Document ID: chunk:federal_register_of_legislation:F2019C00191:reg:9
Version: federal_register_of_legislation:F2019C00191
Segment Type: reg
Provision Reference: reg 9
Character Range: 78012–81641

9                                                         Purified vitamin D3 that is a highly processed derivative of wool grease                                                          All of the following:
                                                                                                                                                                                            (a) the goods are free from extraneous material;
                                                                                                                                                                                            (b) the goods have been processed in a way that ensures that biosecurity risks associated with the goods have been managed to an acceptable level;
                                                                                                                                                                                            (c) the goods are accompanied by a declaration by the manufacturer of the goods stating that:
                                                                                                                                                                                            (i) the goods are a highly processed derivative of wool grease; and
                                                                                                                                                                                            (ii) the only material of terrestrial animal or avian origin used during the manufacture of the goods was wool grease; 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 96%, 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 the standards of quality applicable to the production of stockfeed products, including appropriate standards for prevention of cross‑contamination of production cultures or raw materials