Statements

IFAC Statement on “Effect of Neighborhood Food Environment and Socioeconomic Status on Serum Phosphorus Level for Patients on Chronic Dialysis”

In November 2020, the study titled “Effect of Neighborhood Food Environment and Socioeconomic Status on Serum Phosphorus Level for Patients on Chronic Dialysis” was published in the Journal of the American Society of Nephrology. The authors reviewed data on patients receiving dialysis and the availability of food in their neighborhoods to determine whether greater access to “healthy” food affected on phosphorus levels in the patients. While it was surmised that patients living in geographical areas with more poverty, which the authors suggest have higher amounts of foods containing high levels of phosphorus and are, in their words, “unhealthy,” the authors found no link between phosphorus levels and neighborhood food availability or income. Based on findings that older patients had lower serum phosphorus levels than younger patients, and that patients who identify as Black or Hispanic had slightly lower phosphorus levels than white patients, the authors suggest phosphorus levels may be better managed through personalized diet plans and improved education regarding food labels. An accompanying article in Nephrology News & Issues contains a perspective on the study by Lisa Gutekunst, a renal dietitian, who noted there were no insights into specific foods being purchased or where patients bought food, and that the fact that stores sell “healthy” food does not mean they  contain lower levels of phosphorus or that patients purchase them.

While the above information seems to call into question the health aspects of phosphorus, research supported by the International Food Additives Council (IFAC) has found dietary phosphorus, including phosphate food additives, are not a concern for most people. Research led by Dr. Victor Fulgoni explored the National Health and Nutrition Examination Survey (NHANES), a study which assesses the health and nutritional status of Americans, and intake of foods containing phosphorus. Dr. Fulgoni reviewed data collected from 1988 to 2016, specifically identifying intake levels of foods and beverages containing naturally occurring phosphorus as well as phosphorus that would be added through phosphate food additives. He found that the majority of phosphate intake in the U.S. diet comes from naturally occurring phosphorus, with the top three most common phosphorus-containing foods for adults (+19 years of age) being coffee, yeast breads, and cheese. Only about 12% of phosphorus intake came from added phosphates. These findings show that foods that generally contain higher levels of naturally occurring phosphorus are not necessarily unhealthy and that greater emphasis on the labeling of foods containing phosphate additives is unlikely to have a meaningful impact on phosphorus intake.

While those with chronic kidney disease (CKD) or end stage renal disease (ESRD) should be conscious of their phosphorus intake, the general population should not be concerned about their phosphate intake and potential health risks. The outcome of a 2017 review of 110 primary research articles on dietary phosphorus and human health found no conclusive evidence of phosphate consumption and negative health outcomes in the general population. Phosphate intake recommendations for the general population and those with CKD or ESRD is further explained by Dr. Taylor Wallace in a webinar conducted in March 2020. More information on the webinar can be found here.

For individuals looking to monitor their phosphorus intake, phosphate food additives are included on the ingredient list of all foods and beverages. Although companies are not required to disclose the amount of phosphorus on the Nutrition Facts panel, some volunteer this information and share the amount of phosphorus or other nutrients. Others list detailed product information on their websites if it is not on the label.

IFAC Position Statement on Allegations Around Dietary Emulsifiers and Health Impacts

Emulsifiers are common food ingredients that are used to enhance the flavor, texture, stability, and shelf-life of processed foods. Food emulsifiers range from common products like mustard and canola oil, to food additives such as lecithins, polysorbates, and carrageenan.

In recent years, researchers have published articles that call into question the potential impacts of dietary emulsifiers on gut inflammation and chronic disease. In response to these claims, the International Food Additives Council (IFAC) points to the overwhelming scientific evidence that supports the safety of these ingredients, which is summarized in a 2018 literature review by Vo et al., titled “Dietary Exposures to Common Emulsifiers and Their Impact on the Gut Microbiota: Is There a Cause for Concern?”.

