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Home , Amaranth (dye), Carmine (color), Food coloring, Ponceau 4R, Sunset Yellow FCF, Tartrazine

Global Regulations of Each region has its own definitions of what constitutes a additive, with related use requirements and restrictions.

Sue Ann McAvoy Sensient Colors LLC

t is said, we eat with our eyes . Since antiq - food colors was soon recognized as a threat Iuity, humans have used the color of a to public health. Of concern was that some food to discern its quality. Color provides of the substances were known to be poi - a way to judge ripeness, perceive and sonous and were often incorporated to hide assess quality of food. poor quality, add bulk to and to pass Ancient civilizations introduced color off imitation foods as real. into their foods. The ancient Egyptians col - On February 1, 1899, the executive com - ored their food with , and the mittee of the National Confectioners’ Asso - ancient Mayans used to color their ciation published an official circular which Sue Ann McAvoy is food -. Wealthy Romans ate bread was “to throw upon the vexed question global regulatory scien - that had been whitened by adding alum to of what colors may be safely used in confec - tist for Sensient Food the flour. Color could be used to enhance tionery” as “there may at times be a doubt in Colors LLC. She has worked at Sensient the mind of the honest confectioner as to the physical appearance of the product. since 1979. However, if it made the food appear to be which colors, , or ingredients he may of better quality than it was, that was con - safely use and which he may reject.” This list sidered a deceitful practice. This is the broad contained 21 colors said to be harmful, and definition of adulteration . In Paris in 1396, an 33 colors said to be harmless. edict was issued that forbade the coloring of In 1906, the Food and Act was passed . This was one of the early laws against by Congress. This act banned the addition of intentional adulteration of food. “poisonous” colors to prod - Through the centuries, advances in preser - ucts, and prohibited the addition of colorants vation of food by refrigeration, canning and to foods for the purpose of concealing infe - processing, all of which extended the shelf riority. As a result of the 1906 act, and fur - life of food, also tended to alter the normal ther study by Wiley and Hesse, seven colors color of the food. Large-scale processing (, Ponceau 3R, Orange I, Erythro - and year-round demand for a variety of sine, Naphthol Yellow S, Light SF Yel - foods caused a desire to establish a uniform lowish and Disulfo Acid Sodium Salt) appearance of foods. However, overuse of were voluntarily certified. ➤

The Manufacturing Confectioner • September 2014 77 Global Regulations of Food Colors

Because absolute In 1938, the Food and Drug Act was over - making recommendations of safe levels of safety of any hauled, and certification of colors became use. The Commission substance can mandatory. The responsibility for certifica - was created in 1963 by FAO and WHO to never be proven, tion fell to the newly formed Food and Drug develop food standards, guidelines and FDA must determine Administration. In 1959, the Food, Drug related texts such as codes of practice if the additive is and Cosmetic Act was passed. The Color under the Joint FAO/WHO Food Stan - safe under the Additive Amendment was added in 1960. dards Programme. The laws included a provision, known as The tasks of establishing levels of use proposed conditions the Delaney Clause, which established that for additives and developing food stan - of use, based on no food or color additive could be deemed dards have fallen to the Joint FAO/WHO the best scientific safe — or given FDA approval — if found Expert Committee on Food Additives knowledge to cause cancer in humans or animals. (JECFA), which was established in 1955. available. The act also divided the colors into two Most of these standards are built on the categories — certified and exempt from cer - adi () for additives, tification — and further divided the certi - including color additives. This adi philos - fied colors into permanently and provi - ophy is to spread out the risk of cancer. sionally listed colors. The 1960 act required This type of philosophy is a “Low Risk” manufacturers to sponsor new toxicity test - philosophy. JECFA also has the responsi - ing. Based on these data points and various bility for establishing monographs for the safety factors, FDA determines a safe expo - identity and purity of individual food addi - sure level for the food and color additive. tives. The additives are assigned INS num - FDA compares the safe exposure level bers. The work of JECFA with additives to the amount likely to be consumed in feeds into the Codex General Standard for food, taking into consideration the com - Food Additives (GSFA) food category sys - position and properties of the substance tem. This system is a hierarchical system and the proposed conditions for use. and applies to all foodstuffs, including those Because absolute safety of any substance in which no food additives are permitted. can never be proven, FDA must determine The system has established food category if the additive is safe under the proposed definitions. For example, confectionery is conditions of use, based on the best scien - Category 05.0 and “Includes all cocoa and tific knowledge available. With color addi - chocolate products (05.1), other confec - tives, FDA also must determine their suit - tionery products that may or may not con - ability for use. The Office of tain cocoa (05.2), (05.3), and Safety, formerly the Office of Premarket decorations and icings (05.4), or foods pro - Approval, evaluates this information. duced solely with any combination of foods Because this is a rigorous and exhaustive conforming to these sub-categories.” In the process for additive evaluation, and GSFA, JECFA will eventually establish because of the Delaney Clause, FDA addi - usage limits for all additives, based on con - tives are considered as having “No Risk” or sumption patterns, in each specific food “Minimal Risk” with consumption. product category. www.codexalimentarius.net/ Beginning in 1956, the Food and Agri - gsfaonline/foods/index.html culture Organization (FAO) of the United The General Principle of Codex Alimen - Nations and the World Health Organiza - tarius is to guide and promote the harmo - tion (WHO) began collecting and evalu - nization of food laws among countries and to ating scientific data on food additives and adopt internationally agreed-upon standards. ➤

