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§ 70.5 General restrictions on use of color additives.
?。╝) Color additives for use in the area of the eye. No listing or certification of a color additive shall be considered to authorize the use of any such color additive in any article intended for use in the area of the eye unless such listing or certification of such color additive specifically provides for such use. Any color additive used in or on any article intended for use in the area of the eye, the listing or certification of which color additive does not provide for such use, shall be considered to be a color additive not listed under parts 73, 74, and 81 of this chapter, even though such color additive is certified and/or listed for other uses.
?。╞) Color additives for use in injections. No listing or certification of a color additive shall be considered to authorize the use of any such color additive in any article intended for use in injections unless such listing or certification of such color additive specifically provides for such use. Any color additive used in or on any article intended for use in injections, the listing or certification of which color additive does not provide for such use, shall be considered to be a color additive not listed under parts 73, 74, and 81 of this chapter, even though such color additive is certified and/or listed for other uses.
(c) Color additives for use in surgical sutures. No listing or certification of a color additive shall be considered to authorize the use of any such color additive in any article intended for use as a surgical suture unless such listing or certification of such color additive specifically provides for such use. Any color additive used in or on any article intended for use as a surgical suture, the listing or certification of which color additive does not provide for such use, shall be considered to be a color additive not listed under parts 73, 74, and 81 of this chapter, even though such color additive is certified and/or listed for other uses.
§70.5 著色劑使用的一般限制條件
?。╝)用于眼部的著色劑:除非某著色劑已列入(許用)名單或已取得許可證,否則一種未列入名單或未獲證書的著色劑,應當?shù)玫皆谘鄄渴褂玫氖跈嗪蟛拍苁褂?。任何用于或擬用于眼部的物品的著色劑,若該著色劑的名單和證書未提供這種用途,則應當看做是未列入本章73、74和81部分的著色劑,即便這種著色劑被批準和列入名單中供其它用途。
?。╞)用于注射液的著色劑:除非某著色劑已列入(許用)名單或已取得許可證,否則一種未列入名單或未獲證書的著色劑,應當?shù)玫狡湓谧⑸湟褐惺褂玫氖跈嗪蟛拍苁褂?。任何用于或擬用于注射液制品的著色劑,若該著色劑的名單和證書未提供這種用途,則應當看做是未列入本章73、74和81部分的著色劑,即便這種著色劑被批準和列入表格供其它用途。
?。╟)用于外科手術縫合線的著色劑:除非某著色劑已列入(許用)名單或已取得許可證,否則一種未列入名單或未獲證書的著色劑應當?shù)玫皆谕饪剖中g縫合線中使用的授權后才能使用。任何用于或擬用于外科手術縫合線制品中的著色劑,若該著色劑的名單和證書未提供這種用途,則應當看做是未列入本章73、74和81部分的著色劑,即便這種著色劑被批準和列入名單供其它用途。
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