Official Gazette Notification Text
Official TranscriptOfficial Journal EN of the European Union L series 2024/197 5.1.2024 COMMISSION DELEGATED REGULATION (EU) 2024/197 of 19 October 2023 amending Regulation (EC) No 1272/2008 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...
Official Journal EN of the European Union L series 2024/197 5.1.2024 COMMISSION DELEGATED REGULATION (EU) 2024/197 of 19 October 2023 amending Regulation (EC) No 1272/2008 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 2008on 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) 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(2)on those proposals:
— Opinion of 18 March 2021concerning benzyl(diethylamino)diphenylphosphonium 4-[1,1,1,3,3,3-hexafluoro- 2-(4-hydroxyphenyl)propan-2-yl]phenolate; — Opinion of 18 March 2021 concerning benzyltriphenylphosphonium, salt with 4,4'-[2,2,2-trifluoro- 1-(trifluoromethyl)ethylidene]bis[phenol] (1:1);
— 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 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 18 March 2021 concerning 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol; bisphenol AF; — Opinion of 18 March 2021concerning 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 2021concerning 3,3'-dimethylbiphenyl-4,4'-diyl diisocyanate;
(1) OJ L 353, 31.12.2008, p. 1.
(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/-/.The opinion of 16 September 2021 concerning a reassessment at the request of the Commission is accessible via the following website:
https://echa.europa.eu/about-us/who-we-are/committee-for-risk-assessment/opinions-of-the-rac-adopted-under-specific-echa-s- executive-director-requests.
ELI: http://data.europa.eu/eli/reg_del/2024/197/oj 1/19EN OJ L, 5.1.2024 — 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;
— Opinion of 18 March 2021concerning ethyl acrylate; — Opinion of 18 March 2021concerning methyl acrylate; — methyl propenoate; — Opinion of 18 March 2021 concerning methyl methacrylate; methyl 2-methylprop-2-enoate; methyl 2-methylpropenoate;
— Opinion of 18 March 2021concerning transfluthrin (ISO); 2,3,5,6-tetrafluorobenzyl (1R,3S)-3-(2,2-dichlorovi nyl)-2,2-dimethylcyclopropanecarboxylate; — Opinion of 18 March 2021concerning allyl methacrylate; 2-methyl-2-propenoic acid 2-propenyl ester;
— Opinion of 18 March 2021concerning mepiquat chloride (ISO); 1,1-dimethylpiperidinium chloride; — Opinion of 10 June 2021concerning triethylamine; — Opinion of 10 June 2021concerning di-n-butylamine; — Opinion of 10 June 2021concerning 4-nitrosomorpholine;
— 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 2021concerning N,N-dimethyl-p-toluidine; — Opinion of 10 June 2021concerning potassium chlorate; — Opinion of 10 June 2021concerning 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 2021concerning 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 2021concerning lithium carbonate [1] lithium chloride [2] lithium hydroxide [3];
— Opinion of 16 September 2021concerning dimethyl propylphosphonate; — Opinion of 16 September 2021concerning dibutyltin maleate; — Opinion of 16 September 2021concerning dibutyltin oxide; — 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 2021concerning 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 2021concerning nonylphenol, branched and linear, ethoxylated (with 704 g/mol ≤ average molecular weight ≤ 1 540g/mol) [includes ortho-, meta-, para- isomers or any combination thereof];
— Opinion of 16 September 2021concerning 1-phenylethan-1-one (1-phenylethylidene)hydrazone; — Opinion of 16 September 2021 concerning 9-[2-(ethoxycarbonyl)phenyl]-3,6-bis(ethylamino)-2,7-dimethyl xanthylium chloride; Basic Red 1;
2/19 ELI: http://data.europa.eu/eli/reg_del/2024/197/ojEN OJ L, 5.1.2024 — 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 2021concerning diuron (ISO); 3-(3,4-dichlorophenyl)-1,1-dimethylurea; — Opinion of 16 September 2021concerning diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide; — Opinion of 16 September 2021concerning hydrogen sulphide, hydrogen sulfide;
— Opinion of 16 September 2021concerning benzyl alcohol; — Opinion of 16 September 2021concerning resorcinol; 1,3-benzenediol; — Opinion of 16 September 2021 concerning 2,2',6,6'-tetrabromo-4,4'-isopropylidenediphenol; tetrabromobi sphenol-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 2021concerning 2,2'-[[3-methyl-4-[(4-nitrophenyl)azo]phenyl]imino]bisethanol;
— Opinion of 26 November 2021concerning 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctan-1-ol; — Opinion of 26 November 2021concerning 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 2021concerning tetramethylene dimethacrylate; — Opinion of 26 November 2021concerning 7,7,9(or 7,9,9)-trimethyl-4,13-dioxo-3,14-dioxa-5,12-diazahexade cane-1,16-diyl bismethacrylate;
— Opinion of 26 November 2021concerning 2,2'-ethylenedioxydiethyl dimethacrylate; — Opinion of 26 November 2021concerning bifenox (ISO); methyl 5-(2,4-dichlorophenoxy)-2-nitrobenzoate; — Opinion of 26 November 2021concerning 4-methylimidazole;
— Opinion of 26 November 2021concerning sulfur dioxide; — Opinion of 26 November 2021concerning 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.
