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Document 32024R2564

    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

    C/2024/3992

    OJ L, 2024/2564, 30.9.2024, ELI: http://data.europa.eu/eli/reg_del/2024/2564/oj (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

    ELI: http://data.europa.eu/eli/reg_del/2024/2564/oj

    European flag

    Official Journal
    of the European Union

    EN

    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 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 (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 2022 concerning 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 2022 concerning acetone oxime;

    —

    Opinion of 18 March 2022 concerning (3E)-dec-3-en-2-one;

    —

    Opinion of 18 March 2022 concerning 2,3-epoxypropyl neodecanoate;

    —

    Opinion of 18 March 2022 concerning 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 2022 concerning hexyl salicylate;

    —

    Opinion of 18 March 2022 concerning sulfur;

    —

    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 2022 concerning 2-[ethyl[3-methyl-4-[(5-nitrothiazol-2-yl)azo]phenyl]amino]ethanol;

    —

    Opinion of 30 May 2022 concerning glyphosate (ISO); N-(phosphonomethyl)glycine;

    —

    Opinion of 2 June 2022 concerning silver massive: [particle diameter ≥ 1 mm];

    —

    Opinion of 2 June 2022 concerning silver powder: [particle diameter > 100 nm < 1 mm];

    —

    Opinion of 2 June 2022 concerning 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; (R a S a)-2-chloro-N-(6-ethyl-o-tolyl)-N-[(1S)-2-methoxy-1-methylethyl]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 2022 concerning formaldehyde … %;

    —

    Opinion of 2 June 2022 concerning 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 2022 concerning 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(O2)), sodium salt, monohydrate [3] sodium peroxoborate [4] sodium perborate [5];

    —

    Opinion of 15 September 2022 concerning 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]

    —

    Opinion of 15 September 2022 concerning sodium peroxometaborate;

    —

    Opinion of 15 September 2022 concerning trimethyl borate;

    —

    Opinion of 15 September 2022 concerning ethanethiol;

    ethyl mercaptan;

    —

    Opinion of 15 September 2022 concerning 1H-benzotriazole;

    —

    Opinion of 15 September 2022 concerning methyl-1H-benzotriazole;

    —

    Opinion of 15 September 2022 concerning N,N'-methylenediacrylamide;

    —

    Opinion of 15 September 2022 concerning Sodium 3-(allyloxy)-2-hydroxypropanesulphonate;

    —

    Opinion of 1 December 2022 concerning tert-butyl 2-ethylperoxyhexanoate;

    —

    Opinion of 1 December 2022 concerning n-hexane;

    —

    Opinion of 1 December 2022 concerning biphenyl-2-ol; 2-phenylphenol; 2-hydroxybiphenyl;

    —

    Opinion of 1 December 2022 concerning copper [specific surface area > 0,67 mm2/mg];

    —

    Opinion of 1 December 2022 concerning reaction mass of 1,3-dioxan-5-ol and 1,3-dioxolan-4-ylmethanol;

    —

    Opinion of 1 December 2022 concerning 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 2022 concerning dibenzoyl peroxide; benzoyl peroxide;

    —

    Opinion of 1 December 2022 concerning 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.

    (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.

    It shall apply from 1 May 2026 However, 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

    (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/-/.

    (3)  See RAC Opinion of 1 December 2022 concerning copper [specific surface area > 0,67 mm2/mg], listed above;

    (4)  Ibidem.

    ANNEX

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

    (1)

    the following entries are inserted following the consecutive order of the index numbers corresponding to each entry:

    Index No

    Chemical Name

    EC No

    CAS No

    Classification

    Labelling

    Specific Conc. Limits, M-factors and ATE

    Notes

    Hazard Class and Category Code(s)

    Hazard statement Code(s)

    Pictogram, Signal Word Code(s)

    Hazard statement Code(s)

    Suppl. Hazard statement Code(s)

    ‘005-022-00-4

    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]

    234-390-0 [1]

    234-390-0 [2]

    - [3]

    - [4]

    239-172-9 [5]

    11138-47-9 [1]

    12040-72-1 [2]

    10332-33-9 [3]

    - [4]

    15120-21-5 [5]

