Frequently Asked Questions
Animals – Any member of the animal kingdom except a human including an animal product (e.g., a mount, rug, or other display item composed of the hide, hair, skull, teeth, bones, or claws).
Arthropods – Any living insect including crustaceans, spiders, scorpions, etc. capable of being a host or vector of human disease.
Snails – Any freshwater snails (phylum Mollusca, class Gastropoda) capable of transmitting schistosomiasis.
Bats – All live bats. See below for further information on obtaining an import permit for live bats. Bats may also require a permit from the U.S. Department of Interior, Fish and Wildlife Service. For additional information, see https://www.fws.gov/permits/?ref=topbarexternal icon.
Non-human primate material – All non-human primate material (e.g. blood, plasma, tissue, urine, feces) requires an import permit, unless it has been specifically treated and rendered non-infectious.
Please note that the described material may require a permit from the United States Department of Agriculture (USDA)/Animal and Plant Health Inspection Service (APHIS) or be prohibited from importation under the USDA regulations. Information on USDA transport or import permits is available at: http://www.aphis.usda.gov/import_export/index.shtmlexternal icon.
Please note that we are currently reviewing this information and it will be updated shortly. For any specific enquiries please contact the Customer Services team.
CITES (Convention on the International Trade in Endangered Species of Wild Fauna and Flora)
Some cell lines available from ECACC are derived from species covered by CITES. Depending on the classification of the species, a CITES export permit or both export and import permits may be required. This affects a small number of cell lines i.e. 19 from our General Cell Collection. For further information and to confirm whether a permit is required, visit www.cites.org where your country contact is listed.
Should your order require an export permit we will invoice a fee per permit to help offset our processing costs. This will be detailed in your delivery charges. If an import permit is required send a copy directly to the Culture Collections as we will need to include it with your shipment. Please note UK export applications take approximately 3 weeks.
If your order requires a CITES export permit it will be sent by airfreight (not by door-to-door courier) to the nearest customs clearing airport. This means that you will need to arrange to collect your order from the airport. You will be notified by the Culture Collections with the necessary information, e.g. airway bill number and flight details, to enable you to arrange timely collection of your order from customs. You may find it beneficial to engage a customs clearing agent to aid clearance through customs.
Import Permit Requirements - Ordering from Outside the EU
ECACC cell lines and DNA products are available through Sigma-Aldrich who will take care of all the import regulations for you.
The following instructions only apply if you choose to order direct through the Culture Collections. Please note the Toxic Substance Control Act information on this page which is relevant to all USA orders.
Cell Lines of Livestock and/or Avian Origin
United States Federal Law regulates the importation of biological materials. An import permit is required from the USDA (as per USDA Guideline #) for cell lines of livestock and/or avian origin. The Culture Collections will, as far as possible, provide the necessary documentation requested by the USDA to satisfy questions of origin and freedom from contamination. Once a permit is obtained send it directly to the Culture Collections as we will need to include it with your shipment.
Contact the USDA for further information:
Address: USDA, APHIS, VS
National Center for Import and
River Road, Unit 39
Primate, Fish, Human and Rodent Cell Lines
Under the USDA guidelines, cell lines and products of cell lines which:
- Are not derived from livestock or avian species
- Are for in vitro use
- Have not been exposed to livestock or avian disease agents exotic to the United States
- Do not produce antigens or contain genes of livestock or avian disease agents or do not produce monoclonal antibodies directed against livestock or avian disease agents
may be imported without an USDA permit. Therefore primate, fish, human and rodent cell lines do not require an import permit from the USDA (see USDA Guideline #). For further information about import regulations refer to the USDA website www.aphis.usda.gov.
There are no special import requirements for DNA
For import of NCTC LENTICULE Discs into the USA an import permit from the CDC is required.
