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I am a Very Small Importer, do I need to comply with FSVP?

First, yes.

If you meet the definition of Very Small Importer and elect to import foods as such, you are still required to have a DUNS number and comply with the identification requirements at entry, but you are subject to significantly relaxed requirements in other areas. For example, you are not required to complete hazard analyses on the foods that you import; nor are you required to have supplier evaluation nor perform supplier verification activities. In addition to the identification requirements, you are subject to the following:

  1. You must formally document that you meet the definition of Very Small Importer with respect to human food and/or animal food before initially importing food as a Very Small Importer, and thereafter on an annual basis by December 31 of each calendar year.
  2. You must obtain written assurance, before importing the food and at least every 2 years thereafter that your foreign supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 or 419 of the Federal Food, Drug, and Cosmetic Act, if either is applicable, and implementing regulations, and is producing the food in compliance wit sections 402 and 403(w) (if applicable) of the Federal Food, Drug, and Cosmetic Act.

See also, “Do I qualify as a Very Small Importer

Sources:

  • Federal Register Volume 80, Number 228, Page 74315 Sec 3 M. Very Small Importers
  • 21 CFR 1.512(b)
Updated on May 16, 2017

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