11.8.2020   

EN

Official Journal of the European Union

L 261/2


COMMISSION DELEGATED REGULATION (EU) 2020/1182

of 19 May 2020

amending, for the purposes of its adaptation to technical and scientific progress, Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures

(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)

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 or delete the harmonised classification and labelling of certain other substances have been submitted to the European Chemicals Agency (‘Agency’) pursuant to Article 37 of Regulation (EC) No 1272/2008. Based on the opinions (2) on those proposals issued by the Committee for Risk Assessment of the Agency (RAC), as well as on the comments received from the parties concerned, it is appropriate to introduce, update or delete the harmonised classification and labelling of certain substances. Those RAC opinions are:

Opinion of 8 June 2018 concerning nitric acid ... %[C ≤ 70 %];

Opinion of 9 March 2018 concerning silicon carbide fibres (with diameter < 3 μm, length > 5 μm and aspect ratio ≥ 3:1);

Opinion of 8 June 2018 concerning trimethoxyvinylsilane; trimethoxy(vinyl)silane;

Opinion of 8 June 2018 concerning tris(2-methoxyethoxy)vinylsilane; 6-(2-methoxyethoxy)-6-vinyl-2,5,7,10-tetraoxa-6-silaundecane;

Opinion of 8 June 2018 concerning dimethyl disulphide;

Opinion of 8 June 2018 concerning granulated copper;

Opinion of 30 November 2018 concerning bis(N-hydroxy-N-nitrosocyclohexylaminato-O,O')copper; bis(N-cyclohexyl-diazenium-dioxy)-copper; [Cu-HDO];

Opinion of 14 September 2018 concerning dioctyltin dilaurate; [1] stannane, dioctyl-, bis(coco acyloxy) derivs. [2];

Opinion of 30 November 2018 concerning dibenzo[def,p]chrysene; dibenzo[a,l]pyrene;

Opinion of 9 March 2018 concerning ipconazole (ISO); (1RS,2SR,5RS;1RS,2SR,5SR)-2-(4-chlorobenzyl)-5-isopropyl-1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol;

Opinion of 8 June 2018 concerning bis(2-(2-methoxyethoxy)ethyl)ether; tetraglyme;

Opinion of 8 June 2018 concerning paclobutrazol (ISO); (2RS,3RS)-1-(4-chlorophenyl)-4,4-dimethyl-2-(1H-1,2,4-triazol-1-yl)pentan-3-ol;

Opinion of 8 June 2018 concerning 2,2-bis(bromomethyl)propane-1,3-diol;

Opinion of 14 September 2018 concerning geraniol; (2E)-3,7-dimethylocta-2,6-dien-1-ol;

Opinion of 28 January 2019 concerning 2-(4-tert-butylbenzyl)propionaldehyde;

Opinion of 9 March 2018 concerning MCPA-thioethyl (ISO); S-ethyl (4-chloro-2-methylphenoxy)ethanethioate; S-ethyl 4-chloro-o-tolyloxythioacetate;

Opinion of 9 March 2018 concerning diisooctyl phthalate;

Opinion of 14 September 2018 concerning 4-{[(6-chloropyridin-3-yl)methyl](2,2-difluoroethyl) amino}furan-2(5H)-one; flupyradifurone;

Opinion of 30 November 2018 concerning thiencarbazone-methyl (ISO); methyl 4- [(4,5-dihydro-3-methoxy-4-methyl-5-oxo-1H-1,2,4-triazol-1-yl)carbonylsulfamoyl]-5-methylthiophene-3-carboxylate;

Opinion of 9 March 2018 concerning L-(+)-lactic acid; (2S)-2-hydroxypropanoic acid;

Opinion of 9 March 2018 concerning 2-methoxyethyl acrylate;

Opinion of 8 June 2018 concerning glyoxylic acid …%;

Opinion of 14 September 2018 concerning sodium N-(hydroxymethyl)glycinate; [formaldehyde released from sodium N-(hydroxymethyl)glycinate];

Opinion of 30 November 2018 concerning potassium (oxido-NNO-azoxy)cyclohexane; cyclohexylhydroxydiazene 1-oxide, potassium salt; [K-HDO];

Opinion of 14 September 2018 concerning mecetronium etilsulfate; N-ethyl-N,N-dimethylhexadecan-1-aminium ethyl sulfate; mecetronium ethyl sulphate [MES];

Opinion of 9 March 2018 concerning (2RS)-2-[4-(4-chlorophenoxy)-2-(trifluoromethyl)phenyl]-1-(1H-1,2,4-triazol-1-yl)propan-2-ol; mefentrifluconazole;

Opinion of 30 November 2018 concerning oxathiapiprolin (ISO); 1-(4-{4-[5-(2,6-difluorophenyl)-4,5-dihydro-1,2-oxazol-3-yl]-1,3-thiazol-2-yl}piperidin-1-yl)-2-[5-methyl-3-(trifluoromethyl)-1H-pyrazol-1-yl]ethanone;

