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
原文后附带中文翻译,由食品伙伴网食品论坛网友gaoketian提供,食品伙伴网在此表示感谢!
§ 101.2 Information panel of package form food.
(a) The term information panel as it applies to packaged food means that part of the label immediately contiguous and to the right of the principal display panel as observed by an individual facing the principal display panel with the following exceptions:
(1) If the part of the label immediately contiguous and to the right of the principal display panel is too small to accommodate the necessary information or is otherwise unusable label space, e.g., folded flaps or can ends, the panel immediately contiguous and to the right of this part of the label may be used.
(2) If the package has one or more alternate principal display panels, the information panel is immediately contiguous and to the right of any principal display panel.
(3) If the top of the container is the principal display panel and the package has no alternate principal display panel, the information panel is any panel adjacent to the principal display panel.
(b) All information required to appear on the label of any package of food under §§101.4, 101.5, 101.8, 101.9, 101.13, 101.17, 101.36, subpart D of part 101, and part 105 of this chapter shall appear either on the principal display panel or on the information panel, unless otherwise specified by regulations in this chapter.
(c) All information appearing on the principal display panel or the information panel pursuant to this section shall appear prominently and conspicuously, but in no case may the letters and/or numbers be less than one-sixteenth inch in height unless an exemption pursuant to paragraph (f) of this section is established. The requirements for conspicuousness and legibility shall include the specifications of §§101.105(h) (1) and (2) and 101.15.
(1)(i) Soft drinks packaged in bottles manufactured before October 31, 1975 shall be exempt from the requirements prescribed by this section to the extent that information which is blown, lithographed, or formed onto the surface of the bottle is exempt from the size and placement requirements of this section.
(ii) Soft drinks packaged in bottles shall be exempt from the size and placement requirements prescribed by this section if all of the following conditions are met:
(A) If the soft drink is packaged in a bottle bearing a paper, plastic foam jacket, or foil label, or is packaged in a nonreusable bottle bearing a label lithographed onto the surface of the bottle or is packaged in metal cans, the product shall not be exempt from any requirement of this section other than the exemptions created by §1.24(a)(5) (ii) and (v) of this chapter and the label shall bear all required information in the specified minimum type size, except the label will not be required to bear the information required by §101.5 if this information appears on the bottle closure or on the lid of the can in a type size not less than one-sixteenth inch in height, or if embossed on the lid of the can in a type size not less than one-eighth inch in height.
(B) If the soft drink is packaged in a bottle which does not bear a paper, plastic foam jacket or foil label, or is packaged in a reusable bottle bearing a label lithographed onto the surface of the bottle:
( 1 ) Neither the bottle nor the closure is required to bear nutrition labeling in compliance with §101.9, except that any multiunit retail package in which it is contained shall bear nutrition labeling if required by §101.9; and any vending machine in which it is contained shall bear nutrition labeling if nutrition labeling is not present on the bottle or closure, if required by §101.9.
( 2 ) All other information pursuant to this section shall appear on the top of the bottle closure prominently and conspicuously in letters and/or numbers no less than one thirty-second inch in height, except that if the information required by §101.5 is placed on the side of the closure in accordance with §1.24(a)(5)(ii) of this chapter, such information shall appear in letters and/or numbers no less than one-sixteenth inch in height.
( 3 ) Upon the petition of any interested person demonstrating that the bottle closure is too small to accommodate this information, the Commissioner may by regulation establish an alternative method of disseminating such information. Information appearing on the closure shall appear in the following priority:
( i ) The statement of ingredients.
( ii ) The name and address of the manufacturer, packer, or distributor.
( iii ) The statement of identity.
(2) Individual serving-size packages of food served with meals in restaurants, institutions, and on board passenger carriers, and not intended for sale at retail, are exempt from type-size requirements of this paragraph, provided:
(i) The package has a total area of 3 square inches or less available to bear labeling;
(ii) There is insufficient area on the package available to print all required information in a type size of1/16inch in height;
(iii) The information required by paragraph (b) of this section appears on the label in accordance with the provisions of this paragraph, except that the type size is not less than1/32inch in height.
