{"id":"F2019L00428","name":"Therapeutic Goods (Standard for Tampons) (TGO 103) Order 2019","slug":"therapeutic-goods-standard-for-tampons-tgo-103-order-2019","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":99029,"registerId":"commonwealth-F2019L00428-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 Tampons) (TGO 103) Order 2019.\n  (2) This instrument may also be cited as TGO 103.","sortOrder":0},{"sectionNumber":"3","sectionType":"section","heading":"Authority","content":"#### 3 Authority\n\n  This instrument is made under section 10 of the Therapeutic Goods Act 1989.","sortOrder":1},{"sectionNumber":"4","sectionType":"section","heading":"Definitions","content":"#### 4 Definitions\n\n> Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:\n\n    (a) label;\n    (b) sponsor;\n    (c) therapeutic goods.\n  In this instrument:\n\n> Act means the Therapeutic Goods Act 1989.\n\n> Australian Standard means the Australian Standard AS 2869:2022 Tampons-Menstrual published by, or on behalf of, Standards Australia, as in force or existing at 30 November 2022.\n\n> tampons means therapeutic goods that are menstrual tampons.","sortOrder":2},{"sectionNumber":"5","sectionType":"section","heading":"Standard","content":"#### 5 Standard\n\n  This instrument constitutes a standard for tampons.","sortOrder":3},{"sectionNumber":"6","sectionType":"section","heading":"Requirements","content":"#### 6 Requirements\n\n  The requirements in relation to tampons are:\n    (a) those requirements specified in the Australian Standard; and\n    (b) the requirement that the label of the tampons must include the name and address of the manufacturer or sponsor of the tampons.","sortOrder":4},{"sectionNumber":"6A","sectionType":"section","heading":"Transitional arrangements relating to the Therapeutic Goods (Standard for Tampons) (TGO 103) Amendment Order 2022","content":"#### 6A Transitional arrangements relating to the Therapeutic Goods (Standard for Tampons) (TGO 103) Amendment Order 2022\n\n  (1) Despite the amendments made by the Amendment Order, the requirements relating to labelling that are specified in the old Standard may continue to be complied with, as an alternative to the requirements relating to labelling that are specified in the new Standard, for the duration of the transitional period.\n  (2) In this section:\n\n> Amendment Order means the Therapeutic Goods (Standard for Tampons) (TGO 103) Amendment Order 2022.\n\n> new Standard means the Australian Standard AS 2869:2022 Tampons-Menstrual published by, or on behalf of, Standards Australia, as in force or existing at 30 November 2022.\n\n> old Standard means the Australian Standard AS 2869-2008 Tampons-Menstrual published by, or on behalf of, Standards Australia, as in force or existing at 31 March 2019.\n\n> transitional period means the period beginning on the commencement of the Amendment Order and ending on 31 December 2024.","sortOrder":5}],"analysis":{"kimi_summary":{"content_quality":"ok","complexity_score":2,"scope_assessment":{"changed":false,"description":"The legislation maintains its original narrow scope: setting standards for menstrual tampons. The 2022 amendment updated the referenced Australian Standard from the 2008 version to the 2022 version and added a transitional period, but did not expand the scope beyond tampon safety and labelling requirements."},"complexity_factors":["Very short instrument (6 sections plus definitions)","Only 4 defined terms in the instrument itself (Act, Australian Standard, tampons, plus transitional terms in section 6A)","Simple structure: single operative requirement incorporating external standard by reference","One transitional provision with straightforward date-based cutoff","No nested exceptions, conditional logic, or cross-references beyond the single incorporation of the Australian Standard"],"plain_english_summary":"This order requires tampons sold in Australia to meet the safety and performance specifications of Australian Standard AS 2869:2022, treating them as regulated therapeutic goods. It affects manufacturers and sponsors, who must ensure product compliance and include the manufacturer/sponsor name and address on packaging, and it reassures consumers that tampons meet national safety and quality benchmarks. A grace period to adopt the 2022 labelling rules ended 31 December 2024."},"flash_summary":{"complexity_score":3,"scope_assessment":{"changed":true,"description":"The instrument keeps the same product scope (tampons) but updates the mandatory technical reference from AS 2869-2008 to AS 2869:2022, altering technical and labelling requirements that regulated parties must meet. A transitional provision allows continued reliance on the old standard until 31 December 2024, so the coverage remains identical but the substantive requirements have changed (s5, s6, s6A)."},"complexity_factors":["Direct incorporation by reference of an external technical standard (Australian Standard AS 2869:2022) creates dependency on a separately maintained document (s6).","Simple, single additional labelling prescription (name and address of manufacturer or sponsor) but requires label changes and verification (s6).","Transitional arrangements permit compliance with the old standard (AS 2869-2008) until 31 December 2024, adding conditional compliance paths and timing complexity (s6A).","Definitions rely on terms in the Therapeutic Goods Act 1989 (label, sponsor, therapeutic goods), so interpretation depends on statutory definitions outside this instrument (s4).","Authority for the instrument is statutory (made under s10 of the Act), so enforcement and sanctions follow the Act rather than this instrument alone (s3).","Scope is narrowly limited to tampons, so regulatory reach is confined but technical changes may require product redesign, new testing or labelling updates, shifting costs to manufacturers/sponsors (s5, s6).","Potential shared compliance responsibility between manufacturer and sponsor may create allocation-of-cost and enforcement questions for industry actors (s4, s6)."],"plain_english_summary":"This Order makes the Australian Standard AS 2869:2022 the mandatory technical and labelling standard for menstrual tampons and requires the product label to show the manufacturer’s or sponsor’s name and address. It applies to tampon manufacturers and sponsors, who must meet the referenced standard and update testing, design or labels; the previous AS 2869‑2008 may be used instead during a transition that ends on 31 December 2024."},"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"}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-standard-for-tampons-tgo-103-order-2019","history":"/api/acts/therapeutic-goods-standard-for-tampons-tgo-103-order-2019/history","analysis":"/api/acts/therapeutic-goods-standard-for-tampons-tgo-103-order-2019/analysis","conflicts":"/api/acts/therapeutic-goods-standard-for-tampons-tgo-103-order-2019/conflicts","importantCases":"/api/acts/therapeutic-goods-standard-for-tampons-tgo-103-order-2019/important-cases","documents":"/api/acts/therapeutic-goods-standard-for-tampons-tgo-103-order-2019/documents"}}