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There are many reasons for using coloring agents in food, including:

· It can counteract color loss caused by light, air, extreme temperature, humidity and storage conditions;

· Correcting natural color differences;

· Enhance the colors that are naturally present; and

· For colorless and“hobby”Food provides color.

U.S. Food and Drug Administration(FDA)Regulations require that colorants be proven safe at their intended use levels before they can be added to food.FDAWhen approving the use of colorants in food, our regulations clearly stipulate:

· It can be used for the following types of food.

· The maximum amount allowed, and

· How to declare colorants on food labels.

FDAFood colorings that are permitted to be used are divided into two categories: those that require certification and those that are exempt from certification. Both types of colorings must meet the same safety standards before they can be approved for use in food.

Certified colorants are synthetically produced (or artificial) and widely used because they impart strong, uniform color, are less expensive, and are easier to mix to create a variety of shades. Seven certified colorants are approved for use in food, known as…“FD&C”Colorants, because they can also be used in pharmaceuticals and cosmetics. For example,FD&Cyellow6 Numbers. Please refer to the chart for a complete list.

Colorants exempt from certification typically include dyes and pigments derived from natural sources such as vegetables, minerals, or animals. Examples of colorants exempt from certification include annatto extract (yellow), dehydrated beetroot (blue-red to brown), and caramel (yellow to brownish-yellow).b-Carotene (yellow to orange) and grape skin extract (red or purple).

The Federal Food, Drug, and Cosmetic Act(FD&Cbill) The regulations stipulate that a substance capable of imparting color is a colorant and must meet premarket approval requirements unless the substance is used solely for purposes other than coloring the product and is clearly not important to the product's merchantability.

When assessing the safety of a substance and whether it should be approved,FDAWill consider:

· The composition and properties of matter,

· The amount that is usually consumed

· Immediate and long-term health effects, and

· The availability of analytical methods for determining purity and acceptable levels of impurities.

The assessment determined an appropriate level of use, which included a built-in safety margin.——An additional factor, which takes into account the variability and uncertainty reflected in the data when assessing consumption levels, is to ensure that the proposed use is safe. In other words, the approved use level is far below the level expected to have any adverse effects.FDAWhen reviewing colorants intended for use in products such as meat and poultry or alcoholic beverages, other federal agencies are consulted.

Due to the inherent limitations of science,FDAIt can never be completely certain that the use of any substance is free from any risk. Therefore,FDAIt must be determined based on the best available scientific evidence whether consumers have reasonable certainty that they will not be harmed when using colorants as recommended.FDAThe use of colorants that have been found to induce cancer in humans and animals will not be approved.

If the colorant is approvedFDARegulations will be issued, which may include the types of food it can be used on, the maximum amount to be used, how it should be labeled for product manufacturers to market, and whether bulk certification is required. The levels used in food are generally limited to the amount needed to achieve the desired effect.

If new evidence suggests that a product already in use may be unsafe, or if changes in consumption levels warrant a reassessment, federal authorities may ban its use or conduct further research to determine whether its use can still be considered safe.

List of colorants

FDAAll colorants listed must be divided into two categories:

Colorants requiring volume certification are typically synthetic organic dyes, lakes, or pigments. Colorants used in food are chemically classified as azo, xanthannadi, triphenylmethane, and indigo dyes. While certified colorants are traditionally referred to as coal tar pigments due to their source, they are now primarily synthesized from raw materials obtained from petroleum or coal. Direct colorants requiring volume certification (including dyes and pigments) are listed below.21 CFRNo.74 Some of the lakes requiring batch certification are listed below.21 CFRNo.74 Partial or21 CFRNo.82 part.

Colorants exempt from certification typically include those derived from plant or mineral sources. Cochineal extract (and its lake, carmine) is derived from an insect. Colorants exempt from certification must meet the properties and purity specifications and usage restrictions described in their listed regulations. Users of these colorants are responsible for ensuring that the colorants comply with the listed regulations. Colorants exempt from certification are listed in...21 CFRNo.73 Part. Table1 A complete list of all colorants permitted for use in food is provided.

