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Document 32022R0692

Commission Delegated Regulation (EU) 2022/692 of 16 February 2022 amending, for the purposes of its adaptation to technical and scientific progress, 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)

C/2022/846

OJ L 129, 3.5.2022, p. 1–17 (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

Legal status of the document In force: This act has been changed. Current consolidated version: 03/05/2022

ELI: http://data.europa.eu/eli/reg_del/2022/692/oj

3.5.2022   

EN

Official Journal of the European Union

L 129/1

COMMISSION DELEGATED REGULATION (EU) 2022/692

of 16 February 2022

amending, for the purposes of its adaptation to technical and scientific progress, 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 (the ‘Agency’) pursuant to Article 37 of Regulation (EC) No 1272/2008. The Committee for Risk Assessment of the Agency (RAC) adopted, after having taken account of the comments received from the parties concerned, the following opinions (2) on those proposals:

—

Opinion of 5 December 2019 concerning silanamine, 1,1,1-trimethyl-N-(trimethylsilyl)-, hydrolysis products with silica; pyrogenic, synthetic amorphous, nano, surface treated silicon dioxide;

—

Opinion of 4 May 2020 concerning cyfluthrin (ISO); α-cyano-4-fluoro-3-phenoxybenzyl-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate;

—

Opinion of 4 May 2020 concerning beta-cyfluthrin (ISO); reaction mass of rel-(R)-cyano(4-fluoro-3-phenoxyphenyl)methyl (1S,3S)-3-(2,2-dichloroethenyl)-2,2-dimethylcyclopropane-1-carboxylate and rel-(R)-cyano(4-fluoro-3-phenoxyphenyl)methyl (1S,3R)-3-(2,2-dichloroethenyl)-2,2-dimethylcyclopropane-1-carboxylate;

—

Opinion of 4 May 2020 concerning acetamiprid (ISO); (1E)-N-[(6-chloropyridin-3-yl)methyl]-N’-cyano-N-methylethanimidamide; (E)-N1-[(6-chloro-3-pyridyl)methyl]-N2-cyano-N1-methylacetamidine;

—

Opinion of 11 June 2020 concerning tellurium;

—

Opinion of 11 June 2020 concerning tellurium dioxide;

—

Opinion of 11 June 2020 concerning 2,2-dimethylpropan-1-ol, tribromo derivative; 3-bromo-2,2-bis(bromomethyl)propan-1-ol;

—

Opinion of 11 June 2020 concerning piperonyl butoxide (ISO); 2-(2-butoxyethoxy)ethyl 6-propylpiperonyl ether;

—

Opinion of 11 June 2020 concerning benzophenone;

—

Opinion of 11 June 2020 concerning exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl acrylate; isobornyl acrylate;

—

Opinion of 11 June 2020 concerning daminozide (ISO); 4-(2,2-dimethylhydrazino)-4-oxobutanoic acid; N-dimethylaminosuccinamic acid;

—

Opinion of 11 June 2020 concerning clofentezine (ISO); 3,6-bis(o-chlorophenyl)-1,2,4,5-tetrazine;

—

Opinion of 11 June 2020 concerning fluopicolide (ISO); 2,6-dichloro-N-[3-chloro-5-(trifluoromethyl)-2-pyridylmethyl]benzamide;

—

Opinion of 11 June 2020 concerning trichlorosilane;

—

Opinion of 11 June 2020 concerning 2-ethylhexanoic acid and its salts;

—

Opinion of 11 June 2020 concerning a reassessment at the request of the European Commission of the developmental toxicity of N-carboxymethyliminobis (ethylenenitrilo)tetra(acetic acid) (DTPA) and its pentasodium and pentapotassium salts

—

Opinion of 17 September 2020 concerning dibutyltin bis(2-ethylhexanoate);

—

Opinion of 17 September 2020 concerning dibutyltin di(acetate);

—

Opinion of 17 September 2020 concerning barium diboron tetraoxide;

—

Opinion of 17 September 2020 concerning quinoclamine (ISO); 2-amino-3-chloro-1,4-naphthoquinone;

—

Opinion of 17 September 2020 concerning 4,4'-oxydi(benzenesulphonohydrazide);

—

Opinion of 17 September 2020 toluene-4-sulphonohydrazide;

