16Labelling requirements

16 Labelling requirements

(1) The label of a disinfectant, sanitiser, sanitary fluid or sanitary powder that is, or contains a substance that is, included in a Schedule to the Poisons Standard must comply with any applicable requirements in relation to such a label specified in the Poisons Standard. (2) Subject to subsections (3), (4) and (7), the container and any primary pack for a disinfectant, sanitiser, sanitary fluid or sanitary powder must be labelled with the following information: (a) the trade name (or, if there is no trade name, the name) of the disinfectant, sanitiser, sanitary fluid or sanitary powder; (b) the common name of the disinfectant, sanitiser, sanitary fluid or sanitary powder, located immediately above, below or adjacent to the trade name (or, if there is no trade name, the name); (c) the approved name of each active ingredient of the disinfectant, sanitiser, sanitary fluid or sanitary powder; (d) the quantity or proportion of each active ingredient of the disinfectant, sanitiser, sanitary fluid or sanitary powder together with, where applicable, a statement of the proportion of available chlorine, bromine or iodine in the disinfectant, sanitiser, sanitary fluid or sanitary powder, as a percentage of the total mass or volume of the disinfectant, sanitiser, sanitary fluid or sanitary powder; (e) the quantity of disinfectant, sanitiser, sanitary fluid or sanitary powder; (f) the batch number of the disinfectant, sanitiser, sanitary fluid or sanitary powder, immediately preceded by the words “Batch”, “Batch Number”, “Batch No.”, “Lot”, “Lot Number”, “Lot No.”, “Lot Code” or words with a similar meaning or the symbol “B”, Ⓑ or “(B)”; (g) the expiry date of the disinfectant, sanitiser, sanitary fluid or sanitary powder immediately preceded by the words “Expiry date”, “Expiry”, “Exp.” or “Use by” or words with a similar meaning or an internationally recognisable symbol (such as the hour glass) with the same meaning; (h) the name and address of the manufacturer or sponsor of the disinfectant, sanitiser, sanitary fluid or sanitary powder; (i) clear and adequate instructions for each of the manufacturer’s intended uses of the disinfectant, sanitiser, sanitary fluid or sanitary powder including: (i) the method of use of the goods and a clear warning in any case where a danger exists if an incorrect method of use is employed; (ii) for a hospital grade disinfectantinstructions indicating that the disinfectant is not to be used on medical devices or other therapeutic goods; (iii) except for disinfectants that are surface spray disinfectants or disinfectant wipes or spongesthe words “Do not mix with detergents or other chemicals” or, where relevant, “Do not mix with detergents or other chemicals except [name of detergent or chemical] as directed below”, together with directions in relation to the safe use of such a mix; (iv) except for disinfectants that are liquidsa statement of the recommended dilution of the goods in water or other diluent or, where relevant, the words “Use undiluted”; (v) for disinfectants that are liquidsa statement of the recommended dilution of the goods in water or other diluent, expressed as either “1 in N” meaning that 1 part of the disinfectant is made up with water or other diluent to a total volume of N parts, or “1: N” meaning that 1 part of the disinfectant is added to N parts of water or other diluent; (vi) for a disinfectant requiring preparation before useinstructions for the correct preparation, use and storage conditions of the preparation; (vii) for a disinfectant that contains chlorhexidine as an active ingredient—the words “Not to be used on skin”; (viii) the details, clearly identified, of potential hazards that may occur through accidental body contact with the disinfectant, sanitiser, sanitary fluid or sanitary powder. (3) Subject to subsection (4), the information required to be included on a container and primary pack of a disinfectant, sanitiser, sanitary fluid or sanitary powder referred to in paragraphs (2)(a) to (g) must be set out on the main label. (4) Information in relation to the batch number and the expiry date required by paragraphs (2)(f) and (g) may be engraved or embossed on: (a) the container or primary pack; or (b) a label attached to, or on, the container or primary pack; instead of being set out on the main label. (5) A disinfectant that is a household grade disinfectant must not be labelled as “hospital grade disinfectant”. (6) A statement of dilution in the label of a hospital grade disinfectant must not contain directions for the preparation of a dilution of the disinfectant from another such dilution. (7) The information referred to in subsection (2) must be clearly visible and written: (a) in English; and (b) on the outer face of the label; and (c) in durable and legible characters with a letter height of at least 1.0 millimetre; and (d) in metric units of measurement; and (e) in a colour or colours that will provide a distinct contrast to the background colour. (8) For a hospital grade disinfectant that complies with subsections 13(2) or (4) on the basis of passing the TGA Disinfectant Test under the conditions specified in Option A of that test, the container and primary pack of the disinfectant must clearly indicate that the surface on which the disinfectant is to be used must be pre-cleaned before the disinfectant is used, for the disinfectant to be effective. (9) For a hospital grade disinfectant that is a surface spray disinfectant that complies with subsection 13(3) on the basis of passing a bactericidal carrier test under clean conditions, the container and primary pack of the disinfectant must clearly indicate that the surface on which the disinfectant is to be used must be pre-cleaned before the disinfectant is used, for the disinfectant to be effective.