美国FDA化妆品着色剂色素颜料法规（中英文版）

李锦聪1年前 (2023-02-26)法规

美国化妆品着色剂

根据美国法律《联邦食品、药品和化妆品法案》 [FD&C法案第721条；《美国法典》第21篇第379条e款] ，着色剂受严格的审批制度的约束。除煤焦油染发剂外，能满足美国对着色剂要求导致化妆品掺假[FD&C法案第601条(e)款；《美国法典》第21篇，第361条(e)款]。着色剂违规是扣留试图进入美国境内的进口化妆品的常见原因。

Color additives are subject to a strict system of approval under U.S. law [Federal Food, Drug, and Cosmetic Act (FD&C Act), sec. 721; 21 U.S.C. 379e]. Except in the case of coal-tar hair dyes, failure to meet U.S. color additive requirements causes a cosmetic to be adulterated [FD&C Act, sec. 601(e); 21 U.S. Code 361(e)]. Color additive violations are a common reason for detaining imported cosmetic products offered for entry into this country.

一些基本要求

Some Basic Requirements

如果您的产品（煤焦油染发剂除外）含有着色剂，则根据法律[FD&C法案第721条；《美国法典》第21篇，第379条(e)款；《联邦法规汇编》第21篇第70和第80部分] ，您必须遵守以下规定：

If your product (except coal-tar hair dyes) contains a color additive, by law [FD&C Act, Sec. 721; 21 U.S.C. 379e; 21 CFR Parts 70 and 80] you must adhere to requirements for:

审批：化妆品（或任何其他受FDA监管的产品）中使用的所有着色剂必须通过FDA的审批，而且必须符合专门针对用作着色添加剂的物质制定的法规及相关规范和限制条件。
Approval. All color additives used in cosmetics (or any other FDA-regulated product) must be approved by FDA. There must be a regulation specifically addressing a substance's use as a color additive, specifications, and restrictions.
认证：除了通过审批，拟用于在美国销售的化妆品（或任何其他受FDA监管的产品）的大量着色剂必须通过FDA的批量认证。
Certification. In addition to approval, a number of color additives must be batch certified by FDA if they are to be used in cosmetics (or any other FDA-regulated product) marketed in the U.S.

性质和规范：所有着色剂必须符合《联邦法规汇编》规定的性质和规范要求。
Identity and specifications. All color additives must meet the requirements for identity and specifications stated in the Code of Federal Regulations (CFR).

用途与使用限制：着色剂仅可用于与其相关的条例规定的预期用途。该等条例也对某些染料，如成品中最大程度范围内允许的浓度，的其他使用限制进行了规定。
Use and restrictions. Color additives may be used only for the intended uses stated in the regulations that pertain to them. The regulations also specify other restrictions for certain colors, such as the maximum permissible concentration in the finished product.

如何对着色剂进行分类?

How are color additives categorized?

FD&C法案第721条(c)款[ 《美国法典》第21篇第379条e款(c)项]和着色剂法规[ 《联邦法规汇编》第21篇第70和第80部分]将着色剂分为两大类：需要认证的着色剂（有时被称为 “可认证的”着色剂）和免于认证的着色剂。此外，该法规还涉及其他分类，如纯品色和色淀。

The FD&C Act Section 721(c) [21 U.S. C. 379e(c)] and color additive regulations [21 CFR Parts 70 and 80] separate approved color additives into two main categories: those subject to certification (sometimes called "certifiable") and those exempt from certification. In addition, the regulations refer to other classifications, such as straight colors and lakes.

需要认证的颜料：着色剂主要来自于石油，有时也被称为 “煤焦油染料”或 “合成有机” 颜料。（注：煤焦油染料是一种由一种或多种从煤焦油中提取或能够产生煤焦油中间产物的物质组成的材料。它们也可能包括稀释剂或基质。（参见1939年5月9日版《联邦登记簿》第1922页）。如今，大多数煤焦油染料的原料均是石油。)
Colors subject to certification. These color additives are derived primarily from petroleum and are sometimes known as "coal-tar dyes" or "synthetic-organic" colors. (NOTE: Coal-tar colors are materials consisting of one or more substances that either are made from coal-tar or can be derived from intermediates of the same identity as coal-tar intermediates. They may also include diluents or substrata. (See Federal Register, May 9, 1939, page 1922.) Today, most are made from petroleum.)