—

Opinion of 17 September 2020 concerning theophylline; 1,3-dimethyl-3,7-dihydro-1H-purine-2,6-dione;

—

Opinion of 17 September 2020 concerning 1,3-bis(1-isocyanato-1-methylethyl)benzene; [m-TMXDI];

—

Opinion of 17 September 2020 concerning Bis(isocyanatomethyl)benzene; [m-XDI];

—

Opinion of 17 September 2020 concerning 2,4,6-triisopropyl-m-phenylene diisocyanate;

—

Opinion of 17 September 2020 concerning N-(2-nitrophenyl)phosphoric triamide;

—

Opinion of 17 September 2020 concerning cumene;

—

Opinion of 17 September 2020 concerning 2-ethyl-2-[[(1-oxoallyl)oxy]methyl]-1,3-propanediyl diacrylate; 2,2-bis(acryloyloxymethyl)butyl acrylate;trimethylolpropane triacrylate;

—

Opinion of 17 September 2020 concerning 1,5-naphthylene diisocyanate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];

—

Opinion of 17 September 2020 concerning 1,5-naphthylene diisocyanate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];

—

Opinion of 8 October 2020 concerning ammonium bromide;

—

Opinion of 8 October 2020 concerning 2,4,6-tri-tert-butylphenol;

—

Opinion of 8 October 2020 concerning pyridalyl (ISO); 2,6-dichloro-4-(3,3-dichloroallyloxy)phenyl 3-[5-(trifluoromethyl)-2-pyridyloxy]propyl ether;

—

Opinion of 8 October 2020 concerning pyridine-2-thiol 1-oxide, sodium salt; pyrithione sodium; sodium pyrithione;

—

Opinion of 8 October 2020 concerning N-(5-chloro-2-isopropylbenzyl)-N-cyclopropyl-3-(difluoromethyl)-5-fluoro-1-methyl-1H-pyrazole-4-carboxamide; isoflucypram;

—

Opinion of 8 October 2020 concerning 2-(2-methoxyethoxy)ethanol; diethylene glycol monomethyl ether;

—

Opinion of 8 October 2020 concerning 4,4'-isopropylidenediphenol; bisphenol A;

—

Opinion of 8 October 2020 concerning pendimethalin (ISO); N-(1-ethylpropyl)-2,6-dinitro-3,4-xylidene;

—

Opinion of 8 October 2020 concerning dimoxystrobin (ISO); (2E)-2-{2-[(2,5-dimethylphenoxy)methyl]phenyl}-2-(methoxyimino)-N-methylacetamide; (E)-2-(methoxyimino)-N-methyl-2-[α-(2,5-xylyloxy)-o-tolyl]acetamide;

—

Opinion of 10 December 2020 concerning 4,4'-sulphonyldiphenol; bisphenol S;

—

Opinion of 10 December 2020 2-[N-ethyl-4-[(5-nitrothiazol-2-yl)azo]-m-toluidino]ethyl acetate; C.I. Disperse Blue 124;

—

Opinion of 10 December 2020 concerning perfluoroheptanoic acid; tridecafluoroheptanoic acid;

—

Opinion of 10 December 2020 concerning methyl N-(isopropoxycarbonyl)-L-valyl-(3RS)-3-(4-chlorophenyl)-β-alaninate; valifenalate;

—

Opinion of 10 December 2020 concerning 6-[C12-18-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid, sodium and tris(2-hydroxyethyl)ammonium salts;

—

Opinion of 10 December 2020 concerning 6-[(C10-C13)-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid;

—

Opinion of 10 December 2020 concerning 6-[C12-18-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid;

—

Opinion of 10 December 2020 concerning 1,3,5-triazine-2,4,6-triamine; Melamine;

—

Opinion of 10 December 2020 concerning reaction mass of 3-(difluoromethyl)-1-methyl-N-[(1RS,4SR,9RS)-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide and 3-(difluoromethyl)-1-methyl-N-[(1RS,4SR,9SR)-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide [≥ 78 % syn isomers ≤ 15 % anti isomers relative content]; isopyrazam;

—

Opinion of 10 December 2020 concerning Margosa, ext. [from the kernels of Azadirachta indica extracted with water and further processed with organic solvents];