78 September 2014 • The Manufacturing Confectioner Global Regulations of Food Colors

This will lead to fewer barriers to trade and Two main categories make up the FDA’s Plainly stated, if freer movement of food products among list of permitted color additives. They are the purpose of an countries, which will benefit farmers and their the certified color additives and the additive is to families, and will help to reduce hunger and exempt-from-certification color additives. change the color of poverty. The certified color additives are primarily a food, then the The United States and Japan employ the man-made synthetic organic colors. The additive is a color. No Risk philosophy. JECFA and the Euro - manufacturer submits a sample of the As a color, it has to pean Commission (EC) of the European batch for certification, and the FDA tests be approved as a Union (EU) employ the Low Risk philos - the sample to determine whether it meets color for use in ophy. It is the Low Risk philosophy that the color’s requirement for composition food by the Food we see in new and revised regulations. and purity. When the batch is approved, and Drug As we examine in depth what consti - the FDA issues a certified lot number to Administration. tutes a color additive in each region, it is the batch, and the manufacturer can then also important to remember that entities sell the product. The name is changed to also have purity requirements, and often its unique FD&C nomenclature. Only then restrict colors and other additives based can that lot be used to make FDA-regu - on the finished food product that is being lated colors. Following is the list of color sold to consumers. There are more than additives subject to certification: 100 governmental regulatory bodies, inter - • FD&C Red #3 national trade agreements, nongovern - • FD&C Red #40 mental organizations and industrial trade • FD&C Yellow #5 organizations that oversee food regula - • FD&C Yellow #6 tions. We will examine some of these in • FD&C Green #3 more depth. • FD&C #1 U.S. REGULATION • FD&C Blue #2 In the United States, the act states that The exempt color additives are largely ... a material otherwise meeting the from plant, animal or sources, or definition of color additive to be are synthetic variations of naturally occur - exempt from section 721 of the act, ring colorants. While not subject to batch on the basis that it is used (or certification, they are still artificial color intended to be used) solely for a pur - pose or purposes other than color - additives and must meet the requirements ing, the material must be used in a for composition and purity as listed in the way that any color imparted is clearly Code of Federal Regulations. Some of the unimportant insofar as the appear - colors exempt from certification are limited ance, value, marketability, or con - to certain classifications of food products sumer acceptability is concerned. (It or certain usage levels. It is important to is not enough to warrant exemption check 21 CFR Section 73 for these limita - if conditions are such that the pri - mary purpose of the material is other tions. The common color additives exempt than to impart color.) from certification are shown in Figure 1. Plainly stated, if the purpose of an addi - In the United States, color additives are tive is to change the color of a food, then required to be labeled. Certified colors the additive is a color. As a color, it has to must always be declared by name in the be approved as a color for use in food by ingredient statement. It is not necessary to the Food and Drug Administration. include the FD&C prefix or the term No. ➤