(3) The Commission has received additional information from stakeholders contesting the scientific assessment set out in the RAC opinion of 26 November 2021concerning 1,4-Benzenediamine, N,N’-mixed Ph and tolyl derivs. and in the RAC opinion of 16 September 2021concerning 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 2021concerning 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.
ELI: http://data.europa.eu/eli/reg_del/2024/197/oj 3/19EN OJ L, 5.1.2024
(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 2021and of 16 September 2021respectively 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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 19 October 2023.
For the Commission The President Ursula VON DER LEYEN 4/19 ELI: http://data.europa.eu/eli/reg_del/2024/197/ojELI:
http://data.europa.eu/eli/reg_del/2024/197/oj 5/19 ANNEX In Annex VI to Regulation (EC) No 1272/2008, Table 3 of Part 3 is amended as follows:
(1) the following entries are inserted following the order of the index numbers corresponding to each entry:
Classification Labelling Specific Conc.
Suppl.
Index No Chemical Name EC No CAS No Hazard Pictogram, Hazard Limits, M- Notes Hazard Class and Hazard statement Signal Word statement factors and ATE Category Code(s) statement Code(s) Code(s) Code(s) Code(s) ‘015-204-00-5 benzyl(diethylamino) 479-100-5 577705-90-9 Repr. 1B H360F GHS08 H360F’ diphenylphosphonium Dgr 4-[1,1,1,3,3,3-hexafluoro- 2-(4-hydroxyphenyl)propan-2-yl] phenolate ‘015-205-00-0 benzyltriphenylphosphonium, 278-305-5 75768-65-9 Repr. 1B H360F GHS08 H360F’ salt with 4,4'-[2,2,2-trifluoro- Dgr 1-(trifluoromethyl)ethylidene]bis [phenol] (1:1) ‘015-206-00-6 reaction mass of 4,4'- — — Repr. 1B H360F GHS08 H360F’ [2,2,2-trifluoro- Dgr 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) ‘015-207-00-1 reaction mass of 4,4'- — — Repr. 1B H360F GHS08 H360F’ [2,2,2-trifluoro- Dgr 1-(trifluoromethyl)ethylidene] diphenol and benzyltriphenylphosphonium, salt with 4,4'-[2,2,2-trifluoro- 1-(trifluoromethyl)ethylidene] diphenol (1:1) OJ L,
5.1.2024 EN6/19
ELI:
http://data.europa.eu/eli/reg_del/2024/197/oj Classification Labelling Specific Conc.
Suppl.
