{"id":"F2018L01546","name":"Therapeutic Goods (Standard for Menstrual Cups) (TGO 99) Order 2018","slug":"therapeutic-goods-standard-for-menstrual-cups-tgo-99-order-2018","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":98207,"registerId":"commonwealth-F2018L01546-current","compilationNumber":null,"startDate":"2026-04-02","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Name","content":"#### 1 Name\n\n(1) This instrument is the Therapeutic Goods (Standard for Menstrual Cups) (TGO 99) Order 2018.\n\n(2) This instrument may also be cited as Therapeutic Goods Order 99, or TGO 99.","sortOrder":0},{"sectionNumber":"3","sectionType":"section","heading":"Authority","content":"#### 3 Authority\n\nThis instrument is made under subsection 10(1) of the Act.","sortOrder":1},{"sectionNumber":"4","sectionType":"section","heading":"Definitions","content":"#### 4 Definitions\n\nNote: A number of expressions used in this instrument are defined in definitions section of the Act, including the following:\n\n(a) Secretary;\n\n(b) sponsor;\n\n(c) therapeutic goods.\n\nIn this instrument:\n\nAct means the Therapeutic Goods Act 1989.\n\nbatch means a quantity of menstrual cups which, as far as practicable, consists of material or items of the same type, grade, class and composition, which have been manufactured under essentially the same conditions within a specified period of time.\n\nMenstrual cup means a product made from permissible raw materials that is inserted into the vagina and used to collect or capture menstrual discharge.\n\nPackaging means any of the following layers:\n\n-   unit pack (the pack enclosing a single menstrual cup);\n-   primary pack (the pack containing one or more unit packs);\n-   supply pack (the pack that is supplied to the consumer). The supply pack may consist of a single primary pack, or may contain one or more primary packs; or","sortOrder":2},{"sectionNumber":"5","sectionType":"section","heading":"Application","content":"#### 5 Application\n\n(1) The requirements set out in this instrument apply to all therapeutic goods that are menstrual cups.","sortOrder":3},{"sectionNumber":"6","sectionType":"section","heading":"Permissible Raw Materials","content":"#### 6 Permissible Raw Materials\n\n(1) Menstrual cups must be manufactured from materials that are suitable for the intended purpose of the menstrual cup.\n\n(2) Menstrual cups must not contain ingredients in sufficient concentration to cause a toxic or irritant reaction when used as directed.","sortOrder":4},{"sectionNumber":"7","sectionType":"section","heading":"Design Requirements","content":"#### 7 Design Requirements\n\n(1) The surface and shape of a menstrual cup must be smooth and designed to minimise the risk of trauma.","sortOrder":5},{"sectionNumber":"8","sectionType":"section","heading":"Packaging","content":"#### 8 Packaging\n\n(1) The following requirements apply to the packaging for menstrual cups:\n\n(a) the menstrual cup must be packed in a closed unit pack that is capable of maintaining the menstrual cup’s quality until the unit pack is opened by the consumer; and\n\n(b) the unit pack must be packed in a primary pack which is sufficiently robust to maintain the integrity of, and protect, the menstrual cup during normal transport and storage; and\n\n(c) the primary pack must be designed, overwrapped or sealed in such a manner that tampering will be easily detected.","sortOrder":6},{"sectionNumber":"9","sectionType":"section","heading":"Labelling","content":"#### 9 Labelling\n\n(1) The primary pack must be permanently and legibly marked with the following information:\n\n(a) words identifying the brand name;\n\n(b) the name and address of the manufacturer or supplier;\n\n(c) if the primary pack contains more than one unit pack, the name and quantity of all the menstrual cups within the primary pack;\n\n(d) the batch number of the menstrual cup(s), identified with the use of the words “Batch No.” or “Lot No.”;\n\n(e) words identifying the size (if applicable) of the menstrual cup; and\n\n(f) the following warning in letters with a height of not less than 1mm:\n\n“IMPORTANT: Menstrual cups have been associated with Toxic Shock Syndrome (TSS). TSS is a rare but serious disease that may cause death. Read and keep the enclosed information.”","sortOrder":7},{"sectionNumber":"10","sectionType":"section","heading":"Information to be supplied with menstrual cups","content":"#### 10 Information to be supplied with menstrual cups\n\n(1) The following information must be supplied with the menstrual cup, in a form that is legible and accessible to the consumer:\n\n(a) the manufacturer’s or supplier’s identifying information, including their name and address;\n\n(b) an information leaflet containing the following information:\n\n(i) detailed instructions for use, including the need for hygiene and care in insertion;\n\n(ii) a limit to the duration of use, not exceeding 12 hours;\n\n(iii) detailed instructions for cleaning and maintaining the integrity of the menstrual cup;\n\n(iv) a notification that the menstrual cup