—

Opinion of 10 December 2020 concerning divanadium pentaoxide; vanadium pentoxide;

—

Opinion of 10 December 2020 concerning bentazone (ISO); 3-isopropyl-2,1,3-benzothiadiazine-4-one-2,2-dioxide;

—

Opinion of 10 December 2020 concerning a reassessment at the request of the European Commission of the new information on acute inhalation toxicity of 2-butoxyethanol; ethylene glycol monobutyl ether (EGBE)

(3)

Additional information was received contesting the scientific assessment set out in the RAC opinions of 11 June 2020 concerning 2-ethylhexanoic acid and its salts; of 11 June 2020 concerning a reassessment at the request of the European Commission of the developmental toxicity of N-carboxymethyliminobis (ethylenenitrilo)tetra(acetic acid) (DTPA) and its pentasodium and pentapotassium salts; of 8 October 2020 concerning ammonium bromide; of 10 December 2020 concerning divanadium pentaoxide; of 10 December 2020 concerning a reassessment at the request of the European Commission of the new information on acute inhalation toxicity of 2-butoxyethanol; ethylene glycol monobutyl ether (EGBE); and of 10 December 2020 concerning melamine.

(4)

This additional information was assessed by the Commission and was not found sufficient to cast doubts on the scientific analysis contained in the RAC opinions. It is therefore 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.

(5)

Additional information pertaining to the acute inhalation toxicity of silanamine, 1,1,1-trimethyl-N-(trimethylsilyl)-, hydrolysis products with silica; pyrogenic, synthetic amorphous, nano, surface treated silicon dioxide was received after the RAC opinion was forwarded to the Commission. The classification of silanamine, 1,1,1-trimethyl-N-(trimethylsilyl)-, hydrolysis products with silica; pyrogenic, synthetic amorphous, nano, surface treated silicon dioxide as acute toxic by inhalation Cat. 2, recommended in the RAC opinion of 5 December 2019, should not be included in Annex VI to Regulation (EC) No 1272/2008, as the new scientific information was assessed by the Commission and was found to require further assessment by RAC. However, the classification of this substance as STOT RE 2, recommended in the RAC opinion of 5 December 2019, should be included in Annex VI to Regulation (EC) No 1272/2008, since no new information has been received that would require further assessment for that classification.

(6)

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

(7)

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

Amendments to Regulation (EC) No 1272/2008

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 23 November 2023.

By way of derogation from the second paragraph of this Article, substances and mixtures may be classified, labelled and packaged in accordance with this Regulation from its date of entry into force.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 16 February 2022.

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/-/. – The opinions of 11 June 2020 and of 10 December 2020 concerning a reassessment at the request of the European Commission are accessible via the following website: https://echa.europa.eu/about-us/who-we-are/committee-for-risk-assessment/opinions-of-the-rac-adopted-under-specific-echa-s-executive-director-requests

ANNEX

Annex VI to Regulation (EC) No 1272/2008 is amended as follows:

(1)

in Part 3, Table 3 is amended as follows:

(a)

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)

‘014-052-00-7

silanamine, 1,1,1-trimethyl-N-(trimethylsilyl)-, hydrolysis products with silica; pyrogenic, synthetic amorphous, nano, surface treated silicon dioxide

272-697-1

68909-20-6

STOT RE 2

H373 (lungs) (inhalation)

GHS08

Wng

H373 (lungs) (inhalation)

EUH066’

 

 

‘035-005-00-7

ammonium bromide

235-183-8

12124-97-9

Repr. 1B

Lact.

STOT SE 3

STOT RE 1

Eye Irrit. 2

H360FD

H362

H336

H372 (nervous system)

H319

GHS08

GHS07

Dgr

H360FD

H362

H336

H372 (nervous system)

H319’

 

 

 

‘050-032-00-4

dibutyltin bis(2-ethylhexanoate)

220-481-2

2781-10-4

Muta. 2

Repr. 1B

STOT RE 1

H341

H360FD

H372 (immune system)

GHS08

Dgr

H341

H360FD

H372 (immune system)’

 

 

 

‘050-033-00-X

dibutyltin di(acetate)

213-928-8

1067-33-0

Muta 2

Repr. 1B

STOT RE 1

H341

H360FD

H372 (immune system)

GHS08

Dgr

H341

H360FD

H372 (immune system)’

 

 

 

‘052-001-00-0

tellurium

236-813-4

13494-80-9

Repr. 1B

Lact.