For this review, the authors reviewed all published literature on dietary emulsifiers and human impacts. Despite claims to the contrary, Vo et al., found there is limited evidence indicating adverse effects of emulsifiers on the microbiome. The authors suggest that an established and agreed upon range of different microorganisms within the microbiome would help to provide a reference for future studies in the interpretation and clinical relevance of changes observed in response to various dietary components and ingredients. Given this, the researchers found that consumption of foods containing dietary emulsifiers do not pose any safety concerns and that their history of safe use is not brought into question by the existing scientific literature.

Studies linking animal models to human health outcomes have many limitations. There continues to be limited evidence indicating adverse effects of emulsifiers on the microbiome. More about what we do know can be found here.

Recent publications that have questioned the safety of dietary emulsifiers:

In October 2020, the publication “Dietary Emulsifiers Directly Impact Adherent-Invasive E. coli Gene Expression to Drive Chronic Intestinal Inflammation” by Viennois et al., suggested dietary emulsifiers disturb gut microbiota and promote chronic inflammation. In this study, mice were colonized with Crohn’s-disease-associated adherent-invasive E. coli (AIEC) and administered common emulsifiers carboxymethyl cellulose (CMC) or polysorbate-80 (P80). The authors conclude that dietary emulsifiers promote virulence and encroachment of pathobionts, providing a means by which these compounds may drive inflammation in hosts carrying such bacteria.

Upon further review, the authors note that the underlying prevalence of AIEC (a strain of E. coli known to be a factor in the development of Crohn’s Disease) in humans is not well understood, which calls into question the relevance of these findings to humans. Additionally, while the authors suggest that AIEC interacts with CMC, causing gut inflammation, they also note that the CMC levels used in this study are much higher than those consumed through the diet and incorrectly state that their would be similar in humans, who could have similar exposure over a long period of time compared to an acute exposure like the mice in this study.

Another study, published in November 2020 and titled, “Is sodium carboxymethyl cellulose (CMC) really completely innocent? It may be triggering obesity”, concluded the dietary emulsifier CMC can cause changes in the expression of some genes associated with obesity. Authors Baran et al., provided CMC through the food of zebrafish embryos by the microinjection method at different concentrations. The authors concluded that CMC does not cause a toxic effect in zebrafish embryos, but assert that their findings show that CMC can lead to important effects on lipid metabolism by causing changes in the expression of some genes associated with obesity.

IFAC notes that this study, having been conducted in zebrafish, is not relevant to human exposure and should not alter our use or understanding of the benefits of various emulsifiers that are used to improve food product texture, stability, and shelf life.

IFAC Statement on “Processing” Research on Ultra-Processed Foods & Chronic Disease

Nutrition is a comparatively new type of science. For example, the first vitamin was isolated and chemically defined in 1926 – less than 100 years ago! As nutrition science continuously evolves and research linking food to health outcomes increases, it’s natural to overreact to sweeping conclusions about not one food or nutrient, but many foods commonly consumed by most people. Recently, the media has been mentioning the phrase ‘ultra-processed foods’ – prompting another buzzword to add to your nutrition and health lingo.

Defining the term

By definition, a processed food is a food item that has had a series of mechanical or chemical operations performed on it, typically to change or preserve it. This can range from grinding meat and forming it into a burger patty to manufacturing tofu from soybeans. The term ‘ultra-processed’ was developed over ten years ago by researchers at the University of São Paulo, Brazil. The researchers defined the term as part of a proposed new classification of foods known as the NOVA classification, which categorizes foods according to the extent and purpose of food processing, rather than in terms of its nutritional composition. This is why, for example, breakfast cereals are included in the ultra-processed food category, even though they may contain whole grains or low-fat ingredients that could be a healthy choice in the diet. According to the NOVA system, ultra-processed foods are “…industrial formulations typically with five or more and usually many ingredients. Such ingredients often include those also used in processed foods, such as sugar, oils, fats, salt, anti-oxidants, stabilizers, and preservatives.” Further, ultra-processed foods are described as “convenient (durable, ready to eat, or heatable), hyper-palatable (extremely tasty), highly profitable (low cost ingredients), and designed to replace all other food groups with the aid of attractive packaging and intensive marketing.” While the term ‘ultra-processed’ may be popping up more in the media these days, this doesn’t indicate a new, extreme form of processing that consumers should avoid. In fact, ultra-processed foods may provide more benefits than you think.

