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Global Regulations of Food Colors Each Region Has Its Own Definitions of What Constitutes a Color Additive, with Related Use Requirements and Restrictions

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Global Regulations of Food Colors Each Region Has Its Own Definitions of What Constitutes a Color Additive, with Related Use Requirements and Restrictions Global Regulations of Food Colors Each region has its own definitions of what constitutes a color 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 flavor and sonous and were often incorporated to hide assess quality of food. poor quality, add bulk to foods 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 yellow with saffron, and the mittee of the National Confectioners’ Asso - ancient Mayans used annatto to color their ciation published an official circular which Sue Ann McAvoy is food orange-red. Wealthy Romans ate bread was “to throw light 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, flavors, 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 Drug Act was passed butter. This was one of the early laws against by Congress. This act banned the addition of intentional adulteration of food. “poisonous” colors to confectionery 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 (Amaranth, Ponceau 3R, Orange I, Erythro - and year-round demand for a variety of sine, Naphthol Yellow S, Light Green SF Yel - foods caused a desire to establish a uniform lowish and Indigo 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 Codex Alimentarius 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 (acceptable daily intake) 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 Food Additive tain cocoa (05.2), chewing gum (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 Blue #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 mineral 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.
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