Index No Chemical Name EC No CAS No Hazard Pictogram, Hazard Limits, M- Notes Hazard Class and Hazard statement Signal Word statement factors and ATE Category Code(s) statement Code(s) Code(s) Code(s) Code(s) ‘015-208-00-7 dimethyl propylphosphonate 242-555-3 18755-43-6 Muta. 1B H340 GHS08 H340 Repr. 1B H360Df Dgr H360Df’ ‘050-034-00-5 dibutyltin maleate 201-077-5 78-04-6 Muta. 2 H341 GHS08 H341 inhalation:
Repr. 1B H360FD GHS06 H360FD ATE = Acute Tox. 2 H330 GHS05 H330 0,317 mg/L Acute Tox. 4 H302 Dgr H302 (dusts or mists) STOT RE 1 H372 H372 oral:
Skin Corr. 1 (immune (immune ATE = 510 Eye Dam. 1 system) system) mg/kg bw’ H314 H314 H318 ‘050-035-00-0 dibutyltin oxide 212-449-1 818-08-6 Muta. 2 H341 GHS08 H341 oral:
Repr. 1B H360FD GHS06 H360FD ATE = 170 Acute Tox. 3 H301 GHS05 H301 mg/kg bw’ STOT RE 1 H372 Dgr H372 Skin Irrit. 2 (immune (immune Eye Dam. 1 system) system) H315 H315 H318 H318 ‘603-244-00-1 reaction mass of — — Muta. 2 H341 GHS08 H341 1-(2,3-epoxypropoxy)–2,2-bis Repr. 1B H360F Dgr H360F’ ((2,3-epoxypropoxy)methyl) butane and 1-(2,3-epoxypropoxy)- 2-((2,3-epoxypropoxy)methyl)- 2-hydroxymethyl butane EN OJ L,
5.1.2024ELI:
http://data.europa.eu/eli/reg_del/2024/197/oj 7/19 Classification Labelling Specific Conc.
Index No Chemical Name EC No CAS No Suppl. Limits, M- Notes Hazard Pictogram, Hazard Hazard Class and Hazard factors and ATE statement Signal Word statement Category Code(s) statement Code(s) Code(s) Code(s) Code(s) ‘603-245-00-7 2,2'-[[3-methyl- 221-665-5 3179-89-3 Skin Sens. 1 H317 GHS07 H317’ 4-[(4-nitrophenyl)azo]phenyl] Wng imino]bisethanol ‘603-246-00-2 3,3,4,4,5,5,6,6,7,7,8,8,8-trideca- 211-477-1 647-42-7 STOT RE 2 H373 GHS08 H373 M = 1’ fluorooctan-1-ol Aquatic (teeth, GHS09 (teeth, Chronic 1 bones) Wng bones) H410 H410 ‘604-099-00-7 4,4'-[2,2,2-trifluoro- 216-036-7 1478-61-1 Repr. 1B H360F GHS08 H360F’ 1-(trifluoromethyl)ethylidene] Dgr diphenol; bisphenol AF ‘604-100-00-0 nonylphenol, branched and linear, 500-315-8 127087-87-0 Aquatic Acute 1 H400 GHS09 H410 M = 1 ethoxylated (with average 500-024-6 9016-45-9 Aquatic H410 Wng M = 10’ molecular weight ≤ 1 540g/mol) 500-045-0 26027-38-3 Chronic 1 [includes ortho-, meta-, para- 500-209-1 68412-54-4 isomers or any combination 248-762-5 27986-36-3 thereof] 243-816-4 20427-84-3 248-291-5 27176-93-8 — 1119449-38-- 230-770-5 2- 5 7311-27-5 2- 48-743-1 24- 7942-27-4 26- 7-555-7 248- 264-02-8 271- -293-6 77-05-5 1440- — 9-72-4 and and others others OJ L,
5.1.2024 EN8/19
ELI:
http://data.europa.eu/eli/reg_del/2024/197/oj Classification Labelling Specific Conc.
Index No Chemical Name EC No CAS No Suppl. Limits, M- Notes Hazard Pictogram, Hazard Hazard Class and Hazard factors and ATE statement Signal Word statement Category Code(s) statement Code(s) Code(s) Code(s) Code(s) ‘606-155-00-6 cinnamaldehyde; 3-phenylprop- 203-213-9 104-55-2 [1] Skin Sens. 1A H317 GHS07 H317 Skin Sens. 1;
2-enal; [1] - [2] 14371-10-9 Wng H317: C cinnamic aldehyde; cinnamal; [1] [2] ≥ 0,01 %’
(2E)-3-phenylprop-2-enal [2] ‘607-766-00-0 tetramethylene dimethacrylate 218-218-1 2082-81-7 Skin Sens. 1B H317 GHS07 H317’ Wng ‘607-767-00-6 7,7,9(or 276-957-5 72869-86-4 Skin Sens. 1B H317 GHS07 H317’ 7,9,9)-trimethyl–4,13- Wng dioxo–3,14-dioxa–5,12- diazahexadecane–1,16-diyl bismethacrylate ‘607-768-00-1 2,2'-ethylenedioxydiethyl 203-652-6 109-16-0 Skin Sens. 1B H317 GHS07 H317’ dimethacrylate Wng ‘607-769-00-7 bifenox (ISO); methyl 255-894-7 42576-02-3 Acute Tox. 4 H302 GHS07 H302 oral:
5-(2,4-dichlorophenoxy)- Aquatic Acute 1 H400 GHS09 H410 ATE = 1 500 2-nitrobenzoate Aquatic H410 Wng mg/kg bw Chronic 1 M = 1 000 M = 1 000’ EN OJ L,
5.1.2024ELI:
http://data.europa.eu/eli/reg_del/2024/197/oj 9/19 Classification Labelling Specific Conc.