Color additives do not have a generally accepted safety profile.(GRAS)Terms and Conditions

Federal Food, Drug, and Cosmetic Act (FD&C Act)FD&CThe bill contains a provision that allows certain substances to be deemed safe for their intended use if they are generally recognized as such.GRASIf it falls under the definition of food additives, then it is considered a food additive. However, this clause does not apply to color additives. For example, soy leghemoglobin, used in uncooked ground beef-like products, has been submitted...GRASThe notice states that, due to its usage and its impact on food, it is also classified as a coloring additive. (Regarding...)GRASFor more information on the notification process, please visit [website address].FDAwebsite.

Color Additive Certification

Color additive certification isFDAThe process ensures that newly manufactured batches of certified color additives meet the characteristics and specifications required by market regulations.2022 fiscal year,FDATotal verified2810 Tens of thousands of pounds of color additives, most of which are used in food. Color certification reports are available.FDAFound on the website.

The decision on whether batch certification is required is made when an agency reviews an application to include a color additive in its catalog. Some color additives may contain impurities with toxicological significance that could have adverse effects on human health. Batch certification is necessary when it is required to control the ingredients to protect public health.

Compilation of Federal Regulations 21 Chapter 180 This section details the certification requirements for color additives, as well as the storage, costs, record keeping, and inspection procedures for owners and manufacturers. (Compilation of Federal Regulations, Section [number missing])21 Chapter 170.25 Some regulations specify labeling requirements for color additive batches before and after certification. According to the certification process, samples of each batch of certifiable color additives produced must be sent to [the relevant authority/organization].FDAThe color certification department, and attached a copy“Certification Application”Provide information about the batch, including the name of the color additive, the name of the manufacturer, the batch weight, the batch storage conditions, and the certified purpose.FDACertification fees are charged based on batch weight. Prior to certification, this batch must not be used in food, pharmaceutical, cosmetic, or medical device products and must be stored separately from already certified batches.

After receiving the sample,FDAPersonnel will assess its appearance and conduct chemical analysis. At least [number] tests will be performed.10 The analysis includes purity (total color content), moisture, residual salts, unreacted intermediates, colored impurities other than the primary color (referred to as secondary colors), any other specified impurities, and heavy metals lead, arsenic, and mercury. Evaluation and analysis typically take less than five business days. The results are reviewed to determine if they meet the characteristics and specifications described in the color additive marketing regulations. If the sample is found to meet these requirements,FDAA certificate will be issued for this batch, which will specify the color additive, batch weight, certified purpose of the color additive, owner's name and address, and other necessary information.FDAA unique certification batch number will also be assigned to this batch, and the batch name will be changed. For example,“Lemon Yellow”The batch will become“FD&Cyellow5 Number”。

The analysis and information sections of the certification program have been automated as much as possible. Currently, the online network system allows color additive manufacturers to submit and access information about individual samples, including receipts.FDAThe certificate. The owner of the certified batch needs to accept...FDAInspections of its premises. During these inspections,FDAThe usage records of color additives will be checked, and samples will be taken from the certified batches for analysis, in order to...FDAThe original results were compared.

Color Additive Application Review Process

When assessing the safety of new color additives or new uses of existing color additives,FDAThe following factors will be considered: the potential consumption or exposure from using the color additive, its cumulative effect in the diet, the safety factor, and the availability of analytical methods to determine its purity and acceptable levels of impurities.

Anyone interested can contactFDATo apply for the use of a new color additive, or to modify the marketing information of a color additive for a new purpose, the applicant must provide the following information:

· Characteristics of the proposed color additive

· Physical, chemical and biological properties

· Chemical Specifications

· Production process description

· Stability data

· Intended use and limitations

· Label

· Tolerance and Limitations

· Analytical methods for performing chemical specifications

· Analytical methods for determining color additives in products

· Identify and determine any substances that form in or on a product due to the use of color additives.

· Security research

· Estimation of potential exposure

· Proposed regulations

· Proposed batch certification exemption

· Environmental assessment or classification exclusion statement

Applicants must submit data demonstrating the safety and suitability of the new color additive or its application. Then,FDAThe data in the application, public comments on the application, andFDAOther relevant data in the file.