What does nutrition research say?

In the spring of 2019, the British Medical Journal (BMJ) added fuel to the conversation around ultra-processed foods by publishing two observational studies, one of which linked consumption of ultra-processed foods to increased risk of cardiovascular disease (CVD), and another linking this food category to all-cause mortality. In the first study, researchers at the University of Paris monitored the diets of approximately 100,000 people twice a year for five years using the abovementioned NOVA classification system. The researchers then looked for associations between intake of ultra-processed food and risk of CVD, and found there was a 12% increase in the risk of CVD for every 10% increase in the amount of ultra-processed food consumed. 

In the second study, researchers from the University of Navarra in Spain assessed the diets of almost 20,000 people annually over the course of 15 years (i.e. 1999 to 2014) using the NOVA system. After taking into account other confounding variables such as age, body mass index (BMI), and smoking history, the researchers concluded that there was a 62% greater risk of death for participants eating more than four servings of ultra-processed food a day compared to those eating the least amount of ultra-processed food.

What does this research mean?

While the findings from these studies are strengthened due to the large sample sizes, it’s important to remember that observational study designs do not demonstrate cause and effect. Further, linking ultra-processed foods to CVD is a complicated assumption, especially when multiple factors, including family history and other lifestyle choices, can contribute to disease development. Both unprocessed and processed red meats, for example, are associated with greater risk of developing CVD and type 2 diabetes compared to poultry, fish, or vegetable protein sources. Additionally, the definition of ‘ultra-processed foods’ was not adequately-defined in these studies and is not well-defined by the healthcare community. For example, some define ‘ultra-processed foods’ as “ready to eat, snack foods,” which could include dried fruit that can be a healthy snack.

Putting it All Together

Of course, if we review the definition of ultra-processed foods, it’s not surprising that excess consumption of such foods would likely cause such negative health outcomes. However, processed food intake alone is not a strong enough variable to link to disease development, and the definition and subsequent intake recommendations should be clearer for consumers to understand. It’s absolutely true that certain processed foods should be consumed less often and in smaller portions than others. With that said, it’s important to recognize that not all processed or ultra-processed foods provide the same benefits and nutrients, an aspect not considered by the NOVA classification system. 

The greater body of nutrition research continues to emphasize the importance of a varied and balanced diet, of which processed foods are unavoidable and even often rich in nutrients. As there is no correlation between level of processing and the nutritional value of food, incorporating a rich variety of different foods in your diet is recommended. Such eating patterns are outlined by the Dietary Guidelines for Americans, which encourage intake of whole grains, fruits and vegetables, legumes, nuts, fish, poultry, and heart-healthy oil. Processed foods may include canned fruit, for example, that can be a healthy choice (when not packaged in syrup) and count toward a daily serving of fruit. Additionally, many processed foods are fortified with added fiber, vitamins, and minerals to support a healthy diet. Processed foods even include bread, which is often fortified with folic acid, a key nutrient to prevent birth defects. Fortified and processed foods not only aid in reaching the recommended daily values of key nutrients, but can also be formulated to reduce overall consumption of added sugars, fat, and sodium that, in excess, can contribute to the risk of chronic disease development.

Though new nutrition research and terminology is constantly the subject of media headlines, the widely-accepted and long-proven model for optimal nutrition remains the unsurprising, call it boring, truth – a balanced, varied, and colorful diet is the best way to ensure adequate intake of nutrients that support optimal health. No one is saying processed foods are not part of this equation.

