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Robert R. Maronpot
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This issue of the Foods and Food Ingredients of Japan includes a special section of papers that focus on synthetic and natural food additive colorants with presentation of governmental regulatory procedures in the U.S., Europe and Japan in bringing food colorants to the marketplace. While the food colorant marketplace is still dominated by synthetic colorants, there is growing consumer appeal and commercial interest in developing natural colorants. Contemporary interest in natural colorants is also fostered by potential health benefits from some of these natural food additives. This collection of papers covers the history of regulations related to food colorants, the processes for introduction of new food colorants into the marketplace, safety assessment aspects necessary for ensuring consumer safety, and the challenges and research trends in introducing natural food colorants into commerce.

The importance of color in one’s first encounter with a food or beverage is a critical factor influencing selection of purchases in the supermarket, affects the perception of taste, and can ultimately drive the lucrative multibillion-dollar food colorant industry. The Maronpot et al., paper highlights the history of synthetic food colorants and the emergence of food colorants of natural origin while reminding the reader that synthetic colorants constitute the major source of food colorants in today’s commerce. A description of regulations pertinent to food colorants is summarized for the United States, Europe, and Japan and, while there are many commonalities, there are clearly differences in what is permitted in these different marketplaces and jurisdictions.

To introduce a new colorant into the U.S. marketplace, regardless of whether it is synthetic or is derived from natural sources, requires approval of a Color Additive Petition (CAP) by the U.S. Food and Drug Administration (FDA). There are also provisions for labeling provided by the FDA and it should be noted that it is not permissible to label a color additive as “natural”. Furthermore, unlike other food additives, food colorants cannot be classified as Generally Recognized as Safe (GRAS) in the U.S. Requirements to market a food colorant in the European Union (EU) are equally stringent and, like in the U.S., labeling a food colorant as “natural” in not permitted. Approval of a color additive for the EU marketplace occurs following an acceptable safety package evaluated by the European Food Safety Authority (EFSA) that then submits its recommendation to the European Commission. Not all countries in the EU necessarily coordinate their independent food additive safety rules such that not all food colorants are universally approved in all EU marketplaces. In Japan, food additives, including colorants, that have been in widespread use by Japanese consumers prior to 1995 are designated as “existing” food additives and are available in the Japanese marketplace, while in all subsequent years new synthetic as well as additives regarded as “natural” require comprehensive safety assessment prior to introduction into commerce. Japanese regulatory authorities also actively participate in efforts to globally harmonize food additive standards to protect human health. It is noteworthy that U.S., EU, and Japanese regulatory guidelines for food additive safety are largely consistent with guidelines and expert advice provide by FAO/WHO international scientific and regulatory advisory boards.

The paper by Dr. Rodriguez-Amaya focuses on natural food colorants and speaks to consumer and commercial interests in expanding the presence of natural colorants in the food additive marketplace. Current commercially available natural food colorants discussed in her paper primarily include the large group of carotenoids as well as anthocyanins, betanin, and chlorophylls, all originally of plant origin. Dr Rodriguez-Amaya’s paper describes chemical features, stability, and changes associated with effects of food processing and storage on these main colorants with briefer mention of other natural colorants.

Of special interest is a contemporary search for new sources of natural colorants, including microalgal production, especially of carotenoids. However, microalgal production of carotenoids, while promising, is not yet sufficiently developed to be cost effective on an industrial scale compared to chemical synthesis or extraction from plants. There is also ongoing research of processing methods to enhance stability of natural colorants. With regard to health-related effects associated with natural colorants, carotenoids have been reported to favorably modulate a broad range of cellular processes with health benefits. Dr. Rodriguez-Amaya’s paper highlights these health benefits and, in addition, provides important challenges related to color intensity, stability, and cost-effective production in bringing natural food colorants to the marketplace.

