SEPTEMBER 23, 2009
COUNCIL OF THE CONVENTION SECTION ON THE
QUALITY OF FOOD INGREDIENTS AND DIETARY SUPPLEMENTS
Most recent public concern and policy discussions about issues for food safety focus on surface (microbial) contamination, where substantial morbidity and mortality occurs in the United States (U.S.) each year. However, recent incidents of intentional adulteration of food with melamine have shown that harm arises not only from microbes, but from deliberately-added inappropriate substances as well. Within the U.S., the ability of regulatory bodies and food manufacturers to provide safe, high quality food to consumers is challenged by: 1) the increase in global trade, which places enormous competitive pressure on companies that, in turn, may put good quality and safe foods at risk; 2) supply chains that are longer, more complex, and international; and 3) fragmentation of the U.S. food regulatory framework, which is split among multiple agencies and levels with each frequently lacking sufficient resources. Further, if one looks at the value of all processed food sold globally—$3.2 trillion—the significance to global economies becomes obvious. This huge market is supported by a complex web of domestic and foreign food and food ingredient suppliers. Could the United States Pharmacopeial Convention (USP) help in some way? Does USP have an obligation to do what it can within its standards-setting role to protect U.S. citizens and people around the world from tainted foods and food ingredients?
In general, standards may be voluntary or mandatory and may originate from governmental and non-governmental sources. Conformity assessments to standards may be performed by first (manufacturer), second (purchaser), and third (individual independent of manufacturer and sellers) parties. As a standards-setting organization, USP has been recognized for publishing quality standards in the United States Pharmacopeia (USP), (for drugs and biologics) and the National Formulary (NF) (for excipients). Over time, dietary supplements were added to the USP and now these standards have also been published in a separate compendium for the dietary supplements industry, the USP Dietary Supplements Compendium. USP further expanded its standards-setting activities to food ingredients, and these standards are published in the Food Chemicals Codex (FCC). USP and NF are official U.S. compendia, recognized in the Federal Food, Drug, and Cosmetic Act (FDCA), and are thus mandatory in the U.S. for drugs (and for dietary supplements that are represented to be in compliance with official standards). As discussed further below, FCC is not named in the FDCA and thus, except for certain isolated and specific regulatory references to specific FCC monographs, compliance with FCC standards is voluntary in the U.S. In certain other countries, as also discussed below, compliance with FCC standards may be required.
This white paper is offered by the Council of the Convention Section on the Quality of Food Ingredients and Dietary Supplements to stimulate discussion on the role of a volunteer-driven, standards-setting body in generating sound food and food ingredient standards and assessing conformity to these and other standards. Although overlap and similarities in use, production, and regulatory framework exist between food ingredients and dietary supplements, this document focuses on food ingredients.
The concept of a safe food supply for the world is of vital importance to the entire global community. However, many different approaches to regulating food and food ingredient safety, including the use of standards, exist throughout the world. Some individual countries have been developing their own regulations and standards for foods over the years, while others are more recently establishing their own systems to provide a safe food supply for their country. In addition, the United Nations established a food standards program several decades ago primarily to promote the coordination of various food standards activities around the world, but also to provide food safety standards for any country wishing to adopt World Health Organization (WHO) standards as a basis for their own food safety program.
This document, while not comprehensive, provides information regarding the approach to food safety and regulations both from an international perspective and within several specific countries. The white paper also provides information for consideration of the future role of the USP and its compendium, FCC, in food ingredient standards and regulations.
