Color Regulations: Challenges in the Global Regulatory Environment

Chapter 33

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Color Regulations: Challenges in the Global Regulatory Environment Sue Ann McAvoy Sensient Food Colors, N.A., 2526 Baldwin Street, St. Louis, MO 63106

There are four major influences on international regulations in the areas of color additives: JECFA (FAO/WHO), EU European Commission, US FDA, and Japan FDA. JECFA and the EU employ a 'shared risk' philosophy, while the US and Japan employ a 'low (no) risk' philosophy. Among these four entities there are differences in purity requirements, nomenclature and usage levels. There are also requirements for certification or registration. The use of other additives/ ingredients in conjunction with color additives varies based on the additives permitted, standards of identity for the food product, and the carry-over principle of a country. In addition to additives, other system concerns, such as processing, packaging and shelf life can influence the use of color additives. There are labeling requirements for color additives and these vary among countries. There are regional bias for/against the use of color additives. There are other issues that have to be acknowledged, such as GMO's, Kosher, Halal, vegetarian and organic.

© 2008 American Chemical Society

Culver and Wrolstad; Color Quality of Fresh and Processed Foods ACS Symposium Series; American Chemical Society: Washington, DC, 2008.

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Why are there food regulations? •

Prevention of Food Adulteration

•

Food Safety and Food Security

•

Purity

•

Traceability

•

Informed Choice

•

Trade Barrier

Over 100 governmental regulatory bodies, international trade agreements, non governmental organizations and industrial trade organizations oversee food regulations.

Prevention of Food Adulteration and Food Safety and Food Security

Why are there color regulations? In 5000 BC, Egyptian women used henna to dye their hair and carmine to redden their lips (I). Color was used as an enhancement of physical beauty. In food, color could be used to enhance the physical appearance of the product. However, if it made the food to appear to be of better quality than it was, that was considered a deceitful practice. This is the broad definition of "adulteration." In Paris in 1396, an edict was issued that forbade the coloring of butter (2). This was one of the early laws against intentional adulteration of food.

US Regulations and the "Rest of the World" In 1958 Congress amended the Federal Food Drug and Cosmetic Act of 1938 to include a series of laws addressing food additives. In 1960, the Act was amended to cover color additives. The laws included a provision, known as the "Delaney Clause," which established that no food or color additive could be



507 deemed safe-or given FDA approval--if found to cause cancer in humans or animals (3). FDA's safety assessment of additives includes a review of toxicity data such as the results of controlled animal studies. Short- and long-term toxicity studies, as well as studies that examine possible reproductive, carcinogenic, mutagenic, and sensitization characteristics of the color additive are also gathered and reviewed. Based on these data points and various safety factors, FDA determines a safe exposure level for the food and color additive. FDA compares the safe exposure level to the amount likely to be consumed in food, taking into consideration the composition and properties of the substance and the proposed conditions for use. As absolute safety of any substance can never be proven, FDA must determine if the additive is safe under the proposed conditions of use, based on the best scientific knowledge available. With color additives, FDA also must determine their suitability for use. The Office of Food Additive Safety, formerly the Office of Premarket Approval, evaluates this information. As this is a rigorous and exhaustive process for additive evaluation, and because of the Delaney Clause, FDA additives are considered as having "No Risk" or "Minimal Risk" with consumption (4). Beginning in 1956, the Food and Agriculture Organization (FAO) of the United Nations and the World Health Organization (WHO) began collecting and evaluating scientific data on food additives and making recommendations of safe levels of use. The Codex Alimentarius Commission was created in 1963 by FAO and WHO to develop food standards, guidelines and related texts such as codes of practice under the Joint FAO/WHO Food Standards Programme. The task of establishing levels of use for additives and developing food standards has fallen to the Joint FAO/WHO Expert Committee on Food Additives (JECFA), which was established in 1955. Most of these standards are built on the ADI (Acceptable Daily Intake) for additives, including color additives. This ADI philosophy it to spread out the risk of cancer. This type of philosophy is a "Low Risk" or "Shared Risk" philosophy JECFA also has the responsibility for establishing specifications for the identity and purity of individual food additives. The work of JECFA feeds into the Codex Alimentarius. The General Standards on Food Additives will eventually establish usage limits, based on consumption patterns, for specific food product categories (5). The General Principle of Codex Alimentarius is to guide and promote the harmonization of food laws among countries and to adopt internationally agreed standards. This will lead to fewer barriers to trade and freer movement of food products among countries, which would be to the benefit of farmers and their families, and would also help to reduce hunger and poverty (6).


