Statements

IFAC Statement on Nanotechnology

The International Food Additives Council (IFAC) is a global association representing manufacturers and users of food ingredients. IFAC is committed to ensuring the safety of its members’ products as well as communicating technical information about ingredients in foods.

A term that is sometimes linked to food is nanotechnology, and is often accompanied by words such as “nanoparticles” or just “nano”. Nanotechnology refers to the study and control of matter at an incredibly small scale, generally between 1 and 100 nanometers, and is not well understood by consumers. Although particle size is not commonly considered in the context of food, many foods, beverages and even water are naturally comprised of nanoscale particles. For example, milk is an emulsion of nanoscale fat droplets. While nanoscale particles have always been present in foods and beverages, food scientists have developed technologies to engineer nanomaterials in order to support improvements in the food and beverage industry. Nanotechnology has allowed for advancements such as more protective food packaging materials and increased availability of beneficial nutrients in foods.

As with any new technology, questions have been raised about the need to assess the potential impact of nanoparticles on health, safety and the environment. Global scientific and regulatory agencies are therefore reviewing information and data on nanotechnology and several guidance documents have already been published by the US Food and Drug Administration (FDA), the US Environmental Protection Agency (EPA) and the European Food Safety Authority (EFSA).

IFAC strongly believes that the safety of food ingredients depends on the specific substance in question, and should not be determined based solely on its particle size. In addition, industry’s innovative use of nanotechnology should not impact the credibility of safety assessments for ingredients already on the market, which have a significant history of safe use. To ensure transparency and prevent confusion among consumers and other audiences, it is important to distinguish products with a history of safe use from new ingredients or applications utilizing nanotechnology which have not undergone the same level of safety testing. IFAC believes that clearly defining nanotechnology for industry and consumers is a first step in doing so. Therefore, IFAC urges regulators and scientific communicators to clearly specify that nanotechnology refers to the human engineering of particles in order to create matter smaller than 100 nanometers. As the European Union (EU) describes in Article 3(2) of Regulation (EU) No 2015/2283, engineered nanomaterials are defined as “any intentionally produced material that has one or more dimensions of the order of 100 nm or less or that is composed of discrete functional parts, either internally or at the surface…” Nanotechnology should not be used interchangeably with nanoparticles or the generic term “nano,” which includes particles of nanoscale dimensions that occur naturally and/or are not necessarily produced through new forms of nanotechnology.  In addition, it is important that government labeling and industry sourcing policies serve to address newly engineered nanomaterials, so as not to proliferate irrational fear amongst consumers concerning the foods and beverages they have historically consumed.

IFAC strongly believes it is critical that all food ingredients and food contact materials undergo extensive safety testing prior to entering the food supply. IFAC supports the existing FDA regulatory framework for determining the safety of food additives, GRAS substances and food contact materials, as well as the European Commission’s food additive re-evaluation mandate. Such regulatory requirements ensure all foods and beverages on the market, including those manufactured using nanotechnology, are safe. In addition, while IFAC firmly supports clear, fact-based communications regarding nanotechnology, we also believe that the freedom to innovate through the use of advanced technologies is essential to respond to consumer demand, improve products and processes, and ultimately feed the growing global population.

The ability to innovate while continuing to comply with new and existing strict safety requirements is in line with the U.S. Food and Drug Administration’s (FDA) approach to be “adaptive and flexible and to take into consideration the specific characteristics and the effects of nanomaterials in the particular biological context of each product and its intended use.” Therefore, as innovative processes allow for the engineering of food ingredients and materials reduced to nanoscale, potential safety issues need to be assessed on a case by case basis. FDA has provided specific guidance to industry on the potential impact of significant manufacturing process changes involving nanotechnology on the safety and regulatory status of food substances.

IFAC believes it is the responsibility of both industry and regulators to develop responsible policies and guidance around the definition, labeling requirements, and industry use of nanotechnology. As with all novel ingredients, approvals and opinions intended to inform new standards or regulations should be based on the unbiased assessment of strong peer-reviewed research and stakeholder input.