Index No Chemical Name EC No CAS No Suppl. Limits, M- Notes Hazard Pictogram, Hazard Hazard Class and Hazard factors and ATE statement Signal Word statement Category Code(s) statement Code(s) Code(s) Code(s) Code(s) ‘612-295-00-9 benfluralin (ISO); N-butyl-N- 217-465-2 1861-40-1 Carc. 2 H351 GHS08 H351 M = 10 ethyl-α,α,α- Repr. 2 H361d GHS07 H361d M = 10’ trifluoro-2,6-dinitro-p-toluidine Skin Irrit. 2 H315 GHS09 H315 Eye Irrit. 2 H319 Wng H319 Skin Sens. 1 H317 H317 Aquatic Acute 1 H400 H410 Aquatic H410 Chronic 1 ‘612-296-00-4 N,N-dimethyl-p-toluidine 202-805-4 99-97-8 Carc. 1B H350 GHS08 H350 inhalation:
Acute Tox. 4 H332 GHS06 H332 ATE = 1,4 mg/L Acute Tox. 3 H301 Dgr H301 (dusts or mists) STOT RE 2 H373 H373 oral:
Aquatic (blood (blood ATE = 140 Chronic 3 system, system, mg/kg bw’ respiratory respiratory tract) tract) H412 H412 ‘612-297-00-X 1-phenylethan-1-one 211-979-0 729-43-1 Skin Sens. 1 H317 GHS07 H317’ (1-phenylethylidene)hydrazone Wng ‘612-298-00-5 1,4-Benzenediamine, N,N’-mixed 273-227-8 68953-84-4 Repr. 1B H360FD GHS08 H360FD Ph and tolyl derivs.; Skin Sens. 1 H317 GHS07 H317’ Dgr OJ L,
5.1.2024 EN10/19
ELI:
http://data.europa.eu/eli/reg_del/2024/197/oj Classification Labelling Specific Conc.
Index No Chemical Name EC No CAS No Suppl. Limits, M- Notes Hazard Pictogram, Hazard Hazard Class and Hazard factors and ATE statement Signal Word statement Category Code(s) statement Code(s) Code(s) Code(s) Code(s) ‘613-346-00-8 4-nitrosomorpholine — 59-89-2 Carc. 1B H350 GHS08 H350 Carc. 1B;
Muta. 2 H341 Dgr H341 H350: C STOT RE 1 H372 (liver) H372 (liver) ≥ 0,001 %’ ‘613-347-00-3 difenoconazole (ISO); — 119446-68-3 Carc. 2 H351 GHS08 H351 oral:
1-({2-[2-chloro- Acute Tox. 4 H302 GHS07 H302 ATE = 1 450 4-(4-chlorophenoxy)phenyl]- Eye Irrit. 2 H319 GHS09 H319 mg/kg bw 4-methyl–1,3-dioxolan-2-yl} Aquatic Acute 1 H400 Wng H410 M = 10 methyl)-1H-1,2,4-triazole; Aquatic H410 M = 10’ 3-chloro-4-[(2RS,4RS;2RS,4SR)- Chronic 1 4-methyl-2-(1H-1,2,4-triazol- 1-ylmethyl)-1,3-dioxolan-2-yl] phenyl 4-chlorophenyl ether ‘613-348-00-9 9-[2-(ethoxycarbonyl) 213-584-9 989-38-8 Acute Tox. 3 H301 GHS06 H301 oral:
phenyl]–3,6-bis(ethylamino)–2,7- Eye Dam. 1 H318 GHS05 H318 ATE = 280 dimethylxanthylium chloride; Skin Sens. 1 H317 GHS09 H317 mg/kg bw Basic Red 1 Aquatic Acute 1 H400 Dgr H410 M = 10 Aquatic H410 M = 1’ Chronic 1 ‘613-349-00-4 4-methylimidazole 212-497-3 822-36-6 Carc. 1B H350 GHS08 H350 Repr. 1B H360Fd Dgr H360Fd’ EN OJ L,
5.1.2024ELI:
http://data.europa.eu/eli/reg_del/2024/197/oj 11/19 Classification Labelling Specific Conc.
