{
  "url": "https://openlegislation.uk/eu-regulation-2020-217/annex-III",
  "json_url": "https://openlegislation.uk/eu-regulation-2020-217/annex-III.json",
  "legislation": "eur/2020/217",
  "legislation_title": "Commission Delegated Regulation (EU) 2020/217 of 4 October 2019 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 and correcting that Regulation (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2020-217",
  "path": "annex/III",
  "kind": "annex",
  "number": "III",
  "heading": null,
  "text": "Annex VI to Regulation (EC) No 1272/2008 is amended as follows:\n(1) Part 1 is amended as follows:\n(a) in point 1.1.3.1, the following notes V and W are added:\n‘Note V:\nIf the substance is to be placed on the market as fibres (with diameter < 3 μm, length > 5 μm and aspect ratio ≥ 3:1) or particles of the substance fulfilling the WHO fibre criteria or as particles with modified surface chemistry, their hazardous properties must be evaluated in accordance with Title II of this Regulation, to assess whether a higher category (Carc. 1B or 1A) and/or additional routes of exposure (oral or dermal) should be applied.’\nNote W:\n‘It has been observed that the carcinogenic hazard of this substance arises when respirable dust is inhaled in quantities leading to significant impairment of particle clearance mechanisms in the lung.\nThis note aims to describe the particular toxicity of the substance; it does not constitute a criterion for classification according to this Regulation.’;\n(b) in point 1.1.3.2, the following note 10 is added:\n‘Note 10:\nThe classification as a carcinogen by inhalation applies only to mixtures in powder form containing 1 % or more of titanium dioxide which is in the form of or incorporated in particles with aerodynamic diameter ≤ 10 μm.’;\n(2) in Part 3, Table 3 is amended as follows:\n(a) the rows with index numbers 604-083-00-X and 611-159-00-6 are deleted;\n(b) the rows corresponding to index numbers 015-189-00-5, 027-001-00-9, 028-018-00-4, 603-023-00-X, 605-005-00-7, 606-047-00-9, 607-232-00-7, 607-247-00-9, 608-039-00-0, 613-054-00-0, 616-018-00-2 and 648-055-00-5 are replaced by the following rows respectively:\nIndex No\nChemical name\nEC No\nCAS No\nClassification\nLabelling\nSpecific Conc. Limits, M-factors and ATEs\nNotes\nHazard Class and Category Code(s)\nHazard statement Code(s)\nPictogram, Signal Word Code(s)\nHazard statement Code(s)\nSuppl. Hazard statement Code(s)\n‘015-189-00-5\nphenyl bis(2,4,6-trimethylbenzoyl)-phosphine oxide\n423-340-5\n162881-26-7\nSkin Sens. 1A\nAquatic Chronic 4\nH317\nH413\nGHS07\nWng\nH317\nH413’\n‘027-001-00-9\ncobalt\n231-158-0\n7440-48-4\nCarc. 1B\nMuta. 2\nRepr. 1B\nResp. Sens. 1\nSkin Sens. 1\nAquatic Chronic 4\nH350\nH341\nH360F\nH334\nH317\nH413\nGHS08\nDgr\nH350\nH341\nH360F\nH334\nH317\nH413’\n‘028-018-00-4\nnickel bis(sulfamidate);\nnickel sulfamate\n237-396-1\n13770-89-3\nCarc. 1A\nMuta. 2\nRepr. 1B\nAcute Tox. 4\nSTOT RE 1\nResp. Sens. 1\nSkin Sens. 1\nAquatic Acute 1\nAquatic Chronic 1\nH350i\nH341\nH360D***\nH302\nH372**\nH334\nH317\nH400\nH410\nGHS08\nGHS07\nGHS09\nDgr\nH350i\nH341\nH360D***\nH302\nH372**\nH334\nH317\nH410\noral: ATE = 853 mg/kg bw (anhydrate)\noral: ATE = 1098 mg/kg bw (tetrahydrate)\nSTOT RE 1;\nH372: C ≥ 1 %\nSTOT RE 2;\nH373: 0,1 % ≤ C < 1 %\nSkin Sens. 1;\nH317: C ≥ 0,01 %\nM = 1’\n‘603-023-00-X\nethylene oxide;\noxirane\n200-849-9\n75-21-8\nFlam. Gas 1\nPress. Gas\nCarc. 