 

IFAC Commends USDA for Upholding Organic Principles and Maintaining Carrageenan in Organic Food

On April 4, 2018 the US Department of Agriculture’s (USDA) Agricultural Marketing Service (AMS) announced carrageenan will continue to be allowed in organic foods and beverages, thus rejecting a recommendation by the National Organic Standards Board (NOSB) to remove the substance based on a claim it is not essential to organic production. This decision turns back a potentially precedent-setting proposal that would have permitted an advisory board to discontinue the use of a substance based on inaccurate information and was not in line with organic principles.

Carrageenan has been permitted in organic food production since 2003, and was relisted based on recommendations from the NOSB in 2007 and 2011. While NOSB members raised questions in recent years about carrageenan safety, its November 2016 vote to remove carrageenan was based not on safety concerns, but on a perceived lack of essentiality in organic production. This, despite clear and substantive examples provided by the organic food industry that removing carrageenan would have significant impacts on the organic market and result in products that are less nutritious, less appealing, and more expensive, and in some cases removal of some products from the market altogether.

The AMS decision to keep carrageenan in organic food is not only good news for formulators and consumers, it represents sound scientific policy and demonstrates USDA’s commitment to making organic decisions based on science and technical evidence rather than manipulative opinions and misperceptions. Carrageenan has long been an additive of interest, despite its history of use in foods and repeated positive safety determinations by regulatory authorities worldwide. Upholding the NOSB’s vote and removing carrageenan from organic foods based on flawed arguments would have set a bad precedent for reviews of future organic materials and could have led to a drastic reduction in the options organic formulators have to make innovative products that meet consumer expectations and continue to grow the organic market.

IFAC strongly supports USDA’s sound, science-based decision to keep carrageenan in organic foods and, by doing so, avoid setting a dangerous precedent of delisting additives based on a perceived lack of essentiality. IFAC and its members will continue to work with regulators and the food industry to provide accurate and high quality scientific evidence to support the use of ingredients in organic food.

About IFAC
The International Food Additives Council (IFAC) is a global association representing manufacturers of food ingredients. Founded in 1980, IFAC strives to promote science-based regulation and the global harmonization of food ingredient standards and specifications.

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IFAC Statement on European Commission’s Market Study on Date Marking and Other Information Provided on Food Labels and Food Waste Prevention

In February 2018, the European Commission (EC) released a study investigating the relationship between date marking on food labels and food waste. The overall objective of the study was to help inform the European Union (EU) of actions it can take to help mitigate food waste, which is substantial in the EU and globally. It took a closer look at how date labeling practices are used by food businesses and authorities, and how they are interpreted by consumers and potentially lead to food waste.

Researchers found that up to 10 percent of the 88 million tons of food waste generated by the EU annually is linked to date marking, presumably due to widespread confusion around how to interpret dates on food labels. Of avoidable food waste based on date labels, the study found that the top products wasted were yogurt (70 percent), eggs (59 percent), cooking sauces (59 percent), and cakes and desserts (28 percent).

Date marking practices were originally introduced by supermarkets to help ensure the freshness of foods and optimize stock control. Today, the intended audience has shifted to consumers, and, in accordance with European regulations[i], most packaged foods in the EU display a date and accompanying language to indicate whether the date represents a safety threshold (“use by”) or the point after which quality would likely be diminished (“best before”). However, there is flexibility in how a “best before” date is indicated depending on the length of the product’s shelf life.

The study found variations in how manufacturers made decisions to use certain language. For example, producers of products with longer shelf lives, such as ketchup, tended to use “best before” on the premise of “microbiological stability”, whereas manufacturers of foods with shorter shelf lives, such as dairy products, tended to employ “use by” dates based on food safety. In addition, the study notes that producers are influenced by common date marking practices used in national markets, and consumer preferences or expectations.

While manufacturers often rely on consumer preferences for date marking practices, there is significant evidence that many consumers fundamentally don’t understand how to interpret date marks. The study references a major survey previously commissioned by the EC which found that while a majority of EU consumers (58 percent) consider “use by” and “best before” dates when shopping and preparing meals, only 47 percent actually understand “best before” labelling and 40 percent understand “use by” labeling.  As a result, cautious consumer behavior due to a lack of understanding regarding the safety or quality of a product can lead to the disposal of products despite still being fit for consumption.

The study notes that a possible solution to reducing this problem is extending the product life of foods. While this can be done by revising existing expiration dates, shelf life can also be extended with ingredients, such as xanthan gum or sodium phosphate. For example, as shown in Table 4, extending product life by one extra day would save 16,000 tons (approximately 35,264,000 pounds) of bread annually.

