{
  "url": "https://openlegislation.uk/notification-of-new-substances-regulations-1993/schedule-2/part-D",
  "json_url": "https://openlegislation.uk/notification-of-new-substances-regulations-1993/schedule-2/part-D.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/D",
  "kind": "part",
  "number": "D",
  "heading": "(The provisions set out in this Part were introduced into Annex VII of the Directive by Commission Directive 1993/105/EEC)",
  "text": "Without prejudice to the provisions of Article 3(1) of the Directive tests under this Part shall be according to methods recognized 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.\nA.\nFor the purpose of this Part\n‘homopolymer’ is a polymer consisting of only one kind of monomer unit.\n‘copolymer’ is a polymer consisting of more than one kind of monomer unit.\n‘polymer for which a reduced test package is acceptable’, ‘RTP polymer’, is a polymer that satisfies the criteria laid down in section C.2 of this Part.\n‘family of polymers’ is a group of polymers (either homopolymers or copolymers) with different number-average molecular weights or different compositions resulting from different ratios of monomer units.The difference in the number-average molecular weight or in the composition is determined not by unintentional process-related fluctuations but by deliberate alterations to the process conditions, the process itself remaining the same.\n‘Mn’ is the number-average molecular weight.\n‘MW’ is the molecular weight (of any particular molecule).\nB.\nFamily approach\nTo avoid unnecessary testing, grouping of polymers into families shall be allowed.\nThe concept consists of testing representative members of a family with:\nMn variable for homopolymers or\ncomposition variable with Mn approximately constant for copolymers or\nfor Mn > 1000, Mn variable with composition approximately constant for copolymers In certain cases where there are dissimilarities in the effects seen in the representative members, depending on the Mn- or composition-range, additional testing of other representative members shall be required.\nC.\nInformation required for the technical dossier referred to in regulation 7\nAppropriate available information on the properties of the monomer(s) may be taken into account for the assessment of the properties of the polymer.\nC.1\nPOLYMERS WITH STANDARD TEST PACKAGE\nC.1.1\nPOLYMERS PLACED ON THE COMMUNITY MARKET IN QUANTITIES OF ≥ 1 TONNE PER ANNUM (OR TOTAL QUANTITIES OF ≥ 5 TONNES)\nIn addition to the information and tests referred to in regulation 4(1), laid down in Part A, the following polymer-specific information is required:\n1.\nIDENTITY OF THE SUBSTANCE\n1.2.1\nNumber-average molecular weight\n1.2.2\nMolecular weight distribution (MWD)\n1.2.3\nIdentity and concentration of starting monomers and starting substances which will be bound in the polymer\n1.2.4\nIndication of end groups and identity and frequency of reactive functional groups\n1.3.2.1\nIdentity of non-reacted monomers\n1.3.3.1\nPercentage of non-reacted monomers\n2.\nINFORMATION ON THE SUBSTANCE\n2.1.1.5\nStatement, with relevant information, if the polymer has been developed to be environmentally degradable\n3.\nPHYSICO-CHEMICAL PROPERTIES OF THE SUBSTANCE\n3.6.1\nWater extractivity\nWithout prejudice to regulation 16, further tests may be required additionally in certain cases, eg:\nLight-stability if the polymer is not specifically light stabilized\nLong-term extractivity (leachate test); depending on the results of this test, appropriate tests on the leachate may be requested on a case by case basis.\nC.1.2\nPOLYMERS PLACED ON THE COMMUNITY MARKET IN QUANTITIES OF < 1 TONNE PER ANNUM (OR TOTAL QUANTITIES OF < 5 TONNES) BUT ≥ 100 KGS PER ANNUM (OR TOTAL QUANTITIES OF ≥ 500 KGS)\nIn addition to the information and tests referred to in regulation 6(1), laid down in Part B, the following polymer-specific information is required:\n1.\nIDENTITY OF THE SUBSTANCE\n1.2.1\nNumber-average molecular weight\n1.2.2\nMolecular weight distribution (MWD)\n1.2.3\nIdentity and concentration of starting monomers and starting substances which will be bound in the polymer\n1.2.4\nIndication of end groups and identity and frequency of reactive functional groups\n1.3.2.1\nIdentity of non-reacted monomers\n1.3.3.1\nPercentage of non-reacted monomers\n2.\nINFORMATION ON THE SUBSTANCE\n2.1.1.5\nStatement, with relevant information, if the polymer has been developed to be environmentally degradable\n3.