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§ 70.50 Application of the cancer clause of section 721 of the act.
?。╝） Color additives that may be ingested. Whenever （1） the scientific data before the Commissioner （either the reports from the scientific literature or the results of biological testing） suggest the possibility that the color additive including its components or impurities has induced cancer when ingested by man or animal; or （2） tests which are appropriate for the evaluation of the safety of additives in food suggest that the color additive, including its components or impurities, induces cancer in man or animal, the Commissioner shall determine whether, based on the judgment of appropriately qualified scientists, cancer has been induced and whether the color additive, including its components or impurities, was the causative substance. If it is his judgment that the data do not establish these facts, the cancer clause is not applicable; and if the data considered as a whole establish that the color additive will be safe under the conditions that can be specified in the applicable regulation, it may be listed for such use. But if in the judgment of the Commissioner, based on information from qualified scientists, cancer has been induced, no regulation may issue which permits its use.
（b） Color additives that will not be ingested. Whenever the scientific data before the Commissioner suggest the possibility that the color additive, including its components or impurities, has induced cancer in man or animals by routes other than ingestion, the Commissioner shall determine whether, based on the judgment of appropriately qualified scientists, the test suggesting the possibility of carcinogenesis is appropriate for the evaluation of the color additive for a use which does not involve ingestion, cancer has been induced, and the color additive, including its components or impurities, was the causative substance. If it is his judgment that the data do not establish these facts, the cancer clause is not applicable to preclude external drug and cosmetic uses, and if the data as a whole establish that the color additive will be safe under conditions that can be specified in the regulations, it may be listed for such use. But if, in the judgment of the Commissioner, based on information from qualified scientists, the test is an appropriate one for the consideration of safety for the proposed external use, and cancer has been induced by the color additive, including its components or impurities, no regulation may issue which permits its use in external drugs and cosmetics.
?。╟） Color additives for use as an ingredient of feed for animals that are raised for food production. Color additives that are an ingredient of the feed for animals raised for food production and that have the potential to contaminate human food with residues whose consumption could present a risk of cancer to people must satisfy the requirements of subpart E of part 500 of this chapter.
[42 FR 15636, Mar. 22, 1977, as amended at 43 FR 22675, May 26, 1978; 52 FR 49586, Dec. 31, 1987]
§70.50 本法規(guī)721節(jié)癌癥條款的應(yīng)用
（a）內(nèi)服的著色劑：每當(dāng)（1）專員面前的科學(xué)數(shù)據(jù)（或者根據(jù)科學(xué)文獻(xiàn)報(bào)道或者根據(jù)生物實(shí)驗(yàn)結(jié)果）表明在通過人或者動(dòng)物內(nèi)服了包括其成分或雜質(zhì)在內(nèi)的著色劑后存在致癌的可能性，或（2）在食品中使用添加劑的安全性試驗(yàn)表明該著色劑（包括它的各種成分或雜質(zhì)在內(nèi)）在人體或動(dòng)物體內(nèi)會(huì)致癌，專員可以依據(jù)有資格的科學(xué)家的評(píng)價(jià)做出該著色劑是否會(huì)引發(fā)癌癥，包括其各種成分或雜質(zhì)在內(nèi)，是或不是致癌物質(zhì)的判定。如果他判定這些數(shù)據(jù)未能確定這些事實(shí)，則不能應(yīng)用癌癥條款；如果所考慮的數(shù)據(jù)從總體上確定了該著色劑在可適用規(guī)定的條件下是安全的，則它可以列入名單中以供這類用途。但如果專員依據(jù)來自有資格的科學(xué)家的資料數(shù)據(jù)，判定它會(huì)引發(fā)癌癥，則按規(guī)定不得簽發(fā)這種著色劑的使用許可。
?。╞）不會(huì)被內(nèi)服的著色劑：每當(dāng)擺在專員面前的科學(xué)數(shù)據(jù)表明，著色劑（包括它的各種成分或雜質(zhì)在內(nèi)）通過除內(nèi)服之外的程序使用，在人體或動(dòng)物體內(nèi)存在致癌可能性，專員會(huì)依據(jù)有資格的科學(xué)家的評(píng)價(jià)，和致癌可能性的試驗(yàn)結(jié)果，判定其是否會(huì)引發(fā)癌癥，同時(shí)確定該著色劑（包括它的成分和雜質(zhì)在內(nèi)）是否屬于致癌物質(zhì)。如果他判定有關(guān)數(shù)據(jù)不能確定這些事實(shí)，則不應(yīng)將癌癥條款用來排除著色劑在外用藥和化妝品中使用；如果有關(guān)數(shù)據(jù)作為一個(gè)整體確定該著色劑在規(guī)定范圍內(nèi)的指定條件下是安全的，它可以被列入名單中以供相關(guān)用途使用。但是如果專員依據(jù)有資格的科學(xué)家的資料數(shù)據(jù)，而且擬定外用的安全性試驗(yàn)也是正確的。該著色劑（包括其成分和雜質(zhì)在內(nèi)）已引發(fā)了癌癥，則按規(guī)定不得簽發(fā)它在藥物和化妝品中使用的許可。
（c）用于喂養(yǎng)供人類食用的動(dòng)物的飼料成分的著色劑：用于喂養(yǎng)供人類食用的動(dòng)物的飼料成分的著色劑，和可能存在的殘留物污染食品后會(huì)給人類帶來癌癥風(fēng)險(xiǎn)的著色劑，必須滿足本章500部分E分部中的要求。
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編輯：foodfagui