当前位置: 首页? 政策法规? 国外法规? §570.35 食品添加剂总体安全(GRAS)状态的确定(Affirmation of generally recognized as safe (GRAS) status)

§570.35 食品添加剂总体安全(GRAS)状态的确定(Affirmation of generally recognized as safe (GRAS) status)

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核心提示:专员出于自身意愿或者申请者意愿需要对直接或间接成为食品组分的物质安全性作出确认,出于自己意愿的需要提供基于法院管理司官方公共文件的数据和信息,并在《联邦纪事》上刊登通报该物质的名称、期望用途、非安全性的建议用量,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,本节规定了安全确定者评估申请的格式、专员发布通告期限、浏览期限、专员的权责以及申请失败后的处理、/div>
发布单位
FDA
FDA
发布文号 62 FR 40600
发布日期 1997-07-29 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需要对直接或间接成为食品组分的物质安全性作出确认,出于自己意愿的需要提供基于法院管理司官方公共文件的数据和信息,并在《联邦纪事》上刊登通报该物质的名称、期望用途、非安全性的建议用量,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,本节规定了安全确定者评估申请的格式、专员发布通告期限、浏览期限、专员的权责以及申请失败后的处理、/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 />
   570.35 Affirmation of generally recognized as safe (GRAS status.

  (a The Commissioner, either on his initiative or on the petition of an interested person, may affirm the GRAS status of substances that directly or indirectly become components of food.

  (b)(1 If the Commissioner proposes on his own initiative that a substance is entitled to affirmation as GRAS, he will place all of the data and information on which he relies on public file in the office of the Division of Dockets Management and will publish in the Federal Register a notice giving the name of the substance, its proposed uses, and any limitations proposed for purposes other than safety.

  ? 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 received shall be made available for examination in the Division of Dockets Management's office.

  ? The Commissioner will evaluate all comments received. If he concludes that there is convincing evidence that the substance is GRAS as defined in 570.3(k? he will publish a notice in the Federal Register listing the substance in this subchapter E as GRAS.

  ? If, after evaluation of the comments, the Commissioner concludes that there is a lack of convincing evidence that the substance is GRAS and that it should be considered a food additive subject to section 409 of the act, he shall publish a notice thereof in the Federal Register in accordance with 570.38.

  (c)(1 Persons seeking the affirmation of GRAS status of substances as provided for in 570.30(e? except those subject to the NAS-NRC GRAS list survey ?6 FR 20546? shall submit a petition for GRAS affirmation pursuant to part 10 of this chapter. Such petition shall contain information to establish that the GRAS criteria as set forth in 570.30(b have been met, in the following form:

  (i Description of the substance, including:

   a Common or usual name.

   b Chemical name.

   c Chemical Abstract Service (CAS registry number.

   d Empirical formula.

   e Structural formula.

   f Specifications for food grade material, including arsenic and heavy metals. (Recommendation for any change in the Food Chemicals Codex monograph should be included where applicable.(/p>

   g Quantitative compositions.

   h Manufacturing process (excluding any trade secrets?

  (ii Use of the substance, including:

   a Date when use began.

   b Information and reports or other data on past uses in food.

   c Foods in which used, and levels of use in such foods, and for what purposes.

  (iii Methods for detecting the substance in food, including:

   a References to qualitative and quantitative methods for determining the substance(s in food, including the type of analytical procedures used.

   b Sensitivity and reproducibility of such method(s?

  (iv Information to establish the safety and functionality of the substance in food. Published scientific literature, evidence that the substance is identical to a GRAS counterpart of natural biological origin, and other data may be submitted to support safety. Any adverse information or consumer complaints shall be included. Complete bibliographic references shall be provided where a copy of the article is not provided.

  (v A statement signed by the person responsible for the petition that to the best of his knowledge it is a representative and balanced submission that includes unfavorable information, as well as favorable information, known to him pertinent to the evaluation of the safety and functionality of the substance.

  (vi If nonclinical laboratory studies are involved, additional information and data submitted in support of filed petitions shall include, with respect to each nonclinical study, either a statement that the study was conducted in compliance with the requirements set forth in part 58 of this chapter, or, if the study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance.

  (vii [Reserved]

  (viii A claim for categorical exclusion under 25.30 or 25.32 of this chapter or an environmental assessment under 25.40 of this chapter.

  ? Within 30 days after the date of filing the petition, the Commissioner will place the petition on public file in the Division of Dockets Management and will publish a notice of filing in the Federal Register giving the name of the petitioner and a brief description of the petition including the name of the substance, its proposed use, and any limitations proposed for reasons other than safety. A copy of the notice will be mailed to the petitioner at the time the original is sent to the Federal Register .

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

  ? The Commissioner will evaluate the petition and all available information including all comments received. If the petition and such information provide convincing evidence that the substance is GRAS as defined in 570.3, he will publish an order in the Federal Register listing the substance in this subchapter E as GRAS.

  ? If, after evaluation of the petition and all available information, the Commissioner concludes that there is a lack of convincing evidence that the substance is GRAS and that it should be considered a food additive subject to section 409 of the act, he shall publish a notice thereof in the Federal Register in accordance with 570.38.

  ? The notice of filing in the Federal Register will request submission of proof of any applicable prior sanction for use of the ingredient under conditions different from those proposed to be determined to be GRAS. The failure of any person to come forward with proof of such an applicable prior sanction in response to the notice of filing will constitute a waiver of the right to assert or rely on such sanction at any later time. The notice of filing 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 notice of filing.

  [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. 10, 1977; 50 FR 7517, Feb. 22, 1985; 50 FR 16668, Apr. 26, 1985; 54 FR 18281, Apr. 28, 1989; 62 FR 40600, July 29, 1997]

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