Opinion of 14 September 2018 concerning pyrithione zinc; (T-4)-bis[1-(hydroxy-.kappa.O) pyridine-2(1H)-thionato-.kappa.S]zinc;

Opinion of 30 November 2018 concerning 3-chloro-4-(chloromethyl)-1-[3-trifluoromethyl)phenyl]pyrrolidin-2-one; flurochloridone (ISO);

Opinion of 30 November 2018 concerning 4,5-dichloro-2-octyl-2H-isothiazol-3-one; [DCOIT];

Opinion of 8 June 2018 concerning 2-methyl-1,2-benzothiazol-3(2H)-one; [MBIT];

Opinion of 30 November 2018 concerning 3-(difluoromethyl)-1-methyl-N-(3',4',5'-trifluorobiphenyl-2-yl)pyrazole-4-carboxamide; fluxapyroxad;

Opinion of 8 June 2018 concerning N-(hydroxymethyl)acrylamide; methylolacrylamide; [NMA];

Opinion of 15 October 2018 concerning 5-fluoro-1,3-dimethyl-N-[2-(4-methylpentan-2-yl)phenyl]-1H-pyrazole-4-carboxamide; 2’-[(RS)-1,3-dimethylbutyl]-5-fluoro-1,3-dimethylpyrazole-4-carboxanilide; penflufen;

Opinion of 30 November 2018 concerning iprovalicarb(ISO); isopropyl [(2S)-3-methyl-1-{[1-(4-methylphenyl)ethyl]amino}-1-oxobutan-2-yl]carbamate;

Opinion of 30 November 2018 concerning silthiofam (ISO); N-allyl-4,5-dimethyl-2-(trimethylsilyl)thiophene-3-carboxamide;

Opinion of 9 March 2018 concerning Margosa, ext. [cold-pressed oil of Azadirachta indica seeds without shells extracted with super-critical carbon dioxide];

Opinion of 8 June 2018 concerning nitric acid …%[C> 70 %];

Opinion of 9 March 2018 concerning octamethylcyclotetrasiloxane; [D4];

Opinion of 30 November 2018 concerning pirimiphos-methyl (ISO); O-[2-(diethylamino)-6-methylpyrimidin-4-yl] O,O-dimethyl phosphorothioate;

Opinion of 30 November 2018 concerning phosphine;

Opinion of 14 September 2018 concerning dichlorodioctylstannane;

Opinion of 30 November 2018 concerning 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate; [DOTE];

Opinion of 30 November 2018 concerning lead;

Opinion of 14 September 2018 concerning 2-butoxyethanol; ethylene glycol monobutyl ether;

Opinion of 30 November 2018 concerning m-bis(2,3-epoxypropoxy)benzene; resorcinol diglycidyl ether;

Opinion of 14 September 2018 concerning tribenuron-methyl (ISO); methyl 2- [N-(4-methoxy-6-methyl-1,3,5-triazin-2-yl)-N-methylcarbamoylsulfamoyl]benzoate;

Opinion of 8 June 2018 concerning azoxystrobin (ISO); methyl (E)-2-{2-[6-(2-cyanophenoxy)pyrimidin-4-yloxy]phenyl}-3-methoxyacrylate;

Opinion of 9 March 2018 concerning ethofumesate (ISO); (RS)-2-ethoxy-2,3-dihydro-3,3-dimethylbenzofuran-5-yl methanesulfonate;

Opinion of 30 November 2018 concerning 2,4-dinitrophenol;

Opinion of 14 September 2018 concerning mesotrione (ISO); 2-[4-(methylsulfonyl)-2-nitrobenzoyl]-1,3-cyclohexanedione;

Opinion of 30 November 2018 concerning octhilinone (ISO); 2-octyl-2H-isothiazol-3-one; [OIT];

Opinion of 14 September 2018 concerning hymexazol (ISO); 3-hydroxy-5-methylisoxazole;

Opinion of 30 November 2018 concerning hexythiazox (ISO); trans-5-(4-chlorophenyl)-N-cyclohexyl-4-methyl-2-oxo-3-thiazolidine-carboxamide;

Opinion of 9 March 2018 concerning pymetrozine (ISO); (E)-4,5-dihydro-6-methyl-4-(3-pyridylmethylene amino)-1,2,4-triazin-3(2H)-one;

Opinion of 9 March 2018 concerning imiprothrin (ISO); reaction mass of: [2,4-dioxo-(2-propyn-1-yl)imidazolidin-3-yl]methyl(1R)-cis-chrysanthemate; [2,4-dioxo-(2-propyn-1-yl)imidazolidin-3-yl]methyl(1R)-trans-chrysanthemate;

Opinion of 14 September 2018 concerning butanone oxime; ethyl methyl ketoxime; ethyl methyl ketone oxime;

Opinion of 8 June 2018 concerning bis(α,α-dimethylbenzyl) peroxide;

Opinion of 9 March 2018 concerning branched hexatriacontane;

Opinion of 30 November 2018 concerning hexyl 2-(1-(diethylaminohydroxyphenyl) methanoyl)benzoate; hexyl 2-[4-(diethylamino)-2-hydroxybenzoyl]benzoate.

