{
  "url": "https://openlegislation.uk/eu-directive-2005-25/annex/division-B/division-2/division-2.6/division-2.6.1/division-2.6.1.4",
  "json_url": "https://openlegislation.uk/eu-directive-2005-25/annex/division-B/division-2/division-2.6/division-2.6.1/division-2.6.1.4.json",
  "legislation": "eudr/2005/25",
  "legislation_title": "Council Directive 2005/25/EC of 14 March 2005 amending Annex VI to Directive 91/414/EEC as regards plant protection products containing micro-organisms (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-directive-2005-25",
  "path": "annex/division/B/division/2/division/2.6/division/2.6.1/division/2.6.1.4",
  "kind": "division",
  "number": "2.6.1.4",
  "heading": "Member States shall evaluate the possibility of exposure of other humans (workers exposed after the application of the plant protection product, such as re-entering workers, or bystanders) or animals to the micro-organism and/or to other toxicologically relevant compounds in the plant protection product under the proposed conditions of use. This evaluation will take into consideration the following information:",
  "text": "(a) the medical data and the toxicity, infectivity and pathogenicity studies provided for in Annex IIB, and the results of the evaluation thereof. Tier 1 tests should permit an evaluation to be made of a micro-organism with respect to its ability to persist or grow in the host and its ability to cause effects/reactions in the host. Parameters that indicate the absence of ability to persist and multiply in the host, and the absence of ability to produce non-adverse or adverse effects in a host, include rapid and complete clearance from the body, no activation of the immune system, no histopathological changes, and inability to replicate at mammalian body temperatures. These parameters can in some cases be assessed using acute studies and existing human data, and sometimes can only be assessed using repeated dose studies.\nEvaluation based on relevant parameters of Tier 1 tests should lead to an assessment of the possible effects of occupational exposure, taking into account the intensity and duration of exposure, including exposure due to repeated use during practical use.\nThe toxicity of certain metabolites/toxins can only be assessed, if it has been demonstrated that the test animals are actually exposed to these metabolites/toxins;\n(b) other relevant information on the micro-organism, the metabolites/toxins, residual growth medium, contaminants and co-formulants in the plant protection product, such as their biological, physical and chemical properties (e.g. survival of the micro-organism at the body temperature of humans and animals, ecological niche, behaviour of the micro-organism and/or metabolites/toxins during application);\n(c) the toxicological studies provided for in Annex IIIB;\n(d) other relevant information on the plant protection product as provided for in Annex IIIB such as:\nre-entry periods, necessary waiting periods or other precautions to protect humans and animals,\nmethod of application, in particular spraying,\nmaximum application rate,\nminimum spray application volume,\ncomposition of the preparation,\nexcess remaining on plants and plant products after treatment, taking into account the influence of factors such as temperature, UV light, pH and the presence of certain substances,\nfurther activities whereby workers are exposed.",
  "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/eudr/2005/25/annex/division/B/division/2/division/2.6/division/2.6.1/division/2.6.1.4",
    "retrieved_at": "2026-11-01T15:22:44.100508+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."
}