1B\nMuta. 1B\nRepr. 1B\nAcute Tox. 3\nAcute Tox. 3\nSTOT SE 3\nSTOT SE 3\nSTOT RE 1\nSkin Corr. 1\nEye Dam. 1\nH220\nH350\nH340\nH360Fd\nH331\nH301\nH335\nH336\nH372 (nervous system)\nH314\nH318\nGHS02\nGHS08\nGHS06\nGHS05\nDgr\nH220\nH350\nH340\nH360Fd\nH331\nH301\nH335\nH336\nH372 (nervous system)\nH314\ninhalation: ATE = 700ppm (gases)\noral: ATE = 100 mg/kg bw’\nU\n‘605-005-00-7\nmetaldehyde (ISO);\n2,4,6,8-tetramethyl-1,3,5,7-tetraoxacyclooctane\n203-600-2\n108-62-3\nFlam. Sol. 2\nRepr. 2\nAcute Tox. 3\nAquatic Chronic 3\nH228\nH361f\nH301\nH412\nGHS02\nGHS08\nGHS06\nDgr\nH228\nH361f\nH301\nH412\noral: ATE = 283 mg/kg bw’\n‘606-047-00-9\n2-benzyl-2-dimethylamino-4'-morpholinobutyrophenone\n404-360-3\n119313-12-1\nRepr. 1B\nAquatic Acute 1\nAquatic Chronic 1\nH360D\nH400\nH410\nGHS08\nGHS09\nDgr\nH360D\nH410’\n‘607-232-00-7\npyridate (ISO);\nO-(6-chloro-3-phenylpyridazin-4-yl) S-octyl thiocarbonate\n259-686-7\n55512-33-9\nAcute Tox. 4\nSkin Irrit. 2\nSkin Sens. 1\nAquatic Acute 1\nAquatic Chronic 1\nH302\nH315\nH317\nH400\nH410\nGHS07\nGHS09\nWng\nH302\nH315\nH317\nH410\noral: ATE = 500 mg/kg bw\nM = 1\nM = 10’\n‘607-247-00-9\ndodecyl methacrylate\n205-570-6\n142-90-5\nSTOT SE 3\nH335\nGHS07\nWng\nH335\nSTOT SE 3; H335: C ≥ 10 %’\n‘608-039-00-0\n2-phenylhexanenitrile\n423-460-8\n3508-98-3\nAcute Tox. 4\nAquatic Chronic 2\nH302\nH411\nGHS07\nGHS09\nWng\nH302\nH411\noral:\nATE = 500 mg/kg bw’\n‘613-054-00-0\nthiabendazole (ISO);\n2-(thiazol-4-yl)benzimidazole\n205-725-8\n148-79-8\nAquatic Acute 1 Aquatic Chronic 1\nH400\nH410\nGHS09\nWng\nH410\nM = 1\nM = 1’\n‘616-018-00-2\ndiethyltoluamide (ISO): N,N-diethyl-m-toluamide; [deet]\n205-149-7\n134-62-3\nAcute Tox. 4\nSkin Irrit. 2\nEye Irrit. 2\nH302\nH315\nH319\nGHS07\nWng\nH302\nH315\nH319\noral:\nATE = 1892 mg/kg bw’\n(c) the following rows are inserted:\nIndex No\nChemical Name\nEC No\nCAS No\nClassification\nLabelling\nSpecific Conc. Limits, M-factors and ATEs\nNotes\nHazard Class and Category Code(s)\nHazard statement Code(s)\nPictogram, Signal Word Code(s)\nHazard statement Code(s)\nSuppl. Hazard statement Code(s)\n‘022-006-002\ntitanium dioxide;\n[in powder form containing 1 % or more of particles with aerodynamic diameter ≤ 10 μm]\n236-675-5\n13463-67-7\nCarc. 2\nH351 (inhalation)\nGHS08\nWng\nH351 (inhalation)\nV, W, 10’\n‘080-012-00-0\nmethylmercuric chloride\n204-064-2\n115-09-3\nCarc. 2\nRepr. 1A\nLact.\nAcute Tox. 2\nAcute Tox. 2\nAcute Tox. 2\nSTOT RE 1\nAquatic Acute 1\nAquatic Chronic 1\nH351\nH360Df\nH362\nH330\nH310\nH300\nH372 (nervous system, kidneys)\nH400\nH410\nGHS08\nGHS06\nGHS09\nDgr\nH351\nH360Df\nH362\nH330\nH310\nH300\nH372 (nervous system, kidneys)\nH410\ninhalation: ATE = 0,05 mg/l (dusts or mists)\ndermal: ATE = 50 mg/kg bw\noral: ATE = 5 mg/kg bw\n1’\n‘601-090-00-X\nbenzo[rst]pentaphene\n205-877-5\n189-55-9\nCarc. 1B\nMuta. 2\nH350\nH341\nGHS08\nDgr\nH350\nH341’\n‘601-091-00-5\ndibenzo[b,def]chrysene;\ndibenzo[a,h]pyrene\n205-878-0\n189-64-0\nCarc. 