    Ox. Sol. 3

    Repr. 1B

    Acute Tox. 3

    Acute Tox. 4

    STOT SE 3

    Eye Dam. 1

    H272

    H360FD

    H331

    H302

    H335

    H318

    GHS03

    GHS08

    GHS06

    GHS05

    Dgr

    H272

    H360FD

    H331

    H302

    H335

    H318

     

    inhalation: ATE = 0,75 mg/L (dusts or mists)

    oral: ATE = 890 mg/kg bw

    Eye Dam. 1; H318:

    C ≥ 22 %

    Eye Irrit. 2; H319:

    14 % ≤ C < 22 %

    11’

    ‘005-023-00-X

    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]

    239-172-9 [1]

    234-390-0 [2]

    - [3]

    - [4]

    13517-20-9 [1]

    37244-98-7 [2]

    10486-00-7 [3]

    - [4]

    Repr. 1B

    Acute Tox. 4

    STOT SE 3

    Eye Dam. 1

    H360FD

    H332

    H335

    H318

    GHS08

    GHS05

    GHS07

    Dgr

    H360FD

    H332

    H335

    H318

     

    inhalation: ATE = 1,2 mg/L (dusts or mists)

    Eye Dam. 1; H318: C ≥ 36 %

    Eye Irrit. 2; H319: 22 % ≤ C < 36 %

    11’

    ‘005-024-00-5

    sodium peroxometaborate

    231-556-4

    7632-04-4

    Ox. Sol. 2

    Repr. 1B

    Acute Tox. 3

    Acute Tox. 4

    STOT SE 3

    Eye Dam. 1

    H272

    H360FD

    H331

    H302

    H335

    H318

    GHS03

    GHS08

    GHS06

    GHS05

    Dgr

    H272

    H360FD

    H331

    H302

    H335

    H318

     

    inhalation: ATE = 0,62 mg/L (dusts or mists)

    oral: ATE = 730 mg/kg bw

    Eye Dam. 1; H318:

    C ≥ 22 %

    Eye Irrit. 2; H319: 14 % ≤ C < 22 %

    11’

    ‘006-104-00-2

    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

    —

    —

    Carc. 1B

    STOT RE 1

    H350i

    H372 (lung)(inhalation)

    GHS08

    Dgr

    H350i

    H372 (lung)(inhalation)

     

    STOT RE 1; H372: C ≥ 1 %;

    STOT RE 2; H373: 0,1 % ≤ C < 1 %’

     

    ‘029-026-00-0

    copper [specific surface area > 0,67 mm2/mg]

    231-159-6

    7440-50-8

    Aquatic Acute 1

    Aquatic Chronic 1

    H400

    H410

    GHS09

    Wng

    H410

     

    M = 10

    M = 1’

     

    ‘047-004-00-9

    silver massive: [particle diameter ≥ 1 mm]

    231-131-3

    7440-22-4

    Repr. 2

    STOT RE 2

    H361f

    H373 (nervous system)

    GHS08

    Wng

    H361f

    H373 (nervous system)’

     

     

     

    ‘047-005-00-4

    silver powder: [particle diameter > 100 nm < 1 mm]

    231-131-3

    7440-22-4

    Repr. 2

    STOT RE 2

    Aquatic Acute 1

    Aquatic Chronic 1

    H361f

    H373 (nervous system)

    H400

    H410

    GHS08

    GHS09

    Wng

    H361f

    H373 (nervous system)

    H410

     

    M = 10

    M = 10’

     

    ‘047-006-00-X

    silver nano: [particle diameter > 1 nm ≤ 100 nm]

    231-131-3

    7440-22-4

    Repr. 2

    STOT RE 2

    Aquatic Acute 1

    Aquatic Chronic 1

    H361f

    H373 (nervous system)

    H400

    H410

    GHS08

    GHS09

    Wng

    H361f

    H373 (nervous system)

    H410

     

    M = 1 000

    M = 1 000 ’

     

    ‘603-247-00-8

    reaction mass of 1,3-dioxan-5-ol and 1,3-dioxolan-4-ylmethanol

    —

    —

    Repr. 1B

    H360Df

    GHS08

    Dgr

    H360Df’