508 The "Low Risk" philosophy is the trend we see in new and revised regulations. This philosophy has been adopted by the European Commission (EC) of the European Union and by the Australia New Zealand Food Standards Code (FSANZ).


What is ADI and how is it applied? ADI is an estimate of the amount of a substance in food or drinking water, expressed on a body-weight basis, that can be ingested daily over a lifetime without appreciable risk (Table I). The ADI is listed in units of milligrams per kilogram of body weight. The standard human is considered to weigh 60 kilos (7). ADI is also referenced as the RTD, which is the Reference Toxicity Dose. The ADI is determined by chronic feeding studies on animals. The chronic feeding studies determine the NOEL or NOAEL (No Observed Effect Level or No Observed Adverse Effect Level). The NOEL is divided by 100 to obtain the ADI. The 100-fold safety factor is derived from a factor of 10 to change animal data to human conditions, and another 10 to account for human variability. The ADI is applied to acceptable daily intake by calculation. For example, 7.5 mg/kg/day is the daily intake for Tartrazine. 7.5 mg/kg/day χ 60 kg equals 450 mg per day of Tartrazine. This is considered the amount of the additive that can be consumed by the average human over a lifetime. Food consumption patterns are surveyed and a typical diet is determined. The ADI of the additive is then compared to this typical diet, and the levels are back calculated. This is the level that then gets applied to the food category. This level is expressed in regulations as "ppm" or "mg/kg".

Table I. ADI (Acceptable Daily Intake) for Common U S Colorants (6) Color

ADI (mg/kg)

FD&C Yellow No. 5 (Tartrazine)

0 to 7.5

FD&C Red No. 3 (Erythrosine)

1 to 0.1

FD&C Blue No. 1 (Brilliant Blue FCF)

Oto 12.5

FD&C Yellow No. 6 (Sunset Yellow)

0 to 2.5

FD&C Red No. 40 (Allura Red)

Oto 7

FD&C Blue No. 2 (Indigotine)

Oto 5

FD&C Green No. 3 (Fast Green FCF)

Oto 25


509 Purity and Traceability


What are the purity and traceability challenges for additives? JECFA has a set of purity specifications for additives as outlined in FAO 52/1 and 52/2 (6). The EU has their own set of purity specifications for the colors as outlined in EC Directive 95/45/EC (8). These two purity directives are fairly similar. However, there are a few differences in purity criteria based on nomenclature. In the EC Directive, Ε163 Anthocyanins include anthocyanin colors from all plant sources. INS 163, as listed in the JECFA purity criteria, only allows Blackcurrant Extract and Grape Skin Extract as anthocyanin pigments. The US FDA does not have a specification listed as Anthocyanin. However, they allow for fruit juices and vegetable juices, as well as Grape Skin Extract and Grape Color Extract, to be used as color sources (10). Many of the fruit and vegetable juices, as well as the grape products, contain anthocyanin pigments. In the area of synthetic colors, the US FDA purity requirements, as set forth in 21 CFR sections 70-82, test for many of the same requirements as those listed in the EC directive and the JECFA specifications. However, the US FDA tends to spell out subsidiary dyes and impurities. They also require batch certification of synthetic (petrochemical) based colors. The testing done on the batches for certification relates the batch of color back to the batch of color that was used in the initial toxicology testing. The extensive testing of the color ties back to the extensive toxicological testing the FDA required in order to access these colors suitability for use as "Low Risk" additives. The EC directive does have additional purity criteria that are not covered by the US FDA or JECFA. The two criteria they have added to all synthetic (petrochemical based) colors are "ether extracts" and "heavy metals". Other countries have established their own purity requirements. In many of the South East Asian countries, the amount of chlorides and sulfates as sodium salts in synthetic colors is much less than in the US or in JECFA regulations. The test methods used by different countries can vary, leading to variation in results. A few testing protocols call for spectrophometric determination of the percent pure dye. Other testing protocols may call for titration to determine the percent pure dye. The factors to calculate dye purity can also be different. One interesting variation in pure dye calculation is with Ponceau 4R (E 124 vs. INS 124) and relates to the assigned structure and the resulting molecular weight. In the EC purity directive, the molecular weight is reported as 604.48 (8). In the JECFA monograph, the molecular weight is reported as 631.51 (6). The JECFA monograph had an additional 1.5 H 0 in its structure. This accounts for a 5% variation in the calculation of the pure dye of this color. The pure dye minimum by JECFA is 85%, while the EC minimum pure dye is 80%. These types of 2