(3)

With regard to the substance lead (CAS number 7439-92-1 and index numbers 082-013-00-1 (lead powder; [particle diameter < 1 mm];) and 082-014-00-7 (lead massive; [particle diameter ≥ 1 mm];)), RAC proposed in its opinion of 30 November 2018 to apply the same environmental classification to the massive and the powder form. However, in view of the lower dissolution rate of the massive form, the malleable structure of lead, the specific intentional production of the powder and the different environmental classification between massive and powder forms for existing entries in Annex VI for other metals, further assessment needs to be done by RAC on whether to apply the same environmental classification to the massive as to the powder form of lead. In addition, new scientific data has been made available suggesting that the environmental classification for the massive form as recommended in the RAC opinion might not be appropriate Therefore, the environmental classification for the massive form will not be included in Annex VI to Regulation (EC) No 1272/2008 until RAC has had the opportunity to deliver a revised opinion.

(4)

With regard to the substance 2-butoxyethanol; ethylene glycol monobutyl ether; (CAS number 111-76-2), new scientific data has been made available for the hazard class ‘acute toxicity (inhalation)’ which suggests that the classification for this hazard class as recommended in the RAC opinion, which is based on older data, might not be appropriate. Therefore, this hazard class should not be modified in Annex VI to Regulation (EC) No 1272/2008 until RAC has had the opportunity to deliver a revised opinion based on the new information, while all other hazard classes covered by the RAC opinion should be included.

(5)

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

(6)

Compliance with the new or updated harmonised classifications should not be required immediately as a certain period of time is necessary to allow suppliers to adapt the labelling and packaging of substances and mixtures to the new or revised 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. Such requirements may include those set out in point (f) of Article 22(1) of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (3) or those set out in Article 50 of Regulation (EU) No 528/2012 of the European Parliament and of the Council (4).

(7)

Suppliers should, however, have the possibility to apply the new classification, labelling and packaging provisions on a voluntary basis before the date of application of this Regulation. This is consistent with the approach taken under Article 61(2) of Regulation (EC) No 1272/2008,

HAS ADOPTED THIS REGULATION:

Article 1

Amendments to Regulation (EC) No 1272/2008

Table 3 of Part 3 of Annex VI to Regulation (EC) No 1272/2008 is amended as set out in the Annex to this Regulation.

Article 2

Entry into force and application

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 March 2022.

By way of derogation from the second paragraph of this Article, substances and mixtures may, before 1 March 2022 be classified, labelled and packaged 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 May 2020.

For the Commission

The President

Ursula VON DER LEYEN


(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/-/

(3)  Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006

concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).

(4)  Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1).


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:

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)

‘007-030-00-3

nitric acid …% [C ≤ 70 %]

231-714-2

7697-37-2.

Ox. Liq. 3

Acute Tox. 3

Skin Corr. 1A

H272

H331

H314

GHS03

GHS06

GHS05

Dgr

H272

H331

H314

EUH071

Ox. Liq. 3; H272: C ≥ 65 %

inhalation: ATE = 2,65 mg/L (vapours)

Skin Corr. 1A; H314: C ≥ 20 %

Skin Corr. 1B; H314: 5 % ≤ C < 20 %

B’

‘014-048-00-5

silicon carbide fibres (with diameter < 3 μm, length > 5 μm and aspect ratio ≥ 3:1)

206-991-8

409-21-2

308076-74-6

Carc. 1B

H350i

GHS08

Dgr

H350i’

 

 

 

‘014-049-00-0

trimethoxyvinylsilane; trimethoxy(vinyl)silane

220-449-8

2768-02-7

Skin Sens. 1B

H317

GHS07

Wng

H317’

 

 

 

‘014-050-00-6

tris(2-methoxyethoxy)vinylsilane;

6-(2-methoxyethoxy)-6-vinyl-2,5,7,10-tetraoxa-6-silaundecane

213-934-0

1067-53-4

Repr. 1B

H360FD

GHS08

Dgr

H360FD’

 

 

 

‘016-098-00-3

dimethyl disulphide

210-871-0

624-92-0

Flam. Liq. 2

Acute Tox. 3

Acute Tox. 3

STOT SE 3

STOT SE 1

Eye Irrit. 2

Skin Sens. 1

Aquatic Acute 1

Aquatic Chronic 1

H225

H331

H301

H336

H370 (upper respiratory tract, inhalation)

H319

H317

H400

H410

GHS02

GHS06

GHS08

GHS09

Dgr

H225

H331

H301

H336

H370 (upper respiratory tract, inhalation)

H319

H317

H410

 

inhalation: ATE = 5 mg/L (vapours)

oral: ATE = 190 mg/kg bw

M = 1

M = 10’

 