The paper by Dr. Hayashi identifies regulatory approaches followed in the U.S., EU, and Japan in ensuring the safety of food colorants for consumers by conducting extensive testing in animal surrogates. The degree of safety testing varies to reflect the anticipated extent of human exposure and is influenced by the chemical structure and properties of the colorant. In the U.S. it is based on levels of concern as defined by the FDA. There is a similar tiered approach to safety assessment for color additives by the EU. In Japan, safety assessment of new color additives requires a long list of animal studies, is influenced by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) evaluation of testing data, expected human exposure, and safety testing data from other countries. Safety assessment includes in vitro and in vivo testing for effects on cellular systems as well as in vivo testing using surrogate animals for toxicity, developmental effects, reproductive effects, and cancer. With ever increasing global marketing of foods and food additives, experts in toxicology and pathology are used to evaluate study results from these predictive testing models. All national and international jurisdictions currently use animals and cellular systems to ensure safety of food colorants for human consumption.

The paper by Dr. John Cox focuses on regulatory aspects of food colorant additives in the U.S., although there is clear mention that a need exists for international harmonizing, characterization and regulation of color additives. In the U.S. the two categories of color additives are FDA certified and exempt from certification. There are nine FDA certified color additives and a larger number of color additives exempt from certification. Dr. Cox points out that characterization and standardization of exempt colors derived from natural sources such as plants, minerals, and insects are not necessarily consistent. The AOAC International (originally founded as the Association of Official Agricultural Chemists), a non-profit organization of professionals headquartered in the U.S., assists in standardization of colors from natural sources.

Dr. Cox provides a detailed discussion of questions and concerns linking synthetic colorants and attention-deficit-hyperactivity-disorder (ADHD) in children. ADHD was first suggested in the what is referred to as the Southhampton study. There have been subsequent scientific assessments and recent comprehensive investigations and reviews by the FDA, EFSA, and JECFA expert panels. At the present time there is no convincing evidence of an association between consumption of synthetic food colorants and ADHD, but continued vigilance of this issue is warranted. The Cox paper points out the need for international harmonization of food additive regulations, including food colorants, as a priority in building regulatory coherence and indicates an advocacy role for the International Association of Color Manufacturers (IACM) in achieving this goal.

The paper by Dr. Nishijima covers two main themes: misrepresentation of food additive safety by misinformed journalists and the process for designation of a new food additive in Japan. Consumer anxiety that is fostered by inaccurate claims in popular publications was confirmed by questionnaires leading to an incorrect conclusion that food additives are inherently harmful to consumer health. It may be that this situation is a little more exaggerated in Japan versus elsewhere, although there is some general concern in other countries about the safety of synthetic food additives versus natural additives. This situation as it exists in Japan is based on selectively extracting specific parts of sentences from the scientific literature and reassembling them to incorrectly categorize food additives, including colorants, as inherently harmful. As is clearly described in the paper by Dr. Nishijima, the Food Safety Commission of Japan (FSC) and the Japanese Ministry of Health, Labour and Welfare (MHLW) rigorously assure the safety of all approved food additives in commerce in Japan. Further, of the 489 existing food additives first listed in Japan, subsequent re-evaluation has led the MHLW to remove over 130 of these existing food additives. Interestingly, the rational for their removal was not because of safety concerns but rather because the additives were no longer being used in commerce.

Dr. Nishijima points out that companies wishing to introduce new food additives or revise the use standards of already approved additives can take advantage of consulting support and advice from the Food Additive Designation Consultation Center. This organization, working in conjunction with MHLW, is ready to assist and expedite designation of food additives and has clearly defined requirements for approval of new food additives for the Japanese marketplace. The good news with regard to obtaining permission to market new food additives is that there are many applications. However, it takes approximately 2 years from the submission to the Minister of Health Labour, and Welfare till the promulgation. Furthermore, Japanese approval authorities are also paying close attention to international harmonization of food additive standards and take full advantage of credible scientific data originating from food safety authorities in other countries. The information provided in the paper by Dr. Nishijima represents a clear explanation to convey to the consumer public that approved food additives, including food colorants, in the Japanese marketplace are stringently investigated and monitored for safety.