     

     

     

    ‘605-042-00-9

    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]

    214-881-6 [1]

    - [2]

    - [3]

    1205-17-0 [1]

    737776-68-0 [2]

    737776-59-9 [3]

    Skin Sens. 1B

    H317

    GHS07

    Wng

    H317’

     

     

     

    ‘605-043-00-4

    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]

    268-264-1 [1]

    252-395-6 [2]

    - [3]

    268-263-6 [4]

    267-186-5 [5]

    253-139-6 [6]

    - [7]

    248-742-6 [8]

    272-113-5 [9]

    276-055-1 [10]

    - [11]

    - [12]

    215-833-7 [13]

    215-638-7 [14]

    266-810-3 [15]

    - [16]

    68039-49-6 [1]

    35145-02-9 [2]

    6975-94-6 [3]

    68039-48-5 [4]

    67801-65-4 [5]

    36635-35-5 [6]

    - [7]

    27939-60-2 [8]

    68737-61-1 [9]

    71832-78-5 [10]

    40702-26-9 [11]

    1726-47-2 [12]

    1423-46-7 [13]

    1335-66-6 [14]

    67634-07-5 [15]

    6754-27-4 [16]

    Skin Sens. 1

    H317

    GHS07

    Wng

    H317’

     

     

     

    ‘606-156-00-1

    acetone oxime

    204-820-1

    127-06-0

    Carc. 1B

    Acute Tox. 4

    STOT SE 3

    STOT RE 2

    Eye Dam. 1

    Skin Sens. 1

    H350

    H312

    H336

    H373 (blood system)

    H318

    H317

    GHS08

    GHS07

    GHS05

    Dgr

    H350

    H312

    H336

    H373 (blood system)

    H318

    H317

     

    dermal: ATE = 1 100 mg/kg bw’

     

    ‘606-157-00-7

    (3E)-dec-3-en-2-one

    —

    18402-84-1

    Acute Tox. 4

    Asp. Tox. 1

    Skin Irrit. 2

    Aquatic Chronic 2

    H332

    H304

    H315

    H411

    GHS07

    GHS08

    GHS09

    Dgr

    H332

    H304

    H315

    H411

    EUH071

    inhalation: ATE = 1,5 mg/L (dusts or mists)’

     

    ‘606-158-00-2

    2-(dimethylamino)-2-[(4-methylphenyl)methyl]-1-[4-(morpholin-4-yl)phenyl]butan-1-one

    438-340-0

    119344-86-4

    Repr. 1B

    Aquatic Acute 1

    Aquatic Chronic 1

    H360Df

    H400

    H410

    GHS08

    GHS09

    Dgr

    H360Df

    H410

     

    M = 1

    M = 1’

     

    ‘607-770-00-2

    2,3-epoxypropyl neodecanoate

    247-979-2

    26761-45-5

    Muta. 2

    Skin Sens. 1A

    H341

    H317

    GHS08

    GHS07

    Wng

    H341

    H317

     

    Skin Sens. 1A; H317: C ≥ 0,001 %’

     

    ‘607-771-00-8

    benthiavalicarb-isopropyl (ISO); isopropyl [(S)-1-{[(R)-1-(6-fluoro-1,3-benzothiazol-2-yl)ethyl]carbamoyl}-2-methylpropyl]carbamate

    —

    177406-68-7

    Carc. 1B

    Repr. 2

    Skin Sens. 1

    Aquatic Chronic 2

    H350

    H361fd

    H317

    H411

    GHS08

    GHS07

    GHS09

    Dgr

    H350

    H361fd

    H317

    H411’

     

     

     

    ‘607-772-00-3

    hexyl salicylate

    228-408-6

    6259-76-3

    Repr. 2

    Skin Sens. 1

    H361d

    H317

    GHS08

    GHS07

    Wng

    H361d

    H317’

     

     

     

    ‘607-773-00-9

    7-oxabicyclo[4.1.0]hept-3-ylmethyl 7-oxabicyclo[4.1.0]heptane-3-carboxylate

    219-207-4

    2386-87-0

    Muta. 2

    STOT RE 2

    Skin Sens. 1

    H341

    H373 (nasal cavity)

