BLOG: Understand The Implications of Red No. 3 Bans and Adapt to Regulatory Change
Adapting to Regulatory Changes: The Implications of Red No. 3 Bans and How Gramont Consulting Can Help
by Nóra Markovics-Koreny I Gramont Consultant | February 2025
A highly relevant topic in the food industry is the recent news around Red No. 3, also known as Erythrosine or E127. Red No. 3 is an artificial red food dye commonly found in candies, drinks, medications, and other products. The authorization of this widely used ingredient in food and ingested drugs was revoked by the FDA on January 15, 2025. Manufacturers have approximately 2 years to reformulate their products if they use FD&C Red No. 3 in them, the order is effective January 15, 2027 except for amendatory instruction 4, which is effective January 18, 2028.
Some U.S. states were already taking action independently. For instance, California recently passed AB418, a bill that prohibits the use of this dye and three other additives (brominated vegetable oil, potassium bromate, and propylparaben) in food products sold in the state starting January 1, 2027. Similarly, other states, like New York, are considering their own regulatory measures, such as S6055A and A06424, to restrict the use of artificial dyes and harmful additives in food and pharmaceutical products.
These developments underscore the urgency for companies in the food and pharmaceutical sectors to adapt quickly to new regulatory trends and ensure compliance across their product portfolios. To keep up with the new food safety and regulatory trends, food and pharma companies need to possess a complete end-to-end system, where they can access their product portfolio and act rapidly, when such actions are required as a change of a raw material ingredient in a given product.
Industry Challenge: Managing Rapid Compliance Changes
When faced with regulatory demands to replace banned ingredients like artificial dyes across extensive product portfolios, companies encounter significant challenges, including:
• Identifying impacted products: Pinpointing recipes and formulations that contain the banned ingredient.
• Ensuring compliance: Updating formulations while adhering to allergen, nutrient, and labeling requirements.
• Managing costs: Balancing compliance with financial implications and preserving product quality
Such challenges often strain traditional systems, which may lack the agility and integration required to respond swiftly and effectively.
How to get around this problem from a food science, regulatory or financial perspective? Meet SAP PLM, Your Comprehensive Solution
To navigate these regulatory challenges, companies need a comprehensive and flexible system. SAP PLM provides all the aspects to keep track of raw materials/ingredients and product recipes including their allergen, nutrient and cost calculations as well as passing the relevant data to generate the product label for declaration and consumer information purposes.
SAP Product Lifecycle Management (PLM) offers end-to-end solutions for managing:
• Ingredient Tracking: Maintaining visibility over raw materials, recipes, and compliance data.
• Recipe Adjustments: Supporting updates to product formulations while tracking costs and ensuring compliance with regulatory requirements.
• Label Generation: Streamlining product label updates to reflect accurate consumer information.
By centralizing these processes, SAP PLM enables companies to react quickly to regulatory changes and ensures that products remain compliant across markets.
Gramont Consulting: Enhancing SAP PLM with the Raw Material Simulator
At Gramont Consulting, we empower businesses to meet these challenges through innovative tools like the Gramont Raw Material Simulator, which is designed to proactively identify and address regulatory risks, simulate changes to optimize decisions before implementation, minimize production downtime, and streamline compliance processes. This cutting-edge solution seamlessly integrates with SAP PLM to provide:
Key Features of the Raw Material Simulator
1. Impact Analysis: Rapid identification of all recipes directly or indirectly affected by an ingredient change.
2. Simulation Capabilities: Testing potential raw material replacements for nutrient, allergen, and cost implications.
3. Decision Support: Facilitating cross-functional collaboration, including legal input for product re-declaration and label updates.
Using Gramont Raw Material Simulator, all the directly and indirectly impacted recipes can be quickly identified in SAP PLM, then the simulation of the specific change can be started. To simulate the change of an existing raw material in the existing recipes, the tool performs calculations and comparisons on the impacted recipes. The decision-making process is supported based on the simulation of the ingredient, nutrient, allergen and costing information of the new raw material. This tool additionally allows for legal department intervention and possible redeclaration of the product label.
Preparing for a Regulatory-Driven Future
The recently announced ban of Red No. 3 and potential future restraints of other harmful additives reflects a broader shift towards stricter food and pharmaceutical safety standards. Companies that invest in robust, integrated systems like SAP PLM, enhanced by Gramont’s innovative solutions, will be well-positioned to adapt to these changes.
By partnering with Gramont Consulting, businesses can ensure that compliance efforts are not only seamless but also strategic, balancing regulatory requirements with cost efficiency and product innovation.
Sources & Further Reading:
Federal Register :: Color Additive Petition From Center for Science in the Public Interest, et al.; Request To Revoke Color Additive Listing for Use of FD&C Red No. 3 in Food and Ingested Drugs
FD&C Red No. 3 | FDA
Food Additive and Color Additive Petitions Under Review or Held in Abeyance
FDA says it causes cancer. Yet it’s in hundreds of candies. | Center for Science in the Public Interest
https://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=202320240AB418
https://www.nysenate.gov/legislation/bills/2023/S6055/amendment/A
https://www.nysenate.gov/legislation/bills/2023/A6424/amendment/A
