EU Compliance Is Not FDA Compliance: What Ingredient Status Means for US Market Access
Thursday, 29 January 2026
by Dr Faour Klingbeil
If raw materials aren’t fully FDA-compliant but EU compliant, can we still sell the product in the US ? This question comes up often with complex formulations. From an FDA perspective, the logic is simple. Pointing to approval in other jurisdictions, relying on a long history of use elsewhere, or assuming that a low use level or a so-called “minor” ingredient will be overlooked is not a good argument or approach to access the US market. These factors may feel reassuring, but they do not establish legal status under FDA rules. What does work is a disciplined regulatory approach by mapping each ingredient and sub-ingredient to its US regulatory status, verifying that the intended use levels and conditions of use are covered, and reformulating where no valid approval or GRAS pathway exists. I have prepared this illustration that summarizes the decision logic used to determine a substance’s regulatory and legal status, and shows where compliance ultimately leads to the need for food additive authorization. If you find it useful and choose to share it, attribution would be appreciated. If you have questions, feel free to reach out anytime. We support food businesses with food labeling compliance, risk assessment and management, and food system compliance with the FDA.
- Published in FDA Compliance
DFK at IAFP 2025: Addressing Chemical Hazards in Water Reuse
Wednesday, 30 July 2025
by Dr Faour Klingbeil
DFK was pleased to be invited to present at the 2025 International Association for Food Protection (IAFP) Annual Meeting in Cleveland, Ohio, 27-30 July . The symposium, “Managing Chemical Hazards in Water Reused in Food Production and Processing,” brought together experts to discuss one of today’s most pressing food safety challenges, the risk of emerging chemical contaminants risk in water reuse. These substances have been detected even in regions considered pristine, highlighting the global nature of chemical contamination. As water reuse becomes an increasingly important sustainability strategy in food production, managing chemical risks and ensuring regulatory alignment are more critical than ever. As part of the symposium, Dr Dima Faour-Klingbeil contributed a talk on “Regulations Around the Reuse of Water and Chemical Hazards in Food Industry Settings,” exploring how evolving regulations and risk management strategies can help safeguard food safety while supporting sustainable water practices. The session provided an excellent opportunity to exchange insights with international colleagues, bridging European and U.S. perspectives on emerging regulatory trends and scientific developments in food safety.
BioCraft Achieves Key Milestone in cell-cultured animal food ingredients
Wednesday, 26 March 2025
by Dr Faour Klingbeil
DFK celebrates the collaboration with BioCraft and their achievements! they have been officially registered with Austrian authorities to handle ABP Category 3, marking a significant step forward in the production of cell-cultured animal food ingredients for pet food producers across the EU. Dr. Faour-Klingbeil has been consulted for supporting the BioCraft team to develop a robust HACCP plan tailored to the unique cell-cultured processes in pet food production. This has been an insightful journey, as HACCP in this innovative environment demands patience, adaptability, and a data-driven approach. Dr. Faour-Klingbeil takes great pride to have assisted BioCraft’s team in their dedication to ethical innovation and unwavering commitment to product safety.
World Food Safety Day 2024
Friday, 07 June 2024
by Dr Faour Klingbeil
Prepare for the unexpected Happy World Food Safety Day.. In celebration of World Food Safety Day, themed “Food Safety: Prepare for the Unexpected,” and in our effort to engage consumers, Dr Faour-Klingbeil was joined be joined by Dr. Hussein Hassan, Associate Professor of Food Science and Technology and Director of Academic Compliance at the Lebanese American University, and Mr. Elie Bou Yazbeck, Food Science Expert in the Consumer Protection Directorate at the Ministry of Economy and Trade. A heartfelt thanks to the panelists for their presence and the valuable information they shared on consumers’ roles and awareness in food safety, with a particular focus on Lebanon. We discussed how consumers can effectively contribute to food safety, which plays a crucial role in preventing foodborne diseases and minimizing potential risks, and the current endeavors and coordinated activities between the educational institution and public sector. I hope this video will reach many individuals who are not yet aware of how to report their observations and connect with the official authorities. Consumers are urged to be proactive in reporting any issues related to unsafe practices or conditions that may put food at risk of contamination. For more detailed information, please refer to the video at the minute 50:15. اليوم العالمي لسلامة الأغذية: الاستعداد لما هو غير متوقع Posted by DFK for Safe Food Environment on Friday 7 June 2024
DFK Supports SMEs and Stakeholders Through the USAID TRADE Project on Export Enhancement Program
Tuesday, 26 March 2024
by Dr Faour Klingbeil
As part of the Export Enhancement Program under the USAID TRADE project, in collaboration with the Food Export Council (FEC), DFK has been dedicated to supporting SMEs and key stakeholders by enhancing their knowledge and capabilities. This initiative, which began in September 2022, continued through multiple training sessions held on: The objective of these sessions was to train and build the capacity of industry delegates and trainers on the FDA requirements under the FSMA preventive controls rule key and topics essential for international trade compliance and food safety, including: This effort continued through 2024 with the development of Trainer of Trainers (ToT) guidance documents, including: Through this project, DFK is empowering SMEs with the critical knowledge and skills needed to meet international standards, fostering safer food products and enhancing export capabilities.
