Commission Delegated Regulation (EU) 2024/197

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)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 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 of the Agency (RAC) adopted, after having taken account of the comments received from the parties concerned, the following opinions^note on those proposals:

—Opinion of 18 March 2021 concerning benzyl(diethylamino)diphenylphosphonium 4-[1,1,1,3,3,3-hexafluoro-2-(4-hydroxyphenyl)propan-2-yl]phenolate;

—Opinion of 18 March 2021 concerning ethyl acrylate;

—Opinion of 18 March 2021 concerning methyl acrylate;

—methyl propenoate;

—Opinion of 18 March 2021 concerning methyl methacrylate; methyl 2-methylprop-2-enoate; methyl 2-methylpropenoate;

—Opinion of 18 March 2021 concerning transfluthrin (ISO); 2,3,5,6-tetrafluorobenzyl (1R,3S)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate;

—Opinion of 18 March 2021 concerning allyl methacrylate; 2-methyl-2-propenoic acid 2-propenyl ester;

—Opinion of 18 March 2021 concerning mepiquat chloride (ISO); 1,1-dimethylpiperidinium chloride;

—Opinion of 10 June 2021 concerning triethylamine;

—Opinion of 10 June 2021 concerning di-n-butylamine;

—Opinion of 10 June 2021 concerning 4-nitrosomorpholine;

—Opinion of 18 March 2021 concerning benzyltriphenylphosphonium, salt with 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]bis[phenol] (1:1);

—Opinion of 10 June 2021 concerning difenoconazole (ISO); 1-({2-[2-chloro-4-(4-chlorophenoxy)phenyl]-4-methyl-1,3-dioxolan-2-yl}methyl)-1H-1,2,4-triazole; 3-chloro-4-[(2RS,4RS;2RS,4SR)-4-methyl-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-2-yl]phenyl 4-chlorophenyl ether;

—Opinion 10 June 2021 concerning N,N-dimethyl-p-toluidine;

—Opinion of 10 June 2021 concerning potassium chlorate;

—Opinion of 10 June 2021 concerning sodium chlorate;

—Opinion of 10 June 2021 Concerning reaction mass of 1-(2,3-epoxypropoxy)-2,2-bis ((2,3-epoxypropoxy)methyl) butane and 1-(2,3-epoxypropoxy)-2-((2,3-epoxypropoxy)methyl)-2-hydroxymethyl butane;

—Opinion of 10 June 2021 concerning metribuzin (ISO); 4-amino-6-tert-butyl-3-methylthio-1,2,4-triazin-5(4H)-one; 4-amino-4,5-dihydro-6-(1,1-dimethylethyl)-3-methylthio-1,2,4-triazin-5-one;

—Opinion 16 September 2021 concerning lithium carbonate [1] lithium chloride [2] lithium hydroxide [3];

—Opinion of 16 September 2021 concerning dimethyl propylphosphonate;

—Opinion of 16 September 2021 concerning dibutyltin maleate;

—Opinion of 16 September 2021 concerning dibutyltin oxide;

—Opinion of 18 March 2021 concerning reaction mass of 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol and benzyl(diethylamino)diphenylphosphonium 4-[1,1,1,3,3,3-hexafluoro-2-(4-hydroxyphenyl)propan-2-yl]phenolate (1:1);

—Opinion of 16 September 2021 concerning clothianidin (ISO); (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine;

—Opinion of 16 September 2021 concerning cymoxanil (ISO); 2-cyano-N-[(ethylamino)carbonyl]-2-(methoxyimino)acetamide;

—Opinion of 16 September 2021 concerning nonylphenol, branched and linear, ethoxylated (with average molecular weight < 352 g/mol) [includes ortho-, meta-, para- isomers or any combination thereof];

—Opinion of 16 September 2021 concerning nonylphenol, branched and linear, ethoxylated (with 352 g/mol ≤ average molecular weight < 704 g/mol) [includes ortho-, meta-, para- isomers or any combination thereof];

—Opinion of 16 September 2021 concerning nonylphenol, branched and linear, ethoxylated (with 704 g/mol ≤ average molecular weight ≤ 1540 g/mol) [includes ortho-, meta-, para- isomers or any combination thereof];