H360Df

H362

GHS08

Dgr

H360Df

H362’

 

 

 

‘052-002-00-6

tellurium dioxide

231-193-1

7446-07-3

Repr. 1B

Lact.

H360Df

H362

GHS08

Dgr

H360Df

H362’

 

 

 

‘056-005-00-3

barium diboron tetraoxide

237-222-4

13701-59-2

Repr. 1B

Acute Tox. 4

Acute Tox. 3

H360FD

H332

H301

GHS08

GHS06

Dgr

H360FD

H332

H301

 

inhalation:

ATE = 1,5 mg/L (dusts or mists)

oral:

ATE = 100 mg/kg bw’

 

‘601-097-00-8

Propylbenzene

203-132-9

103-65-1

Flam. Liq. 3

Asp. Tox. 1

STOT SE 3

Aquatic Chronic 2

H226

H304

H335

H411

GHS02

GHS08

GHS07

GHS09

Dgr

H226

H304

H335

H411’

 

 

 

‘603-243-00-6

2,2-dimethylpropan-1-ol, tribromo derivative; 3-bromo-2,2-bis(bromomethyl)propan-1-ol

253-057-0

36483-57-5; 1522-92-5

Carc. 1B

Muta. 2

H350

H341

GHS08

Dgr

H350

H341’

 

 

 

‘604-096-00-0

piperonyl butoxide (ISO); 2-(2-butoxyethoxy)ethyl 6-propylpiperonyl ether

200-076-7

51-03-6

STOT SE 3

Eye Irrit. 2

Aquatic Acute 1

Aquatic Chronic 1

H335

H319

H400

H410

GHS07

GHS09

Wng

H335

H319

H410

EUH066

M = 1

M = 1’

 

‘604-097-00-6

2,4,6-tri-tert-butylphenol

211-989-5

732-26-3

Repr. 1B

Acute Tox. 4

STOT RE 2

Skin Sens. 1B

H360D

H302

H373 (liver)

H317

GHS08

GHS07

Dgr

H360D

H302

H373 (liver)

H317

 

oral:

ATE = 500 mg/kg bw’

 

‘604-098-00-1

4,4'-sulphonyldiphenol; bisphenol S

201-250-5

80-09-1

Repr. 1B

H360FD

GHS08

Dgr

H360FD’

 

 

 

‘606-153-00-5

benzophenone

204-337-6

119-61-9

Carc. 1B

H350

GHS08

Dgr

H350’

 

 

 

‘606-154-00-0

quinoclamine (ISO); 2-amino-3-chloro-1,4-naphthoquinone

220-529-2

2797-51-5

Carc. 2

Repr. 2

Acute Tox. 4

STOT RE 2

Eye Irrit. 2

Skin Sens. 1A

Aquatic Acute 1

Aquatic Chronic 1

H351

H361d

H302

H373 (blood system, kidneys)

H319

H317

H400

H410

GHS08

GHS07

GHS09

Wng

H351

H361d

H302

H373 (blood system, kidneys)

H319

H317

H410

 

oral:

ATE = 500 mg/kg bw

M = 10

M = 10’

 

‘607-756-00-6

exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl acrylate; isobornyl acrylate

227-561-6

5888-33-5

Skin Sens. 1A

H317

GHS07

Wng

H317’

 

 

 

‘607-757-00-1

daminozide (ISO); 4-(2,2-dimethylhydrazino)-4-oxobutanoic acid; N-dimethylaminosuccinamic acid

216-485-9

1596-84-5

Carc. 2

H351

GHS08

Wng

H351’

 

 

 

‘607-758-00-7

4,4'-oxydi(benzenesulphonohydrazide)

201-286-1

80-51-3

Self-react. D

Aquatic Acute 1

Aquatic Chronic 1

H242

H400

H410

GHS02

GHS09

Dgr

H242

H410

 

M = 1

M = 1’

 

‘607-759-00-2

toluene-4-sulphonohydrazide

216-407-3

1576-35-8

Self-react. D

H242

GHS02

Dgr

H242’

 

 

 