(d)(1) Except as provided by §§101.9(j)(13) and (j)(17) and 101.36(i)(2) and (i)(5), all information required to appear on the principal display panel or on the information panel under this section shall appear on the same panel unless there is insufficient space. In determining the sufficiency of the available space, except as provided by §§101.9(j)(17) and 101.36(i)(5), any vignettes, designs, and other nonmandatory label information shall not be considered. If there is insufficient space for all of this information to appear on a single panel, it may be divided between these two panels, except that the information required under any given section or part shall all appear on the same panel. A food whose label is required to bear the ingredient statement on the principal display panel may bear all other information specified in paragraph (b) of this section on the information panel.
(2) Any food, not otherwise exempted in this section, if packaged in a container consisting of a separate lid and body, and bearing nutrition labeling pursuant to §101.9, and if the lid qualifies for and is designed to serve as a principal display panel, shall be exempt from the placement requirements of this section in the following respects:
(i) The name and place of business information required by §101.5 shall not be required on the body of the container if this information appears on the lid in accordance with this section.
(ii) The nutrition information required by §101.9 shall not be required on the lid if this information appears on the container body in accordance with this section.
(iii) The statement of ingredients required by §101.4 shall not be required on the lid if this information appears on the container body in accordance with this section. Further, the statement of ingredients is not required on the container body if this information appears on the lid in accordance with this section.
(e) All information appearing on the information panel pursuant to this section shall appear in one place without other intervening material.
