Commission Delegated Regulation (EU) 2021/849 of 11 March 2021 amending, for the purposes of its adaptation to technical and scientific progress, Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (Text with EEA relevance)
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Address https://gelex.eu/eli/EU/regulation/2021/849@2021-03-11/en
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, 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. The Committee for Risk Assessment of the Agency (RAC) adopted opinions on those proposals, after having taken account of the comments received from the parties concerned. Those RAC opinions are:
Opinion of 15 March 2019 concerning 1,2,4-triazole,
Opinion of 15 March 2019 concerning 1,4-dioxane,
Opinion of 15 March 2019 concerning benzyl salicylate,
Opinion of 15 March 2019 concerning flumioxazin (ISO),
Opinion of 15 March 2019 concerning mancozeb (ISO),
Opinion of 15 March 2019 concerning M-factors for long-term aquatic hazard for the copper substances listed in Commission Regulation (EU) 2016/1179,
Opinion of 15 March 2019 concerning N-{2-[[1,1'-bi(cyclopropyl)]-2-yl]phenyl}-3-(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxamide; sedaxane,
Opinion of 15 March 2019 concerning N-methoxy-N-[1-methyl-2-(2,4,6-trichlorophenyl)-ethyl]-3-(difluoromethyl)-1-methylpyrazole-4-carboxamide; pydiflumetofen,
Opinion of 15 March 2019 concerning p-cymene; 1-isopropyl-4-methylbenzene,
Opinion of 15 March 2019 concerning p-mentha-1,3-diene; alpha-terpinene; 1-isopropyl-4-methylcyclohexa-1,3-diene,
Opinion of 15 March 2019 concerning prothioconazole,
Opinion of 15 March 2019 concerning (R)-p-mentha-1,8-diene; d-limonene,
Opinion of 15 March 2019 concerning thiophanate-methyl,
Opinion of 15 March 2019 concerning tolclofos-methyl (ISO); O-(2,6-dichloro-p-tolyl) O,O-dimethyl thiophosphate,
Opinion of 15 March 2019 concerning tolpyralate,
Opinion of 15 March 2019 concerning trinickel disulphide,
Opinion of 13 June 2019 concerning azamethiphos,
Opinion of 13 June 2019 concerning 2-phenoxyethanol,
Opinion of 13 June 2019 concerning 2,2-dibromo-2-cyanoacetamide,
Opinion of 13 June 2019 concerning 3-aminomethyl-3,5,5-trimethylcyclohexylamine,
Opinion of 13 June 2019 concerning 6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol,
Opinion of 13 June 2019 concerning diflufenican (ISO) N-(2,4-difluorophenyl)-2-[3-(trifluoromethyl)phenoxy]-3-pyridinecarboxamide,
Opinion of 13 June 2019 concerning imidacloprid (ISO); 1-(6-chloropyridin-3-ylmethyl)-N-nitroimidazolidin-2-ylidenamine,
Opinion of 13 June 2019 concerning pyriofenone,
Opinion of 13 June 2019 concerning S-abscisic acid,
Opinion of 13 June 2019 concerning tetrakis(2,6-dimethylphenyl)-m-phenylene biphosphate,
Opinion of 20 September 2019 concerning 1,2-epoxy-4-epoxyethylcyclohexane,
Opinion of 20 September 2019 concerning 4-methylpentan-2-one,
Opinion of 20 September 2019 concerning boric acid; diboron trioxide; tetraboron disodium heptaoxide hydrate; disodium tetraborate anhydrous; orthoboric acid sodium salt; disodium tetraborate decahydrate; disodium tetraborate pentahydrate,
Opinion of 20 September 2019 concerning citric acid,
Opinion of 20 September 2019 concerning clomazone,
Opinion of 20 September 2019 concerning desmedipham,
Opinion of 20 September 2019 concerning dimethomorph,
Opinion of 20 September 2019 concerning emamectin benzoate,
Opinion of 20 September 2019 concerning esfenvalerate (ISO) (S)-α-cyano-3-phenoxybenzyl (S)-2-(4-chlorophenyl)-3-methylbutyrate,
Opinion of 20 September 2019 concerning ethametsulfuron-methyl (ISO),
Opinion of 20 September 2019 concerning mecoprop-P (ISO); (R)-2-(4-chloro-2-methylphenoxy)propionic acid and its salts,
Opinion of 20 September 2019 concerning methyl salicylate,
Opinion of 20 September 2019 concerning phenmedipham (ISO),
Opinion of 20 September 2019 concerning trifloxystrobin (ISO),
Opinion of 20 September 2019 concerning triticonazole,
Opinion of 5 December 2019 concerning 1,4-dimethylnaphthalene,
Opinion of 5 December 2019 concerning (3aS,5S,6R,7aR,7bS,9aS,10R,12aS,12bS)-10-[(2S,3R,4R,5R)-3,4-dihydroxy-5,6-dimethylheptan-2-yl]-5,6-dihydroxy-7a,9a-dimethylhexadecahydro-3H-benzo[c]indeno[5,4-e]oxepin-3-one; 24-epibrassinolide,
Opinion of 5 December 2019 concerning 3-methylpyrazole,
Opinion of 5 December 2019 concerning carbendazim (ISO); methyl benzimidazol-2-ylcarbamate,
Opinion of 5 December 2019 concerning cypermethrin cis/trans +/- 40/60; (RS)-α-cyano-3-phenoxybenzyl (1RS,3RS;1RS,3SR)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate,
Opinion of 5 December 2019 concerning imazamox (ISO); (RS)-2-(4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl)-5-methoxymethylnicotinic acid,
Opinion of 5 December 2019 concerning tetrafluoroethylene,
Opinion of 5 December 2019 concerning thiamethoxam (ISO); 3-(2-chloro-thiazol-5-ylmethyl)-5-methyl[1,3,5]oxadiazinan-4-ylidene-N-nitroamine,
Opinion of 5 December 2019 concerning trinexapac-ethyl (ISO); ethyl 4-[cyclopropyl(hydroxy)methylene]-3,5-dioxocyclohexanecarboxylate.
