IFAC Updates
IFAC Signs on to Industry Comments on Proposed Rule on Gene Editing On August 6, IFAC and other food and agriculture associations submitted the attached comments on the U.S. Department of Agriculture’s (USDA) proposed rule titled “Movement of Certain Genetically Engineered Organisms”. The new rule would allow crops grown with genetic modification techniques with a long history of safe use to bypass USDA’s regulatory process. Furthermore, crops produced with gene-editing techniques such as CRISPR would also continue to be nonregulated if they don’t pose a plant pest risk. Note, the rule will not impact how the U.S. Food and Drug Administration (FDA) regulates GM food products.
Given that this rule would permit genetically-engineered plants on the market that are not acknowledged by USDA, consumer transparency would be limited. Industry comments requested the proposed rule be modified to ensure transparency between industry and consumers. Other than avoiding risking consumer transparency and trust, the letter also highlighted the potential for the proposed rule to generate trade disruptions for U.S. exports.
According to an article published August 6 by Feedstuffs, several comments submitted to the docket were in favor of the new science-based regulatory approach, while several strongly encouraged USDA to require developers to notify the agency of their intent to market new plants produced through biotechnology. Many organizations expressed concerns on the reduction of consumer awareness and potential for trade disruptions.
IFAC Submits Resolution for 2020 USP Convention; Endorses USP & IPEC Resolutions On August 30, IFAC submitted the attached proposed resolution for next year’s U.S. Pharmacopeia (USP) Convention. As agreed at IFAC’s Mid-Year Meeting, staff also shared the resolution with FDA as well as dietary supplement organizations, including the Council for Responsible Nutrition (CRN), the Natural Products Association (NPA), and the International Probiotics Association (IPA), for their potential endorsement at the 2020 USP Convention.
Based on member support, IFAC also endorsed a resolution developed by the USP Council of Conventions titled “Quality Standards”. The resolution states, “USP will be a definitive source and a recognized leader in quality standards for medicines, dietary supplements, excipients, and food ingredients, to help protect patient and consumer safety and to meet the needs of regulators and policy makers, healthcare practitioners, and industry working in evolving global regulatory environments. In doing so, USP will work to identify emerging trends, align with technological advances, and develop innovative and agile approaches to address the future needs of industry, regulators, practitioner, and patient needs.”
Finally, based on member feedback, IFAC agreed to endorse the International Pharmaceutical Excipients Council’s (IPEC) resolution titled “Quality Standards for Dietary Supplements and Their Ingredients” (IA USP Resolution 1; attached) and their second resolution titled “Develop a Framework for Non-Standard Excipient Monographs” (IA USP Resolution 2; attached) at the 2020 USP Convention.
August 2019 IFAC China Monitoring Report Attached is the August 2019 IFAC China Regulatory Monitoring Report, which contains the following four public announcements published by the China National Center for Food Safety Risk Assessment (CFSA) and the National Health Commission of the People's Republic of China (NHC). Call for Comments on 21 New Food Related Products including Wollastonite: On August 21, CFSA announced an expanded scope of use and usage amount allowed for food additives used for food contact material and its products. The products include Wollastonite, Erucamide; cis-13- Docosenam. They also included new food additives, expansion of use scope of resins, new resins. The list can be found on the attached document. The deadline to submit comments on these products is September 19. As the additives covered do not appear relevant to members, IFAC does not plan to provide comments unless otherwise advised by Friday, September 20.
Call for Comments on 8 New Food Additives including Polygalacturonase: On August 9, CFSA requested comments on food additives such as Polygalacturonase and maltotetraohyrolase. There were also increased of use scope of processing aid and food nutrition enhancer. As the deadline has passed and the additives covered do not appear relevant to members, IFAC does not plan to submit comments unless otherwise advised by Friday, September 20.
Announcement of Maximum Limits for Pesticide Residue in Food: On August 28, NHC issued three national food safety standards relating to limits of pesticide residue, identification of pesticides, and determination of oxine-copper residue in plant-based foods. The regulations will go into effect 6 months after the announcement, or approximately February 15, 2020.
Announcement of 2019 National Food Safety Standards Development Plan: On August 12, NHC announced the final working plan for the 2019 work on food standards. This final working plan has some changes from the previous draft of working plan that called for public comments in May. The order of projects has been modified due to the removal or modification of certain previously proposed projects. The attached IFAC China update has a list of the final version.