(f) If the label of any package of food is too small to accommodate all of the information required by §§101.4, 101.5, 101.8, 101.9, 101.13, 101.17, 101.36, subpart D of part 101, and part 105 of this chapter, the Commissioner may establish by regulation an acceptable alternative method of disseminating such information to the public, e.g., a type size smaller than one-sixteenth inch in height, or labeling attached to or inserted in the package or available at the point of purchase. A petition requesting such a regulation, as an amendment to this paragraph, shall be submitted under part 10 of this chapter.
[42 FR 14308, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977; 42 FR 45905, Sept. 13, 1977; 42 FR 47191, Sept. 20, 1977; 44 FR 16006, Mar. 16, 1979; 49 FR 13339, Apr. 4, 1984; 53 FR 16068, May 5, 1988; 58 FR 44030, Aug. 18, 1993; 60 FR 17205, Apr. 5, 1995; 62 FR 43074, Aug. 12, 1997; 62 FR 49847, Sept. 23, 1997; 63 FR 14817, Mar. 27, 1998]
§101.2 包装食品上的信息版面
(a)用于包装食品的"信息版面"一词是指标签的一部分。这部分,当
(1)如果紧靠主要显示版面右方的部分太小,不能容纳必需的资料,或者这部分不能使用,例如折叠边或罐盖,则用紧靠这部分的右侧版面。
(2)如果包装上有一个或数个可替换的主要显示版面,信息版面可紧靠任一主要显示版面的右方。
(3)如果容器的顶部是主要显示版面,包装上并无其它可替换的主要显示版面,则信息版面紧靠主要显示版面。
(b)在§101.4、101.5、101.8、101.9、101.13、101.17与101.36等各节,101部分的D分部及本章105部分中要求标注在包装标签上的资料,必须展示在主要显示版面或信息版面上,但本章另有规定者除外。
(c)根据本节要求标注在主要显示版面或信息版面上的所有资料必须突出、醒目,字体及?或数字高度不小于1/16in,但属于本节(f)中所述情况者例外。关于字迹清晰、醒目的要求见§101.105(h)(1)与(2)以及101.15中具体规定。
(1)(i)在1975年10月31日前生产的瓶装软饮料免除本节规定的要求,其范围为瓶子表面模制成的、印刷的或以其它方式构成的资料,免除本节对字体大小和位置要求的规定。
(ii)如果符合下述各条件,瓶装软饮料可免除本节对字体大小和位置要求的规定:
(A)如果瓶装软饮料带有纸质、塑料泡沫套或金属箔标签;或装在表面印有(平版印刷)标签的、不可重复使用的瓶子中或用金属罐包装,这样的产品不能免除本节任何要求,但本章§1.24(a)(5)(ii)和(v)中的豁免不包括在内,标签上必须以规定的最小字体标注所有要求的资料,但是如果某种信息以高度不小于1/16in的字体标注在瓶盖上或罐盖上,或者以高度不小于1/8in的字体压印在罐盖上,则根据§101.5要求,标签上可不标注这种信息。
(B)如果瓶装软饮料并无纸、泡沫塑料套或金属箔标签,或装在表面印有标签的重复使用的瓶内,则:
1)根据§101.9规定,瓶和瓶盖均不需带营养标签。但是任何含有这些瓶装软饮料的多单元零售包装,根据§101.9的要求,必须带有营养标签;同时,任何含有这些瓶装软饮料的自动售货机,如果软饮料的瓶和瓶盖都不带营养标签,根据§101.9的要求,它必须带有营养标签。
2)本节规定的所有其它资料必须标注在瓶盖的顶部,要求清晰、突出。其字体及?或数字高度不小于1/32in,但如果根据本章§1.24(a)(5)(ii)规定,§101.5所要求的资料标注在瓶盖的侧面,这些资料的字体或数字的高度不小于1/16in。
3)关注这一问题的人提出瓶盖太小不够容纳这些资料,对于这样的申请,专员可按常规制订一个补充的传播此种资料的方法。标注于瓶盖上的资料顺序如下:
i)配料说明;
ii)制造者、包装商或销售商的名称及地址;
iii)特性说明。
(2)用于餐厅、机关、学校及车船旅客就餐的和不用于零售的单份包装食品如果符合下列条件,可免除本段中要求的字体大小的要求:
(i)包装上容纳标签的总面积为3in2或更小。
(ii)包装上无足够的面积供字体高度为1/16in的文字标注所有必需的资料。
(iii)标签上按本段规定标注本节(b)中所需资料。但字体高度不小于1/32in。
(d)(1)除§101.9(j)(13)、(j)(17)和§101.36(i)(2)、(i)(5)的规定以外,根据本节要求,所有要求标注在主要显示版面或信息版面上的资料必须标注在同一版面上,除非版面不够。在确定能用的版面是否够用时,除§101.9(j)(17)、§101.36(i)(5)的规定以外,任何花饰、图样和其它非强制性的标签资料不予考虑。如果在一个版面上没有足够的地方标注,可分注在两个版面上,除非有关小节或部分要求所有资料必须展示在同一版面上。要求在主要显示版面上载有配料说明的食品,可以在信息版面上标注本节(b)规定的所有其它资料。
(2)任何食品,不包括本节豁免者,如果包装在容器内,而容器是由分开的盖和身构成并带有§101.9规定的营养标签,如果盖子能够并用做主要显示版面,则在下列方面可免除本节定位的要求:
