Commission Delegated Regulation (EU) 2025/1222 of 2 April 2025 amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council as regards the harmonised classification and labelling of certain substances
Date: 2025-04-02
Institutions: Directorate-General for Environment, European Commission
Subjects: chemical product, chemicals legislation, classification, dangerous substance, environmental protection, labelling, packaging, public health








L_202501222EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2025/1222


20.6.2025







            COMMISSION DELEGATED REGULATION (EU) 2025/1222
of 2 April 2025
         
amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council as regards the harmonised classification and labelling of certain substances
(Text with EEA relevance)


THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,


Having regard to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging 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 Article 37(5) thereof,

Whereas:







(1)


Part 3, Table 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 the harmonised classification and labelling of certain other substances have been submitted to the European Chemicals Agency (‘the Agency’) pursuant to Article 37 of Regulation (EC) No 1272/2008. The Committee for Risk Assessment (RAC) of the Agency adopted, after having taken account of the comments received from the parties concerned, the following opinions (2) on those proposals:






—


Opinion of 16 March 2023 concerning 2-ethylhexanoic acid, monoester with propane-1,2-diol;










—


Opinion of 16 March 2023 concerning Aqueous extract from the germinated seeds of sweet Lupinus albus;










—


Opinion of 16 March 2023 concerning N-1-naphthylaniline; N-phenylnaphthalen-1-amine;










—


Opinion of 16 March 2023 concerning propyl 4-hydroxybenzoate;










—


Opinion of 16 March 2023 concerning α,α’-propylenedinitrilodi-o-cresol;










—


Opinion of 16 March 2023 concerning ozone;










—


Opinion of 16 March 2023 concerning dinitrogen oxide;










—


Opinion of 16 March 2023 concerning tetrairon tris(pyrophosphate); ferric pyrophosphate;










—


Opinion of 16 March 2023 concerning 2-phenylpropene; α-methylstyrene;










—


Opinion of 16 March 2023 concerning tetraphosphorus trisulphide; phosphorus sesquisulphide;










—


Opinion of 16 March 2023 concerning pethoxamid (ISO); 2-chloro-N-(2-ethoxyethyl)-N-(2-methyl-1-phenylprop-1-enyl)acetamide;










—


Opinion of 8 June 2023 concerning 1,1-dichloroethylene; vinylidene chloride;










—


Opinion of 8 June 2023 concerning bixlozone (ISO); 2-(2,4-dichlorobenzyl)-4,4-dimethyl-1,2-oxazolidin-3-one;










—


Opinion of 8 June 2023 concerning 9-octadecenoic acid (Z)-, sulfonated, potassium salts [1]; Reaction products of fatty acids, C18 (unsaturated) alkyl with sulfur trioxide, potassium salts [2]; 9(or 10)-sulphooctadecanoic acid, potassium salt [3];










—


Opinion of 8 June 2023 concerning barium bis[2-chloro-5-[(2-hydroxy-1- naphthyl)azo]toluene-4-sulphonate]; C.I. Pigment Red 53:1;










—


Opinion of 8 June 2023 concerning barium chromate;










—


Opinion of 8 June 2023 concerning Chrysanthemum cinerariaefolium, extract from open and mature flowers of Tanacetum cinerariifolium obtained with hydrocarbon solvents;










—


Opinion of 8 June 2023 concerning Chrysanthemum cinerariaefolium extract from open and mature flowers of Tanacetum cinerariifolium obtained with supercritical CO2;










—


Opinion of 8 June 2023 concerning fluoroethylene;










—


Opinion of 8 June 2023 concerning tetrahydrofurfuryl methacrylate;










—


Opinion of 8 June 2023 concerning 2,3-epoxypropyl isopropyl ether;










—


Opinion of 8 June 2023 concerning trimethyl phosphate;










—


Opinion of 8 June 2023 concerning 3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate; isophorone di-isocyanate;










—


Opinion of 8 June 2023 concerning 2-bromo-2-(bromomethyl)pentanedinitrile; [DBDCB];










—


Opinion of 8 June 2023 concerning folpet (ISO); N-(trichloromethylthio)phthalimide;










—


Opinion of 14 September 2023 concerning 2-bromo-3,3,3-trifluoroprop-1-ene;










—


Opinion of 14 September 2023 concerning clopyralid (ISO); 3,6-dichloropyridine-2- carboxylic acid;










—


Opinion of 14 September 2023 concerning 3-iodo-2-propynyl butylcarbamate; 3-iodoprop-2-yn-1-yl butylcarbamate;










