{
  "url": "https://openlegislation.uk/eu-directive-2005-25/annex/division-B",
  "json_url": "https://openlegislation.uk/eu-directive-2005-25/annex/division-B.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",
  "kind": "division",
  "number": "B",
  "heading": "EVALUATION",
  "text": "The objective of an evaluation is to identify and assess, on a scientific basis and until further experience is reached on a case-by-case basis, potential adverse effects on human and animal health and the environment of the use of a microbial plant protection product. The evaluation shall also be carried out in order to identify the need for risk management measures and to identify and recommend suitable measures.\nDue 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. Moreover, micro-organisms consist of a wide range of different organisms, all with their own unique characteristics. These differences between micro-organisms should be taken into account in the evaluation.\nThe micro-organism in the plant protection product should ideally function as a cell factory working directly on the spot where the target organism is harmful. Thus understanding the mode of action is a crucial step in the evaluation process.\nMicro-organisms may produce a range of different metabolites (e.g. bacterial toxins or mycotoxins) many of which may have toxicological significance, and one or more of which may be involved in the mode of action of the plant protection product. The characterisation and identification of relevant metabolites should be assessed and the toxicity of these metabolites should be addressed. Information on production and/or relevance of metabolites may be deduced from:\n(a) toxicity studies,\n(b) biological properties of the micro-organism,\n(c) relationship to known plant, animal or human pathogens,\n(d) mode of action,\n(e) analytical methods.\nOn the basis of this information, metabolites may be considered as possibly being relevant. Therefore potential exposure to these metabolites should be assessed, in order to decide on their relevance.",
  "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",
    "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."
}