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In previous articles we discussed the Food Safety Modernization Act (FSMA) and Foreign Supplier Verification Program (FSVP) as a FSMA rule that applies to US importers with direct implications on foreign suppliers. FSVP calls for supplier verification through onsite audits, product testing, or records reviews, depending on risk.

Cargo ship

While the process of supplier verification is not new to some importers, others have found it challenging, as it requires supplier collaboration and resources to educate suppliers and assess the effectiveness of the implemented verification activities. Accredited FSMA certification could therefore be a viable option for both importers and foreign suppliers.

On the international level, suppliers have been inquiring about the nature of the Preventive Controls audits. Some suppliers find themselves subject to multiple “FSMA audits” to comply with the requests of their clients – the US importers. This has created a need for a form of FSMA approval certification that would satisfy all importers.

Until April 2018 FSMA certification was a regulatory publication governed by the third-party accredited certification rule. However, following the recognition of Accreditation Bodies by the US Food and Drug Administration (FDA), its application has become practical, governed by Accreditation Bodies and the FDA.

So why would FSMA certification be of benefit to foreign suppliers?

  1. Accredited FSMA certification (or Voluntary Qualified Importers Program (VQIP) certification – the technical designation) is the only certification program recognized by FDA
  2. VQIP certification provides an FDA-recognized route for foreign (non-US) food suppliers to demonstrate FSMA compliance to their US importers
  3. VQIP certification is a prerequisite for US importers applying for the Voluntary Qualified Importers Program – for expedited entry of food into the US
  4. FDA may also request VQIP certification for high risk products and/or countries

VQIP certification requirements:

  • There are two kinds of VQIP audits:
    • Consultancy audit – for internal purposes (i.e. to prepare the company for certification)
    • Regulatory audit – the actual certification audit
  • Regulatory audit would have to be unannounced
  • Eligibility for certification is based on the company demonstrating compliance with all the applicable US regulations according to the products that they intend to sell to the US
  • Certification is also open to food categories that are not necessarily fully covered by the Preventive Controls rules, such as juices and seafood
  • FSMA certification is valid for one year, and can be renewed annually

VQIP Certification: Take-Home Points

  • Only for non-US suppliers
  • Prerequisite for VQIP
  • Only certification program recognized by the FDA
  • Third-party certification by FDA-recognized Accredited Bodies
  • Demonstrates FSMA compliance to US importers
  • Annual renewal

Which regulations should a company comply with?

The VQIP regulatory (certification) audit requires that all applicable US regulations be audited at the site. For example, the regulatory audit of a seafood facility would cover:

  • Preventative Controls for Human Food (21 CFR 117, subparts A, B, F)
  • Seafood HACCP (21 CFR 123)
  • Electronic Records and Signatures (21 CFR 11)
  • General (21 CFR 100)
  • Food Labeling (Part 101) – if applicable
  • Common or Usual Names for Non-Standard Foods (21 CFR 102) – if applicable
  • Food Standards General (21 CFR 130)

FSVP Certification

An alternative to VQIP certification has also been launched by the American National Standards Institute (ANSI) under the name “FSVP certification”. Although this certification is not the FDA recognized third party certification program, it could be an option for suppliers and their importers to demonstrate compliance.

With the above said, FSMA certification is finally here. While Certification Bodies and stakeholders are working towards developing the proper scheme requirements and processes for accreditation, it would be advisable for companies to start preparing for certification through pre-certification audits, employee training, and ensuring their environmental monitoring programs and product labels, as well as other product-specific aspects are in line with the US regulations.

For the complete range of SGS services and support visit SGS US FDA Food Safety Modernization Act.

For further information, please contact:

Hank Karayan
Global FSMA Program Director
t: +1 (201) 508 3000