Toxic Substances Control Act (TSCA) - relevant to all USA orders
All chemical imports to the USA are subject to the Toxic Substances Control Act. The Culture Collections Terms and Conditions of Supply state items supplied are to be used for "research purposes only" and as such, cell lines and cell products being imported from the Culture Collections qualify for R&D exemption under Section 5(h)(3) of the TSCA. However, the importer (yourself) will need to certify compliance with Regulations 40 CFR (cc), , and These sections relate to procedural, record keeping and R&D requirements and can be found using the following website address: www.gpoaccess.gov/cfr/index.html
To complete the import documentation we require a FAX containing the following signed statement:
"I certify that all chemical substances in this shipment comply with all applicable rules or orders under TSCA and that I am not offering a chemical substance for entry in violation of TSCA or any applicable rule or order under TSCA."
Your order cannot be shipped without this signed statement. A form including this statement (TSCA Compliance Form) can be printed from the Culture Collections website. We will keep your certification on file for your future shipments. Please inform us if your certification becomes invalid. The Culture Collections will provide all the necessary documentation to accompany orders and cannot be held responsible if packages are delayed in US customs.
Health Canada has introduced regulations to control the importation of cell lines into Canada, and to ensure that adequate facilities exist for proper laboratory handling and containment of these pathogens. These regulations allow Health Canada to assess, control and manage the risk of inadvertent transmission of communicable disease caused by imported pathogens.
The regulations came into effect in An application to import cell lines into Canada must be submitted to Health Canada. After evaluation and approval by Health Canada, an import permit will be issued which must accompany the shipment of the cell line into Canada. A single- or multiple-entry permit will be issued according to the particular situation. Once a permit is obtained send it directly to the Culture Collections as we will need to include it with your shipment.
The Office of Laboratory Security, Health Canada, issues permits for the importation of cell lines. For further details contact:
Office of Laboratory Security
Colonnade Road, Loc. : A
Ottawa ON K1A 0K9
For import of NCTC LENTICULE Discs into Canada an import permit from Health Canada is required.
ECACC cell lines are available through Sigma-Aldrich who will take care of all the import regulations for you. The following instructions only apply if you choose to order direct through the Culture Collections.
All cell lines imported into Australia require a permit issued by the Australian Quarantine and Inspection Service (AQUIS). Further details can be obtained by contacting AQUIS on + 61 2 or the AQUIS office in your State or Territory. Once a permit is obtained send it directly to the Culture Collections as we will need to include it with your shipment.
The National Department of Agriculture (NDA) and the Department of Health have a regulatory function with respect to the import of cell lines to South Africa. The origin of the cell line dictates which office you need to contact. Before sending your order to the Culture Collections contact both of these organisations to ensure that the correct procedure is followed.
The National Department of Agriculture
Department of Health
Private Bag X
TSCA Requirements for Importing Chemicals
TSCA Import Certification Requirements
Imports of chemical substances, mixtures or articles that contain a chemical substance or mixture must comply with the Toxic Substances Control Act (TSCA) in order to enter the U.S. Importers must certify that imported chemicals either comply with TSCA (positive certification) or, if not otherwise clearly identified as a chemical excluded from TSCA, are not subject to TSCA (negative certification).
The requirements are described in section 13 of the Toxic Substances Control Act (TSCA) (15 U.S.C. ) and in implementing regulations developed by the U.S. Customs and Border Protection (CBP), in consultation with EPA, at 19 CFR through In addition, EPA has a companion policy statement on chemical imports at 40 CFR (PDF) (3 pp, kb).
Who Must Certify
A certification must be signed and filed electronically or in writing with CBP by the importer or an authorized agent of the importer. A certification must also include the certifier's name, email address, and telephone number. Certification is required for substances that are imported and are received by mail or commercial carrier, including those intended for research and development.
Certifications filed electronically must be filed in the Automated Commercial Environment (ACE).
For paper certification, the statement must be typed, preprinted on the invoice, or otherwise included in the entry documentation and must be filed with the director of the port of entry before release of the shipment.
An importer's statement must certify either that the chemical shipment is:
- subject to TSCA and complies with all applicable rules and orders (positive certification)
- or that the chemical shipment is not subject to TSCA (negative certification)
Positive Certification Statement:
The following is a positive certification statement.
"I certify that all chemical substances in this shipment comply with all applicable rules or orders under TSCA and that I am not offering a chemical substance for entry in violation of TSCA or any applicable rule or order thereunder."
