更多關(guān)于美國食品標(biāo)簽方面法規(guī),請詳見 美國FDA 21 CFR 第101部分食品標(biāo)簽法規(guī)匯總
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§ 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 inpidual facing the principal display panel with the following exceptions:
?。?) 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.
?。?) 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.
?。?) 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.
?。╞) 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.
?。╟) 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.
?。?)(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.
?。╥i) 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.
?。˙) 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) Inpidual 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:
?。╥) 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;
?。╥ii) 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 pided 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.
?。?) 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.
?。╥i) 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.
?。╡) All information appearing on the information panel pursuant to this section shall appear in one place without other intervening material.
?。╢) 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 包裝食品上的信息版面
(a)用于包裝食品的"信息版面"一詞是指標(biāo)簽的一部分。這部分,當(dāng)
?。?)如果緊靠主要顯示版面右方的部分太小,不能容納必需的資料,或者這部分不能使用,例如折疊邊或罐蓋,則用緊靠這部分的右側(cè)版面。
(2)如果包裝上有一個或數(shù)個可替換的主要顯示版面,信息版面可緊靠任一主要顯示版面的右方。
?。?)如果容器的頂部是主要顯示版面,包裝上并無其它可替換的主要顯示版面,則信息版面緊靠主要顯示版面。
?。╞)在§101.4、101.5、101.8、101.9、101.13、101.17與101.36等各節(jié),101部分的D分部及本章105部分中要求標(biāo)注在包裝標(biāo)簽上的資料,必須展示在主要顯示版面或信息版面上,但本章另有規(guī)定者除外。
?。╟)根據(jù)本節(jié)要求標(biāo)注在主要顯示版面或信息版面上的所有資料必須突出、醒目,字體及或數(shù)字高度不小于1/16in,但屬于本節(jié)(f)中所述情況者例外。關(guān)于字跡清晰、醒目的要求見§101.105(h)(1)與(2)以及101.15中具體規(guī)定。
(1)(i)在1975年10月31日前生產(chǎn)的瓶裝軟飲料免除本節(jié)規(guī)定的要求,其范圍為瓶子表面模制成的、印刷的或以其它方式構(gòu)成的資料,免除本節(jié)對字體大小和位置要求的規(guī)定。
?。╥i)如果符合下述各條件,瓶裝軟飲料可免除本節(jié)對字體大小和位置要求的規(guī)定:
