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§ 73.100 Cochineal extract; carmine.
（a） Identity. （1） The color additive cochineal extract is the concentrated solution obtained after removing the alcohol from an aqueous-alcoholic extract of cochineal （ Dactylopius coccus costa （ Coccus cacti L.））. The coloring principle is chiefly carminic acid.
（2） The color additive carmine is the aluminum or calcium-aluminum lake on an aluminum hydroxide substrate of the coloring principles, chiefly carminic acid, obtained by an aqueous extraction of cochineal （ Dactylopius coccus costa （ Coccus cacti L.））.
（3） Color additive mixtures for food use made with cochineal extract or carmine may contain only diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring foods.
（b） Specifications. （1） Cochineal extract shall conform to the following specifications:
pH, not less than 5.0 and not more than 5.5 at 25 °C.
Protein （N × 6.25）, not more than 2.2 percent.
Total solids, not less than 5.7 and not more than 6.3 percent.
Methyl alcohol, not more than 150 parts per million.
Lead （as Pb）, not more than 10 parts per million.
Arsenic （as As）, not more than 1 part per million.
Carminic acid, not less than 1.8 percent.
（2） Carmine shall conform to the following specifications:
Volatile matter （at 135 °C. for 3 hours）, not more than 20.0 percent.
Ash, not more than 12.0 percent.
Lead （as Pb）, not more than 10 parts per million.
Arsenic （as As）, not more than 1 part per million.
Carminic acid, not less than 50.0 percent.
Carmine and cochineal extract shall be pasteurized or otherwise treated to destroy all viable Salmonella microorganisms. Pasteurization or such other treatment is deemed to permit the adding of safe and suitable substances （other than chemical preservatives） that are essential to the method of pasteurization or other treatment used. For the purposes of this paragraph, safe and suitable substances are those substances that perform a useful function in the pasteurization or other treatment to render the carmine and cochineal extract free of viable Salmonella microorganisms, which substances are not food additives as defined in section 201（s） of the act or, if they are food additives as so defined, are used in conformity with regulations established pursuant to section 409 of the act.
（c） Uses and restrictions. Carmine and cochineal extract may be safely used for coloring foods generally in amounts consistent with good manufacturing practice, except that they may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards.
（d） Labeling requirements . （1） The label of the color additives and any mixtures intended solely or in part for coloring purposes prepared therefrom shall conform to the requirements of §70.25 of this chapter.
（2） The label of food products intended for human use, including butter, cheese, and ice cream, that contain cochineal extract or carmine shall specifically declare the presence of the color additive by listing its respective common or usual name, “cochineal extract” or “carmine,” in the statement of ingredients in accordance with §101.4 of this chapter.
（e） Exemption from certification. Certification of these color additives is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721（c） of the act.
[42 FR 15643, Mar. 22, 1977, as amended at 74 FR 216, Jan 5, 2009]
§73.100 胭脂蟲提取物；胭脂紅
（a）特性：
（1）著色劑胭脂蟲提取物，系用含水醇提取胭脂蟲（Dactylopius coccus costa;Coccus cacti L.），然后除去醇后所得的濃縮液，其著色物質(zhì)主要是胭脂紅酸。
（2）著色劑胭脂紅，系胭脂蟲經(jīng)水提取后所得的以胭脂紅酸為主要著色物質(zhì)的基料，經(jīng)氫氧化鋁處理而成的鋁或鈣鋁色淀。
（3）用胭脂蟲提取物或由胭脂紅配制成的食用著色劑混合物，只能選用合適的本分部所列的可安全地用于食品著色的著色劑混合物稀釋劑。
（b）質(zhì)量規(guī)格：
（1）胭脂蟲提取物應(yīng)符合下列質(zhì)量指標(biāo)：
pH，在25℃時(shí)，為5.0～5.5。
蛋白質(zhì)（N×6.25），不超過2.2%。
總固體，5.7%～6.3%。
甲醇，不超過150mL/kg。
鉛（以Pb計(jì)），不超過10mg/kg。
砷（以As計(jì)），不超過1mg/kg。
胭脂紅酸，不低于1.8%。
（2）胭脂紅應(yīng)符合下列質(zhì)量指標(biāo)：
揮發(fā)物（135℃，3h），不超過20.0%。
灰分，不超過12.0%。
鉛（以Pb計(jì)），不超過10mg/kg。
砷（以As計(jì)），不超過1mg/kg。
胭脂紅酸，不低于50.0%。
胭脂紅和胭脂蟲提取物均需經(jīng)巴氏滅菌或類似處理，以殺滅所有活的沙門氏菌，在巴氏滅菌或類似的處理中，可加入安全且合適的物質(zhì)（不包括化學(xué)防腐劑）。作為巴氏滅菌或其它處理方法也不可少的物質(zhì)，它們?cè)诎褪蠝缇蚱渌幚碇械墓δ埽鞘闺僦t或胭脂蟲提取物中不存在活的沙門氏菌，這些物質(zhì)不屬于法規(guī)§201（S）中的食品添加劑，或者，如果它們?cè)谠摲ㄒ?guī)中屬于食品添加劑，但其用量應(yīng)符合法規(guī)§409中的規(guī)定。
（c）使用和限制條件：胭脂紅和胭脂蟲提取物在其用量符合現(xiàn)行GMP用量條件下，可安全地用于一般食品的著色，但不能用于本法規(guī)§401所頒布的已確定標(biāo)準(zhǔn)的食品的著色，除非所加入的色素是這類標(biāo)準(zhǔn)所允許的。
（d）標(biāo)簽標(biāo)注方式：本著色劑和任何由本著色劑所配制成的混合物，擬單獨(dú)使用或起部分著色效果時(shí)，其標(biāo)簽必須符合本章§70.25中的要求。
（e）免除產(chǎn)品證書：本著色劑免除產(chǎn)品證書以保護(hù)公眾健康。所生產(chǎn)的每批產(chǎn)品也免除按法規(guī)721（c）中所規(guī)定的需要產(chǎn)品證書。
