Official Gazette Notification Text
Official TranscriptOfficial Journal EN of the European Union L series 2024/2564 30.9.2024 COMMISSION DELEGATED REGULATION (EU) 2024/2564 of 19 June 2024 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...
Official Journal EN of the European Union L series 2024/2564 30.9.2024 COMMISSION DELEGATED REGULATION (EU) 2024/2564 of 19 June 2024 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 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) 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 or delete 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(2)on those proposals:
— Opinion of 18 March 2022concerning multi-walled carbon tubes (synthetic graphite in tubular shape) with a geometric tube diameter range ≥ 30 nm to < 3 μm and a length ≥ 5 μm and aspect ratio > 3:1, including multi-walled carbon nanotubes, MWC(N)T;
— Opinion of 18 March 2022 concerning α-methyl-1,3-benzodioxole-5-propionaldehyde [1]
(S)-α-methyl-1,3-benzodioxole-5-propionaldehyde;
(2S)-3-(1,3-benzodioxol-5-yl)-2-methylpropanal [2] (R)-α-methyl-1,3-benzodioxole-5-propionaldehyde;
(2R)-3-(1,3-benzodioxol-5-yl)-2-methylpropanal [3]; — Opinion of 18 March 2022concerning acetone oxime; — Opinion of 18 March 2022concerning (3E)-dec-3-en-2-one; — Opinion of 18 March 2022concerning 2,3-epoxypropyl neodecanoate;
— Opinion of 18 March 2022concerning propyl 3,4,5-trihydroxybenzoate; — Opinion of 18 March 2022 concerning benthiavalicarb-isopropyl (ISO); isopropyl [(S)-1-{[(R)-1-(6-fluoro-1,3-benzothiazol-2-yl)ethyl]carbamoyl}-2-methylpropyl]carbamate;
— Opinion of 18 March 2022concerning hexyl salicylate; — Opinion of 18 March 2022concerning sulfur;
(1) OJ L 353, 31.12.2008, p. 1, ELI: http://data.europa.eu/eli/reg/2008/1272/oj.
(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/-/.
ELI: http://data.europa.eu/eli/reg_del/2024/2564/oj 1/20EN OJ L, 30.9.2024 — Opinion of 18 March 2022 concerning reaction mass of N,N'-ethane-1,2-diylbis(decanamide) and 12-hydroxy-N-[2-[(1-oxodecyl)amino]ethyl]octadecanamide and N,N'-ethane-1,2-diylbis(12-hydroxyoctadecanamide) [1] reaction mass of N,N'-ethane-1,2-diylbis(decanamide) and 12-hydroxy-N-[2-[(1-oxodecyl)amino]ethyl]octadecanamide [2];
— Opinion of 18 March 2022concerning 2-[ethyl[3-methyl-4-[(5-nitrothiazol-2-yl)azo]phenyl]amino]ethanol; — Opinion of 30 May 2022concerning glyphosate (ISO); N-(phosphonomethyl)glycine; — Opinion of 2 June 2022concerning silver massive: [particle diameter ≥ 1 mm];
— Opinion of 2 June 2022concerning silver powder: [particle diameter > 100 nm < 1 mm]; — Opinion of 2 June 2022concerning silver nano: [particle diameter > 1 nm ≤ 100 nm]; — Opinion of 2 June 2022 concerning S-metolachlor (ISO); 2-chloro-N-(2-ethyl-6-methylphenyl)-N-[(2S)- 1-methoxypropan-2-yl]acetamide; (RS)-2-chloro-N-(6-ethyl-o-tolyl)-N-[(1S)-2-methoxy-1-methylethyl] a a acetamide [contains 80-100 % 2-chloro-N-(2-ethyl-6-methylphenyl)-N-[(2S)-1-methoxypropan-2-yl] acetamide and 0-20 % 2-chloro-N-(2-ethyl-6-methylphenyl)-N-[(2R)-1-methoxypropan-2-yl]acetamide];
— Opinion of 2 June 2022 concerning 2-(dimethylamino)-2-[(4-methylphenyl)methyl]-1-[4-(morpholin-4-yl) phenyl]butan-1-one; — Opinion of 2 June 2022concerning formaldehyde … %; — Opinion of 2 June 2022concerning formic acid … %;
— Opinion of 2 June 2022 concerning dicamba (ISO); 2,5-dichloro-6-methoxybenzoic acid; 3,6-dichloro- 2-methoxybenzoic acid; — Opinion of 2 June 2022 concerning 7-oxabicyclo[4.1.0]hept-3-ylmethyl 7-oxabicyclo[4.1.0]heptane- 3-carboxylate;
— Opinion of 2 June 2022concerning peracetic acid … %; — Opinion of 2 June 2022 concerning tetrasodium 4-amino-5-hydroxy-3,6-bis[[4-[[2-(sulphonatooxy) ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonate [1] Reaction products of 4-amino-5-hydroxynaphthalene-2,7-disulfonic acid, coupled twice with diazotised 2-[(4-aminophenyl) sulfonyl]ethyl hydrogen sulfate, sodium salts [2] disodium 4-amino-5-hydroxy-3,6-bis{[4-(vinylsulfonyl) phenyl]diazenyl}naphthalene-2,7-disulfonate [3];
