3-(α,α,α-tr ifluor­
o-o-tolyl)pr opionate — 400882-07-7 Carc. 2 
Skin Sens. 1A H351 
H317 GHS08 
GHS07 
Wng H351 
H317’    EN Offi cial Jour nal of the European Union 18.2.2020                                                                                                                                           L 44/11   Index No Chemical Name EC No CAS No Classif ication Labelling 
Specif ic Conc. 
Limits, M-factors 
and ATEs Notes Hazard Class and 
Categor y Code(s) Hazard 
statement 
Code(s) Pictogram, 
Signal Word 
Code(s) Hazard 
statement 
Code(s) Suppl. 
Hazard 
statement 
Code(s) 
‘607-734-00-6 pentapotassium 
2,2’,2’’ ,2’’’,2’’’’-(ethane-1,2- 
diylnitr ilo)pentaacetat e 404-290-3 7216-95-7 Acute Tox. 4 STOT 
RE 2 
Eye Irrit. 2 H332 
H373 (inhala­
tion) 
H319 GHS08 
GHS07 
Dgr H332 
H373 (inhala­
tion) 
H319  inhalation: 
ATE = 1,5 mg/l 
(dusts or mists)’  
‘607-735-00-1 N-carbo xymethyliminobis 
(ethyl enenitr ilo)tetra 
(acetic acid) 200-652-8 67-43-6 Acute Tox. 4 STOT 
RE 2 
Eye Irrit. 2 H332 
H373 (inhala­
tion) 
H319 GHS08 
GHS07 
Dgr H332 
H373 (inhala­
tion) 
H319  inhalation: 
ATE = 1,5 mg/l 
(dusts or mists)’  
‘607-736-00-7 pentasodium (carbo xyla­
tometh yl)iminobis(ethy le­
nenitr ilo)tetraacetat e 205-391-3 140-01-2 Acute Tox. 4 
STOT RE 2 H332 
H373 (inhala­
tion) GHS08 
GHS07 
Dgr H332 
H373 (inhala­
tion)  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 fludio xonil (ISO); 4-(2,2- 
difluoro-1,3-benzodio xol- 
4-yl)-1H-p yrrole-3-carbo­
nitrile — 131341-86-1 Aquati c Acute 1 
Aquatic Chronic 1 H400 
H410 GHS09 
Wng H410  M = 1 
M = 10’  
‘613-329-00-5 halosulfuron-methy l 
(ISO); 
meth yl 3-chloro-5-{[(4,6- 
dimetho xypyrimidin-2-yl) 
carbamo yl]sulf amo yl}-1- 
meth yl-1H-p yrazole-4- 
carbo xylate — 100784-20-1 Repr . 1B 
Aquati c Acute 1 
Aquatic Chronic 1 H360D 
H400 
H410 GHS08 
GHS09 
Dgr H360D 
H410  M = 1000 
M = 1000’  
613-330-00-0 2-methyl imidazole 211-765-7 693-98-1 Repr . 1B H360Df GHS08 
Dgr H360Df    EN Offi cial Jour nal of the European Union L 44/12                                                                                                                                           18.2.2020   Index No Chemical Name EC No CAS No Classif ication Labelling 
Specif ic Conc. 
Limits, M-factors 
and ATEs Notes Hazard Class and 
Categor y Code(s) Hazard 
statement 
Code(s) Pictogram, 
Signal Word 
Code(s) Hazard 
statement 
Code(s) Suppl. 
Hazard 
statement 
Code(s) 
‘616-225-00-8 (RS)-2-metho xy-N- 
meth yl-2-[α-(2,5-xyly­
loxy)-o-to lyl]acetamide; 
mandestrobin — 173662-97-0 Aquatic Acute 1 
Aquatic Chronic 1 H400 
H410 GHS09 
Wng H410  M = 1 
M = 10’  
‘616-226-00-3 carbo xin (ISO); 
2-methyl -N-phenyl-5,6- 
dihy dro-1,4-o xathiine-3- 
carbo xamide; 5,6-dihydro- 
2-methyl -1,4-o xathiine-3- 
carbo xanilide 226-031-1 5234-68-4 STOT RE 2 
Skin Sens. 1 
Aquati c Acute 1 
Aquatic Chronic 1 H373 (kid­
neys) 
H317 
H400 
H410 GHS08 
GHS07 
GHS09 
Wng H373 (kid­
neys) 
H317 
H410  M = 1 
M = 1’  
‘616-227-00-9 metaf lumizone (ISO); 
(EZ)-2’-[2-(4-cyanophe­
nyl)-1-(α,α,α -trifluoro-m- 
tolyl)ethylidene]-[4-(tri ­
fluorometho xy)phen yl] 
carbanilohydrazi de [E-iso­
mer ≥ 90 %, Z-isomer ≤ 10 
% relative content]; [1] 
(E)-2’-[2-(4-cyanophen yl)- 
1-(α,α,α -trifluoro-m-tolyl) 
ethyliden e]-[4-(tr ifluoro­
metho xy)phenyl ]carbani­
lohydrazide [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 (im­
mune syste m) GHS08 
Dgr H360FD 
H372 (im­
mune sys­
tem)’ .      EN Offi cial Jour nal of the European Union 18.2.2020                                                                                                                                           L 44/13   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 followi ng:                                                                     
Index No Chemical name EC No Cas No Classif ication Labelling 
Specif ic Conc. 
Limits, M-factors 
and ATEs Notes Hazard Class and 
Categor y 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-tem p.; 
[The residue from the dis­
tillation of high tempera­
ture coal tar. A blac k solid 
with an appro ximat e soft­
ening point from 30 °C to 
180 °C (86 °F to 356 °F). 
Com posed primar ily of a 
compl ex mixture of three 
or more membered con­
densed ring aromatic hy­
drocarbons.] 266-028-2 65996-93-2 Carc. 1A 
Muta. 1B 
Repr . 1B H350 
H340 
H360FD GHS08 
Dgr H350 
H340 
H360FD’ .      EN Offi cial Jour nal of the European Union L 44/14                                                                                                                                           18.2.2020