1. CODEX ALIMENTARIUS
The rules of global trade are set by the World Trade Organization (WTO) , which defers to the Codex Alimentarius Commission (CAC) for questions regarding food safety and standards. Created in 1963 by the United Nations’ Food and Agriculture Organization (FAO) and the WHO, the CAC develops food standards, guidelines, and related texts, such as codes of practice under the Joint FAO/WHO Food Standards Program. The main purposes of the CAC are to protect consumer health, ensure fair food trade practices, and promote coordination of food standards activities undertaken by international governmental and non-governmental organizations. The general food standards adopted by the CAC are known as the Codex Alimentarius or food code. The CAC has established numerous committees to advance standards for consideration by the Commission. These include: 1) the Codex Committee on Food Additives (CCFA), 2) the Codex Committee on Contaminants in Foods (CCCF), 3) the Codex Committee on Methods of Analysis and Sampling (CCMAS), 4) the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU), and 5) the Joint FAO/WHO Expert Committee on Food Additives (JECFA). The importance of CAC standards has been strengthened through their incorporation into the Sanitary and Phytosanitary Measures (SPS) and the Technical Barriers to Trade (TBT) Agreements of the WTO. These agreements uphold Codex Alimentarius standards as one of the “international standards, guidelines or recommendations” necessary for protecting human health. CAC standards have been applied to settle disputes on global food trade. International Organization for Standardization (ISO) standards (see below) also are incorporated in the TBT agreement.
USP/FCC has applied for observer status in CAC, and is awaiting a decision on its application.
2. JOINT FAO/WHO EXPERT COMMITTEE ON FOOD ADDITIVES
The Joint FAO/WHO Expert Committee on Food Additives (JECFA) is an international scientific expert committee administered jointly by the FAO and the WHO. JECFA has evaluated more than 1500 food additives, approximately 40 contaminants and naturally-occurring toxicants, and the residues of approximately 90 veterinary drugs. The safety review of a food additive by JECFA is often time consuming, and the committee has a significant back-log of new ingredients to review. The following represents some of the work of JECFA and allied FAO and WHO groups.
1) Combined Compendium of Food Additive Specifications—four volumes based on JECFA decisions from the first to the 65th meetings (1956 to 2005); the fourth volume in the series provides procedures, similar to AOAC Official Methods of Analysis;
2) WHO Food Additive Series—monographs containing biological and toxicological data as well as exposure assessments with references;
3) WHO Technical Report Series—reports summarizing the conclusions of the Committee, with concise toxicological evaluations and exposure assessments;
4) A web site that provides general analytical procedures for colorants.
3. INTERNATIONAL ORGANIZATION FOR STANDARDIZATION
The International Organization for Standardization (ISO) is the world's largest developer and publisher of international standards. ISO publishes numerous standards regarding food analysis and composition and the most broadly recognized third party quality systems, ISO 22000:2005, “Food safety management systems -- Requirements for any organization in the food chain.” ISO standards are voluntary by nature, however, recognized by WTO under the TBT agreement, and, while not referenced in U.S. law, are often incorporated into national legislation in many countries.
4. GLOBAL FOOD SAFETY INITIATIVE
The Global Food Safety Initiative (GFSI), an industry association, established a very comprehensive third-party audit system that within the U.S. is jointly operated by the American National Standards Institute (ANSI) and the Grocery Manufacturers Association (GMA) under the name Safe Quality Foods (SQF). SQF has gained significant momentum in the last few years, mostly due to the fact that the world’s largest food retailer mandated SQF certification from most of its suppliers.
2. NATIONAL/REGIONAL APPROACHES
Selected national and regional approaches to food quality and safety standards and conformity assessment to these standards are briefly summarized below. In general, most countries distinguish between food additives that are the subject of premarket approval and food ingredients that are subject to other regulatory processes.
In Canada, food additives must comply with relevant specifications in regulations issued by Health Canada. If no such regulations exist, food additives must meet the specifications of the FCC 4th Edition “as amended from time to time.” The definition of “food additive” excludes spices, most vitamins, minerals, some amino acids, natural extracts, food packaging materials, and food ingredients. FCC occupies a supporting position in Canada as a source of information on the identity and specifications of food additives and related substances. Thus, when there is no official Canadian regulatory specification, a food additive manufacturer must comply with the specifications contained in the current edition of the FCC.
The Ministry of Health publishes food additive standards in “Health Standards for the Use of Food Additives.” China develops its food additive standards based on Codex Alimentarius, not FCC. Because of the recent devastating human and economic consequences resulting from the adulteration of toothpaste, pet food, and infant formula products made in China, the Chinese government is assigning increased importance to the issue of food safety. China is also consolidating its regulatory approaches for assuring food and food ingredient safety in the Bureau of Safety in the Ministry of Health.