(3) Acute Toxicity Estimates (ATE) are mainly used to determine the classification for human health acute toxicity of mixtures containing substances classified for acute toxicity. The inclusion of harmonised ATE values in the entries listed in Annex VI to Regulation (EC) No 1272/2008 facilitates the harmonisation of the classification of mixtures and provides support for enforcement authorities. Following further scientific assessmentsof some substances, ATE values have been derived by the Agency for dicopper oxide, dicopper chloride trihydroxide, tetracopper hexahydroxide sulphate and tetracopper hexahydroxide sulphate hydrate, copper flakes (coated with aliphatic acid), copper(II) carbonate--copper(II) hydroxide (1:1), copper dihydroxide; copper(II) hydroxide, bordeaux mixture; reaction products of copper sulphate with calcium dihydroxide and copper sulphate pentahydrate, in addition to those proposed in the RAC opinions for other substances. Those ATE values should be inserted in the penultimate column of Table 3 of Part 3 of Annex VI to Regulation (EC) No 1272/2008.
(4) Additional information was received by the Commission contesting the scientific assessment set out in the RAC opinions of 15 March 2019 concerning mancozeb, of 20 September 2019 concerning 4-methylpentan-2-one, and of 20 September 2019 concerning dimethomorph. That information was assessed by the Commission and was not found sufficient to cast doubts on the scientific analysis contained in the RAC opinions.
(5) The Commission therefore considers appropriate to introduce, update or delete the harmonised classification and labelling of certain substances.
(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 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 or those set out in Article 50 of Regulation (EU) No 528/2012 of the European Parliament and of the Council. 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 and as of the date of entry into force 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
Table 3 of Part 3 of Annex VI to Regulation (EC) No 1272/2008 is amended as set out in the Annex to this Regulation.
Article 2 Entry into force and application
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 17 December 2022. 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, 11 March 2021. For the Commission The President Ursula von der Leyen
ANNEX
ANNEX
In Annex VI to Regulation (EC) No 1272/2008, Table 3 of Part 3 is amended as follows:
(1) the following entries are inserted: Index No Chemical Name EC No CAS No Classification Labelling Specific Conc. Limits, M-factors and ATE Notes Hazard Class and Category Code(s) Hazard statement Code(s) Pictogram, Signal Word Code(s) Hazard statement Code(s) Suppl. Hazard statement Code(s) 601-093-00-6 1,4-dimethylnaphthalene 209-335-9 571-58-4 Acute Tox. 4 Asp. Tox. 1 Eye Irrit. 