(i)§101.5中要求的企业名称及地址,如果按本节要求出现在盖子上,罐身上就不再标注。
(ii)§101.9中要求的营养资料,如要根据本节要求标注在罐身上,罐盖上就不再标注。
(iii)如果§101.4要求的配料说明,按本节规定已显示于罐身,罐盖上不再标注。另外,如果这些资料按本节规定已显示在罐盖上,罐身上就不再标注。
(e)信息版面上所有符合本节要求的资料必须标注在一处,中间不得插入其它资料。
(f)如果包装食品标签太小,不能容纳§101.4、101.5、101.8、101.9、101.13、101.17、101.36、101部分的D分部及本章105部分所要求的资料,专员可用一个规章来建立一个可以接受的替代方法以传播这些资料,例如字体高度不小于1/16in,或将标签附在包装上或插入包装内,或在售货处提供标签,这一规章作为对本段的修改,按本章第10部分规定,必须提出请求。
[42 FR 14308,Mar.15,1977于42 FR 15673,Mar.22,1977;42 FR 45905,Sep.13,1977;42 FR 47191,Sep.20,1977;44 FR 16006,Mar. 16,1979;49 FR 13339,Apr.4,1984;53 FR 16068,May 5,1988;58 FR 44030,Aug.18,1993;60 FR 17205,Apr.5,1995;62 FR 43074,Aug.12,1997;62FR 49847,Sep.23,1997;63 FR 14817,Mar.27,1998修订]
§101.3 包装食品特性的标注
(a)包装食品的主要显示版面上必须标明商品的特性,作为其主要特色之一。
(b)包装食品的特性说明包括下列方面:
(1)有关的联邦法律或规章中已有的或以后规定的名称,如果没有相应的名称,则用:
(2)食品常用名称,如果没有常用名称,则用:
(3)适当描绘性术语,或食品的特性明显,则用公众通常由此想象出来的名称。
(c)如果食品在市场上具有多种任选形状(整个,片状,小方块等等),某种具体形状便是特性说明的一个必需部分,其所用字体大小与特性说明中其它部分字体形成合理比例。但是,如果所选形状通过容器可以看到;或由适当的小插图加以描述,则具体形状不必包括在说明中。这一规定不影响法规401节公布的关于商品定义和标准所要求的对特性说明的要求。
(d)这种特性说明用黑体字标注在主要显示版面上,其大小与该显示版面上大多数印刷资料的字体相协调,说明文字排列成行,一般地与该食品所设计放置的展示底面平行。
(e)如果一种食品是另一种食品的仿制品,按照联邦食品、药物、化妆品法403(c)的规定,必须在它的标签上显著地标有同样大小的"仿制"字样,并紧跟在仿制食品名称的后面,否则即为错标。
(1)如果一种食品是另一种食品的代用品并与另一种食品相似,但营养较差,则该食品应视为仿制食品,必须符合"法规"403节(c)的要求。
(2)一种食品是另一种食品的代用品并与其相似,倘若符合下述要求,则不被认为是仿制食品:
(i)它的营养不低于所代用的及相似的食品。
(ii)标签上标有符合本章§102.5规定的普通的或常用的名称,不虚假、不误导。如果没有现成的常用名称,用一个不虚假、不误导的适当的描述性名称,另外还可以用一个不虚假、不误导的自行创意的名称。
(3)在规章中已确定了常用名称的食品(例如法规401节特性标准,本章102部分中的常用名称规章或本章104部分中营养品质导则规章),并且符合这些规章中所有有关要求,这样的食品不视为仿制食品。
(4)营养低次的含义
(i)一种主要营养素含量的降低达到可以测出的量,但不包括下述情况下热量或脂肪含量的降低,即食品按§101.9规定作了标注,并且关于热量降低的说明符合本章105部分中关于热量的规定。
(ii)本节所说的食品中某种主要营养素的可测量为§101.9(c)(7)(iii)中所列的蛋白质及§101.9(c)(9)中所列的钾每日参考值(Daily Reference Value,DRV)的2%或以上,以及§101.9(c)(8)(iv)中所列的任何维生素或矿物质每日参考摄入量(Reference Daily Intake,RDI)的2%或以上,这是根据通常消费的参考量而定的。硒、钼、铬、氯化物则不必考虑。
(iii)如果专员断定某种食品是另一种食品的代用品,并与另一种食品相似,但不是由于本段所说的其它原因而是营养低于这种食品,他可建议对该规范作适当的修订,或建议采用另一个规章来管理这类特殊食品。
(f)按照本章第102部分B分部规定,标签上可能要求标注特征性配料的百分比;或者关于含有或不含有某种配料的信息;或者需添加某些配料的信息,将这些信息作为食品常用名称的一部分。
(g)各种膳食补充剂用"膳食补充剂"(dietary supplement)一词表示,作为特性说明(名称)的一部分。此外,"膳食"可以删去,用产品中所含配料的名称代替[例如:钙补充剂(calcium supplement)],或者用适当的表示产品中配料的术语代替[例如:含维生素的草本植物补充剂(herbal supplement with vitamins)]。
[42 FR 14308,Mar.15,1977于48 FR 10811,Mar.15,1983;58 FR 2227,Jan.6,1993;60 FR 67174,Dec.28,1995;62 FR 49847,Sep.23,1997修订]