‘029-024-00-X

granulated copper;

[particle length: from 0,9 mm to 6,0 mm; particle width: from 0,494 to 0,949 mm]

231-159-6

7440-50-8

Aquatic Chronic 2

H411

GHS09

H411’

 

 

 

‘029-025-00-5

bis(N-hydroxy-N-nitrosocyclohexylaminato-O,O’)copper;

bis(N-cyclohexyl-diazenium-dioxy)-copper;

[Cu-HDO]

239-703-4

312600-89-8

15627-09-5

Flam. Sol. 1

Acute Tox. 4

STOT RE 2

Eye Dam. 1

Aquatic Acute 1

Aquatic Chronic 1

H228

H302

H373 (liver)

H318

H400

H410

GHS02

GHS07

GHS08

GHS05

GHS09

Dgr

H228

H302

H373(liver)

H318

H410

 

oral: ATE = 360 mg/kg bw

M = 1

M = 1’

 

‘050-031-00-9

dioctyltin dilaurate; [1]

stannane, dioctyl-, bis(coco acyloxy) derivs. [2]

222-883-3 [1] 293-901-5 [2]

3648-18-8 [1] 91648-39-4 [2]

Repr. 1B

STOT RE 1

H360D

H372 (immune system)

GHS08

Dgr

H360D

H372 (immune system)’

 

 

 

‘601-092-00-0

dibenzo[def,p]chrysene;

dibenzo[a,l]pyrene

205-886-4

191-30-0

Carc. 1B

Muta. 2

H350

H341

GHS08

Dgr

H350

H341

 

Carc. 1B; H350: C ≥ 0,001 %’

 

‘603-237-00-3

ipconazole (ISO);

(1RS,2SR,5RS;1RS,2SR,5SR)-2-(4-chlorobenzyl)-5-isopropyl-1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol

-

125225-28-7

115850-69-6

115937-89-8

Repr. 1B

Acute Tox. 4

STOT RE 2

Aquatic Chronic 1

H360D

H302

H373 (eyes, skin, liver)

H410

GHS08

GHS07

GHS09

Dgr

H360D

H302

H373 (eyes, skin, liver)

H410

 

oral: ATE = 500 mg/kg bw

M = 100’

 

‘603-238-00-9

bis(2-(2-methoxyethoxy)ethyl)ether; tetraglyme

205-594-7

143-24-8

Repr. 1B

H360FD

GHS08

Dgr

H360FD’

 

 

 

‘603-239-00-4

paclobutrazol (ISO);

(2RS,3RS)-1-(4-chlorophenyl)-4,4-dimethyl-2-(1H-1,2,4-triazol-1-yl)pentan-3-ol

-

76738-62-0

Repr. 2

Acute Tox. 4

Acute Tox. 4

Eye Irrit. 2

Aquatic Acute 1

Aquatic Chronic 1

H361d

H332

H302

H319

H400

H410

GHS08

GHS07

GHS09

Wng

H361d

H332

H302

H319

H410

 

inhalation: ATE = 3,13 mg/L (dusts or mists)

oral: ATE = 490 mg/kg bw

M = 10

M = 10’

 

‘603-240-00-X

2,2-bis(bromomethyl)propane-1,3-diol

221-967-7

3296-90-0

Carc. 1B

Muta. 1B

H350

H340

GHS08

Dgr

H350

H340’

 

 

 

‘603-241-00-5

geraniol;

(2E)-3,7-dimethylocta-2,6-dien-1-ol

203-377-1

106-24-1

Skin Sens. 1

H317

GHS07

Wng

H317’

 

 

 

‘605-041-00-3

2-(4-tert-butylbenzyl)propionaldehyde

201-289-8

80-54-6

Repr. 1B

H360Fd

GHS08

Dgr

H360Fd’

 

 

 

‘607-738-00-8

MCPA-thioethyl (ISO);

S-ethyl (4-chloro-2-methylphenoxy)ethanethioate; S-ethyl 4-chloro-o-tolyloxythioacetate

246-831-4

25319-90-8

Acute Tox. 4

STOT RE. 2

Aquatic Acute 1 Aquatic Chronic 1

H302

H373 (liver)

H400

H410

GHS07

GHS08

GHS09

Wng

H302

H373 (liver)

H410

 

oral: ATE = 450 mg/kg bw

M = 10

M = 10’

 

‘607-740-00-9

diisooctyl phthalate

248-523-5

27554-26-3

Repr. 1B

H360FD

GHS08

Dgr

H360FD’

 

 

 

‘607-741-00-4

4-{[(6-chloropyridin-3-yl)methyl](2,2-difluoroethyl)amino}furan-2(5H)-one; flupyradifurone

-

951659-40-8

Acute Tox. 4

STOT RE 2

Aquatic Acute 1

Aquatic Chronic 1

H302

H373 (muscle)

H400

H410

GHS07

GHS08

GHS09

Wng

H302

H373 (muscle)