‘607-760-00-8

2-[N-ethyl-4-[(5-nitrothiazol-2-yl)azo]-m-toluidino]ethyl acetate; C.I. Disperse Blue 124

239-203-6

15141-18-1

Skin Sens. 1A

H317

GHS07

Wng

H317

 

Skin Sens. 1A; H317: C ≥ 0,001 %’

 

‘607-761-00-3

Perfluoroheptanoic acid; tridecafluoroheptanoic acid

206-798-9

375-85-9

Repr. 1B

STOT RE 1

H360D

H372 (liver)

GHS08

Dgr

H360D

H372 (liver)’

 

 

 

‘607-762-00-9

methyl N-(isopropoxycarbonyl)-L-valyl-(3RS)-3-(4-chlorophenyl)-β-alaninate; valifenalate

-

283159-90-0

Carc. 2

Aquatic Chronic 2

H351

H411

GHS08

GHS09

Wng

H351

H411’

 

 

 

‘607-763-00-4

6-[C12-18-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid, sodium and tris(2-hydroxyethyl)ammonium salts

-

-

Repr. 1B

Eye Irrit. 2

H360FD

H319

GHS08

GHS07

Dgr

H360FD

H319’

 

 

 

‘607-764-00-X

6-[(C10-C13)-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid

-

2156592-54-8

Repr. 1B

Eye Irrit. 2

H360FD

H319

GHS08

GHS07

Dgr

H360FD

H319’

 

 

 

‘607-765-00-5

6-[C12-18-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid

-

-

Repr. 1B

H360FD

GHS08

Dgr

H360FD’

 

 

 

‘613-341-00-0

clofentezine (ISO); 3,6-bis(o-chlorophenyl)-1,2,4,5-tetrazine

277-728-2

74115-24-5

Aquatic Chronic 1

H410

GHS09

Wng

H410

 

M = 1’

 

‘613-342-00-6

theophylline; 1,3-dimethyl-3,7-dihydro-1H-purine-2,6-dione

200-385-7

58-55-9

Repr. 1B

H360D

GHS08

Dgr

H360D’

 

 

 

‘613-343-00-1

pyridalyl (ISO); 2,6-dichloro-4-(3,3-dichloroallyloxy)phenyl 3-[5-(trifluoromethyl)-2-pyridyloxy]propyl ether

-

179101-81-6

Skin Sens. 1

Aquatic Acute 1

Aquatic Chronic 1

H317

H400

H410

GHS07

GHS09

Wng

H317

H410

 

M = 1 000

M = 100’

 

‘613-344-00-7

Pyridine-2-thiol 1-oxide, sodium salt; pyrithione sodium; sodium pyrithione

223-296-5;

240-062-8

3811-73-2;

15922-78-8

Acute Tox. 3

Acute Tox. 3

Acute Tox. 4

STOT RE 1

Skin Irrit. 2

Eye Irrit. 2

Skin Sens. 1

Aquatic Acute 1

Aquatic Chronic 2

H331

H311

H302

H372 (nervous system)

H315

H319

H317

H400

H411

GHS06

GHS08

GHS09

Dgr

H331

H311

H302

H372 (nervous system)

H315

H319

H317

H410

EUH070

inhalation:

ATE = 0,5 mg/L (dusts or mists)

dermal:

ATE = 790 mg/kg bw

oral:

ATE = 500 mg/kg bw

M = 100’

 

‘613-345-00-2

1,3,5-triazine-2,4,6-triamine;

melamine

203-615-4

108-78-1

Carc. 2

STOT RE 2

H351

H373 (urinary tract)

GHS08

Wng

H351

H373 (urinary tract)’

 

 

 

‘615-046-00-2

1,3-bis(1-isocyanato-1-methylethyl)benzene; [m-TMXDI]

220-474-4

2778-42-9

Resp. Sens. 1

Skin Sens. 1A

H334

H317

GHS08

Dgr

H334

H317’

 

 

 

‘615-047-00-8

1,3-bis(isocyanatomethyl)benzene; [m-XDI]

222-852-4

3634-83-1

Resp. Sens. 1

Skin Sens. 1A

H334

H317

GHS08

Dgr

H334

H317

 

Skin Sens. 1A; H317: C ≥ 0,001 %’

 

