{
  "url": "https://openlegislation.uk/eu-regulation-2013-503/annex-II/division-II/division-2",
  "json_url": "https://openlegislation.uk/eu-regulation-2013-503/annex-II/division-II/division-2.json",
  "legislation": "eur/2013/503",
  "legislation_title": "Commission Implementing Regulation (EU) No 503/2013 of 3 April 2013 on applications for authorisation of genetically modified food and feed in accordance with Regulation (EC) No 1829/2003 of the European Parliament and of the Council and amending Commission Regulations (EC) No 641/2004 and (EC) No 1981/2006 (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2013-503",
  "path": "annex/II/division/II/division/2",
  "kind": "division",
  "number": "2",
  "heading": "EXPOSURE ASSESSMENT — ANTICIPATED INTAKE/EXTENT OF USE",
  "text": "An estimate of the expected intake shall be an essential element in the risk assessment of genetically modified food and feed and shall also be required for the nutritional evaluation. Information shall be provided by the applicant on the intended function, the dietary role, and the expected level of use of the genetically modified food and feed .... In addition, the expected range of concentrations of newly produced proteins or existing plant proteins deliberately modified in the genetically modified food(s) and feed(s) to be placed on the market shall be provided.\nOn the basis of representative consumption data for products obtained from the respective conventional plants, the applicant shall estimate the anticipated average and maximum intake of the genetically modified food and feed. Probabilistic methods may be used to determine ranges of plausible values rather than single values or point estimates. The applicant shall identify and consider particular groups of the population of the United Kingdom and the EU with an expected higher exposure and shall consider this higher exposure within the risk assessment. Any assumptions made in the exposure assessment shall be described. Recent developments in methodologies and appropriate consumption data shall be used. Data on import and production quantities may provide additional information for the intake assessment.\nThe applicant shall determine by appropriate methods the concentrations of the newly expressed proteins, other new constituents and endogenous food and feed constituents, of which the levels have been altered as a result of the genetic modification (for example, due to changes in metabolic pathways) in those parts of the genetically modified plant intended for food or feed use. Expected intake of these constituents shall be estimated taking into account the influences of processing, storage and expected treatment of the food and feed in question, for example, potential accumulation or reduction. In cases where the genetic modification has resulted in an altered level of a natural constituent, or if a new constituent occurs naturally in other food and feed products, the anticipated change in total intake of this constituent shall be assessed considering realistic as well as worst case intake scenarios.\nThe applicant shall provide information on known or anticipated human/animal intake of analogous genetically modified food and feed and on other routes of exposure to the respective new and natural constituents, including amount, frequency and other factors influencing exposure.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in Annex 2 s. 2 para. 2 omitted (31.12.2020) by virtue of The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 55(a)(ix)(aa); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in Annex 2 s. 2 para. 2 substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 55(a)(ix)(bb); 2020 c. 1, Sch. 5 para. 1(1)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2013/503/annex/II/division/II/division/2",
    "retrieved_at": "2026-11-01T14:48:39.117159+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."
}