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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

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Official Journal

3.5.2022

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
Index No	Chemical Name	EC No	CAS No	Hazard Class and Category Code(s)	Hazard statement Code(s)	Pictogram, Signal Word Code(s)	Hazard statement Code(s)	Suppl. Hazard statement Code(s)	Specific Conc. Limits, M- factors and ATE	Notes
‘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
Index No	Chemical Name	EC No	CAS No	Hazard Class and Category Code(s)	Hazard statement Code(s)	Pictogram, Signal Word Code(s)	Hazard statement Code(s)	Suppl. Hazard statement Code(s)	Specific Conc. Limits, M- factors and ATE	Notes
‘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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