\nPHYSICO-CHEMICAL PROPERTIES OF THE SUBSTANCE\n3.6.1\nWater extractivity\nC.1.3\nPOLYMERS PLACED ON THE COMMUNITY MARKET IN QUANTITIES OF < 100 KGS PER ANNUM (OR TOTAL QUANTITIES OF < 500 KGS)\nIn addition to the information and tests referred to in regulation 6(2), laid down in Part C, the following polymer-specific information is required:\n1.\nIDENTITY OF THE SUBSTANCE\n1.2.1\nNumber-average molecular weight\n1.2.2\nMolecular weight distribution (MWD)\n1.2.3\nIdentity and concentration of starting monomers and starting substances which will be bound in the polymer\n1.2.4\nIndication of end groups and identity and frequency of reactive functional groups\n1.3.2.1\nIdentity of non-reacted monomers\n1.3.3.1\nPercentage of non-reacted monomers\n2.\nINFORMATION ON THE SUBSTANCE\n2.1.1.5\nStatement, with relevant information, if the polymer has been developed to be environmentally degradable\nC.2\nPOLYMERS FOR WHICH A REDUCED TEST PACKAGE (RTP POLYMERS) IS ACCEPTABLE\nUnder certain conditions the base-set test package for polymers can be reduced.\nCRITERIA FOR POLYMERS FOR WHICH A REDUCED TEST PACKAGE IS ACCEPTABLE\nSubstances with a high number-average molecular weight, a low content of low molecular weight species and low solubility/extractivity will be rded as being non-bioavailable.Consequently the following criteria shall be used to determine the polymers for which a reduced test package is acceptable:\n(a) for non-readily degradable polymers placed on the Community market in quantities of ≥ 1 t/a (or total quantities of ≥ 5 t), the following criteria define those polymers for which a reduced test package is acceptable:\n(I) High number-average molecular weight (Mn).The competent authority shall decide whether or not a polymer satisfies this criterion;\n(II) Extractivity in water (3.6.1) < 10 mg/l excluding any contribution from additives and impurities;\n(III) Less than 1% with MW < 1000; the percentage refers only to molecules (components) directly derived from and including monomer(s), excluding other components e.g. additives or impurities.\nIf all the above criteria are fulfilled, the polymer is regarded as a polymer for which a reduced test package is acceptable.\n(b) in the case of non-readily degradable polymers placed on the Community market in quantities < 1 t/a (or total quantities of < 5 t), it is sufficient that criteria I and II above are fulfilled.\nIf it is not possible to prove the criteria with the assigned tests, the notifier has to demonstrate compliance witha the criteria by other means. Under certain circumstances toxicological and ecotoxicological tests may be required.\nC.2.1\nRTP POLYMERS PLACED ON THE COMMUNITY MARKET IN QUANTITIES OF ≥ 1 TONNE PER ANNUM (OR TOTAL QUANTITIES OF ≥ 5 TONNES): FULL LIST OF INFORMATION AND TESTS REQUIRED\n0.\nIDENTITY OF MANUFACTURER AND THE IDENTITY OF THE NOTIFIER: LOCATION OF THE PRODUCTION SITE\nFor substances manufactured outside the Community and for which, for the purpose of notification, the notifier has been designated as the manufacturer’s sole representative, the identities and the addresses of the importers who will be bringing the substance into the Community.\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\n1.2.1\nNumber-average molecular weight\n1.2.2\nMolecular weight distribution (MWD)\n1.2.3\nIdentity and concentration of starting monomers and starting substances which will be bound in the polymer\n1.2.4\nIndication of end groups and identity and frequency of reactive functional groups\n1.3\nComposition of the substance\n1.3.1\nDegree of purity (%)\n1.3.2\nNature of impurities, including by-products\n1.3.2.1\nIdentity of non-reacted monomers\n1.3.3\nPercentage of (significant) main impurities\n1.3.3.1\nPercentage of non-reacted monomers\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)\n1.3.6.1\nGPC\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 shall be given on analytical methods which are known to the notifier and 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 the 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 used in production\n2.0.2\nExposure estimates 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 (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 marketing 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\n2.1.4\nWaste quantities and composition of waste resulting from the proposed uses (where known)\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 the substances manufactured outside the Community 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\n2.3.6\nIf relevant, information concerning the susceptibility of the substance to explode when presented in the form of a dust\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°C and 101.3 kPa\n3.1\nMelting range (e.g. from the thermal stability test)\n3.3\nRelative density\n3.6.1\nWater extractivity\n3.10\nFlammability\n3.11\nExplosive properties\n3.12\nAuto-flammability\n3.15\nParticle size\nFor those substances which may be marketed in a form which gives rise to the danger of exposure by the inhalatory route, a test should be conducted to determine the particle distribution of the substance as it will be marketed.