— Opinion of 15 September 2022 concerning perboric acid, sodium salt [1] perboric acid, sodium salt, monohydrate [2] perboric acid (HBO(O )), sodium salt, monohydrate [3] sodium peroxoborate [4] sodium 2 perborate [5];
— Opinion of 15 September 2022 concerning perboric acid (H BO (O )), monosodium salt trihydrate [1] 3 2 2 perboric acid, sodium salt, tetrahydrate [2] perboric acid (HBO(O )), sodium salt, tetrahydrate [3] sodium 2 peroxoborate, hexahydrate [4] — Opinion of 15 September 2022concerning sodium peroxometaborate;
— Opinion of 15 September 2022concerning trimethyl borate; — Opinion of 15 September 2022concerning ethanethiol; ethyl mercaptan; — Opinion of 15 September 2022concerning 1H-benzotriazole; — Opinion of 15 September 2022concerning methyl-1H-benzotriazole;
2/20 ELI: http://data.europa.eu/eli/reg_del/2024/2564/ojEN OJ L, 30.9.2024 — Opinion of 15 September 2022concerning N,N'-methylenediacrylamide; — Opinion of 15 September 2022concerning Sodium 3-(allyloxy)-2-hydroxypropanesulphonate;
— Opinion of 1 December 2022concerning tert-butyl 2-ethylperoxyhexanoate; — Opinion of 1 December 2022concerning n-hexane; — Opinion of 1 December 2022concerning biphenyl-2-ol; 2-phenylphenol; 2-hydroxybiphenyl;
— Opinion of 1 December 2022concerning copper [specific surface area > 0,67 mm2/mg]; — Opinion of 1 December 2022concerning reaction mass of 1,3-dioxan-5-ol and 1,3-dioxolan-4-ylmethanol; — Opinion of 1 December 2022concerning 1,4-dichloro-2-nitrobenzene;
— Opinion of 1 December 2022 concerning 2,4-dimethylcyclohex-3-ene-1-carbaldehyde [1] (1α,2α,5α)-2,5-dimethylcyclohex-3-ene-1-carbaldehyde [2] 2,6-dimethylcyclohex-3-ene-1-carbaldehyde [3] 3,5-dimethylcyclohex-3-ene-1-carbaldehyde [4] 3,6-dimethylcyclohex-3-ene-1-carbaldehyde [5] 4,6-dimethylcyclohex-3-ene-1-carbaldehyde [6] reaction mass of 3,5-dimethylcyclohex-3-ene- 1-carbaldehyde and 2,4-dimethylcyclohex-3-ene-1-carbaldehyde [7] dimethylcyclohex-3-ene-1-carbaldehyde
[8] Dimethylcyclohex-3-ene-1-carbaldehyde [9] 1,2,4(or 1,3,5)-trimethylcyclohex-3-ene-1-carbaldehyde [10] 1,3,4-trimethylcyclohex-3-ene-1-carbaldehyde [11] 2,2,4-trimethylcyclohex-3-ene-1-carbaldehyde [12] 2,4,6-trimethylcyclohex-3-enecarbaldehyde [13] isocyclocitral [14] 3,5,6-trimethylcyclohex-3-ene- 1-carbaldehyde [15] 4,6,6-trimethylcyclohex-3-ene-1-carbaldehyde [16];
— Opinion of 1 December 2022 concerning pyraclostrobin (ISO); methyl N-(2-{[1-(4-chlorophenyl)-1H- pyrazol-3-yl]oxymethyl}phenyl) N-methoxy carbamate; — Opinion of 1 December 2022concerning dibenzoyl peroxide; benzoyl peroxide;
— Opinion of 1 December 2022concerning fenpropidin (ISO); (R,S)-1-[3-(4-tert-butylphenyl)-2-methylpropyl] piperidine.
(3) The Commission has received additional information from stakeholders contesting the scientific assessment set out in the RAC opinions of 18 March 2022 concerning benthiavalicarb-isopropyl, 2,3-epoxypropyl neodecanoate, multi-walled carbon tubes, hexyl salicylate, in the RAC opinions of 2 June 2022 concerning silver massive, silver powder and silver nano and in the RAC opinions of 1 December 2022 concerning n-hexane and copper. 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) With regard to the substance copper flakes (coated with aliphatic acid) (index number 029-019-01-X(3)), its entry for its classification as hazardous for the aquatic environment should be amended to be in accordance with the more generic entry copper [specific surface area > 0,67 mm2/mg] (index number 029-026-00-0), inserted in the Annex.
(5) With regard to the substance granulated copper(4)(index number 029-024-00-X), its entry should be deleted as it is covered by the more generic entry copper [specific surface area > 0,67 mm2/mg] (index number 029-026-00-0), inserted in the Annex.
(3) See RAC Opinion of 1 December 2022 concerning copper [specific surface area > 0,67 mm2/mg], listed above;
(4) Ibidem.