The Manufacturing Confectioner • September 2014 79 Global Regulations of Food Colors

Regardless of the in the declaration, although the term lake Harmonization of food additives was source of the color, must be included where applicable (e.g., the push throughout the community, and FDA regulations do Yellow 5, Blue 1 Lake). was achieved in the Framework Directive not consider any Exempt-from-certification colors are 89/107. The framework directive covered added color to be described in 21 CFR Part 73. Labeling three separate directives on color, sweet - natural unless the options for most exempt-from-certification eners and all other additives. It had sup - color is “natural to” colors are varied, and include the following: porting directives containing purity crite - ria. However, this required adoption and the food product • artificial color implementation by member states. itself, such as • artificial color added Risk management responsibility for strawberry • color added additives lies with the Directorate General with • colored with ______(fill in with the color name as described in Part 73) for Health and Consumer Protection (DG strawberry juice. FDA also allows for alternative equally Sanco). Specific risk assessment for the informative terms, as long as it is clearly safety of food ingredients is reviewed under indicated that a color has been used. the European Food Safety Authority Exceptions to the above options are indi - (EFSA). EFSA has two panels. It is the cated by a statement in the exempt color panel on Food Additives and Nutrient description in Part 73 to the effect that dec - Sources Added to Food (ANS) that deals laration must be by name. Currently, the with questions of safety in the use of food only exempt-from-certification colors to additives, nutrient sources and other sub - require declaration by name are stances deliberately added to food, exclud - extract and . ing flavorings and . The ANS panel Although industry often refers to applies the Low Risk philosophy, with an Common Exempt- exempt-from-certification colors as natural added “precautionary principle” philoso - from-Certification colors , use of this term is prohibited on an phy. The precautionary principle is a “better Color Additives ingredient statement. Regardless of the safe than sorry” outlook. Annatto extract source of the color, FDA regulations do Starting in 2008, directives were replaced not consider any added color to be natural with a new, broader framework for addi - Beet juice Beta carotene unless the color is “natural to” the food tives. The new Regulation 1333/2008 Beta-apo-8’ caroteneal product itself, such as coloring strawberry entered into force on January 20, 2010. In Canthanxanthin ice cream with strawberry juice. November 2011, the detailed provisions Caramel designed to replace the requirements of Carmine/Cochineal Dehydrated beets (beet EU REGULATIONS the directives were published in Regula - powder) The European Union is a group of 26 mem - tion 1129/2011, which introduced substan - Fruit juice Grape color extract ber states (countries), with five candidate tial amendments to Regulation 1333/2008. Grape skin extract countries. The EU has spent many years These entered into force on June 1, 2013. Paprika oleoresin arriving at its current structure in its regu - Purity criteria were updated to align with lations. The first directive for additives the JECFA monographs, and were pub - Saffron Sodium copper chlorophyll agreed to was for colors in 1962. They used lished in Regulation 231/2012. Spirulina extract the E-number classification system. This In the EU, ingredients that are added to Synthetic iron oxide was followed by other directives for preser - foods to change their color are classified Tomato vatives, antioxidants and emulsifiers. This one of three ways: as a color additive, as a oleoresin system still allowed the member states to flavor or as a coloring food. Vegetable juice specify which foods could contain the sub - Regulation 1333/2008 has several tables Figure 1 stances and the maximum levels permitted. of additives that can be used, additives that ➤

