Commission Delegated Regulation (EU) 2020/1182

Contents

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

—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 8 June 2018 concerning trimethoxyvinylsilane; trimethoxy(vinyl)silane;

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

—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 8 June 2018 concerning dimethyl disulphide;

—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 8 June 2018 concerning granulated copper;

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

—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;

(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^note or those set out in Article 50 of Regulation (EU) No 528/2012 of the European Parliament and of the Council^note.

(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 1Amendments 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 2Entry 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.

(1)the following entries are inserted:Index No | Chemical name | EC No | CAS No | Classification | Labelling | Specific Conc. Limits, M-factors and ATE | NotesHazard 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. 3Acute Tox. 3Skin Corr. 1A | H272H331H314 | GHS03GHS06GHS05Dgr | H272H331H314 | 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 % | B014-048-00-5 | silicon carbide fibres (with diameter < 3 μm, length > 5 μm and aspect ratio ≥ 3:1) | 206-991-8 | 409-21-2308076-74-6 | Carc. 1B | H350i | GHS08Dgr | H350i | | |014-049-00-0 | trimethoxyvinylsilane; trimethoxy(vinyl)silane | 220-449-8 | 2768-02-7 | Skin Sens. 1B | H317 | GHS07Wng | 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 | GHS08Dgr | H360FD | | |016-098-00-3 | dimethyl disulphide | 210-871-0 | 624-92-0 | Flam. Liq. 2Acute Tox. 3Acute Tox. 3STOT SE 3STOT SE 1Eye Irrit. 2Skin Sens. 1Aquatic Acute 1Aquatic Chronic 1 | H225H331H301H336H370 (upper respiratory tract, inhalation)H319H317H400H410 | GHS02GHS06GHS08GHS09Dgr | H225H331H301H336H370 (upper respiratory tract, inhalation)H319H317H410 | | inhalation: ATE = 5 mg/L (vapours)oral: ATE = 190 mg/kg bwM = 1M = 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 | 312600-89-815627-09-5 | Flam. Sol. 1Acute Tox. 4STOT RE 2Eye Dam. 1Aquatic Acute 1Aquatic Chronic 1 | H228H302H373 (liver)H318H400H410 | GHS02GHS07GHS08GHS05GHS09Dgr | H228H302H373(liver)H318H410 | | oral: ATE = 360 mg/kg bwM = 1M = 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. 1BSTOT RE 1 | H360DH372 (immune system) | GHS08Dgr | H360DH372 (immune system) | | |601-092-00-0 | dibenzo[def,p]chrysene;dibenzo[a,l]pyrene | 205-886-4 | 191-30-0 | Carc. 1BMuta. 2 | H350H341 | GHS08Dgr | H350H341 | | 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 | - | 125225-28-7115850-69-6115937-89-8 | Repr. 1BAcute Tox. 4STOT RE 2Aquatic Chronic 1 | H360DH302H373 (eyes, skin, liver)H410 | GHS08GHS07GHS09Dgr | H360DH302H373 (eyes, skin, liver)H410 | | oral: ATE = 500 mg/kg bwM = 100 |603-238-00-9 | bis(2-(2-methoxyethoxy)ethyl)ether; tetraglyme | 205-594-7 | 143-24-8 | Repr. 1B | H360FD | GHS08Dgr | 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. 2Acute Tox. 4Acute Tox. 4Eye Irrit. 