    H317

    GHS08

    GHS07

    Wng

    H341

    H373 (nasal cavity)

    H317’

     

     

     

    ‘607-774-00-4

    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 diazotized 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]

    241-164-5 [1]

    - [2]

    - [3]

    17095-24-8 [1]

    - [2]

    100556-82-9 [3]

    Resp. Sens. 1A

    Skin Sens. 1

    H334

    H317

    GHS08

    Dgr

    H334

    H317’

     

     

     

    ‘607-775-00-X

    Sodium 3-(allyloxy)-2-hydroxypropanesulphonate

    258-004-5

    52556-42-0

    Repr. 1B

    Eye Dam. 1

    H360F

    H318

    GHS08

    GHS05

    Dgr

    H360F

    H318’

     

     

     

    ‘609-074-00-4

    1,4-dichloro-2-nitrobenzene

    201-923-3

    89-61-2

    Carc. 1B

    H350

    GHS08

    Dgr

    H350’

     

     

     

    ‘611-182-00-1

    2-[ethyl[3-methyl-4-[(5-nitrothiazol-2-yl)azo]phenyl]amino]ethanol

    271-183-4

    68516-81-4

    Skin Sens. 1A

    H317

    GHS07

    Wng

    H317

     

    Skin Sens. 1A; H317: C ≥ 0,001 %’

     

    ‘612-299-00-0

    fenpropidin (ISO); (R,S)-1-[3-(4-tert-butylphenyl)-2-methylpropyl]piperidine

    —

    67306-00-7

    Repr. 2

    Acute Tox. 4

    Acute Tox. 4

    STOT SE 3

    STOT SE 3

    STOT RE 2

    Skin Irrit. 2

    Eye Dam. 1

    Skin Sens. 1

    Aquatic Acute 1

    Aquatic Chronic 1

    H361d

    H332

    H302

    H335

    H336

    H373 (nervous system, eyes, lungs)

    H315

    H318

    H317

    H400

    H410

    GHS08

    GHS07

    GHS05

    GHS09

    Dgr

    H361d

    H332

    H302

    H335

    H336

    H373 (nervous system, eyes, lungs)

    H315

    H318

    H317

    H410

     

    Inhalation: ATE = 1,2 mg/L (dusts or mists)

    oral: ATE = 1 330 mg/kg bw

    M = 1 000

    M = 10 000 ’

     

    ‘613-350-00-X

    1H-benzotriazole

    202-394-1

    95-14-7

    Aquatic Chronic 2

    H411

    GHS09

    Wng

    H411’

     

     

     

    ‘613-351-00-5

    methyl-1H-benzotriazole

    249-596-6

    29385-43-1

    Aquatic Chronic 2

    H411

    GHS09

    Wng

    H411’

     

     

     

    ‘616-243-00-6

    N,N'-methylenediacrylamide

    203-750-9

    110-26-9

    Muta. 1B

    H340

    GHS08

    Dgr

    H340’

     

     

     

    ‘617-024-00-8

    tert-butyl 2-ethylperoxyhexanoate

    221-110-7

    3006-82-4

    Repr. 1B

    Skin Sens. 1

    H360FD

    H317

    GHS08

    GHS07

    Dgr

    H360FD

    H317’

     

     

     

    (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, M-factors and ATE

    Notes

    Hazard Class and Category Code(s)

    Hazard statement Code(s)

    Pictogram, Signal Word Code(s)

    Hazard statement Code(s)

    Suppl. Hazard statement Code(s)

    ‘005-005-00-1

    trimethyl borate

    204-468-9

    121-43-7

    Flam. Liq. 3

    Repr. 1B

    Acute Tox. 4*

    H226

    H360FD

    H312

    GHS02

    GHS08

    GHS07

    Dgr

    H226

    H360FD

    H312

     

     

    11’

    ‘016-022-00-9

    ethanethiol;

    ethyl mercaptan

    200-837-3

    75-08-1

    Flam. Liq. 1

    Acute Tox. 3

    Acute Tox. 4

    Aquatic Acute 1

    Aquatic Chronic 1

    H224

    H331

    H302

    H400

    H410

    GHS02

    GHS06

    GHS09

    Dgr

    H224

    H331

    H302

    H410

     

    inhalation: ATE = 7,1 mg/L (vapours)

    oral: ATE = 680 mg/kg bw’