IFAC Statement on the Role of Food Additives During COVID-19

The effects of the Novel Coronavirus (COVID-19) continue to present many global challenges. However, the International Food Additives Council wants to remind consumers that the safety and quality of the global food supply remains strong and that food additives continue to play an important role in maintaining the quality of foods in your pantry. Food additives help ensure food products remain shelf-stable, extend product shelf life, and allow consumers to stock up on food products without fear of immediate expiration. For more information on the different types of food ingredients and food additives, click here.

While there have been isolated reports of shortages of certain food products at retail, which are primarily due to transportation and restocking issues, it is important to note that COVID-19 has not made an impact on food safety. According to the U.S. Food and Drug Administration (FDA) and the European Food Safety Authority (EFSA), there is no evidence of COVID-19 transmission through food or food packaging, including imported goods such as food and drugs for animals and pets. There have also been no cases of COVID-19 in the U.S. associated with imported goods.

During this time, when consumers want to minimize their time in the store and may wish to stock up on food, packaged foods containing food additives are an excellent option. In addition to contributing to taste, texture, freshness, and appearance of food, food additives contribute to product stability and shelf life. Below are several important food additive classifications and how they contribute to product stability.

Preservatives

Preservatives help extend the life of foods and prevent spoilage. Preservatives also help foods maintain their appearance, taste, and texture. Preservatives are found in a variety of foods including jellies, cereals, oils, and baked goods.

Preservatives come in many forms. For example, sugar, salt, and vinegar are often used to delay the growth of bacteria in foods. Antioxidants help reduce oxidation in foods, increasing shelf life and preventing spoilage. And phosphates are used to help preserve processed meat and poultry products.

Emulsifiers, Stabilizers, and Thickeners

Emulsifiers, Stabilizers, and Thickeners are common food additives and help maintain the appearance of foods while preserving freshness and quality.

• Emulsifiers help to prevent oil and water mixtures from separating within a product and are found in a variety of foods, including margarine, ice cream, bread, chocolate, and some processed meats. Mono- and diglycerides of fatty acids are a common example of an emulsifier that disperses fat in foods to allow it to become more water-soluble. They can also help reduce food waste by keeping foods mixed.
• Stabilizers help ingredients stay dispersed and suspended in a product solution. Stabilizers are commonly used in beverages – such as fruit and vegetable juices – as well as liquid infant formula. Some common stabilizers include gellan gum and carrageenan.
• Thickeners enhance the texture of foods and can give low fat or reduced calorie foods the texture of full fat/calorie options. Xanthan gum is a common thickener and can even be purchased in grocery stores.

Firming Agents

Firming agents help foods maintain their crisp quality and strength. They are also commonly used to help prolong shelf life. Firming agents are used in a variety of foods including canned meats, pickles, fruits, and vegetables. Sodium citrate, also known as citric acid, is a common firming agent derived from citrus fruit.

IFAC statement regarding potential allergen labeling for food culture preparations in the United States

The International Food Additives Council (IFAC) is a global association representing manufacturers and users of food ingredients, including live microbial food ingredients. IFAC strives to promote science-based regulations, standards, and specifications for food ingredients and food additives worldwide. IFAC developed the following statement to provide clarification to manufacturers and users when considering potential United States allergen labeling requirements of food and probiotic cultures preparations used in final food products.

U.S. Food Allergen Labeling Laws and Regulations

The U.S. Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004 requires that eight major food allergens be labeled on product packaging. These are defined in section 403(w) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and include: milk, egg, fish (e.g., bass, flounder, or cod), crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans.

Food Ingredients

Food and food ingredient manufacturers must follow FALCPA requirements if a product contains protein derived from one of the eight major food allergens, with the exception of any highly refined oil derived from one of these allergens or any ingredient derived from such highly refined oil. The food source from which a major food allergen is derived must be labeled.