2 Aquatic Acute 1 Aquatic Chronic 3 H302 H304 H319 H400 H412 GHS07 GHS08 GHS09 Dgr H302 H304 H319 H410 oral: ATE = 1300 mg/kg bw M = 1 601-094-00-1 1-isopropyl-4-methylbenzene; p-cymene 202-796-7 99-87-6 Flam. Liq. 3 Acute Tox. 3 Asp. Tox. 1 Aquatic Chronic 2 H226 H331 H304 H411 GHS02 GHS06 GHS08 GHS09 Dgr H226 H331 H304 H411 inhalation: ATE = 3 mg/l (vapours) 601-095-00-7 p-mentha-1,3-diene; 1-isopropyl-4-methylcyclohexa-1,3-diene; alpha-terpinene 202-795-1 99-86-5 Flam. Liq. 3 Acute Tox. 4 Skin Sens. 1 Asp. Tox. 1 Aquatic Chronic 2 H226 H302 H317 H304 H411 GHS02 GHS07 GHS08 GHS09 Dgr H226 H302 H317 H304 H411 oral: ATE = 1680 mg/kg bw 602-110-00-X tetrafluoroethylene 204-126-9 116-14-3 Carc. 1B H350 GHS08 Dgr H350 604-095-00-5 6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol; [DBMC] 204-327-1 119-47-1 Repr. 1B H360F GHS08 Dgr H360F 606-152-00-X (5-chloro-2-methoxy-4-methyl-3-pyridyl)(4,5,6-trimethoxy-o-tolyl)methanone; pyriofenone - 688046-61-9 Carc. 2 Aquatic Chronic 1 H351 H410 GHS08 GHS09 Wng H351 H410 M = 1 607-747-00-7 2,2-dibromo-2-cyanoacetamide; [DBNPA] 233-539-7 10222-01-2 Acute Tox. 2 Acute Tox. 3 STOT RE 1 Skin Irrit. 2 Eye Dam. 1 Skin Sens. 1 Aquatic Acute 1 Aquatic Chronic 1 H330 H301 H372 (respiratory tract) (inhalation) H315 H318 H317 H400 H410 GHS06 GHS08 GHS05 GHS09 Dgr H330 H301 H372 (respiratory tract) (inhalation) H315 H318 H317 H410 inhalation: ATE = 0,24 mg/l (dusts or mists) oral: ATE = 118 mg/kg bw M = 1 M = 1 607-748-00-2 [S-(Z,E)]-5-(1-hydroxy-2,6,6-trimethyl-4-oxocyclohex-2-en-1-yl)-3-methylpenta-2,4-dienoic acid; S-abscisic acid 244-319-5 21293-29-8 Aquatic Acute 1 Aquatic Chronic 1 H400 H410 GHS09 Wng H410 M = 1 M = 1 607-749-00-8 methyl salicylate 204-317-7 119-36-8 Repr. 2 Acute Tox. 4 Skin Sens. 1B Aquatic Chronic 3 H361d H302 H317 H412 GHS07 GHS08 Wng H361d H302 H317 H412 oral: ATE = 890 mg/kg bw 607-750-00-3 citric acid 201-069-1 77-92-9 Eye Irrit. 2 STOT SE 3 H319 H335 GHS07 Wng H319 H335 607-751-00-9 ethametsulfuron-methyl (ISO); methyl 2-({[4-ethoxy-6-(methylamino)-1,3,5-triazin-2-yl]carbamoyl}sulfamoyl)benzoate - 97780-06-8 Eye Irrit. 2 Aquatic Acute 1 Aquatic Chronic 1 H319 H400 H410 GHS07 GHS09 Wng H319 H410 M = 1000 M = 100 607-752-00-4 trinexapac-ethyl (ISO); ethyl 4-[cyclopropyl(hydroxy)methylene]-3,5-dioxocyclohexanecarboxylate - 95266-40-3 STOT RE 2 Skin Sens. 1B Aquatic Chronic 1 H373 (gastrointestinal tract) H317 H410 GHS08 GHS07 GHS09 Wng H373 (gastrointestinal tract) H317 H410 M = 1 607-753-00-X (3aS,5S,6R,7aR,7bS,9aS,10R,12aS,12bS)-10-[(2S,3R,4R,5R)-3,4-dihydroxy-5,6-dimethylheptan-2-yl]-5,6-dihydroxy-7a,9a-dimethylhexadecahydro-3H-benzo[c]indeno[5,4-e]oxepin-3-one; 24-epibrassinolide - 78821-43-9 Aquatic Chronic 4 H413 H413 607-754-00-5 benzyl salicylate 204-262-9 118-58-1 Skin Sens. 1B H317 GHS07 Wng H317 607-755-00-0 (RS)-1-{1-ethyl-4-[4-mesyl-3-(2-methoxyethoxy)-o-toluoyl]pyrazol-5-yloxy}ethyl methyl carbonate; tolpyralate - 1101132-67-5 Carc. 2 Repr. 2 STOT RE 2 Aquatic Acute 1 Aquatic Chronic 1 H351 H361fd H373 (eye) H400 H410 GHS08 GHS09 Wng H351 H361fd H373 (eye) H410 M = 10 M = 100 613-337-00-9 prothioconazole (ISO); 2-[2-(1-chlorocyclopropyl)-3-(2-chlorophenyl)-2-hydroxypropyl]-2,4-dihydro-3H-1,2,4-triazole-3-thione - 178928-70-6 Aquatic Acute 1 Aquatic Chronic 1 H400 H410 GHS09 Wng H410 M = 10 M = 1 613-338-00-4 azamethiphos (ISO); S-[(6-chloro-2-oxooxazolo[4,5-b]pyridin-3(2H)-yl)methyl] O,O-dimethyl thiophosphate 252-626-0 35575-96-3 Carc. 2 Acute Tox. 3 Acute Tox. 