{
  "url": "https://openlegislation.uk/eu-regulation-2008-429/annex-III/division-4/division-4.2/division-4.2.3/division-4.2.3.3",
  "json_url": "https://openlegislation.uk/eu-regulation-2008-429/annex-III/division-4/division-4.2/division-4.2.3/division-4.2.3.3.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/III/division/4/division/4.2/division/4.2.3/division/4.2.3.3",
  "kind": "division",
  "number": "4.2.3.3",
  "heading": "Studies concerning the safety of the additive for users/workers",
  "text": "The whole of subsection 3.3 of Annex II applies except:\nenzymes and micro-organisms, as proteinaceous substances, are assumed to be respiratory sensitisers unless convincing evidence to the contrary is provided. Therefore, no direct testing is required.\nthe formulation of the product (e.g. micro-encapsulation) may obviate the need for some or all tests. In such cases, appropriate justification shall be provided.",
  "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/III/division/4/division/4.2/division/4.2.3/division/4.2.3.3",
    "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."
}