Impact of Color Regulations on a Global Beverage Company

Safe and Compliant Product - It is the obligation of the beverage company to ensure .... The next scenario discusses the regulatory issues created by ...
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Impact of Color Regulations on a Global Beverage Company Victor V. Margiotta and Nancy A. Higley Scientific and Regulatory Affairs Group, PepsiCo, Inc., Pepsi-Cola Company, 100 Stevens Avenue, Valhalla, NY 10595

Multinational companies continually seek that one "global" formula that would allow them to do business internationally while taking advantage of economies of scale. Country variability of the legality and specifications for color additives often necessitates the design of different product formulae for different markets, making the "global" formula elusive. The use of different coloring agents can dramatically impact a product's appearance, taste, stability, cost and consumer perception. Examples of how internationally marketed beverages are impacted by the variability of color regulations will be presented.

© 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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496 Color is usually the first characteristic noted in a food or beverage. Color often predetermines our expectations, as we use color to identify a food and to judge its quality. Studies have demonstrated that color affects our expectation of flavor and taste. For example, consumers expect that lemon flavored products should be yellow. Studies have also shown that color affects the observed sweetness level. A strongly red-colored strawberry flavored drink is perceived to be sweeter than a less strongly colored version. Color gives a perception of safety, as the color intensity and hue of a beverage often determines whether a consumer perceives the beverage to be spoiled or "off. In addition, synthetic colors tend to be perceived as less safe than colors sourced from natural materials. Finally, there is cost. Natural colors are more costly than synthetic colors and may need to be used at higher concentrations to give the same color intensity and stability as synthetic colors. Food and beverage companies attempt to achieve economies of scale in production by manufacturing as few formulas as possible for all markets. To achieve this goal, the product must meet certain criteria: •

Safe and Compliant Product - It is the obligation of the beverage company to ensure that all products are safe and comply with regulations of the country in which they are sold



Meet Consumer Expectations - Consumers have both organoleptic and cost expectations as well as expectations of safety



Consistent Quality - To avoid consumer and safety complaints, the product must have a consistent and uniform appearance and flavor

To reach the goal of a single "global" formula, a beverage company must navigate through the various country regulations and specifications for color additives (7, 2). Through a series of scenarios, the effects of some regulations on product quality and the attainment of consumer expectations will be demonstrated.

Scenario 1: Ingredients of Biological Origin The first scenario discusses the issues related to seasonal and geographical variations of a product of biological origin. Geographical origin and climatic conditions result in seasonal variation of foods of biological origin, such as fruit juices. Color additives are often employed to supplement the colors already present and ensure product uniformity. In the example pictured in Figure 1, the

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

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497 regulatory challenge is to achieve uniformity of a 100% orange juice by either the addition of a highly colored juice, such as tangerine juice, or by the addition of beta-carotene to create a juice beverage that is acceptable to the consumer. Codex permits the addition of 5% tangerine juice to orange juice. Other countries, such as New Zealand, have food standards that permit the addition of up to 10% juice. In the New Zealand example, the addition of juice is specified to be mandarin or tangelo juice. Addition of any other juice or at higher concentrations would result in the product being labeled as a juice blend. In some regions, the juice that is to be added for uniformity is not available and it is desirable to add beta-carotene. However, in some countries, such as New Zealand, beta-carotene addition is not permitted. Additional complexity in adjusting juice color for seasonal uniformity is further noted in the various EU Countries: •

In all EU countries, including Russia and Turkey, tangerine juice addition is not allowed to normalize seasonal color variations.



Tangerine juice addition must be declared in the name of the product: e.g. orange and tangerine juice (+ QUID in the ingredient list in EU).