ELI: http://data.europa.eu/eli/reg_del/2024/2564/oj 3/20EN OJ L, 30.9.2024
(6) Acute Toxicity Estimates (ATE) are mainly used to determine the classification for human health acute toxicity of mixtures containing substances classified for acute toxicity. The inclusion of harmonised ATE values in the entries listed in Annex VI to Regulation (EC) No 1272/2008 facilitates the harmonisation of the classification of mixtures and provides support for enforcement authorities. Following further scientific assessment, an ATE value for the inhalation route has been derived for fenpropidin (index number 612-299-00-0), in addition to those proposed in the RAC opinions for other substances. That ATE value should be inserted in the penultimate column of Table 3 of Part 3 of Annex VI to Regulation (EC) No 1272/2008.
(7) The entries corresponding to index numbers 005-017-00-7, 005-017-01-4, 005-018-00-2, 005-018-01-X, 005-019-00-8, 005-019-01-5 have been replaced by the entries for perboric acid, sodium salt [1] perboric acid, sodium salt, monohydrate [2] perboric acid (HBO(O2)), sodium salt, monohydrate [3] sodium peroxoborate [4] sodium perborate [5] (index number 005-022-00-4), for perboric acid (H3BO2(O2)), monosodium salt trihydrate
[1] perboric acid, sodium salt, tetrahydrate [2] perboric acid (HBO(O2)), sodium salt, tetrahydrate [3] sodium peroxoborate, hexahydrate [4] (index number 005-023-00-X) and for sodium peroxometaborate (index number 005-024-00-5) and should therefore be deleted.
(8) In light of the RAC opinions, it is appropriate to introduce, update or delete the harmonised classification and labelling of the substances concerned on the basis of the assessment made in those opinions and following the further assessments.
(9) Regulation (EC) No 1272/2008 should therefore be amended accordingly.
(10) 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.
4/20 ELI: http://data.europa.eu/eli/reg_del/2024/2564/ojEN OJ L, 30.9.2024 It shall apply from 1 May 2026However, substances and mixtures may be classified, labelled and packaged 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, 19 June 2024.
For the Commission The President Ursula VON DER LEYEN
ELI: http://data.europa.eu/eli/reg_del/2024/2564/oj 5/20ANNEX 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 Labelling Specific Conc. Notes Limits, M-factors Hazard Class and Hazard Pictogram, Hazard Suppl. and ATE Category Code(s) statement Signal Word statement Hazard Code(s) Code(s) Code(s) statement Code(s) ‘005-022-00-4 perboric acid, sodium salt 234-390-0 11138-47-9 Ox. Sol. 3 H272 GHS03 H272 inhalation: 11’
[1] [1] [1] Repr. 1B H360FD GHS08 H360FD ATE = perboric acid, sodium salt, 234-390-0 12040-72-1 Acute Tox. 3 H331 GHS06 H331 0,75 mg/L monohydrate [2] [2] [2] Acute Tox. 4 H302 GHS05 H302 (dusts or mists) perboric acid (HBO(O )), - [3] 10332-33-9 STOT SE 3 H335 Dgr H335 oral: ATE = 890 2 sodium salt, monohydrate - [4] [3] Eye Dam. 1 H318 H318 mg/kg bw
[3] sodium peroxoborate 239-172-9 - [4] Eye Dam. 1;
[4] [5] 15120-21-5 H318: sodium perborate [5] [5] C ≥ 22 % Eye Irrit. 2;
H319:
14 % ≤ C < 22 % ‘005-023-00- perboric acid (H BO (O )), 239-172-9 13517-20-9 Repr. 1B H360FD GHS08 H360FD inhalation: 11’ 3 2 2 X monosodium salt trihy [1] [1] Acute Tox. 4 H332 GHS05 H332 ATE = 1,2 mg/L drate [1] 234-390-0 37244-98-7 STOT SE 3 H335 GHS07 H335 (dusts or mists) perboric acid, sodium salt, [2] [2] Eye Dam. 1 H318 Dgr H318 Eye Dam. 1;
tetrahydrate [2] - [3] 10486-00-7 H318: C ≥ 36 % perboric acid (HBO(O )), - [4] [3] Eye Irrit. 2;
2 sodium salt, tetrahydrate - [4] H319: 22 % ≤ C
