{
  "url": "https://openlegislation.uk/eu-regulation-2011-546/annex/part-II/division-B/division-2/division-2.6",
  "json_url": "https://openlegislation.uk/eu-regulation-2011-546/annex/part-II/division-B/division-2/division-2.6.json",
  "legislation": "eur/2011/546",
  "legislation_title": "Commission Regulation (EU) No 546/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2011-546",
  "path": "annex/part/II/division/B/division/2/division/2.6",
  "kind": "division",
  "number": "2.6",
  "heading": "Impact on human or animal health",
  "text": "The impact on human or animal health must be evaluated. In particular, competent authorities must take account of the following principles:\n(a)due to the ability of micro-organisms to replicate, there is a clear difference between chemicals and micro-organisms used as plant protection products. Hazards arising are not necessarily of the same nature as those presented by chemicals, especially in relation to the capacity of micro-organisms to persist and multiply in different environments;\n(b)the pathogenicity of the micro-organism to humans and non-target animals, the infectiveness of the micro-organism, the ability of the micro-organism to colonise, the toxicity of metabolites/toxins as well as the toxicity of the residual growth medium, contaminants and co-formulants, are important endpoints in assessing adverse effects arising from the plant protection product;\n(c)colonisation, infectiveness and toxicity comprise a complex set of interactions between micro-organisms and hosts and these endpoints may not be resolved easily as independent endpoints;\n(d)in combining these endpoints, the most important aspects of the micro-organism that must be assessed are:\nability to persist and multiply in a host (indicative of colonisation or infectivity),\nability to produce non-adverse or adverse effects in a host, indicative of infectivity, pathogenicity, and/or toxicity;\n(e)moreover, the complexity of the biological issues shall be taken into account in evaluating the hazards and risks presented by use of these plant protection products for human and animals. An assessment of pathogenicity and infectiveness is necessary even if the potential of exposure is deemed low;\n(f)for risk assessment purposes the acute toxicity studies used shall, where available, include at least two doses (e.g. one very high dose and one corresponding to the expected exposure under practical conditions).",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in Annex Pt. 2.B point 2.6 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(9)(b)(xv); 2020 c. 1, Sch. 5 para. 1(1)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2011/546/annex/part/II/division/B/division/2/division/2.6",
    "retrieved_at": "2026-11-01T14:50:05.430430+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."
}