510 differences result in variations beyond what is common variation caused by sample preparation or instrumentation differences. The US and Canada require certification of synthetic colors by the labs at the respective government agencies. This color is checked against the purity requirements as set forth in the regulations. Certification allow for the color to be sold in that country for use in food (10, 14). In Japan and China, samples of color being imported are tested by the respective government lab (15). Upon passing, the color is allowed for importation. In other countries, including Vietnam, Russia and Thailand, registration or licensing of the color is required by the importer. Another challenge in international trade is the name associated with the color. In the US, D&C Yellow No. 10 has the common name of Quinoline Yellow (10). However, the ratio of the mono-sulfonic acid to the di-sulfonic acid is directly opposite of the ratio of dye in E104 Quinoline Yellow (10, 8). This different nomenclature can lead to the use of the incorrect purity of product in the manufacture of a product. An additional illustration of this is with US and Japanese names. US FD&C Yellow No. 5 is known as Food Yellow 4 in Japan. US FD&C Yellow No. 6 is known as Food Yellow 5 in Japan (15). This difference in nomenclature again can lead to the use of the incorrect product, especially when a formulation for a food product is transferred from one country to the other.

What Are the Challenges to Watch for? Food additives and processing aids are regulated by the various regulatory bodies. The four major influences on international regulations for food additives and processing aids are the same as the influences for color additives: JECFA (FAO/WHO), EU European Commission, US FDA, and Japan FDA. These regulatory bodies shape what can be used with colors to carry them into or incorporate them into a food product. Commonly, liquid systems are used to color food products. These liquids can be used to keep dust levels low for colors that are powdered, such as dyes; or the liquids may be the natural form of the color additive, as is the case in many fruit and vegetable juices. However, there are regulations as to what can go into these liquids as far as such items as carriers, preservatives, and acidulates (6, 10). These regulations are commonly called incidental additive regulations or carry-over regulations. What can be used with color is subject to these types of regulations. The food additives and processing aids have to meet certain purity criteria as outlined in the various government's regulations (12). While having to be listed in the appropriate regulation, they may also have to be labeled, especially when they are considered allergens (10). In many parts of the world, the additives and processing aids have to be free of Genetically Modified Organisms