Safety and quality of water use and reuse in the production and processing of dairy products
Wednesday, 07 June 2023
by Dr Faour Klingbeil
In 2020, the 43rd session of the Codex Alimentarius Commission approved the new work entitled “Development of Guidelines for the Safe Use and Reuse of Water in Food Production” proposed by the 51st session of the Codex Committee on Food Hygiene. To support this work, the Joint FAO/WHO Expert Meeting on Microbiological Risk Assessment (JEMRA) was asked to provide scientific advice regarding safe use and reuse of water in the dairy sector. Dr. Dima participated in the JEMRA experts panel tasked to provide clear and practical guidance on risk-based approaches to assess and manage fit-for-purpose water sourcing, use and reuse in the dairy sector. The collective efforts led to publication of a report that describes the application of the concept of fit-for-purpose water for use in the production and processing of dairy products. Report available in this link: FAO & WHO. 2023. Safety and quality of water use and reuse in the production and processing of dairyproducts – Meeting report. Microbiological Risk Assessment Series, No. 40. Rome, FAO.https://doi.org/10.4060/cc4081en
PCQI WORKSHOP – USAID Trade Reform & Development in Egypt (TRADE) 2023
Friday, 24 March 2023
by Dr Faour Klingbeil
For the second year, and as part of the integrated capacity enhancement initiative of the USAID TRADE project to strengthen the Egyptian Food Export Council (FEC) and their members’ capacity to access the US market, Dr Faour-Klingbeil delivered the official course “Preventive Controls Qualified Individual (PCQI)” for 12 SMEs at the FEC premises from 07.- 09.03.2023. The course aimed to support Egyptian SMEs in the food sector better understand how to develop a Food Safety Plan and meet the FDA food safety requirements to improve regulatory compliance and enhance food exports.
FAFS Lecture Series | An overview of the FSMA and its implications for food exporters
Wednesday, 16 December 2020
by Dr Faour Klingbeil
As part of the American University of Beirut FAFS (The Faculty of Agricultural and Food Sciences ) Lecture Series, Dr. Dima was invited to deliver an open lecture on “An overview of the Food and Drug Administration Food Safety Modernization Act (FSMA) and its implications for food exporters” that took place on the 10th of October 2019. About the lecture: Foodborne disease is a significant burden worldwide. In the United States, it is estimated that 48 million people get sick, 128 000 are hospitalized, and 3000 die annually from contaminated food or beverages. Prompted by the increasing prevalence of imports, high-profile food outbreaks, food fraud, and emerging hazards, the U.S. Food Safety Modernization Act was signed into law in 2011, the first historical reform to the legislative landscape of the food and beverage industry in over 70 years. FSMA has made fundamental changes to U.S. food laws. It shifted the focus of food safety from reactive to preventive approach and gave the U.S. Food and Drug Administration explicit authority and broader prevention mandate to protect consumers’ health. Instead of relying only on port-of-entry inspection, FSMA emphasizes key regulations that span across the food supply chain. Among other modifications, it imposes new responsibilities on food importers to verify that their foreign suppliers of food for human and animal consumption meet applicable FDA safety standards to ensure the safety of food imported into the U.S.
Joint FAO/WHO Expert meeting on the Safety and Quality of Water Used in Food Production and Processing
Saturday, 14 September 2019
by Dr Faour Klingbeil
Dr. Dima was invited to participate in the Joint FAO/WHO Expert meeting on the Safety and Quality of Water Used in Food Production and Processing in Geneva, Switzerland, 23-27 September 2019. The purpose of the meeting was to develop clear and practical guidance on the criteria and parameters that can be used to determine if water is ‘fit-for-purpose’ for several different agricultural purposes. This work is still under review. As a member of the FAO/WHO joint Expert Meeting on the Microbiological Risk Assessment (JEMRA), she contributed to developing practical guidance and fit-for-purpose microbiological criteria for water used in fresh fruit and vegetables and the published WHO document. Enjoy the read: FAO and WHO 2021. Safety and quality of water used with fresh fruits and vegetables. Microbiological Risk Assessment Series No. 37. Rome. https://doi.org/10.4060/cb7678en
Tagged under:
FAO, Fit-for-purpose, Food Safety, Risk assessment, Wastewater reuse, WHO, WHO guidelines
Programm „Aktiv und gesund durchs Leben“ – Lebensmittelsicherheit – Active and healthy through food safety
Sunday, 28 October 2018
by Dr Faour Klingbeil
Vortrag zum Thema “Lebensmittelsicherheit” von Dr. Dima Faour-Klingbeil. Wie entstehen Lebensmittelvergiftungen? Wie kann ich sie vermeiden? Wann sind Lebensmittel nicht mehr genießbar? Lecture on “Food Safety” by Dr. Dima Faour-Klingbeil. How does food poisoning occur? How can I avoid it? When is food no longer edible? presented for Kargah health awareness program. Kargah is a non-profit intercultural organization in Hanover that focuses on providing educational, consulting, and cultural activities.
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