—


Opinion of 14 September 2023 concerning captan (ISO); 1,2,3,6-tetrahydro-N- (trichloromethylthio)phthalimide;










—


Opinion of 14 September 2023 concerning dinotefuran (ISO); (RS)-1-methyl-2-nitro-3-(tetrahydro-3-furylmethyl)guanidine;










—


Opinion of 14 September 2023 concerning methyl oct-2-ynoate;










—


Opinion of 14 September 2023 concerning proquinazid (ISO); 6-iodo-2-propoxy-3- propylquinazolin-4(3H)-one;










—


Opinion of 14 September 2023 concerning 2,3-epoxypropyl o-tolyl ether;










—


Opinion of 14 September 2023 concerning 2-methyl-2H-isothiazol-3-one hydrochloride; 2-methyl-2,3-dihydro-1,2-thiazol-3-one hydrochloride.
















(3)


The Commission has received additional information from stakeholders contesting the scientific assessment set out in the RAC opinion of 16 March 2023 concerning dinitrogen oxide. The additional information has been assessed by the Commission and has not been found sufficient to cast doubts on the scientific analysis contained in the RAC opinions.












(4)


In light of the RAC opinions, it is appropriate to introduce or update the harmonised classification and labelling of the substances concerned on the basis of the assessment made in those opinions and following the further assessment by the Commission.












(5)


Regulation (EC) No 1272/2008 should therefore be amended accordingly.












(6)


Compliance with the new or updated harmonised classifications should not be required immediately as a certain period of time is necessary to allow suppliers to adapt the labelling and packaging of substances and mixtures to the new or updated classifications and to sell existing stocks subject to the pre-existing regulatory requirements. That period of time is also necessary to allow suppliers sufficient time to take the actions required to ensure continuing compliance with other legal requirements following the changes made under this Regulation. Suppliers should, however, have the possibility to apply the new or updated harmonised classifications, and to adapt the labelling and packaging accordingly, on a voluntary basis before the date of application of this Regulation, to ensure a high level of protection of human health and of the environment and to provide sufficient flexibility to suppliers,





HAS ADOPTED THIS REGULATION:



Article 1
Annex VI to Regulation (EC) No 1272/2008 is amended as set out in the Annex to this Regulation.


Article 2
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 1 February 2027.
However, suppliers may classify, label and package substances and mixtures in accordance with Regulation (EC) No 1272/2008 as amended by this Regulation from the date of entry into force of this Regulation.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 2 April 2025.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 353, 31.12.2008, p. 1, ELI: http://data.europa.eu/eli/reg/2008/1272/oj.

(2)  The opinions are accessible via the following website: https://echa.europa.eu/registry-of-clh-intentions-until-outcome/-/dislist/name/-/ecNumber/-/casNumber/-/dte_receiptFrom/-/dte_receiptTo/-/prc_public_status/Opinion+Adopted/dte_withdrawnFrom/-/dte_withdrawnTo/-/sbm_expected_submissionFrom/-/sbm_expected_submissionTo/-/dte_finalise_deadlineFrom/-/dte_finalise_deadlineTo/-/haz_addional_hazard/-/lec_submitter/-/dte_assessmentFrom/-/dte_assessmentTo/-/prc_regulatory_programme/-/.




ANNEX
Part 3, Table 3, of Annex VI to Regulation (EC) No 1272/2008 is amended as follows:






(1)


the following entries are inserted following the consecutive order of the index numbers corresponding to each entry:















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)




‘607-776-00-5


2-ethylhexanoic acid, monoester with propane-1,2-diol


285-503-5


85114-00-7


Repr. 1B


H360D


GHS08
Dgr


H360D’


 


 


 




‘612-300-00-4



N-1-naphthylaniline;

N-phenylnaphthalen-1-amine


201-983-0


90-30-2


Acute Tox. 4
STOT RE 2
Skin Sens. 1


H302
H373 (blood system, liver)
H317


GHS07
GHS08
Wng








 


H302




H373 (blood system, liver)
H317


 


oral: ATE = 1 200  mg/kg bw’


 




‘026-005-00-8


tetrairon tris(pyrophosphate); ferric pyrophosphate


233-190-0


10058-44-3


Eye Irrit. 2


H319


GHS07
Wng


H319’


 


 


 




‘604-103-00-7


α,α’-propylenedinitrilodi-o-cresol


202-374-2


94-91-7


Repr. 1B


H360FD


GHS08
Dgr


H360FD’


 


 


 