‘615-048-00-3

2,4,6-triisopropyl-m-phenylene diisocyanate

218-485-4

2162-73-4

Resp. Sens. 1

Skin Sens. 1

H334

H317

GHS08

Dgr

H334

H317’

 

 

 

‘615-049-00-9

1,5-naphthylene diisocyanate

[containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]

221-641-4

3173-72-6

STOT SE 3

Skin Irrit. 2

Eye Irrit. 2

Resp. Sens. 1

Skin Sens. 1A

Aquatic Chronic 3

H335

H315

H319

H334

H317

H412

GHS07

GHS08

Dgr

H335

H315

H319

H334

H317

H412’

 

 

 

‘615-050-00-4

1,5-naphthylene diisocyanate

[containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]

221-641-4

3173-72-6

Acute Tox. 2

STOT SE 3

Skin Irrit. 2

Eye Irrit. 2

Resp. Sens. 1

Skin Sens. 1A

Aquatic Chronic 3

H330

H335

H315

H319

H334

H317

H412

GHS06

GHS08

Dgr

H330

H335

H315

H319

H334

H317

H412

 

inhalation:

ATE = 0,27 mg/L (dusts or mists)’

 

‘616-237-00-3

fluopicolide (ISO); 2,6-dichloro-N-[3-chloro-5-(trifluoromethyl)-2-pyridylmethyl]benzamide

-

239110-15-7

Repr. 2

H361d

GHS08

Wng

H361d’

 

 

 

‘616-238-00-9

N-(2-nitrophenyl)phosphoric triamide

477-690-9

874819-71-3

Repr. 1B

STOT RE 2

H360Fd

H373 (kidneys)

GHS08

Dgr

H360Fd

H373 (kidneys)’

 

 

 

‘616-239-00-4

N-(5-chloro-2-isopropylbenzyl)-N-cyclopropyl-3-(difluoromethyl)-5-fluoro-1-methyl-1H-pyrazole-4-carboxamide; isoflucypram

-

1255734-28-1

Repr. 2

Acute Tox. 4

Skin Sens. 1B

Aquatic Acute 1

Aquatic Chronic 1

H361f

H332

H317

H400

H410

GHS08

GHS07

GHS09

Wng

H361f

H332

H317

H410

 

inhalation:

ATE = 2,2 mg/L (dusts or mists)

M = 10

M = 1’

 

‘616-240-00-X

Reaction mass of 3-(difluoromethyl)-1-methyl-N-[(1RS,4SR,9RS)-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide and 3-(difluoromethyl)-1-methyl-N-[(1RS,4SR,9SR)-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide [≥ 78 % syn isomers ≤ 15 % anti isomers relative content]; isopyrazam

-

881685-58-1

Carc. 2

Repr. 1B

Skin Sens. 1B

Aquatic Acute 1 Aquatic Chronic 1

H351

H360D

H317

H400

H410

GHS08

GHS07

GHS09

Dgr

H351

H360D

H317

H410

 

Repr. 1B; H360D:

C ≥ 3 %

M = 10

M = 10’

 

‘650-058-00-1

Margosa, ext. [from the kernels of Azadirachta indica extracted with water and further processed with organic solvents]

283-644-7

84696-25-3

Repr. 2

Skin Sens. 1

Aquatic Chronic 1

H361d

H317

H410

GHS08

GHS07

GHS09

Wng

H361d

H317

H410

 

M = 10’

 

(b)

the entries corresponding to index numbers 014-001-00-9; 023-001-00-8; 601-024-00-X; 603-014-00-0; 603-107-00-6; 604-030-00-0; 607-111-00-9; 607-230-00-6; 607-253-00-1; 607-254-00-7; 607-734-00-6; 607-735-00-1; 607-736-00-7; 608-032-00-2; 609-042-00-X; 613-012-00-1; 616-164-00-7 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)

‘014-001-00-9

trichlorosilane

233-042-5

10025-78-2

Flam. Liq. 1

Water-react. 1

Acute Tox. 3

Acute Tox. 4

Skin Corr. 1A

Eye Dam. 1

H224

H260

H331

H302

H314

H318

GHS02

GHS06

GHS05

Dgr

H224

H260

H331

H302

H314

EUH014

EUH029

EUH071

inhalation:

ATE = 7,6 mg/L (vapour)

oral:

ATE = 1 000 mg/kg bw’

 

‘023-001-00-8

divanadium pentaoxide; vanadium pentoxide

215-239-8

1314-62-1

Muta. 2

Carc. 1B

Repr. 2

Lact.