is not supplied in a sterile state;\n\n(v) information about Toxic Shock Syndrome, noting that while it is rarely associated with the use of menstrual cups, it can still occur;\n\n(vi) the following warning in letters with a height of not less than 1mm:\n\n“IMPORTANT: Menstrual cups have been associated with Toxic Shock Syndrome (TSS). TSS is a rare but serious disease that may cause death. Read and keep the enclosed information.”","sortOrder":8}],"analysis":{"flash_summary_failed":{"failed":true,"reason":"A positive credit balance is required for all requests, including BYOK, so fallback providers remain available. Add credits at https://vercel.com/d?to=%2F%5Bteam%5D%2F%7E%2Fai%3Fmodal%3Dtop-up to continue.","source":"analysis-cron"},"kimi_summary":{"content_quality":"ok","complexity_score":2,"scope_assessment":{"changed":false,"description":"The legislation maintains a narrow, focused scope on menstrual cup safety standards. It does not appear to have expanded beyond its original purpose of establishing manufacturing, packaging, and labelling requirements for this specific product category."},"complexity_factors":["Short instrument with only 10 sections","Minimal cross-referencing (only refers to the parent Act for definitions of 'Secretary', 'sponsor', and 'therapeutic goods')","Straightforward conditional logic with no nested exceptions","Only 4 defined terms specific to this instrument ('batch', 'menstrual cup', 'packaging', 'Act')","Clear, prescriptive requirements without alternative compliance pathways"],"plain_english_summary":"This law establishes mandatory safety and quality rules for menstrual cups sold in Australia, applying to all manufacturers and suppliers. It requires cups be made and designed from safe, non‑toxic materials with smooth surfaces, sold in sealed packaging, and accompanied by clear labelling and consumer information.\n\nPackages must include brand and batch details plus a prominent Toxic Shock Syndrome warning and instructions (cleaning, non‑sterile status, and a 12‑hour maximum wear time)."},"flash_summary":{"complexity_score":3,"scope_assessment":{"changed":false,"description":"The instrument states it applies to all therapeutic goods that are menstrual cups and sets product, packaging, labelling and information requirements. There are no provisions in the text that broaden or narrow that stated application beyond those expressed obligations."},"complexity_factors":["Narrow product scope limited to menstrual cups (see s 5) reduces breadth but concentrates obligations.","Cross-references to definitions in the Therapeutic Goods Act create dependency on external statutory terms (see s 4).","Broad performance phrases such as “suitable for the intended purpose” (s 6(1)) and prohibition on ingredient concentrations causing toxic/irritant reactions (s 6(2)) create interpretive and testing uncertainty.","Packaging regime distinguishes unit/primary/supply packs and requires tamper-evidence and transport robustness (definitions and s 8), increasing design and production tasks.","Mandatory labelling elements and minimum type size for a TSS warning (s 9(f)) impose precise compliance checks and artwork controls.","Obligations to supply a detailed information leaflet including hygiene, cleaning, non-sterile status and a 12-hour use limit (s 10) add ongoing documentation and consumer-advice obligations.","Batch definition and mandatory batch numbering (definition of batch; s 9(d)) create traceability and record-keeping burdens for manufacturers/sponsors.","Regulatory authority is conferred under the Act (s 3), leaving enforcement mechanisms and discretionary action to the regulator rather than set out in this instrument.","Absence of referenced test methods or objective performance metrics (e.g. biocompatibility assays, cytotoxicity standards) increases implementation risk and may require sponsors to infer suitable conformity processes."],"plain_english_summary":"*This Order sets mandatory product standards for menstrual cups classified as therapeutic goods. It requires suitable non‑toxic materials, a smooth design to minimise trauma, tamper‑evident packaging, batch traceability, specified labelling including a Toxic Shock Syndrome (TSS) warning, and a consumer information leaflet with cleaning instructions and a maximum 12‑hour use limit.* It affects manufacturers, sponsors, importers and suppliers who must meet these obligations and consumers who receive the mandated safety information."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-standard-for-menstrual-cups-tgo-99-order-2018","history":"/api/acts/therapeutic-goods-standard-for-menstrual-cups-tgo-99-order-2018/history","analysis":"/api/acts/therapeutic-goods-standard-for-menstrual-cups-tgo-99-order-2018/analysis","conflicts":"/api/acts/therapeutic-goods-standard-for-menstrual-cups-tgo-99-order-2018/conflicts","importantCases":"/api/acts/therapeutic-goods-standard-for-menstrual-cups-tgo-99-order-2018/important-cases","documents":"/api/acts/therapeutic-goods-standard-for-menstrual-cups-tgo-99-order-2018/documents"}}