Vitamins and Minerals 1122

Vitamins and Minerals

GUIDELINES FOR IMPORTATION #1122 (revised July 2017)

Introduction:

Materials derived from animals, or produced with animal-origin ingredients, are potentially subject to U.S. Department of Agriculture (USDA) regulations and must be cleared by Department of Homeland Security (DHS) Customs and Border Protection (CBP) personnel at the port of arrival before entry into the United States is authorized. 

*IMPORTANT: Imported products containing plant materials may be subject to regulations enforced by

USDA Plant Protection and Quarantine (PPQ), Analysis and Support. Please contact USDA APHIS PPQ Quarantine Policy, Analysis and Support at (301) 851-2220 for more information. 

The U.S. Food and Drug Administration (FDA) also regulates the importation of foods for human consumption and animal feeds and ingredients intended for incorporation into animal feeds. FDA should be contacted regarding their import requirements:

FDA, Division of Import Operations and Policy, HFC-170
5600 Fishers Lane, Rockville, MD 20857
Telephone: (301) 796-0356
Web address: http://www.fda.gov/ora/import/
 

Background:

Most commercially derived vitamins and minerals are synthetically produced from non-animal origin ingredients. Exceptions include vitamin D3, vitamin A, and dicalcium phosphate.

Procedures:

  1. A USDA VS Import Permit will NOT be required for bulk shipments or articles containing vitamin A derived from porcine gelatin, vitamins coated with porcine gelatin, and/or vitamin D3 derived from sheep wool grease as the only animal origin ingredients (i.e., bulk shipment of animal-derived vitamin D3).

    Excluding those commodities that meet the terms of #2 or #3 below, bulk shipments or articles containing the above referenced materials will be allowed entry without a USDA VS Import Permit only when the shipment is accompanied by an original certificate issued by a full-time, salaried veterinarian of the national government of the country of export certifying the vitamin A derived from porcine gelatin, vitamins coated with porcine gelatin, and/or vitamin D3 derived from sheep wool grease as the only animal-origin ingredients.
  1.  A USDA VS Import Permit or Government Certification will NOT be required for fully finished food products for human consumption containing vitamin A derived from porcine gelatin, vitamins coated with porcine gelatin, or vitamin D3 as the only animal origin ingredients, or in combination with other exempted animal origin ingredients or  non-exempted animal origin ingredients such as milk and eggs when all applicable APHIS  import requirements for those other animal origin ingredients have been met. The fully finished food product must be commercially labeled and shelf-stable (not requiring refrigeration).

    Food products or articles containing vitamin A derived from porcine gelatin, vitamins coated with porcine gelatin, or vitamin D3 derived from sheep wool grease (lanolin) listed as animal origin ingredients will be allowed entry without a USDA VS Import Permit and without Government Certification only when meeting the description listed above.

    Examples of fully finished food products include the following as a partial, not all-inclusive list: candy and/or confectioneries, baking mixes, cocoa mixes, drink mixes, instant cake mixes, instant pudding mixes, liquid drink mixes containing reconstituted dry mix or dry milk products (including those containing sugar), pancake mixes, potato flakes, powdered infant formula, cookie fillings, fully baked goods (excluding moon cakes), egg protein shampoos, mayonnaise, dry plain pasta, dry plain noodles, salad dressings, sauces, pancake mixes, and cake mixes.
  1.  A USDA VS Import Permit will NOT be required for vitamin D3 derived from non-animal origin sources (e.g., recombinant yeast, lichen, or mushrooms).

    Articles other than fully finished food products for human consumption (as described above in #2) containing the aforementioned materials will be allowed entry without a USDA VS Import Permit only when the shipment is accompanied by a manufacturer’s declaration stating the vitamin D3:
    1. was produced 1) from lichen, or 2) from mushrooms, or 3) by a fermentation process using a genetically modified yeast, or 4) using a manufacturing process that does not include animal derived material [describe the process]; AND
    2. was not derived from any animal origin ingredients, including sheep wool grease (lanolin).
  1.  A USDA VS Import Permit will NOT be required for dicalcium phosphate being exported from a region that APHIS considers to be of negligible risk or controlled risk for BSE.

Articles containing dicalcium phosphate being exported from a region that APHIS considers to be of negligible risk or controlled risk for BSE will be allowed entry without a USDA VS Import Permit only when the shipment is accompanied by an original certificate signed by a full-time salaried veterinary officer of the national government of the exporting region, or issued by a veterinarian designated by the national government of the exporting region and endorsed by a full-time salaried veterinary officer of the national government of the exporting region, representing that the veterinarian issuing the certificate was authorized to do so.

The certificate must state the name and BSE risk classification of the exporting region and:

    1. The dicalcium phosphate contains no trace of protein or fat, OR
    2. The dicalcium phosphate originates from a region of negligible risk (name of the region) for BSE, OR
    3. The dicalcium phosphate originates from a region of controlled risk (name of the region) for BSE, is derived from bovines that have passed ante-mortem and post-mortem inspections, and does not contain SRMs as defined for regions of controlled risk for BSE in 9 CFR § 92.1. SRMS include: (a) Brain skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and the dorsal root ganglia from animals aged 30 months and older; (b) The tonsils and distal ileum of the small intestine from cattle.

If the material cannot meet the criteria outlined in this guideline, then a USDA, APHIS, VS import permit may be required.

IMPORT PERMIT:

The permit application and instructions, including information on the user fee and e-authentication, is available on our web site at http://www.aphis.usda.gov/animal_health/permits/.

The current permit processing fee is $150 and permit duration is one year.

Applications can be submitted by any of the following methods:

USDA, APHIS, VS
National Import Export Services (NIES)
4700 River Road, Unit 40
Riverdale, MD 20737
(301) 851-3300, Option 1

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