—Opinion of 16 September 2021 concerning 1-phenylethan-1-one (1-phenylethylidene)hydrazone;

—Opinion of 16 September 2021 concerning 9-[2-(ethoxycarbonyl)phenyl]-3,6-bis(ethylamino)-2,7-dimethylxanthylium chloride; Basic Red 1;

—Opinion of 16 September 2021 concerning picolinafen (ISO); N-(4-fluorophenyl)-6-[3-(trifluoromethyl)phenoxy]pyridine-2-carboxamide; 4′-fluoro-6-[(α,α,α-trifluoro-m-tolyl)oxy]picolinanilide;

—Opinion of 16 September 2021 concerning diuron (ISO); 3-(3,4-dichlorophenyl)-1,1-dimethylurea;

—Opinion of 16 September 2021 concerning diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide;

—Opinion of 18 March 2021 concerning reaction mass of 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol and benzyltriphenylphosphonium, salt with 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol (1:1);

—Opinion of 16 September 2021 concerning hydrogen sulphide, hydrogen sulfide;

—Opinion of 16 September 2021 concerning benzyl alcohol;

—Opinion of 16 September 2021 concerning resorcinol; 1,3-benzenediol;

—Opinion of 16 September 2021 concerning 2,2',6,6'-tetrabromo-4,4'-isopropylidenediphenol; tetrabromobisphenol-A;

—Opinion of 16 September 2021 concerning a reassessment at the request of the Commission to review the harmonised classification of lead (environment);

—Opinion of 26 November 2021 concerning 2,2'-[[3-methyl-4-[(4-nitrophenyl)azo]phenyl]imino]bisethanol;

—Opinion of 26 November 2021 concerning 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctan-1-ol;

—Opinion of 26 November 2021 concerning 1,4-Benzenediamine, N,N’-mixed Ph and tolyl derivs.; Reaction mass of N-phenyl,N’-o-tolyl-phenylene diamine, N,N’-diphenyl-p-phenylene diamine and N,N’-di-o-tolyl-phenylene diamine;

—Opinion of 26 November 2021 concerning tetramethylene dimethacrylate;

—Opinion of 26 November 2021 concerning 7,7,9(or 7,9,9)-trimethyl-4,13-dioxo-3,14-dioxa-5,12-diazahexadecane-1,16-diyl bismethacrylate;

—Opinion of 18 March 2021 concerning 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol; bisphenol AF;

—Opinion of 26 November 2021 concerning 2,2'-ethylenedioxydiethyl dimethacrylate;

—Opinion of 26 November 2021 concerning bifenox (ISO); methyl 5-(2,4-dichlorophenoxy)-2-nitrobenzoate;

—Opinion of 26 November 2021 concerning 4-methylimidazole;

—Opinion of 26 November 2021 concerning sulfur dioxide;

—Opinion of 26 November 2021 concerning 1,2-benzisothiazol-3(2H)-one; 1,2-benzisothiazolin-3-one;

—Opinion of 26 November 2021 concerning benalaxyl (ISO); methyl N-(2,6-dimethylphenyl)-N-(phenylacetyl)-DL-alaninate.

—Opinion of 18 March 2021 concerning cinnamaldehyde; 3-phenylprop-2-enal; cinnamic aldehyde; cinnamal [1], (2E)-3-phenylprop-2-enal [2];

—Opinion of 18 March 2021 concerning benfluralin (ISO); N-butyl-N-ethyl-α,α,α-trifluoro-2,6-dinitro-p-toluidine;

—Opinion 18 March 2021 concerning 3,3'-dimethylbiphenyl-4,4'-diyl diisocyanate;

—Opinion of 18 March 2021 concerning foramsulfuron (ISO); 2-{[(4,6-dimethoxypyrimidin-2-yl)carbamoyl]sulfamoyl}-4-formamido-N,N-dimethylbenzamide; 1-(4,6-dimethoxypyrimidin-2-yl)-3-(2-dimethylcarbamoyl-5-formamidophenylsulfonyl)urea;

(3)The Commission has received additional information from stakeholders contesting the scientific assessment set out in the RAC opinion of 26 November 2021 concerning 1,4-Benzenediamine, N,N’-mixed Ph and tolyl derivs. and in the RAC opinion of 16 September 2021 concerning dibutyltin oxide. The additional information has been assessed and has not been found sufficient to cast doubts on the scientific analysis contained in the RAC opinions. It is therefore appropriate to introduce the harmonised classification and labelling of the substances concerned on the basis of the assessment made in those opinions.

