{
  "url": "https://openlegislation.uk/eu-directive-2007-19/annex-III",
  "json_url": "https://openlegislation.uk/eu-directive-2007-19/annex-III.json",
  "legislation": "eudr/2007/19",
  "legislation_title": "Commission Directive 2007/19/EC of 2 April 2007 amending Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with food and Council Directive 85/572/EEC laying down the list of simulants to be used for testing migration of constituents of plastic materials and articles intended to come into contact with foodstuffs (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-directive-2007-19",
  "path": "annex/III",
  "kind": "annex",
  "number": "III",
  "heading": null,
  "text": "Annex III to Directive 2002/72/EC is amended as follows:\n(1) Section A is amended as follows:\n(a) the following additives are inserted in the appropriate numerical order:\nRef. No\nCAS No\nName\nRestrictions and/or specifications\n(1)\n(2)\n(3)\n(4)\n‘ 38885\n002725-22-6\n2,4-Bis(2,4-dimethylphenyl)-6-(2-hydroxy-4-n-octyloxyphenyl)-1,3,5-triazine\nSML = 0,05 mg/kg. For aqueous foods only.\n42080\n001333-86-4\nCarbon black\nIn compliance with the specifications laid down in Annex V.\n45705\n166412-78-8\n1,2-cyclohexanedicarboxylic acid, diisononyl ester\n62020\n007620-77-1\n12-Hydroxystearic acid, lithium salt\nSML(T) = 0,6 mg/kg ( 8 ) (expressed as lithium)\n67180\n—\nMixture of (50 % w/w) phthalic acid n-decyl n-octyl ester, (25 % w/w) phthalic acid di-n-decyl ester, (25 % w/w) phthalic acid di-n- octyl ester.\nSML = 5 mg/kg ( 1 )\n71960\n003825-26-1\nPerfluorooctanoic acid, ammonium salt\nOnly to be used in repeated use articles, sintered at high temperatures.\n74560\n000085-68-7\nPhthalic acid, benzyl butyl ester\nTo be used only as:\n(a) plasticizer in repeated use materials and articles;\n(b) plasticizer in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae as defined by Directive 91/321/EEC and products according to Directive 96/5/EC;\n(c) technical support agent in concentrations up to 0,1 % in the final product.\nSML = 30 mg/kg food simulant.\n74640\n000117-81-7\nPhthalic acid, bis (2-ethylhexyl) ester\nTo be used only as:\n(a) plasticizer in repeated use materials and articles contacting non-fatty foods;\n(b) technical support agent in concentrations up to 0,1 % in the final product.\nSML = 1,5 mg/kg food simulant.\n74880\n000084-74-2\nPhthalic acid, dibutyl ester\nTo be used only as:\n(a) plasticizer in repeated use materials and articles contacting non-fatty foods;\n(b) technical support agent in polyolefines in concentrations up to 0,05 % in the final product.\nSML = 0,3 mg/kg food simulant.\n75100\n068515-48-0\n028553-12-0\nPhthalic acid, diesters with primary, saturated C 8 -C 10 branched alcohols, more than 60 % C 9 .\nTo be used only as:\n(a) plasticizer in repeated use materials and articles;\n(b) plasticizer in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae as defined by Directive 91/321/EEC and products according to Directive 96/5/EC;\n(c) technical support agent in concentrations up to 0,1 % in the final product.\nSML(T) = 9 mg/kg food simulant ( 42 ).\n75105\n068515-49-1\n026761-40-0\nPhthalic acid, diesters with primary, saturated C 9 -C 11 alcohols more than 90 % C 10\nTo be used only as:\n(a) plasticizer in repeated use materials and articles;\n(b) plasticizer in single-use materials and articles contacting non-fatty foods except for infant formulae and follow-on formulae as defined by Directive 91/321/EEC and products according to Directive 96/5/EC;\n(c) technical support agent in concentrations up to 0,1 % in the final product.\nSML(T) = 9 mg/kg food simulant ( 42 ).\n79920\n009003-11-6\n106392-12-5\nPoly(ethylene propylene) glycol\n81500\n9003-39-8\nPolyvinylpyrrolidone\nIn compliance with the specifications laid down in Annex V.\n93760\n000077-90-7\nTri-n-butyl acetyl citrate\n95020\n6846-50-0\n2,2,4-Trimethyl-1,3-pentanediol diisobutyrate\nSML = 5 mg/kg food. To be used in single-use gloves only.