Before a substance may be added to a food, it must be shown to be safe and suitable based on its intended conditions of use. Most countries and regions have their own agency dedicated to reviewing the safety of substances added to food, also known as food ingredients and food additives. For example, the Food and Drug Administration (FDA) is tasked with determining the safety of food additives in the United States, while the European Food Safety Authority (EFSA) conducts safety reviews in Europe. After the safety of an ingredient is established, regulatory authorities establish requirements to ensure its continued safe use in food. Following is information on determining the safety of and regulating food ingredients, including food additives, globally.
JECFA and Codex Alimentarius
National authorities are responsible for establishing the safety of food additives and implementing regulations prescribing their safe use. For countries that don’t have the resources or infrastructure to develop their own safety evaluations and regulations, the Joint Food and Agriculture Organization (FAO) / World Health Organization (WHO) Food Standards Programme, known as the Codex Alimentarius, develops harmonized, voluntary, international food standards utilizing a transparent, science-based process to ensure food safety and quality, as well as fair trade.
Codex work is conducted primarily through a committee structure, and food additives are addressed through the Codex Committee on Food Additives (CCFA). The Joint FAO/WHO Expert Committee on Food Additives, abbreviated JECFA, is an international scientific body that evaluates and determines the safety of food additives prior to entering the Codex process. JECFA works in several key areas: risk assessment and safety evaluation of food additives, processing aids, flavorings, residues of veterinary drugs in animal products, contaminants, and natural toxins; exposure assessments; specifications and analytical methods; and development of general principles. JECFA holds meetings throughout the year to focus on specific work areas, and brings together experts from around the world to conduct its business.
With regard to food additives, JECFA reviews the safety of an additive or group of additives, and based on available safety data develops a specification, which includes such information as a description of the additive, its functional uses in food, identity and purity characteristics, and tests used to characterize the additive. A JECFA specification monograph is finalized and published for each additive or group of additives. Importantly, the monograph includes information about the additive’s “acceptable daily intake level” or ADI, which is the amount of the substance that can be ingested on a daily basis over the course of a lifetime and not result in an appreciable health risk. ADIs are calculated in milligrams per kilogram, body weight per day, and are extremely conservative to take into account sub-populations, including pregnant and lactating women, children, and the elderly.
In order for a food additive to be recognized within CCFA, it must be listed in the General Standard for Food Additives (GSFA). The GSFA establishes conditions under which additives may be used in foods, and notes those food categories and use levels for which food additives may be used. To be listed in the GSFA, an additive must have a JECFA specification monograph confirming its safety, as well as an INS number. The Codex International Numbering System (INS) is similar to the “E number” system in Europe, whereby each additive or group of additives is assigned a specific number for the purpose of identifying the additive globally on ingredient lists. To learn more about Codex and its many committees, click here.
U.S. Food Additive Safety and Regulation
In the United States, the primary food regulatory authority is the Food and Drug Administration (FDA), a sector of the U.S. Department of Health and Human Services. FDA is responsible for nearly all foods that are produced, marketed, sold, and consumed in the U.S., including food ingredients and food additives. The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) is responsible for ensuring the safety of meat, poultry, and egg products.
The Federal Food, Drug, and Cosmetic Act (FFDCA) provides FDA the authority to regulate the safety of food, drugs, medical devices, and cosmetics. Food additives are regulated under the Food Additives Amendment of 1958, which provides for two regulatory mechanisms by which substances may be added to food. They are the food additive petition process and the Generally Recognized as Safe (GRAS) process. FDA is tasked with evaluating and reviewing the safety of food additives and GRAS substances.
Food Additive Petition Process
Food additives follow a premarket review and approval process that involves the submission of a Food Additive Petition (FAP), along with the associated technical data package, for review by FDA subject matter experts. Contingent upon the conclusion by FDA that the proposed use and use levels of a substance do not present a safety concern, the review step is followed by an administrative procedural step whereby a new or amended food additive regulation is published in the Federal Register. This process includes one or more rounds of public review and comment, followed by codification of the final regulation in the Code of Federal Regulations (CFR). The technical data submitted can be privately held and is not required to be publicly available, although the FAP information (minus confidential business information) may be obtained through the Freedom of Information Act. The FFDCA provides FDA with 180 days to act on a FAP. However, the process has been known to take years to complete because the review clock is stopped when questions are asked of the petitioner and responses (which may include the generation of additional data) are developed.