U.S. FDA Updates
FDA Issues Fact Sheet on Menu Labeling Implementation On August 13, the U.S. Food and Drug Administration (FDA) released a fact sheet to notify parties about the agency’s efforts to institute menu labeling in chain restaurants and similar food establishments. FDA stated that they will continue to work with industry as well as engage with regulatory partners to ensure common implementation of the menu labeling requirements. Chain restaurants and similar retail food establishments were required to implement the menu labeling requirements on May 7, 2018. The requirements are meant to provide consumers with consistent nutrition information to enable informed and healthy dietary choices. For the first year, FDA worked with food establishments to understand the requirements; going forward the agency will continue to provide assistance and flexibly to successfully implement the requirements. FDA also plans to analyze industry implementation efforts of the menu labeling requirements to improve agency education and outreach.
FDA Announces Public Meeting on Connection between Color Additives and Children's Behavior On September 12, the Science Board to the FDA announced in the Federal Registrar that it will host a public meeting on October 7 in Silver Spring, Maryland, to discuss the effects of color additives in children’s behavior. The Science Board is an FDA Advisory Committee that provides advice to the FDA Commissioner and other officials on specific, complex scientific and technical issues important to FDA and its mission.
The meeting will be available via webcast for those unable to attend in person. There is also an opportunity to provide written comments by September 30, 2019. IFAC staff is not planning to attend. However, please let me know if you are planning to attend or would like IFAC to develop written comments by Tuesday, September 24.
FDA Issues Warning Letter to Importer of Tahini On August 13, FDA announced its first warning letter using the specific authority granted by the Food Safety Modernization Act (FSMA) Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals. Until now, FDA had been conducting FSVP inspections to help educate firms on FSVP expectations. Now, the agency is taking more steps to ensure industry compliance with FSVP. The warning letter was issued to the Brodt Zenatti Holdings LLC, which imported tahini from an Israel-based manufacturer. This tahini was recalled due to a Salmonella outbreak in May. FDA found the company in significant violation of the FSVP rule.
FDA Issues Guidance on Conversion of Certain Nutrients for Labeling On August 15, FDA issued a final guidance for industry on how to convert past units of measure for folate, niacin, vitamin A, vitamin D, and vitamin E to new units required on the updated Nutrition Facts and Supplement Facts labels. The guidance serves to address the 2016 amendment to FDA’s regulation for labels to include updated Daily Values (DV) as Reference Daily Intakes (RDIs), which reflect new units of measure associated with updated Recommended Dietary Allowances (RDAs) established by the National Academies of Medicine. The conversions are as follows:
Folate: Micrograms Micrograms dietary folate equivalents (mcg DFE) Niacin: Milligrams (mg) Milligrams Niacin Equivalents (mg NE) Vitamins A: International units (IU) Micrograms (mcg) Vitamins D: International units (IU) Micrograms (mcg) Vitamin E: International units (IU) mg alpha (α) tocopherol
The compliance date for these changes is January 1, 2020 for manufacturers generating $10 million or more in annual food sales. Manufacturers generating less than $10 million annually have an additional year to comply.
Other U.S. Updates
White House Announces new Tariffs that will Impact Dietary Supplements On August 2, NutraIngredients reported on President Trump’s announcement of new 10% tariffs on an additional $300 billion worth of Chinese goods. The proposed levies were later postponed until December on August 13. These tariffs were supposed to be applied to most dietary supplements, which contain ingredients from China. Industry leaders stated the price of the tariffs could be mostly absorbed before a product is sold in stores, with parts of the supply chain taking a part of the burden. However, eventually, the consumer will have to pay and feel the effects of the tariffs. Daniel Fabricant, president and CEO of the Natural Products Association (NPA) mentioned two ingredients (sucralose and glucosamine) which were previously on lists and granted exemptions. Fabricant stated, “We are going to continue to work for an exemption process. We fought for an exemption process on the earlier lists and we will continue to work for one on list four.”
NSF International Updates Non-GMO Certification Program On August 5, Food Navigator USA reported that NSF International has revamped its Non-GMO certification system and logo. NSF's certification program, established in 2016, was created to validate non-GMO claims on foods and beverages, dietary supplements, cosmetics, personal care and household cleaning products. According to Sarah Krol, global managing director of food safety product certification, the revised certification is not just a simple rebranding, but will streamline the process as well. The program now reflects the USDA’s National Bioengineered Food Disclosure Standard, recognizes USDA organic certification as part of the GMO certification, clarifies those derived ingredients that do not meet requirements, and incorporates simplified certification requirements.
Codex Committee on Food Hygiene Sends Invitation for 51st session of CCFH On August 15, the Codex Committee on Food Hygiene (CCFH) circulated the attached invitation for the Committee’s 51st Session, which will be held November 4-8 in Cleveland, Ohio. The invitation included the provisional agenda (attached here) and confirmed the related public meeting to discuss draft U.S. positions for CCFH51 will take place on September 26 from 1-4 pm US ET. IFAC has not historically been involved with CCFH, and does not plan to attend the U.S. public meeting or the 51st Session. However, IFAC members may attend other Codex meetings and represent IFAC in accordance with IFAC’s Codex Policy (attached). Therefore, please let me know if you’d like to attend CCFH and sit on the IFAC delegation by Friday, September 27.
