Commission Delegated Regulation (EU) 2025/1222of 2 April 2025amending 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)

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

Annex

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 NoChemical NameEC NoCAS NoClassificationLabellingSpecific Conc. Limits, M-factors and ATEsNotesHazard Class and Category Code(s)Hazard statement Code(s)Pictogram, Signal Word Code(s)Hazard statement Code(s)Suppl. Hazard statement Code(s)607-776-00-52-ethylhexanoic acid, monoester with propane-1,2-diol285-503-585114-00-7Repr. 1BH360D GHS08 Dgr H360D612-300-00-4 N-1-naphthylaniline; N-phenylnaphthalen-1-amine 201-983-090-30-2 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 = 1200 mg/kg bw026-005-00-8tetrairon tris(pyrophosphate); ferric pyrophosphate233-190-010058-44-3Eye Irrit. 2H319 GHS07 Wng H319604-103-00-7α,α’-propylenedinitrilodi-o-cresol202-374-294-91-7Repr. 1BH360FD GHS08 Dgr H360FD008-004-00-4ozone233-069-210028-15-6 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 = 1 007-031-00-9dinitrogen oxide233-032-010024-97-2 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 056-006-00-9barium chromate233-660-510294-40-3Carc. 1BH350 GHS08 Dgr H350650-060-00-2Chrysanthemum cinerariaefolium, extract from open and mature flowers of Tanacetum cinerariifolium obtained with supercritical CO2289-699-389997-63-7 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 = 1000 M = 100 650-059-00-7Chrysanthemum cinerariaefolium, extract from open and mature flowers of Tanacetum cinerariifolium obtained with hydrocarbon solvents289-699-389997-63-7 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 = 1000 M = 100 607-777-00-0barium bis[2-chloro-5-[(2-hydroxy-1-naphthyl)azo]toluene-4-sulphonate]; C.I. Pigment Red 53:1225-935-35160-02-1Carc. 2H351 GHS08 Wng H351608-070-00-X2-bromo-2-(bromomethyl)pentanedinitrile; [DBDCB]252-681-035691-65-7 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 % 607-779-00-19-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. 1BH360D GHS08 Dgr H360D 613-352-00-0bixlozone (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 = 10 603-248-00-32,3-epoxypropyl isopropyl ether223-672-94016-14-2Repr. 1BH360F GHS08 Dgr H360F607-778-00-6tetrahydrofurfuryl methacrylate219-529-52455-24-5 Repr. 1B Skin Sens. 1A H360Df H317 GHS08 GHS07 Dgr H360Df H317 015-209-00-2trimethyl phosphate208-144-8512-56-1 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 = 1300 mg/kg bw602-111-00-5fluoroethylene200-832-675-02-5 Carc. 1A Muta. 2 H350 H341 GHS08 Dgr H350 H341 D602-112-00-02-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 613-353-00-62-methyl-2H-isothiazol-3-one hydrochloride; 2-methyl-2,3-dihydro-1,2-thiazol-3-one hydrochloride247-499-326172-54-3 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 = 1 603-249-00-92,3-epoxypropyl o-tolyl ether218-645-32210-79-9 Skin Irrit. 2 Skin Sens. 1A Muta. 2 Aquatic Chronic 2 H315 H317 H341 H411 GHS07 GHS08 GHS09 Wng H315 H317 H341

H411 C607-780-00-7methyl oct-2-ynoate203-836-6111-12-6Skin Sens. 1AH317 GHS07 Wng H317612-301-00-Xdinotefuran (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 = 2000 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 NoChemical NameEC NoCAS NoHazard 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 ATEsNotes601-027-00-62-phenylpropene; α-methylstyrene202-705-098-83-9 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 616-145-00-3pethoxamid (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 = 10 015-012-00-1tetraphosphorus trisulphide; phosphorus sesquisulphid215-245-01314-85-8 Flam. Sol. 1 Self-heat. 1 Acute Tox. 4 H228 H251 H302 GHS02 GHS07 Dgr H228 H251 H302 T602-025-00-81,1-dichloroethylene; vinylidene chloride200-864-075-35-4 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 D615-008-00-53-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate; isophorone di-isocyanate223-861-64098-71-9 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 % 2 613-045-00-1folpet (ISO); N-(trichloromethylthio)phthalimide205-088-6133-07-3 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 = 10 613-044-00-6captan (ISO); 1,2,3,6-tetrahydro-N-(trichloromethylthio)phthalimide205-087-0133-06-2 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 = 10 607-231-00-1clopyralid (ISO); 3,6-dichloropyridine-2-carboxylic acid216-935-41702-17-6 Eye Dam. 1 Aquatic Chronic 1 H318 H410 GHS05 GHS09 Dgr H318 H410 EUH066M = 10616-211-00-1proquinazid (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 = 10 616-212-00-73-iodo-2-propynyl butylcarbamate; 3-iodoprop-2-yn-1-yl butylcarbamate259-627-555406-53-6 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