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Vitamins and Minerals

GUIDELINE FOR IMPORTATION #1122

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. A USDA Veterinary Service (VS) Import Permit is required for animal origin material that may pose a risk of introducing epizootic livestock or poultry diseases exotic to the United States. However, certain vitamins and minerals, and articles containing certain vitamins and minerals as their ONLY animal origin ingredients, may be imported without a USDA VS Import Permit provided the conditions of this guideline are met.

*IMPORTANT: Imported products containing plant materials may be subject to regulations enforced by USDA Plant Protection and Quarantine (PPQ). Please contact (301) 851-2046 for more information.

The U.S. Food and Drug Administration (FDA) also regulates the importation of 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 articles containing vitamin A derived from porcine gelatin, vitamins coated with porcine gelatin, or vitamin D3 derived from sheep wool grease as the only animal origin ingredients.

Articles containing the above referenced materials as the only animal origin ingredients will be allowed entry without a USDA VS Import Permit only when the shipment is accompanied by an official certificate issued by a full-time, salaried veterinarian of the national government of the country of export certifying that the article(s) contain 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.

2) 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 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, 2) from mushrooms, 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).


3) A USDA VS Import Permit will NOT be required for dicalcium phosphate derived from bovines.

Articles containing  bovine derived dicalcium phosphate as the only animal origin ingredient 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 all cattle


If the material to be imported cannot meet the criteria outlined in this guideline, a USDA VS Import Permit may be required.

USDA Veterinary Service Import Permit applications may be obtained several ways:

1. On-line at: http://www.aphis.usda.gov/animal_health/permits/
2. By writing/faxing to:

USDA, APHIS, VS
National Center for Import and Export
4700 River Road, Unit 40
Riverdale, MD 20737
(301) 851-3300 telephone
(301) 734-6402 fax

 

 



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