The same rule applies for beta-carotene when used as a food color because color additives are not allowed in fruit juice by EC legislation. However, betacarotene could be added as vitamin A. In this case, it must be declared and labeled as a fortified product and contain a minimum level of 15% RDA for vitamin A per 100 mL. Beta-carotene must be included in the ingredient list. Figure 1 shows a selection of orange juice samples. The first sample on the left is 100% orange juice from Brazilian concentrate. It has a slight greenish tint that could be adjusted to the target color with the addition of Mandarin orange juice. The second sample with added Mandarin orange juice has a deeper orange tone with the desired target color. The third sample shows the impact of beta-carotene addition, which also provides the desired effect. All these options can be used as long as the beverage formula complies with regulations in the country of sale. The fourth sample, 100% Mandarin orange juice, shows the consumer's preferred color for orange juice in some markets. Delivering against that expectation is a challenge while complying with the regulations.

Scenario 2:

Additives in Colors

The second scenario discusses challenges created by additives in food colors. Color ingredients often contain other additives that add to functionality. These additives are added to facilitate solubility, for encapsulation, and to

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

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Figure 1. From left: 100% orange juice; juice with 5% Mandarin juice; with beta-carotene; and 100% Mandarin juice. (Photographs by Cathy Culver) (See page 25 of color inserts.)

prevent caking. The regulatory challenges are that these additives may not be permitted, or may require identification on the product label. Figure 2 shows products made with different commercial preparations of beta-carotenes. Beta-carotenes are excellent examples of how color preparations are often manufactured with different functional additives, based on the target application and the manufacturers' preferences. These beverages show how the beta-carotene formulation results in differences in beverage color intensity, hue, and clarity. Beverage labeling is impacted when stabilizers or preservatives are used in beta-carotene emulsions. Fish gelatin is often used as a stabilizer, which could require disclosure on the finished beverage label due to its status as an allergen in certain countries, including the US.

Scenario 3: Meeting the Customer Requirements A third scenario discusses the challenges colors create in meeting customers' requirements in different global markets. Customers may require that

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

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Figure 2. Beverage base formulated with different commercially-available beta-carotene preparations. (Photographs by Cathy Culver) (See page 26 of color inserts.)

colors meet kosher, vegan, natural, or organic standards for their beverages. Others restrict the use of ingredients from genetically modified sources. The regulatory challenge is to meet these customer requirements and deliver product with the same color to all markets. Some vendors can supply organic or non-GM versions of existing colors. For example, non-GM caramel color may be purchased at a higher price, but the color hue may be different from the typically used caramel color. Cochineal is a natural color, but does not meet vegan or most kosher standards due to its insect origin, and may not be approved for use. For example, cochineal is not approved in China or India. Synthetic red colors provide limited choices for replacement. Allura Red (FD&C Red 40) use is not approved in Finland, Norway, Paraguay, Thailand, or India. Carmoisine is not approved in China, Croatia, Japan, Guatemala, Norway, Laos, Philippines, Taiwan, South Korea, or Venezuela. Figure 3 shows beverages prepared with different red colors, both synthetic and from natural sources. When used at similar concentrations, these colors give a range of shades, ranging from more orange with Allura Red and Ponceau 4R to

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

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a bluer shade from carmoisine and amaranth and a bright pink from cochineal. Once again, diversity in color additive regulations creates a challenge for product developers in formulating consistent products for a variety of markets.

Figure 3. Beverages prepared with artificial and natural red colors. (Photographs by Cathy Culver). (See page 26 of color inserts.)

Scenario 4: Meeting the Customer Requirements This scenario discusses meeting the requirements of customers in different countries that may have unique specifications for color additives. Some of the regulatory challenges are created by differences in specifications themselves, or by analytical methods cited in the specification. These differences have a significant business impact. For example, Korean specifications for Brilliant Blue requires the heavy metal content to be: •

Not more than 50 ppm as Cr, not more than 50 ppm as Mn, and not more than 20 ppm as Pb.

