1 The identification of the organism, hereinafter referred to as “production organism”, and the organ, if applicable, from which the biochemical or biopolymer is isolated, including
(a) synonyms and common and superseded names, if known; and
(b) its source and history.
2 A description of any known adverse environmental or human health effects associated with exposure to the production organism.
3 The concentration of the viable production organism in the biochemical or biopolymer and, if known, in end-use products.
4 A description of the method used to separate the production organism from the biochemical or biopolymer.
5 The identification of the encoded products, if known.
6 A description of any known biological activity or adverse environmental or human health effects associated with the nucleic acid or with the encoded products specified under item 5.
7 A description of all known catalytic functions.
8 The Enzyme Commission (EC) number as designated by the nomenclature committee of the International Union of Biochemistry and Molecular Biology (IUBMB), if available.
9 The known substrate specificity for each of the catalytic functions specified under item 7.
10 The optimum pH and temperature for the substrates specified under item 9.
11 The catalytic constants Km and Kcat and the conditions under which they were measured.
12 The known cofactors necessary for enzymatic activity.
13 The enzymatic activity per unit of weight of products and, if known, of end-use products.
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