27Circumstances in which introductions are reported introductions

27 Circumstances in which introductions are reported introductions

(1) For the purposes of step 3 of the method statement in section 24, the introduction of an industrial chemical is covered by this section if subsection (2), (3), (4), (4A) or (6) of this section applies to the introduction. Low volume introductions of industrial chemicals that are solely for use in research and development (2) This subsection applies to the introduction of an industrial chemical by a person if: (a) the introduction of the industrial chemical is: (i) solely for the industrial chemical to be used in research and development by the person; or (ii) solely for the purposes of making the industrial chemical available to another person for that other person to use solely in research and development; and (b) either: (i) the industrial chemical is a solid, or is in a dispersion, at the time of introduction and it consists of solid particles, in an unbound state or as an aggregate or agglomerate, where at least 50% (by number size distribution) of the particles have at least one external dimension in the nanoscale; or (ii) it had not been determined, at the time of introduction, whether the industrial chemical meets the description in subparagraph (i); and (c) the industrial chemical is not made available to the general public: (i) on its own; or (ii) in combination with one or more other industrial chemicals; or (iii) as part of an article, including where the industrial chemical undergoes a physical or chemical change to produce the article; and (d) control measures are used to eliminate or minimise the risks from the introduction and use of the industrial chemical to: (i) persons involved in the research and development for which the industrial chemical is introduced; and (ii) the environment; and (e) the total volume of the industrial chemical introduced in a registration year by the person is greater than 10 kg and less than or equal to 100 kg. Other introductions of industrial chemicals that are solely for use in research and development (3) This subsection applies to the introduction of an industrial chemical by a person if: (a) the introduction of the industrial chemical is solely for the industrial chemical to be used in research and development by the person (the introducer); and (b) the industrial chemical is not an industrial chemical that: (i) is a solid, or is in a dispersion, at the time of introduction; and (ii) consists of solid particles, in an unbound state or as an aggregate or agglomerate, where at least 50% (by number size distribution) of the particles have at least one external dimension in the nanoscale; and (c) the industrial chemical is not made available to the general public: (i) on its own; or (ii) in combination with one or more other industrial chemicals; or (iii) as part of an article, including where the industrial chemical undergoes a physical or chemical change to produce the article; and (d) control measures are used to eliminate or minimise the risks from the introduction and use of the industrial chemical to: (i) persons involved in the research and development for which the industrial chemical is introduced; and (ii) the environment; and (e) the total volume of the industrial chemical introduced in a registration year by the introducer is greater than 250 kg, and no amount of the industrial chemical that meets the description in subparagraph (2)(b)(i) has been introduced by the person in the registration year; and (f) the use of the industrial chemical is subject to the control of the introducer. Low‑risk flavour or fragrance blend introductions (4) This subsection applies to the introduction of an industrial chemical by a person if: (a) the introduction of the industrial chemical is either: (i) a flavour blend introduction; or (ii) a fragrance blend introduction; and (b) the concentration of the industrial chemical at introduction and at end use is 1% or less; and (d) the industrial chemical does not have: (i) any of the human health hazard characteristics in human health hazard band C; or (ii) any of the environment hazard characteristics in environment hazard band D; and (e) either: (i) when the pre‑introduction report for the industrial chemical is given to the Executive Director by the person, the industrial chemical is included on the IFRA Transparency List; or (ii) before the industrial chemical is first introduced by the person, the Executive Director is given written notice of the information specified in subsection (5). (4A) This subsection applies to the introduction of an industrial chemical by a person if: (a) the introduction of the industrial chemical is either: (i) a flavour blend introduction; or (ii) a fragrance blend introduction; and (b) either: (i) the concentration of the industrial chemical at introduction and at end use is 1% or less, and the total volume of the industrial chemical introduced by the person in a registration year does not exceed 1,000 kg; or (ii) the total volume of the industrial chemical introduced by the person in a registration year does not exceed 10 kg; and (d) the industrial chemical is not known by the person to satisfy the criteria for any of the following hazard classes in the GHS: (i) germ cell mutagenicity; (ii) carcinogenicity; (iii) reproductive toxicity; and (e) the industrial chemical is not known by the person to be persistent, bioaccumulative and toxic (within the meaning of subsection (8)); and (f) the industrial chemical is not known by the person to cause adverse effects mediated by an endocrine mode of action (within the meaning given by the Guidelines); and (g) either: (i) when the pre‑introduction report for the industrial chemical is given to the Executive Director by the person, the industrial chemical is included on the IFRA Transparency List; or (ii) before the industrial chemical is first introduced by the person, the Executive Director is given written notice of the information specified in subsection (5); and (h) use of the industrial chemical is in accordance with any applicable IFRA Standards, published by the International Fragrance Association (also known as the IFRA), as existing from time to time.