除煤焦油染发剂外，不得使用该等染料，除非FDA已证实批量染料的成分与纯度已通过FDA自设的实验室的分析。如果批量染料未通过FDA的认证，请切勿使用。
Except in the case of coal-tar hair dyes, these colors must not be used unless FDA has certified that the batch in question has passed analysis of its composition and purity in FDA's own labs. If the batch is not FDA-certified, don't use it.
经过认证的染料名称一般由三个部分组成：名称包含前缀FD&C 、D&C或外部D&C 、颜色及编号。例如： “FD&C黄色5号” 。经过认证的染料也应通过颜色和编号（无需前缀）在化妆品成分声明中进行鉴定（如 “黄色5号”）。
These certified colors generally have three-part names. The names include a prefix FD&C, D&C, or External D&C; a color; and a number. An example is "FD&C Yellow No. 5." Certified colors also may be identified in cosmetic ingredient declarations by color and number alone, without a prefix (such as "Yellow 5").

免于认证的染料：该等着色剂主要从矿物、植物或动物源提取。它们无需受制于批量认证要求。但是，它们仍被视为人工色素，当其被用于生产化妆品或其他受FDA监管的产品时，它们必须符合条例[ 《联邦法规汇编》第21篇第73部分]规定的性质、规范、用途、使用限制及标识要求。
Colors exempt from certification. These color additives are obtained primarily from mineral, plant, or animal sources. They are not subject to batch certification requirements. However, they still are considered artificial colors, and when used in cosmetics or other FDA-regulated products, they must comply with the identity, specifications, uses, restrictions, and labeling requirements stated in the regulations [21 CFR 73].

纯品色：“纯品色”是指《联邦法规汇编》第21篇第73部分和74部分以及第81部分[ 《联邦法规汇编》第21篇第70.3条(j)款]中列出的任何着色剂。
Straight color. "Straight color" refers to any color additive listed in 21 CFR 73, 74, and 81 [21 CFR 70.3(j)].

色淀色淀：是指通过吸附、共沉淀或化合作用（不包含通过简单的混合过程进行的任何成分混合）掺杂在底色上的纯品色[ 《联邦法规汇编》第21篇第70.3条(l)款] 。由于色淀不溶于水，经常在需要防止颜色扩散时使用色淀，如口红。在某些情况下，色淀的使用必须满足特殊限制条件。与任何着色剂一样，检查美国列出的用于食品、药品、化妆品和医疗器械的着色添加剂概要和规定[ 《联邦法规汇编》第21篇，第82部分，B部分和C部分]非常重要，确保您仅将色淀用于批准的用途。
Lake. A lake is a straight color extended on a substratum by adsorption, coprecipitation, or chemical combination that does not include any combination of ingredients made by a simple mixing process [21 CFR 70.3(l)]. Because lakes are not soluble in water, they often are used when it is important to keep a color from "bleeding," as in lipstick. In some cases, special restrictions apply to their use. As with any color additive, it is important to check the Summary of Color Additives Listed for Use in the United States in Foods, Drugs, Cosmetics and Medical Devices and the regulations themselves [21 CFR 82, Subparts B and C] to be sure you are using lakes only for their approved uses.

如何防范颜色添加剂的违规行为？

How can I guard against color additive violations?

以下预防措施能够帮助您避免您的化妆品因使用被掺假的着色剂而违规。

Several precautions can help you avoid color additive violations that will cause your cosmetic to be adulterated:

不要将经过认证的染料与未经过认证的相似物混淆使用：例如，FD&C黄色5号是酒石黄经认证的组成部分且在一般情况下被批准用于化妆品。但未经过FDA分析且未获得FDA认证的酒石黄不得代替FD&C黄色5号或作为FD&C黄色5号在化妆品成分声明中进行鉴定。
Do not confuse certified colors with their uncertified counterparts. For example, FD&C Yellow No. 5 is the certified form of tartrazine, and is approved for use in cosmetics generally. But tartrazine, which has not undergone FDA analysis and received FDA certification, must not be substituted for or identified in an ingredient declaration as FD&C Yellow No. 5.