2Aquatic Acute 1Aquatic Chronic 1 | H361dH332H302H319H400H410 | GHS08GHS07GHS09Wng | H361dH332H302H319H410 | | inhalation: ATE = 3,13 mg/L (dusts or mists)oral: ATE = 490 mg/kg bwM = 10M = 10 |603-240-00-X | 2,2-bis(bromomethyl)propane-1,3-diol | 221-967-7 | 3296-90-0 | Carc. 1BMuta. 1B | H350H340 | GHS08Dgr | H350H340 | | |603-241-00-5 | geraniol;(2E)-3,7-dimethylocta-2,6-dien-1-ol | 203-377-1 | 106-24-1 | Skin Sens. 1 | H317 | GHS07Wng | H317 | | |605-041-00-3 | 2-(4-tert-butylbenzyl)propionaldehyde | 201-289-8 | 80-54-6 | Repr. 1B | H360Fd | GHS08Dgr | 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. 4STOT RE. 2Aquatic Acute 1 Aquatic Chronic 1 | H302H373 (liver)H400H410 | GHS07GHS08GHS09Wng | H302H373 (liver)H410 | | oral: ATE = 450 mg/kg bwM = 10M = 10 |607-740-00-9 | diisooctyl phthalate | 248-523-5 | 27554-26-3 | Repr. 1B | H360FD | GHS08Dgr | 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. 4STOT RE 2Aquatic Acute 1Aquatic Chronic 1 | H302H373 (muscle)H400H410 | GHS07GHS08GHS09Wng | H302H373 (muscle)H410 | | oral: ATE = 500 mg/kg bwM = 10M = 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 1Aquatic Chronic 1 | H400H410 | GHS09Wng | H410 | | M = 1000M = 1000 |607-743-00-5 | L-(+)-lactic acid;(2S)-2-hydroxypropanoic acid | 201-196-2 | 79-33-4 | Skin Corr. 1CEye Dam. 1 | H314H318 | GHS05Dgr | H314 | EUH071 | |607-744-00-0 | 2-methoxyethyl acrylate | 221-499-3 | 3121-61-7 | Flam. Liq. 3Muta. 2Repr. 1BAcute Tox. 3Acute Tox. 4Skin Corr. 1CEye Dam. 1Skin Sens. 1 | H226H341H360FDH331H302H314H318H317 | GHS02GHS05GHS06GHS08Dgr | H226H341H360FDH331H302H314H317 | 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. 1Skin Sens. 1B | H318H317 | GHS05GHS07Dgr | H318H317 | | | B607-746-00-1 | sodium N-(hydroxymethyl)glycinate;[formaldehyde released from sodium N-(hydroxymethyl)glycinate] | 274-357-8 | 70161-44-3 | Carc. 1BMuta. 2Acute Tox. 4Acute Tox. 4STOT SE 3Skin Irrit. 2Eye Irrit. 2Skin Sens. 1 | H350H341H332H302H335H315H319H317 | GHS08GHS07Dgr | H350H341H332H302H335H315H319H317 | | inhalation: ATE = 3 mg/L (dusts or mists)oral: ATE = 1100 mg/kg bw | 89611-181-00-6 | potassium (oxido-NNO-azoxy)cyclohexane;cyclohexylhydroxydiazene 1-oxide, potassium salt;[K-HDO] | - | 66603-10-9 | Flam. Sol. 1Acute Tox. 3STOT RE 2Skin Irrit. 2Eye Dam. 1Aquatic Chronic 2 | H228H301H373 (liver)H315H318H411 | GHS02GHS06GHS08GHS05GHS09Dgr | H228H301H373 (liver)H315H318H411 | | 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. 1Eye Dam. 1Aquatic Acute 1Aquatic Chronic 1 | H314H318H400H410 | GHS05GHS09Dgr | H314H410 | EUH071 | M = 100M = 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. 1Aquatic Acute 1Aquatic Chronic 1 | H317H400H410 | GHS07GHS09Wng | H317H410 | | M = 1M = 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 | GHS09Wng | 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. 1BAcute Tox. 2Acute Tox. 3STOT RE 1Eye Dam. 1Aquatic Acute 1Aquatic Chronic 1 | H360DH330H301H372H318H400H410 | GHS08GHS06GHS05GHS09Dgr | H360DH330H301H372H318H410 | | inhalation: ATE = 0,14 mg/L (dusts or mists)oral: ATE = 221 mg/kg bwM = 1000M = 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. 