(4)The RAC opinion of 16 September 2021 concerning the environmental toxicity of lead put forward various possible options to update the harmonised classification of lead for aquatic toxicity. These options give the possibility to either have a single entry for both lead in powder form (‘lead powder’) and in massive form (‘lead massive’) or to keep two separate entries, one for each form. However, as data for lead massive indicates a lower dissolution in water than for lead powder, a calculation in accordance with Part 4 of Annex I to Regulation (EC) No 1272/2008 leads to a less severe classification for lead massive. It is therefore appropriate to amend the existing aquatic toxicity classification for lead powder with regard to the M-factor and to introduce a different aquatic toxicity classification for lead massive.

(5)In light of the RAC opinions, it is therefore 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 assessments.

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

(7)As regards the classification of methyl methacrylate as a respiratory sensitiser and the classification of lithium carbonate, lithium chloride and lithium hydroxide as reproductive toxic substances the Commission has received additional information from stakeholders after obtaining the RAC opinions of 18 March 2021 and of 16 September 2021 respectively concerning those substances. Since that new scientific information requires further assessment by RAC, methyl methacrylate, lithium carbonate, lithium chloride and lithium hydroxide recommended in the RAC opinions should not be subject to harmonised classification and labelling at this stage.

(8)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 September 2025.However, suppliers may already before that date classify, label and package substances and mixtures in accordance with Regulation (EC) No 1272/2008 as amended by this Regulation.