Based on the study findings, the authors suggest food waste linked to date marking would be reduced if:

  • Date marks are present and legible, with clear meaning;
  • Consumers have a good understanding of date labelling (notably the distinction between “use by” – as an indicator of safety – and “best before” – as an indicator of quality);
  • “Use by” dates are used only where there is a safety-based rationale for doing so, consistent with the FIC Regulation;
  • The product life stated on the packaging is consistent with the findings of safety and quality tests; and/or
  • There is a level of consistency in storage of food at retail and guidance for consumers regarding the temperatures at which products should be stored in the home.

Misunderstandings regarding date labeling terminology and appropriate responses to date marks can lead to wasted food. Although this study is intended to inform actions of the EU, its findings and recommendations can be applied internationally to all consumers, retailers and manufacturers. The International Food Additives Council (IFAC) endorses the EU’s efforts to shed light on the global issue of food waste, and is committed to advocating for food practices and ingredients that can help the food manufacturing industry and consumers prevent it. IFAC supports continued cooperation and innovation amongst all those involved in the food supply chain in preventing food waste and its related impacts on human and environmental health.

Learn more about the types of food ingredients used to ensure the safety and sustainability of foods here.


[i] Official Journal of the European Union. (2011). Regulation (EU) No 1169/2011 on Food Information to Consumers. http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32011R1169&from=EN.

 

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IFAC Agrees with EFSA Re-Affirming Safety of Cellulose

A recent scientific opinion from the European Food Safety Authority (EFSA) on the re-evaluation of celluloses as food additives confirmed previous conclusions that celluloses are safe, and that there are no concerns or issues at reported-use levels.

Cellulose is a non-digestible carbohydrate that is naturally present in many plant foods. Cellulose is also used to thicken and stabilize a variety of prepared foods. Celluloses have been approved for use in foods and beverages for decades and have recently been re-examined as part of the European Commission’s broader re-evaluation mandate.

EFSA’s Panel on Food Additives and Nutrient Sources added to Food (ANS) conducted the re-evaluation on various forms of celluloses, which was last completed in 1989.  The ANS Panel evaluated the following forms of cellulose:

 Microcrystalline cellulose

  • Powdered cellulose
  • Methyl cellulose, ethyl cellulose
  • Hydroxypropyl cellulose
  • Hydroxypropyl methyl cellulose
  • Ethyl methyl cellulose
  • Sodium carboxy methyl cellulose
  • Enzymatically hydrolysed carboxy methyl cellulose
  • Cross-linked carboxy methyl cellulose

 Due to the similarities in structural, physicochemical and biological properties, the Panel was able to determine all celluloses are safe based on the data submitted. According to EFSA’s opinion, research that included animal and human data confirmed there are no safety concerns at the current levels being consumed through celluloses that are naturally present and those that are modified for use in food applications. Additionally, the Panel concluded there was no need to set an acceptable daily intake level or ADI for cellulose, given there is no safety concern with the reported uses and use levels in food.

IFAC fully supports the conclusion found by the EFSA Panel and hopes this evaluation will provide more clarity to food manufacturers and consumers who may be concerned with various celluloses found in their food. Celluloses provide naturally-sourced benefits in foods like ice cream, dressings, sauces, some types of bread and processed meats.

Learn more about the functions and benefits of cellulose and cellulose gum in foods here.


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Dietary Phosphorous – Health, Nutrition, and Regulatory Aspects: IFAC Response

In September 2017, the book Dietary Phosphorous – Health, Nutrition, and Regulatory Aspects was published by CRC Press. Authors Mona Calvo and Jaime Uribarri review dietary intake levels of phosphorus and discuss health endpoints associated with phosphorus consumption. The authors argue that current intakes of phosphorus are higher than human physiological requirements, and assert higher serum phosphorus concentrations are shown to be significantly associated with a higher incidence of morbidity and mortality in North America and Europe.

Phosphorus is an essential nutrient that is required for human health. Published dietary reference intakes for phosphorus include estimates of average requirements and recommended dietary allowances. However, not all authoritative bodies have provided tolerable upper intake levels for dietary phosphorus due to inadequate scientific evidence.

