6ABLow volume introduction (Act, s. 21)

6AB Low volume introduction (Act, s. 21)

(1) For subparagraph 21(4)(b)(i) of the Act, the requirements set out in this regulation are prescribed. (1A) For subparagraph 21(4)(b)(ii) of the Act, the requirements set out in subregulations (4), (7A), (8) and (9) are prescribed. (1B) For subparagraph 21(6)(c)(iv) of the Act, the requirements set out in subregulations (2) to (4) and (7A), (8) and (9) are prescribed. (1C) For the purposes of subparagraph 21(6)(d)(ii) of the Act, the requirements set out in subregulations (7A), (8) and (9) are prescribed. (2) The chemical must not be used in the cosmetic as: (a) a preservative; or (b) a colouring agent; or (c) an ultraviolet filter. (3) The chemical must not be prohibited or restricted for use as a cosmetic, or for use in cosmetics: (a) in the European Union under Council Directive 76/768/EEC as in force on 1 November 2011; or (b) in the United States of America under the Federal Food, Drug, and Cosmetic Act as in force on 1 November 2011. (4) The chemical must comply with any law of the Commonwealth, a State or a Territory that relates, whether expressly or by implication, to the manufacture or importation of the chemical. (5) If the chemical is present in the cosmetic at a concentration of 1% or more, the person who introduces the chemical must have information that indicates that the chemical will be safe for use by potentially high‑risk groups (including, for example, infants, elderly persons and atopic persons), consistent with the anticipated pattern of consumer exposure. (6) The person who introduces the chemical must notify the Director in writing of the introduction. (7) The notification under subregulation (6) must include: (a) in relation to a chemical that is introduced in a cosmetic at a concentration of 1% or more and in an amount that is greater than 10 kilograms but not greater than 100 kilograms in a period of 12 months: (i) a statement setting out each requirement of subregulations (2) to (5) and how that requirement is complied with; and (ii) a declaration that the contents of the notification are correct as far as the person knows; and (b) in relation to a chemical that is introduced in a cosmetic at a concentration of less than 1% and in an amount that is greater than 10 kilograms but less than 100 kilograms in a period of 12 months: (i) a statement setting out each requirement of subregulations (2) to (4) and how that requirement is complied with; and (ii) a declaration that the contents of the notification are correct as far as the person knows. (7A) The person who introduces the chemical must keep in writing, for 5 years after the introduction, all information available to the person about occupational health and safety, public health matters and the environmental effects of the chemical. (8) The information kept under subregulation (7A) must be produced to the Director on request. (9) For subregulation (7A), information is taken to be available to a person if, having regard to the person’s abilities, experience, qualifications and other attributes, the person ought reasonably to have been aware of the information.