511 (GMO's). Additional certifications may need to be made to assure the additive is freeofBSE/TSE. Many food-processing companies are international in their scope. In some cases, these companies want to produce one product and fill the region's or the world's requirements. Because some colors are not permitted for use in food products in the country in which they are produced, segregated production is required at the facility. Segregated production also requires segregated mix-off, as cross- contamination and traceability are paramount. There are often government guidance documents or policy documents on the handling of such circumstances (10. 15). Labeling requirements vary among countries. A global label of color declaration is not possible. In the US, certified colors have to be declared by their certified name (e.g. Blue 1). If exempt from certification, the color can be declared as "artificial color", "color added", or an equally informative term. The use of the term, "natural color", is not permitted unless the color is that of the product colored. For example, strawberry juice that colors strawberry ice cream can be declared as "natural color" (10). However, if beet juice is used to color the strawberry ice cream, that cannot be declared as "natural", as beets are not found in strawberries. In Canada, the term used is "colours" (14). In the EU, the color can be declared by the qualifier term "colour" and its respective "E" number; or it must be declared by the qualifier term "colour" and its "common name" in the language of the country where it is to be sold (13). Labeling of colors and their carriers have been impacted by allergen labeling requirements for incidental additives (10, 13, 14). In addition, the color may have to be declared if it is a potential allergen. Carmine and cochineal extract, which are the color additives obtained by an aqueous extraction of cochineal Dactylopius coccus costa (Coccus cacti L.)), contains a protein to which a small number of people who have been identified as having an IgEmediated allergic response. In 1994, the Center for Science and the Public Interest (CSPI) submitted a petition to FDA to require the listing of carmine on the label of food products. At that time, the FDA took no action. However, in 2006, the FDA has proposed that food products containing Carmine or Cochineal extract be labeled with their respective names on food labels, so consumers who have shown a reaction to the product can avoid the color and a potential allergenic response (18). The listing of "carmine color" or "cochineal extract color" is likely to go into effect in the US in 2007.

Informed Choice and Trade Barriers What are the informed choice issues and barriers to trade with additives? The requirement for compliance with religious dietary practices is one type of informed choice. The two largest religious dietary practices that are observed



512 in food manufacturing are "Kosher," which is the Jewish dietary restrictions, and "Halal", which is the Islamic dietary restrictions. In the US, there is no federal regulation on marking a product as Kosher. Laws governing Kosher marking are state or city laws (16). It is generally accepted that in order for a food product to carry a Kosher symbol, it must have been made under the supervision of a Rabbi. It is customary for the Rabbi or Rabbinical Service to inspect the facility on a regular basis and require Kosher certification of the ingredients used in the manufacturing of the food. Equipment used to manufacture the food, and processing guidelines may effect the Kosher certification of an ingredient, additive, or food product. If a product is qualified as Kosher, then the Rabbi or Rabbinical service usually issues a letter attesting to the status of the product and authorizes a mark to go onto the label. As with Kosher, there is no US federal regulation for making a product as Halal. In the US, the benefit of a Halal certification is at the consumer level. The consumer knows that if a product is Halal certified, they don't have to bother checking all the ingredients. They can purchase the product with the assurance it does not contain anything that is haram or doubtful (77). The general prohibitions for Halal are: • Swine/pork and its by-products • Animals improperly slaughtered or dead before slaughtering • Animals killed in the name of anyone other than ALLAH (God) • Alcohol and intoxicants • Blood and blood by-products • Foods contaminated with any of the above products Most color additives are considered Halal, as long as they do not contain one of the prohibited substances listed above. There are trade barriers and regional preferences that affect the use of color additives. Part per million (ppm) limits can limit the use of a color, and its use in a respective product. An example of regional preferences would be lists of prohibited additives that are set forth by Grocery Chains or by manufacturers. These prohibitions are not based on an illegal use of the color, but rather on a perceived or real consumer preference.

What colors are permitted worldwide? The question that is often asked is "what colors are permitted worldwide?" As shown in the examples in this article, there is no simple answer to that question. Color regulations are fluid and not easily "charted." The permitted colors for a country need to be checked in the local regulations. Any usage levels restrictions need to be calculated and checked against the regulations.


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Purity criteria for the color additive and any carriers need to be ascertained. The "best bets" are: • Most of the US approved color additives exempt from certification, the "natural" colors • FD&C Red 40 • FD&C Yellow 5 • FD&C Yellow 6 • FD&C Blue 1

References 1.