The U.S. Food and Drug Administration (FDA) provides guidance for industry on Food Allergen Labeling Exemption Petitions and Notifications and defines ingredients as substances that are “derived (e.g., through chemical, biochemical, mechanical, fermentation or bioengineering processes) from a major food allergen and that contain proteins or peptides.” If an allergen is used when manufacturing a food culture, and if the food culture preparation in its finished state does not contain the allergen, a petition to the FDA for labeling exemption must be filed and accepted as per 21 U.S.C. 343(w)(6) and (7).

Use of Substances Added to Food Cultures Preparations

Food cultures, including probiotics, are used as ingredients in the production of final foods including use in dietary supplements. Food cultures are produced by fermentation. After fermentation, food cultures are processed further. The final food culture preparation that is placed on the market may contain additives or other ingredients. These are added after fermentation and are necessary for survival, storage, and to facilitate the application of the food culture preparation in the food production process.

Equipment

In addition to food and dietary supplement labeling laws, the U.S. has food processing regulations as another measure of safety and prevention of cross-contact with food allergens during production. Pursuant to the U.S. Food Safety Modernization Act (FSMA),¹ manufacturers are required to sanitize equipment and surfaces to prevent food allergen cross-contact (21 CFR 117.35(d)). Additional requirements manufacturers must follow include but are not limited to: document hazards, including allergens (21 CFR 117.130(a)(2)); develop a preventive control plan (21 CFR 117.135(b)), and develop a written recall program (21 CFR 117.139(a)).

IFAC Position

If the food culture or probiotic product contains one of the 8 major allergens, then it must be labeled as per FALCPA. This applies to all raw materials introduced during the production that could result in allergenic properties. In order to be exempt from allergen labeling, a notification or petition to the FDA must be filed and accepted as per 21 U.S.C. 343(w)(6) and (7).

It is the responsibility of the manufacturer of the final food to ensure that these products are labeled and in compliance with U.S. food labeling laws and regulations mentioned above. In addition, it is the responsibility of food business operators (food culture or probiotic manufactures) that supply to manufacturers of final foods to ensure that those manufacturers are provided with sufficient information to enable them to meet their food allergen labeling obligations.

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¹ The U.S. Food Safety Modernization Act (FSMA), enacted in January 2011, fundamentally shifts the focus of food safety in the United States from responding to food safety incidents after they occur to preventing them from happening. FSMA applies to the safe production of all foods sold in the U.S., including agricultural products, raw materials, processed foods, food additives and Generally Recognized As Safe (GRAS) substances, and includes requirements for appropriate Quality Systems, Preventive Controls and Good Manufacturing Practices (GMPs) during product manufacture, transport and storage. These requirements appear in the U.S. Code of Federal Regulations at Title 21, Section 117 (21 CFR 117).

The European Food & Feed Cultures Association (EFFCA) also released a statement on the provision of information relating to allergenic substances which are present in food culture preparations. Click the button below to read more.

Read more from EFFCA here.

IFAC Statement on Coronavirus and Potential Implications on the Global Trade of Food Ingredients/Additives

On December 31, 2019, the first case of novel coronavirus (COVID-19) was reported in Wuhan, China. Since this time, COVID-19 has become of international concern, spreading to more than 25 countries, although the majority of cases remain in China.

Due to the widespread outbreak of the virus in China, there is a possibility the region’s food additives industry will be impacted. Food manufacturers may find that the supply of some ingredients, such as amino acids and certain vitamins, may be affected as a result. However, suppliers located outside of China report a ready supply to ensure minimal disruption to end users during this time.

Currently, COVID-19 has not made an impact on food safety in the U.S. According to the U.S. Food and Drug Administration (FDA), there is no evidence as to the association of COVID-19 transmission to food or food packaging, including imported goods such as food and drugs for animals and pets. There have also been no cases of COVID-19 in the U.S. associated with imported goods. As a result, FDA states there is no reason for concern.