H410

 

oral: ATE = 500 mg/kg bw

M = 10

M = 10’

 

‘607-742-00-X

thiencarbazone-methyl (ISO);

methyl 4-[(4,5-dihydro-3-methoxy-4-methyl-5-oxo-1H-1,2,4-triazol-1-yl)carbonylsulfamoyl]-5- methylthiophene-3-carboxylate

-

317815-83-1

Aquatic Acute 1

Aquatic Chronic 1

H400

H410

GHS09

Wng

H410

 

M = 1000

M = 1000’

 

‘607-743-00-5

L-(+)-lactic acid;

(2S)-2-hydroxypropanoic acid

201-196-2

79-33-4

Skin Corr. 1C

Eye Dam. 1

H314

H318

GHS05

Dgr

H314

EUH071’

 

 

‘607-744-00-0

2-methoxyethyl acrylate

221-499-3

3121-61-7

Flam. Liq. 3

Muta. 2

Repr. 1B

Acute Tox. 3

Acute Tox. 4

Skin Corr. 1C

Eye Dam. 1

Skin Sens. 1

H226

H341

H360FD

H331

H302

H314

H318

H317

GHS02

GHS05

GHS06

GHS08

Dgr

H226

H341

H360FD

H331

H302

H314

H317

EUH071

inhalation: ATE = 2,7 mg/L (vapours)

oral: ATE = 404 mg/kg bw’

 

‘607-745-00-6

glyoxylic acid …%

206-058-5

298-12-4

Eye Dam. 1

Skin Sens. 1B

H318

H317

GHS05

GHS07

Dgr

H318

H317

 

 

B’

‘607-746-00-1

sodium N-(hydroxymethyl)glycinate;

[formaldehyde released from sodium N-(hydroxymethyl)glycinate]

274-357-8

70161-44-3

Carc. 1B

Muta. 2

Acute Tox. 4

Acute Tox. 4

STOT SE 3

Skin Irrit. 2

Eye Irrit. 2

Skin Sens. 1

H350

H341

H332

H302

H335

H315

H319

H317

GHS08

GHS07

Dgr

H350

H341

H332

H302

H335

H315

H319

H317

 

inhalation: ATE = 3 mg/L (dusts or mists)

oral: ATE = 1100 mg/kg bw

8

9’

‘611-181-00-6

potassium (oxido-NNO-azoxy)cyclohexane;

cyclohexylhydroxydiazene 1-oxide, potassium salt;

[K-HDO]

-

66603-10-9

Flam. Sol. 1

Acute Tox. 3

STOT RE 2

Skin Irrit. 2

Eye Dam. 1

Aquatic Chronic 2

H228

H301

H373 (liver)

H315

H318

H411

GHS02

GHS06

GHS08

GHS05

GHS09

Dgr

H228

H301

H373 (liver)

H315

H318

H411

 

oral: ATE = 136 mg/kg bw’

 

‘612-294-00-3

mecetronium etilsulfate;

N-ethyl-N,N-dimethylhexadecan-1-aminium ethyl sulfate;

mecetronium ethyl sulphate;

[MES]

221-106-5

3006-10-8

Skin Corr. 1

Eye Dam. 1

Aquatic Acute 1

Aquatic Chronic 1

H314

H318

H400

H410

GHS05

GHS09

Dgr

H314

H410

EUH071

M = 100

M = 1000’

 

‘613-331-00-6

(2RS)-2-[4-(4-chlorophenoxy)-2-(trifluoromethyl)phenyl]-1-(1H-1,2,4-triazol-1-yl)propan-2-ol;

mefentrifluconazole

-

1417782-03-6

Skin Sens. 1

Aquatic Acute 1

Aquatic Chronic 1

H317

H400

H410

GHS07

GHS09

Wng

H317

H410

 

M = 1

M = 1’

 

‘613-332-00-1

oxathiapiprolin (ISO);

1-(4-{4-[5-(2,6-difluorophenyl)-4,5-dihydro-1,2-oxazol-3-yl]-1,3-thiazol-2-yl}piperidin-1-yl)-2-[5-methyl-3-(trifluoromethyl)-1H-pyrazol-1-yl]ethanone

-

1003318-67-9

Aquatic Chronic 1

H410

GHS09

Wng

H410

 

M = 1’

 

‘613-333-00-7

pyrithione zinc; (T-4)-bis[1-(hydroxy-.kappa.O)pyridine-2(1H)-thionato-.kappa.S]zinc

236-671-3

13463-41-7

Repr. 1B

Acute Tox. 2

Acute Tox. 3

STOT RE 1

Eye Dam. 1

Aquatic Acute 1

Aquatic Chronic 1

H360D

H330

H301

H372

H318

H400

H410

GHS08

GHS06

GHS05

GHS09

Dgr

H360D

H330

H301

H372

H318

H410

 

inhalation: ATE = 0,14 mg/L (dusts or mists)

oral: ATE = 221 mg/kg bw

M = 1000

M = 10’

 

