TraceGains Inc.

TraceGains Recommends Food Industry Leaders Assess the Effects of Manufacturing Process Changes


Westminster, CO -- (SBWIRE) -- 07/21/2014 -- Jennifer Brusco, Marketing Specialist for TraceGains shared important information from the Food and Drug Administration (FDA) on the company’s blog. Brusco reported that the FDA recently issued "Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that Are Color Additives." This guidance is intended for manufacturers of food ingredients and food contact substances.

This guidance represents the FDA's current thinking regarding considerations for assessing the impact of a significant manufacturing process change on the safety and regulatory status of a food substance. In addition, the guidance provides relevant recommendations for assessing the effect of a significant manufacturing process change on the safety and regulatory status of food substances, including those that are the subject of a food additive or color additive regulation, a food contact substance notification, or a generally recognized as safe (GRAS) determination.

According to the report, the guidance describes the factors to consider when determining whether a significant change in manufacturing process for a food substance already in the market including…

-Affects the identity of the food substance;
-Affects the safety of the use of the food substance;
-Affects the regulatory status of the use of the food substance; and
-Warrants a regulatory submission to FDA.

To read the entire blog, go to:

About TraceGains
TraceGains ( provides food and ingredient manufacturers and brokers with a web-based, full-service supplier, compliance, and regulatory document management solution that automates the management of supplier risk, data, and documentation, making companies 365 Audit Ready™.

TraceGains’ cloud-based SaaS solution works with in-house solutions such as quality management systems (QMS), enterprise resource planning (ERP), and product life-cycle management (PLM), to close the loop on upstream risk. This solution provides collaborative supplier management, and eases compliance with the Food Safety Modernization Act (FSMA), the Global Food Safety Initiative (GFSI), and internal business compliance requirements including hazard analysis and critical control points (HACCP).

TraceGains digitizes all incoming supplier documents, making them easily searchable. TraceGains also extracts critical data and analyzes them against customer-specific business and compliance rules, alerting stakeholders to any non-compliance.

TraceGains’ customers boast a four to six month return on their investment. TraceGains is Food Logistics Top 100 software and technology providers. Learn more about conquering the supplier data revolution at: Follow TraceGains on Twitter @TraceGains.

TraceGains, Inc.
Jennifer Brusco
Marketing Strategist