{
  "url": "https://openlegislation.uk/notification-of-new-substances-regulations-1993/schedule-2/part-C",
  "json_url": "https://openlegislation.uk/notification-of-new-substances-regulations-1993/schedule-2/part-C.json",
  "legislation": "uksi/1993/3050",
  "legislation_title": "The Notification of New Substances Regulations 1993",
  "legislation_url": "https://openlegislation.uk/notification-of-new-substances-regulations-1993",
  "path": "schedule/2/part/C",
  "kind": "part",
  "number": "C",
  "heading": "information required for the technical dossier for a notification under regulation 6(2)",
  "text": "Tests under this Part shall be according to methods recognised and recommended by the competent international bodies where such recommendations exist.\nIf it is not technically possible or if it does not appear scientifically necessary to give information, the reasons shall be clearly stated and be subject to acceptance by the competent authority.\nThe name of the body or bodies responsible for carrying out the studies shall be mentioned.\n0.\nIDENTITY OF MANUFACTURER AND THE NOTIFIER IF THESE ARE NOT THE SAME: LOCATION OF THE PRODUCTION SITE:\nFor substances manufactured outside the Communities and for which, for the purpose of notification, the notifier has been designated as the manufacturer’s sole representative, the identities and addresses of the importers who will be bringing the substance into the Communities.\n1.\nIDENTITY OF THE SUBSTANCE\n1.1\nName\n1.1.1\nNames in the IUPAC nomenclature\n1.1.2\nOther names (usual name, trade name, abbreviation)\n1.1.3\nCAS number and CAS name (if available)\n1.2\nMolecular and structural formula\n1.3\nComposition of the substance\n1.3.1\nDegree of purity (%)\n1.3.2\nNature of impurities, including isomers and by-products\n1.3.3\nPercentage of (significant) main impurities\n1.3.4\nIf the substance contains a stabilizing agent or an inhibitor or other additives, specify: nature, order of magnitude: ..ppm; .. %\n1.3.5\nSpectral data (UV, IR, NMR or mass spectrum)\n1.3.6\nChromatographic data (HPLC, GC)\n1.4\nMethods of detection and determination\nA full description of the methods used or the appropriate bibliographical references. Apart from methods of detection and determination, information on analytical methods which are known to the notifier and which allow detection of a substance and its transformation products after discharge into the environment as well as determination of the direct exposure of humans.\n2.\nINFORMATION ON THE SUBSTANCE\n2.0\nProduction\nInformation given in this section should be sufficient to allow an approximate but realistic estimation of human and environmental exposure, associated with the production process.Precise details of the production process, particularly those of a commercially sensitive nature, are not required.\n2.0.1\nTechnological process(es) used in production\n2.0.2\nExposure estimate related to production:\nworking environment,\nenvironment\n2.1\nProposed uses\nInformation given in this section should be sufficient to allow an approximate but realistic estimation of human and environmental exposure to the substances as associated with the proposed/expected uses.\n2.1.1\nTypes of use: description of the function and the desired effects\n2.1.1.1\nTechnological process(es) related to the use of the substance (where known)\n2.1.1.2\nExposure estimate(s) related to the use of the substance (where known):\nworking environment,\nenvironment\n2.1.1.3\nForm under which the substance is marketed: substance, preparation, product\n2.1.1.4\nConcentration of the substance in marketed preparations and products (where known)\n2.1.2\nFields of application with approximate breakdown:\nindustries,\nfarmers and skilled trades,\nuse by the public at large\n2.1.3\nWhere known and where appropriate, the identity of the recipients of the substance\n2.2\nEstimated production and/or imports for each of the anticipated uses or fields of application\n2.2.1\nOverall production and/or imports in tonnes per year:\nthe first calendar year,\nthe following calendar years\nFor substances manufactured outside the Communities and for which, for the purpose of notification, the notifier has been designated as the manufacturer’s sole representative, this information must be given for each of the importers identified under section 0 above.\n2.2.2\nProduction and/or imports, broken down in accordance with 2.1.1 and 2.1.2 expressed as a percentage:\nthe first calendar year,\nthe following calendar years\n2.3\nRecommended methods and precautions concerning:\n2.3.1\n– Handling\n2.3.2\n– Storage\n2.3.3\n– Transport\n2.3.4\nFire (nature of combustion gases or pyrolysis, where proposed uses justify this)\n2.3.5\nOther dangers, particularly chemical reaction with water\n2.4\nEmergency measures in the case of accidental spillage\n2.5\nEmergency measures in the case of injury to persons (e.g. poisoning)\n2.6\nPackaging\n3.\nPHYSICO-CHEMICAL PROPERTIES OF THE SUBSTANCE\n3.0\nState of the substance at 20 degrees C and 101.3 kPa\n3.9\nFlash point\n3.10\nFlammability\n4.\nTOXICOLOGICAL STUDIES\n4.1\nAcute toxicity\nOne route of administration is sufficient.Substances other than gases should be tested by oral administration. Gases should be tested by inhalation.\n4.1.1\nAdministered orally\n4.1.2\nAdministered by inhalation.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [
    {
      "type": "words substituted",
      "affecting": "uksi/2004/568",
      "affecting_title": "The Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations 2004"
    },
    {
      "type": "word substituted",
      "affecting": "uksi/2007/1573",
      "affecting_title": "The Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations 2007"
    },
    {
      "type": "am",
      "affecting": "uksi/2002/2176",
      "affecting_title": "The Notification of New Substances (Amendment) Regulations 2002"
    }
  ],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1993/3050/schedule/2/part/C",
    "retrieved_at": "2026-10-29T13:45:27.938319+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."
}