In adopting regulations, pursuant to Section 110070 of this part, the department shall consider all of the following factors that the petitioner shall furnish:
(a) The name and all pertinent information concerning the poisonous or deleterious substance, food additive, pesticide chemical, or color additive, including its chemical identity and composition, its proposed use, including directions, recommendations, and suggestions, its proposed labeling, and all other relevant data bearing on its physical or other technical effect, and the quantity required to produce that effect.
(b) The probable composition of any substance formed in or on a food, drug, device, or cosmetic resulting from the use of the substance.
(c) The probable consumption and effect of the substance in the diet of man or any other animal.
(d) Safety factors that, in the opinion of qualified experts, are generally recognized as appropriate for the use of animal experimentation data.
(e) Practicable methods of analysis for determining the identity and quantity of all of the following:
(1) Any substance which is in or on the food, drug, device, or cosmetic.
(2) Any substance formed in or on the food, drug, device, or cosmetic because of the use of the substance.
(3) The pure substance and its anticipated breakdown products and impurities.
(f) Facts supporting the contention that the use of the substance will serve a useful purpose.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)
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