A positive certification means that the chemical substance complies with all applicable TSCA regulations, including:
- Section 5 premanufacture notification rules
- Section 5 significant new use rules
- Section 5(e) orders
- Section 5(f) rules and orders
- Section 6 rules and orders
- Section 7 judicial actions
- Title IV rules and orders
Note that sections 4 and 8 rules do not pertain to section 13 import certification requirements. Although importers must satisfy all applicable requirements of sections 4 and 8 rules, compliance with those provisions is not related to individual chemical shipments and therefore does not affect import certification.
Negative Certification Statement:
The following is a negative certification statement.
"I certify that all chemicals in this shipment are not subject to TSCA."
A negative certification is required for the following products when not clearly identified:
- Any pesticide
- Any food, food additive, drug, cosmetic or device
- Source material, special nuclear material, or by-product material
- Firearms and ammunitions as defined in section 3 of TSCA
Note that these products may be considered clearly identified when they are associated with another relevant agency’s entry documentation or electronic entry filing requirements (e.g., Notice of Arrival for pesticides or applicable entry documentation for FDA regulated products).
No certification is required for the following:
- Chemicals that are a part of articles, unless required by a specific rule under TSCA
- Tobacco or tobacco products
Section 6 TSCA Requirements for Specific Chemicals
Some chemicals have specific import and export requirements under section 6 of TSCA. These chemicals include, but aren't limited to PCBs, mercury, and, asbestos.
Import of New Chemicals and New Uses of Chemicals
TSCA section 3(7) defines the term "manufacture" to include import. This means that the section 5(a)(1)(B) requirement to submit a pre-manufacture notice ("PMN") to EPA at least days before commencing non-exempt commercial manufacture of a new chemical substance in the United States applies to the import of new chemicals, as does the section 5(a)(2) significant new use notice ("SNUN") requirement. Thus, the intended import of chemical substances can trigger the following provisions:
Learn more about EPA's new chemicals program.
Import Requirements in TSCA Section 5(e) Orders and Section 5(a)(2) Significant New Use Rules
When appropriate, EPA issues section 5 regulatory requirements on new chemicals or significant new uses of chemicals via a TSCA section 5(e) order or section 5(a)(2) significant new use rule (SNUR, 40 CFR Part or Subparts L and M).
TSCA section 5(e) orders may include use prohibitions, labeling and Safety Data Sheet (SDS) requirements, restrictions on the amount of the chemical allowed to be manufactured (including imported), as well as other restrictions. (The import/production limits often serve as triggers for toxicity or related testing requirements.) SNURs require notifying EPA at least 90 days before manufacture (including import), or processing for uses/activities designated by EPA as a significant new use.
To comply with these requirements when applicable, chemical substances must:
- Not be imported for any prohibited use
- Satisfy all applicable labeling and MSDS requirements
- Not exceed any specified restrictions on permissible import volume
- Not be imported for any designated significant new use
- Comply with any other applicable requirements
Importation of TSCA Title VI Regulated Articles (Formaldehyde Emission Standards for Composite Wood Products)
The TSCA Title VI import certification requirement applies to composite wood products (i.e., panels of hardwood plywood, particleboard, medium density fiberboard, and thin-medium density fiberboard), component parts containing such composite wood products, and finished goods containing such composite wood products that are imported into the U.S. beginning March 22,
Under the TSCA Title VI regulation, importers must also:
- Keep Records. Take reasonable precautions by retaining, for three years, bills of lading, invoices, or comparable documents that include a written statement from the supplier that the composite wood products (or component parts/finished goods) are TSCA Title VI compliant.
- Provide Records on Request. When EPA requests, make available within 30 days records identifying 1) the panel producer and the date the composite wood products were produced; and 2) records identifying the supplier, if different, and the date the composite wood products (or component parts/finished goods) were purchased.
Learn more about the TSCA Title VI program and access rule resources and guidance material. Review the TSCA Tip Sheet for Filers and CATAIR guidance.
