Food Safety Regulations
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Food Safety Regulations

Understanding Food Safety Certifications

Food safety regulations can feel overwhelming, so let’s start off with the basics. First, there are two Federal regulatory agencies in the US: The FDA and the USDA.

FDA

In the United States, the primary food safety regulatory agency is the Food and Drug Administration (FDA). The FDA has jurisdiction over the safety of most food products (~80%), with the exception of meat, poultry, and some egg products, which are regulated by the United States Department of Agriculture (USDA). This includes:

  • All domestic food sold across state lines, including shell eggs, but NOT meat and poultry
  • Seafood (except catfish)
  • Game meat (i.e. venison)
  • Shell eggs and egg containing products outside of USDA control
  • Bottled water
  • Wine beverages with less than 7% alcohol

USDA

The USDA regulates certain meat, poultry, and some egg products. This includes:

  • Domestic and imported meat and poultry (excluding game meat)
  • Meat-containing products (i.e. stews, pizzas, frozen foods, etc)
  • Processed egg products (liquid, frozen or dried pasteurized egg products)
  • Catfish

Both the FDA and UDSA have established certain baseline standards.

Food Safety Modernization Act (FSMA)

The FDA’s Food Safety Modernization Act (FSMA) created most of the standards we have today. It mandates the Current Good Manufacturing Practice (CGMP, also known as GMP) regulations, which outline the minimum requirements for the design, construction, and maintenance of food processing facilities.

In addition to CGMPs, there are a number of other food safety certifications and programs that a contract manufacturer may be required to have, depending on the products they are producing and the markets they are selling to. Some examples include:

  • Hazard Analysis and Critical Control Points (HACCP) certification: This is a preventive approach to food safety that involves identifying and controlling potential hazards that could occur at different stages of the food production process.
  • Global Food Safety Initiative (GFSI) certification: This is a set of food safety standards that are recognized by many major retailers and food service companies around the world. There are several different GFSI-recognized schemes, including SQF, BRC, and FSSC 22000.

Let’s break it down simply

First, determine if your product is regulated by the FDA or USDA. If your product doesn’t contain poultry, meat, or eggs, it is FDA. If your product contains poultry, meat, or eggs, use this chart to determine who regulates your product.

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Next, let’s determine what food safety requirements you need. Often times, small business will say they want everything, however that is not only unnecessary, but often hinders finding a good match. There is a baseline of safety that any FDA or USDA registered facility has to abide by. In addition to that, some companies will get a GFSI certification (SQF is currently the most common in the US). This certification is required by some larger retailers, however if you are just starting out with smaller volumes and aren’t selling to a retailer requiring that this year, it is not necessary and will be difficult to find a small co-man who has that certification. See if your retailer requires it, and if not, leave it be for now.

Commonly asked Food Safety Questions

What is GFSI?

Global Food Safety Initiative (GFSI) is a private, industry-led initiative that aims to improve food safety, reduce audit duplication, and foster collaboration among food safety experts worldwide. It is not a food safety standard itself, but rather creates the benchmarks for food safety programs. It does so by evaluating and recognizing food safety certification programs, ensuring they meet a set of globally accepted food safety requirements. Some GFSI-recognized certification programs include SQF, BRCGS, IFS, and FSSC 22000.

Do I need an SQF certified co-man?

Whether you need an SQF (Safe Quality Food) certified co-manufacturer depends on various factors, primarily the requirements of your business and the standards you want to uphold. SQF certification is a globally recognized food safety and quality management system that ensures products meet rigorous standards throughout the supply chain.

Here are some considerations to help you determine if you need an SQF certified co-manufacturer:

  1. Customer Requirements: If your customers, especially retailers or larger food distributors, require SQF certification from their suppliers, you may need an SQF certified co-manufacturer to meet these requirements and maintain your business relationships.
  2. Market Access: In some markets, SQF certification may be a prerequisite for entering or maintaining a presence. If your target market values or requires SQF certification, it would be beneficial to work with a co-manufacturer who is SQF certified.
  3. Food Safety and Quality Standards: If you prioritize high food safety and quality standards in your products, having an SQF certified co-manufacturer can provide assurance that your products meet or exceed these standards.
  4. Regulatory Compliance: SQF certification can help you demonstrate compliance with various regulatory requirements related to food safety. If your industry or market has strict regulations, an SQF certified co-manufacturer can assist in meeting these standards.
  5. Risk Mitigation: SQF certification involves a comprehensive food safety management system that helps mitigate the risk of food safety incidents. If your business wants to minimize the risk of recalls and ensure the safety of your products, working with an SQF certified co-manufacturer can be a strategic choice.
  6. Supply Chain Integrity: SQF certification covers not only the manufacturing process but also extends to other aspects of the supply chain. This can help you ensure the integrity and safety of your entire supply chain.

It's important to note that achieving SQF certification involves a commitment to implementing and maintaining a robust food safety and quality management system. If you decide to work with an SQF certified co-manufacturer, you may also need to undergo the certification process yourself, depending on your role in the supply chain.

Ultimately, the decision to work with an SQF certified co-manufacturer depends on your business goals, customer requirements, and the regulatory landscape in your target markets. If you have low volumes and are just getting started, your manufacturing partner options will be limited if you require this. PartnerSlate recommends this for later stage brands with retailer requirements.

Food Safety Management System (FSMS)

This is a systematic approach to controlling and ensuring food safety throughout the entire food supply chain — from production and processing to distribution and consumption. The primary goal of an FSMS is to identify, control, and manage food safety hazards to ensure that the food reaching consumers is safe for consumption. Implementing an FSMS helps organizations comply with food safety regulations, meet customer requirements, and reduce the risk of foodborne illnesses.

Key components of a Food Safety Management System typically include:

  1. Hazard Analysis: Identify and assess potential hazards associated with the production and handling of food products. These hazards may include biological, chemical, and physical contaminants.
  2. Prerequisite Programs: Establish basic hygiene and operational practices that form the foundation for a food safety system. These may include sanitation, pest control, personnel hygiene, and facility maintenance.
  3. Critical Control Points (CCPs): Identify specific points in the production process where control measures can be applied to prevent, eliminate, or reduce food safety hazards to an acceptable level.
  4. Monitoring and Measurement: Implement procedures to monitor and measure processes and activities to ensure that they are operating within specified limits. This includes regular testing, inspections, and other forms of observation.
  5. Corrective Actions: Develop and implement procedures to address deviations from critical limits or other issues identified during monitoring. Corrective actions are taken to bring the process back into control and prevent the release of unsafe products.
  6. Verification: Periodically review and assess the effectiveness of the FSMS through activities such as internal audits, validation of control measures, and verification of monitoring procedures.
  7. Documentation and Record Keeping: Maintain accurate records documenting the implementation and performance of the FSMS. This documentation is crucial for demonstrating compliance with food safety requirements.
  8. Training and Communication: Ensure that personnel involved in food production and handling are adequately trained in food safety practices. Effective communication of food safety information is also essential.

The most widely recognized international standard for Food Safety Management Systems is ISO 22000, which provides a framework for establishing, implementing, maintaining, and continually improving an FSMS. Other standards, such as the Safe Quality Food (SQF) Code and the Hazard Analysis and Critical Control Points (HACCP) system, also contribute to the development and implementation of effective food safety management.

Implementing an FSMS helps organizations build a culture of food safety, enhance consumer confidence, comply with regulatory requirements, and prevent foodborne illnesses and product recalls.