Phosphates are common food additives used to leaven cakes, cookies, pancakes, waffles, and donuts; to maintain the structure and hydration of meat, poultry, and seafood products; to improve fluidity of evaporated milk; flavor or add minerals to beverages; and to maintain the structure of canned fruit and vegetable products. Often there are no alternatives that can be used in the same small quantities to accomplish these functions in foods. In addition, some food-additive phosphates contain other minerals, such as calcium, potassium, and magnesium, which are consumed by some populations in quantities below what is recommended. Therefore, consumption of these phosphates help assist with intake of such nutrients.

In addition to reviewing intake levels, the book authors discuss health endpoints associated with phosphorous intake that go beyond physiologic requirements such as progression of chronic kidney disease (CKD), mineral bone disease and calcification of soft tissue, cardiovascular disease, mortality, anemia, and cancer (strictly in-vitro studies). The authors suggest phosphorus intake is associated with each of these conditions, and present different levels of evidence for each endpoint. While phosphorus intake has been associated with certain endpoints in specific sub-populations, including those predisposed to such conditions, in 2017 an extensive research review identified only two primary research publications that focused on data specific to a direct association between a food-additive phosphate and clinical outcomes in the general population. Otherwise, the investigator in the review found that any associations between phosphorus intake and health endpoints are inconclusive.

The outcome of the 2017 research review is consistent with the National Academy of Medicine as well as the European Food Safety Authority’s (EFSA) 2015 Scientific Opinion on dietary reference values for phosphorus, which stated “available data were not sufficient to establish a Tolerable Upper Intake Level (UL) for phosphorus.” Thus, future research on upper level intake is needed as the causality of any association between dietary phosphorous and clinical outcomes identified in studies could not be determined.

Difficulties in determining dietary phosphorus intake and, in particular, the intake of food-additive phosphate include: the inherent limitations of widely used dietary ascertainment methods, such as 24-hour dietary recalls and food frequency questionnaires (FFQs); likely inaccuracies in nutrient composition tables, as well as inherent difficulties in determining the quantity of phosphorus intake.

Though there is inadequate evidence currently available regarding dietary phosphorous intake, concerns related to health outcomes remain. Any policy or regulatory actions taken should be based in high quality evidence and align with recommendations made by authorities such as EFSA and the National Academy of Medicine.

 

IFAC Publishes White Paper on Dietary Phosphorus

WASHINGTON, DC (October 11, 2017) – A new publication from the International Food Additives Council (IFAC) summarizes scientific literature on the consumption of dietary phosphorus and phosphates in consumer foods and potential impacts on human health. It finds insufficient evidence to support claims that the consumption of phosphates in food causes negative effects in humans.

The publication, titled “Dietary Food-Additive Phosphate and Human Health Outcomes,” was prepared by Cato Research and appears in the September issue of Comprehensive Reviews in Food Science and Food Safety. Researchers reviewed 110 primary research articles spanning 20 years that studied relationships of dietary phosphorus and food-additive phosphate intake with potential impacts on human health. While a small number of these studies raised concern for high intakes of dietary phosphorous, other studies found potentially beneficial effects in humans. Based on the review, the researchers determined no firm conclusions can be drawn on the possible risks of food-additive phosphate consumption in the general population.

“As a leader in the food additives industry, we wanted to address claims that the consumption of phosphates could impact human health,” said Robert Rankin, IFAC executive director. “After careful consideration and research into the available scientific literature, it was determined that food phosphate consumption does not present a risk to the general population. Consumers should have no concerns about the presence of phosphates in their favorite foods.”

Dietary phosphorus, like calcium, benefits the growth, maintenance and repair of body tissues. Phosphates are formed from mined phosphate rock, which is refined and purified to isolate phosphorus and reacts with alkaline salts to produce purified phosphate salts. Food-grade phosphates must meet strict manufacturing and quality standards set by the U.S. Food and Drug Administration and other regulatory bodies around the world. Food-grade phosphates can be found in finished foods such as baked goods, meat, poultry, seafood products, beverages and dairy products.

To view the publication, click here.

About IFAC

The International Food Additives Council (IFAC) is a global association representing manufacturers of food ingredients. Founded in 1980, IFAC strives to promote science-based regulation and the global harmonization of food ingredient standards and specifications.

