USDA rules and regulations that could affect your business.
We assist in preparing inspection reports for export to Korea and China, and quarantine permits for export to quarantine.
We do in procedure every single year, to process it better, faster, and more accurate.
Our processes are all procedure-driven, and we do not veer away from that.
Our Company will do Vetnarinty feed, and pet food registration, and your business can help.
In the U.S. We can help simplify this process if you need assistance export to Korea, China and all of the worlds with your animal product,
Export health certificates for Korea must be endorsed PRIOR to the date the product is shipped. If the date the product is shipped precedes the date of endorsement of the export certificate, the shipment will be refused entry by Korea.
APHIS Veterinary Services (VS) will not back-date certificates. Export certificates are dated with the actual date they are endorsed. APHIS will also not be able to facilitate the release of shipments refused entry by the Korean authorities because the product was certified for export after the product was shipped. Exporters must ensure that the export certificates are endorsed prior to the date the product is shipped to Korea.
PET FOOD CERTIFICATES: STERILIZED VS. NON-STERILIZED
There are two certificates which can be used for the export of pet foods to Korea:
1. Veterinary Sanitary Certificate for the Export of Pet Food from the United States to Korea
2. Veterinary Sanitary Certificate for the Export of Sterilized Pet Food from the United States to Korea
Both of these certificates are available through the Korea home page of the International Animal Product Regulations. *Only one certificate may be issued per shipment.*
• Nutritional supplements intended for use in pets should be certified for export using one of the two pet food certificates.
• Although the certificates refer to pet food, Korea has requested that fish food containing animal-origin ingredients be certified using one of the two pet food certificates.
• Animal-origin, non-ruminant digests intended for use in pet food may also be certified for export using one of the two pet food certificates. Alternatively, poultry digests may be certified for export to Korea following the instructions on the International Animal Product Regulations for poultry digests.
• Digests intended for end-use OTHER than in pet food are currently prohibited entry into Korea.
Use of the “Veterinary Sanitary Certificate for the Export of Sterilized Pet Food from the United States to Korea” requires verification by VS that the pet food being exported has been subjected to one of the following heat processing treatments:
a. With moisture at a minimum of 121°C for at least 15-20 minutes; OR
b. With moisture at a minimum of 115°C for at least 35 minutes; OR
c. With dry heat at a minimum of 160-170°C for at least 1-2 hours
The Use of the certificate for sterilized pet foods may reduce the quarantine times and measures the shipment is subjected to upon importation into Korea. APHIS has verified, however, that U.S. origin pet foods should not be subjected to fumigation during quarantine in Korea so long as the United States is considered free of highly pathogenic avian influenza (HPAI) and foot-and-mount disease (FMD) – regardless of which certificate is used.
INSTRUCTIONS APPLICABLE TO BOTH PET FOOD CERTIFICATES
1. The manufacturing facility must be inspected annually by VS to document official supervision and
compliance with the required certification statements. Exporters interested in being approved to export pet foods to Korea should contact their pertinent VS Service Center to arrange for facility inspection.
2. The bilaterally negotiated certification statements found on the certificates may not be amended or revised. Statements must not be added or deleted without express permission from VS National Import Export Services (NIES) Riverdale.
NOTE: If exporters have an import permit or a waiver from Korea allowing alteration of the bilaterally negotiated certification statements, they should provide this documentation to the pertinent VS Service Center. The VS Service Center will consult with VS NIES Riverdale.
3. Exporters should complete the pertinent fillable pet food certificate and submit to the VS Service Center for endorsement.
* In instances when the exporter is NOT the manufacturer, the manufacturer must indicate on their shipping documentation (e.g. bill of lading, shipping manifest, letter of guarantee, etc.) that the product was produced under the requirements of Korea. This documentation must be provided to the VS Service Center with the request for certificate endorsement and must:
a. Clearly identify the pet food name, quantity, and lot number; and
b. Include one of the following statements:
- The product meets Korean requirements for pet food.
- The product meets Korean requirements for export on the non-sterilized pet food certificate.
- The product meets Korean requirements for export on the sterilized pet food certificate.
This lot-specific documentation may be provided to the VS Service Center by the exporter or the manufacturer, but ultimately the confirmation of eligibility must originate from the manufacturer.
The Service Center will print out the certificate on security paper using the VS Service Center letterhead stationery.
4. With the exception of fish, dairy, and egg ingredients, source animals from which raw materials for use in pet food production were obtained must have been subjected to antemortem slaughter inspection.
5. Animal-origin materials used in the pet food must be U.S. origin. This requirement applies only to mammalian and avian-origin ingredients. Fish ingredients do not need to be U.S. origin and are exempt from the certification statement: “The pet food is produced from U.S. origin animal ingredients.”
6. All pet food containing ruminant-origin proteins (except for milk, rawhide, and other dairy ingredients) is prohibited from importation into Korea.
7. Tallow containing a maximum level of 0.15% insoluble impurities by weight is permissible for inclusion in pet food exported to Korea and must be verified by laboratory analysis.