Index No Chemical Name EC No CAS No Suppl. Limits, M- Notes Hazard Pictogram, Hazard Hazard Class and Hazard factors and ATE statement Signal Word statement Category Code(s) statement Code(s) Code(s) Code(s) Code(s) ‘615-051-00-X 3,3'-dimethylbiphenyl–4,4'-diyl 202-112-7 91-97-4 Carc. 2 H351 GHS08 H351 Skin Sens. 1A;
diisocyanate Resp. Sens. 1 H334 Dgr H334 H317: C Skin Sens. 1A H317 H317 ≥ 0,001 %’ ‘616-241-00-5 foramsulfuron (ISO); — 173159-57-4 Carc. 2 H351 GHS08 H351 M = 1 000 2-{[(4,6-dimethoxypyrimidin- Aquatic Acute 1 H400 GHS09 H410 M = 100’ 2-yl)carbamoyl]sulfamoyl}- Aquatic H410 Wng 4-formamido-N,N- Chronic 1 dimethylbenzamide;
1-(4,6-dimethoxypyrimidin-2-yl)- 3-(2-dimethylcarbamoyl- 5-formamidophenylsulfonyl)urea ‘616-242-00-0 picolinafen (ISO); N- — 137641-05-5 STOT RE 2 H373 GHS08 H373 M = 1 000 (4-fluorophenyl)- Aquatic Acute 1 (blood GHS09 (blood M = 1 000’ 6-[3-(trifluoromethyl)phenoxy] Aquatic system, Wng system, pyridine-2-carboxamide; 4′- Chronic 1 thyroid) thyroid) fluoro-6-[(α,α,α-trifluoro-m-tolyl) H400 H410 oxy]picolinanilide H410 OJ L,
5.1.2024 EN12/19
ELI:
http://data.europa.eu/eli/reg_del/2024/197/oj
(2) the entries corresponding to index numbers 006-015-00-9; 015-203-00-X; 016-001-00-4; 016-011-00-9; 017-004-00-3; 017-005-00-9; 082-013-00-1; 082-014-00-7;
603-057-00-5; 604-010-00-1; 604-074-00-0; 606-034-00-8; 607-032-00-X; 607-034-00-0; 607-223-00-8; 607-246-00-3; 612-004-00-5; 612-049-00-0; 612-056-00-9;
613-088-00-6; 613-127-00-7; 613-307-00-5; 616-035-00-5; 616-104-00-X are replaced by the following entries respectively:
Classification Labelling Specific Conc.
Index No Chemical Name EC No CAS No Suppl. Limits, M-factors Notes Hazard Pictogram, Hazard Hazard Class and Hazard and ATE statement Signal Word statement Category Code(s) statement Code(s) Code(s) Code(s) Code(s) ‘006-015-00-9 diuron (ISO); 206-354-4 330-54-1 Carc. 1B H350 GHS08 H350 M = 100 3-(3,4-dichlorophenyl)–1,1- STOT RE 2 H373 GHS09 H373 M = 100’ dimethylurea Aquatic Acute 1 (blood Dgr (blood Aquatic system) system) Chronic 1 H400 H410 H410 ‘015-203-00-X diphenyl(2,4,6-trimethylbenzoyl) 278-355-8 75980-60-8 Repr. 1B H360Fd GHS08 H360Fd phosphine oxide Skin Sens. 1B H317 GHS07 H317’ Dgr ‘016-001-00-4 hydrogen sulphide, hydrogen 231-977-3 7783-06-4 Flam. Gas 1A H220 GHS02 H220 inhalation: U’ sulfide Press. Gas H330 GHS06 H330 ATE = 440 Acute Tox. 2 H400 GHS09 H400 ppmV (gases) Aquatic Acute 1 Dgr ‘016-011-00-9 sulphur dioxide; sulfur dioxide 231-195-2 7446-09-5 Press. Gas H331 GHS04 H331 inhalation: U, 5’ Acute Tox. 3 H370 GHS06 H370 ATE = 1 000 STOT SE 1 (respiratory GHS08 (respiratory ppmV (gases) Skin. Corr. 1B system) GHS05 system)
(inhalation) Dgr (inhalation) H314 H314 EN OJ L,
5.1.2024ELI:
http://data.europa.eu/eli/reg_del/2024/197/oj 13/19 Classification Labelling Specific Conc.