(A)如果瓶裝軟飲料帶有紙質(zhì)、塑料泡沫套或金屬箔標(biāo)簽;或裝在表面印有(平版印刷)標(biāo)簽的、不可重復(fù)使用的瓶子中或用金屬罐包裝,這樣的產(chǎn)品不能免除本節(jié)任何要求,但本章§1.24(a)(5)(ii)和(v)中的豁免不包括在內(nèi),標(biāo)簽上必須以規(guī)定的最小字體標(biāo)注所有要求的資料,但是如果某種信息以高度不小于1/16in的字體標(biāo)注在瓶蓋上或罐蓋上,或者以高度不小于1/8in的字體壓印在罐蓋上,則根據(jù)§101.5要求,標(biāo)簽上可不標(biāo)注這種信息。
?。˙)如果瓶裝軟飲料并無紙、泡沫塑料套或金屬箔標(biāo)簽,或裝在表面印有標(biāo)簽的重復(fù)使用的瓶內(nèi),則:
1)根據(jù)§101.9規(guī)定,瓶和瓶蓋均不需帶營養(yǎng)標(biāo)簽。但是任何含有這些瓶裝軟飲料的多單元零售包裝,根據(jù)§101.9的要求,必須帶有營養(yǎng)標(biāo)簽;同時,任何含有這些瓶裝軟飲料的自動售貨機(jī),如果軟飲料的瓶和瓶蓋都不帶營養(yǎng)標(biāo)簽,根據(jù)§101.9的要求,它必須帶有營養(yǎng)標(biāo)簽。
2)本節(jié)規(guī)定的所有其它資料必須標(biāo)注在瓶蓋的頂部,要求清晰、突出。其字體及或數(shù)字高度不小于1/32in,但如果根據(jù)本章§1.24(a)(5)(ii)規(guī)定,§101.5所要求的資料標(biāo)注在瓶蓋的側(cè)面,這些資料的字體或數(shù)字的高度不小于1/16in。
3)關(guān)注這一問題的人提出瓶蓋太小不夠容納這些資料,對于這樣的申請,專員可按常規(guī)制訂一個補(bǔ)充的傳播此種資料的方法。標(biāo)注于瓶蓋上的資料順序如下:
i)配料說明;
ii)制造者、包裝商或銷售商的名稱及地址;
iii)特性說明。
?。?)用于餐廳、機(jī)關(guān)、學(xué)校及車船旅客就餐的和不用于零售的單份包裝食品如果符合下列條件,可免除本段中要求的字體大小的要求:
?。╥)包裝上容納標(biāo)簽的總面積為3in2或更小。
?。╥i)包裝上無足夠的面積供字體高度為1/16in的文字標(biāo)注所有必需的資料。
?。╥ii)標(biāo)簽上按本段規(guī)定標(biāo)注本節(jié)(b)中所需資料。但字體高度不小于1/32in。
?。╠)(1)除§101.9(j)(13)、(j)(17)和§101.36(i)(2)、(i)(5)的規(guī)定以外,根據(jù)本節(jié)要求,所有要求標(biāo)注在主要顯示版面或信息版面上的資料必須標(biāo)注在同一版面上,除非版面不夠。在確定能用的版面是否夠用時,除§101.9(j)(17)、§101.36(i)(5)的規(guī)定以外,任何花飾、圖樣和其它非強(qiáng)制性的標(biāo)簽資料不予考慮。如果在一個版面上沒有足夠的地方標(biāo)注,可分注在兩個版面上,除非有關(guān)小節(jié)或部分要求所有資料必須展示在同一版面上。要求在主要顯示版面上載有配料說明的食品,可以在信息版面上標(biāo)注本節(jié)(b)規(guī)定的所有其它資料。
?。?)任何食品,不包括本節(jié)豁免者,如果包裝在容器內(nèi),而容器是由分開的蓋和身構(gòu)成并帶有§101.9規(guī)定的營養(yǎng)標(biāo)簽,如果蓋子能夠并用做主要顯示版面,則在下列方面可免除本節(jié)定位的要求:
?。╥)§101.5中要求的企業(yè)名稱及地址,如果按本節(jié)要求出現(xiàn)在蓋子上,罐身上就不再標(biāo)注。
?。╥i)§101.9中要求的營養(yǎng)資料,如要根據(jù)本節(jié)要求標(biāo)注在罐身上,罐蓋上就不再標(biāo)注。
?。╥ii)如果§101.4要求的配料說明,按本節(jié)規(guī)定已顯示于罐身,罐蓋上不再標(biāo)注。另外,如果這些資料按本節(jié)規(guī)定已顯示在罐蓋上,罐身上就不再標(biāo)注。
(e)信息版面上所有符合本節(jié)要求的資料必須標(biāo)注在一處,中間不得插入其它資料。
?。╢)如果包裝食品標(biāo)簽太小,不能容納§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部分所要求的資料,專員可用一個規(guī)章來建立一個可以接受的替代方法以傳播這些資料,例如字體高度不小于1/16in,或?qū)?biāo)簽附在包裝上或插入包裝內(nèi),或在售貨處提供標(biāo)簽,這一規(guī)章作為對本段的修改,按本章第10部分規(guī)定,必須提出請求。
?。?2 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修訂]
§101.3 包裝食品特性的標(biāo)注