8. All pet food must be packaged and ready for retail sale.
*****Export to China: Pet Food (including treats and chews) containing animal-origin ingredients.********
This information pertains to pet foods, defined as commercially-processed, finished food (including snacks, treats, or chews) intended for feeding to companion animals (e.g. dogs, cats, or other non-livestock species kept as household pets); includes dry, canned and wet, and semi-moist products.
*********Facility Approval Process**********
Manufacturing facilities must be inspected and approved by APHIS Veterinary Services (VS) prior to export and annually to maintain approval to export. Please contact your pertinent VS Service Center for more information regarding the APHIS inspection and approval process. Manufacturing facilities must also be currently registered with the U.S. Food and Drug Administration.
New facilities will receive an APHIS approval number after APHIS inspection and approval. APHIS then submits the information to China’s General Administration of Customs (GACC), and GACC assigns the facility a Chinese approval number (NR-USA-XXX) and publishes the information on its website. A manufacturing facility must have both an APHIS and a Chinese approval number, and be listed on GACC’s website, for pet foods they produce to be eligible for export.
APHIS will submit facility updates to GACC on a monthly basis, and GACC will update its website within 20 working days of receipt. Once GACC updates its website, APHIS will notify the facility. It is the responsibility of the facility to confirm their information is listed accurately on the Chinese website and this may be verified through the Chinese importer.
In addition to the facility approval and registration process, the exporting company must complete a separate product registration process with China’s Ministry of Agriculture and Rural Affairs (MARA). Exporters are encouraged to work with their Chinese importers to accomplish this process. APHIS does not verify product registration prior to endorsement of certificates, therefore it is the exporter’s responsibility to ensure product eligibility prior to shipment.
China permits the inclusion of animal-origin ingredients derived from poultry, livestock (swine and ruminants), farmed terrestrial animals, aquatic animals (farmed or wild-caught), and bees. Ingredients derived from wild terrestrial animals, reptiles, amphibians, and insects other than bees are prohibited. All U.S. origin bovine (cattle and bison) ingredients authorized for domestic pet food production are allowed.
*****************Export Certification Requirements**********************
The fillable “Export Certificate for Animal Products” VS Form 16-4 may NOT be used for pet food certified under this protocol. The required letterhead certificate is available as a fillable PDF on the main China IREGs page. The certificate should be printed on security paper as is, and NOT transferred to the local VS office letterhead. The certificate may not be modified. The product that does not meet the requirements will not be permitted into China.
A notarized affidavit should be prepared with the required certification statements listed under the notarized affidavit line on the certificate. If assistance is needed in preparing a properly notarized affidavit, please work with the VS Service Center that will be endorsing the export certificate.
A. Leave the “Certificate Number” and “Date” blocks at the top of each certificate page blank.
[These sections will be completed by the VS Service Center endorsing the certificate.]
B. Under the statement “This office has on file a notarized affidavit from,” enter the name of the company providing the notarized affidavit. The affidavit should come from the manufacturer.
C. For statement #4, do not line out or otherwise alter this statement.
D. For statement #5, mark the applicable box [only one may be checked].
E. For statement #6, mark all applicable boxes. For imported bovine ingredients, do not line out or otherwise alter this statement.
F. For statement #9, mark all applicable boxes. Do not line out or otherwise alter this statement. Please submit copies of relevant negative lot-specific test results, as required per the facility’s approvals.
G. Leave the “Date,” “Signature,” “Printed name and title of the signatory,” and “VS Office issuing certificate” sections blank. [These sections will be completed by the VS Service Center endorsing the certificate.]
H. In the “Product” section I, the type of animal product(s) and the species of origin must be included, as well as quantity and unit of measure. No additional information should be included.
I. In the “Name and Address of Exporter” section II, the Chinese registration/approval number (NR-USA-XXX) must also be included. If the exporter is not the manufacturer, the manufacturing facility’s name, address, and the Chinese approval number must be listed in the “Manufactured by” section. If the exporter and the manufacturer are the same, list “SAME” in this section.
J. In the “Identification of Shipment” section IV, enter the pertinent information sufficient to link the products being exported with the certificate (e.g. container numbers, lot numbers, or other similar identifying information appearing on other export documents accompanying the shipment). Include the container and seal numbers if appropriate.
Lot-specific test results for Salmonella and Enterobacteriaceae are only required when pet foods are produced under the third processing option for dry and other products; endorsing officials should reference VS’ internal database to confirm whether test results are needed.
*****6 steps to successful exporting
APHIS can help US exporters meet the import requirements of other countries
Pet food companies that export, or want to export, can make it as painless as possible by following six steps. This article is based on the Animal and Plant Health Inspection Service (APHIS) guidelines and assumes the exporter is from the US. However, much of it applies to a pet food exporter from any country, but instead of APHIS, the home country's inspection service will be used.
The role of APHIS
The National Center for Import and Export (NCIE) is at the forefront of APHIS's effort to safeguard the health of US agricultural resources. Its many animal health experts work closely with other federal agencies, states, foreign governments, industry, trade associations, professional groups, and others to enhance international trade and cooperation while preventing the introduction of dangerous and costly pests and diseases.