Index No Chemical Name EC No CAS No Suppl. Limits, M-factors Notes Hazard Pictogram, Hazard Hazard Class and Hazard and ATE statement Signal Word statement Category Code(s) statement Code(s) Code(s) Code(s) Code(s) ‘017-004-00-3 potassium chlorate 223-289-7 3811-04-9 Ox. Sol. 1 H271 GHS03 H271 oral: ATE = 100 Acute Tox. 3 H301 GHS06 H301 mg/kg bw’ Dgr ‘017-005-00-9 sodium chlorate 231-887-4 7775-09-9 Ox. Sol. 1 H271 GHS03 H271 oral: ATE = 100 Acute Tox. 3 H301 GHS06 H301 mg/kg bw’ Dgr ‘082-013-00-1 lead powder; 231-100-4 7439-92-1 Repr. 1A H360FD GHS08 H360FD Repr. 1A;
[particle diameter < 1 mm] Lact. H362 GHS09 H362 H360D: C Aquatic Acute 1 H400 Dgr H410 ≥ 0,03 % Aquatic H410 M = 10 Chronic 1 M = 100’ ‘082-014-00-7 lead massive: 231-100-4 7439-92-1 Repr. 1A H360FD GHS08 H360FD M = 10’ [particle diameter ≥ 1 mm] Lact. H362 GHS09 H362 Aquatic H410 Dgr H410 Chronic 1 ‘603-057-00-5 benzyl alcohol 202-859-9 100-51-6 Acute Tox. 4 H302 GHS07 H302 oral: ATE = Eye Irrit. 2 H319 Wng H319 1 200mg/kg Skin Sens. 1B H317 H317 bw’ OJ L,
5.1.2024 EN14/19
ELI:
http://data.europa.eu/eli/reg_del/2024/197/oj Classification Labelling Specific Conc.
Index No Chemical Name EC No CAS No Suppl. Limits, M-factors Notes Hazard Pictogram, Hazard Hazard Class and Hazard and ATE statement Signal Word statement Category Code(s) statement Code(s) Code(s) Code(s) Code(s) ‘604-010-00-1 resorcinol; 1,3-benzenediol 203-585-2 108-46-3 Acute Tox. 4 H302 GHS07 H302 oral: ATE = 500 STOT SE 1 H370 GHS08 H370 mg/kg bw Skin Irrit. 2 (nervous GHS09 (nervous M = 1’ Eye Irrit. 2 system) Dgr system) Skin Sens. 1B H315 H315 Aquatic Acute 1 H319 H319 H317 H317 H400 H400 ‘604-074-00-0 2,2',6,6'-tetrabromo–4,4'- 201-236-9 79-94-7 Carc. 1B H350 GHS08 H350 isopropylidenediphenol; Aquatic Acute 1 H400 GHS09 H410’ tetrabromobisphenol-A Aquatic H410 Dgr Chronic 1 ‘606-034-00-8 metribuzin (ISO); 4-amino-6-tert- 244-209-7 21087-64-9 Acute Tox. 4 H302 GHS07 H302 oral: ATE = 320 butyl-3-methylthio-1,2,4-triazin- STOT RE 2 H373 GHS08 H373 mg/kg bw 5(4H)-one; 4-amino-4,5-dihydro- Aquatic Acute 1 (blood GHS09 (blood M = 10 6-(1,1-dimethylethyl)- Aquatic system) Wng system) M = 10’ 3-methylthio-1,2,4-triazin-5-one Chronic 1 H400 H410 H410 EN OJ L,
5.1.2024ELI:
http://data.europa.eu/eli/reg_del/2024/197/oj 15/19 Classification Labelling Specific Conc.