不要混淆经认证的染料与仅通过比色指数（CI）编码或有时用于欧洲显色鉴定的E编码鉴定的染料：您不得使用需要认证的颜料，除非FDA已对该等染料进行批量认证[FD&C法案第721条(a)款(1)项(A)目] 。CI或E编码并不代表FDA认证。
Do not confuse certified colors with colors identified only by a Colour Index (CI) number, or by the E number sometimes used in European color identification. You must not use a color subject to certification unless FDA has certified the batch in question [FD&C Act, sec. 721(a)(1)(A). A CI or E number does not indicate FDA certification.
当购买需要认证的着色剂时，请检查标签：如果批量染料都经过认证，染料的标签必须说明染料的合法名称（如 “FD&C黄色5号”），或如果是混合染料，需说明每种成分的名称、FDA批量认证编号以及[ 《联邦法规汇编》第21篇第70.25条)载明的染料的用途和使用限制。
When purchasing color additives subject to certification, check the label. If the lot is certified, the color's label must state the legal name for the color (such as "FD&C Yellow No. 5"), or, if it is a mixture, the name of each ingredient; the FDA lot certification number; and the color's uses and restrictions as stated in the CFR [21 CFR 70.25).

检查FDA网站上的着色剂概述：虽然此表格不能替代相关法规，但它是非常便于阅读的参考资料，可以引导您了解FDA批准的着色添加剂和涉及特定着色添加剂的法规。
Check the Summary of Color Additives on FDA's Web site. Although this table is not a substitute for the regulations, it is an easy-to-use reference that introduces you to FDA-approved color additives and directs you to the regulations addressing specific color additives.

熟悉相关法规的内容：着色添加剂法规可参见《联邦法规汇编》第21篇第70部分至第82部分。《联邦法规汇编》第73、74和82部分有涉及特定着色添加剂的法规。着色添加剂法规已发布在FDA的网站上。如需使用信用卡购买纸质版《联邦法规汇编》，请于周一至周五上午8点至下午4点（美国东部标准时间）期间致电美国政府印刷局，电话：(202) 512- 1800 。如需使用支票付款，请给文献总监处开支票，收件人：新订单，邮局。Box 371954, Pittsbur gh, PA 15250-7954.直接联系美国政府印刷局咨询目前的费用。
Become familiar with the regulations themselves. The color additive regulations are in 21 CFR Parts 70 through 82. Specific color additives are addressed in Parts 73, 74, and 82. The color additive regulations are posted on FDA's Web site. To purchase printed copies of the CFR by credit card, call the Government Printing Office at (202) 512-1800, Monday through Friday, from 8:00 a.m. to 4:00 p.m., Eastern Standard Time. To pay by check, write to the Superintendent of Documents, Attn: New Orders, P.O. Box 371954, Pittsburgh, PA 15250-7954. Contact the Government Printing Office directly for current costs.

在使用前确认着色添加剂的状态：着色添加剂的批文及着色添加剂的用途和使用限制可能发生变更。该等变更可能对需要认证的着色添加剂以及免于认证的着色添加剂产生影响。如需了解最新的相关法规，您可以查看《联邦法规汇编》和FDA法规摘要的最新版本。您也可以通过Color.Cert@fda.hhs.gov联系FDA。
Confirm the status of color additives before use. There may be changes in color additive approvals and changes in the uses and restrictions that apply to a color additive. Such changes may affect colors subject to certification as well as colors exempt from certification. To stay current with the regulations, you can check the latest edition of the CFR and FDA Dockets. You also may contact FDA at Color.Cert@fda.hhs.gov .

购买需要认证的染料时，必须确认制造商已申请认证：例如，您可以从过去两年内已申请染料认证的FDA的公司名单中选择符合要求的制造商。如果发现在着色剂标签上的公司不在该名单之列，您可通过Color.Cert@fda.hhs.gov联系FDA以确定该公司是否已实际上申请对其着色剂进行认证。
When purchasing colors subject to certification, confirm that the manufacturer has requested certification. For example, you can choose a manufacturer from FDA's list of companies that have requested color certification within the past two years. If the company that appears on the color additive label is not on this list, you may contact FDA at Color.Cert@fda.hhs.gov to determine whether the company has in fact requested certification of its color additives.