‘008-004-00-4


ozone


233-069-2


10028-15-6


Ox. Gas 1
Carc. 2
Muta. 2
Acute Tox. 1
STOT SE 1
STOT RE 1
Aquatic Acute 1
Aquatic Chronic 1


H270
H351
H341
H330
H370 (nervous system, respiratory system, cardiovascular system)
H372 (nervous system, respiratory system)
H400
H410


GHS03
GHS08
GHS06
GHS09
Dgr


H270
H351
H341
H330
H370 (nervous system, respiratory system, cardiovascular system)
H372 (nervous system, respiratory system)
H410


 


inhalation: ATE = 10 ppmV
STOT SE 1; H370: C ≥ 0,002 %
STOT SE 2; H371: 0,0005 % ≤ C < 0,002 %
STOT RE 1; H372: C ≥ 0,05 %
STOT RE 2; H373: 0,01 % ≤ C < 0,05 %
M = 100
M = 1’


 




‘007-031-00-9


dinitrogen oxide


233-032-0


10024-97-2


Repr. 1B
STOT SE 3
STOT RE 1
Ozone 1


H360Df
H336
H372 (nervous
system)
H420


GHS08
GHS07
Dgr


H360Df
H336
H372 (nervous
system)
H420’


 


 


 




‘056-006-00-9


barium chromate


233-660-5


10294-40-3


Carc. 1B


H350


GHS08
Dgr


H350’


 


 


 




‘650-060-00-2



Chrysanthemum cinerariaefolium, extract from open and mature flowers of Tanacetum cinerariifolium obtained with supercritical CO2



289-699-3


89997-63-7


Acute Tox. 4
Acute Tox. 4
STOT SE 1
STOT RE 2
Skin Sens. 1
Aquatic Acute 1
Aquatic Chronic 1


H332
H302
H370 (nervous system)
H373 (respiratory tract, inhalation)
H317
H400
H410


GHS07
GHS08
Dgr


H332
H302
H370 (nervous system)
H373 (respiratory tract, inhalation)
H317
H410


 


inhalation: ATE = 2,6 mg/L (dusts or mists)
oral: ATE = 730 mg/kg bw
M = 1 000 
M = 100’


 




‘650-059-00-7



Chrysanthemum cinerariaefolium, extract from open and mature flowers of Tanacetum cinerariifolium obtained with hydrocarbon solvents


289-699-3


89997-63-7


Acute Tox. 4
Acute Tox. 4
STOT SE 1
STOT RE 2
Skin Sens. 1
Aquatic Acute 1
Aquatic Chronic 1


H332
H302
H370 (nervous system)
H373 (respiratory tract, inhalation)
H317
H400
H410


GHS07
GHS08
Dgr


H332
H302
H370 (nervous system)
H373 (respiratory tract, inhalation)
H317
H410


 


inhalation: ATE = 2,6 mg/L (dusts or mists)
oral: ATE = 730 mg/kg bw
M = 1 000 
M = 100’


 




‘607-777-00-0


barium bis[2-chloro-5-[(2-hydroxy-1-naphthyl)azo]toluene-4-sulphonate]; C.I. Pigment Red 53:1


225-935-3


5160-02-1


Carc. 2


H351


GHS08
Wng


H351’


 


 


 




‘608-070-00-X


2-bromo-2-(bromomethyl)pentanedinitrile; [DBDCB]


252-681-0


35691-65-7


Acute Tox. 2
Acute Tox. 4
STOT RE 2
Eye Dam. 1
Skin Sens. 1A
Aquatic Chronic 2


H330
H302
H373 (thyroid, central nervous system)
H318
H317
H411


GHS06
GHS08
GHS05
GHS09
Dgr


H330
H302
H373 (thyroid, central nervous system)
H318
H317
H411


 


inhalation: ATE = 0,27 mg/L (dusts or mists)
oral: ATE = 500 mg/kg bw
Skin Sens. 1A; H317: C ≥ 0,001 %’


 




‘607-779-00-1


9-octadecenoic acid (Z)-, sulfonated, potassium salts [1]; Reaction products of fatty acids, C18 (unsaturated) alkyl with sulfur trioxide, potassium salts [2]; 9(or 10)-sulphooctadecanoic acid, potassium salt [3]


271-843-1 [1];
- [2];
267-966-5 [3]


68609-93-8 [1];
- [2];
67968-63-2 [3]


Repr. 1B


H360D


GHS08
Dgr


H360D’


 


 


 




‘613-352-00-0


bixlozone (ISO); 2-(2,4-dichlorobenzyl)-4,4-dimethyl-1,2-oxazolidin-3-one


—


81777-95-9


Aquatic Acute 1
Aquatic Chronic 1


H400
H410


GHS09
Wng


H410


 


