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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2017.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2017]
[CITE: 21CFR1.640]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A--GENERAL

PART 1 -- GENERAL ENFORCEMENT REGULATIONS

Subpart M--Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications

Accreditation of Third-Party Certification Bodies Under This Subpart

Sec. 1.640 Who is eligible to seek accreditation?

(a) A foreign government, agency of a foreign government, foreign cooperative, or any other third party may seek accreditation from a recognized accreditation body (or, where direct accreditation is appropriate, FDA) to conduct food safety audits and to issue food and facility certifications to eligible entities under this subpart. An accredited third-party certification body may use documentation of conformance with ISO/IEC 17021: 2011 or ISO/IEC 17065: 2012, supplemented as necessary, in meeting the applicable requirements of this subpart.

(b) A foreign government or an agency of a foreign government is eligible for accreditation if it can demonstrate that its food safety programs, systems, and standards meet the requirements of 1.641 through 1.645.

(c) A foreign cooperative or other third party is eligible for accreditation if it can demonstrate that the training and qualifications of its agents used to conduct audits (or, in the case of a third-party certification body that is an individual, such individual) and its internal systems and standards meet the requirements of 1.641 through 1.645.

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