\n95420\n745070-61-5\n1,3,5-tris (2,2-dimethylpropanamido)benzene\nSML = 0,05 mg/kg food. ’\n(b) for the following additives, the entries in columns 3 ‘ Name ’ and 4 ‘ Restrictions and/or specifications ’ are replaced by the following:\nRef. No\nCAS No\nName\nRestrictions and/or specifications\n(1)\n(2)\n(3)\n(4)\n‘ 43480\n064365-11-3\nCharcoal, activated\nIn compliance with the specifications laid down in Annex V.\n45200\n001335-23-5\nCopper iodide\nSML(T) = 5 mg/kg ( 7 ) (expressed as copper) and SML = 1 mg/kg ( 11 ) (expressed as iodine)\n76845\n031831-53-5\nPolyester of 1,4-butanediol with caprolactone\nThe restriction for Ref. No 14260 and Ref. No 13720 shall be respected.\nIn compliance with the specifications laid down in Annex V.\n81760\n—\nPowders, flakes and fibres of brass, bronze, copper, stainless steel, tin and alloys of copper, tin and iron\nSML(T) = 5 mg/kg ( 7 ) (expressed as copper);\nSML = 48 mg/kg (expressed as iron)\n88640\n008013-07-8\nSoybean oil, epoxidised\nSML = 60 mg/kg. However in the case of PVC gaskets used to seal glass jars containing infant formulae and follow-on formulae as defined by Directive 91/321/EEC or containing processed cereal-based foods and baby foods for infants and young children as defined by Directive 96/5/EC, the SML is lowered to 30 mg/kg.\nIn compliance with the specifications laid down in Annex V. ’\n(c) the following additive is deleted:\nRef. No\nCAS No\nName\nRestrictions and/or specifications\n(1)\n(2)\n(3)\n(4)\n‘ 35760\n001309-64-4\nAntimony trioxide\nSML = 0,04 mg/kg ( 39 ) (expressed as antimony).’\n(2) Section B is amended as follows:\n(a) the following additives are inserted, in the appropriate numerical order:\nRef. No\nCAS No\nName\nRestrictions and/or specifications\n(1)\n(2)\n(3)\n(4)\n‘ 35760\n001309-64-4\nantimony trioxide\nSML = 0,04 mg/kg ( 39 ) (expressed as antimony)\n47500\n153250-52-3\nN,N′-Dicyclohexyl-2,6-naphthalene dicarboxamide\nSML = 5 mg/kg.\n72081/10\n—\nPetroleum hydrocarbon resins (hydrogenated)\nSML = 5 mg/kg ( 1 ) and in compliance with the specifications laid down in Annex V\n93970\n—\nTricyclodecanedimethanol bis(hexahydrophthalate)\nSML = 0,05 mg/kg. ’\n(b) for the following additives, the entries in columns 3 ‘ Name ’ and 4 ‘ Restrictions and/or specifications ’ are replaced by the following:\nRef. No\nCAS No\nName\nRestrictions and/or specifications\n(1)\n(2)\n(3)\n(4)\n‘ 47600\n084030-61-5\nDi-n-dodecyltin bis(isooctyl mercaptoacetate)\nSML(T) = 0,05 mg/kg food ( 41 ) (as sum of mono-n-dodecyltin tris(isooctyl mercaptoacetate), di-n- dodecyltin bis(isooctyl mercaptoacetate), mono-dodecyltin trichloride and di-dodecyltin dichloride) expressed as the sum of mono- and di-dodecyltin chloride\n67360\n067649-65-4\nMono-n-dodecyltin tris(isooctyl mercaptoacetate)\nSML(T) = 0,05 mg/kg food ( 41 ) (as sum of mono-n-dodecyltin tris(isooctyl mercaptoacetate), di-n- dodecyltin bis(isooctyl mercaptoacetate), mono-dodecyltin trichloride and di-dodecyltin dichloride) expressed as the sum of mono- and di-dodecyltin chloride’\n(c) The following additives are deleted:\nRef. No\nCAS No\nName\nRestrictions and/or specifications\n(1)\n(2)\n(3)\n(4)\n‘ 67180\n—\nMixture of (50 % w/w) phthalic acid n-decyl n-octyl ester, (25 % w/w) phthalic acid di-n-decyl ester, (25 % w/w) phthalic acid di-n- octyl ester.\nSML = 5 mg/kg ( 1 )\n76681\n—\nPolycyclopentadiene, hydrogenated\nSML = 5 mg/kg ( 1 )’",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "X",
      "label": "X1",
      "text": "Substituted by Corrigendum to Commission Directive 2007/19/EC of 30 March 2007 amending Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with food and Council Directive 85/572/EEC laying down the list of simulants to be used for testing migration of constituents of plastic materials and articles intended to come into contact with foodstuffs (Official Journal of the European Union L 91 of 31 March 2007)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudr/2007/19/annex/III",
    "retrieved_at": "2026-11-01T15:22:28.112328+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."
}