The JECFA heavy metal specification for Brilliant Blue does not include a Mn specification. The Korean specification is likely based on the need to

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

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501 control Μη in color manufacturing for a process that no longer exists. However, this difference means that in order to meet that country's requirements, we need to obtain a different supplier and inventory for product for the Korean market. Another challenge is when specifications are determined by different analytical test methods in a particular market. For example, Japan includes specification test methods that are often quite different from Food Chemicals Codex or JECFA (5, 4). The outcome of these requirements for the global beverage company is the need to maintain different inventories of color components for various countries that meet local specifications. Failure to source colors appropriately can lead to significant delay in obtaining customs clearances for beverage concentrates shipped into these countries from concentrate facilities that provide materials globally. This scenario can significantly impact economies of scale.

Scenario 5: End Use Restrictions To make a global product with the same color intensity is not a simple task when the given color may not be approved for use in all markets and, if approved, may have different restrictions on maximum permitted levels. Tartrazine provides an excellent example, with allowable levels such: •

GMP - US, Bahamas, South Africa, Singapore, Saudi Arabia



300 ppm max. - Philippines, Kenya, Canada



70 ppm max. - New Zealand, Thailand, Vietnam



50 ppm max. - Mexico, Columbia

These restrictions impede the ability to have a single product formula for all markets. The challenge to product developers is to find color systems that use broadly legal yellow colors at a generally permitted usage level. Figure 4 shows samples of beverages prepared with different levels of tartrazine (FD&C Yellow 5). The sample containing 300 ppm tartrazine has a very bright, almost fluorescent color, while the samples prepared with 100 ppm and 50 ppm are much paler. One could argue that it would make sense then to use the lowest common level of color additive that would be allowable in all markets. But what if the target color falls outside this range for a specific application? Product

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

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Figure 4. Beverages prepared with 300, 100, and 50 ppm tartrazine (FD&C Yellow #5; Photographs by Cathy Culver) (See page 27 of color inserts.)

developers face the challenge of delivering a consistent product with a desired color because of varying end use restrictions.

Scenario 6 Complex Colors

The next scenario discusses the regulatory issues created by using more than one color in a product, as not all of the colors may be permitted for use. For instance, purple blends contain both blue and red colors. Brilliant Blue (FD&C Blue 1) is permitted for use in most markets, but the situation for synthetic red colors is more complex: •

Ponceau Red - Allowed in UK, Russia, Italy at 50 ppm



Amaranth - Allowed at 50 ppm in Argentine, China (Australia at 30 ppm)



Carmoisine - Allowed at 50 ppm in Algeria, Belgium, Spain

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

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Allura Red - most places allowed at 100 ppm, but Australia & New Zealand at 70 pp, and Sudan at 50 ppm.

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Figure 5 shows the impact of using different red colors at similar concentrations in combination with Brilliant Blue to create a purple beverage. The beverage color ranges from reddish-brown (Allura Red and Ponceau 4R) to grape-like purples (carmoisine and amaranth) to a candy purple (cochineal). These beverages show the product development challenge faced when designing beverages with color blends for more than one country.

Figure 5. Beverages containing Brilliant Blue and: Allura Red, Ponceau 4R, carmoisine, amaranth, and cochineal (Photographs by Cathy Culver) (See page 27 of color inserts.)

Conclusions The scenarios presented in this paper discuss a few of the considerations that affect the design of a global beverage formula. These factors include potential requirements for compliance with natural, kosher, vegan, and organic standards, as well as those for the use of ingredients from genetically modified organisms. Colors may contain additives that are not permitted, are restricted in their use, or require specific labeling on finished products. Restrictions on color usage and usage levels add complexity to product development.

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

504 The food and beverage industry goal of creating "global" formulas that comply with color additive regulations and specifications in all markets remains elusive.

References

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Catalog of Food Colors; Color Committee; International Life Sciences Institute: Washington, DC, 1991 ; Volumes I, II & III. Food Additives; Flowerdew, D.W.; Leatherhead Food International, Leatherhead, SU, 2005; Volumes I & II. Food Chemicals Codex, 5 Edition; Committee on Food Chemicals Codex, Institute of Medicine of the National Academies; National Academies Press: Washington, DC; 2003. Japan's Specifications and Standards for Food Additives, 7 Edition; Japan Food Additives Association: Tokyo, 2000; pp 101-360. th

th

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