Acute Tox. 3

Acute Tox. 2

STOT SE 3

STOT RE 1

Aquatic Chronic 2

H341

H350

H361fd

H362

H301

H330

H335

H372 (respiratory tract, inhalation)

H411

GHS06

GHS08

GHS09

Dgr

H341

H350

H361fd

H362

H301

H330

H335

H372 (respiratory tract, inhalation)

H411

 

inhalation:

ATE = 0,05 mg/L (dusts or mists)

oral:

ATE = 220 mg/kg bw’

 

‘601-024-00-X

Cumene

202-704-5

98-82-8

Flam. Liq. 3

Carc. 1B

Asp. Tox. 1

STOT SE 3

Aquatic Chronic 2

H226

H350

H304

H335

H411

GHS02

GHS08

GHS07

GHS09

Dgr

H226

H350

H304

H335

H411’

 

 

 

‘603-014-00-0

2-butoxyethanol; ethylene glycol monobutyl ether

203-905-0

111-76-2

Acute Tox. 3

Acute Tox. 4

Skin Irrit. 2

Eye Irrit. 2

H331

H302

H315

H319

GHS06

Dgr

H331

H302

H315

H319

 

inhalation:

ATE = 3 mg/L (Vapours)

oral:

ATE = 1 200 mg/kg bw’

 

‘603-107-00-6

2-(2-methoxyethoxy)ethanol; diethylene glycol monomethyl ether

203-906-6

111-77-3

Repr. 1B

H360D

GHS08

Dgr

H360D

 

Repr. 1B; H360D: C ≥ 3 %’

 

‘604-030-00-0

4,4'-isopropylidenediphenol; bisphenol A

201-245-8

80-05-7

Repr. 1B

STOT SE 3

Eye Dam. 1

Skin Sens. 1

Aquatic Acute 1

Aquatic Chronic 1

H360F

H335

H318

H317

H400

H410

GHS08

GHS07

GHS05

GHS09

Dgr

H360F

H335

H318

H317

H410

 

M = 1

M = 10’

 

‘607-111-00-9

2-ethyl-2-[[(1-oxoallyl)oxy]methyl]-1,3-propanediyl diacrylate; 2,2-bis(acryloyloxymethyl)butyl acrylate;

trimethylolpropane triacrylate

239-701-3

15625-89-5

Carc. 2

Skin Irrit. 2

Eye Irrit. 2

Skin Sens. 1

Aquatic Acute 1

Aquatic Chronic 1

H351

H315

H319

H317

H400

H410

GHS08

GHS07

GHS09

Wng

H351

H315

H319

H317

H410

 

M = 1

M = 1

D’

‘607-230-00-6

2-ethylhexanoic acid and its salts, with the exception of those specified elsewhere in this Annex

-

-

Repr. 1B

H360D

GHS08

Dgr

H360D’

 

 

 

‘607-253-00-1

cyfluthrin (ISO); α-cyano-4-fluoro-3-phenoxybenzyl-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate

269-855-7

68359-37-5

Lact.

Acute Tox. 2

Acute Tox. 2

STOT SE 1

Aquatic Acute 1

Aquatic Chronic 1

H362

H330

H300

H370 (nervous system)

H400

H410

GHS06

GHS08

GHS09

Dgr

H362

H330

H300

H370 (nervous system)

H410

 

inhalation:

ATE = 0,14 mg/L (dusts or mists)

oral:

ATE = 14 mg/kg bw

M = 1 000 000

M = 1 000 000 ’

 

‘607-254-00-7

beta-cyfluthrin (ISO); reaction mass of rel-(R)-cyano(4-fluoro-3-phenoxyphenyl)methyl (1S,3S)-3-(2,2-dichloroethenyl)-2,2-dimethylcyclopropane-1-carboxylate and rel-(R)-cyano(4-fluoro-3-phenoxyphenyl)methyl (1S,3R)-3-(2,2-dichloroethenyl)-2,2-dimethylcyclopropane-1-carboxylate

-

1820573-27-0

Lact.

