{
  "url": "https://openlegislation.uk/eu-regulation-2013-503/annex-II/division-II/division-1/division-1.7",
  "json_url": "https://openlegislation.uk/eu-regulation-2013-503/annex-II/division-II/division-1/division-1.7.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/1.7",
  "kind": "division",
  "number": "1.7",
  "heading": "Standardised guidelines for toxicity tests",
  "text": "The applicant shall use for toxicity testing internationally agreed guidelines and test methods described by Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (see Tables 1 and 2). A non-exhaustive list of validated test methods which, where necessary, shall be used in a possibly adapted form for GMO toxicological testing is provided in Tables 1 and 2.\nThe performance of test methods depends on the type of genetically modified food and feed, type of the genetic modification and resulting intended and unintended alterations, intended use and exposure/intake, and the available knowledge. Some of the tests were developed for the assessment of risks at the workplace (see Sections 1.4 and 1.5).\nTable 1\nNon-exhaustive list of validated test methods for chemicals as provided by Regulation (EC) No 440/2008 and which may be used in a possibly adapted form for GMO toxicological testing\nTitle\nReference of the method in Part B of the Annex to Regulation (EC) No 440/2008\nACUTE TOXICITY (DERMAL)\nB.3.\nSKIN SENSITISATION\nB.6.\nREPEATED-DOSE (28 DAYS) TOXICITY (ORAL)\nB.7.\nREPEATED-DOSE (28 DAYS) TOXICITY (DERMAL)\nB.9.\nSUBCHRONIC ORAL TOXICITY TEST REPEATED-DOSE 90-DAY ORAL TOXICITY STUDY IN RODENTS\nB.26.\nCHRONIC TOXICITY TEST\nB.30.\nCARCINOGENICITY TEST\nB32.\nCOMBINED CHRONIC TOXICITY/CARCINOGENICITY TEST\nB.33.\nONE-GENERATION REPRODUCTION TOXICITY TEST\nB.34.\nTWO-GENERATION REPRODUCTION TOXICITY STUDY\nB.35.\nTOXICOKINETICS\nB.36.\nNEUROTOXICITY STUDY IN RODENTS\nB.43.\nTable 2\nGenotoxicity tests as provided by Regulation (EC) No 440/2008\nTitle\nReference of the method in Part B of the Annex to Regulation (EC) No 440/2008\nMUTAGENICITY — IN VIVO MAMMALIAN BONE MARROW CHROMOSOME ABERRATION TEST\nB.11.\nMUTAGENICITY — IN VIVO MAMMALIAN ERYTHROCYTE MICRONUCLEUS TEST\nB.12.\nMUTAGENICITY: REVERSE MUTATION TEST USING BACTERIA\nB.13/14.\nMUTAGENICITY TESTING AND SCREENING FOR CARCINOGENICITY GENE MUTATION — SACCHAROMYCES CEREVISIAE\nB.15.\nMITOTIC RECOMBINATION — SACCHAROMYCES CEREVISIAE\nB.16.\nDNA DAMAGE AND REPAIR — UNSCHEDULED DNA SYNTHESIS — MAMMALIAN CELLS IN VITRO\nB.18.\nMUTAGENICITY — IN VITRO MAMMALIAN CELL GENE MUTATION TEST\nB.17.\nSISTER CHROMATID EXCHANGE ASSAY IN VITRO\nB.19.\nIN VITRO MAMMALIAN CELL TRANSFORMATION TESTS\nB.21.\nMAMMALIAN SPERMATOGONIAL CHROMOSOME ABERRATION TEST\nB.23.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "OJ L 142, 31.5.2008, p. 1."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2013/503/annex/II/division/II/division/1/division/1.7",
    "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."
}