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This Order amends the Therapeutic Goods Order No. 54 - Standard for Disinfectants and Sterilants.
Administered by: Health
Registered 06 Nov 2008
Gazetted 29 Sep 1999
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

Therapeutic Goods Act 1989



Therapeutic Goods Order Number 54B




I, Clive Morris, delegate of the Minister for Health and Aged Care, for the purposes of the exercise of the Minister’s powers under section 10 of the Therapeutic Goods Act 1989 and acting under subsection 10(1), hereby DETERMINE that the matters specified in this Order shall constitute an amendment to the Therapeutic Goods Order No. 54, the Standard for Composition, Packaging, Labelling and Performance of Disinfectants and Sterilants.


Therapeutic Goods Order No. 54 is amended as follows:


Clause 5 – Standards for Packaging and Labelling of Disinfectants and Sterilants


(a)           Delete from the heading “Clause 5” and replace with “Clause 4”.


(b)          Delete from paragraph 5(4)(a) “subparagraphs 5(5)(a)(i), (ii) and (iii)” and replace with “subparagraphs 4(4)(a)(i), (ii) and (iii)”.


(c)           Oval:  B

Delete from paragraph 5(4)(e) “the Upper Case (Capital) letter B surrounded by a circle” and replace with “             .”


(d)          Delete from subparagraph 5(4)(h)(ii) “subclauses 5(8) and 5(9)” and replace with “subclauses 4(7) and 4(8)”


(e)           Delete from subparagraph 5(4)(h)(iii) “subclause 5(10)” and replace with “subclause 4(9)”.


(f)            Delete from subclauses 5(5) and 5(6) “paragraphs 5(5)(h) and (i)” and replace with “subparagraphs 4(4)(h)(i)”.


(g)           Delete from subclause 5(7) “paragraphs 5(5)(h) and (ii)” and replace with “subparagraphs 4(4)(h)(ii)”.


(h)           Delete from subclause 5(8) “Paragraphs 5(5)(h)(ii) and (iii)” and replace with “Subparagraphs 4(4)(h)(ii) and (iii)”.


(i)             Delete from subclauses 5(9) and (10) “paragraphs 5(5)(h)(iii)’ and replace with “subparagraph 4(4)(h)(iii)”.


(j)            Delete from subclause 5(11) “paragraphs 5(5)(a)” and replace with “paragraphs 4(4)(a)”.


(k)          Delete from subclause 5(12) “subclause 5(5)” and replace with “subclause 4(4)”.


(l)             Add after subclause 4(12):


“(13)  Despite subclause 4(12) the batch and expiry particulars required by paragraphs 4(4)(e) and 4(4)(f) may be embossed on a label attached to or appearing on the container or any primary pack containing a disinfectant or sterilant.”


(m)         Delete from subclause 5(13) “(13)” and replace with “(14)”.


(n)           Delete from subclause 5(13) “subclause 5(5)” and replace with “paragraph 4(4)(a)”.


(o)          Delete subclause 5(14).




Commencement Dates


This Order shall commence to operate from the date it is gazetted in the Commonwealth Gazette.



Dated this    23RD    day of September 1999.







Clive Morris A/G

Delegate of the Minister for Health and Aged Care