Commission Delegated Regulation (EU) 2025/1222

Contents

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^note, 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^note on those proposals:

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

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

—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 16 March 2023 concerning N-1-naphthylaniline; N-phenylnaphthalen-1-amine;

—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.

—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;

(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.

(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. 1BH360DGHS08DgrH360D’‘612-300-00-4N-1-naphthylaniline;N-phenylnaphthalen-1-amine201-983-090-30-2Acute Tox. 4STOT RE 2Skin Sens. 1H302H373 (blood system, liver)H317GHS07GHS08Wng

H302

H373 (blood system, liver)H317oral: ATE = 1200 mg/kg bw’‘026-005-00-8tetrairon tris(pyrophosphate); ferric pyrophosphate233-190-010058-44-3Eye Irrit. 2H319GHS07WngH319’‘604-103-00-7α,α’-propylenedinitrilodi-o-cresol202-374-294-91-7Repr. 1BH360FDGHS08DgrH360FD’‘008-004-00-4ozone233-069-210028-15-6Ox. Gas 1Carc. 2Muta. 2Acute Tox. 1STOT SE 1STOT RE 1Aquatic Acute 1Aquatic Chronic 1H270H351H341H330H370 (nervous system, respiratory system, cardiovascular system)H372 (nervous system, respiratory system)H400H410GHS03GHS08GHS06GHS09DgrH270H351H341H330H370 (nervous system, respiratory system, cardiovascular system)H372 (nervous system, respiratory system)H410inhalation: ATE = 10 ppmVSTOT 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 = 100M = 1’‘007-031-00-9dinitrogen oxide233-032-010024-97-2Repr. 1BSTOT SE 3STOT RE 1Ozone 1H360DfH336H372 (nervoussystem)H420GHS08GHS07DgrH360DfH336H372 (nervoussystem)H420’‘056-006-00-9barium chromate233-660-510294-40-3Carc. 1BH350GHS08DgrH350’‘650-060-00-2Chrysanthemum cinerariaefolium, extract from open and mature flowers of Tanacetum cinerariifolium obtained with supercritical CO₂289-699-389997-63-7Acute Tox. 4Acute Tox. 4STOT SE 1STOT RE 2Skin Sens. 1Aquatic Acute 1Aquatic Chronic 1H332H302H370 (nervous system)H373 (respiratory tract, inhalation)H317H400H410GHS07GHS08DgrH332H302H370 (nervous system)H373 (respiratory tract, inhalation)H317H410inhalation: ATE = 2,6 mg/L (dusts or mists)oral: ATE = 730 mg/kg bwM = 1000M = 100’‘650-059-00-7Chrysanthemum cinerariaefolium, extract from open and mature flowers of Tanacetum cinerariifolium obtained with hydrocarbon solvents289-699-389997-63-7Acute Tox. 4Acute Tox. 4STOT SE 1STOT RE 2Skin Sens. 1Aquatic Acute 1Aquatic Chronic 1H332H302H370 (nervous system)H373 (respiratory tract, inhalation)H317H400H410GHS07GHS08DgrH332H302H370 (nervous system)H373 (respiratory tract, inhalation)H317H410inhalation: ATE = 2,6 mg/L (dusts or mists)oral: ATE = 730 mg/kg bwM = 1000M = 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. 2H351GHS08WngH351’‘608-070-00-X2-bromo-2-(bromomethyl)pentanedinitrile; [DBDCB]252-681-035691-65-7Acute Tox. 2Acute Tox. 4STOT RE 2Eye Dam. 1Skin Sens. 1AAquatic Chronic 2H330H302H373 (thyroid, central nervous system)H318H317H411GHS06GHS08GHS05GHS09DgrH330H302H373 (thyroid, central nervous system)H318H317H411inhalation: ATE = 0,27 mg/L (dusts or mists)oral: ATE = 500 mg/kg bwSkin 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. 1BH360DGHS08DgrH360D’‘613-352-00-0bixlozone (ISO); 2-(2,4-dichlorobenzyl)-4,4-dimethyl-1,2-oxazolidin-3-one—81777-95-9Aquatic Acute 1Aquatic Chronic 1H400H410GHS09WngH410M = 1M = 10’‘603-248-00-32,3-epoxypropyl isopropyl ether223-672-94016-14-2Repr. 1BH360FGHS08DgrH360F’‘607-778-00-6tetrahydrofurfuryl methacrylate219-529-52455-24-5Repr. 1BSkin Sens. 1AH360DfH317GHS08GHS07DgrH360DfH317’‘015-209-00-2trimethyl phosphate208-144-8512-56-1Carc. 1BMuta. 1BRepr. 1BAcute Tox. 4STOT RE 2H350H340H360FDH302H373 (nervous system)GHS08GHS07DgrH350H340H360FDH302H373 (nervous system)oral: ATE = 1300 mg/kg bw’‘602-111-00-5fluoroethylene200-832-675-02-5Carc. 1AMuta. 2H350H341GHS08DgrH350H341D’‘602-112-00-02-bromo-3,3,3-trifluoroprop-1-ene—1514-82-5Repr. 1BSTOT SE 3STOT SE 3H360FDH335H336GHS08GHS07DgrH360FDH335H336’‘613-353-00-62-methyl-2H-isothiazol-3-one hydrochloride; 2-methyl-2,3-dihydro-1,2-thiazol-3-one hydrochloride247-499-326172-54-3Acute Tox. 2Acute Tox. 3Acute Tox. 3Skin Corr. 1Eye Dam. 1Skin Sens. 1AAcute Aquatic 1Acute Chronic 1H330H311H301H314H318H317H400H410GHS06GHS05GHS09DgrH330H311H301H314H317H410EUH071inhalation: ATE = 0,15 mg/L (dusts or mists)dermal: ATE = 320 mg/kg bworal: ATE = 180 mg/kg bwSkin. Sens 1A; H317: C ≥ 0,0015 %M = 10M = 1’‘603-249-00-92,3-epoxypropyl o-tolyl ether218-645-32210-79-9Skin Irrit. 2Skin Sens. 1AMuta. 2Aquatic Chronic 2H315H317H341H411GHS07GHS08GHS09WngH315H317H341H411C’‘607-780-00-7methyl oct-2-ynoate203-836-6111-12-6Skin Sens. 1AH317GHS07WngH317’‘612-301-00-Xdinotefuran (ISO); (RS)-1-methyl-2-nitro-3-(tetrahydro-3-furylmethyl)guanidine-165252-70-0Acute Tox. 4Aquatic Acute 1Aquatic Chronic 1H302H400H410GHS07GHS09WngH302H410oral: ATE = 2000 mg/kg bwM = 10M = 10’

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

Article 1#

Article 2#

Article 1 #

Article 2 #