The primary role of APHIS is to assist US exporters in meeting the import requirements of other countries. In this role, APHIS negotiates with foreign governments to establish export requirements. The agency also does the following:
• Inspects exporting facilities if required by the importing country.
• Maintains lists of approved facilities as needed and provides this information to foreign governments.
• Assists exporters when products are put on hold overseas.
• Explains APHIS policies to foreign officials and the general public.
The exporter's role
Countries may change their import requirements without notice. In all cases, the exporter has the responsibility of having their importer confirm with the responsible authority in the importing country the import requirements prior to shipping. The exporter should obtain any required animal health product certificates prior to shipping any product. Most countries will not recognize zoo sanitary certificates issued after products have shipped.
1. Use the right requirements
The Veterinary Services (VS) branch of APHIS has created the International Animal Product Export Regulations (IREGS) to provide exporters of certain animal-origin products with the requirements of importing countries. These IREGS are detailed at www.aphis.usda.gov/ncie/iregs/products/. IREGS are invaluable for finding the latest requirements for exporting pet foods to various countries around the world but should be verified with the importer in all cases, because countries may change their requirements at any time.
If you have any questions or concerns regarding the procedures and requirements to obtain a health certificate for an animal product being exported, you should contact the VS Area Office covering the area from where the product will be exported (or the area in which your office is located).
2. Prepare export certificate
Different countries require different paperwork. The VS Form 16-4 is the generic export certificate for animal products and can be obtained through your APHIS area office. It is only used for products that contain animal-origin ingredients.
For countries that do not accept the VS Form 16-4, APHIS uses "Letterhead Certificates." You can apply for one by contacting your Veterinary Services area office. Once you complete the appropriate form, the area office will copy it onto their letterhead, add a certificate number and then sign and seal it.
3. Have all documents
Any export certificate that indicates a product has been tested may not be endorsed until the test results have been verified. If a negative result is cited or a product is said to be "free" of something, lab results are needed. Test results must clearly support the statement listed on the certificate and relate to a lot of material being certified.
If a statement on the export certificate is not based on an affidavit, it must be confirmed by inspection. If the importing country requires the exporting facility to be inspected, make sure it is done prior to export. Remember, APHIS-NCIE will not sign a statement they cannot verify.
4. Obtain prior to export
Many countries, including the European Union (EU) countries, require export certificates to be endorsed prior to the date of export. APHIS will not predate or postdate an export certificate. VS area offices have been authorized to date export certificates with the date they are received in their office. Offices usually complete certificates in 24-48 hours. But, sometimes they may be delayed due to workload or movement of personnel.
5. Request timely re-inspections
To meet EU requirements, many facilities must be inspected and approved. Please note that the inspection date is the date the facility was physically inspected. The approval date is the date the facility was actually approved as meeting all the requirements. These dates can be weeks apart, so it's important for facilities to be aware of both dates. Facilities must be re-inspected one year from the inspection date. In order to prevent lapses in approval, exporters should start the re-approval process two months before the anniversary of your inspection date.
6. Make inspections efficient
If you are exporting to several different countries and will need several export certificates, ask that the APHIS inspector do as many inspections as possible at the same time.
Exporting your pet food products can be a confusing process and keeping up with the most up-to-date information can be difficult. The following resources can help.
Facilitating trade: USDA's National Center for Import and Export (NCIE) helps facilitate the trade of agricultural products through defining criteria for trade.
Import requirements: The International Animal Product Export Regulations (IREGS) site provides exporters with the APHIS understanding of importing countries' requirements for certain animal-origin products.
The USDA's Foreign Agriculture Service (FAS): provides links and information to the offices and responsible parties for countries around the world.
Export certificate forms: The VS Form 16-4 is the generic export certificate for animal products, and can be obtained through your APHIS area office.
Export data: The USDA's FAS is also a source of a plethora of export data from around the world.
Export basics: www.export.gov provides information regarding export basics, market information, tariff rates, trade leads, etc. It is a collaborative effort of 19 government agencies.
Market Access Program
US exports of pet food are growing and exceed $1 billion. The Pet Food Institute (PFI) uses the Market Access Program (MAP), which is part of the FAS within the USDA. MAP includes a program that matches marketing funds for promoting US pet foods in other countries.
The PFI MAP program was launched in 1993. The program currently operates in Japan, Mexico, China, Chile, Russia, Taiwan, and Central America. In 2007 PFI received US$1.3 million for the promotion of non-branded US pet food. PFI MAP activities focus on consumer education and outreach to veterinarians. The program is a major contributor to building markets and maintaining access for US products.
What exporters need to do
1. Make sure you are using the most current export requirements.
2. Properly prepare the export certificate and affidavit (if needed) to send it to the APHIS area office.
3. Have other documents as needed (test results).
4. Ensure that your certificate is obtained prior to the date of export.
5. If applicable, request reinspections of export facilities in a timely manner (two months prior to export).
6. Have as many export inspections done at one time as possible.