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:
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.
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
In Annex VI to Regulation (EC) No 1272/2008, Table 3 of Part 3 is amended as follows:
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’ | ||||
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’ | |||
the entries corresponding to index numbers 601-064-00-8 and 607-693-00-4 are deleted.
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/-/
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).
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).