Index No Chemical Name EC No CAS No Suppl. Limits, M-factors Notes Hazard Pictogram, Hazard Hazard Class and Hazard and ATE statement Signal Word statement Category Code(s) statement Code(s) Code(s) Code(s) Code(s) ‘607-032-00-X ethyl acrylate 205-438-8 140-88-5 Flam. Liq. 2 H225 GHS02 H225 inhalation: D’ Acute Tox. 3 H331 GHS06 H331 ATE = 9 mg/L Acute Tox. 4 H312 Dgr H312 (vapours) Acute Tox. 4 H302 H302 dermal: ATE = STOT SE 3 H335 H335 1 800mg/kg Skin Irrit. 2 H315 H315 bw Eye Irrit. 2 H319 H319 oral: ATE = Skin Sens. 1 H317 H317 1 120mg/kg bw STOT SE 3;
H335: C ≥ 5 % Skin Irrit. 2;
H315: C ≥ 5 % Eye Irrit. 2;
H319: C ≥ 5 % ‘607-034-00-0 methyl acrylate; 202-500-6 96-33-3 Flam. Liq. 2 H225 GHS02 H225 inhalation: D’ methyl propenoate Acute Tox. 3 H331 GHS06 H331 ATE = 3 mg/L Acute Tox. 4 H312 Dgr H312 (vapours) Acute Tox. 4 H302 H302 dermal: ATE = STOT SE 3 H335 H335 1 100mg/kg Skin Irrit. 2 H315 H315 bw Eye Irrit. 2 H319 H319 oral: ATE = 500 Skin Sens. 1 H317 H317 mg/kg bw OJ L,
5.1.2024 EN16/19
ELI:
http://data.europa.eu/eli/reg_del/2024/197/oj Classification Labelling Specific Conc.
Index No Chemical Name EC No CAS No Suppl. Limits, M-factors Notes Hazard Pictogram, Hazard Hazard Class and Hazard and ATE statement Signal Word statement Category Code(s) statement Code(s) Code(s) Code(s) Code(s) ‘607-223-00-8 transfluthrin (ISO); 405-060-5 118712-89-3 Carc. 2 H351 GHS08 H351 EUH066 oral: ATE = 580 2,3,5,6-tetrafluorobenzyl (1R,3S)- Acute Tox. 4 H302 GHS07 H302 mg/kg bw 3-(2,2-dichlorovinyl)-2,2-dime- STOT SE 1 H370 GHS09 H370 M = 1 000 thylcyclopropanecarboxylate Aquatic Acute 1 (nervous Wng (nervous M = 1 000’ Aquatic system) system) Chronic 1 H400 H410 H410 ‘607-246-00-3 allyl methacrylate; 202-473-0 96-05-9 Flam. Liq. 3 H226 GHS02 H226 inhalation:
2-methyl-2-propenoic acid Acute Tox. 2 H330 GHS06 H330 ATE = 1,5 mg/L 2-propenyl ester Acute Tox. 3 H311 GHS09 H311 (vapours) Acute Tox. 4 H302 Dgr H302 dermal: ATE = Aquatic Acute 1 H400 H400 300 mg/kg bw
oral: ATE = 400 mg/kg bw’ ‘612-004-00-5 triethylamine 204-469-4 121-44-8 Flam. Liq. 2 H225 GHS02 H225 inhalation:
Acute Tox. 3 H331 GHS06 H331 ATE = 7,2 mg/L Acute Tox. 3 H311 GHS05 H311 (vapours) Acute Tox. 3 H301 Dgr H301 dermal: ATE = Skin Corr. 1A H314 H314 300 mg/kg bw Eye Dam. 1 H318 oral: ATE = 100 mg/kg bw STOT SE 3;
H335: C ≥ 1 %’ EN OJ L,
5.1.2024ELI:
http://data.europa.eu/eli/reg_del/2024/197/oj 17/19 Classification Labelling Specific Conc.