Moving forward, the International Food Additives Council recommends food and food additive manufacturers keep up to date on COVID-19 and individually analyze its potential impact on ingredient supplies, seeking out alternative solutions where COVID-19 poses a potential risk. Following are additional resources from global health, scientific, and regulatory authorities.

• World Health Organization: Q&A on coronaviruses
• U.S. FDA: Coronavirus Update: FDA steps to ensure quality of foreign products
• U.S. Centers for Disease Control and Prevention: Q&A
• European Food Safety Authority: Coronavirus: no evidence that food is a source or transmission route
• European Centre for Disease Prevention and Control: Q&A on COVID-19
• BfR (Germany): Can the new type of coronavirus be transmitted via food and toys?
• Hong Kong Center for Food Safety: Advice on Prevention of Novel Coronavirus and FAQs
• Japan Ministry of Health, Labour and Welfare: Q&A about new coronavirus (in Japanese)
• Food Standards Australia New Zealand: Novel Coronavirus and Food Safety

IFAC Statement on Brexit

On June 23, 2016 the United Kingdom (UK) voted to leave the European Union (EU), a decision commonly referred to as “Brexit.” The UK was set to leave the EU on March 29, 2019; however, the withdrawal agreement received a series of rejections by the UK Parliament and Brexit has been delayed. The debate has been over whether to implement a “soft” Brexit, representing a close trading relationship and regulatory and legal alignment between the UK and the EU, or a “hard” Brexit, which would include no agreement over the future trade relationship and allow the UK to create independent trade deals with other countries.

The food industry is global, and most food and beverage companies import and export products to and from the EU. The same is true for food additive and food ingredient companies. While the general consensus within the food industry is that the UK will have to follow EU regulations regarding food additives, there is concern that the UK will not be able to inform the regulations the same way they did pre-Brexit. The UK would have the option to develop its own new regulations, which would help support the UK government’s autonomy; however, this could produce additional barriers for innovation and market entry. In the case of food additive manufacturers wanting to produce new additives or develop new uses for existing additives, they would likely need to apply for authorization both in the EU and the UK.

The International Food Additives Council (IFAC) is closely monitoring Brexit developments, the outcome of which may have widespread impacts on its member companies that operate and/or conduct trade in the UK and the EU. As a global association representing manufacturers and end-users of food additives, IFAC is particularly concerned about the potential implications of the various scenarios (e.g., deal, no deal, delayed exit) on the food industry. IFAC encourages that all parties align on the clear need for – and shared benefits of – limited trade disruptions between the EU and UK, and rules that support the continued growth and success of their respective markets. In addition, as IFAC strongly supports global harmonization of food additive standards and specifications to help cultivate a more responsible food environment and promote global trade, IFAC is hopeful that food regulations in the UK will not deviate far from the EU.

Below are several resources for companies concerned about Brexit’s impact on the food and beverage industry:

• The UK government has developed an online tool for preparing your business or organization for the UK leaving the EU.
• The European Commission has also issued a list of guidance notes and links which address issues of concern to the food industry, including trade, health and food safety, chemicals regulations, competition, and trademarks.
• For advice from the UK government on food label changes in a no deal Brexit, click here.
• The EU has published Guidance on labeling requirements titled “Notice to Stakeholders – Withdrawal of the United Kingdome and EU Food Law and EU Rules on Quality Schemes”
• For information on trading and labeling organic food in a no deal Brexit, click here.
• For rules around Bioengineered (BE) organisms (or “GMOs”) in a no deal Brexit, click here.
• The Information Commissioner’s Office (ICO) of the UK has published guidance for data protection if there is no Brexit deal. The ICO has also provided a checklist highlighting six steps to take to prepare for data protection compliance if the UK leaves the EU without a deal.