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Contact

Randy Spoon

678-303-3017

rspoon@kellencompany.com

 

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IFAC Statement on NOSB Decision to Remove Carrageenan from the National List

On November 17, 2016, the U.S. National Organic Standards Board (NOSB) members voted to remove carrageenan from the National List of Allowed and Prohibited Substances, a decision that, if implemented by the U.S. Department of Agriculture (USDA), will force many organic food producers to reformulate or consider taking products of the market entirely. The use of alternative ingredients, which do not possess the same functionality as carrageenan, may negatively impact the quality of many organic foods and beverages and may reduce organic options.

Throughout the NOSB meeting, public commenters representing carrageenan producers, organic food manufacturers, farmers and other interested parties presented evidence demonstrating carrageenan is a safe and essential organic food ingredient. Although the NOSB ultimately recommended that USDA remove carrageenan from organic foods, they were clear in their discussion that carrageenan is safe for consumption and that their decision was not based on safety concerns.

Carrageenan’s use in food is supported by decades of research and approvals by every food regulatory body in the world, including the U.S. Food and Drug Administration (FDA). Carrageenan is unmatched in its ability to bind protein and water to create desirable textures, prevent ingredient separation, reduce fat and extend shelf-life in meat and dairy products. It is also extremely important as a stabilizer in liquid infant formula, ensuring that critical nutrients remain in suspension and promoting optimal infant nutrition. Removal of carrageenan from organic foods and beverages will result in products that are less nutritious, less appealing, less enjoyable and more expensive.

The NOSB decision to remove carrageenan when there are no wholly organic alternatives sets a concerning precedent and raises questions about the weight of objective scientific research when applied to food ingredients. It also means that larger amounts or multiple non-organic ingredients will be needed to replace the small amounts of carrageenan. At a time when the organic industry wants to continue to grow and deliver more options to consumers, the removal of carrageenan will ultimately reduce the number of organic foods and beverages.

IFAC will continue provide accurate and high quality scientific evidence to support the safety and essentiality of carrageenan and other ingredients in organic food. We will also continue working with the U.S. Department of Agriculture and FDA to ensure that major food regulatory decisions are based on sound science.

About IFAC

The International Food Additives Council (IFAC) is a global association representing manufacturers of food ingredients. Founded in 1980, IFAC strives to promote science-based regulation and the global harmonization of food ingredient standards and specifications.

 

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IFAC Statement on U.S. Food and Drug Administration Final Rule Regarding Substances Generally Recognized as Safe

On August 17, 2016, the U.S. Food and Drug Administration (FDA) published a final rule regarding substances that are “generally recognized as safe” or GRAS. This rule formalizes the steps food manufacturers must take to ensure GRAS substances are safe for human consumption and reaffirms a process that has worked extremely well for many years. The FDA has created a number of resources to help stakeholders comply with the rule, including a frequently asked questions (FAQ) document that was updated in October 2016 to incorporate provisions of the final rule. A copy of the FAQ is available here while other FDA GRAS resources are available here.

The rule finalizes a 1997 proposed rule that replaced the GRAS affirmation process with the GRAS notification procedure, under which the industry has been operating for nearly 20 years. The final rule codifies many of the concepts found in the proposed rule and does not represent a major shift in FDA’s thinking or regulatory policies towards GRAS substances. In fact, the final rule mandates many of the common procedures that International Food Additives Council (IFAC) members were already conducting voluntarily under the proposed rule. As such, the final rule includes many useful clarifications and procedures that IFAC members strongly support. While it does not fundamentally alter the GRAS concept or create over burdensome requirements, it provides a clearer explanation of how general recognition of safety is demonstrated under the law, what is expected when a company makes a GRAS determination and what companies must do when submitting a GRAS notification to the Agency for review.