On February 28, 2009, China enacted the Food Safety Law and Hygienic Standard for Uses of Additives in Food Containers and Packaging Materials of the People’s Republic of China, which became effective on June 1, 2009. The new law consolidates disparate food standards and regulations into one unified national standard. The new law strengthens monitoring and supervisory powers, toughens safety standards, mandates the recall of substandard products, and subjects offenders to severe sanctions. The law also includes provisions for third party testing and encourages importers to follow standards that are more strict than the national standards developed by the Ministry of Health. It is too soon to know what impact the new law will have in addressing the Chinese government’s concerns and in providing assurances of food safety to the global community.
3. EUROPEAN UNION
The European Union (EU) food safety policy is based on a comprehensive and integrated approach mandating traceability through all sectors of the food chain from “farm to fork,” i.e. feed production, primary agricultural and livestock production, food processing, storage, transportation, and retail sale. This approach is also built partly on the principles of Hazard Analysis and Critical Control Point (HACCP), a risk-based prevention and verification model. While food manufacturers and operators are primarily responsible for compliance with EU food and food additive standards, competent authorities appointed by the EU in Member States are responsible for monitoring compliance with the standards.
The EU food safety approach is considered to be one of the more comprehensive approaches practiced by food importing nations. The food additives standards are primarily based on those set by the CAC but may be more stringent. Although the EU officially does not recognize FCC standards, some European Commission agencies, such as the European Food Safety Authority (EFSA), are aware of FCC and refer to FCC standards when setting their own guidelines on new food additives and flavorings.
The EU has mandatory food and food additive standards that apply to domestic and international parties, who grow, manufacture, distribute, and market food products in the EU. The standards are mentioned in various regulations of the European Parliament and Council and directives of the European Commission. All EU Member States are required to follow these standards. The Member States can formulate national laws and standards on food ingredients within the broader framework of the standards and guidelines outlined in the various EU laws.
In India, several laws deal with food safety. The most important of these laws is the Prevention of Food Adulteration Act, which provides a list of food standards. The other significant piece of food safety legislation is the Food Safety and Standards Act of 2006 which establishes the Food Safety and Standards Authority of India, the primary standard-setting body for food and food additives . This Indian authority is the counterpart of the U.S. Food and Drug Administration (FDA) for foods.
Although India’s Prevention of Food Adulteration Act requires Indian food ingredient standards to be based on international standards, it does not specify or define which international food ingredient standards should be used. Therefore, FCC could be used as a resource for developing quality specifications. However, the Ministry of Health and Family Welfare (MHFW), which is in charge of setting food additive standards through its Notifications, requires these standards to be based on Codex Alimentarius.
In addition to the mandatory standards required by MHFW, the Government of India’s Department of Marketing and Inspection (DMI) formulates its own standards on food additives. Compliance with these standards is voluntary for manufacturers, suppliers, retailers, and importers of food ingredients. Those who comply with these standards, receive the Agmark certificate from the DMI, providing a grade for agricultural and related products. The products are tested for compliance with national standards and to discern whether they are adulterated.
5. UNITED STATES: GOVERNMENT
Congress/Food, Drug, and Cosmetic Act
In the U.S., the controlling law for much of the food supply is the Federal Food, Drug and Cosmetic Act (FDCA). Under the FDCA, which applies to food in interstate commerce, “a food shall be deemed to be adulterated if it bears or contains any added poisonous or added deleterious substance …that is unsafe” or “if it is otherwise unfit for food.” The FDCA defines a “food additive” as “…any substance, the intended use of which results or may be expected to result, directly or indirectly, in it becoming a component or otherwise affecting the characteristic of any food …if such substance is not generally recognized among experts qualified by scientific training and experience…to be safe under the conditions of intended use.” The 1958 Food Additives Amendment requires a strict premarket approval regimen and safety standard. Prior to marketing, new food additives are presumed to be unsafe for their intended uses unless and until they are proven “safe” on the basis of scientific data and information. Safe is defined as “reasonable certainty of no harm.” The petitioner bears the burden of proof of safety and must present to the FDA all safety data concerning the proposed uses of the food additive. These data are reviewed by FDA scientists who independently determine if the data support the safe use of the additive.