‘613-334-00-2

flurochloridone (ISO);

3-chloro-4-(chloromethyl)-1-[3-(trifluoromethyl)phenyl]pyrrolidin-2-one

262-661-3

61213-25-0

Repr. 1B

Acute Tox. 4

Skin Sens. 1

Aquatic Acute 1

Aquatic Chronic 1

H360FD

H302

H317

H400

H410

GHS08

GHS07

GHS09

Dgr

H360FD

H302

H317

H410

 

oral: ATE = 500 mg/kg bw

M = 100

M = 100’

 

‘613-335-00-8

4,5-dichloro-2-octyl-2H-isothiazol-3-one; [DCOIT]

264-843-8

64359-81-5

Acute Tox. 2

Acute Tox. 4

Skin Corr. 1

Eye Dam. 1

Skin Sens. 1A

Aquatic Acute 1

Aquatic Chronic 1

H330

H302

H314

H318

H317

H400

H410

GHS06

GHS05

GHS09

Dgr

H330

H302

H314

H317

H410

EUH071

inhalation: ATE = 0,16 mg/L (dusts or mists)

oral: ATE = 567 mg/kg bw

Skin Irrit. 2; H315: 0,025 % ≤ C < 5 %

Eye Irrit. 2; H319: 0,025 % ≤ C < 3 %

Skin Sens. 1A; H317: C ≥ 0,0015 %

M = 100

M = 100’

 

‘613-336-00-3

2-methyl-1,2-benzothiazol-3(2H)-one;

[MBIT]

-

2527-66-4

Acute Tox. 4

Acute Tox. 3

Skin Corr. 1C

Eye Dam. 1

Skin Sens. 1A

Aquatic Acute 1

Aquatic Chronic 2

H312

H301

H314

H318

H317

H400

H411

GHS06

GHS05

GHS09

Dgr

H312

H301

H314

H317

H410

EUH071

dermal: ATE = 1100 mg/kg bw

oral: ATE = 175 mg/kg bw

Skin Sens. 1A; H317: C ≥ 0,0015 %

M = 1’

 

‘616-228-00-4

3-(difluoromethyl)-1-methyl-N-(3',4',5'-trifluorobiphenyl-2-yl)pyrazole-4-carboxamide;

fluxapyroxad

-

907204-31-3

Lact.

Aquatic Acute 1

Aquatic Chronic 1

H362

H400

H410

GHS09

Wng

H362

H410

 

M = 1

M = 1’

 

‘616-230-00-5

N-(hydroxymethyl)acrylamide; methylolacrylamide; [NMA]

213-103-2

924-42-5

Carc. 1B

Muta. 1B

STOT RE 1

H350

H340

H372 (peripheral nervous system)

GHS08

Dgr

H350

H340

H372 (peripheral nervous system)’

 

 

 

‘616-231-00-0

5-fluoro-1,3-dimethyl-N-[2-(4-methylpentan-2-yl)phenyl]-1H-pyrazole-4-carboxamide; 2'-[(RS)-1,3-dimethylbutyl]-5-fluoro-1,3-dimethylpyrazole-4-carboxanilide;

penflufen

-

494793-67-8

Carc. 2

Aquatic Acute 1

Aquatic Chronic 1

H351

H400

H410

GHS08

GHS09

Wng

H351

H410

 

M = 1

M = 1’

 

‘616-232-00-6

iprovalicarb (ISO);

isopropyl [(2S)-3-methyl-1-{[1-(4-methylphenyl)ethyl]amino}-1-oxobutan-2-yl]carbamate

-

140923-17-7

Carc. 2

H351

GHS08

Wng

H351’

 

 

 

‘616-233-00-1

silthiofam (ISO);

N-allyl-4,5-dimethyl-2-(trimethylsilyl)thiophene-3-carboxamide

-

175217-20-6

STOT RE 2

Aquatic Chronic 2

H373

H411

GHS08

GHS09

Wng

H373

H411’

 

 

 

‘650-057-00-6

Margosa, ext. [cold-pressed oil of Azadirachta indica seeds without shells extracted with super-critical carbon dioxide]

283-644-7

84696-25-3

Aquatic Chronic 3

H412

 

H412’

 

 

 

(2)

the entries corresponding to index numbers 007-004-00-1; 014-018-00-1; 015-134-00-5; 015-181-00-1; 050-021-00-4; 050-027-00-7; 082-013-00-1; 603-014-00-0; 603-065-00-9; 605-019-00-3; 607-177-00-9; 607-256-00-8; 607-314-00-2; 609-041-00-4; 609-064-00-X; 613-112-00-5; 613-115-00-1; 613-125-00-6; 613-202-00-4; 613-259-00-5; 616-014-00-0 and 617-006-00-X 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)

‘007-004-00-1

nitric acid …% [C > 70 %]