80 September 2014 • The Manufacturing Confectioner Global Regulations of Food Colors can be used in additives and foods in which Southampton Six colors in the EU have In the EU, additives may be used, and the maximum been virtually eliminated. ingredients that are usage level limits. Each additive has an “E” Some additives have a flavor aspect as added to foods to number which corresponds to the INS well as a color aspect. Flavorings, as defined change their color numbers listed in Codex. By definition, in EC Regulation 1334/2009, are products are classified one colors from synthetic sources, and selec - which are added to food in order to impart of three ways: as a tively extracted colors from natural sources, or modify odor and/or taste. Flavorings color additive, as a as well as inorganic , are regu - with a secondary coloring effect are flavor or as a lated together. Some additives are allowed exempted from the food additive defini - coloring food. at quantum satis (gm p), while others have tion. Some items, such as spice oleoresins part per million levels based on the food (paprika oleoresin and turmeric oleoresin), category. The website maintained by DG are classified as flavors. Sanco is a useful tool to investigate the On November 29, 2013, the Standing regulation. https://webgate.ec.europa.eu/ Committee on Food Chain and Animal sanco_foods/main/?event=display Health issued Guidance Notes on the Clas - Since 2008, this regulation has been sification of Food Extracts With Coloring amended over 30 times. Since it is new and Properties, Version 1. These guidance notes often changing, it can feel disjointed and should be read in conjunction with the lead to some confusion. For the confec - appropriate legislation, especially Regu - tionery industry, one of the amendments lation (EC) No 1333/2008 on food addi - of impact is Commission Regulation (EU) tives. These guidance notes do not repre - No 380/2012 of 3 May 2012 amending sent the official position of the commission Annex II as regards the conditions of use and they do not intend to produce legally and the use levels for aluminum-contain - binding effects. ing food additives. This regulation reduced The guidance notes contain a decision the number of permitted aluminum addi - tree. The decision tree helps in determin - tives because consumption levels of alu - ing if the ingredient is a color additive, a fla - minum are considered too high. Specifi - vor or a food, or a coloring food. It is cally, this limits the use of aluminum lakes. important to note that foods normally con - In confection products in general, the use sumed as such in the EU, for example, of lakes is restricted by the color, and fur - cherry juice added to yogurt, would be ther by the aluminum, to 70 ppm. regarded as a food. As a food, they would Regulation EC 1333/2008 EU contained be labelled as such, even when added prin - a list of food colors (Article 24) for which cipally for coloring purposes. In addition, the labeling of foods shall include addi - products extracted from foods by other tional information. These colors (Sunset processes than drying or concentration to Yellow, Quinoline Yellow, Carmoisine, be used in food for their coloring proper - Allura Red, and ) ties should not automatically be regarded are required to state the following: name of as coloring food and should be examined of color(s): may have an adverse and classified in accordance with the deci - effect on the activity and attention in chil - sion tree. dren . The phrase coined for these colors Extraction can range from simple is the Southampton Six , which refers to the extraction, to degrees of selective extrac - university that completed the study. With tion, up to isolation of the pure pigments. this required labeling, the uses of the It is essential to identify when the prod - ➤

The Manufacturing Confectioner • September 2014 81 Global Regulations of Food Colors

