中國食品網(wǎng)

§71.4 著色劑樣品及其它資料(Samples; additional information)

   2011-09-01 中國食品網(wǎng)中食網(wǎng)5540

    更多關(guān)于著色劑使用申請的法規(guī),請詳見美國FDA 21 CFR 第71部分關(guān)于著色劑使用申請的法規(guī)匯總。

  § 71.4   Samples; additional information.

  The Commissioner may request samples of the color additive, articles used as components thereof, or of the food, drug, or cosmetic in which the color additive is proposed to be used, or which comprises the color additive, and any additional information needed to clarify a submitted method or other aspect of a petition at any time while a petition is under consideration. The Commissioner shall specify in the request for a sample of the color additive, or articles used as components thereof, or of the food, drug, or cosmetic in which the color additive is proposed to be used, or which comprises the color additive, a quantity deemed adequate to permit tests of analytical methods to determine quantities of the color additive present in products for which it is intended to be used or adequate for any study or investigation reasonably required with respect to the safety of the color additive or the physical or technical effect it produces. The date used for computing the 90-day limit for the purposes of section 721(d)(1) of the act shall be moved forward 1 day for each day, after mailing date of the request, taken by the petitioner to submit the information and/or sample. If the information or sample is requested a reasonable time in advance of the 180 days, but is not submitted within such 180 days after filing of the petition, the petition will be considered withdrawn without prejudice.

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編輯:foodfagui

 
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