What Does It Mean to be GFSI Certified in an FSMA Environment?

What Does It Mean to be GFSI Certified in an FSMA Environment?

GFSI Certified in an FSMA Environment


FSMA stands for the “Food Safety Modernization Act” which is a set of laws enacted by the US government to ensure food safety and decrease the risk of foodborne illness. Congress enacted FSMA in response to dramatic changes in the global food system and in our understanding of foodborne illness and its consequences, including the realization that preventable foodborne illness is both a significant public health problem and a threat to the economic well-being of the food system. About 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, according to recent data from the Centers for Disease Control and Prevention. This is a significant public health burden that is largely preventable.

What is the FSMA Act?

The Food Safety Modernization Act (FSMA) enables FDA to better protect public health by strengthening the food safety system. It enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. The law also provides FDA with new enforcement authorities designed to achieve higher rates of compliance with prevention- and risk-based food safety standards and to better respond to and contain problems when they do occur. The law also gives FDA important new tools to hold imported foods to the same standards as domestic foods and directs FDA to build an integrated national food safety system in partnership with state and local authorities.

What does FSMA require of food facilities?

For the first time, FDA will have a legislative mandate to require comprehensive, science-based preventive controls across the food supply. This mandate includes:

  • Mandatory preventive controls for food facilities: Food facilities are required to implement a written preventive controls plan. This involves: (1) evaluating the hazards that could affect food safety, (2) specifying what preventive steps, or controls, will be put in place to significantly minimize or prevent the hazards, (3) specifying how the facility will monitor these controls to ensure they are working, (4) maintaining routine records of the monitoring, and (5) specifying what actions the facility will take to correct problems that arise.
  • Mandatory produce safety standards: FDA must establish science-based, minimum standards for the safe production and harvesting of fruits and vegetables. Those standards must consider naturally occurring hazards, as well as those that may be introduced either unintentionally or intentionally, and must address soil amendments (materials added to the soil such as compost), hygiene, packaging, temperature controls, animals in the growing area, and water.
  • Authority to prevent intentional contamination: FDA must issue regulations to protect against the intentional adulteration of food, including the establishment of science-based mitigation strategies to prepare and protect the food supply chain at specific vulnerable points.

How does FSMA impact US food imports?

The FSMA gives FDA unprecedented authority to better ensure that imported products meet U.S. standards and are safe for U.S. consumers. New authorities include:

  • Importer accountability: For the first time, importers have an explicit responsibility to verify that their foreign suppliers have adequate preventive controls in place to ensure that the food they produce is safe. (Final regulation and guidance due 1 year following enactment)
  • Third Party Certification: The FSMA establishes a program through which qualified third parties can certify that foreign food facilities comply with U.S. food safety standards. This certification may be used to facilitate the entry of imports. (Establishment of a system for the FDA to recognize accreditation bodies is due 2 years after enactment)
  • Certification for high-risk foods: FDA has the authority to require that high-risk imported foods be accompanied by a credible third-party certification or other assurance of compliance as a condition of entry into the U.S.
  • Voluntary qualified importer program: FDA must establish a voluntary program for importers that provides for expedited review and entry of foods from participating importers. Eligibility is limited to, among other things, importers offering food from certified facilities. (Implementation due 18 months after enactment)
  • Authority to deny entry: FDA can refuse entry into the U.S. of food from a foreign facility if FDA is denied access by the facility or the country in which the facility is located.

What are GFSI Schemes?

A food safety scheme is recognized by GFSI when it meets the food safety requirements defined in the GFSI Guidance Documents. GFSI is an organization that benchmarks and approves different auditing standards. There isn’t technically any single audit called “The GFSI Audit,” but there are several standards that are GFSI-benchmarked. GFSI benchmarked schemes include:

  • Primus GFS
  • Global Aquaculture Alliance Seafood
  • Global Gap
  • FSSC 22000
  • Global Red Meat Standard
  • Canadagap
  • SQF
  • BRCGS Global Standard
  • IFS International Featured Standards
  • Japan Food Safety Management Association

If you are a food processor or manufacturer in the United States you can choose any of the applicable GFSI schemes, though, getting a GFSI audit will most likely mean getting a BRCGS or SQF audit.

What are the benefits of GFSI Certification?

GFSI certification is a way for companies to demonstrate that their products meet the highest standards of food safety. Food safety is a large part of GFSI’s mission, which is why they created this program. The GFSI sets out quality standards to create an environment where consumers can safely buy and consume products without worrying about whether or not they will become sick from eating them.

The benefits of using GFSI-certified raw materials are clear: you can be sure that your product will meet all requirements when it comes down to it. In turn, this reduces overall costs associated with making sure your goods are safe enough for consumption by users around the world.


GFSI certification is a big deal and deserves some attention. As the world continues to look for ways to ensure food safety, GFSI certification will continue to be one of the most important standards in this industry.

How can Quality Smart Solutions serve you?

Firstly, QSS can help with formula review, product labeling, and nutrition facts creation (for Canada and the USA).

Secondly, we can also help with registering supplemented foods with TMALs (Temporary Market Authorization License) or reviewing when the new Supplemented Food Regulations are published. 

Thirdly, we help with Safe Foods for Canadians Regulations (HACCP, PCP, Import Licensing, and GRAS Notifications). 

Help with facility registration, FSVP agent, and US Agent. 

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