International Food Additives Council Releases New Guide for Industry Compliance with FDA Food Safety Modernization Act

The International Food Additives Council (IFAC) is pleased to release the anticipated revision of the IFAC Quality Systems, Food Safety and Good Manufacturing Practices Guide for Food Additives and GRAS Substances. The IFAC “GMP Guide” represents voluntary guidance, developed by IFAC members, and is intended to help suppliers and users of food additives and GRAS substances comply with the U.S. FDA Food Safety Modernization Act (FSMA), specifically Title 21, Part 117 of the Code of Federal Regulations (CFR).

The original IFAC GMP Guide was developed to address FSMA, which was enacted in 2011 under the Obama Administration and shifted the focus of food safety practices in the United States from reacting to food safety incidents after they occurred to proactively preventing them from happening. FSMA applies to all foods sold in the U.S., including processed and ready-to-eat foods, produce, food additives and GRAS substances, and animal food/feed. While FSMA signaled a paradigm shift in food safety management practices, its requirements for appropriate Quality Systems, Preventive Controls and Good Manufacturing Practices (GMPs) remain consistent with Current Good Manufacturing Practice (CGMP) requirements followed by industry that existed prior to FSMA under 21 CFR Part 110.  As a result of FSMA, FDA updated 21 CFR Part 110 and promulgated 21 CFR Part 117. To incorporate these new and updated regulations, IFAC revised its GMP Guide to incorporate both FSMA and 21 CFR Part 117 CGMP principles.

Recognizing that not all food manufacturing processes and facilities are alike or possess the same risk profiles, IFAC developed the GMP Guide to assist its industry partners in understanding and applying the Quality Systems, food safety principles, GMPs, and Quality Assurance Principles in accordance with FSMA, as well as preceding CGMP requirements. IFAC believes that this Guide fills a critical gap, providing a resource focused on the manufacture and use of food additives while taking into consideration the types of processes and facilities that are often very different than those used in the production of finished foods. The comprehensive 44-page guide, complete with a glossary of definitions explained by industry, has been aligned with 21 CFR Part 117, and thereby presents a mechanism for companies to apply current federal food safety requirements. The Guide translates these requirements to address areas that may be unique to food additives, and is meant to be easily applied and customized based on the manufacturing facility’s distinct attributes.

In addition, IFAC has updated its GMP Audit Guide, which reflects the IFAC GMP Guide and related FSMA principles. The Audit Guide may be used alone or in tandem with the GMP Guide to help firms prepare for FSMA inspections and facility audits. For companies seeking to gain additional safety certifications, the Audit Guide may also be used as an appropriate alternative to third party food safety standards which are often difficult to apply to food additive processes and facilities.

IFAC does not assert its Guides to be Federal Guidance Documents, nor does it claim that they bear legal or enforcement authority. Rather, the Guides represent what IFAC members* believe are best practices to comply with federal law and maximize safety. Therefore, in some cases IFAC provides recommendations which go beyond what is legally required by FSMA. IFAC’s recommendations are indicated by use of the word “should” throughout the Guide, whereas practices or activities required by U.S. law are indicated by “shall” or “must”. IFAC worked with its member companies and other industry stakeholders, representing a diverse range of expertise in the manufacture of food additives and GRAS substances, to ensure the Guide does not include false or misleading statements. The Guide can be found here.  

As a regulatory agency, FDA is responsible for regulating and enforcing the highest level of safety within the food supply. However, it is up to industry to comply with government requirements and meet consumer expectations for the highest level of safety and quality of the foods, beverages, and ingredients used and consumed every day. IFAC is proud to provide its GMP and Audit Guides and help industry fulfill its commitment to consumer expectations, thus reinforcing America’s trust in the food supply and assisting the broader food industry in consistently executing best practices.

*IFAC is a global association representing manufacturers of food ingredients, including food additives and GRAS substances. IFAC members include experienced personnel from food safety and quality teams of small, medium, and large companies that produce and use ingredients in foods, beverages, and dietary supplements.  Drawing on the expertise of its membership, IFAC strives for global harmonization of food ingredient standards and specifications.