[3] sodium peroxoborate, < 36 % hexahydrate [4] 6/20
ELI:
http://data.europa.eu/eli/reg_del/2024/2564/oj EN OJ L,
30.9.2024Index No Chemical Name EC No CAS No Classification Labelling Specific Conc. Notes Limits, M-factors Hazard Class and Hazard Pictogram, Hazard Suppl. and ATE Category Code(s) statement Signal Word statement Hazard Code(s) Code(s) Code(s) statement Code(s) ‘005-024-00-5 sodium peroxometaborate 231-556-4 7632-04-4 Ox. Sol. 2 H272 GHS03 H272 inhalation: 11’ Repr. 1B H360FD GHS08 H360FD ATE = Acute Tox. 3 H331 GHS06 H331 0,62 mg/L Acute Tox. 4 H302 GHS05 H302 (dusts or mists) STOT SE 3 H335 Dgr H335 oral: ATE = 730 Eye Dam. 1 H318 H318 mg/kg bw Eye Dam. 1;
H318:
C ≥ 22 % Eye Irrit. 2;
H319: 14 % ≤ C < 22 % ‘006-104-00-2 multi-walled carbon tubes — — Carc. 1B H350i GHS08 H350i STOT RE 1; (synthetic graphite in tub STOT RE 1 H372 Dgr H372 (lun H372: C ≥ 1 %; ular shape) with a geo (lung)(in g)(inhala STOT RE 2;
metric tube diameter range nhalation) ation) H373: 0,1 % ≤ C ≥ 30 nm to < 3 μm and a < 1 %’ length ≥ 5 μm and aspect ratio > 3:1, including multi-walled carbon nanotubes, MWC(N)T ‘029-026-00-0 copper [specific surface 231-159-6 7440-50-8 Aquatic Acute 1 H400 GHS09 H410 M = 10 area > 0,67 mm2/mg] Aquatic Chronic 1 H410 Wng M = 1’
ELI:
http://data.europa.eu/eli/reg_del/2024/2564/oj 7/20 OJ L,
30.9.2024 ENIndex No Chemical Name EC No CAS No Classification Labelling Specific Conc. Notes Limits, M-factors Hazard Class and Hazard Pictogram, Hazard Suppl. and ATE Category Code(s) statement Signal Word statement Hazard Code(s) Code(s) Code(s) statement Code(s) ‘047-004-00-9 silver massive: [particle 231-131-3 7440-22-4 Repr. 2 H361f GHS08 H361f diameter ≥ 1 mm] STOT RE 2 H373 Wng H373 (ner (nervous vous sys system) tem)’ ‘047-005-00-4 silver powder: [particle 231-131-3 7440-22-4 Repr. 2 H361f GHS08 H361f M = 10 diameter > 100 nm < 1 STOT RE 2 H373 GHS09 H373 (ner M = 10’ mm] Aquatic Acute 1 (nervous Wng vous sys Aquatic Chronic 1 system) tem) H400 H410 H410 ‘047-006-00- silver nano: [particle dia 231-131-3 7440-22-4 Repr. 2 H361f GHS08 H361f M = 1 000 X meter > 1 nm ≤ 100 nm] STOT RE 2 H373 GHS09 H373 (ner M = 1 000’ Aquatic Acute 1 (nervous Wng vous sys Aquatic Chronic 1 system) tem) H400 H410 H410 ‘603-247-00-8 reaction mass of — — Repr. 1B H360Df GHS08 H360Df’ 1,3-dioxan-5-ol Dgr and 1,3-dioxolan- 4-ylmethanol 8/20
ELI:
http://data.europa.eu/eli/reg_del/2024/2564/oj EN OJ L,
30.9.2024Index No Chemical Name EC No CAS No Classification Labelling Specific Conc. Notes Limits, M-factors Hazard Class and Hazard Pictogram, Hazard Suppl. and ATE Category Code(s) statement Signal Word statement Hazard Code(s) Code(s) Code(s) statement Code(s) ‘605-042-00-9 α-methyl-1,3-benzodiox 214-881-6 1205-17-0 Skin Sens. 1B H317 GHS07 H317’ ole-5-propionaldehyde [1] [1] [1] Wng
(S)-α-methyl-1,3-benzo - [2] 737776-68- dioxole-5-propionalde - [3] 0 [2] hyde; 737776-59-
(2S)-3-(1,3-benzodioxol- 9 [3] 5-yl)-2-methylpropanal
[2]
(R)-α-methyl-1,3-benzo dioxole-5-propionalde hyde;
(2R)-3-(1,3-benzodioxol- 5-yl)-2-methylpropanal
[3] ‘605-043-00-4 2,4-dimethylcyclohex- 268-264-1 68039-49-6 Skin Sens. 1 H317 GHS07 H317’ 3-ene-1-carbaldehyde [1] [1] [1] Wng (1α,2α,5α)-2,5-dimethyl 252-395-6 35145-02-9 cyclohex-3-ene-1-carbal [2] [2] dehyde [2] - [3] 6975-94-6 2,6-dimethylcyclohex- 268-263-6 [3] 3-ene-1-carbaldehyde [3] [4] 68039-48-5 3,5-dimethylcyclohex- 267-186-5 [4] 3-ene-1-carbaldehyde [4] [5] 67801-65-4 3,6-dimethylcyclohex- 253-139-6 [5] 3-ene-1-carbaldehyde [5] [6] 36635-35-5 4,6-dimethylcyclohex- - [7] [6] 3-ene-1-carbaldehyde [6] 248-742-6 - [7] reaction mass of [8] 27939-60-2 3,5-dimethylcyclohex- 272-113-5 [8] 3-ene-1-carbaldehyde [9] 68737-61-1 276-055-1 [9]