It is essential to uct is no longer “a food normally con - cal reasons it is recommended to use refer - identify when the sumed as such or normally used as a char - ence values based on the literature relevant product is no acteristic ingredient of food,” but a color to the edible part from which the coloring longer “a food which needs approval. food is extracted. A table with the generally normally consumed Whether an extraction is selective or not applicable reference values will be estab - as such or depends on the ratio of the pigments rela - lished as Annex III to this guidance. normally used as a tive to the nutritive or aromatic con - In the EU, color additives must be characteristic stituents. [Regulation (EC) No 1333/2008] declared by the category name (color) and In order to determine when selective ingredient of E number of the specific color, e.g., Color (E extraction occurs, the guidance provides food,” but a color 171). If it is a flavor with a coloring property, an enrichment factor calculation. The ratio which needs it shall be designated either by the term fla - of the pigments, the nutritive constituents approval. voring or by a more specific name or and the aromatic constituents relative to description of the flavoring, such as turmeric the source material are all considered. oleoresin. Coloring food shall be designated Based on the calculation, a threshold value by its specific name, e.g., elderberry con - is determined. For coloring food, the value centrate/extract. The term coloring food is is less than 6. For selective extraction, the not a legal category name nor a specific value is greater than 6. The decision tree is name for the relevant ingredient. shown in Figure 2. In December 2013, the EU published a One factor being gathered for this guid - guidance document describing the food ance is the reference values for the source categories. This guidance document materials. The source material reference val - roughly aligns the food categories with the ues might have significant impact on the Codex GFSA food category system. While enrichment factor calculations. For practi - we have discussed what constitutes a color, and the purity of colors, the DG Sanco EU Decision Tree— Coloring Food vs Additive Food Color maintains the database on food additives, as a tool to inform about the food addi - tives approved for use in food in the EU and their conditions of use. https://web - gate.ec.europa.eu/sanco_foods/main/?event=dis - play . While solely for informational pur - poses, it can help in the search for the connection between food categories and the additives allowed.

OTHER COUNTRIES Here is a review of some of the other regions and how they compare in the areas of purity requirements, nomenclature, usage levels, certification and registration, and labeling. In application of the regula - tions, it is important to keep in mind the definition of the food product in the region Figure 2 and regulation. ➤

82 September 2014 • The Manufacturing Confectioner Global Regulations of Food Colors

Canada has a labeling hotline to which you can Like most regions Canada has a long history of food regula - submit questions via email: labelwindow around the world, tion. The enabling legislation is the Food @inspection.gc.ca . The labeling page is found Canada states that and Drug Act. Currently, the use of addi - at http://www.inspection.gc.ca/food/labelling/ it is the intent of tives is under the direction of Health eng/1299879892810/1299879939872. the ingredient that Canada. Food colors are listed in Division makes it a color. Mexico 6- B.06.01. “‘Synthetic color’ means any Just because it has organic color, other than caramel, that is Mexico has Norma Official Mexicana another function produced by chemical synthesis and has (Official Mexican Standard), abbreviated other than color, it no counterpart in nature.” as NOM. This is a series of official, com - is still a color, and Table 3 on the Health Canada website pulsory standards and regulations for needs to be (http://www.hc-sc.gc.ca/fn-an/securit/addit/list/3- diverse activities in Mexico. For food, if no declared as such. colour-color-eng.php) is a List of Permitted NOM exists, then Codex, EU or U.S. reg - Coloring Agents (Lists of Permitted Food ulations can be applied. Currently, there is Additives) and is subdivided into three no NOM for confectionery products. parts. Part 1 is colors that are from natural sources, are synthetic equivalents or are China inorganic pigments, and are generally per - In China, color regulations are under mitted to gm p. P arts 1.1-1.7 and 1A are col - GB2760-2011 - National Food Safety Stan - ors that have limits in certain food products. dard - Standard for uses of food additives. Part 2 is caramel and Part 3 is the synthetic The latest version was implemented June . The Canadian regulations allow for 20, 2011. Colors are registered and the tox - the same certified colors as the United icology data has to be submitted for new States, with the additional allowance for colors. Each color is petitioned for its use amaranth. Certification of color additives is and usage level on an individual basis. Col - required in Canada. The usage limits in foods ors have their own purity specifications in general is 300 ppm total, with not more along the lines of Codex. However, there than 100 ppm being Brilliant Blue (FD&C are some unusual importation regulations Blue 1) or Fast Green FCF (FD&C when you blend colors with other addi - Green 3). Health Canada maintains their tives. GB 26687-2011 The National Stan - regulations on their website. dards for Food Safety, General Rules Like most regions around the world, Regarding Compound Food Additives lim - Canada states that it is the intent of the its the combined level of lead to less than ingredient that makes it a color. Just 2ppm, and the combined level of to because it has another function other than less than 2 ppm, despite the limit on the color, it is still a color, and needs to be individual additive. declared as such. Currently, the permitted labeling of color in Canada is Colour in Japan both English and French. Additional infor - Japan has established their own regula - mation on the name of the color additive tions based on their own knowledge, much can be given. Alternative dual labeling for in the manner of the United States. The U.S. and Canadian requirements can also Specifications and Standards for Foods, be used, e.g., Colour: Allura Red (red 40) . Food Additives, etc., under the Food San - In addition to the HC website, Canada itation Act is published in English by the ➤