Index No Chemical Name EC No CAS No Suppl. Limits, M-factors Notes Hazard Pictogram, Hazard Hazard Class and Hazard and ATE statement Signal Word statement Category Code(s) statement Code(s) Code(s) Code(s) Code(s) ‘612-049-00-0 di-n-butylamine 203-921-8 111-92-2 Flam. Liq. 3 H226 GHS02 H226 EUH 071 inhalation:
Acute Tox. 2 H330 GHS06 H330 ATE = 1,2 mg/L Acute Tox. 3 H311 GHS05 H311 (vapours) Acute Tox. 3 H301 Dgr H301 dermal: ATE = Skin Corr. 1B H314 H314 300 mg/kg bw Eye Dam. 1 H318 oral: ATE = 220 mg/kg bw’ ‘612-056-00-9 N,N-dimethyl-m-toluidine; [1] 204-495-6 121-72-2 [1] Acute Tox. 3 * H331 GHS06 H331 * C’ N,N-dimethyl-o-toluidine [2] [1] 609-72-3 [2] Acute Tox. 3 * H311 GHS08 H311 210-199-8 Acute Tox. 3 * H301 Dgr H301
[2] STOT RE 2 * H373 ** H373 ** Aquatic H412 H412 Chronic 3 ‘613-088-00-6 1,2-benzisothiazol-3(2H)-one; 220-120-9 2634-33-5 Acute Tox. 2 H330 GHS06 H330 inhalation:
1,2-benzisothiazolin-3-one Acute Tox. 4 H302 GHS05 H302 ATE = Skin Irrit. 2 H315 GHS09 H315 0,21 mg/L Eye Dam. 1 H318 Dgr H318 (dusts or mists) Skin Sens. 1A H317 H317 oral: ATE = 450 Aquatic Acute 1 H400 H410 mg/kg bw Aquatic H410 Skin Sens. 1A;
Chronic 1 H317: C ≥ 0,036 % M = 1 M = 1’ OJ L,
5.1.2024 EN18/19
ELI:
http://data.europa.eu/eli/reg_del/2024/197/oj Classification Labelling Specific Conc.
Index No Chemical Name EC No CAS No Suppl. Limits, M-factors Notes Hazard Pictogram, Hazard Hazard Class and Hazard and ATE statement Signal Word statement Category Code(s) statement Code(s) Code(s) Code(s) Code(s) ‘613-127-00-7 mepiquat chloride (ISO); 246-147-6 24307-26-4 Acute Tox. 4 H332 GHS06 H332 inhalation:
1,1-dimethylpiperidinium Acute Tox. 3 H301 Dgr H301 ATE = 2,8 mg/L chloride Aquatic H412 H412 (dusts or mists) Chronic 3 oral:
ATE = 270 mg/kg bw’ ‘613-307-00-5 clothianidin (ISO); 433-460-1 210880-92-5 Repr. 2 H361f GHS08 H361f oral: ATE = 390
(E)-1-(2-chloro–1,3-thiazol- Acute Tox. 4 H302 GHS07 H302 mg/kg bw 5-ylmethyl)-3-methyl- STOT SE 1 H370 GHS09 H370 M = 10 2-nitroguanidine Aquatic Acute 1 (nervous Dgr (nervous M = 100’ Aquatic system) system) Chronic 1 H400 H410 H410 ‘616-035-00-5 cymoxanil (ISO); 2-cyano-N- 261-043-0 57966-95-7 Repr. 2 H361fd GHS08 H361fd oral: ATE = 360 [(ethylamino)carbonyl]- [1] [1] Acute Tox. 4 H302 GHS07 H302 mg/kg bw 2-(methoxyimino)acetamide; [1] - [2] 166900-80-7 STOT RE 2 H373 GHS09 H373 M = 1
(2E)-2-cyano-N-[(ethylamino) [2] Skin Sens. 1 (blood Wng (blood M = 1’ carbonyl]-2-(methoxyimino) Aquatic Acute 1 system, system, acetamide; [2] Aquatic thymus, thymus, Chronic 1 eyes) eyes) H317 H317 H400 H410 H410 EN OJ L,
5.1.2024ELI:
http://data.europa.eu/eli/reg_del/2024/197/oj 19/19 Classification Labelling Specific Conc.
Index No Chemical Name EC No CAS No Suppl. Limits, M-factors Notes Hazard Pictogram, Hazard Hazard Class and Hazard and ATE statement Signal Word statement Category Code(s) statement Code(s) Code(s) Code(s) Code(s) ‘616-104-00-X benalaxyl (ISO); methyl N- 275-728-7 71626-11-4 Acute Tox. 4 H302 GHS07 H302 oral: ATE = (2,6-dimethylphenyl)-N- Aquatic Acute 1 H400 GHS09 H410 1 000mg/kg
(phenylacetyl)-DL-alaninate Aquatic H410 Wng bw Chronic 1 M = 1 M = 1’ OJ L,
5.1.2024 EN