中国食品网

§ 71.37 研究用着色剂的豁免(Exemption of color additives for investigational use)

2011-09-01 中国食品网 中食网 900 0

更多关于着色剂使用申请的法规,请详见美国FDA 21 CFR 第71部分关于着色剂使用申请的法规汇总

  § 71.37 Exemption of color additives for investigational use.

  (a) A shipment or other delivery of a color additive or of a food, drug, or cosmetic containing such a color additive for investigational use by experts qualified to determine safety shall be exempt from the requirements of section 402(c), 501(a), or 601(e) of the act, provided that the color additive or the food, drug, or cosmetic containing the color additive bears a label which states prominently, “Caution—Contains new color additive—For investigational use only.” No animals used in such investigations, or their products, such as milk or eggs, shall be used for food purposes, unless the sponsor or the investigator has submitted to the Commissioner data demonstrating that such use will be consistent with the public health, and the Commissioner, proceeding as he would in a matter involving section 409(i) of the act, has notified the sponsor or investigator that the proposed disposition for food is authorized. Any person who contests a refusal to grant such authorization shall have an opportunity for a regulatory hearing before the Food and Drug Administration pursuant to part 16 of this chapter.

  (b) The person who introduced such shipment or who delivers the color additive or a food, drug, or cosmetic containing such an additive into interstate commerce shall maintain adequate records showing the name and post-office address of the expert to whom the color additive is shipped, date, quantity, and batch or code mark of each shipment and delivery for a period of 2 years after such shipment and delivery. Upon the request of a properly authorized employee of the Department, at reasonable times, he shall make such records available for inspection and copying.

更多国外法规翻译,请联系食品翻译中心
编辑:foodfagui

举报0 收藏0 打赏0 评论0
推荐图文
推荐资讯
点击排行
    网站首页| 关于我们| 新手帮助| 信息发布规则| 版权隐私| 服务条款| 联系我们| 网站地图| 排名推广| 广告服务| 积分换礼| RSS订阅| 违规举报
    Baidu
    map