1B\nMuta. 2\nH350\nH341\nGHS08\nDgr\nH350\nH341’\n‘603-236-00-8\nethanol, 2,2’-iminobis-, N-(C13-15-branched and linear alkyl) derivs.\n308-208-6\n97925-95-6\nRepr. 1B\nH360D\nGHS08\nDgr\nH360D’\n‘607-733-00-0\ncyflumetofen (ISO);\n2-methoxyethyl (RS)-2-(4-tert-butylphenyl)-2-cyano-3-oxo-3-(α,α,α-trifluoro-o-tolyl)propionate\n—\n400882-07-7\nCarc. 2\nSkin Sens. 1A\nH351\nH317\nGHS08\nGHS07\nWng\nH351\nH317’\n‘607-734-00-6\npentapotassium 2,2’,2’’,2’’’,2’’’’-(ethane-1,2-diylnitrilo)pentaacetate\n404-290-3\n7216-95-7\nAcute Tox. 4 STOT RE 2\nEye Irrit. 2\nH332\nH373 (inhalation)\nH319\nGHS08\nGHS07\nDgr\nH332\nH373 (inhalation)\nH319\ninhalation:\nATE = 1,5 mg/l (dusts or mists)’\n‘607-735-00-1\nN-carboxymethyliminobis(ethylenenitrilo)tetra(acetic acid)\n200-652-8\n67-43-6\nAcute Tox. 4 STOT RE 2\nEye Irrit. 2\nH332\nH373 (inhalation)\nH319\nGHS08\nGHS07\nDgr\nH332\nH373 (inhalation)\nH319\ninhalation:\nATE = 1,5 mg/l (dusts or mists)’\n‘607-736-00-7\npentasodium (carboxylatomethyl)iminobis(ethylenenitrilo)tetraacetate\n205-391-3\n140-01-2\nAcute Tox. 4\nSTOT RE 2\nH332\nH373 (inhalation)\nGHS08\nGHS07\nDgr\nH332\nH373 (inhalation)\ninhalation:\nATE = 1,5 mg/l (dusts or mists)’\n‘607-737-00-2\ndiisohexyl phthalate\n276-090-2\n71850-09-4\nRepr. 1B\nH360FD\nGHS08\nDgr\nH360FD’\n‘608-069-00-4\nfludioxonil (ISO); 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile\n—\n131341-86-1\nAquatic Acute 1\nAquatic Chronic 1\nH400\nH410\nGHS09\nWng\nH410\nM = 1\nM = 10’\n‘613-329-00-5\nhalosulfuron-methyl (ISO);\nmethyl 3-chloro-5-{[(4,6-dimethoxypyrimidin-2-yl)carbamoyl]sulfamoyl}-1-methyl-1H-pyrazole-4-carboxylate\n—\n100784-20-1\nRepr. 1B\nAquatic Acute 1\nAquatic Chronic 1\nH360D\nH400\nH410\nGHS08\nGHS09\nDgr\nH360D\nH410\nM = 1000\nM = 1000’\n613-330-00-0\n2-methylimidazole\n211-765-7\n693-98-1\nRepr. 1B\nH360Df\nGHS08\nDgr\nH360Df\n‘616-225-00-8\n(RS)-2-methoxy-N-methyl-2-[α-(2,5-xylyloxy)-o-tolyl]acetamide; mandestrobin\n—\n173662-97-0\nAquatic Acute 1 Aquatic Chronic 1\nH400\nH410\nGHS09\nWng\nH410\nM = 1\nM = 10’\n‘616-226-00-3\ncarboxin (ISO);\n2-methyl-N-phenyl-5,6-dihydro-1,4-oxathiine-3-carboxamide; 5,6-dihydro-2-methyl-1,4-oxathiine-3-carboxanilide\n226-031-1\n5234-68-4\nSTOT RE 2\nSkin Sens. 1\nAquatic Acute 1\nAquatic Chronic 1\nH373 (kidneys)\nH317\nH400\nH410\nGHS08\nGHS07\nGHS09\nWng\nH373 (kidneys)\nH317\nH410\nM = 1\nM = 1’\n‘616-227-00-9\nmetaflumizone (ISO); (EZ)-2’-[2-(4-cyanophenyl)-1-(α,α,α -trifluoro-m-tolyl)ethylidene]-[4-(trifluoromethoxy)phenyl]carbanilohydrazide [E-isomer ≥ 90 %, Z-isomer ≤ 10 % relative content]; [1]\n(E)-2’-[2-(4-cyanophenyl)-1-(α,α,α -trifluoro-m-tolyl)ethylidene]-[4-(trifluoromethoxy)phenyl]carbanilohydrazide [2]\n—\n139968-49-3 [1]\n852403-68-0 [2]\nRepr. 2\nLact.\nSTOT RE 2\nH361fd\nH362\nH373\nGHS08\nWng\nH361fd\nH362\nH373’\n‘650-056-00-0\ndibutylbis(pentane-2,4-dionato-O,O’)tin\n245-152-0\n22673-19-4\nRepr. 1B\nSTOT RE 1\nH360FD\nH372 (immune system)\nGHS08\nDgr\nH360FD\nH372 (immune system)’.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2020/217/annex/III",
    "retrieved_at": "2026-11-01T14:42:49.760578+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}