The GRAS concept, which is rooted in the 1958 Food Additives Amendment to the Food, Drug and Cosmetic Act, is intended to address ingredients that have a long history of use or where a general recognition of safety exists in the public domain. Over the last two decades, FDA’s proposed GRAS notification system has evolved and the quality and rigor of GRAS notifications have also generally improved. Most manufacturers that have submitted a GRAS notification under the proposed rule will not find much in the final rule that is new or that FDA has not previously communicated to submitters. However, as the final rule becomes effective on October 17, 2016, IFAC notes the following highlights and key differences between the proposed and final rules which are intended to help IFAC members and their customers navigate the requirements of the final rule:

  • The final rule defines the following terms (among others) which were not defined in the proposed rule: “GRAS,” “GRAS notice,” “notified substance,” “notifier,” “qualified expert” and “supplement.”
  • While the proposed rule suggested that GRAS notifiers could incorporate into a GRAS submission data and information previously submitted to the Agency, the final rule makes it expressly clear that such information can be incorporated.
  • FDA makes it clear in the final rule that the Agency would like GRAS submissions to be more uniform in format. As such, the final rule specifies that GRAS notifications must contain seven parts and lays out the information that is needed in each part.
  • To provide greater clarity regarding a notified substance, the Agency now requires that an “appropriately descriptive term” of the notified substance be submitted rather than the “common or usual name” (as was included in the proposed rule).
  • The final rule now includes a requirement that the notifier must identify any data or information in the notice that should be exempt from disclosure under the Freedom of Information Act (FOIA) (e.g., trade secret, commercial or financial information that is privileged or confidential).
  • To avoid incomplete submissions and ensure that all submissions accurately reflect all information about the substance, the final rule expressly requires that the notice be signed to certify that is complete, representative, and balanced. Balanced means it must include favorable and unfavorable information known to the notifier and pertinent to the evaluation of the safety and GRAS status of the use of the substance. While this was common practice under the proposed rule, it is now mandatory.
    • In regard to information that may not support GRAS status, the final rule requires that the submitter either: (1) Identify, discuss, and place in context, data and information that are, or may appear to be, inconsistent with the conclusion of GRAS status; or (2) state that the notifier has reviewed the available data and information and is not aware of any data and information that are, or may appear to be, inconsistent with the conclusion of GRAS status.
    • This implies that the submitter must be thorough in his or her review of the body of literature and include reference to any information that could be relevant to the determination in the notification.
  • The final rule also explicitly states that source information including applicable data and information at the sub-species level (e.g., variety, strain) for a notified substance of natural biological origin be provided. This is in addition to genus and species information that was noted in the proposed rule. This reflects FDA’s current thinking on the issue and is consistent with other FDA documents such as the revised draft guidance on New Dietary Ingredient Notifications.
  • Greater clarity is provided in regard to what must be provided to describe the manufacturing method. FDA now requires a description of sufficient detail to evaluate the safety of the notified substance as manufactured; trade secret information may be included so long as it is clearly marked as confidential and not subject to FOIA disclosures.
  • The final rule expressly requires relevant information on the physical or other technical effect the notified substance is intended to produce when necessary to demonstrate safety, including the quantity of the notified substance required to produce such effect. This information was generally provided in notices under the proposed rule, but is now mandatory.
  • In order to help FDA calculate the impact on dietary exposure of the intended use of the substance, the final rule expressly requires the notifier to consider dietary exposure, regardless of whether the conclusion of GRAS status is through scientific procedures or through experience based on common use in food. The final rule also creates two distinct parts for dietary exposure:
    • Part 3, which addresses how much of the notified substance consumers would eat as part of the total diet (including exposure from its intended use and all sources in the diet), as well as how much consumers would eat of other substances (e.g., contaminants or byproducts); and
    • Part 6, which requires the submitted to address the safety of the notified substance, considering all dietary sources and taking into account any chemically or pharmacologically related substances in such diet.
  • While notifications under the proposed rule commonly included a “comprehensive discussion,” the final rule requires a narrative (Part 6 of a GRAS notice), and a list of supporting data and information (Part 7 of a GRAS notice). The narrative is intended to provide FDA with greater understanding of the basis on which the GRAS conclusion is being made.
  • In the narrative, FDA also requires an explanation of how there could be a basis for a conclusion of GRAS status if qualified experts generally do not have access to non-public, safety related data and information.
  • The final rule also provides greater clarity in regard to the review process itself. For example:
    • The final rule permits the notifier to submit a timely “amendment” to a GRAS notice before FDA makes a determination and allows the notifier to ask FDA to cease review.
    • It also states that FDA will conduct an initial evaluation of the submission to determine whether to file it as a GRAS notice for evaluation within 30 days as specified in the proposed rule. In the proposed rule FDA was only obligated to acknowledge receipt.
    • When a submission is filed as a GRAS notice, FDA is required to send a letter informing the notifier. If a submission is not filed, FDA will must inform the notifier and provide reasons for not filing the submission as a GRAS notice.
    • FDA is obligated to respond to the notifier within 180 days of filing (as opposed to 90 in the proposed rule) based on FDA’s evaluation of the notice. FDA may extend this response window by 90 days on an as needed basis. If extended FDA will inform the notifier “as soon as practicable” but no later than within 180 days of filing.
    • If FDA ceases review or responds to a submission, the notifier is entitled to submit a “supplement” to a GRAS notice addressing the FDA response.

