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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)
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Detailed characterisation of the qualitative and, where applicable, quantitative analytical method(s) for determining compliance with maximum or minimum proposed levels of the active substance(s)/agent(s) in the additive, premixtures, feedingstuffs and, when appropriate, water, shall be provided.
comply with relevant Community rules (e.g. Community methods of analysis) where they exist;
comply with internationally recognised rules or protocols, for example those that the European Committee for Standardisation (CEN) has accepted, or those agreed in national legislation (e.g. CEN Standard methods);
are fit for the intended purpose, developed in accordance with scientific protocols and validated in a ring test in accordance with an internationally recognised protocol on collaborative trials (e.g. ISO 5725 or IUPAC); or
are validated in-house according to international harmonised guidelines for the in-house validation of methods of analysis(1) with respect to the characterising parameters mentioned in 2.6.1.2.
M. Thompson et al.: Harmonized Guidelines For Single Laboratory Validation Of Methods Of Analysis (IUPAC Technical Report) Pure Appl. Chem., Vol. 74, No. 5, pp. 835-855, 2002.
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