{
  "url": "https://openlegislation.uk/eu-regulation-2008-429/annex-II/division-3/division-3.4/division-3.4.1",
  "json_url": "https://openlegislation.uk/eu-regulation-2008-429/annex-II/division-3/division-3.4/division-3.4.1.json",
  "legislation": "eur/2008/429",
  "legislation_title": "Commission Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2008-429",
  "path": "annex/II/division/3/division/3.4/division/3.4.1",
  "kind": "division",
  "number": "3.4.1",
  "heading": "Phase I assessment",
  "text": "The purpose of Phase I assessment is to determine if a significant environmental effect of the additive or its metabolites is likely and whether a Phase II assessment is necessary (see decision tree).\nExemption from Phase II assessment may be made on one of two criteria, unless there is scientifically-based evidence for concern:\n(a)the chemical nature and the biological effect of the additive and its conditions of use indicate that impact will be negligible, i.e. where the additive is:\na physiological or natural substance that will not result in a substantial increase of the concentration in the environment; or\nintended for non-food producing animals;\n(b)the worst case Predicted Environmental Concentration (PEC) is too low to be of concern. The PEC shall be evaluated for each compartment of concern (see below), assuming that 100 % of the dose ingested is excreted as the parent compound.\nIf the applicant cannot demonstrate that the additive falls into one of these exemption categories, a Phase II assessment will be required.",
  "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/2008/429/annex/II/division/3/division/3.4/division/3.4.1",
    "retrieved_at": "2026-11-01T14:52:17.021143+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."
}