4 STOT SE 1 Skin Sens. 1 Aquatic Acute 1 Aquatic Chronic 1 H351 H331 H302 H370 (nervous system) H317 H400 H410 GHS06 GHS08 GHS09 Dgr H351 H331 H302 H370 (nervous system) H317 H410 inhalation: ATE = 0,5 mg/l (dusts or mists) oral: ATE = 500 mg/kg bw M = 1000 M = 1000 613-339-00-X 3-methylpyrazole 215-925-7 1453-58-3 Repr. 1B Acute Tox. 4 STOT RE 2 Skin Corr. 1 Eye Dam. 1 H360D H302 H373 (lung) H314 H318 GHS08 GHS07 GHS05 Dgr H360D H302 H373 (lung) H314 oral: ATE = 500 mg/kg bw 613-340-00-5 clomazone (ISO); 2-(2-chlorobenzyl)-4,4-dimethyl-1,2-oxazolidin-3-one - 81777-89-1 Acute Tox. 4 Acute Tox. 4 Aquatic Acute 1 Aquatic Chronic 1 H332 H302 H400 H410 GHS07 GHS09 Wng H332 H302 H410 inhalation: ATE = 4,85 mg/l (dusts or mists) oral: ATE = 768 mg/kg bw M = 1 M = 1 614-030-00-2 emamectin benzoate (ISO); (4"R)-4"-deoxy-4"-(methylamino) avermectin B1 benzoate - 155569-91-8 Acute Tox. 3 Acute Tox. 3 Acute Tox. 3 STOT SE 1 STOT RE 1 Eye Dam. 1 Aquatic Acute 1 Aquatic Chronic 1 H331 H311 H301 H370 (nervous system) H372 (nervous system) H318 H400 H410 GHS06 GHS05 GHS08 GHS09 Dgr H331 H311 H301 H370 (nervous system) H372 (nervous system) H318 H410 inhalation: ATE = 0,663 mg/l (dusts or mists) dermal: ATE = 300 mg/kg bw oral: ATE = 60 mg/kg bw STOT RE 1; H372: C ≥ 5 %; STOT RE 2; H373: 0,5 % ≤ C < 5 % M = 10000 M = 10000 616-234-00-7 N-methoxy-N-[1-methyl-2-(2,4,6-trichlorophenyl)-ethyl]-3-(difluoromethyl)-1-methylpyrazole-4-carboxamide; pydiflumetofen - 1228284-64-7 Carc. 2 Repr. 2 Aquatic Acute 1 Aquatic Chronic 1 H351 H361f H400 H410 GHS08 GHS09 Wng H351 H361f H410 M = 1 M = 1 616-235-00-2 N-{2-[[1,1'-bi(cyclopropyl)]-2-yl]phenyl}-3-(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxamide; sedaxane - 874967-67-6 Carc. 2 Aquatic Acute 1 Aquatic Chronic 2 H351 H400 H411 GHS08 GHS09 Wng H351 H410 M = 1
(2) the entries corresponding to index numbers 005-007-00-2; 005-008-00-8; 005-011-00-4; 005-011-01-1; 005-011-02-9; 006-069-00-3; 006-076-00-1; 015-113-00-0; 028-007-00-4; 029-002-00-X; 029-015-00-0; 029-016-00-6; 029-017-00-1; 029-018-00-7; 029-019-01-X; 029-020-00-8; 029-021-00-3; 029-022-00-9; 029-023-00-4; 601-029-00-7; 601-096-00-2; 603-024-00-5; 603-066-00-4; 603-098-00-9; 606-004-00-4; 607-421-00-4; 607-424-00-0; 607-434-00-5; 608-058-00-4; 612-067-00-9; 612-252-00-4; 613-048-00-8; 613-102-00-0; 613-111-00-X; 613-166-00-X; 613-208-00-7; 613-267-00-9; 613-282-00-0; 616-032-00-9; 616-106-00-0 and 616-113-00-9 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) 005-007-00-2 boric acid [1] boric acid [2] 233-139-2 [1] 234-343-4 [2] 10043-35-3 [1] 11113-50-1 [2] Repr. 1B H360FD GHS08 Dgr H360FD 005-008-00-8 diboron trioxide 215-125-8 1303-86-2 Repr. 1B H360FD GHS08 Dgr H360FD 005-011-00-4 tetraboron disodium heptaoxide, hydrate; [1] disodium tetraborate, anhydrous; [2] orthoboric acid, sodium salt [3] disodium tetraborate decahydrate [4] disodium tetraborate pentahydrate [5] 235-541-3 [1] 215-540-4 [2] 237-560-2 [3] 215-540-4 [4] 215-540-4 [5] 12267-73-1 [1] 1330-43-4 [2] 13840-56-7 [3] 1303-96-4 [4] 12179-04-3 [5] Repr. 1B H360FD GHS08 Dgr H360FD 006-069-00-3 thiophanate-methyl (ISO); dimethyl (1,2-phenylenedicarbamothioyl)biscarbamate; dimethyl 