我必须按照预期用途使用染料吗?

Must I match colors with intended use?

是的。不论特定的染料是否需要认证或免于认证，美国法律禁止其在化妆品（或任何其他FDA监管的产品）中使用，除非其已获得预期用途的特别批准[FD&C法案第721条(a)款(1)项(A)目；《美国法典》第21篇第379e条(a)款(1)项(A)目]。

Yes. No matter whether a particular color is subject to certification or exempt from certification, U.S. law prohibits its use in cosmetics (or any other FDA-regulated product) unless it is approved specifically for the intended use [FD&C Act, sec. 721(a)(1)(A); 21 U.S.C. 379e(a)(1)(A)].

相关法规还对预期用途施加以下限制：

The regulations also restrict intended use as follows:

眼部使用：您不得将着色剂用于眼部，除非该等添加剂法规特别许可该用途[ 《联邦法规汇编》第21篇第70.5条(a)款]。 “眼部”包括 “眶上嵴和眶下嵴周围包含的区域，包括眉毛、眉毛以下的皮肤、眼睑与睫毛、眼睛的结膜囊、眼球以及位于眶下嵴边缘的软蜂窝组织”[《联邦法规汇编》第21篇第70.3条(s)款]。虽然存在获准用于眼部产品的着色添加剂，如睫毛膏和眉笔，但是不存在获准用于眉毛或睫毛的染色产品。
Eye-area use: You may not use a color additive in the area of the eye unless the regulation for that additive specifically permits such use [21 CFR 70.5(a)]. The "area of the eye" includes "the area enclosed within the circumference of the supra-orbital ridge and the infra-orbital ridge, including the eyebrow, the skin below the eyebrow, the eyelids and the eyelashes, and conjunctival sac of the eye, the eyeball, and the soft areolar tissue that lies within the perimeter of the infra-orbital ridge" [21 CFR 70.3(s)]. Although there are color additives approved for use in products such as mascara and eyebrow pencils, silver nitrate is the only color additive approved for dyeing the eyebrows or eyelashes, but for professional use only. The FDA has provided for the safe use of silver nitrate as a color additive, in professional-use only cosmetics, to color eyebrows and eyelashes [21 CFR 73.2550]. Use is restricted to up to 4 percent silver nitrate (by weight) in a viscous gel product. These silver nitrate containing cosmetic products are not intended for use on persons under the age of 16 or for application for longer than 1 minute. Furthermore, these products are not for distribution or direct sale to consumers.

外用化妆品：本术语不适用于嘴唇或被粘膜覆盖的任何体表。例如，如果某种着色剂获准用于制造外用化妆品，您不得将其用于制造口红之类的产品，除非相关法规特别许可该用途[ 《联邦法规汇编》第21篇第70.3条(v)款] 。
Externally applied cosmetics: This term does not apply to the lips or any body surface covered by mucous membrane. For instance, if a color additive is approved for use in externally applied cosmetics, you may not use it in products such as lipsticks unless the regulation specifically permits this use [21 CFR 70.3 (v)].

注射剂：严禁任何着色剂用于制作注射剂，除非对该用途作出特别规定的法规将其列为注射剂的材料。注射剂也包括为了纹身或化永久性彩妆而注入皮肤的物质。即使某种着色剂有任何其他批准的用途也并不意味着其可用作注射剂[相关规定请见《联邦法规汇编》第21篇第70.5条(b)款] 。该等规定中未列出经批准可用作注射剂的着色剂。
Injection: No color additive may be used in injections unless its listing in the regulations specifically provides for such use. This includes injection into the skin for tattooing or permanent makeup. The fact that a color additive is listed for any other use does not mean that it may be used for injections [21 CFR 70.5(b)]. There are no color additives listed in the regulations as approved for injections.

什么是特殊效果和新奇用途？

What about special effects and novelty use?