1BAcute Tox. 4Skin Sens. 1Aquatic Acute 1Aquatic Chronic 1 | H360FDH302H317H400H410 | GHS08GHS07GHS09Dgr | H360FDH302H317H410 | | oral: ATE = 500 mg/kg bwM = 100M = 100 |613-335-00-8 | 4,5-dichloro-2-octyl-2H-isothiazol-3-one; [DCOIT] | 264-843-8 | 64359-81-5 | Acute Tox. 2Acute Tox. 4Skin Corr. 1Eye Dam. 1Skin Sens. 1AAquatic Acute 1Aquatic Chronic 1 | H330H302H314H318H317H400H410 | GHS06GHS05GHS09Dgr | H330H302H314H317H410 | EUH071 | inhalation: ATE = 0,16 mg/L (dusts or mists)oral: ATE = 567 mg/kg bwSkin Irrit. 2; H315: 0,025 % ≤ C < 5 %Eye Irrit. 2; H319: 0,025 % ≤ C < 3 %Skin Sens. 1A; H317: C ≥ 0,0015 %M = 100M = 100 |613-336-00-3 | 2-methyl-1,2-benzothiazol-3(2H)-one;[MBIT] | - | 2527-66-4 | Acute Tox. 4Acute Tox. 3Skin Corr. 1CEye Dam. 1Skin Sens. 1AAquatic Acute 1Aquatic Chronic 2 | H312H301H314H318H317H400H411 | GHS06GHS05GHS09Dgr | H312H301H314H317H410 | EUH071 | dermal: ATE = 1100 mg/kg bworal: ATE = 175 mg/kg bwSkin 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 1Aquatic Chronic 1 | H362H400H410 | GHS09Wng | H362H410 | | M = 1M = 1 |616-230-00-5 | N-(hydroxymethyl)acrylamide; methylolacrylamide; [NMA] | 213-103-2 | 924-42-5 | Carc. 1BMuta. 1BSTOT RE 1 | H350H340H372 (peripheral nervous system) | GHS08Dgr | H350H340H372 (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. 2Aquatic Acute 1Aquatic Chronic 1 | H351H400H410 | GHS08GHS09Wng | H351H410 | | M = 1M = 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 | GHS08Wng | H351 | | |616-233-00-1 | silthiofam (ISO);N-allyl-4,5-dimethyl-2-(trimethylsilyl)thiophene-3-carboxamide | - | 175217-20-6 | STOT RE 2Aquatic Chronic 2 | H373H411 | GHS08GHS09Wng | H373H411 | | |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 | NotesHazard 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. 2Acute Tox. 1Skin Corr. 1A | H272H330H314 | GHS03GHS06GHS05Dgr | H272H330H314 | EUH071 | Ox. Liq. 2; H272: C ≥ 99 %Ox. Liq. 3; H272: 70 % ≤ C < 99 % | B014-018-00-1 | octamethylcyclotetrasiloxane;[D4] | 209-136-7 | 556-67-2 | Repr. 2Aquatic Chronic 1 | H361f ***H410 | GHS08GHS09Wng | 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. 4STOT RE 1Aquatic Acute 1Aquatic Chronic 1 | H302H372 (nervous system)H400H410 | GHS07GHS08GHS09Dgr | H302H372 (nervous system)H410 | | oral: ATE = 1414 mg/kg bwM = 1000M = 1000 |015-181-00-1 | phosphine | 232-260-8 | 7803-51-2 | Flam. Gas 1Press. GasAcute Tox. 1Skin Corr. 1BAquatic Acute 1 | H220H330H314H400 | GHS02GHS04GHS06GHS05GHS09Dgr | H220H330H314H400 | | inhalation:ATE = 10 ppmV (gases) | U050-021-00-4 | dichlorodioctylstannane | 222-583-2 | 3542-36-7 | Repr. 1BAcute Tox. 2STOT RE 1Aquatic Chronic 3 | H360DH330H372 **H412 | GHS08GHS06Dgr | H360DH330H372 **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. 1BSTOT RE 1Aquatic Acute 1Aquatic Chronic 1 | H360DH372 (immune system)H400H410 | GHS08GHS09Dgr | H360DH372 (immune system)H410 | | |082-013-00-1 | lead powder; [particle diameter < 1 mm] | 231-100-4 | 7439-92-1 | Repr. 1ALact.Aquatic Acute 1Aquatic Chronic 1 | H360FDH362H400H410 | GHS08GHS09Dgr | H360FD H362H410 | | Repr. 1A; H360D: C ≥ 0,03 %M = 1M = 10 |603-014-00-0 | 2-butoxyethanol;ethylene glycol monobutyl ether | 203-905-0 | 111-76-2 | Acute Tox. 4*Acute Tox. 4Skin Irrit. 