[10] 71832-78-5 - [11] [10] - [12] 40702-26-9 215-833-7 [11] 1726-47-2
[12] 1423-46-7
[13] 1335-66-6
[14]
ELI:
http://data.europa.eu/eli/reg_del/2024/2564/oj 9/20 OJ L,
30.9.2024 ENIndex No Chemical Name EC No CAS No Classification Labelling Specific Conc. Notes Limits, M-factors Hazard Class and Hazard Pictogram, Hazard Suppl. and ATE Category Code(s) statement Signal Word statement Hazard Code(s) Code(s) Code(s) statement Code(s) and 2,4-dimethylcyclohex- [13] 67634-07-5 3-ene-1-carbaldehyde [7] 215-638-7 [15] dimethylcyclohex-3-ene- [14] 6754-27-4 1-carbaldehyde [8] 266-810-3 [16] Dimethylcyclohex-3-ene- [15] 1-carbaldehyde [9] - [16] 1,2,4(or 1,3,5)-trimethyl cyclohex-3-ene-1-carbal dehyde [10] 1,3,4-trimethylcyclohex- 3-ene-1-carbaldehyde [11] 2,2,4-trimethylcyclohex- 3-ene-1-carbaldehyde [12] 2,4,6-trimethylcyclohex- 3-enecarbaldehyde [13] isocyclocitral [14] 3,5,6-trimethylcyclohex- 3-ene-1-carbaldehyde [15] 4,6,6-trimethylcyclohex- 3-ene-1-carbaldehyde [16] 10/20
ELI:
http://data.europa.eu/eli/reg_del/2024/2564/oj EN OJ L,
30.9.2024Index No Chemical Name EC No CAS No Classification Labelling Specific Conc. Notes Limits, M-factors Hazard Class and Hazard Pictogram, Hazard Suppl. and ATE Category Code(s) statement Signal Word statement Hazard Code(s) Code(s) Code(s) statement Code(s) ‘606-156-00-1 acetone oxime 204-820-1 127-06-0 Carc. 1B H350 GHS08 H350 dermal: ATE = Acute Tox. 4 H312 GHS07 H312 1 100mg/kg STOT SE 3 H336 GHS05 H336 bw’ STOT RE 2 H373 Dgr H373 Eye Dam. 1 (blood sys (blood sys Skin Sens. 1 tem) tem) H318 H318 H317 H317 ‘606-157-00-7 (3E)-dec-3-en-2-one — 18402-84-1 Acute Tox. 4 H332 GHS07 H332 EUH071 inhalation:
Asp. Tox. 1 H304 GHS08 H304 ATE = 1,5 mg/L Skin Irrit. 2 H315 GHS09 H315 (dusts or mists)’ Aquatic Chronic 2 H411 Dgr H411 ‘606-158-00-2 2-(dimethylamino)- 438-340-0 119344 Repr. 1B H360Df GHS08 H360Df M = 1 2-[(4-methylphenyl) -86-4 Aquatic Acute 1 H400 GHS09 H410 M = 1’ methyl]-1-[4-(morpholin- Aquatic Chronic 1 H410 Dgr 4-yl)phenyl]butan-1-one ‘607-770-00-2 2,3-epoxypropyl neode 247-979-2 26761-45-5 Muta. 2 H341 GHS08 H341 Skin Sens. 1A;
canoate Skin Sens. 1A H317 GHS07 H317 H317: C Wng ≥ 0,001 %’ ‘607-771-00-8 benthiavalicarb-isopropyl — 177406 Carc. 1B H350 GHS08 H350
(ISO); isopropyl [(S)- -68-7 Repr. 2 H361fd GHS07 H361fd 1-{[(R)-1-(6-fluor Skin Sens. 1 H317 GHS09 H317 o-1,3-benzothiazol-2-yl) Aquatic Chronic 2 H411 Dgr H411’ ethyl]carbamoyl}- 2-methylpropyl]carba mate ‘607-772-00-3 hexyl salicylate 228-408-6 6259-76-3 Repr. 2 H361d GHS08 H361d Skin Sens. 1 H317 GHS07 H317’ Wng
ELI:
http://data.europa.eu/eli/reg_del/2024/2564/oj 11/20 OJ L,
30.9.2024 ENIndex No Chemical Name EC No CAS No Classification Labelling Specific Conc. Notes Limits, M-factors Hazard Class and Hazard Pictogram, Hazard Suppl. and ATE Category Code(s) statement Signal Word statement Hazard Code(s) Code(s) Code(s) statement Code(s) ‘607-773-00-9 7-oxabicyclo[4.1.0]hept- 219-207-4 2386-87-0 Muta. 2 H341 GHS08 H341 3-ylmethyl 7-oxabicy STOT RE 2 H373 GHS07 H373 (nasal clo[4.1.0]heptane-3-car Skin Sens. 1 (nasal cav Wng cavity) boxylate ity) H317’ H317 ‘607-774-00-4 tetrasodium 4-amino- 241-164-5 17095-24-8 Resp. Sens. 1A H334 GHS08 H334 5-hydro [1] [1] Skin Sens. 1 H317 Dgr H317’ xy-3,6-bis[[4-[[2-(sulpho - [2] - [2] onatooxy)ethyl]sulpho - [3] 100556-82- nyl]phenyl]azo]naphthale 9 [3] ne-2,7-disulphonate [1] Reaction products of 4-amino-5-hydroxy naphthalene-2,7-disulfo nic acid, coupled twice with diazotized 2-[(4-ami nophenyl)sulfonyl]ethyl hydrogen sulfate, sodium salts [2] disodium 4-amino- 5-hydroxy-3,6-bis {[4-(vinylsulfonyl) phenyl] diazenyl}naphthale ne-2,7-disulfonate [3] ‘607-775-00- Sodium 3-(allyloxy)- 258-004-5 52556-42-0 Repr. 1B H360F GHS08 H360F X 2-hydroxypropanesulpho Eye Dam. 1 H318 GHS05 H318’ nate Dgr 12/20
