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§171.100基于申请的法规(Regulation based on petition)
2014-10-16 16:26  点击:2229
发布单位:美国FDA
发布文号:§171.100
发布日期:暂无
生效日期:暂无
有效性状态:
废止日期:暂无
备注:

(a)专员将于申请备案后90天(或是按照法案第409节(c)(2)该时间被延长至180天)内于《联邦公报》发布一条法规,内容包括:规定食品添加剂可安全使用的条件(包括但不限于,这些添加剂可用于其中或其上的具体食品或食品类别的规格、可用于或允许存在于这些食品中或上的最大量、这些添加剂添加或用于这些食品中或上的方式,以及专员认为确保这些使用安全性所必需的有关这些添加剂的任何说明或其它标签或包装要求),并于法令转寄至《联邦公报》发布前,将该法令及有关原因通知申请人;或是以法令形式拒绝申请,并就该法令及拒绝原因通知申请人。(b)法规将规定这些物质可安全使用于《联邦肉类检验法》(FMIA)(21 U.S.C. 601 et seq.)或《家禽产品检验法》(PPIA)(21 U.S.C. 451 et seq.)下任何肉类产品、肉类产品制品或家禽制品的条件。(c)如果专员确定需更多时间对申请进行研究和调查,他将以书面形式通知申请人,将申请备案后90天期限延长至不超过180天。

  §171.100   Regulation based on petition.

  (a) The Commissioner will forward for publication in the Federal Register, within 90 days after filing of the petition (or within 180 days if the time is extended as provided for in section 409(c)(2) of the Act), a regulation prescribing the conditions under which the food additive may be safely used (including, but not limited to, specifications as to the particular food or classes of food in or on which such additive may be used, the maximum quantity that may be used or permitted to remain in or on such food, the manner in which such additive may be added to or used in or on such food, and any directions or other labeling or packaging requirements for such additive deemed necessary by him to assure the safety of such use), and prior to the forwarding of the order to the Federal Register for publication shall notify the petitioner of such order and the reasons for such action; or by order deny the petition, and shall notify the petitioner of such order and of the reasons for such action.

  (b) The regulation shall describe the conditions under which the substance may be safely used in any meat product, meat food product, or poultry product subject to the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.) or the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq.).

  (c) If the Commissioner determines that additional time is needed to study and investigate the petition, he shall by written notice to the petitioner extend the 90-day period for not more than 180 days after the filing of the petition.

  [42 FR 14489, Mar. 15, 1977, as amended at 65 FR 51763, Aug. 25, 2000]

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