4,4′-(o-phenylene)bis(3-thioallophanate) 245-740-7 23564-05-8 Carc. 2 Muta. 2 Acute Tox. 4 Skin Sens. 1 Aquatic Acute 1 Aquatic Chronic 1 H351 H341 H332 H317 H400 H410 GHS08 GHS07 GHS09 Wng H351 H341 H332 H317 H410 inhalation: ATE = 1,7 mg/l (dusts and mists) M = 10 M = 10 006-076-00-1 mancozeb (ISO); manganese ethylenebis(dithiocarbamate) (polymeric) complex with zinc salt - 8018-01-7 Carc. 2 Repr. 1B STOT RE 2 Skin Sens. 1 Aquatic Acute 1 Aquatic Chronic 1 H351 H360D H373 (thyroid, nervous system) H317 H400 H410 GHS08 GHS07 GHS09 Dgr H351 H360D H373 (thyroid, nervous system) H317 H410 M = 10 M = 10 015-113-00-0 tolclofos-methyl (ISO); O-(2,6-dichloro-p-tolyl) O,O-dimethyl thiophosphate 260-515-3 57018-04-9 Skin Sens. 1B Aquatic Acute 1 Aquatic Chronic 1 H317 H400 H410 GHS07 GHS09 Wng H317 H410 M = 1 M = 1 028-007-00-4 trinickel disulfide; nickel subsulfide; [1] heazlewoodite [2] 234-829-6 [1] - [2] 12035-72-2 [1] 12035-71-1 [2] Carc. 1A Muta. 2 Acute Tox. 3 STOT RE 1 Skin Sens. 1 Aquatic Acute 1 Aquatic Chronic 1 H350i H341 H331 H372** H317 H400 H410 GHS08 GHS06 GHS09 Dgr H350i H341 H331 H372** H317 H410 inhalation: ATE = 0,92 mg/l (dusts or mists) 029-002-00-X dicopper oxide; copper (I) oxide 215-270-7 1317-39-1 Acute Tox. 4 Acute Tox. 4 Eye Dam. 1 Aquatic Acute 1 Aquatic Chronic 1 H332 H302 H318 H400 H410 GHS07 GHS05 GHS09 Dgr H332 H302 H318 H410 inhalation: ATE = 3,34 mg/l (dusts or mists) oral: ATE = 500 mg/kg bw M = 100 M = 10 029-015-00-0 copper thiocyanate 214-183-1 1111-67-7 Aquatic Acute 1 Aquatic Chronic 1 H400 H410 GHS09 Wng H410 EUH032 M = 10 M = 10 029-016-00-6 copper(II) oxide 215-269-1 1317-38-0 Aquatic Acute 1 Aquatic Chronic 1 H400 H410 GHS09 Wng H410 M = 100 M = 10 029-017-00-1 dicopper chloride trihydroxide 215-572-9 1332-65-6 Acute Tox. 4 Acute Tox. 3 Aquatic Acute 1 Aquatic Chronic 1 H332 H301 H400 H410 GHS06 GHS09 Dgr H332 H301 H410 inhalation: ATE = 2,83 mg/l (dusts or mists) oral: ATE = 299 mg/kg bw M = 10 M = 10 029-018-00-7 tetracopper hexahydroxide sulphate; [1] tetracopper hexahydroxide sulphate hydrate [2] 215-582-3 [1] 215-582-3 [2] 1333-22-8 [1] 12527-76-3 [2] Acute Tox. 4 Aquatic Acute 1 Aquatic Chronic 1 H302 H400 H410 GHS07 GHS09 Wng H302 H410 oral: ATE = 500 mg/kg bw M = 10 M = 10 029-019-01-X copper flakes (coated with aliphatic acid) - - Acute Tox. 3 Acute Tox. 4 Eye Irrit. 2 Aquatic Acute 1 Aquatic Chronic 1 H331 H302 H319 H400 H410 GHS06 GHS09 Dgr H331 H302 H319 H410 inhalation: ATE = 0,733 mg/l (dusts or mists) oral: ATE = 500 mg/kg bw M = 10 M = 10 029-020-00-8 copper(II) carbonate—copper(II) hydroxide (1:1) 235-113-6 12069-69-1 Acute Tox. 4 Acute Tox. 4 Eye Irrit. 2 Aquatic Acute 1 Aquatic Chronic 1 H332 H302 H319 H400 H410 GHS07 GHS09 Wng H332 H302 H319 H410 inhalation: ATE = 1,2 mg/l (dusts or mists) oral: ATE = 500 mg/kg bw M = 10 M = 10 029-021-00-3 copper dihydroxide; copper(II) hydroxide 243-815-9 20427-59-2 Acute Tox. 2 Acute Tox. 4 Eye Dam. 1 Aquatic Acute 1 Aquatic Chronic 1 H330 H302 H318 H400 H410 GHS06 GHS05 GHS09 Dgr H330 H302 H318 H410 inhalation: ATE = 0,47 mg/l (dusts or mists) oral: ATE = 500 mg/kg bw M = 10 M = 10 029-022-00-9 bordeaux