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 [link to partial-access Guide].
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.