{
  "url": "https://openlegislation.uk/eu-regulation-2013-284/annex/section-7/division-7.1/division-7.1.5",
  "json_url": "https://openlegislation.uk/eu-regulation-2013-284/annex/section-7/division-7.1/division-7.1.5.json",
  "legislation": "eur/2013/284",
  "legislation_title": "Commission Regulation (EU) No 284/2013 of 1 March 2013 setting out the data requirements for plant protection products, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2013-284",
  "path": "annex/section/7/division/7.1/division/7.1.5",
  "kind": "division",
  "number": "7.1.5",
  "heading": "Eye irritation",
  "text": "The results of the study shall provide the potential for eye irritation of the plant protection product, including the potential reversibility of the effects observed.\nBefore undertaking in vivo studies for eye corrosion/irritation of the plant protection product, a weight-of-evidence analysis shall be performed on the existing relevant data. Where available data are considered insufficient, further data may be developed through application of sequential testing.\nThe testing strategy shall follow a tiered approach:\n(1)the use of an in vitro dermal irritation/corrosion test to predict eye irritation/corrosion;\n(2)the performance of a validated or accepted in vitro eye irritation study to identify severe eye irritants/corrosives (such as BCOP, ICE, IRE, HET-CAM), and where negative results are obtained;\n(3)the assessment of eye irritation using an available, in vitro test method validated for plant protection products for identification of non-irritants or irritants, and when not available;\n(4)an initial in vivo eye irritation study using one animal, and where no adverse effects are noted;\n(5)confirmatory testing using one or two additional animals.",
  "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/2013/284/annex/section/7/division/7.1/division/7.1.5",
    "retrieved_at": "2026-11-01T14:48:45.647621+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."
}