SAFEGUARDS | Food NO. 196/15

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On November 13, 2015, the United States Food and Drug Administration (US FDA) released the final rule on the Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications.[1] It will be published in the US federal register on November 27, 2015.

Certifications produced by this program can be used by foreign entities for participation in the Voluntary Qualified Importer Program (VQIP) and to prevent harmful produce being imported into the United States (US). The US FDA has the option to require specific foods being imported into the US to be accompanied by a certificate produced through this program. Programs will be assessed utilizing ISO 17021 instead of ISO 17065.

Requirements of Accreditation Bodies

  • Assess third-party certification bodies for accreditation
  • Monitor performance of third-party certification bodies
  • Assess and correct any problem that their accreditation body may have
  • Submit reports to the US FDA, maintain records of the program and provide US FDA access to them

Third-Party Certification Bodies

  • Ensure that their auditors are competent and objective
  • Verify the effectiveness of the corrective actions identified during the audit
  • Assess and correct any problem that their certification body may have
  • Maintain and provide US FDA access to records to the program
  • Accredited third-party certification bodies can be a foreign government, a third-party entity or individual

Two Types of Audit

Certification bodies will be allowed to perform two types of audit; consultative and regulatory. The consultative audit is a gap assessment of compliance to the regulatory standard, and standard industry practices. The regulatory audit is for compliance and certification.

Before this program can be implemented, the Model Accreditation Standard guidance, currently in draft form, must be finalized.[2] Once this is finalized then this program will be immediately implemented. The US FDA has proposed user fees [3] and draft guidance to the industry on how the Voluntary Qualified Importer Program (VQIP) [4] will work.

This program will not apply to foreign facilities producing alcoholic beverages and meat, poultry and egg products subjected to the United States Department of Agricultural Food Safety Inspection Service.

SGS is committed to keeping you informed of regulatory news and developments. Leveraging our global network of laboratories and food experts, SGS provides a comprehensive range of food safety and quality solutions, including analytical testing, audits, certifications, inspections and technical support. We continually invest in our world class testing capabilities and state-of-the-art technology to help you reduce risks, and improve food safety and quality. For further information please visit our website.

For enquiries, please contact:

James Cook
Food Scientific and Regulatory Affairs Manager
t: +01 973 461 1493

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