mixture; reaction products of copper sulphate with calcium dihydroxide - 8011-63-0 Acute Tox. 4 Eye Dam. 1 Aquatic Acute 1 Aquatic Chronic 1 H332 H318 H400 H410 GHS07 GHS05 GHS09 Dgr H332 H318 H410 inhalation: ATE = 1,97 mg/l (dusts or mists) M = 10 M = 1 029-023-00-4 copper sulphate pentahydrate 231-847-6 7758-99-8 Acute Tox. 4 Eye Dam. 1 Aquatic Acute 1 Aquatic Chronic 1 H302 H318 H400 H410 GHS07 GHS05 GHS09 Dgr H302 H318 H410 oral: ATE = 481 mg/kg bw M = 10 M = 1 601-029-00-7 dipentene; limonene [1] (S)-p-mentha-1,8-diene; l-limonene [2] trans-1-methyl-4-(1-methylvinyl)cyclohexene; [3] (±)-1-methyl-4-(1-methylvinyl)cyclohexene [4] 205-341-0 [1] 227-815-6 [2] 229-977-3 [3] 231-732-0 [4] 138-86-3 [1] 5989-54-8 [2] 6876-12-6 [3] 7705-14-8 [4] Flam. Liq. 3 Skin Irrit. 2 Skin Sens. 1 Aquatic Acute 1 Aquatic Chronic 1 H226 H315 H317 H400 H410 GHS02 GHS07 GHS09 Wng H226 H315 H317 H410 C 601-096-00-2 (R)-p-mentha-1,8-diene; d-limonene 227-813-5 5989-27-5 Flam. Liq. 3 Skin Irrit. 2 Skin Sens. 1B Asp. Tox. 1 Aquatic Acute 1 Aquatic Chronic 3 H226 H315 H317 H304 H400 H412 GHS02 GHS07 GHS08 GHS09 Dgr H226 H315 H317 H304 H410 M = 1 603-024-00-5 1,4-dioxane 204-661-8 123-91-1 Flam. Liq. 2 Carc. 1B STOT SE 3 Eye Irrit. 2 H225 H350 H335 H319 GHS02 GHS08 GHS07 Dgr H225 H350 H335 H319 EUH019 EUH066 D 603-066-00-4 7-oxa-3-oxiranylbicyclo[4.1.0]heptane; 1,2-epoxy-4-epoxyethylcyclohexane; 4-vinylcyclohexene diepoxide 203-437-7 106-87-6 Carc. 1B Muta. 2 Repr. 1B Acute Tox. 3 Acute Tox. 4 H350 H341 H360F H331 H302 GHS08 GHS06 Dgr H350 H341 H360F H331 H302 inhalation: ATE = 0,5 mg/l (dusts or mists) oral: ATE = 1847 mg/kg bw 603-098-00-9 2-phenoxyethanol 204-589-7 122-99-6 Acute Tox. 4 STOT SE 3 Eye Dam. 1 H302 H335 H318 GHS05 GHS07 Dgr H302 H335 H318 oral: ATE = 1394 mg/kg bw 606-004-00-4 4-methylpentan-2-one; isobutyl methyl ketone 203-550-1 108-10-1 Flam. Liq. 2 Carc. 2 Acute Tox. 4 STOT SE 3 Eye Irrit. 2 H225 H351 H332 H336 H319 GHS02 GHS07 GHS08 Dgr H225 H351 H332 H336 H319 EUH066 inhalation: ATE = 11 mg/l (vapours) 607-421-00-4 cypermethrin (ISO); α-cyano-3-phenoxybenzyl 3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate; cypermethrin cis/trans +/- 40/60 257-842-9 52315-07-8 Acute Tox. 4 Acute Tox. 4 STOT SE 3 STOT RE 2 Aquatic Acute 1 Aquatic Chronic 1 H332 H302 H335 H373 (nervous system) H400 H410 GHS07 GHS08 GHS09 Wng H332 H302 H335 H373 (nervous system) H410 oral; ATE = 500 mg/kg bw inhalation; ATE = 3,3 mg/l (dusts or mists) M = 100000 M = 100000 607-424-00-0 trifloxystrobin (ISO); methyl (E)-methoxyimino-{(E)-α-[1-(α,α,α-trifluoro-m-tolyl)ethylideneaminooxy]-o-tolyl}acetate - 141517-21-7 Lact. Skin Sens. 1 Aquatic Acute 1 Aquatic Chronic 1 H362 H317 H400 H410 GHS07 GHS09 Wng H362 H317 H410 M = 100 M = 10 607-434-00-5 mecoprop-P (ISO) [1] and its salts; (R)-2-(4-chloro-2-methylphenoxy)propionic acid [1] and its salts 240-539-0 [1] 16484-77-8 [1] Acute Tox. 4 Eye Dam. 1 Aquatic Acute 1 Aquatic Chronic 1 H302 H318 H400 H410 GHS07 GHS05 GHS09 Dgr H302 H318 H410 oral: ATE = 431 mg/kg bw M = 10 M = 10 608-058-00-4 esfenvalerate (ISO); (S)-α-cyano-3-phenoxybenzyl-(S)-2-(4-chlorophenyl)-3-methylbutyrate - 66230-04-4 Acute Tox. 3 Acute