Congress is currently in the process of amending the FDCA in an attempt to enhance the safety of the U.S. food supply for consumers, provide industry with clear regulatory direction, and develop a funding plan. Congress is keenly aware that the U.S. food economy is dependent on the sourcing of food and food ingredients beyond U.S. borders. Unfortunately, this may mean an elevated safety risk to the U.S. as some food ingredient suppliers are located in countries that practice little or no regulatory oversight, enforcement, or sanitary control over their respective food economies. In addition, the specter of intentional adulteration for economic gain is a constant concern in the global food economy. There is growing recognition that additional regulatory oversight in the U.S. is required to adequately protect the food supply. The FCC, discussed more fully below, is believed by some to merit consideration as part of the solution sought by Congress, by offering through its food ingredient standards a means by which food-related risks could be reduced.
Food and Drug Administration
The FDA is the federal agency tasked with implementing the statutory provisions set forth by Congress in the FDCA. The FDA protects the public health principally by screening out unsafe or otherwise inadequate products in pre-market review, and by establishing, on the basis of scientific knowledge, general regulatory requirements for the design, manufacture, testing, labeling, and in limited circumstances, advertising of marketed products. The FDA promulgates the Code of Federal Regulations (CFR) containing the rules applicable to food manufacturers, distributors, packagers, and suppliers in the U.S.
Specific provisions of the CFR incorporate, by reference, certain individual FCC standards. These references require manufacturers of certain food ingredients to meet the specified FCC standards (typically for now-outdated editions) or be out of compliance. This is in contrast to the USP, where the general statutory recognition allows for standards to be updated and automatically requires compliance to the current standards. In general, FCC standards provide an informational, but not binding, resource of the identity and purity requirements of a majority of substances added to foods. These standards specify food grade material and are thus helpful to suppliers and manufacturers who otherwise would have to develop their own procedures and acceptance criteria.
Food and color additives in the U.S. require pre-market approval; other food ingredients must be Generally Recognized As Safe (GRAS) for their intended use. The FDA may publish or incorporate by reference specifications for food and color additives, which may subsequently be published in the FCC.
Unique to the U.S. system is the GRAS concept, which, in essence, is a legal classification of substances added directly or indirectly to food and judged by experts whose “scientific training and experience” (see above) and their examination of the relevant information lead them to conclude that the article is generally safe for consumption at the levels proposed for its intended use. This concept of an expert GRAS review may be carried out under the aegis of the food ingredient producer or user or other interested party. According to 21 CFR 170.30(a), “General recognition of safety may be based only on the views of experts qualified by scientific training and experience to evaluate safety of substances directly or indirectly added to food.” According to 21 CFR 170.30(b), this general recognition of safety is: based upon scientific procedure; requires the same quantity and quality of evidence as for approval of a food additive; is ordinarily based upon published studies that may be corroborated with unpublished studies and information; and is based on common use in food prior to January 1, 1958. As stated in 21 CFR 170.30(c)(2), information on the history of use must be widely available in the country of use.
It is recommended, but not required, that findings of the GRAS review be submitted along with all relevant data to FDA—known as a “GRAS notification.” In response to the notification, the FDA may issue a letter stating that the agency has no questions concerning the notifier’s determination that a substance is GRAS. The legal status of a food ingredient that went through a GRAS review without the notification of the FDA is referred to as “self-affirmed” or “self-determined GRAS.” In these cases, the seller and buyer of the self-affirmed GRAS substance are relying solely on such determination without FDA’s knowledge or involvement that the article has been self-determined as GRAS. Additionally, while a new substance may be determined as GRAS for a particular use, GRAS is a common mechanism for expanding on existing uses of substances.
U.S.Department of Agriculture
Regulatory oversight of the U.S. food industry is split between the U.S. Department of Agriculture (USDA)—responsible for the regulation of meat, poultry, seafood, and grains —and the FDA —responsible for food safety and food defense and for setting standards for certain foods, food additives, packaging, labeling, good manufacturing practices, and GRAS substances, as described above. Jurisdiction over food matters that overlap these two agencies is handled through a Memorandum of Understanding (MOU) that dictates the roles and responsibilities of each agency. For example, the owner of a meat processing plant is required to have a USDA inspector on-site whose job is to assure that the meat is safe for consumption pursuant to the Federal Meat Inspection Act. An FDA inspector can also inspect the plant to determine whether any unsanitary conditions exist in or outside the plant that could cause the meat to be contaminated, adulterated, or unfit for human consumption before, during, or after processing. The jurisdiction of the USDA extends to the actual meat being processed while the FDA exercises jurisdiction over the plant, processing area, and employees to ensure that good manufacturing practices are being followed. The continuing overlap of jurisdiction between USDA and FDA, and the resulting regulatory confusion in the eyes of some, has revived proposed legislation in Congress to create a single food agency with authority over all food activity in the U.S.
