§70.5 着色剂使用的一般限制条件(General restrictions on use of color additives)

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　　   § 70.5   General restrictions on use of color additives.

　　（a） 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.

　　（b） 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　着色剂使用的一般限制条件

　　（a）用于眼部的着色剂：除非某着色剂已列入（许用）名单或已取得许可证，否则一种未列入名单或未获证书的着色剂，应当得到在眼部使用的授权后才能使用。任何用于或拟用于眼部的物品的着色剂，若该着色剂的名单和证书未提供这种用途，则应当看做是未列入本章73、74和81部分的着色剂，即便这种着色剂被批准和列入名单中供其它用途。

　　（b）用于注射液的着色剂：除非某着色剂已列入（许用）名单或已取得许可证，否则一种未列入名单或未获证书的着色剂，应当得到其在注射液中使用的授权后才能使用。任何用于或拟用于注射液制品的着色剂，若该着色剂的名单和证书未提供这种用途，则应当看做是未列入本章73、74和81部分的着色剂，即便这种着色剂被批准和列入表格供其它用途。

　　（c）用于外科手术缝合线的着色剂：除非某着色剂已列入（许用）名单或已取得许可证，否则一种未列入名单或未获证书的着色剂应当得到在外科手术缝合线中使用的授权后才能使用。任何用于或拟用于外科手术缝合线制品中的着色剂，若该着色剂的名单和证书未提供这种用途，则应当看做是未列入本章73、74和81部分的着色剂，即便这种着色剂被批准和列入名单供其它用途。