Speculation Published Around Trump Administration Diminishing Dietary Guidelines On August 30, the Washington Post published an article that highlighted how the Trump administration is limiting scientific contributions to the 2020 Dietary Guidelines for Americans (DGAs) and concurrently expanding the influence of industry. Similarly, the American Prospect reported that the Trump administration aims to disintegrate the DGAs. The article heavily critiques the Dietary Guidelines Advisory Committee’s (DGAC) current review process as many members have connections to industry or industry-supported groups, and accuses industry of manipulating research.
The Food & Beverage Issue Alliance (FBIA) is planning to submit comments that address a number of nutrition and food policy topics. In addition to voicing support for the 2020 DGA process, the attached draft letter applauds USDA and the Department of Health and Human Services for being transparent on DGA work. The agencies have stated that such a letter would be greatly welcomed as teams continue work on the 2020 DGAs and development on the next set of DGAs, which would be in 2025. At this time, FBIA has decided to hold off on submitting the letter because of the surrounding press on the topic. Discussions on the letter will continue internally. We ask members to provide feedback on the letter and how FBIA should proceed for future meetings.
CRN Unveils 2019 Agenda for Annual Day of Science Workshop On August 8, Nutra Ingredients reported that the Council for Responsible Nutrition (CRN) will be examining healthy aging and advances in nutrition research tools on its annual Day of Science workshop taking place on November 6 in Carlsbad, California. The workshop (agenda here) is scheduled in tandem with CRN’s annual conference taking place November 6-9, and will encompass two thematic topics: (1) optimizing nutrition to promote healthy aging and (2) advancing nutrition research tools. The aging session will discuss nutrients like nicotinamide riboside for metabolic stress and vitamin K in bone and cardiovascular health. The research block will incorporate the importance of genetics in helping develop observable traits. Other topics what will be examined are: mobile-based diet tracking and the rise of health-based technologies for consumers.
International Updates
JECFA Requests Data for 89th Meeting On August 21, the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) published a request for interested parties submit data on the food additives in Annex 1 of the request (link here) ahead of the 89th meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA), which will take place June 2-11, 2020. The formal request and list of the food additives in Annex 1 is attached, and includes additives of possible IFAC interest such as natamycin and nisin. The 89th JECFA meeting will evaluate and re-evaluate the list of food additives. Which is based on recommendations from previous Expert Committees, requests from governments and other stakeholders, and from the Codex Committee on Food Additives (CCFA). A list of enzymes schedules for evaluation or re-evaluation will be published at later date.
The submission of data on additives listed in Annex 1 is requested before December 15, 2019. Please contact IFAC staff if you are interested in the submitting data on the listed food additives.
China Announces National Health Strategy Guidelines On August 5, Food Navigator reported that China has announced its national health strategy guidelines, named the “Healthy China Movement”, which aim to cut dietary oil consumption by 30-40%, salt consumption by 50%, and sugar consumption by at least 17% by 2030 based on 2012 numbers. The guidelines are aligned with China’s overall “Healthy China 2030” initiative. China’s Center for Disease Control and Prevention’s Dr. Ding Gangqiang explains the action plan will be implemented through the following four main actions:
1. Push for the normalization of related nutritional health activities in society; 2. Promote the correct usage of three items: a quantity-limiting salt scoop, volume-limiting oil bottles, and waist-measuring tape; 3. Conduct further research on standards surrounding these three food items and recommended daily limits, and encourage grocery stores to set up specific aisles for low fat, low salt and low sugar products; 4. Advocate for the use of safe natural sweeteners to replace sucrose and reduce sucrose content in processed foods.
Deputy Director of the National Health Commission (NHC), Zhang Zhiqiang, is quoted predicting that NHC is also looking at recommended standards, which would involve guidance, society participation and action on the part of the food industry.
EU Initiative Focuses on Microbiome to Assign Additives to Animal Feed In light of Europe’s increased intake of meat compared to fifty years ago and the desire to reduce waste associated with farmed animals, the EU has announced an initiative to harness the power of the microbiome to increase efficiencies to reduce the number of resources (e.g., food, antibiotics, and other chemical inputs) needed. On August 26, Food Navigator discussed this project, named “HoloFood”, which involves academic and industry experts from Germany, Spain, Poland, Denmark, Norway and the UK. The aim of Halofood is to understand the molecular and physiological processes triggered by feed additives, so that they can be better matched to animals. Researchers plan to start with salmon and chicken to maximize efficiency. HoloFood’s project coordinator, Tom Gilbert, explains that if the project is successful, industry would require fewer resources to produce the same amount of food, which would also reduce food waste. Gilbert notes, “This would have significant economic impacts for the food industry, and in turn, for consumers as well.”