231-714-2

7697-37-2

Ox. Liq. 2

Acute Tox. 1

Skin Corr. 1A

H272

H330

H314

GHS03

GHS06

GHS05

Dgr

H272

H330

H314

EUH071

Ox. Liq. 2; H272: C ≥ 99 %

Ox. Liq. 3; H272: 70 % ≤ C < 99 %

B’

‘014-018-00-1

octamethylcyclotetrasiloxane;

[D4]

209-136-7

556-67-2

Repr. 2

Aquatic Chronic 1

H361f ***

H410

GHS08

GHS09

Wng

H361f ***

H410

 

M = 10’

 

‘015-134-00-5

pirimiphos-methyl (ISO);

O-[2-(diethylamino)-6-methylpyrimidin-4-yl] O,O-dimethyl phosphorothioate

249-528-5

29232-93-7

Acute Tox. 4

STOT RE 1

Aquatic Acute 1

Aquatic Chronic 1

H302

H372 (nervous system)

H400

H410

GHS07

GHS08

GHS09

Dgr

H302

H372 (nervous system)

H410

 

oral: ATE = 1414 mg/kg bw

M = 1000

M = 1000’

 

‘015-181-00-1

phosphine

232-260-8

7803-51-2

Flam. Gas 1

Press. Gas

Acute Tox. 1

Skin Corr. 1B

Aquatic Acute 1

H220

H330

H314

H400

GHS02

GHS04

GHS06

GHS05

GHS09

Dgr

H220

H330

H314

H400

 

inhalation:

ATE = 10 ppmV (gases)

U’

‘050-021-00-4

dichlorodioctylstannane

222-583-2

3542-36-7

Repr. 1B

Acute Tox. 2

STOT RE 1

Aquatic Chronic 3

H360D

H330

H372 **

H412

GHS08

GHS06

Dgr

H360D

H330

H372 **

H412

 

Repr. 1B; H360 D: C ≥ 0,03 %

inhalation: ATE = 0,098 mg/L (dusts or mists)’

 

‘050-027-00-7

2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate; [DOTE]

239-622-4

15571-58-1

Repr. 1B

STOT RE 1

Aquatic Acute 1

Aquatic Chronic 1

H360D

H372 (immune system)

H400

H410

GHS08

GHS09

Dgr

H360D

H372 (immune system)

H410’

 

 

 

‘082-013-00-1

lead powder; [particle diameter < 1 mm]

231-100-4

7439-92-1

Repr. 1A

Lact.

Aquatic Acute 1

Aquatic Chronic 1

H360FD

H362

H400

H410

GHS08

GHS09

Dgr

H360FD H362

H410

 

Repr. 1A; H360D: C ≥ 0,03 %

M = 1

M = 10’

 

‘603-014-00-0

2-butoxyethanol;

ethylene glycol monobutyl ether

203-905-0

111-76-2

Acute Tox. 4*

Acute Tox. 4

Skin Irrit. 2

Eye Irrit. 2

H332

H302

H315

H319

GHS07

Wng

H332

H302

H315

H319

 

oral: ATE = 1200 mg/kg bw’

 

‘603-065-00-9

m-bis(2,3-epoxypropoxy)benzene;

resorcinol diglycidyl ether

202-987-5

101-90-6

Carc. 1B

Muta. 2

Acute Tox. 3

Acute Tox. 4

Skin Irrit. 2

Eye Irrit. 2

Skin Sens. 1

Aquatic Chronic 3

H350

H341

H311

H302

H315

H319

H317

H412

GHS08

GHS06

Dgr

H350

H341

H311

H302

H315

H319

H317

H412

 

dermal: ATE = 300 mg/kg bw oral: ATE = 500 mg/kg bw’

 

‘607-177-00-9

tribenuron-methyl (ISO);

methyl 2-[N-(4-methoxy-6-methyl-1,3,5-triazin-2-yl)-N-methylcarbamoylsulfamoyl]benzoate

401-190-1

101200-48-0

STOT RE 2

Skin Sens. 1

Aquatic Acute 1

Aquatic Chronic 1

H373

H317

H400

H410

GHS08

GHS07

GHS09

Wng

H373

H317

H410

 

M = 100

M = 100’

 

‘607-256-00-8

azoxystrobin (ISO);

methyl (E)-2-{2-[6-(2-cyanophenoxy)pyrimidin-4-yloxy]phenyl}-3-methoxyacrylate

-

131860-33-8

Acute Tox. 3

Aquatic Acute 1

Aquatic Chronic 1

H331

H400

H410

GHS06

GHS09

Dgr

H331

H410

 

inhalation:

ATE = 0,7 mg/L (dusts or mists)

M = 10

M = 10’

 

‘607-314-00-2

ethofumesate (ISO);

(RS)-2-ethoxy-2,3-dihydro-3,3-dimethylbenzofuran-5-yl methanesulfonate

247-525-3

26225-79-6

Aquatic Acute 1

Aquatic Chronic 1

H400

H410

GHS09

Wng

H410

 

M = 1

M = 1’

 