Every state in the U.S. has enacted a food and drug law, and local authorities conduct the bulk of compliance inspections and enforcement of food facilities in the U.S. The FDA partners with the states through MOUs that prescribe specific regulatory targets and goals for each state and, in return, the states receive federal funding to bolster their food safety programs. The FDA also trains state inspectors and monitors the states’ regulatory compliance and enforcement activities. The FDA can exercise its preemption authority and supersede a state’s authority to regulate food facilities when state food requirements are in conflict with the FDCA.
UNITED STATES: NON-GOVERNMENT
1. UNITED STATES PHARMACOPEIAL CONVENTION
FCC began in 1961 following passage of the 1958 Food Additive Amendments to the FDCA. Volunteer experts of the Committee on the Food Chemicals Codex of the Institute of Medicine’s (IOM) Food and Nutrition Board developed and maintained FCC through the 5th edition. In August 2006, the United States Pharmacopeial Convention’s (USP) Board of Trustees purchased FCC from IOM. FCC standards are now the responsibility of the Food Ingredients Expert Committee of USP’s Council of Experts. USP published the 6th Edition of FCC in February 2008 and the first Supplement to this edition in February 2009. The second supplement was published in August 2009. Public comments to draft FCC standards are invited through a freely available web-based publication, the FCC Forum (www.usp.org/FCC).
More than 1000 monographs are listed in the FCC and many more monographs are needed to cover ingredients and additives that are used globally for food production but not listed in the FCC. USP metrology routinely employs reference standards, but only approximately 15% of FCC monographs use reference standards. FCC contains mostly food ingredient standards to support the authentication of these ingredients and in-process testing; however, there seems to be some reluctance by the food industry for developing reference standards for FCC articles—in some cases for proprietary reasons. USP has no authority to compel manufacturers to provide either information to support FCC monographs or candidate reference materials.
To the extent that the goal of FCC is to create standards for all legally-marketed food ingredients, the U.S. GRAS process adds complexity to the effort. Food ingredients that have gone through the GRAS notification process, and received an FDA response indicating the agency found no objection to the GRAS determination, can readily be adapted for publication of a monograph for the article in the FCC as FDA makes a list of all GRAS notices available on its Web site. However, in most cases this needs the support of a sponsor as technical questions are common, and USP also seeks to establish physical reference standards together with any monograph. In instances where the FDA has not received or issued an opinion of concurrence with the self-GRAS determination, FCC will need to rely exclusively on the cooperation of a sponsor to establish a monograph. To reflect the different regulatory status, FCC implemented a process to publish such a monograph as a “Provisional Monograph.” FCC’s requirements for a provisional monograph are identical to other monographs, except for the lack of notice from FDA or other governmental authority that the item is authorized to be used in food. Therefore, FCC will only move those provisional monographs to normal monographs for which the sponsor forwards an official approval by FDA or another governmental authority to FCC.
2. AOAC INTERNATIONAL
AOAC International (AOAC) is an independent, not-for-profit association that publishes AOAC® Official Methods. These Official Methods are accepted and recognized by regulatory agencies and organizations worldwide. Some methods are specifically required in the enforcement of some state, provincial, municipal, and local laws and many national food standards worldwide.
In the U.S., AOAC “Official Methods of Analysis” have been defined as “official” by regulations promulgated for enforcement of the FDCA (21 CFR 2.19), recognized in Title 9 of the USDA-FSIS Code of Federal Regulations, and in some cases, by the U.S. Environmental Protection Agency. Furthermore, AOAC has held official observer status in Codex Alimentarius since its inception and a majority of the methods cited in the Codex standards originated from the AOAC “Official Methods of Analysis.”
