Commission Regulation (EC) No 429/2008Show full title

2.2. Characterisation of the active substance(s)/agent(s)

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.

2.2.2. Relevant properties

2.2.2.1. Chemical substances

Description of physical and chemical properties shall be given. Dissociation constant, pKa, electrostatic properties, melting point, boiling point, density, vapour pressure, solubility in water and in organic solvents, K_ow and K_d/K_oc, mass spectrometry and absorption spectra, NMR data, possible isomers and any other appropriate physical properties shall be provided, where appropriate.

Substance produced via fermentation shall be free of antimicrobial activities relevant to the use of antibiotics in humans or animals.

2.2.2.2. Micro-organisms

• Toxins and virulence factors

  Toxins or virulence factors shall be demonstrated to be absent or of no concern. Strains of bacteria belonging to a taxonomic group that includes members known to be capable of producing toxins or other virulence factors shall be subject to appropriate tests to demonstrate at a molecular and, if necessary, cellular level the absence of any cause for concern.

  For strains of micro-organisms for which there is no history of an apparent safe use and whose biology remains poorly understood, a full package of toxicological studies shall be necessary.

• Antibiotic production and antibiotic resistance

  Micro-organisms used as additives or as production strain, shall be free of antibiotic activity or shall not be capable of producing antibiotic substances that are relevant as antibiotics in humans and animals.

  Strains of micro-organisms intended for use as additives shall not contribute further to the reservoir of antibiotic resistance genes already present in the gut flora of animals and the environment. Consequently, all strains of bacteria shall be tested for resistance to antibiotics in use in human and veterinary medicine. Where resistance is detected, the genetic basis of the resistance and the likelihood of transfer of resistance to other gut-inhabiting organisms shall be established.

  Strains of micro-organisms carrying an acquired resistance to antimicrobial(s) shall not be used as feed additives, unless it can be demonstrated that resistance is a result of chromosomal mutation(s) and it is not transferable.