     

    ‘016-094-00-1

    sulfur

    231-722-6

    7704-34-9

    Skin Irrit. 2

    H315

    GHS07

    Wng

    H315’

     

     

     

    ‘029-019-01-X

    copper flakes (coated with aliphatic acid)

     

     

    Acute Tox. 3 Acute Tox. 4

    Eye Irrit. 2 Aquatic Acute 1 Aquatic Chronic 1

    H331

    H302

    H319

    H400

    H410

    GHS06

    GHS09

    Dgr

    H331

    H302

    H319

    H410

     

    inhalation: ATE = 0,733 mg/l (dusts or mists)

    oral: ATE = 500 mg/kg bw

    M = 10

    M = 1’

     

    ‘601-037-00-0

    n-hexane

    203-777-6

    110-54-3

    Flam. Liq. 2

    Repr. 2

    Asp. Tox. 1

    STOT SE 3

    STOT RE 1

    Skin Irrit. 2

    Aquatic Chronic 2

    H225

    H361f***

    H304

    H336

    H372 (nervous system)

    H315

    H411

    GHS02

    GHS08

    GHS07

    GHS09

    Dgr

    H225

    H361f***

    H304

    H336

    H372 (nervous system)

    H315

    H411’

     

     

     

    ‘604-020-00-6

    biphenyl-2-ol; 2-phenylphenol; 2-hydroxybiphenyl

    201-993-5

    90-43-7

    Carc. 2

    Skin Corr. 1

    Eye Dam. 1

    Skin Sens. 1B

    Aquatic Acute 1

    Aquatic Chronic 1

    H351

    H314

    H318

    H317

    H400

    H410

    GHS08

    GHS05

    GHS07

    GHS09

    Dgr

    H351

    H314

    H317

    H410

     

    M = 1

    M = 1’

     

    ‘605-001-00-5

    formaldehyde … %

    200-001-8

    50-00-0

    Carc. 1B

    Muta. 2

    Acute Tox. 2

    Acute Tox. 4

    Skin Corr. 1B

    Skin Sens. 1A

    H350

    H341

    H330

    H302

    H314

    H317

    GHS08

    GHS06

    GHS05

    Dgr

    H350

    H341

    H330

    H302

    H314

    H317

    EUH071

    inhalation: ATE = 100 ppmV (gases)

    oral: ATE = 500 mg/kg bw

    STOT SE 3; H335: C ≥ 5 %

    Skin Corr. 1B; H314: C ≥ 25 %

    Skin Irrit. 2; H315: 5 % ≤ C < 25 %

    Eye Irrit. 2; H319: 5 % ≤ C < 25 %

    B, D, F’

    ‘607-001-00-0

    formic acid … %

    200-579-1

    64-18-6

    Flam. Liq. 3

    Met. Corr. 1

    Acute Tox. 3

    Acute Tox. 4

    Skin Corr. 1A

    Eye Dam. 1

    H226

    H290

    H331

    H302

    H314

    H318

    GHS02

    GHS05

    GHS06

    Dgr

    H226

    H290

    H331

    H302

    H314

    EUH071

    inhalation: ATE = 7,4 mg/L (vapours)

    oral: ATE = 500 mg/kg bw

    Flam. Liq. 3; H226: 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 %

    B’

    ‘607-043-00-X

    dicamba (ISO); 2,5-dichloro-6-methoxybenzoic acid; 3,6-dichloro-2-methoxybenzoic acid

    217-635-6

    1918-00-9

    Acute Tox. 4

    Acute Tox. 4

    STOT SE 3

    STOT SE 3

    Eye Dam. 1

    Aquatic Acute 1

    Aquatic Chronic 2

    H332

    H302

    H335

    H336

    H318

    H400

    H411

    GHS07

    GHS05

    GHS09

    Dgr

    H332

    H302

    H335

    H336

    H318

    H410

     

    inhalation: ATE = 4,0 mg/L (dusts or mists)

    oral: ATE = 1 500 mg/kg bw

    M = 1’