(1)the following entries are inserted following the 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 ATE | NotesHazard Class and Category Code(s) | Hazard statement Code(s) | Pictogram, Signal Word Code(s) | Hazard statement Code(s) | Suppl. Hazard statement Code(s)015-204-00-5 | benzyl(diethylamino)diphenylphosphonium 4-[1,1,1,3,3,3-hexafluoro-2-(4-hydroxyphenyl)propan-2-yl]phenolate | 479-100-5 | 577705-90-9 | Repr. 1B | H360F | GHS08Dgr | H360F | | |015-205-00-0 | benzyltriphenylphosphonium, salt with 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]bis[phenol] (1:1) | 278-305-5 | 75768-65-9 | Repr. 1B | H360F | GHS08Dgr | H360F | | |015-206-00-6 | reaction mass of 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol and benzyl(diethylamino)diphenylphosphonium 4-[1,1,1,3,3,3-hexafluoro-2-(4-hydroxyphenyl)propan-2-yl]phenolate (1:1) | — | — | Repr. 1B | H360F | GHS08Dgr | H360F | | |015-207-00-1 | reaction mass of 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol and benzyltriphenylphosphonium, salt with 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol (1:1) | — | — | Repr. 1B | H360F | GHS08Dgr | H360F | | |015-208-00-7 | dimethyl propylphosphonate | 242-555-3 | 18755-43-6 | Muta. 1BRepr. 1B | H340H360Df | GHS08Dgr | H340H360Df | | |050-034-00-5 | dibutyltin maleate | 201-077-5 | 78-04-6 | Muta. 2Repr. 1BAcute Tox. 2Acute Tox. 4STOT RE 1Skin Corr. 1Eye Dam. 1 | H341H360FDH330H302H372 (immune system)H314H318 | GHS08GHS06GHS05Dgr | H341H360FDH330H302H372 (immune system)H314 | | inhalation:ATE = 0,317 mg/L (dusts or mists)oral:ATE = 510 mg/kg bw |050-035-00-0 | dibutyltin oxide | 212-449-1 | 818-08-6 | Muta. 2Repr. 1BAcute Tox. 3STOT RE 1Skin Irrit. 2Eye Dam. 1 | H341H360FDH301H372 (immune system)H315H318 | GHS08GHS06GHS05Dgr | H341H360FDH301H372 (immune system)H315H318 | | oral:ATE = 170 mg/kg bw |603-244-00-1 | reaction mass of 1-(2,3-epoxypropoxy)–2,2-bis ((2,3-epoxypropoxy)methyl) butane and 1-(2,3-epoxypropoxy)-2-((2,3-epoxypropoxy)methyl)-2-hydroxymethyl butane | — | — | Muta. 2Repr. 1B | H341H360F | GHS08Dgr | H341H360F | | |603-245-00-7 | 2,2'-[[3-methyl-4-[(4-nitrophenyl)azo]phenyl]imino]bisethanol | 221-665-5 | 3179-89-3 | Skin Sens. 1 | H317 | GHS07Wng | H317 | | |603-246-00-2 | 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctan-1-ol | 211-477-1 | 647-42-7 | STOT RE 2Aquatic Chronic 1 | H373 (teeth, bones)H410 | GHS08GHS09Wng | H373 (teeth, bones)H410 | | M = 1 |604-099-00-7 | 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol; bisphenol AF | 216-036-7 | 1478-61-1 | Repr. 1B | H360F | GHS08Dgr | H360F | | |604-100-00-0 | nonylphenol, branched and linear, ethoxylated (with average molecular weight ≤ 1540 g/mol) [includes ortho-, meta-, para- isomers or any combination thereof] | 500-315-8500-024-6500-045-0500-209-1248-762-5243-816-4248-291-5—230-770-5 248-743-1 247-555-7 248-293-6—and others | 127087-87-09016-45-926027-38-368412-54-427986-36-320427-84-327176-93-81119449-38-5 7311-27-5 27942-27-4 26264-02-8 27177-05-5 14409-72-4 and others | Aquatic Acute 1Aquatic Chronic 1 | H400H410 | GHS09Wng | H410 | | M = 1M = 10 |606-155-00-6 | cinnamaldehyde; 3-phenylprop-2-enal;cinnamic aldehyde; cinnamal; [1](2E)-3-phenylprop-2-enal [2] | 203-213-9 [1] - [2] | 104-55-2 [1] 14371-10-9 [2] | Skin Sens. 1A | H317 | GHS07Wng | H317 | | Skin Sens. 1; H317: C ≥ 0,01 % |607-766-00-0 | tetramethylene dimethacrylate | 218-218-1 | 2082-81-7 | Skin Sens. 1B | H317 | GHS07Wng | H317 | | |607-767-00-6 | 7,7,9(or 7,9,9)-trimethyl–4,13-dioxo–3,14-dioxa–5,12-diazahexadecane–1,16-diyl bismethacrylate | 276-957-5 | 72869-86-4 | Skin Sens. 1B | H317 | GHS07Wng | H317 | | |607-768-00-1 | 2,2'-ethylenedioxydiethyl dimethacrylate | 203-652-6 | 109-16-0 | Skin Sens. 1B | H317 | GHS07Wng | H317 | | |607-769-00-7 | bifenox (ISO); methyl 5-(2,4-dichlorophenoxy)-2-nitrobenzoate | 255-894-7 | 42576-02-3 | Acute Tox. 4Aquatic Acute 1Aquatic Chronic 1 | H302H400H410 | GHS07GHS09Wng | H302H410 | | oral:ATE = 1500 mg/kg bwM = 1000M = 1000 |612-295-00-9 | benfluralin (ISO); N-butyl-N-ethyl-α,α,α-trifluoro-2,6-dinitro-p-toluidine | 217-465-2 | 1861-40-1 | Carc. 2Repr. 2Skin Irrit. 2Eye Irrit. 2Skin Sens. 1Aquatic Acute 1Aquatic Chronic 1 | H351H361dH315H319H317H400H410 | GHS08GHS07GHS09Wng | H351H361dH315H319H317H410 | | M = 10M = 10 |612-296-00-4 | N,N-dimethyl-p-toluidine | 202-805-4 | 99-97-8 | Carc. 1BAcute Tox. 4Acute Tox. 3STOT RE 2Aquatic Chronic 3 | H350H332H301H373 (blood system, respiratory tract)H412 | GHS08GHS06Dgr | H350H332H301H373 (blood system, respiratory tract)H412 | | inhalation:ATE = 1,4 mg/L (dusts or mists)oral:ATE = 140 mg/kg bw |612-297-00-X | 1-phenylethan-1-one (1-phenylethylidene)hydrazone | 211-979-0 | 729-43-1 | Skin Sens. 1 | H317 | GHS07Wng | H317 | | |612-298-00-5 | 1,4-Benzenediamine, N,N’-mixed Ph and tolyl derivs.; | 273-227-8 | 68953-84-4 | Repr. 1BSkin Sens. 1 | H360FDH317 | GHS08GHS07Dgr | H360FDH317 | | |613-346-00-8 | 4-nitrosomorpholine | — | 59-89-2 | Carc. 1BMuta. 2STOT RE 1 | H350H341H372 (liver) | GHS08Dgr | H350H341H372 (liver) | | Carc. 1B; H350: C ≥ 0,001 % |613-347-00-3 | difenoconazole (ISO); 1-({2-[2-chloro-4-(4-chlorophenoxy)phenyl]-4-methyl–1,3-dioxolan-2-yl}methyl)-1H-1,2,4-triazole; 3-chloro-4-[(2RS,4RS;2RS,4SR)-4-methyl-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-2-yl]phenyl 4-chlorophenyl ether | — | 119446-68-3 | Carc. 2Acute Tox. 4Eye Irrit. 2Aquatic Acute 1Aquatic Chronic 1 | H351H302H319H400H410 | GHS08GHS07GHS09Wng | H351H302H319H410 | | oral:ATE = 1450 mg/kg bwM = 10M = 10 |613-348-00-9 | 9-[2-(ethoxycarbonyl)phenyl]–3,6-bis(ethylamino)–2,7-dimethylxanthylium chloride; Basic Red 1 | 213-584-9 | 989-38-8 | Acute Tox. 3Eye Dam. 1Skin Sens. 1Aquatic Acute 1Aquatic Chronic 1 | H301H318H317H400H410 | GHS06GHS05GHS09Dgr | H301H318H317H410 | | oral:ATE = 280 mg/kg bwM = 10M = 1 |613-349-00-4 | 4-methylimidazole | 212-497-3 | 822-36-6 | Carc. 1BRepr. 1B | H350H360Fd | GHS08Dgr | H350H360Fd | | |615-051-00-X | 3,3'-dimethylbiphenyl–4,4'-diyl diisocyanate | 202-112-7 | 91-97-4 | Carc. 2Resp. Sens. 1Skin Sens. 1A | H351H334H317 | GHS08Dgr | H351H334H317 | | Skin Sens. 1A; H317: C ≥ 0,001 % |616-241-00-5 | foramsulfuron (ISO); 2-{[(4,6-dimethoxypyrimidin-2-yl)carbamoyl]sulfamoyl}-4-formamido-N,N-dimethylbenzamide; 1-(4,6-dimethoxypyrimidin-2-yl)-3-(2-dimethylcarbamoyl-5-formamidophenylsulfonyl)urea | — | 173159-57-4 | Carc. 2Aquatic Acute 1Aquatic Chronic 1 | H351H400H410 | GHS08GHS09Wng | H351H410 | | M = 1000M = 100 |616-242-00-0 | picolinafen (ISO); N-(4-fluorophenyl)-6-[3-(trifluoromethyl)phenoxy]pyridine-2-carboxamide; 4′-fluoro-6-[(α,α,α-trifluoro-m-tolyl)oxy]picolinanilide | — | 137641-05-5 | STOT RE 2Aquatic Acute 1Aquatic Chronic 1 | H373 (blood system, thyroid)H400H410 | GHS08GHS09Wng | H373 (blood system, thyroid)H410 | | M = 1000M = 1000 |

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

Article 1#

Article 2#

Article 1 #

Article 2 #