After the application is approved,FDANew listing regulations or changes to existing regulations will be issued to accommodate new color additives or new applications. (Compilation of Federal Regulations)70 Chapter and No.71 This document details the application process, including the format, administrative requirements, and the necessary information and data. The data supporting a color additive application will vary depending on whether the application pertains to a new color additive or a new use of an already marketed color additive, the proposed level and type of use of the color additive, and the amount of color additive and its impurities that may enter body tissues.FDAThe website also describes the application process and provides information on recently launched and pending color additive applications. Once a new color additive is released,FDAIts safe use will be continuously monitored to ensure that new data and safety information are taken into account. Historically, this activity has led to regulatory changes in color additives that are necessary to protect public health.

FDAWe manage and maintain a public inventory in which we list all those currently...FDAActively under review or submitted but due toFDAColor additive applications that were not activated due to defects discovered during the review process.

Enforcement of colorant regulations

whenFDAWhen an investigation determines that a colorant violation has occurred, the agency can take a variety of actions to enforce the Federal Food, Drug, and Cosmetic Act (FDA).FD&C ActAnd protect public health. If the responsible company does not voluntarily take action (e.g., product recall) to correct the problem,FDAThere are several advisory, administrative, and judicial options, including warning letters, detention, issuing import alerts, and seizure.

existFDAof“Colorant compliance and enforcement”You can find it on the pageFDASome colorant enforcement actions.FDAA warning letter has been issued because of undeclared substances in dehydrated papaya.FD&Cyellow6Number, among baked goods that were not declaredFD&Cred40Number andFD&Cyellow6Number, and undeclared noodle productsFD&Cblue1Number andFD&Cyellow5Number.FDAA recall was also reported due to undeclared substances in bottled food coloring.FD&Cred40Number and incorrect declarationFD&Cyellow6The product contained the unapproved coloring agent Ponceau Red in the strawberry filling.4R。

FDARegular guidance on the correct use of colorants is provided.20An example of a long-standing policy since the beginning of the century is the sale of small silver balls used to decorate cookies, cakes, etc.“Silver Pearl Candy”As stated in the compliance policy guide (CPGAs expressed in ),“When called‘Silver Pearl Candy’The small silver balls are specifically designed for decorating cakes, and they are not considered food or candy when used under conditions that prevent them from being consumed as candy.”

FDAIt is also recommended that home and commercial bakers avoid using glitter and dust products to decorate cakes and other foods unless these products are specially manufactured for consumption.

In conclusion, federal regulation of food colorings has a long history and remains so.FDAAn important program to ensure consumers have access to safe and properly labeled food.

Historical perspective: the basis of current regulations

Natural colorants derived from vegetables and minerals were used in ancient times to color food, medicine, and cosmetics. Chili powder, turmeric, saffron, iron and lead oxides, and copper sulfate are some examples. Early Egyptians used artificial pigments in cosmetics and hair dyes. At least from BC300Wine has been artificially colored since 1960.

1856In 1948, William·Henry·Perkin discovered the first synthetic organic dye, called aniline purple. Similar dyes followed quickly, and they were soon used to color food, pharmaceuticals, and cosmetics. Because these dyes were originally produced as a byproduct of coal processing, they were called...“Coal tar pigments”。

Federal oversight of food colorings began19century80The assessment of coloring agents in food was one of the earliest public initiatives undertaken in the United States.1881In 1990, the U.S. Department of Agriculture (USDAThe Chemicals Bureau began investigating the use of color in food. Butter and cheese were the first foods for which the federal government authorized the use of artificial colorings.

arrive1900In 1949, many food, pharmaceutical, and cosmetic products on the US market contained artificial colorings. However, not all colorants were harmless; some were used to mask inferior or defective foods. A careful evaluation of the chemicals used for food coloring at the time revealed the addition of many known toxic substances, such as lead, arsenic, and mercury. In many cases, the toxicity of the starting materials used to synthesize colorants was well-known and they could be toxins, irritants, sensitizers, or carcinogens.