{
  "url": "https://openlegislation.uk/eu-regulation-2016-863/annex",
  "json_url": "https://openlegislation.uk/eu-regulation-2016-863/annex.json",
  "legislation": "eur/2016/863",
  "legislation_title": "Commission Regulation (EU) 2016/863 of 31 May 2016 amending Annexes VII and VIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards skin corrosion/irritation, serious eye damage/eye irritation and acute toxicity (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2016-863",
  "path": "annex",
  "kind": "annex",
  "number": null,
  "heading": null,
  "text": "Annexes VII and VIII to Regulation (EC) No 1907/2006 are amended as follows:\n(1) points 8.1 and 8.2 of Annex VII shall be replaced by the following:\n‘\n8.1.\nSkin corrosion/irritation\n8.1.\nThe study/ies do(es) not need to be conducted if:\nthe substance is a strong acid (pH ≤ 2,0) or base (pH ≥ 11,5) and the available information indicates that it should be classified as skin corrosion (Category 1), or\nthe substance is spontaneously flammable in air or in contact with water or moisture at room temperature, or\nthe substance is classified as acute toxicity by the dermal route (Category 1), or\nan acute toxicity study by the dermal route does not indicate skin irritation up to the limit dose level (2 000 mg/kg body weight).\nIf results from one of the two studies under point 8.1.1 or 8.1.2 already allow a conclusive decision on the classification of a substance or on the absence of skin irritation potential, the second study need not be conducted.\n8.1.1.\nSkin corrosion, in vitro\n8.1.2.\nSkin irritation, in vitro\n8.2.\nSerious eye damage/eye irritation\n8.2.\nThe study/ies do(es) not need to be conducted if:\nthe substance is classified as skin corrosion, leading to classification as serious eye damage (Category 1), or\nthe substance is classified as skin irritation and the available information indicates that it should be classified as eye irritation (Category 2), or\nthe substance is a strong acid (pH ≤ 2,0) or base (pH ≥ 11,5) and the available information indicates that it should be classified as serious eye damage (Category 1), or\nthe substance is spontaneously flammable in air or in contact with water or moisture at room temperature.\n8.2.1.\nSerious eye damage/eye irritation, in vitro\n8.2.1.\nIf results from a first in vitro study do not allow a conclusive decision on the classification of a substance or on the absence of eye irritation potential, (an)other in vitro study/ies) for this endpoint shall be considered.\n’\n(2) points 8.1 and 8.2 of Annex VIII shall be replaced by the following:\n‘\n8.1.\nSkin corrosion/irritation\n8.1.\nAn in vivo study for skin corrosion/irritation shall be considered only if the in vitro studies under points 8.1.1 and 8.1.2 in Annex VII are not applicable, or the results of these studies are not adequate for classification and risk assessment.\nThe study does not need to be conducted if:\nthe substance is a strong acid (pH ≤ 2,0) or base (pH ≥ 11,5), or\nthe substance is spontaneously flammable in air or in contact with water or moisture at room temperature, or\nthe substance is classified as acute toxicity by the dermal route (Category 1), or\nan acute toxicity study by the dermal route does not indicate skin irritation up to the limit dose level (2 000 mg/kg body weight).\n8.2.\nSerious eye damage/eye irritation\n8.2.\nAn in vivo study for eye corrosion/irritation shall be considered only if the in vitro study(ies) under point 8.2.1 in Annex VII are not applicable, or the results obtained from these study(ies) are not adequate for classification and risk assessment.\nThe study does not need to be conducted if:\nthe substance is classified as skin corrosion, or\nthe substance is a strong acid (pH ≤ 2,0) or base (pH ≥ 11,5), or\nthe substance is spontaneously flammable in air or in contact with water or moisture at room temperature.\n’\n(3) point 8.5 of Annex VIII shall be replaced by the following:\n‘\n8.5.\nAcute toxicity\n8.5.\nThe study/ies do(es) not generally need to be conducted if:\nthe substance is classified as skin corrosion.\nIn addition to the oral route (Annex VII, 8.5.1.), for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. If there is only one route of exposure, information for only that route needs to be provided.\n8.5.2.\nBy inhalation\n8.5.2.\nTesting by the inhalation route is appropriate if exposure of humans via inhalation is likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size.\n8.5.3.\nBy dermal route\n8.5.3.\nTesting by the dermal route is appropriate if:\n(1) inhalation of the substance is unlikely; and\n(2) skin contact in production and/or use is likely; and\n(3) the physicochemical and toxicological properties suggest potential for a significant rate of absorption through the skin.\nTesting by the dermal route does not need to be conducted if:\nthe substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and\nno systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation) or, in the absence of an in vivo study by the oral route, no systemic effects after dermal exposure are predicted on the basis of non-testing approaches (e.g. read across, QSAR studies).\n’",
  "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/2016/863/annex",
    "retrieved_at": "2026-11-01T14:45:48.466858+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."
}