{
  "url": "https://openlegislation.uk/eu-regulation-2016-621/annex",
  "json_url": "https://openlegislation.uk/eu-regulation-2016-621/annex.json",
  "legislation": "eur/2016/621",
  "legislation_title": "Commission Regulation (EU) 2016/621 of 21 April 2016 amending Annex VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2016-621",
  "path": "annex",
  "kind": "annex",
  "number": null,
  "heading": null,
  "text": "The following entries are added to Annex VI to Regulation (EC) No 1223/2009 as reference numbers 30 and 30a:\nIn case of combined use of zinc oxide and zinc oxide (nano), the sum shall not exceed the limit given in column g.’\nReference number\nSubstance identification\nConditions\nWording of conditions of use and warnings\nChemical name/INN\nName of Common Ingredients Glossary\nCAS number\nEC number\nProduct type, body parts\nMaximum concentration in ready for use preparation\nOther\na\nb\nc\nd\ne\nf\ng\nh\ni\n‘30\nZinc oxide\nZinc Oxide\n1314-13-2\n215-222-5\n25 %\nNot to be used in applications that may lead to exposure of the end-user's lungs by inhalation.\n30a\nZinc oxide\nZinc Oxide (nano)\n1314-13-2\n215-222-5\n25 %\nNot to be used in applications that may lead to exposure of the end-user's lungs by inhalation.\nOnly nanomaterials having the following characteristics are allowed:\npurity ≥ 96 %, with wurtzite crystalline structure and physical appearance as clusters that are rod-like, star-like and/or isometric shapes, with impurities consisting only of carbon dioxide and water, whilst any other impurities are less than 1 % in total,\nmedian diameter of the particle number size distribution D50 (50 % of the number below this diameter) > 30 nm and D1 (1 % below this size) > 20 nm,\nwater solubility < 50 mg/L\nuncoated, or coated with triethoxycaprylylsilane, dimethicone, dimethoxydiphenylsilanetriethoxycaprylylsilane cross-polymer, or octyl triethoxy silane.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "In case of combined use of zinc oxide and zinc oxide (nano), the sum shall not exceed the limit given in column g.’"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2016/621/annex",
    "retrieved_at": "2026-11-01T14:45:53.528766+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."
}