ELI:
http://data.europa.eu/eli/reg_del/2024/2564/oj EN OJ L,
30.9.2024Index No Chemical Name EC No CAS No Classification Labelling Specific Conc. Notes Limits, M-factors Hazard Class and Hazard Pictogram, Hazard Suppl. and ATE Category Code(s) statement Signal Word statement Hazard Code(s) Code(s) Code(s) statement Code(s) ‘609-074-00-4 1,4-dichloro-2-nitroben 201-923-3 89-61-2 Carc. 1B H350 GHS08 H350’ zene Dgr ‘611-182-00-1 2-[ethyl[3-methyl- 271-183-4 68516-81-4 Skin Sens. 1A H317 GHS07 H317 Skin Sens. 1A;
4-[(5-nitrothiazol-2-yl) Wng H317: C azo]phenyl]amino]etha ≥ 0,001 %’ nol ‘612-299-00-0 fenpropidin (ISO); (R,S)- — 67306-00-7 Repr. 2 H361d GHS08 H361d Inhalation:
1-[3-(4-tert-butylphenyl)- Acute Tox. 4 H332 GHS07 H332 ATE = 1,2 mg/L 2-methylpropyl]piperi Acute Tox. 4 H302 GHS05 H302 (dusts or mists) dine STOT SE 3 H335 GHS09 H335 oral: ATE = STOT SE 3 H336 Dgr H336 1 330mg/kg STOT RE 2 H373 H373 (ner bw Skin Irrit. 2 (nervous vous sys M = 1 000 Eye Dam. 1 system, tem, eyes, M = 10 000’ Skin Sens. 1 eyes, lungs) Aquatic Acute 1 lungs) H315 Aquatic Chronic 1 H315 H318 H318 H317 H317 H410 H400 H410 ‘613-350-00- 1H-benzotriazole 202-394-1 95-14-7 Aquatic Chronic 2 H411 GHS09 H411’ X Wng ‘613-351-00-5 methyl-1H-benzotriazole 249-596-6 29385-43-1 Aquatic Chronic 2 H411 GHS09 H411’ Wng ‘616-243-00-6 N,N'-methylenediacryla 203-750-9 110-26-9 Muta. 1B H340 GHS08 H340’ mide Dgr ‘617-024-00-8 tert-butyl 2-ethylperoxy 221-110-7 3006-82-4 Repr. 1B H360FD GHS08 H360FD hexanoate Skin Sens. 1 H317 GHS07 H317’ Dgr
ELI:
http://data.europa.eu/eli/reg_del/2024/2564/oj 13/20 OJ L,
30.9.2024 EN(2) the entries corresponding to index numbers 005-005-00-1, 016-022-00-9, 016-094-00-1, 029-019-01-X, 601-037-00-0, 604-020-00-6, 605-001-00-5, 607-001-00-0, 607-043-00-X, 607-094-00-8, 607-198-00-3, 607-315-00-8, 607-432-00-4, 613-272-00-6, 616-127-00-5 and 617-008-00-0 are replaced by the following entries
respectively:
Index No Chemical Name EC No CAS No Classification Labelling Specific Conc. Limits, Notes M-factors and ATE Hazard Class and Hazard Pictogram, Hazard Suppl.
Category Code(s) statement Signal Word statement Hazard Code(s) Code(s) Code(s) statement Code(s) ‘005-005-00-1 trimethyl borate 204-468-9 121-43-7 Flam. Liq. 3 H226 GHS02 H226 11’ Repr. 1B H360FD GHS08 H360FD Acute Tox. 4* H312 GHS07 H312 Dgr ‘016-022-00-9 ethanethiol; 200-837-3 75-08-1 Flam. Liq. 1 H224 GHS02 H224 inhalation: ATE = ethyl mercaptan Acute Tox. 3 H331 GHS06 H331 7,1 mg/L (vapours) Acute Tox. 4 H302 GHS09 H302 oral: ATE = 680 Aquatic Acute 1 H400 Dgr H410 mg/kg bw’ Aquatic Chronic 1 H410 ‘016-094-00-1 sulfur 231-722-6 7704-34 Skin Irrit. 2 H315 GHS07 H315’ -9 Wng ‘029-019-01-X copper flakes Acute Tox. 3 Acute H331 GHS06 H331 inhalation: ATE = (coated with ali Tox. 4 H302 GHS09 H302 0,733 mg/l (dusts phatic acid) Eye Irrit. 2 Aquatic H319 Dgr H319 or mists) Acute 1 Aquatic H400 H410 oral: ATE = 500 Chronic 1 H410 mg/kg bw M = 10 M = 1’ 14/20
ELI:
http://data.europa.eu/eli/reg_del/2024/2564/oj EN OJ L,
30.9.2024Index No Chemical Name EC No CAS No Classification Labelling Specific Conc. Limits, Notes M-factors and ATE Hazard Class and Hazard Pictogram, Hazard Suppl.