M = 1
M = 10’


 




‘603-248-00-3


2,3-epoxypropyl isopropyl ether


223-672-9


4016-14-2


Repr. 1B


H360F


GHS08
Dgr


H360F’


 


 


 




‘607-778-00-6


tetrahydrofurfuryl methacrylate


219-529-5


2455-24-5


Repr. 1B
Skin Sens. 1A


H360Df
H317


GHS08
GHS07
Dgr


H360Df
H317’


 


 


 




‘015-209-00-2


trimethyl phosphate


208-144-8


512-56-1


Carc. 1B
Muta. 1B
Repr. 1B
Acute Tox. 4
STOT RE 2


H350
H340
H360FD
H302
H373 (nervous system)


GHS08
GHS07
Dgr


H350
H340
H360FD
H302
H373 (nervous system)


 


oral: ATE = 1 300  mg/kg bw’


 




‘602-111-00-5


fluoroethylene


200-832-6


75-02-5


Carc. 1A
Muta. 2


H350
H341


GHS08
Dgr


H350
H341


 


 


D’




‘602-112-00-0


2-bromo-3,3,3-trifluoroprop-1-ene


—


1514-82-5


Repr. 1B
STOT SE 3
STOT SE 3


H360FD
H335
H336


GHS08
GHS07
Dgr


H360FD
H335
H336’


 


 


 




‘613-353-00-6


2-methyl-2H-isothiazol-3-one hydrochloride; 2-methyl-2,3-dihydro-1,2-thiazol-3-one hydrochloride


247-499-3


26172-54-3


Acute Tox. 2
Acute Tox. 3
Acute Tox. 3
Skin Corr. 1
Eye Dam. 1
Skin Sens. 1A
Acute Aquatic 1
Acute Chronic 1


H330
H311
H301
H314
H318
H317
H400
H410


GHS06
GHS05
GHS09
Dgr


H330
H311
H301
H314
H317
H410


EUH071


inhalation: ATE = 0,15 mg/L (dusts or mists)
dermal: ATE = 320 mg/kg bw
oral: ATE = 180 mg/kg bw
Skin. Sens 1A; H317: C ≥ 0,0015 %
M = 10
M = 1’


 




‘603-249-00-9


2,3-epoxypropyl o-tolyl ether


218-645-3


2210-79-9


Skin Irrit. 2
Skin Sens. 1A
Muta. 2
Aquatic Chronic 2


H315
H317
H341
H411


GHS07
GHS08
GHS09
Wng


H315
H317
H341
H411


 


 


C’




‘607-780-00-7


methyl oct-2-ynoate


203-836-6


111-12-6


Skin Sens. 1A


H317


GHS07
Wng


H317’


 


 


 




‘612-301-00-X


dinotefuran (ISO); (RS)-1-methyl-2-nitro-3-(tetrahydro-3-furylmethyl)guanidine


-


165252-70-0


Acute Tox. 4
Aquatic Acute 1
Aquatic Chronic 1


H302
H400
H410


GHS07
GHS09
Wng


H302
H410


 


oral: ATE = 2 000  mg/kg bw
M = 10
M = 10’


 














(2)


the entries corresponding to index numbers 015-012-00-1, 601-027-00-6, 602-025-00-8, 607-231-00-1, 613-044-00-6, 613-045-00-1, 615-008-00-5, 616-145-00-3, 616-211-00-1, 616-212-00-7 are replaced by the following entries respectively:















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




‘601-027-00-6


2-phenylpropene; α-methylstyrene


202-705-0


98-83-9


Flam. Liq. 3
Carc. 2
STOT SE 3
Eye Irrit. 2
Skin Sens. 1B
Aquatic Chronic 2


H226
H351
H335
H319
H317
H411


GHS02
GHS08
GHS07
GHS09
Wng


H226
H351
H335
H319
H317
H411


 


STOT SE 3; H335: C ≥ 25 %


D’




‘616-145-00-3


pethoxamid (ISO); 2-chloro-N-(2-ethoxyethyl)-N-(2-methyl-1-phenylprop-1-enyl)acetamide


-


106700-29-2


Acute Tox. 4
Skin Sens. 1A
Aquatic Acute 1
Aquatic Chronic 1


H302
H317
H400
H410


GHS07
GHS09
Wng


H302
H317
H410


 


oral: ATE = 980 mg/kg bw
M = 100
M = 10’


 




