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Division (iv) Any relevant metabolites (i.e. of concern for human health and/or the environment) formed by the test organism under any relevant environmental conditions shall be characterised. If relevant metabolites are present in or produced by the micro-organism, data as outlined under Section 7 of Part A of this Annex may be required, if all of the following conditions are met:

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  • the relevant metabolite is stable outside the micro-organism, see point 2.8, and

  • a toxic effect of the relevant metabolite is independent of the presence of the micro-organism, and

  • the relevant metabolite is expected to occur in the environment in concentrations considerably higher than under natural conditions.