Chemically defined substances should be described by generic name, chemical name according to the International Union of Pure and Applied Chemistry (IUPAC) nomenclature, other generic international names and abbreviations and the Chemical Abstract Service (CAS) number and the European Inventory of Existing Commercial chemical Substances number (EINECS), European Community number and European Enzyme Commission number if available. The structural and molecular formula, the openSMILES notation and the molecular weight must be included. Where relevant, the isomeric forms should be given. Information on structurally related substances should be included, when appropriate.
For chemically defined compounds used as flavourings, the EU Flavour Information System (FLAVIS) number in connection with relevant chemical group should be included.
For additives of plant origin, the characterisation should include the scientific name of the plant of origin and its botanical classification (family, genus, species, if appropriate subspecies). The parts of the plant used to obtain the active substance(s) (e.g. leaves, flowers, seeds, fruits, tubers, roots) should be indicated. The identification criteria and other relevant aspects of the plants should be indicated. For complex mixtures of many compounds obtained by an extraction process, it is recommended to follow the relevant terminology such as essential oil, absolute, tincture, extract and related terms widely used for botanically defined flavouring products to describe the extraction process. Reasonable efforts should be made to identify and quantify all components of the mixture. One or more marker compounds should be selected, which will allow the additive to be identified in the different studies. Information on the variability in composition of comparable products should be provided. This could be done by reference to published literature.
For natural products of non‐plant origin, an equivalent approach to the above may be used.
Additives in which not all constituents can be identified should be characterised by the constituent(s) contributing to its activity. One or more marker compounds should be selected which will allow the additive to be identified in the different studies.
For clays' data on elemental and mineralogical composition as well as information on the structure should be provided by appropriate methods (e.g. atomic absorption spectrophotometry, X‐ray diffraction, differential thermal analysis).
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 ’ should 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.
When the active substance(s)/agent(s) is/are supplied by a third party, the requirements/specifications (e.g. purity and impurities with safety relevance) set by the applicant should be provided.
For chemical substances produced by fermentation, the microbial origin should also be described (see Section2.2.1.2 ).
For chemically defined compounds used as flavourings, the EU Flavour Information System (FLAVIS) number in connection with relevant chemical group should be included.
For additives of plant origin, the characterisation should include the scientific name of the plant of origin and its botanical classification (family, genus, species, if appropriate subspecies). The parts of the plant used to obtain the active substance(s) (e.g. leaves, flowers, seeds, fruits, tubers, roots) should be indicated. The identification criteria and other relevant aspects of the plants should be indicated. For complex mixtures of many compounds obtained by an extraction process, it is recommended to follow the relevant terminology such as essential oil, absolute, tincture, extract and related terms widely used for botanically defined flavouring products to describe the extraction process. Reasonable efforts should be made to identify and quantify all components of the mixture. One or more marker compounds should be selected, which will allow the additive to be identified in the different studies. Information on the variability in composition of comparable products should be provided. This could be done by reference to published literature.
For natural products of non‐plant origin, an equivalent approach to the above may be used.
Additives in which not all constituents can be identified should be characterised by the constituent(s) contributing to its activity. One or more marker compounds should be selected which will allow the additive to be identified in the different studies.
For clays' data on elemental and mineralogical composition as well as information on the structure should be provided by appropriate methods (e.g. atomic absorption spectrophotometry, X‐ray diffraction, differential thermal analysis).
For enzyme and enzyme preparations, the number and systematic name proposed by the International Union of Biochemistry (IUB) in the most recent edition of ‘
When the active substance(s)/agent(s) is/are supplied by a third party, the requirements/specifications (e.g. purity and impurities with safety relevance) set by the applicant should be provided.
For chemical substances produced by fermentation, the microbial origin should also be described (see Section
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