IFAC and its member companies strongly supports this final rule and believes its requirements largely reflect industry best practices under the 1997 proposed rule. However, the final rule brings certainty and clarity about FDA’s expectations for GRAS determinations and notifications to the Agency. IFAC continues to be very supportive of GRAS, which represents the pinnacle of public and private sector collaboration, but also supports FDA’s continued efforts to strengthen the process. Further, IFAC welcomes forthcoming Agency guidance documents intended to clarify its interpretation of what it means for a substance to be GRAS and minimize conflicts of interest in GRAS expert panels. GRAS offers industry and FDA many benefits and shifts the resource burden of determining safety of some substances to industry while allowing FDA resources to be directed at activities that have the greatest impact on public health, such as implementing the FDA Food Safety Modernization Act. The GRAS process, and this final rule, provides a clear legal framework under which food manufacturers can bring innovative, safe food and beverage products to market to meet consumer demands.

IFAC and its members look forward to working with FDA and other stakeholders to implement this final rule and achieve our common goal of maintaining the safest food supply in the world. Moving forward, all stakeholders should make GRAS conclusions and submit GRAS notifications following FDA’s final rule. To help companies navigate future submissions, IFAC is updating its GRAS Best Practices Guide to include all of the requirements in the final rule. The updated GRAS Guide will be made available in the near future.

 

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IFAC and IDF sign Memorandum of Understanding

Washington DC, and Brussels, October 17, 2016 — The International Food Additives Council (IFAC) and the International Dairy Federation (IDF) signed a Memorandum of Understanding (MOU) to promote the global harmonization of food additives and food ingredients for milk and milk products.

Specifically, IFAC and IDF have agreed to cooperate in submitting relevant science-based information and positions to intergovernmental organizations such as Codex Alimentarius. In addition, the organizations will exchange relevant information and collaborate in aligning communication efforts relating to food additives and ingredients affecting the dairy sector. Providing technical assistance regarding global specifications as well as the interpretation and implementation of regulations is also within the scope of the agreement.

“The dairy industry is very important to IFAC members,” said Robert Rankin, Executive Director of IFAC. “Many dairy products contain ingredients produced by IFAC member companies, so this partnership with IDF will help enhance our visibility within the dairy industry and facilitate alignment on key issues facing our industries, organizations and ultimately, consumers.”

“It is critical for the dairy sector to be proactively involved in the setting of international standards given the impact on safeguarding consumer health and safety, protecting the environment, facilitating the global trade of milk and milk products and supporting sustainable economic growth” said Dr. Nico van Belzen, Director General of IDF. “IDF’s strategy includes an objective to develop collaborations with relevant organisations to create synergies and increase effectiveness in international harmonization of standards affecting the dairy sector. The collaboration with IFAC is a close fit with this strategy.”

IFAC logo

About IFAC

The International Food Additives Council is a global association representing manufacturers of food ingredients. Founded in 1980, IFAC strives to promote science-based regulation and the global harmonization of food ingredient standards and specifications. For more information about IFAC visit www.foodadditives.org

IDF-logo

About IDF

The International Dairy Federation provides science-based information to its National Committees as well as to international organizations, governments and legislators. IDF places great emphasis and importance on ensuring that the work conducted by its Standing Committees and Task Forces is of the highest scientific quality and integrity and is relevant and applicable to the entire dairy sector and industry worldwide. For more information, visit www.fil-idf.org.

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IFAC CONTACT:

Randy Spoon

+1 678 303 3017

rspoon@kellencompany.com

 

IDF CONTACT:

Apolina Fos

+32 2 325 67 40

afos@fil-idf.org