Document ID: chunk:federal_register_of_legislation:F2022C01065:reg:12
Version: federal_register_of_legislation:F2022C01065
Segment Type: reg
Provision Reference: reg 12
Character Range: 177698–181243

12                                                        Purified amino acid that is a highly processed and purified extract from a microbial fermentation process                                All of the following:
                                                                                                                                                                                                   (a) the goods have been processed in a way that ensures that biosecurity risks associated with the goods have been managed to an acceptable level;
                                                                                                                                                                                                   (b) the goods are accompanied by a declaration by the manufacturer of the goods stating that:
                                                                                                                                                                                                   (i) the goods are a highly processed and purified extract from a microbial fermentation process and the culture media used in manufacture of the goods has been sterilised; and
                                                                                                                                                                                                   (ii) no materials of terrestrial animal or avian origin have been used during manufacture; and
                                                                                                                                                                                                   (iii) the goods have been manufactured to be compliant with the relevant monograph from at least one of the following published standards: United States Pharmacopeia, European Pharmacopoeia, British Pharmacopoeia or USP Food Chemicals Codex; and
                                                                                                                                                                                                   (iv) the level of purity of the goods (excluding any non‑biological carrier) has been shown to be at least 98%, calculated on a dry weight basis; and
                                                                                                                                                                                                   (v) the goods are not on a grain or animal‑based carrier; and
                                                                                                                                                                                                   (vi) the goods have not been exposed to contamination after processing; and
                                                                                                                                                                                                   (vii) the goods have been packed in clean and new packaging only; and
                                                                                                                                                                                                   (viii) the goods were manufactured in a facility that is operated according to standards of quality applicable to the production of stockfeed products, including appropriate standards for prevention of cross‑contamination of production cultures or raw materials