Wijesiri, L. Read my lips, Sunday Observer, Sunday April 10, 2005 http://www.sundayobserver.lk/2005/04/10/mag03.html (accessed Mar 12, 2007) 2. Marmion, D. M. Handbook of U.S. Colorants, 3 Ed.; John Wiley & Sons: New York, 1991; p 3. 3. Bren, L. FDA Consumer Magazine Animal Health and Consumer Protection January/February 2006, http://www.fda.gov/fdac/ features/2006/106_cvm.html (accessed Mar 12, 2007) 4. Di Novi, M. J.; Kuznesof, P. M. Estimating Exposure To Direct Food Additives And Chemical Contaminants in the Diet, http://www.cfsan. fda.gov/~dms/opa-cg8.html#sources (accessed Mar 12, 2007) 5. Codex Alimentarius Home Page. http://www.codexalimentarius. net/web/index_en.jsp (accessed Mar 12, 2007) 6. Understanding the Codex Alimentarius. ftp://ftp.fao.org/docrep/ fao/008/y7867e/y7867e00.pdf (accessed Mar 12, 2007) 7. Questions and Answers About Acceptable Daily Intake, August 1996, http://ific.org/publications/qa/adiqa.cfm (accessed Mar 12, 2007) 8. Commission Directive 95/45/EC of 26 July 1995 laying down specific purity criteria concerning colours for use in foodstuffs, as amended. 1995L0045 — EN — 10.05.2004 — 003.001 — 1 9. COMMISSION DIRECTIVE 2006/33/EC of 20 March 2006 amending Directive 95/45/EC as regards sunset yellow FCF (E 110) and titanium dioxide (E 171) http://eur-lex.europa.eu/LexUriServ/site/en/oj/2006/ 1_82/1_08220060321en00100013.pdf(accessed Mar 12, 2007) 10. Code of Federal Regulations - Title 21 - Food and Drugs http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm (accessed Mar 12, 2007) 11. Commission Directive 95/2/EC on food additives other than colours and sweeteners, as amended. http://eur-lex.europa.eu/LexUriServ/site/ en/oj/2004/1_113/1_1320040420en00190023.pdf (accessed Mar 12, 2007) rd



514 12. Commission Directive 96/77/EC laying down specific purity criteria on food additives other than colours and sweeteners, as amended. http://eurlex.europa.eu/LexUriServ/site/en/oj/2006/l_346/ l_34620061209en00150025.pdf(accessed Mar 12, 2007) 13. Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000on the approximation of the laws of the Member States relating to the labeling, presentation and advertising of foodstuffs, as amended http://eur-lex.europa.eu/LexUriServ/site/en/oj/2000/ 1_109/1_10920000506en00290042.pdf(accessed Mar 12, 2007) 14. Consolidation of the Food and Drugs Act and the Food and Drug Regulations, Part B, Foods, Division I. http://www.hc-sc.gc.ca/fnan/alt_formats/hpfb-dgpsa/pdf/legislation/e_b-text-l.pdf (accessed Mar 12, 2007) 15. The Japan Food Chemical Research Foundation http://www.ffcr.or.jp/zaidan/FFCRHOME.nsf/pages/eng. (accessed Mar 12, 2007) 16. Survey of State Statutes, re: Jewish Issues. http://www.jlaw.com/Statutes/state.html(accessed Mar 12, 2007) 17. Halal Certification Benefits, Islamic Food and Nutritional Council of America. http://www.ifanca.org/benefits/(accessed Mar 12, 2007) 18. Listing of Color Additives Exempt From Certification; Food, Drug, and Cosmetic Labeling: Cochineal Extract and Carmine Declaration, 71 Federal Register 4839, January 30, 2006. [Docket No. 1998P-0724, formerly 9 8 P 0724] http://www.cfsan.fda.gov/~lrd/fr060130.html (accessed Mar 12, 2007)


Color Regulations: Challenges in the Global Regulatory Environment

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