Tox. 3 STOT SE 1 STOT RE 2 Skin Sens. 1 Aquatic Acute 1 Aquatic Chronic 1 H331 H301 H370 (nervous system) H373 H317 H400 H410 GHS06 GHS08 GHS09 Dgr H331 H301 H370 (nervous system) H373 H317 H410 oral; ATE = 88,5 mg/kg bw inhalation; ATE = 0,53 mg/l (dusts or mists) M = 10000 M = 10000 612-067-00-9 3-aminomethyl-3,5,5-trimethylcyclohexylamine 220-666-8 2855-13-2 Acute Tox. 4 Skin Corr. 1B Eye Dam. 1 Skin Sens. 1A H302 H314 H318 H317 GHS05 GHS07 Dgr H302 H314 H317 oral: ATE = 1030 mg/kg bw Skin Sens. 1A; H317: C ≥ 0,001 % 612-252-00-4 imidacloprid (ISO); (E)-1-(6-chloro-3-pyridylmethyl)-N-nitroimidazolidin-2-ylideneamine; (2E)-1-[(6-chloropyridin-3-yl) methyl]-N-nitroimidazolidin-2-imine 428-040-8 138261-41-3 Acute Tox. 3 Aquatic Acute 1 Aquatic Chronic 1 H301 H400 H410 GHS06 GHS09 Dgr H301 H410 oral: ATE = 131 mg/kg bw M = 100 M = 1000 613-048-00-8 carbendazim (ISO); methyl benzimidazol-2-ylcarbamate 234-232-0 10605-21-7 Muta. 1B Repr. 1B Skin Sens. 1 Aquatic Acute 1 Aquatic Chronic 1 H340 H360FD H317 H400 H410 GHS07 GHS08 GHS09 Dgr H340 H360FD H317 H410 M = 10 M = 10 613-102-00-0 dimethomorph (ISO); (E,Z)-4-(3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)acryloyl)morpholine 404-200-2 110488-70-5 Repr. 1B Aquatic Chronic 2 H360F H411 GHS08 GHS09 Dgr H360F H411 613-111-00-X 1,2,4-triazole 206-022-9 288-88-0 Repr. 1B Acute Tox. 4 Eye Irrit. 2 H360FD H302 H319 GHS08 GHS07 Dgr H360FD H302 H319 oral: ATE = 1320 mg/kg bw 613-166-00-X flumioxazin (ISO); N-(7-fluoro-3,4-dihydro-3-oxo-4-prop-2-ynyl-2H-1,4-benzoxazin-6-yl)cyclohex-1-ene-1,2-dicarboximide - 103361-09-7 Repr. 2 Aquatic Acute 1 Aquatic Chronic 1 H361d H400 H410 GHS08 GHS09 Wng H361d H410 M = 1000 M = 1000 613-208-00-7 imazamox (ISO); (RS)-2-(4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl)-5-methoxymethylnicotinic acid - 114311-32-9 Repr. 2 Aquatic Acute 1 Aquatic Chronic 1 H361d H400 H410 GHS08 GHS09 Wng H361d H410 M = 10 M = 10 613-267-00-9 thiamethoxam (ISO); 3-(2-chloro-thiazol-5-ylmethyl)-5-methyl[1,3,5]oxadiazinan-4-ylidene-N-nitroamine 428-650-4 153719-23-4 Repr. 2 Acute Tox. 4 Aquatic Acute 1 Aquatic Chronic 1 H361fd H302 H400 H410 GHS07 GHS08 GHS09 Wng H361fd H302 H410 oral: ATE = 780 mg/kg bw M = 10 M = 10 613-282-00-0 triticonazole (ISO); (RS)-(E)-5-(4-chlorobenzylidene)-2,2-dimethyl-1-(1H-1,2,4-triazol-1-methyl)cyclopentanol - 138182-18-0 Repr. 2 STOT RE 2 Aquatic Acute 1 Aquatic Chronic 1 H361f H373 H400 H410 GHS08 GHS09 Wng H361f H373 H410 M = 1 M = 1 616-032-00-9 diflufenican (ISO); N-(2,4-difluorophenyl)-2-[3-(trifluoromethyl)phenoxy]-3-pyridinecarboxamide; 2′,4′-difluoro-2-(α,α,α-trifluoro-m-tolyloxy) nicotinanilide - 83164-33-4 Aquatic Acute 1 Aquatic Chronic 1 H400 H410 GHS09 Wng H410 M = 10000 M = 1000 616-106-00-0 phenmedipham (ISO); methyl 3-(3-methylcarbaniloyloxy)carbanilate 237-199-0 13684-63-4 Aquatic Acute 1 Aquatic Chronic 1 H400 H410 GHS09 Wng H410 M = 10 M = 10 616-113-00-9 desmedipham (ISO); ethyl 3-phenylcarbamoyloxyphenylcarbamate 237-198-5 13684-56-5 Repr. 2 Aquatic Acute 1 Aquatic Chronic 1 H361d H400 H410 GHS08 GHS09 Wng H361d H410 M = 10 M = 10
(3) the entry corresponding to index number 015-192-00-1 is deleted.
