{
  "url": "https://openlegislation.uk/eu-regulation-2013-503/annex-II/division-II/division-1/division-1.4",
  "json_url": "https://openlegislation.uk/eu-regulation-2013-503/annex-II/division-II/division-1/division-1.4.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/1/division/1.4",
  "kind": "division",
  "number": "1.4",
  "heading": "Toxicology",
  "text": "The toxicological impact of any changes on the whole genetically modified food/feed resulting from the genetic modification such as the introduction of new genes, gene silencing or over-expression of an endogenous gene shall be assessed.\nToxicological assessment shall be performed in order to:\n(a)demonstrate that the intended effect(s) of the genetic modification has no adverse effects on human and animal health;\n(b)demonstrate that unintended effect(s) of the genetic modification(s) identified or assumed to have occurred based on the preceding comparative molecular, compositional or phenotypic analyses, have no adverse effects on human and animal health;\n(c)identify potential adverse effects of new constituents and determine their highest dose level that does not result in adverse effects. From data obtained from an appropriate animal study, an acceptable daily intake (ADI) of single compounds by humans may be derived by using uncertainty or safety factors that take into account differences between test animal species and humans, and inter-individual variations among humans;\n(d)identify potential adverse effects on the whole genetically modified food/feed or address remaining uncertainties through the performance of 90-day feeding studies.\nThe applicant shall consider the nature of toxicological testing to be conducted on new constituents and whole genetically modified food/feed based on the outcome of the molecular and comparative analysis referred to in Sections 1.2 and 1.3, namely the differences identified between the genetically modified product and its conventional counterpart, including intended as well as unintended changes. The applicant shall also assess the results of the performed toxicological tests to consider the need to conduct additional testing on new constituents or on whole genetically modified food/feed as set out in Sections 1.4.4.2 and 1.4.4.3.\nThe applicant shall take into account the presence of: newly expressed proteins, the potential presence of other new constituents and/or possible changes in the level of natural constituents beyond normal variation. The specific information requirements and testing strategies are set out in Sections 1.4.1 to 1.4.4.\nAs regards applications of which the scope include or is restricted to genetically modified food and feed produced from genetically modified plants, toxicological studies with the processed products shall be provided except if the applicant provides a risk assessment of the genetically modified plant (or relevant parts of it) demonstrating its safety and there are no indications that the processed genetically modified food and feed would be any different from their respective conventional counterpart. The applicant shall provide adequate justification in this regard.\nToxicology studies designed to evaluate risks to human and/or animal health shall complement each other. Most studies required for the assessment of the safety of the genetically modified food are also valid for the assessment of genetically modified feed.\nBesides the exposure of consumers and animals through intake of food and feed, any adverse effect(s) on individuals that could be due to their exposure to genetically modified food and feed material as part of their professional activities, for example, farming, seed processing, shall be reported by the applicant. Appropriate studies shall be performed to further characterise these indications of potential adverse effects.\nThe applicant shall use internationally agreed protocols and test methods for toxicity testing (see Tables 1 and 2 of Section 1.7). Adaptations of these protocols or use of any methods that differ from such protocols shall be justified in the application.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2013/503/annex/II/division/II/division/1/division/1.4",
    "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."
}