Document ID: chunk:federal_register_of_legislation:F2020C00357:clause:1_1:p1
Version: federal_register_of_legislation:F2020C00357
Segment Type: clause
Provision Reference: sch 1 cl 1 (pt 1/2)
Character Range: 6622–12259

1                                                                                                           hand sanitiser in relation to which all of the following paragraphs apply:                                                                                                                                                                                                                                      when:
                                                                                                               (a) the final formulation of the hand sanitiser contains only the following ingredients:                                                                                                                                                                                                                       (a) presented for supply with the front and back labels set out in Part 1 of Schedule 2 attached to the goods, and not presented for supply in any other way, with the following exceptions:
                                                                                                                  (i) ethanol 80% v/v (pharmacopoeial grade or food standard grade) in an aqueous solution that may contain a denaturant such as denatonium benzoate (NLT 5ppm), sucrose octaacetate (0.12%w/v) or tertiary butyl alcohol (0.25%v/v);                                                                            (i) the labels may include a business name or logo of the manufacturer or supplier, and a trade name for the goods, neither of which may suggest or imply that the goods have been recommended or approved by or on behalf of a government or government authority;
                                                                                                                  (ii) purified water derived from potable water that has been rendered sterile or otherwise purified by boiling, distillation or other purification process;                                                                                                                                                    (ii) the labels may include a batch number;
                                                                                                                  (iii)  glycerol 1.45% v/v (pharmacopoeial grade or food standard grade);                                                                                                                                                                                                                                       (iii) the labels may include an expiry date, which must not be more than 36 months after the completion of the manufacture of the goods;
                                                                                                                  (iv) hydrogen peroxide 0.125% v/v (pharmacopoeial grade);                                                                                                                                                                                                                                                      (iv) the labels may state that the formulation of the goods is based on the handrub formulation of the World Health Organization;
                                                                                                               and does not contain any other active or inactive ingredients, including colours, fragrances or emollients;                                                                                                                                                                                                       (v) the labels may include any caution, warning or other marking that relates to the safe use, transportation or storage of the goods;
                                                                                                               (b) the concentration of ethanol specified in subparagraph (a)(i) is verified by the manufacturer testing samples of each batch of the final formulation of the hand sanitiser using gas chromatography, alcoholmeter, hydrometer, or other chemical analysis of equivalent or greater accuracy;                  (vi) the labels may be printed in colour;
                                                                                                               (ba) the purified water specified in subparagraph (a)(ii) is used as soon as practicable following purification to maintain the acceptable chemical quality, and the acceptable microbiological quality, of the water;                                                                                            (vii) the front and back labels may be combined into a single label or may otherwise be co-located on the goods; and
                                                                                                               (c) the hand sanitiser is manufactured under sanitary conditions using equipment that is well maintained and fit for purpose;                                                                                                                                                                                  (b) not presented for supply in a way that is likely to result in the goods being mistaken for or confused with food or beverages; and
                                                                                                               (d) records relating to the manufacture of the hand sanitiser are kept by the manufacturer in relation to each of the matters specified in paragraphs (a), (b), (ba) and (c)