{
  "url": "https://openlegislation.uk/eu-regulation-2011-546/annex/part-II/division-B/division-2/division-2.8",
  "json_url": "https://openlegislation.uk/eu-regulation-2011-546/annex/part-II/division-B/division-2/division-2.8.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/2.8",
  "kind": "division",
  "number": "2.8",
  "heading": "Effects on and exposure of non-target organisms",
  "text": "Information on the ecology of the micro-organism and effects on the environment shall be assessed as well as possible exposure levels and the effects of its relevant metabolites/toxins. An overall assessment of the environmental risks that the plant protection product may cause, taking into account the normal levels of exposure to micro-organisms both in the environment as well as in the body of organisms, is necessary.\nCompetent authorities shall evaluate the possibility of exposure of non-target organisms under the proposed conditions of use and if this possibility exists they shall evaluate the risks arising for the non-target organisms concerned.\nWhere applicable, an assessment of infectivity and pathogenicity is necessary, unless it can be justified that non-target organisms shall not be exposed.\nTo assess the possibility of exposure the following information shall also be taken into consideration:\n(a)the survival of the micro-organism in the respective compartment;\n(b)its ecological niche;\n(c)the natural background level of the micro-organism, where it is indigenous;\n(d)information on fate and behaviour in the various parts of the environment;\n(e)where relevant, other authorised uses of the plant protection product in the area of envisaged use containing the same active substance or which give rise to the same residues.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in Annex Pt. 2.B points 2.7.3, 2.7.4, 2.8, 2.8.1, 2.8.2, 2.8.3, 2.8.4, 2.8.5, 2.8.6, 2.8.6.2, 2.9 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)(xxii); 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/2.8",
    "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."
}