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On November 27th, 2015, the U.S. Food and Drug Administration (FDA) published a final rule establishing the Foreign Supplier Verification Program (FSVP), one of the seven major rules of FDA’s Food Safety Modernization Act (FSMA).  FSVP regulations place new responsibilities upon importers to verify that the food they import into the United States has been produced in a manner that meets US safety standards.  Importantly, the “food” that is covered by this final rule includes not only food for consumption and food additives, but also:

  • Food contact substances (FCSs), and
  • Substances that have both food and non-food uses, if the substance is reasonably likely to be directed to a food use.

What are Food Contact Substances?

FDA defines a food contact substance as “any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have any technical effect in the food.”  Examples of FCSs include polymers, can coatings, and sealants for lids.  An FCS is a single substance used to compose a Food Contact Material (FCM).  FCMs are then used to create Food Contact Articles, such as films, bottles, trays, etc.

What does this mean for importers?

U.S. importers of food contact substances will be required to monitor the manufacturers of the FCSs for compliance with FDA regulations and create verification programs for each FCS they import. The compliance date for most importers is May 27th, 2017 (18 months from the publication date of the rule).

In March 2016, FDA hosted a public meeting focused on FSMA’s provisions as they relate to importers. During the public comment session, there were several exchanges regarding the relationship between FCSs and FSVP.  FDA officials reiterated that FCSs did indeed fall under FSVP and revealed an interesting piece of information: FCSs are not covered by existing equivalency agreements, such as the one reached with New Zealand and those currently in the works for Australia and Canada.  Furthermore, FCSs will not qualify for the Voluntary Qualified Importer Program (VQIP).

Registrar Corp will inform industry as more information becomes available on the regulation of FCSs under FSVP.  It is prudent for importers to understand the FSVP regulations that apply to the products they import.  Assessing requirements under FSVP and starting the compliance process early may save you from costly mistakes later on.

Registrar Corp’s FDA Compliance Monitor allows importers to monitor their suppliers for Import Alerts and Warning Letters as required by FSVP.  For assistance determining what FSVP requirements apply to the products you import and how Registrar Corp can help you comply, contact +1-757-224-0177 or chat with a Regulatory Advisor 24-Hours a day at www.registrarcorp.com/livehelp.

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Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.

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