The Manufacturing Confectioner • September 2014 83 Global Regulations of Food Colors

Because the general Japan External Trade Organization the Australia New Zealand Food Standards principle of Codex (JETRO). In the act, they list the colors Code. It is established on the Codex model. Alimentarius is to and other additives that are permitted. Col - Confectionery is in food type 5. Colors are guide and promote ors can be under the following: Food addi - listed in Schedules 3 and 4. Schedule 3 the harmonization of tives with standards of use; Food additives additives are generally the colors from nat - food laws among with no standards of use; Existing food ural sources, synthetic equivalents of nat - countries and to additives; and Substances which are gen - ural sourced colors or are inorganic pig - adopt internationally erally provided as Food and which are used ments. These additives are permitted to agreed-u pon as food additives. In addition, Japan has gm p limits in confectionery products. standards, this is a the standard definitions of food categories, Schedule 4 additives are the synthetic color good model to along with two special food categories: additives, and are permitted to a combined follow. Food for Specified Health Uses (FOSHU) maximum level of 290 mg/kg in processed and Food with Nutrient Function Claims foods. The website is http://www.foodstan - (FNFC). The English translation of the dards.gov.au/Pages/default.aspx . Specifications and Standards for Foods is located at http://www.jetro.go.jp/en/reports/ MENA — Middle East and Northern regulations/pdf/foodext201112e.pdf. Africa Israel, Jordan, Lebanon, Malta and Syria Korea follow the EU regulations in general. Often Korea follows the Japanese model. Food there are registration requirements and regulation is under the Ministry of Food food category differences which affect the and Drug Safety (MFDS), formerly the color usage. KFDA. The Food Code contains the rele - These countries follow the GCC: vant information regarding the quality and Bahrain, Kuwait, Oman, Qatar, Saudi Ara - safety of foods covering specific maximum bia and United Arab Emirates. Recently levels for contaminants, heavy metals, pes - proposed to the World Trade Organization ticides residues, veterinary drug residues, is a change to adopt the Codex Alimenta - etc. One of the nuisances for Korea is the rius GFSA. A drawback with this adop - “stop sign” program. To protect young stu - tion is that all additives have not fully pro - dents from junk foods, the government gressed in the GFSA. decided to ban fast foods and soda within These countries in MENA follow their 200 meters of the selected schools. These own regulation of some type or are not junk food-free school areas are called easily tracked: Algeria, Djibouti, Egypt, Green Food Zones. Most confectionery Iran, Iraq, Libya, Morocco, Tunisia, West products, because of low nutritive value, Bank and Gaza, and Yemen. usually are labeled with the “Yellow” sign, and not allowed to be sold in this area. The Other Regions MFDS website is http://www.mfds.go.kr/eng/ Many countries in South America and Africa index.do?nMenuCode=4 . follow the JECFA/Codex model discussed earlier. Because the general principle of Australia Codex Alimentarius is to guide and pro - The Food Standards Australia and New mote the harmonization of food laws among Zealand (FSANZ) is a binational govern - countries and to adopt internationally ment agency. This agency had developed agreed-upon standards, this is a good model ➤

84 September 2014 • The Manufacturing Confectioner Global Regulations of Food Colors to follow. When fully implemented, this color additives exempt from certification. Which colors are model will lead to fewer barriers to trade Figure 3 lists the most common colors, with permitted and freer movement of food products their respective INS number and a typical worldwide? Even among countries, which will benefit farm - color designation. with the ers and their families, and will help to reduce Southampton story, hunger and poverty. OTHER ISSUES the best bets still are In general, there are a few additional reg - Red 40, Yellow 5, WORLDWIDE ulatory acceptance issues that need to be Yellow 6 and Blue 1, Which colors are permitted worldwide? considered. Color regulations are not eas - and most of the U.S.- Even with the Southampton story, the best ily charted. Many countries, such as the approved color bets still are Red 40, Yellow 5, Yellow 6 United States, EU and JECFA, have their additives exempt and Blue 1, and most of the U.S.-approved own set of purity specifications. Certifica - from certification.