Category Code(s) statement Signal Word statement Hazard Code(s) Code(s) Code(s) statement Code(s) ‘601-037-00-0 n-hexane 203-777-6 110-54-3 Flam. Liq. 2 H225 GHS02 H225 Repr. 2 H361f*** GHS08 H361f*** Asp. Tox. 1 H304 GHS07 H304 STOT SE 3 H336 GHS09 H336 STOT RE 1 H372 (nervous Dgr H372 (nervous Skin Irrit. 2 system) system) Aquatic Chronic 2 H315 H315 H411 H411’ ‘604-020-00-6 biphenyl-2-ol; 201-993-5 90-43-7 Carc. 2 H351 GHS08 H351 M = 1 2-phenylphenol; Skin Corr. 1 H314 GHS05 H314 M = 1’ 2-hydroxybiphenyl Eye Dam. 1 H318 GHS07 H317 Skin Sens. 1B H317 GHS09 H410 Aquatic Acute 1 H400 Dgr Aquatic Chronic 1 H410 ‘605-001-00-5 formaldehyde … % 200-001-8 50-00-0 Carc. 1B H350 GHS08 H350 EUH071 inhalation: ATE = B, D, Muta. 2 H341 GHS06 H341 100 ppmV (gases) F’ Acute Tox. 2 H330 GHS05 H330 oral: ATE = 500 Acute Tox. 4 H302 Dgr H302 mg/kg bw Skin Corr. 1B H314 H314 STOT SE 3; H335:
Skin Sens. 1A H317 H317 C ≥ 5 % Skin Corr. 1B;
H314: C ≥ 25 % Skin Irrit. 2; H315:
5 % ≤ C < 25 % Eye Irrit. 2; H319:
5 % ≤ C < 25 %
ELI:
http://data.europa.eu/eli/reg_del/2024/2564/oj 15/20 OJ L,
30.9.2024 ENIndex No Chemical Name EC No CAS No Classification Labelling Specific Conc. Limits, Notes M-factors and ATE Hazard Class and Hazard Pictogram, Hazard Suppl.
Category Code(s) statement Signal Word statement Hazard Code(s) Code(s) Code(s) statement Code(s) ‘607-001-00-0 formic acid … % 200-579-1 64-18-6 Flam. Liq. 3 H226 GHS02 H226 EUH071 inhalation: ATE = B’ Met. Corr. 1 H290 GHS05 H290 7,4 mg/L (vapours) Acute Tox. 3 H331 GHS06 H331 oral: ATE = 500 Acute Tox. 4 H302 Dgr H302 mg/kg bw Skin Corr. 1A H314 H314 Flam. Liq. 3; H226:
Eye Dam. 1 H318 C > 85 % Skin Corr. 1A;
H314: C ≥ 90 % Skin Corr. 1B; 314:
10 % ≤ C < 90 % Skin Irrit. 2; H315:
2 % ≤ C < 10 % Eye Dam. 1; H318:
C ≥ 10 % Eye Irrit. 2; H319:
2 % ≤ C < 10 % ‘607-043-00-X dicamba (ISO); 217-635-6 1918-00 Acute Tox. 4 H332 GHS07 H332 inhalation: ATE = 2,5-dichloro- -9 Acute Tox. 4 H302 GHS05 H302 4,0 mg/L (dusts or 6-methoxybenzoic STOT SE 3 H335 GHS09 H335 mists) acid; 3,6-dichloro- STOT SE 3 H336 Dgr H336 oral: ATE = 1 500 2-methoxybenzoic Eye Dam. 1 H318 H318 mg/kg bw acid Aquatic Acute 1 H400 H410 M = 1’ Aquatic Chronic 2 H411 16/20
ELI:
http://data.europa.eu/eli/reg_del/2024/2564/oj EN OJ L,
30.9.2024Index No Chemical Name EC No CAS No Classification Labelling Specific Conc. Limits, Notes M-factors and ATE Hazard Class and Hazard Pictogram, Hazard Suppl.