Acute Tox. 2

Acute Tox. 2

STOT SE 1

Aquatic Acute 1

Aquatic Chronic 1

H362

H330

H300

H370 (nervous system)

H400

H410

GHS06

GHS08

GHS09

Dgr

H362

H330

H300

H370 (nervous system)

H410

 

inhalation:

ATE = 0,081 mg/L (dusts or mists)

oral:

ATE = 11 mg/kg bw

M = 1 000 000

M = 1 000 000 ’

 

‘607-734-00-6

pentapotassium 2,2',2",2"',2""-(ethane-1,2-diylnitrilo)pentaacetate

404-290-3

7216-95-7

Repr. 1B

Acute Tox. 4

STOT RE 2

Eye Irrit. 2

H360D

H332

H373 (inhalation)

H319

GHS08

GHS07

Dgr

H360D

H332

H373 (inhalation)

H319

 

Repr. 1B; H360D: C ≥ 3 %

inhalation:

ATE = 1,5 mg/L (dusts or mists)’

 

‘607-735-00-1

N-carboxymethyliminobis(ethylenenitrilo)tetra(acetic acid)

200-652-8

67-43-6

Repr. 1B

Acute Tox. 4

STOT RE 2

Eye Irrit. 2

H360D

H332

H373 (inhalation)

H319

GHS08

GHS07

Dgr

H360D

H332

H373 (inhalation)

H319

 

Repr. 1B; H360D: C ≥ 3 %

inhalation:

ATE = 1,5 mg/L (dusts or mists)’

 

‘607-736-00-7

pentasodium (carboxylatomethyl)iminobis(ethylenenitrilo)tetraacetate

205-391-3

140-01-2

Repr. 1B

Acute Tox. 4

STOT RE 2

H360D

H332

H373 (inhalation)

GHS08

GHS07

Dgr

H360D

H332

H373 (inhalation)

 

Repr. 1B; H360D: C ≥ 3 %

inhalation:

ATE = 1,5 mg/L (dusts or mists)’

 

‘608-032-00-2

acetamiprid (ISO); (1E)-N-[(6-chloropyridin-3-yl)methyl]-N’-cyano-N-methylethanimidamide; (E)-N1-[(6-chloro-3-pyridyl)methyl]-N2-cyano-N1-methylacetamidine

-

135410-20-7 160430-64-8

Repr. 2

Acute Tox. 3

Aquatic Chronic 1

Aquatic Acute 1

H361d

H301

H410

H400

GHS08

GHS06

GHS09

Dgr

H361d

H301

H410

 

oral:

ATE = 140 mg/kg bw

M = 10

M = 10’

 

‘609-042-00-X

pendimethalin (ISO); N-(1-ethylpropyl)-2,6-dinitro-3,4-xylidene

254-938-2

40487-42-1

Repr. 2

Aquatic Acute 1

Aquatic Chronic 1

H361d

H400

H410

GHS08

GSH09

Wng

H361d

H410

 

M = 100

M = 10’

 

‘613-012-00-1

bentazone (ISO); 3-isopropyl-2,1,3-benzothiadiazine-4-one-2,2-dioxide

246-585-8

25057-89-0

Repr. 2

Acute Tox. 4

Eye Irrit. 2

Skin Sens. 1

H361d

H302

H319

H317

GHS08

GHS07

Wng

H361d

H302

H319

H317

 

oral: ATE = 1 600 mg/kg bw’

 

‘616-164-00-7

dimoxystrobin (ISO); (2E)-2-{2-[(2,5-dimethylphenoxy)methyl]phenyl}-2-(methoxyimino)-N-methylacetamide; (E)-2-(methoxyimino)-N-methyl-2-[α-(2,5-xylyloxy)-o-tolyl]acetamide

 

149961-52-4

Carc. 2

Repr. 2

Acute Tox. 4

Aquatic Acute 1

Aquatic Chronic 1

H351

H361d

H332

H400

H410

GHS08

GHS07

GHS09

Wng

H351

H361d

H332

H410

 

inhalation:

ATE = 1,3 mg/L (dusts or mists)

M = 100

M = 100’

 

(c)

the entry corresponding to index number 615-007-00-X is deleted.
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