While CE marking traditionally applies to medical devices and consumer technical goods in Europe, in the botanical and mushroom extract sector, buyers reference "CE Certification" as shorthand for full adherence to European Union food safety and chemical safety directives (Regulation (EC) No 178/2002, Regulation (EC) No 852/2004 on hygiene, and Novel Food qualification where applicable). For New York and US domestic distribution, regulatory authority falls under the US FDA 21 CFR Part 111 (cGMP in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements) and 21 CFR Part 117 (FSMA preventive controls).
Shaanxi Torzi Biotech satisfies both jurisdictions concurrently: our facility runs under certified ISO 22000 and cGMP management systems audited by SGS, and all batches undergo testing matching both European Pharmacopoeia (EP) and United States Pharmacopeia (USP) specifications.