Colors from Around the World

Colorant ANS# pH Pantone Colorant ANS# pH Pantone FD&C Red #40 (Allura Red) 129 2-8 1797 Riboflavin 101i 2-8 114 Amaranth* 123 2-8 7433 FD&C Yellow #5 (Tartrazine) 102 2-8 115 Carrot 163 3 1945 Turmeric/ 100 2.5-6.5 107 Carmine 120 3 7425 Yellow Iron Oxide* 172iii 2-8 129 Carmoisine* 122 2-8 200 Chlorophyll* 140i 2-8 7742 Cochineal Extract/Carminic Acid 120 7 225 Copper Chlorophyll* 141i 2-8 7742 Beet 162 4-7 674 FD&C Blue #1 Elderberry Juice 163 5 237 (Brilliant Blue FCF) 133 2-8 300 FD&C Red #3 (Erythrosine) 127 3-8 1915 Gardenia Blue* – 4-8 7690 Grape Juice 163 3 674 Huito* – 4-6 7694 Grape Skin Extract 163ii 3 674 FD&C Blue #2 (Indigotine) 132 2-8 285 Lycopene (from tomato) 160dii 3-7 1795 Red Cabbage 163 7.5 7683 Lycopene (synthetic)* 160di 3-7 1795 Spirulina – 5-8 3005 Monascus Color* – 5-8 7433 Natural Blue Vegetable Juice Color – 4-8 2935 Ponceau 4R 124 2-8 199 Black Carrot 163 7 7678 163 3 212 Blue Carmine 120 7 7447 Red Cabbage 163 3 1935 Purple Sweet Potato 163 4 2080 Red Iron Oxide* 172ii 2-8 7621 Black Iron Oxide* 172i 2-8 Black Red Radish 163 3 214 Brilliant Black* 151 2-8 Black Annatto - 160bi 2-6 173 Vegetable Carbon* 153 2-8 Black Annatto - Norbixin 160bii 3.5-8 173 Avalanche Opacity Agent – 2-8 Beta-Apo-8’-Carotenal 160e 2-8 1585 * 170 2-8 White Beta-Carotene 160ai-iv 2.5-8 136 Titanium Dioxide 171 2-8 White Canthaxanthin 161g 2-8 2028 I 150a 2-8 1615 Cochineal Extract 120 3 1635 Caramel Color II 150b 2-8 1615 * 161b 3-8 1385 Caramel Color III 150c 2-8 1615 Paprika Oleoresin 160c 2-8 166 Caramel Color IV 150d 2-8 1615 Saffron – 2-8 152 Aluminum* 173 2-10 Silver FD&C Yellow #6 (Sunset Yellow FCF) 110 2-8 021 * 175 2-10 Gold Beta-Carotene 160ai-iv 2.5-8 1375 Mica-Based Pearlescent Pigments 171 & 555 2-8 Various Carrot Oil* 160a 2-8 136 Silver* 1754 2-10 Silver Quinoline Yellow* 104 2-8 102 *Items are not generally permitted for food use in the United States

Figure 3 ➤

The Manufacturing Confectioner • September 2014 85 Global Regulations of Food Colors