‘015-012-00-1


tetraphosphorus trisulphide; phosphorus sesquisulphid


215-245-0


1314-85-8


Flam. Sol. 1
Self-heat. 1
Acute Tox. 4*


H228
H251
H302


GHS02
GHS07
Dgr


H228
H251
H302


 


 


T’




‘602-025-00-8


1,1-dichloroethylene; vinylidene chloride


200-864-0


75-35-4


Flam. Liq. 1
Carc. 1B
Muta. 2
Acute Tox. 1
Acute Tox. 3
STOT RE 1
Aquatic Chronic 3


H224
H350
H341
H330
H301
H372 (respiratory tract, kidney, liver)
H412


GHS02
GHS08
GHS06
Dgr


H224
H350
H341
H330
H301
H372 (respiratory tract, kidney, liver)
H412


 


inhalation: ATE = 0,5 mg/L (vapours)
oral: ATE = 300 mg/kg bw


D’




‘615-008-00-5


3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate; isophorone di-isocyanate


223-861-6


4098-71-9


Acute Tox. 1
Skin Corr. 1
Eye Dam. 1
Resp. Sens. 1
Skin Sens. 1A
Aquatic Chronic 2


H330
H314
H334
H317
H411


GHS06
GHS05
GHS08
GHS09
Dgr


H330
H314
H318
H334
H317
H411


EUH071


inhalation: ATE = 0,03 mg/L (dusts or mists)
Resp. Sens. 1; H334: C ≥ 0,5 % Skin Sens. 1A; H317: C ≥ 0,001 %


2’




‘613-045-00-1


folpet (ISO); N-(trichloromethylthio)phthalimide


205-088-6


133-07-3


Carc. 2
Acute Tox. 2
STOT RE 1
Eye Dam. 1
Skin Sens. 1A
Aquatic Acute 1
Aquatic Chronic 1


H351
H330
H372 (respiratory tract)
H318
H317
H400
H410


GHS08
GHS06
GHS05
GHS09
Dgr


H351
H330
H372 (respiratory tract)
H318
H317
H410


EUH066


inhalation: ATE = 0,30 mg/L (dusts or mists)
STOT RE 1: C ≥ 5 %
STOT RE 2: 0,5 % ≤ C < 5 %
Skin Sens. 1A; H317: C ≥ 0,001 %
M = 10
M = 10’


 




‘613-044-00-6


captan (ISO); 1,2,3,6-tetrahydro-N-(trichloromethylthio)phthalimide


205-087-0


133-06-2


Carc. 2
Repr. 2
Acute Tox. 2
STOT RE 1
Eye Dam. 1
Skin Sens. 1A
Aquatic Acute 1
Aquatic Chronic 1


H351
H361f
H330
H372
H318
H317
H400
H410


GHS08
GHS06
GHS05
GHS09
Dgr


H351
H361f
H330
H372
H318
H317
H410


 


inhalation: ATE
= 0,22 mg/L
(dusts or
mists)
Skin Sens. 1A; H317: C≥ 0,001 %
M = 10
M = 10’


 




‘607-231-00-1


clopyralid (ISO); 3,6-dichloropyridine-2-carboxylic acid


216-935-4


1702-17-6


Eye Dam. 1
Aquatic Chronic 1


H318
H410


GHS05
GHS09
Dgr


H318
H410


EUH066


M = 10’


 




‘616-211-00-1


proquinazid (ISO); 6-iodo-2-propoxy-3-propylquinazolin-4(3H)-one


—


189278-12-4


Carc. 2
STOT RE 1
Aquatic Acute 1
Aquatic Chronic 1


H351
H372 (thyroid,
liver)
H400
H410


GHS08
GHS09
Dgr


H351
H372 (thyroid,
liver)
H410


 


M = 1
M = 10’


 




‘616-212-00-7


3-iodo-2-propynyl butylcarbamate; 3-iodoprop-2-yn-1-yl butylcarbamate


259-627-5


55406-53-6


Acute Tox. 2
Acute Tox. 4
STOT RE 1
Eye Dam. 1
Skin Sens. 1
Aquatic Acute 1
Aquatic Chronic 1


H330
H302
H372 (larynx)
H318
H317
H400
H410


GHS06
GHS08
GHS05
GHS09
Dgr


H330
H302
H372 (larynx)
H318
H317
H410


 


inhalation: ATE
= 0,17 mg/L
(dusts or mists)
M = 10
M = 10’


 











ELI: http://data.europa.eu/eli/reg_del/2025/1222/oj
ISSN 1977-0677 (electronic edition)