Health Canada Expands Uses of Potassium Phosphate, Sodium Potassium, Tocopherols and Polysorbate 80 On August 7, Health Canada published an announcement permitting the use of potassium phosphate, dibasic in infant cereal products, and sodium potassium hexametaphosphate in whey products for use in infant formula by updating the List of Permitted Sequestering Agents. Potassium phosphate, dibasic is already permitted for use as a sequestering agent in some meat products, and sodium potassium hexametaphosphate is already permitted as a sequestering agent in liquid whey used to manufacture concentrated or dried whey products. However, the use of these ingredients in infant cereal and infant formula could not be enabled until an amendment was made to the Marketing Authorization for Food Additives That May Be Used as Sequestering Agents to allow for the necessary exemption for these additives in section B.25.062 of the Food and Drug Regulations.
On August 8, Health Canada published a notice announcing it is modifying part of the List of Permitted Preservatives to expand the use of tocopherols in dehydrated fish broth and dehydrated mollusc broth. The use of tocopherols as an antioxidant is already widely permitted in Canada in foods such as frozen fish fillets and frozen prepared fish fillets.
On August 14, Health Canada issued a notice that it has completed a premarket assessment of a food additive submission seeking approval for the use of polysorbate 80 in infant formula powders, dried infant cereal products and nutritional supplement powders. Polysorbate 80 is already permitted for use in a variety of foods as an emulsifying, gelling, stabilizing, or thickening agent. The results of the assessment support that polysorbate 80 is safe to use for its requested uses. Because of its safety, Health Canada has amended the List of Permitted Food Additives with Other Accepted Uses and documented the additional use of polylobate 80.
Japanese Stakeholders Argue Against Additive-Free Labeling On July 19, USDA reported that Japanese food industry leaders are fighting against the implementation of an additive-free label. The Japanese Consumer Affairs Agency (CAA) held the second and the third review committee meetings for the labeling of food additives on May 30 and June 27, respectively. For each meeting, the CAA invited consumer groups and industry representatives to provide an all- encompassing perspective on the issue. All presenters requested the CAA to either standardize or ban additive-free labeling. Consumer group stated that no-additive labeling would mislead consumers while food industry representatives indicated that they would not be in favor of the proposed required disclosure of food additives because updating it would be a burden to manufacturers.
India Notifies WTO of Draft Amendments to Food Laws (ATTACH WTO DOCUMENT) On August 20, the Food Safety and Standards Authority of India (FSSAI) notified the World Trade Organization (WTO) of a large number of draft amendments to its food laws titled “Draft Food Safety and Standards (Food Products Standards and Food Additives) Amendment Regulations, 2019”. An abbreviated document in English is provided here. According to the attached WTO notice, the amendments will include several standards for ingredients and food categories. Of potential interest to IFAC, the amendments include additional processing aids for use in various food categories, microbiological standards for egg and egg products and procedures for retesting of microbiologically contaminated samples. The date to submit comments is October 19. Therefore, please inform staff by Friday, September 27 or sooner if you are interested in IFAC submitting comments.
French Food Label Measures the Amount of Processing of Foods On August 12, Food Navigator published an article reporting that a French startup company named Siga has developed a label that measures the amount of processing food products have undergone, rather than the food’s nutritional composition. The label’s developers aim to help consumers be more aware of what they are eating and hopefully support the purchase and consumption of less processed foods. The article also discussed more classification methods like NOVA, a system developed by Brazilian researchers which categorizes foods into four groups according to their level of processing. NOVA and Siga labels are similar, but NOVA lacks the same level of power to analyze ultra-processed ingredients. Systems like NOVA and Siga may be used to promote supply chain transparency demanded by many consumers.
Study Finds ‘Junk Food’ Tax More Effective than Sugar Tax On August 1, a study was published in The Lancet Public Health which found that a "junk food" tax could be more effective in promoting healthy eating than a levy on sugar. The study, conducted by the University of Auckland, used virtual reality to examine how price changes could impact consumers' grocery shopping lifestyles and asked adult participants in New Zealand to complete up to five weekly shops in a virtual supermarket. The researchers then assessed the healthiness of the total shopping basket for each weekly shop (% of total unit food items defined as health) and investigated how a subsidy on fruit and vegetables and tariffs on salt, saturated fat and sugar could change the healthy proportion of their purchases. The sweetened beverage tax and fruit and vegetable subsidy resulted in non-significant increases. Both the saturated fat tax and salt tax resulted in the following important substitution effects: an increase in fruit and vegetable purchases as a percentage by weight of all food purchases, but also an increase in sugar as a percentage of total energy. Therefore, the researchers conclude that a combination of different tax and subsidy policies might be the most effective way to improve diets and decrease diet- related chronic diseases.