At the current time, tion or registration may be required. Label - FAO/WHO Scientific Basis for Codex. Codex ing requirements will vary from country Alimentarius: Home. FAO/WHO, n.d. Web. no color is coming 26 May 2014. http:// www.codexalimentarius. from a genetically to country. Regulations are often fluid and net/web/index_en.jsp modified source. are subject to interpretation. FDA http://www.fda.gov/RegulatoryInformation/Leg - Colors and additives may have some islation/FederalFoodDrugandCosmetic ActFD - However, the CAct/default.htm allergenicity issues. Carmine has caused an carriers and Guidance Notes on the Classification of Food emulsifiers used in allergic reaction in a small number of con - Extracts with Colouring Properties. Stand - colors can be from sumers. Some types of caramel have sul - ing Committee on the Food Chain and Ani - fites. Sulfites can be used in some fruit and mal Health (Nov. 11, 2013): n. pag. Print. genetically http://ec.europa.eu/food/food/fAEF/additives/ vegetable juices. In addition, the carriers modified sources, guidance_en.htm. and emulsifiers used in color mixtures can such as soy and Japan http://www.jetro.go.jp/en/reports/regula be sources of allergens and insensitivities. tions/pdf/foodext201112e.pdf corn. At the current time, no color is coming Jukes, David, PhD. Food Law . Food Law - from a genetically modified source. How - Reading. N.p., n.d. Web. 26 May 2014. http://www.reading.ac.uk/foodlaw/ ever, the carriers and emulsifiers used in Korea http://www.mfds.go.kr/eng/index.do?n Menu colors can be from genetically modified Code=4 sources, such as soy and corn. Marmion, Daniel M. Handbook of U.S. Col - There are religious sensitivities that vary orants: Foods, , , and Med - ical Devices . New York: Wiley, 1991. Print by region. For example, alcohol ingredi - ents can be problematic for kosher and McAvoy, Sue Ann. Color Regulations: Chal - lenges in the Global Regulatory Environ - halal products. Some animal ingredients ment. Color Quality of Fresh and Processed can be problematic for kosher and halal, Foods. N.p.: American Chemical Society 983:505-14, 2008. Print. June 13, 2008. and items from animals are an issue for Milestones in Food and Drug Law History. vegetarian products. n About FDA. N.p., n.d. Web. 9 Nov. 2010. http://www.fda.gov/aboutFDA/whatwedo/His tory/milestones/ucm081229.htm REFERENCES Pack, MM. Coloring, Food. Encyclopedia of Australia http://www.foodstandards.gov.au/ Pages/ Food and Culture . 2003. Encyclopedia.com . 9 default.aspx Feb 2014. http://www.encyclopedia.com Burrows, Adam, JD. Palette of Our Palates: A Brief History of Food Coloring and Its Reg - Questions and Answers About Acceptable ulation. Comprehensive Reviews in Food Daily Intake. IFIC . N.p., Aug. 1996. Web. 26 Science and Food Safety 8: 394-408, 2009. May 2014. http://ific.org/publications/qa/adiqa. cfm Canada http://www.hc-sc.gc.ca/fn-an/securit/ addit/list/3-colour-color-eng.php Science Matters. Prime Minister’s speech to the Royal Society. ePolitix, 23 May 2002. Canivet, Nicolas. Food Safety Certi- fication. FAO Food Certification. White Junod, Suzanne, PhD. Colors and Cos - FAO/WHO, June-July 2005. Web 21 Mar metics at The Centennial. Food and Drug Law Institute May/June Pp 43-50, 2006. 2006. ftp://ftp.fao. org/ag/agn/food/certifi cation_programmes.pdf Wijesiri, Lionel. Read my lips. Sunday Observer CFR - Code of Federal Regulations Title 21. Sunday April 10, 2005. http://www. sunday observer.lk/2005/04/10/mag03. html N.p., n.d. http://www.accessdata.fda.gov/ scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm DG Sanco https://webgate.ec.europa.eu/ sanco_ foods/main/?event=display EU https://webgate.ec.europa.eu/sanco_foods/main /?event=display EU http://ec.europa.eu/food/food/fAEF/additives/ lists_authorised_fA_en.htm Presented at the PMCA Production Conference

86 September 2014 • The Manufacturing Confectioner