SGS Informs Manufacturers on FDA Proposed Rule for Accreditation of Third Party Auditor and Certification Bodies

On 29 July 2013 the United States Food and Drug Administration (US FDA) published the proposed rule for the Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and Issue Certifications (1). This proposed rule is part of the Food Safety Modernization Act (FSMA). Comment period for this proposed rule ends 26 November 2013.

Fairfield, NJ, September 05, 2013 --( Accreditation of Third Parties to Conduct Food Safety Audits and for Other Related Purposes

The proposed regulation, as required by FSMA, will establish a system for accreditation of third-party auditors/certification bodies to conduct food safety audits of facilities outside of the United States and territories and to issue food and facility certifications. In this proposed regulation the US FDA has established the procedure to recognize accreditation bodies, the requirements and the recognition of those accreditation bodies. This regulation sets up the procedure and requirements for accreditation of third-party auditors/certification bodies. Additionally the recognition of accreditation of third-party auditors/certification bodies is established. The proposal includes requirements of the third party auditor/certification body to notify the US FDA of conditions in an audited facility that could cause or contribute to a serious public health risk. It also allows accredited third-party auditors/certification bodies to provide certificates of product and facility compliance to the Voluntary Qualified Importer Program (VQIP) or the Foreign Supplier Verification Program (FSVP) (SafeGuards 141/13 (

Eligibility Requirements

The proposed rule sets eligibility requirements for recognition as an accreditation body and third-party auditor. An accreditation body can be a foreign government agency or a private third-party. A third-party auditor can be a foreign government, foreign co-operative or other third-party. Both the accreditation body and the third-party auditors must meet standards for legal authority, competency and capacity, impartiality, quality assurance, and records procedures.

In the future the US FDA will issue qualification standards for auditors and certification bodies and issue the Model Accreditation Standards.

The US FDA plans to implement this program soon after the publication of the final rule and the final Model Accreditation Standards.

More information on FSMA and how to comment on the proposed regulations is available on the website of the Food and Drug Administration (


(1) “Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications” – US Federal Register

About SGS Food Safety Services

SGS is committed to keeping you informed of regulatory news and developments. Leveraging a 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. SGS continually invests in world class testing capabilities and state-of-the-art technology to help you reduce risks, and improve food safety and quality.

For further information do not hesitate to contact the SGS experts.

Contact details:

SGS Consumer Testing Services
James Cook
Food Safety Technologist
291 Fairfield Ave, Fairfield
New Jersey 07004, USA

t +1 973 461 1493

SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 75 000 employees, SGS operates a network of over 1 500 offices and laboratories around the world.
SGS Consumer Testing Services
James Cook
+1 973 461 1493