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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

Type Delegated Regulation

Publication 2025-06-20

State In force

Text As published

Department European Commission, ENV

Source EUR-Lex

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This is the act as published. Later amendments are not folded into the text below: each one is a separate act in this repository and an entry in this law's history.

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Image omitted; see official source	Official Journal of the European Union	EN L series

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	2025/1222	20.6.2025

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 [^ntr1-L_202501222EN.000101-E0001], 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 [^ntr2-L_202501222EN.000101-E0002] 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

[^ntr1-L_202501222EN.000101-E0001]: OJ L 353, 31.12.2008, p. 1, ELI: http://data.europa.eu/eli/reg/2008/1272/oj.

[^ntr2-L_202501222EN.000101-E0002]: 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	Classification	Labelling	Labelling	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
‘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)

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