- Y Diweddaraf sydd Ar Gael (Diwygiedig)
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Commission Regulation (EC) No 429/2008Dangos y teitl llawn
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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2.2.1.Description
A qualitative description of the active substance or agent shall be given. This shall include purity and origin of the substance or agent, plus any other relevant characteristics.
2.2.1.1.Chemical substances
Chemically well-defined substances shall be described by generic name, chemical name according to IUPAC (International Union of Pure and Applied Chemistry) nomenclature, other generic international names and abbreviations and/or Chemical Abstract Service Number (CAS). The structural and molecular formula and molecular weight must be included.
For chemically defined compound used as flavourings, the FLAVIS number in connection with relevant chemical group shall be included. For plant extracts the phytochemical markers must be included.
Mixtures in which the constituents cannot be described by a single chemical formula and/or not all of them can be identified shall be characterised by constituent(s) contributing to its activity and/or typical major constituent(s). Marker compound shall be identified to allow stability to be assessed and to provide a means of traceability.
For enzyme and enzyme preparations, the number and systematic name proposed by the International Union of Biochemistry (IUB) in the most recent edition of ‘Enzyme Nomenclature’ shall be given for each declared activity. For activities not yet included, a systematic name consistent with the IUB rules of nomenclature shall be used. Trivial names are acceptable provided that they are unambiguous and used consistently throughout the dossier, and they can be clearly related to the systematic name and IUB number at their first mention. The biological origin of each enzyme activity must be given.
The microbial origin of chemical substances produced by fermentation shall also be described (see 2.2.1.2 Micro-organisms).
2.2.1.2.Micro-organisms
For all micro-organisms, whether used as product or as production strain, the origin shall be provided.
For micro-organisms used as a product or as production strain, any history of modification shall be indicated. The name and taxonomic classification of each micro-organism shall be provided, according to the latest published information in the International Codes of Nomenclature (ICN). Microbial strains shall be deposited in an internationally recognised culture collection (preferably in the European Union) and maintained by the culture collection for the authorised life of the additive. A certificate of deposition from the collection, which shall specify the accession number under which the strain is held, must be provided. In addition, all relevant morphological, physiological and molecular characteristics necessary to provide the unique identification of the strain and the means to confirm its genetic stability shall be described. For GMOs the description of the genetic modifications shall be given. The unique identifier for each GMO, as referred in Commission Regulation (EC) No 65/2004 of 14 January 2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms, shall be included.
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Mae deddfwriaeth ar gael mewn fersiynau gwahanol:
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