Versions
Cited by
- Commission Regulation (EU) 2022/1531 of 15 September 2022 amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the use in cosmetic products of certain substances classified as carcinogenic, mutagenic or toxic for reproduction and correcting that Regulation (Text with EEA relevance) Regulation · Grade B
This Regulation covers substances classified as CMR substances of categories 1A, 1B or 2 by Commission Delegated Regulation (EU) 2021/849, which will apply from 17 December 2022.
- Commission Regulation (EU) 2022/1531 of 15 September 2022 amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the use in cosmetic products of certain substances classified as carcinogenic, mutagenic or toxic for reproduction and correcting that Regulation (Text with EEA relevance) Regulation · Grade B
With regard to all substances other than Methyl Salicylate, which were classified as CMR substances pursuant to Regulation (EC) No 1272/2008 by Delegated Regulation (EU) 2021/849, no request for use in cosmetic products by way of exception has been submitted. Consequently, the CMR substances that are not already listed in Annex II to Regulation (EC) No 1223/2009 should be added to the list of substances prohibited in cosmetic products in that Annex.
- Commission Regulation (EU) 2022/1531 of 15 September 2022 amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the use in cosmetic products of certain substances classified as carcinogenic, mutagenic or toxic for reproduction and correcting that Regulation (Text with EEA relevance) Regulation · Grade B
The amendments to Regulation (EC) No 1223/2009 that are based on the classifications of the relevant substances as CMR substances by Delegated Regulation (EU) 2021/849 should apply from the same date as those classifications.
- Commission Delegated Regulation (EU) 2023/1435 of 2 May 2023 amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures as regards the modification of entries in Part 3 of Annex VI for 2-ethylhexanoic acid and its salts, boric acid, diboron trioxide, tetraboron disodium heptaoxide hydrate, disodium tetraborate anhydrous, orthoboric acid sodium salt, disodium tetraborate decahydrate, and disodium tetraborate pentahydrate (Text with EEA relevance) Regulation · Grade B
As Delegated Regulation (EU) 2023/1434 was adopted on 25 April 2023, the notes included in that Regulation could not be inserted in Table 3 of Annex VI at the time of the adoption of Commission Delegated Regulation (EU) 2021/849 and Commission Delegated Regulation (EU) 2022/692 which added the respective entries to Table 3 of Annex VI to Regulation (EC) No 1272/2008. It is therefore necessary to update the entries concerning boric acid; diboron trioxide; tetraboron disodium heptaoxide hydrate; disodium tetraborate anhydrous; orthoboric acid sodium salt; disodium tetraborate decahydrate; disodi
- Commission Regulation (EU) 2021/2204 of 13 December 2021 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), as regards carcinogenic, mutagenic or reproductive toxicant (CMR) substances (Text with EEA relevance) Regulation · Grade B
The classification of substances listed in Delegated Regulation (EU) 2021/849 will apply from 17 December 2022. The restriction introduced by this Regulation as regards substances classified as CMR category 1A or 1B by Delegated Regulation (EU) 2021/849 should therefore apply from 17 December 2022. The date of application does not prevent operators from applying the restrictions related to the CMR substances category 1A or 1B classified under Delegated Regulation (EU) 2021/849 earlier.
- Commission Implementing Regulation (EU) 2024/1207 of 29 April 2024 concerning the non-renewal of the approval of the active substance dimethomorph, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance) Regulation · Grade B
In its conclusion, the Authority identified several areas of concern. In particular, dimethomorph has been classified as toxic to reproduction, category 1B. On 20 September 2019, the Committee for Risk Assessment of the European Chemicals Agency adopted an opinion in accordance with Article 37(4) of Regulation (EC) No 1272/2008 of the European Parliament and of the Council in which it concluded that dimethomorph has been classified as toxic to reproduction, category 1B (H360F may damage fertility). Commission Delegated Regulation (EU) 2021/849 consequently amended Annex VI to Regulation (EC) N
- Commission Implementing Regulation (EU) 2022/43 of 13 January 2022 renewing the approval of the active substance flumioxazin in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annexes to Commission Implementing Regulation (EU) No 540/2011 and to Implementing Regulation (EU) 2015/408 (Text with EEA relevance) Regulation · Grade B
In the light of the updated classification of flumioxazin as toxic for reproduction category 2 under Commission Delegated Regulation (EU) 2021/849, it does no longer fulfil the criteria to be considered a candidate for substitution pursuant to Article 24 of Regulation (EC) No 1107/2009. Accordingly, flumioxazin should be deleted from the Annex to Implementing Regulation (EU) 2015/408.