\n3.16\nThermal stability\n3.17\nExtractivity with:\nwater at pH 2 and 9 at 37°C\ncyclohexane\n4.\nTOXICOLOGICAL STUDIES\nOn a case by case basis and without delaying acceptance of the notification the competent authority may on the basis of the presence of reactive groups or structural/physical characteristics or knowledge about the properties of low molecular weight components of the polymer or exposure potential require certain tests to be carried out. In particular tests for inhalation toxicity (e.g.4.1.2, 4.2.1) may be required if exposure by the inhalatory route is considered possible.\n5.\nECOTOXICOLOGICAL STUDIES\nOn a case by case basis and without delaying acceptance of the notification, the competent authority may on the basis of the presence of reactive groups, structural/physical characteristics or knowledge of the properties of low molecular weight components of the polymer or exposure potential, require certain tests to be carried out.\nIn particular, the following additional tests may be required:\nLight-stability, if the polymer is not specifically light-stabilized\nLong-term extractivity (leachate test) Depending on the results of this test, any appropriate test on the leachate may be requested on a case by case basis.\n6.\nPOSSIBILITY OF RENDERING THE SUBSTANCE HARMLESS\n6.1\nFor industry/skilled trades\n6.1.1\nPossibility of recycling\n6.1.2\nPossibility of neutralization of unfavourable effects\n6.1.3\nPossibility of destruction:\ncontrolled discharge\nincineration\nwater purification station\nothers\n6.2\nFor the public at large\n6.2.1\nPossibility of recycling\n6.2.2\nPossibility of neutralization of unfavourable effects\n6.2.3\nPossibility of destruction:\ncontrolled discharge\nincineration\nwater purification station\nothers\nC.2.2\nRTP POLYMERS PLACED ON THE COMMUNITY MARKET IN QUANTITIES OF < 1 TONNE PER ANNUM (OR TOTAL QUANTITIES OF < 5 TONNES): FULL LIST OF INFORMATION AND TESTS REQUIRED\n0.\nIDENTITY OF MANUFACTURER AND THE IDENTITY OF THE NOTIFIER: 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 the 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\n1.2.1\nNumber-average molecular weight\n1.2.2\nMolecular weight distribution (MWD)\n1.2.3\nIdentity and concentration of starting monomers and starting substances which will be bound in the polymer\n1.2.4\nIndication of end groups and identity and frequency of reactive functional groups\n1.3\nComposition of the substance\n1.3.1\nDegree of purity (%)\n1.3.2\nNature of impurities, including by-products\n1.3.2.1\nIdentity of non-reacted monomers\n1.3.3\nPercentage of (significant) main impurities\n1.3.3.1\nPercentage of non-reacted monomers\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)\n1.3.6.1\nGPC\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 shall be given on analytical methods which are known to the notifier and 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 the 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 used in production\n2.0.2\nExposure estimates 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 (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 marketing 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\n2.1.4\nWaste quantities and composition of waste resulting from the proposed uses (where known)\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 the substances manufactured outside the Community and for which, for the purposes 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\n2.3.6\nIf relevant, information concerning the susceptibility of the substance to explode when present in the form of a dust\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\n3.1\nMelting range (e.g. from the thermal stability test)\n3.6.1\nWater extractivity\n3.10\nFlammability",
  "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/D",
    "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."
}