‘609-041-00-4

2,4-dinitrophenol

200-087-7

51-28-5

Acute Tox. 3 *

Acute Tox. 3

Acute Tox. 2

STOT RE 1

Aquatic Acute 1

H331

H311

H300

H372

H400

GHS06

GHS08

GHS09

Dgr

H331

H311

H300

H372

H400

 

dermal: ATE = 300 mg/kg bw oral: ATE = 30 mg/kg bw’

 

‘609-064-00-X

mesotrione (ISO);

2-[4-(methylsulfonyl)-2-nitrobenzoyl]-1,3-cyclohexanedione

-

104206-82-8

Repr. 2

STOT RE 2

Aquatic Acute 1

Aquatic Chronic 1

H361d

H373 (eyes, nervous system)

H400

H410

GHS08

GHS09

Wng

H361d

H373 (eyes, nervous system)

H410

 

M = 10

M = 10’

 

‘613-112-00-5

octhilinone (ISO);

2-octyl-2H-isothiazol-3-one; [OIT]

247-761-7

26530-20-1

Acute Tox. 2

Acute Tox. 3

Acute Tox. 3

Skin Corr. 1

Eye Dam. 1

Skin Sens. 1A

Aquatic Acute 1 Aquatic Chronic 1

H330

H311

H301

H314

H318

H317

H400

H410

GHS06

GHS05

GHS09

Dgr

H330

H311

H301

H314

H317

H410

EUH071

inhalation: ATE = 0,27 mg/L (dusts or mists)

dermal: ATE = 311 mg/kg bw oral: ATE = 125 mg/kg bw

Skin Sens. 1A; H317: C ≥ 0,0015 %

M = 100

M = 100’

 

‘613-115-00-1

hymexazol (ISO);

3-hydroxy-5-methylisoxazole

233-000-6

10004-44-1

Repr. 2

Acute Tox. 4

Eye Dam. 1

Skin Sens. 1

Aquatic Chronic 2

H361d

H302

H318

H317

H411

GHS08

GHS07

GHS05

GHS09

Dgr

H361d

H302

H318

H317

H411

 

oral: ATE = 1600 mg/kg bw’

 

‘613-125-00-6

hexythiazox (ISO);

trans-5-(4-chlorophenyl)-N-cyclohexyl-4-methyl-2-oxo-3-thiazolidine-carboxamide

-

78587-05-0

Aquatic Acute 1

Aquatic Chronic 1

H400

H410

GHS09

Wng

H410

 

M = 1

M = 1’

 

‘613-202-00-4

pymetrozine (ISO);

(E)-4,5-dihydro-6-methyl-4-(3-pyridylmethyleneamino)-1,2,4-triazin-3(2H)-one

-

123312-89-0

Carc. 2

Repr. 2

Aquatic Chronic 1

H351

H361fd

H410

GHS08

GHS09

Wng

H351

H361fd

H410

 

M = 1’

 

‘613-259-00-5

imiprothrin (ISO);

reaction mass of: [2,4-dioxo-(2-propyn-1-yl)imidazolidin-3-yl]methyl(1R)-cis-chrysanthemate; [2,4-dioxo-(2-propyn-1-yl)imidazolidin-3-yl]methyl(1R)-trans-chrysanthemate

428-790-6

72963-72-5

Carc. 2

Acute Tox. 4

Acute Tox. 4

STOT SE 2

Aquatic Acute 1

Aquatic Chronic 1

H351

H332

H302

H371 (nervous system; oral, inhalation)

H400

H410

GHS08

GHS07

GHS09

Wng

H351

H332

H302

H371 (nervous system; oral, inhalation)

H410

 

inhalation: ATE = 1,4 mg/L (dusts or mists)

oral: ATE = 550 mg/kg bw

M = 10

M = 10’

 

‘616-014-00-0

butanone oxime; ethyl methyl ketoxime; ethyl methyl ketone oxime

202-496-6

96-29-7

Carc. 1B

Acute Tox. 4

Acute Tox. 3

STOT SE 3

STOT SE 1

STOT RE 2

Skin Irrit. 2

Eye Dam. 1

Skin Sens. 1

H350

H312

H301

H336

H370 (upper respiratory tract)

H373 (blood system)

H315

H318

H317

GHS08

GHS06

GHS05

Dgr

H350

H312

H301

H336

H370 (upper respiratory tract)

H373 (blood system)

H315

H318

H317

 

dermal: ATE = 1100 mg/kg bw oral: ATE = 100 mg/kg bw’

 

‘617-006-00-X

bis(α,α-dimethylbenzyl) peroxide

201-279-3

80-43-3

Org. Perox. F

Repr. 1B

Skin Irrit. 2

Eye Irrit. 2

Aquatic Chronic 2

H242

H360D

H315

H319

H411

GHS02

GHS08

GHS07

GHS09

Dgr

H242

H360D

H315

H319

H411’

 

 

 

(3)

the entries corresponding to index numbers 601-064-00-8 and 607-693-00-4 are deleted.