2Eye Irrit. 2 | H332H302H315H319 | GHS07Wng | H332H302H315H319 | | 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. 1BMuta. 2Acute Tox. 3Acute Tox. 4Skin Irrit. 2Eye Irrit. 2Skin Sens. 1Aquatic Chronic 3 | H350H341H311H302H315H319H317H412 | GHS08GHS06Dgr | H350H341H311H302H315H319H317H412 | | 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 2Skin Sens. 1Aquatic Acute 1Aquatic Chronic 1 | H373H317H400H410 | GHS08GHS07GHS09Wng | H373H317H410 | | M = 100M = 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. 3Aquatic Acute 1Aquatic Chronic 1 | H331H400H410 | GHS06GHS09Dgr | H331H410 | | inhalation:ATE = 0,7 mg/L (dusts or mists)M = 10M = 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 1Aquatic Chronic 1 | H400H410 | GHS09Wng | H410 | | M = 1M = 1 |609-041-00-4 | 2,4-dinitrophenol | 200-087-7 | 51-28-5 | Acute Tox. 3 *Acute Tox. 3Acute Tox. 2STOT RE 1Aquatic Acute 1 | H331H311H300H372H400 | GHS06GHS08GHS09Dgr | H331H311H300H372H400 | | 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. 2STOT RE 2Aquatic Acute 1Aquatic Chronic 1 | H361dH373 (eyes, nervous system)H400H410 | GHS08GHS09Wng | H361dH373 (eyes, nervous system)H410 | | M = 10M = 10 |613-112-00-5 | octhilinone (ISO);2-octyl-2H-isothiazol-3-one; [OIT] | 247-761-7 | 26530-20-1 | Acute Tox. 2Acute Tox. 3Acute Tox. 3Skin Corr. 1Eye Dam. 1Skin Sens. 1AAquatic Acute 1 Aquatic Chronic 1 | H330H311H301H314H318H317H400H410 | GHS06GHS05GHS09Dgr | H330H311H301H314H317H410 | EUH071 | inhalation: ATE = 0,27 mg/L (dusts or mists)dermal: ATE = 311 mg/kg bw oral: ATE = 125 mg/kg bwSkin Sens. 1A; H317: C ≥ 0,0015 %M = 100M = 100 |613-115-00-1 | hymexazol (ISO);3-hydroxy-5-methylisoxazole | 233-000-6 | 10004-44-1 | Repr. 2Acute Tox. 4Eye Dam. 1Skin Sens. 1Aquatic Chronic 2 | H361dH302H318H317H411 | GHS08GHS07GHS05GHS09Dgr | H361dH302H318H317H411 | | 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 1Aquatic Chronic 1 | H400H410 | GHS09Wng | H410 | | M = 1M = 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. 2Repr. 2Aquatic Chronic 1 | H351H361fdH410 | GHS08GHS09Wng | H351H361fdH410 | | 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. 2Acute Tox. 4Acute Tox. 4STOT SE 2Aquatic Acute 1Aquatic Chronic 1 | H351H332H302H371 (nervous system; oral, inhalation)H400H410 | GHS08GHS07GHS09Wng | H351H332H302H371 (nervous system; oral, inhalation)H410 | | inhalation: ATE = 1,4 mg/L (dusts or mists)oral: ATE = 550 mg/kg bwM = 10M = 10 |616-014-00-0 | butanone oxime; ethyl methyl ketoxime; ethyl methyl ketone oxime | 202-496-6 | 96-29-7 | Carc. 1BAcute Tox. 4Acute Tox. 3STOT SE 3STOT SE 1STOT RE 2Skin Irrit. 2Eye Dam. 1Skin Sens. 1 | H350H312H301H336H370 (upper respiratory tract)H373 (blood system)H315H318H317 | GHS08GHS06GHS05Dgr | H350H312H301H336H370 (upper respiratory tract)H373 (blood system)H315H318H317 | | 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. FRepr. 1BSkin Irrit. 2Eye Irrit. 2Aquatic Chronic 2 | H242H360DH315H319H411 | GHS02GHS08GHS07GHS09Dgr | H242H360DH315H319H411 | | |

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

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