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§570.38 食品添加剂安全性的确定(Determination of food additive status)

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放大字体缩小字体2011-09-14 02:09:54 来源:GPO 浏览次数9span id="hits">3953
核心提示:专员出于自身意愿或者申请者意愿根据规定在《联邦纪事》上发表通告确定一种物质不是GRAS但是符合法案409部分规定的食品添加剂,该通报有效期为60天,允许感兴趣的人员浏览数据、信息和/或法院管理司的文件评论,专员对收到的评论进行评价,之后推断缺乏被认为GRAS可信证据的不足以及是否为符合法案409部分的食品添加剂,本节对该物质作了相关规定,若食品药品管理专员提前意识到该物质的使用卫生,则会在E部分的基础上做出单独规定条例,若没有意识到则需要申请人提供相关证据、/div>
发布单位
FDA
FDA
发布文号 54 FR 18281
发布日期 1989-04-27 生效日期 暂无
有效性状?/th> 废止日期 暂无
备注 专员出于自身意愿或者申请者意愿根据规定在《联邦纪事》上发表通告确定一种物质不是GRAS但是符合法案409部分规定的食品添加剂,该通报有效期为60天,允许感兴趣的人员浏览数据、信息和/或法院管理司的文件评论,专员对收到的评论进行评价,之后推断缺乏被认为GRAS可信证据的不足以及是否为符合法案409部分的食品添加剂,本节对该物质作了相关规定,若食品药品管理专员提前意识到该物质的使用卫生,则会在E部分的基础上做出单独规定条例,若没有意识到则需要申请人提供相关证据、/td>

更多关于食品添加剂的法规,请详见美国FDA 21 CFR ?70部分关于食品添加剂的法规汇怺/font>、br />
   570.38 Determination of food additive status.

  (a The Commissioner may, in accordance with 570.35 (b)(4 or (c)(5? publish a notice in the Federal Register determining that a substance is not GRAS and is a food additive subject to section 409 of the act.

  (b)(1 The Commissioner, on his own initiative or on the petition of any interested person, pursuant to part 10 of this chapter, may issue a notice in the Federal Register proposing to determine that a substance is not GRAS and is a food additive subject to section 409 of the act. Any petition shall include all relevant data and information of the type described in 571.130(b of this chapter. The Commissioner will place all of the data and information on which he relies on public file in the Division of Dockets Management and will include in the Federal Register notice the name of the substance, its known uses, and a summary of the basis for the determination.

  ? The Federal Register notice will allow a period of 60 days during which any interested person may review the data and information and/or file comments with the Division of Dockets Management. Copies of all comments shall be made available for examination in the Division of Dockets Management.

  ? The Commissioner will evaluate all comments received. If he concludes that there is a lack of convincing evidence that the substance is GRAS or is otherwise exempt from the definition of a food additive in section 201(s of the act, he will publish a notice thereof in the Federal Register . If he concludes that there is convincing evidence that the substance is GRAS, he will publish an order in the Federal Register listing the substance in this subchapter E as GRAS.

  (c A Federal Register notice determining that a substance is a food additive shall provide for the use of the additive in food or food-contact surfaces as follows:

  ? It may promulgate a food additive regulation governing use of the additive.

  ? It may promulgate an interim food additive regulation governing use of the additive.

  ? It may require discontinuation of the use of the additive.

  ? It may adopt any combination of the above three approaches for different uses or levels of use of the additive.

  (d If the Commissioner of Food and Drugs is aware of any prior sanction for use of the substance, he will concurrently propose a separate regulation covering such use of the ingredient under this subchapter E. If the Commissioner is unaware of any such applicable prior sanction, the proposed regulation will so state and will require any person who intends to assert or rely on such sanction to submit proof of its existence. Any regulation promulgated pursuant to this section constitutes a determination that excluded uses would result in adulteration of the food in violation of section 402 of the act, and the failure of any person to come forward with proof of such an applicable prior sanction in response to the proposal will constitute a waiver of the right to assert or rely on such sanction at any later time. The notice will also constitute a proposal to establish a regulation under this subchapter E., incorporating the same provisions, in the event that such a regulation is determined to be appropriate as a result of submission of proof of such an applicable prior sanction in response to the proposal.

  [41 FR 38644, Sept. 10, 1976, as amended at 42 FR 4717, Jan. 25, 1977; 42 FR 15675, Mar. 22, 1977; 42 FR 55207, Oct. 14, 1977; 54 FR 18281, Apr. 28, 1989]

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