However, the Official Methods do not establish quality criteria for the identity, purity, and quality of food ingredients and additives. AOAC does not supply any reference standards to accompany a detection method. Although AOAC operates proficiency programs, it does not supply reference standards to support their collaboratively-studied test methods.
Through the Council of Experts and staff, USP has shown considerable initiative in developing quality standards in USP (and the Dietary Supplements Compendium) and FCC that can be used by food additive producers and users and conformity assessment bodies. This work has been supported by the USP Convention and recognized as valuable to public health efforts. However, USP’s ability to expand the global relevance and recognition of the FCC relies on financial resources from the sale of the compendia and reference materials. This model for FCC is not yet robust, and to date the food industry has shown little interest in using reference materials in carrying out FCC assays. The absence of strong national regulatory recognition, on one hand, does not facilitate the FCC’s position globally; however, on the other hand, it provides the flexibility to incorporate food ingredients that are legal in foods in other parts of the world, making the FCC more relevant to the global food community.
USP relies on the voluntary donation of information and materials to support monograph and reference material generation. As a result, as with the USP–NF, FCC lacks a full complement of monographs, and many monographs currently in the FCC require updating to move the compendium towards modern metrology while maintaining useful older methods. USP might contribute more significantly to public health by expanding FCC’s text to include process standards and ancillary information— for example, general information on adulterants— that could be useful to the food industry while expanding the reach of quality standards geographically. Taken together, the opportunities for advancing food standards and conformity to FCC standards through actions of an independent standards-setting body appear to be strong. USP has taken the first steps toward creating a foundation for assuring the quality of food ingredients. The Council of the Convention Section on Quality of Food Ingredients and Dietary Supplements encourages further consideration of ways to amplify these initial efforts. Examples where progress could occur include:
1. REGULATORY FRAMEWORK FOR FOOD INGREDIENTS
FCC quality standards for food ingredients can provide a baseline for quality and a description of their identities, thus increasing food safety by making it easier to identify adulterated products. This will increase overall food safety and protect the consumer from qualitatively inferior and potentially dangerous products. In particular, USP might support the following:
- Updating /expanding reference to FCC specifications/monographs in the CFRs, which would strengthen existing regulations and improve domestic food safety by requiring that food ingredients meet acceptable quality levels;
- Supplying food ingredient reference standards to interested parties for procedures in FCC monographs to enable all stakeholders in the food supply chain to perform independent tests to ensure identity and quality against a certified authentic and “real” food ingredient;
- If there is sufficient interest, USP could work with all partners as feasible to offer food ingredient reference materials for FCC as well as JECFA specifications; and
- Serving as a resource that offers a full range of services, including monographs, reference materials, general chapters, and training courses and workshops, all of which support regulators, industry, and other stakeholders to increase food quality and better protect the consumer from the potential risks of harm caused by adulterated food.
2. GLOBAL FOOD TRADE
All efforts aimed at protecting public health must take into account complex international supply chains, thus making it critical to develop tools with an eye toward the impact on the international community.
- USP’s international presence facilitates the development of monographs relevant to different geographical regions, which in turn enhances the global relevance of the FCC.
- USP can facilitate food trade through collaborations with JECFA. Quality standards enable JECFA to perform an expedited safety evaluation while expending fewer resources.
- USP can extend its prominence as a resource to national (e.g., FDA, USDA) and international regulators, and the Codex Alimentarius, by increasing FCC recognition.
 The World Trade Organization (WTO) is the only global international organization dealing with the rules of trade between nations. The U.S. is represented by the Office of the United States Trade Representative. For further information, see www.wto.org and www.ustr.gov.
 The World Trade Organization (WTO) is the only global international organization dealing with the rules of trade between nations. The U.S. is represented by the Office of the United States Trade Representative. For further information, see www.wto.org and www.ustr.gov.
 China Legal Developments Bulletin, Volume 16, No. 2, April – June 2009, Baker & McKenzie (2009).
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 Agrmark (Unknown). Promotion of Standardization and Grading of Agricultural and Allied Produce, Retrieved from the Agmark website. URL: http://agmarknet.nic.in/agm_std1.htm
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