Under sections 201(s) and 409 of the FFDCA, and FDA’s implementing regulations in 21 CFR 170.30, substances may be regarded as “generally recognized as safe” or GRAS and therefore exempt from FDA pre-market review and approval based on common knowledge and general acceptance among qualified scientific experts that the substance is safe under its intended conditions of use. The GRAS designation allows food manufacturers to classify an ingredient as GRAS for a specific use based on a long history of safe use in food or qualified review of publicly available scientific evidence by experts. The same quantity and quality of scientific evidence is needed to demonstrate a substance is GRAS as compared to an approved food additive. However, to receive a GRAS designation, the pivotal evidence demonstrating the safety of the ingredient must be publicly available. This is not the case for approved food additives.
The GRAS process provides benefits to consumers, the FDA, and manufacturers while ensuring the safety of our food supply. The process allows for continuous improvement and innovation in the food and beverage industry, which helps industry meet consumer demand and bring new products to market more quickly. The GRAS process also benefits the FDA by placing the majority of the burden on industry to demonstrate safety. GRAS may be preferred because it takes less time to market in a more efficient process that does not compromise.
As IFAC represents manufacturers and users of food ingredients, much of the work we do is to support regulatory and industry efforts to ensure a safe food supply. A product of such efforts is the IFAC GRAS Best Practices Guide, which serves as a resource to ingredient producers who wish to establish a GRAS position on a substance to be used in a food, as well as food and dietary supplement manufacturers in developing GRAS positions on ingredients to be used in their products.
FDA Food Safety Modernization Act
Historically, FDA approached food safety issues in a very reactive way, addressing outbreaks after they occurred. In 2011, the FDA Food Safety Modernization Act (FSMA) was enacted, which initiated a significant shift and moved to a more proactive approach in identifying potential hazards and implementing preventive measures to reduce the risks that such incidents will occur. FSMA also provided FDA with new enforcement authorities to foster compliance, respond to food safety incidents more effectively and quickly, optimize oversight and management of imported foods, and build partnerships with state and local authorities who will have significant compliance and enforcement responsibilities under the law. FDA recognizes the importance of partnering with the food industry to ensure a safe food supply, and has done an excellent job in communicating relevant FSMA provisions to stakeholders while seeking public feedback.
IFAC strongly supports all efforts to strengthen the safety of the food supply, including FSMA and other recently issued national food safety laws such as the Safe Foods For Canadians Act. However, IFAC also recognizes that many of these laws have been developed with finished food products versus food ingredients in mind. Therefore, IFAC has been an active participant in the development of FSMA to offer technical expertise in how the law and its implementation of regulations can best be applied to food ingredients. IFAC has also worked very hard in developing its “Quality Systems, Food Safety and Good Manufacturing Practices Guide for Food Additives and GRAS Substances,” also known as the IFAC GMP Guide. The IFAC GMP Guide provides workable guidelines to help food additive and GRAS substance suppliers comply with FSMA and related requirements. It is also useful for food manufacturers that use food additives and GRAS substances, as well as regulators who oversee food safety and quality.
Food Additive Safety and Regulation in Europe
The European Commission is responsible for policy and regulation related to ensuring the safety of food and food products in Europe. The General Food Law Regulation, mandated and overseen by the European Commission, is the foundation for food law in Europe – providing a comprehensive framework for the development of food and feed legislation at the European Union and national levels in Europe. The General Food Law sets out the principles, requirements, and procedures which direct decision making in regards to food and feed safety through all stages of production and distribution.
The European Food Safety Authority (EFSA) is the official agency tasked with conducting food additive safety reviews, providing independent scientific advice on topics related to food, and communicating to stakeholders regarding existing or potential risks in the food supply chain. Established in 2002 to replace the Scientific Committee for Food, EFSA is concerned with matters relevant to:
- Food and feed safety (like animal health and welfare)
- Plant protection
- Plant health & nutrition
- Safety within the food supply
- Safety of the food chain
Most of EFSA’s work is done at the request of the Commission, the European Parliament, and EU Member States. One of EFSA’s largest tasks has been to conduct the re-evaluation of all food additives that were authorized for use in food prior to 2009, which was mandated through EU legislation in 2008. See this video for more information on EFSA.
Food Additive Safety and Regulation in Canada
Health Canada is the department of the Canadian government responsible for overseeing Canadian health, including food regulatory, policies. The Food Directorate executes tasks such as the evaluation of food additives (and other food products) for their conditions of use, which then translates to Canadian mandates such as Food and Drug Regulations and Lists of Permitted Food Additives.
Most countries have their own national authorities which establish and enforce food regulations. Examples include: the National Health Commission of the People’s Republic of China, Japan’s Ministry of Health, Labour, and Welfare; Food Standards Australia New Zealand; and the Food Safety and Standards Authority of India. Depending on the country, food laws and regulation can be governed by territory or by federal governments. In Australia, for example, food standards found in the Food Standards Code (which are law) are enforced by States and Territories by their own interpretations of the law.