{
  "url": "https://openlegislation.uk/eu-regulation-2011-10/annex-V/chapter-2/division-2.1/division-2.1.3",
  "json_url": "https://openlegislation.uk/eu-regulation-2011-10/annex-V/chapter-2/division-2.1/division-2.1.3.json",
  "legislation": "eur/2011/10",
  "legislation_title": "Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2011-10",
  "path": "annex/V/chapter/2/division/2.1/division/2.1.3",
  "kind": "division",
  "number": "2.1.3",
  "heading": "Conditions of contact when using food simulants",
  "text": "The sample shall be placed in contact with the food simulant in a manner representing the worst of the foreseeable conditions of use as regard contact time in Table 1 and as regard contact temperature in Table 2.\nBy way of derogation to the conditions set out in Tables 1 and 2, the following rules apply:\n(i)If it is found that carrying out the tests under the combination of contact conditions specified in Tables 1 and 2 causes physical or other changes in the test specimen which do not occur under worst foreseeable conditions of use of the material or article under examination, the migration tests shall be carried out under the worst foreseeable conditions of use in which these physical or other changes do not take place;\n(ii)if the material or article during it intended use is subjected only to precisely controlled time and temperature conditions in food processing equipment, either as part of food packaging or as part of the processing equipment itself, testing may be done using the worst foreseeable contact conditions that can occur during the processing of the food in that equipment;\n(iii)if the material or article is intended to be employed only for hot-fill conditions, only a 2-hour test at 70 °C shall be carried out. However, if the material or article is intended to be used also for storage at room temperature or below, the test conditions set out in Tables 1 and 2 of this Section or in Section 2.1.4 of this Chapter apply depending on the duration of storage.\n(iv)if the plastic material or article intended to come into contact with food of which the compliance must be verified becomes in its final application part of a food processing equipment or an appliance, or a part thereof, the migration tests may be carried out by determining the specific migration into the food or food simulant produced or processed by the whole equipment or appliance, or the part thereof, as appropriate, subject to the following conditions:\nthe food or food simulant is processed during testing by the equipment or part thereof in accordance with the worst foreseeable conditions that can be achieved if the equipment or its part is operated in accordance with its operating instructions, and\nthe migration from parts used for storage such as from reservoirs, containers, or capsules or pads which are part of the equipment during the processing of the food, is determined using conditions representative for their use, unless the applied testing conditions for the whole tested equipment or appliance are representative also of their use.\nWhen migration testing is done under the above conditions, and the transfer of constituents from the equipment or appliance as a whole does not exceed the migration limits, the plastic parts or materials present in the equipment or appliance shall be considered to comply with Article 11(1).\nThe testing of the parts used for storage or supply such as reservoirs, containers, capsules or pads shall be under conditions representative of their use, and shall include the foreseeable storage conditions of the food in these parts.\nThe supporting documentation referred to in Article 16 shall clearly document the testing on the whole food processing and/or food producing equipment or appliance, or on parts thereof. It shall demonstrate that the testing was representative of its foreseeable use, and shall indicate for which substances migration testing was carried out and provide all testing results. The manufacturer of individual plastic parts shall ensure the absence of migration for substances for which the Regulation specifies that their migration shall not be detectable at a specified level of detection in accordance with Article 11(4).\nCompliance documentation supplied in accordance with the Regulation to the producer of the final equipment or appliance, or part thereof, shall list all substances subject to migration limits that might be exceeded under the foreseeable use of the supplied part or material.\nWhen the result is not in compliance with the Regulation it shall be determined whether the source of the non-compliance is a plastic part subject to the Regulation or a part made from another material not subject to the Regulation on the basis of documentary evidence or analytical testing. Without prejudice to Article 3 of Regulation (EU) No 1935/2004, non-compliance to the Regulation shall only be established if the migration originates from a plastic part.\nIf the testing conditions representative for the worst foreseeable conditions of intended use of the material or article, are not technically feasible in food simulant D2, migration tests shall be done using ethanol 95 % and isooctane. In addition a migration test shall be done using food simulant E if the temperature under the worst foreseeable conditions of intended use exceeds 100 °C. The test that results in the highest specific migration shall be used to establish compliance with this Regulation.\nTable 1\nSelection of test time\nContact time in worst foreseeable use\nTime to be selected for testing\nt ≤ 5 min\n5 min\n5 min < t ≤ 0,5 hour\n0,5 hour\n0,5 hours < t ≤ 1 hour\n1 hour\n1 hour < t ≤ 2 hours\n2 hours\n2 hours < t ≤ 6 hours\n6 hours\n6 hours < t ≤ 24 hours\n24 hours\n1 day < t ≤ 3 days\n3 days\n3 days < t ≤ 30 days\n10 days\nAbove 30 days\nSee specific conditions\nTable 2\nSelection of test temperature\nThis temperature shall be used only for food simulants D2 and E. For applications heated under pressure, migration testing under pressure at the relevant temperature may be performed. For food simulants A, B, C or D1 the test may be replaced by a test at 100 °C or at reflux temperature for duration of four times the time selected according to the conditions in Table 1.\nWorst foreseeable contact temperature\nContact temperature to be selected for testing\nT ≤ 5 °C\n5 °C\n5 °C < T ≤ 20 °C\n20 °C\n20 °C < T ≤ 40 °C\n40 °C\n40 °C < T ≤ 70 °C\n70 °C\n70 °C < T ≤ 100 °C\n100 °C or reflux temperature\n100 °C < T ≤ 121 °C\n121 °C\n121 °C < T ≤ 130 °C\n130 °C\n130 °C < T ≤ 150 °C\n150 °C\n150 °C < T < 175 °C\n175 °C\n175 °C < T ≤ 200 °C\n200 °C\nT > 200 °C\n225 °C",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Substituted by Commission Regulation (EU) 2016/1416 of 24 August 2016 amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Inserted by Commission Regulation (EU) 2020/1245 of 2 September 2020 amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food (Text with EEA relevance)."
    },
    {
      "type": "footnote",
      "label": "f1",
      "text": "This temperature shall be used only for food simulants D2 and E. For applications heated under pressure, migration testing under pressure at the relevant temperature may be performed. For food simulants A, B, C or D1 the test may be replaced by a test at 100 °C or at reflux temperature for duration of four times the time selected according to the conditions in Table 1."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2011/10/annex/V/chapter/2/division/2.1/division/2.1.3",
    "retrieved_at": "2026-11-01T14:50:23.550534+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."
}