Category Code(s) statement Signal Word statement Hazard Code(s) Code(s) Code(s) statement Code(s) ‘607-094-00-8 peracetic acid … % 201-186-8 79-21-0 Org. Perox. D H242 GHS02 H242 EUH071 inhalation: ATE = B, D, Acute Tox. 2 H330 GHS06 H330 0,2 mg/L (dusts or T’ Acute Tox. 2 H310 GHS05 H310 mists) Acute Tox. 3 H301 GHS09 H301 dermal: ATE = 60 Skin Corr. 1A H314 Dgr H314 mg/kg bw Aquatic Acute 1 H400 H410 oral: ATE = 80 Aquatic Chronic 1 H410 mg/kg bw STOT SE 3; H335:
C ≥ 1 % M = 10 M = 100 ‘607-198-00-3 propyl 3,4,5-trihy 204-498-2 121-79-9 Acute Tox. 4 H302 GHS07 H302 oral: ATE = 1 700 droxybenzoate Skin Sens. 1 H317 GHS09 H317 mg/kg bw Aquatic Acute 1 H400 Wng H410 M = 1 Aquatic Chronic 1 H410 M = 1’ ‘607-315-00-8 glyphosate (ISO); 213-997-4 1071-83 Eye Dam. 1 H318 GHS05 H318 N-(phosphonome -6 Aquatic Chronic 2 H411 GHS09 H411’ thyl)glycine Dgr ‘607-432-00-4 S-metolachlor — 87392-1 Carc. 2 H351 GHS08 H351 EUH066 M = 10
(ISO); 2-chlor 2-9 Skin Sens. 1 H317 GHS07 H317 M = 10’ o-N-(2-ethyl- Aquatic Acute 1 H400 GHS09 H410 6-methylphe Aquatic Chronic 1 H410 Wng nyl)-N-[(2S)- 1-methoxypropan- 2-yl]acetamide;
(RS)-2-chlor a a o-N-(6-ethyl-o-
ELI:
http://data.europa.eu/eli/reg_del/2024/2564/oj 17/20 OJ L,
30.9.2024 ENIndex No Chemical Name EC No CAS No Classification Labelling Specific Conc. Limits, Notes M-factors and ATE Hazard Class and Hazard Pictogram, Hazard Suppl.
Category Code(s) statement Signal Word statement Hazard Code(s) Code(s) Code(s) statement Code(s) tolyl)-N-[(1S)- 2-methoxy- 1-methylethyl] acetamide [contains 80-100 % 2-chloro-N-(2-e thyl-6-methylphe nyl)-N-[(2S)- 1-methoxypropan- 2-yl]acetamide and 0-20 % 2-chloro-N-(2-e thyl-6-methylphe nyl)-N-[(2R)- 1-methoxypropan- 2-yl]acetamide] ‘613-272-00-6 pyraclostrobin — 175013- Repr. 2 H361d GHS08 H361d inhalation: ATE =
(ISO); methyl 18-0 Acute Tox. 3 H331 GHS06 H331 0,58 mg/L (dusts or N-(2-{[1-(4-chloro Acute Tox. 4 H302 GHS09 H302 mists) phenyl)-1H-pyra STOT SE 3 H335 Dgr H335 oral: ATE = 450 zol-3-yl]oxy STOT RE 2 H373 (liver, H373 (liver, mg/kg bw methyl}phenyl) N- Skin Irrit. 2 gastrointestinal gastrointest M = 100 methoxy carbamate Aquatic Acute 1 tract, nasal inal tract, nasal M = 100’ Aquatic Chronic 1 cavity) cavity) H315 H315 H400 H410 H410 18/20
ELI:
http://data.europa.eu/eli/reg_del/2024/2564/oj EN OJ L,
30.9.2024Index No Chemical Name EC No CAS No Classification Labelling Specific Conc. Limits, Notes M-factors and ATE Hazard Class and Hazard Pictogram, Hazard Suppl.
Category Code(s) statement Signal Word statement Hazard Code(s) Code(s) Code(s) statement Code(s) ‘616-127-00-5 reaction mass of N, 430-050-2 - [1] Skin Sens. 1 H317 GHS07 H317 M = 100 N'-ethane-1,2-diyl [1] - [2] Aquatic Acute 1 H400 GHS09 H410 M = 10’ bis(decanamide) - [2] Aquatic Chronic 1 H410 Wng and 12-hydro xy-N-[2-[(1-oxode cyl)amino]ethyl] octadecanamide and N,N'-etha ne-1,2-diyl bis(12-hydroxyoc ctadecanamide) [1] reaction mass of N, N'-ethane-1,2-diyl bis(decanamide) and 12-hydro xy-N-[2-[(1-oxode cyl)amino]ethyl] octadecanamide [2]
ELI:
http://data.europa.eu/eli/reg_del/2024/2564/oj 19/20 OJ L,
30.9.2024 ENIndex No Chemical Name EC No CAS No Classification Labelling Specific Conc. Limits, Notes M-factors and ATE Hazard Class and Hazard Pictogram, Hazard Suppl.
Category Code(s) statement Signal Word statement Hazard Code(s) Code(s) Code(s) statement Code(s) ‘617-008-00-0 dibenzoyl peroxide; 202-327-6 94-36-0 Org. Perox. B H241 GHS01 H241 M = 10 benzoyl peroxide Eye Irrit. 2 H319 GHS02 H319 M = 10’ Skin Sens. 1 H317 GHS07 H317 Aquatic Acute 1 H400 GHS09 H410 Aquatic Chronic 1 H410 Dgr
(3) the entries corresponding to index numbers 005-017-00-7, 005-017-01-4, 005-018-00-2, 005-018-01-X, 005-019-00-8, 005-019-01-5 and 029-024-00-X are deleted.
20/20
ELI:
http://data.europa.eu/eli/reg_del/2024/2564/oj EN OJ L,
30.9.2024