     

    ‘607-094-00-8

    peracetic acid … %

    201-186-8

    79-21-0

    Org. Perox. D

    Acute Tox. 2

    Acute Tox. 2

    Acute Tox. 3

    Skin Corr. 1A

    Aquatic Acute 1

    Aquatic Chronic 1

    H242

    H330

    H310

    H301

    H314

    H400

    H410

    GHS02

    GHS06

    GHS05

    GHS09

    Dgr

    H242

    H330

    H310

    H301

    H314

    H410

    EUH071

    inhalation: ATE = 0,2 mg/L (dusts or mists)

    dermal: ATE = 60 mg/kg bw

    oral: ATE = 80 mg/kg bw

    STOT SE 3; H335: C ≥ 1 %

    M = 10

    M = 100

    B, D, T’

    ‘607-198-00-3

    propyl 3,4,5-trihydroxybenzoate

    204-498-2

    121-79-9

    Acute Tox. 4

    Skin Sens. 1

    Aquatic Acute 1

    Aquatic Chronic 1

    H302

    H317

    H400

    H410

    GHS07

    GHS09

    Wng

    H302

    H317

    H410

     

    oral: ATE = 1 700 mg/kg bw

    M = 1

    M = 1’

     

    ‘607-315-00-8

    glyphosate (ISO); N-(phosphonomethyl)glycine

    213-997-4

    1071-83-6

    Eye Dam. 1

    Aquatic Chronic 2

    H318

    H411

    GHS05

    GHS09

    Dgr

    H318

    H411’

     

     

     

    ‘607-432-00-4

    S-metolachlor (ISO); 2-chloro-N-(2-ethyl-6-methylphenyl)-N-[(2S)-1-methoxypropan-2-yl]acetamide; (R a S a)-2-chloro-N-(6-ethyl-o-tolyl)-N-[(1S)-2-methoxy-1-methylethyl]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]

    —

    87392-12-9

    Carc. 2

    Skin Sens. 1

    Aquatic Acute 1

    Aquatic Chronic 1

    H351

    H317

    H400

    H410

    GHS08

    GHS07

    GHS09

    Wng

    H351

    H317

    H410

    EUH066

    M = 10

    M = 10’

     

    ‘613-272-00-6

    pyraclostrobin (ISO); methyl N-(2-{[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxymethyl}phenyl) N-methoxy carbamate

    —

    175013-18-0

    Repr. 2

    Acute Tox. 3

    Acute Tox. 4

    STOT SE 3

    STOT RE 2

    Skin Irrit. 2

    Aquatic Acute 1

    Aquatic Chronic 1

    H361d

    H331

    H302

    H335

    H373 (liver, gastrointestinal tract, nasal cavity)

    H315

    H400

    H410

    GHS08

    GHS06

    GHS09

    Dgr

    H361d

    H331

    H302

    H335

    H373 (liver, gastrointestinal tract, nasal cavity)

    H315

    H410

     

    inhalation: ATE = 0,58 mg/L (dusts or mists)

    oral: ATE = 450 mg/kg bw

    M = 100

    M = 100’

     

    ‘616-127-00-5

    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]

    430-050-2 [1]

    - [2]

    - [1]

    - [2]

    Skin Sens. 1

    Aquatic Acute 1

    Aquatic Chronic 1

    H317

    H400

    H410

    GHS07

    GHS09

    Wng

    H317

    H410

     

    M = 100

    M = 10’

     

    ‘617-008-00-0

    dibenzoyl peroxide; benzoyl peroxide

    202-327-6

    94-36-0

    Org. Perox. B

    Eye Irrit. 2

    Skin Sens. 1

    Aquatic Acute 1

    Aquatic Chronic 1

    H241

    H319

    H317

    H400

    H410

    GHS01

    GHS02

    GHS07

    GHS09

    Dgr

    H241

    H319

    H317

    H410

     

    M = 10

    M = 10’

     

    (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.

    ELI: http://data.europa.eu/eli/reg_del/2024/2564/oj

    ISSN 1977-0677 (electronic edition)

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