不论着色剂或其预期用途多么奇异或新奇，都必须和更加寻常的染料和产品一样符合同样的法规。以下产品为抽取的与众不同的着色剂的样品。以下列表虽然不详尽，但其旨在表明相关法规是如何适用于该等染料的：

No matter how exotic or novel the color additive or its intended use, it is subject to the same regulations as the more everyday colors and products. The following items are a sampling of some out-of-the-ordinary color additives. This list is not exhaustive. Rather, it is intended to show how the regulations apply to such colors:

变色颜料：随着酸碱度因素的变化而变化或因暴露在氧气中或高温中而变化的颜料均须与所有其他着色剂一样符合同样的法规。
Color-changing pigments: Colors that change in response to such factors as change in pH or exposure to oxygen or temperature are subject to the same regulations as all other color additives.

复合颜料：为实现不同的效果而混合使用的着色剂，如珠光产品中的着色剂，和所有其他着色剂均须符合同样的法规。某些着色剂在混合使用时有可能产生因其预期用途导致的不被批准的新颜料。例如，黏在蚀刻塑料薄膜上、由铝构成的全息闪粉就是一种获得批准的着色剂。
Composite pigments: Color additives used in combination to achieve variable effects, such as those found in pearlescent products, are subject to the same regulations as all other color additives. Some color additives, when used in combination, may form new pigments, which may not be approved for the intended use. An example is a "holographic" glitter, consisting of aluminum, an approved color additive, bonded to an etched plastic film.

荧光染料：只有以下荧光染料获得了用于化妆品的批准，其预期用途受到一定的限制：D &C橙色5号、10号、11号与D&C红色21号、22号、27号和28号[《联邦法规汇编》第21篇，第74.2254、74.2260、74.2261、74.2321 、74.2322、74.2327与第74.2328条] 。
Fluorescent colors: Only the following fluorescent colors are approved for use in cosmetics, and there are limits on their intended uses: D&C Orange No. 5, No. 10, and No. 11; and D&C Red No. 21, No. 22, No. 27, and No. 28 [21 CFR 74.2254, 74.2260, 74.2261, 74.2321, 74.2322, 74.2327, and 74.2328].

夜光染料：发光硫化锌是唯一获批的夜光着色剂[ 《联邦法规汇编》第21篇第73.2995 条]。
Glow-in-the-dark colors: Luminescent zinc sulfide is the only approved glow-in-the-dark color additive [21 CFR 73.2995].

万圣节彩妆：该等产品均被视为化妆品[FD&C法案第201条(i)款；《美国法典》第21篇第32 1条(i)款]，因此，其与其他化妆品一样必须符合同样的法规，包括适用于着色剂的限制条件。
Halloween makeup: These products are considered cosmetics [FD&C Act, sec. 201(i); 21 U.S.C. 321(i)] and are therefore subject to the same regulations as other cosmetics, including the same restrictions on color additives.

液晶染料：通过衍射在产品中产生颜色装饰图案的液晶添加剂均为未经批准的着色剂。因此，将液晶染料用于化妆品是违反[FD&C法案第601条(e)款；《美国法典》第21篇，第 361条(e)款] 。
Liquid crystal colors: These additives, which produce color motifs in a product through diffraction, are unapproved color additives. Their use in cosmetics is therefore illegal [FD&C Act, sec. 601(e); 21 U.S.C. 361(e)].

纹身颜料：综上所述，任何着色剂均不得注入皮肤，即使在纹身和化永久性彩妆时也是如此。
Tattoo pigments: As noted above, no color additives are approved for injection into the skin, as in tattoos and permanent makeup.

舞台彩妆：和万圣节彩妆一样，该等产品均被视为化妆品[FD&C法案第201条(i)款；《美国法典》第21篇第321条(i)款] ，因此，必须与其他化妆品一样符合同样的法规，包括对着色添加剂的限制。
Theatrical makeup: Like Halloween makeup, these products are considered cosmetics [FD&C Act, sec. 201(i); 21 U.S.C. 321(i)] and are therefore subject to the same regulations as other cosmetics, including the same restrictions on color additives.