当前位置: 首页 » 政策法规 » 国外法规 »§101.108 为进行以授权的食品标签试验而设置的临时豁免权(Temporary exemptions for purposes of conducting authorized food labeling experiments)

§101.108 为进行以授权的食品标签试验而设置的临时豁免权(Temporary exemptions for purposes of conducting authorized food labeling experiments)

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放大字体  缩小字体 2011-08-15 16:11:31  来源:GPO  浏览次数:3281
核心提示:鼓励食品工业在有控制条件下与食品与药物管理局合作,自愿进行用已提供的格式或其他格式作营养素和其他有关的食品标签信息标注的试验,食品标注信息符合本章§101.9和§105.66中现行剂量体制。若要求豁免本章§109和§105.66中的某些规定的标注,应提交书面建议。
发布单位
FDA
FDA
发布文号 48 FR 15240
发布日期 1983-04-08 生效日期 暂无
有效性状态 废止日期 暂无
备注 鼓励食品工业在有控制条件下与食品与药物管理局合作,自愿进行用已提供的格式或其他格式作营养素和其他有关的食品标签信息标注的试验,食品标注信息符合本章§101.9和§105.66中现行剂量体制。若要求豁免本章§109和§105.66中的某些规定的标注,应提交书面建议。

      更多关于美国食品标签方面法规,请详见 美国FDA 21 CFR 第101部分食品标签法规汇总

  § 101.108   Temporary exemptions for purposes of conducting authorized food labeling experiments.

  (a) The food industry is encouraged to experiment voluntarily, under controlled conditions and in collaboration with the Food and Drug Administration, with and other formats for presenting nutrition and other related food labeling information that is consistent with the current quantitative system in §§101.9 and 105.66 of this chapter.

  (b) Any firm that intends to undertake a labeling experiment that requires exemptions from certain requirements of §§101.9 and 105.66 of this chapter should submit a written proposal containing a thorough discussion of each of the following information items that apply to the particular experiment:

  (1) A description of the labeling format to be tested;

  (2) A statement of the criteria to be used in the experiment for assigning foods to categories, e.g., nutrient or other values defining “low” and “reduced”;

  (3) A draft of the material to be used in the store, e.g., shelf tags, booklets, posters, etc.;

  (4) The dates on which the experiment will begin and end and on which a written report of analysis of the experimental data will be submitted to FDA, together with a commitment not to continue the experiment beyond the proposed ending date without FDA approval;

  (5) The geographic area or areas in which the experiment is to be conducted;

  (6) The mechanism to measure the effectiveness of the experiment;

  (7) The method for conveying to consumers the required nutrition and other labeling information that is exempted from the label during the experiment;

  (8) The method that will be or has been used to determine the actual nutritional characteristics of foods for which a claim is made; and

  (9) A statement of the sections of the regulations for which an exemption is sought.

  (c) The written proposal should be sent to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. The proposal should be clearly identified as a request for a temporary exemption for purposes of conducting authorized food labeling experiments and submitted as a citizen petition under §10.30 of this chapter.

  (d) Approval for food labeling experiments will be given by FDA in writing. Foods labeled in violation of existing regulations will be subject to regulatory action unless an FDA-approved exemption to the specific regulation has been granted for that specific product.

  (e) Reporting requirements contained in §101.108(b) have been approved by this Office of Management and Budget and assigned number 0910–0151.

  [48 FR 15240, Apr. 8, 1983, as amended at 59 FR 14364, Mar. 28, 1994; 62 FR 15343, Mar. 31, 1997]101.108   Temporary exemptions for purposes of conducting authorized food labeling experiments.

  (a) The food industry is encouraged to experiment voluntarily, under controlled conditions and in collaboration with the Food and Drug Administration, with and other formats for presenting nutrition and other related food labeling information that is consistent with the current quantitative system in §§101.9 and 105.66 of this chapter.

  (b) Any firm that intends to undertake a labeling experiment that requires exemptions from certain requirements of §§101.9 and 105.66 of this chapter should submit a written proposal containing a thorough discussion of each of the following information items that apply to the particular experiment:

  (1) A description of the labeling format to be tested;

  (2) A statement of the criteria to be used in the experiment for assigning foods to categories, e.g., nutrient or other values defining “low” and “reduced”;

  (3) A draft of the material to be used in the store, e.g., shelf tags, booklets, posters, etc.;

  (4) The dates on which the experiment will begin and end and on which a written report of analysis of the experimental data will be submitted to FDA, together with a commitment not to continue the experiment beyond the proposed ending date without FDA approval;

  (5) The geographic area or areas in which the experiment is to be conducted;

  (6) The mechanism to measure the effectiveness of the experiment;

  (7) The method for conveying to consumers the required nutrition and other labeling information that is exempted from the label during the experiment;

  (8) The method that will be or has been used to determine the actual nutritional characteristics of foods for which a claim is made; and

  (9) A statement of the sections of the regulations for which an exemption is sought.

  (c) The written proposal should be sent to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. The proposal should be clearly identified as a request for a temporary exemption for purposes of conducting authorized food labeling experiments and submitted as a citizen petition under §10.30 of this chapter.

  (d) Approval for food labeling experiments will be given by FDA in writing. Foods labeled in violation of existing regulations will be subject to regulatory action unless an FDA-approved exemption to the specific regulation has been granted for that specific product.

  (e) Reporting requirements contained in §101.108(b) have been approved by this Office of Management and Budget and assigned number 0910–0151.

  [48 FR 15240, Apr. 8, 1983, as amended at 59 FR 14364, Mar. 28, 1994; 62 FR 15343, Mar. 31, 1997]
 

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