?。╝)包裝食品的主要顯示版面上必須標(biāo)明商品的特性,作為其主要特色之一。
?。╞)包裝食品的特性說明包括下列方面:
(1)有關(guān)的聯(lián)邦法律或規(guī)章中已有的或以后規(guī)定的名稱,如果沒有相應(yīng)的名稱,則用:
?。?)食品常用名稱,如果沒有常用名稱,則用:
?。?)適當(dāng)描繪性術(shù)語,或食品的特性明顯,則用公眾通常由此想象出來的名稱。
?。╟)如果食品在市場上具有多種任選形狀(整個,片狀,小方塊等等),某種具體形狀便是特性說明的一個必需部分,其所用字體大小與特性說明中其它部分字體形成合理比例。但是,如果所選形狀通過容器可以看到;或由適當(dāng)?shù)男〔鍒D加以描述,則具體形狀不必包括在說明中。這一規(guī)定不影響法規(guī)401節(jié)公布的關(guān)于商品定義和標(biāo)準(zhǔn)所要求的對特性說明的要求。
?。╠)這種特性說明用黑體字標(biāo)注在主要顯示版面上,其大小與該顯示版面上大多數(shù)印刷資料的字體相協(xié)調(diào),說明文字排列成行,一般地與該食品所設(shè)計放置的展示底面平行。
?。╡)如果一種食品是另一種食品的仿制品,按照聯(lián)邦食品、藥物、化妝品法403(c)的規(guī)定,必須在它的標(biāo)簽上顯著地標(biāo)有同樣大小的"仿制"字樣,并緊跟在仿制食品名稱的后面,否則即為錯標(biāo)。
?。?)如果一種食品是另一種食品的代用品并與另一種食品相似,但營養(yǎng)較差,則該食品應(yīng)視為仿制食品,必須符合"法規(guī)"403節(jié)(c)的要求。
(2)一種食品是另一種食品的代用品并與其相似,倘若符合下述要求,則不被認(rèn)為是仿制食品:
?。╥)它的營養(yǎng)不低于所代用的及相似的食品。
?。╥i)標(biāo)簽上標(biāo)有符合本章§102.5規(guī)定的普通的或常用的名稱,不虛假、不誤導(dǎo)。如果沒有現(xiàn)成的常用名稱,用一個不虛假、不誤導(dǎo)的適當(dāng)?shù)拿枋鲂悦Q,另外還可以用一個不虛假、不誤導(dǎo)的自行創(chuàng)意的名稱。
?。?)在規(guī)章中已確定了常用名稱的食品(例如法規(guī)401節(jié)特性標(biāo)準(zhǔn),本章102部分中的常用名稱規(guī)章或本章104部分中營養(yǎng)品質(zhì)導(dǎo)則規(guī)章),并且符合這些規(guī)章中所有有關(guān)要求,這樣的食品不視為仿制食品。
?。?)營養(yǎng)低次的含義
(i)一種主要營養(yǎng)素含量的降低達(dá)到可以測出的量,但不包括下述情況下熱量或脂肪含量的降低,即食品按§101.9規(guī)定作了標(biāo)注,并且關(guān)于熱量降低的說明符合本章105部分中關(guān)于熱量的規(guī)定。
?。╥i)本節(jié)所說的食品中某種主要營養(yǎng)素的可測量為§101.9(c)(7)(iii)中所列的蛋白質(zhì)及§101.9(c)(9)中所列的鉀每日參考值(Daily Reference Value,DRV)的2%或以上,以及§101.9(c)(8)(iv)中所列的任何維生素或礦物質(zhì)每日參考攝入量(Reference Daily Intake,RDI)的2%或以上,這是根據(jù)通常消費(fèi)的參考量而定的。硒、鉬、鉻、氯化物則不必考慮。
?。╥ii)如果專員斷定某種食品是另一種食品的代用品,并與另一種食品相似,但不是由于本段所說的其它原因而是營養(yǎng)低于這種食品,他可建議對該規(guī)范作適當(dāng)?shù)男抻?,或建議采用另一個規(guī)章來管理這類特殊食品。
?。╢)按照本章第102部分B分部規(guī)定,標(biāo)簽上可能要求標(biāo)注特征性配料的百分比;或者關(guān)于含有或不含有某種配料的信息;或者需添加某些配料的信息,將這些信息作為食品常用名稱的一部分。
(g)各種膳食補(bǔ)充劑用"膳食補(bǔ)充劑"(dietary supplement)一詞表示,作為特性說明(名稱)的一部分。此外,"膳食"可以刪去,用產(chǎn)品中所含配料的名稱代替[例如:鈣補(bǔ)充劑(calcium supplement)],或者用適當(dāng)?shù)谋硎井a(chǎn)品中配料的術(shù)語代替[例如:含維生素的草本植物補(bǔ)充劑(herbal supplement with vitamins)]。
?。?2 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修訂]
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