US Import Documents
Importing Drosophila into the U.S. and moving Drosophila between states
It is illegal to import any item into the U.S. without describing it accurately on customs documents. Live animals must be listed by species name on customs declaration forms. Customs inspectors expect to see appropriate documentation with shipments of live animals. If documentation is not provided, shipments will likely be returned to the shipper, delayed in delivery or destroyed.
It is also illegal to move some animals across state lines without documentation.
The kinds of documentation needed for importation or interstate movement of Drosophila strains depend on the genetic details of the strains. Here we outline U.S. Department of Agriculture practices with respect to Drosophila melanogaster. If you are working with another Drosophila species, see importation and interstate movement of non-melanogaster Drosophila strains.
Importing Drosophila melanogaster strains
Any Drosophila melanogaster strain will fall into one of three categories with respect to USDA regulations and import documents.
Some strains that carry transgenic microorganisms and some transgenic strains that carry sequences associated with select agents or biased inheritance require special permits. It is important that you review our webpage on permits for these "nonroutine” strains carefully to determine if they are relevant to you.
If you are absolutely sure that a transgenic strain does not fall into one of the categories of “nonroutine” strains, then it can be imported using documentation for “routine” transgenic strains.
All other strains—nontransgenic strains not carrying transgenic microorganisms—require a permit for "routine" nontransgenic strains.
Using import documents
Depending on the strains being imported, a shipment may need to transit through a USDA inspection station at a port of entry on its way to you. If you wish to import more than one kind of strain in a single shipment, you will need to include all the appropriate documents. For details, see What should I do with import documents once I receive them?
Interstate movement of Drosophila melanogaster strains
No permits are required for transporting Drosophila melanogaster strains among the continental U.S. states unless the strains fall into one of the nonroutine classes, where an Interstate Movement Permit may be required.
If you have a permit for importing strains from another country, you do not need an Interstate Movement Permit for transporting the shipment from the U.S. border to you.
Carrying Drosophila cultures on airline flights
and why it's a really bad idea.
What about old-style permits?
We revised these webpages in April to reflect new USDA regulations and practices. Can I still use the old paperwork?
If you have read the webpages above and still want more information, take a look at Background on USDA regulations and practices.
Statement for customs usda
Stakeholder Alert: USDA APHIS Permanent Allowance of Copies of Veterinary Health Certificates for Select Animal Product and Byproduct Imports
Stakeholder Alert: USDA APHIS Permanent Allowance of Copies of Veterinary Health Certificates for Select Animal Product and Byproduct Imports
The United States Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) will continue to efficiently support trade of animal origin commodity imports by permanently implementing the use of copies of health certification for select animal products and byproducts.
APHIS has provided the following guidance to U.S. Customs and Border Protection (CBP) agriculture specialists assigned to review required import information for animal products and byproducts regulated by USDA APHIS. This guidance replaces previous editions that were communicated with CBP.
CBP’s agriculture specialists may accept all import documents ‒ including veterinary certificates ‒ uploaded to the Automated Commercial Environment (ACE) Document Image System (DIS) regardless of disease status of the exporting country. ACE is the United States’ single window customs system used by CBP to collect information on imports (import declarations). ACE manages DIS to collect scans of documents and requires specific customs brokerage software. Acceptable import documents include veterinary certificates, endorsed by a full-salaried veterinarian of the exporting country, and other supporting documents for veterinary import permit requirements.
USDA APHIS continues to require original hard copy veterinary health certificates, endorsed by a full-salaried veterinarian of the exporting country, under the following conditions:
Shipments of high-risk products:
- Bovine serum: fetal bovine serum, newborn calf serum, calf serum, donor bovine serum, adult bovine serum from all countries; and
- Fresh and/or frozen meat and poultry from all countries in situations when the original hard copy veterinary health certificate has not been provided to USDA’s Food Safety and Inspection Service (FSIS). If the original certificate has been provided to FSIS, CBP agriculture specialists may accept a copy of the certificate uploaded to ACE-DIS.
Stakeholders are reminded that APHIS Core Message Set data must be submitted in the ACE when an APHIS permit or foreign government certificate is required by APHIS as a condition for import of the commodity. The permit and/or certificate number and other identifying information must be accurately and thoroughly entered in the Message Set. When both permit and certificate are present, be sure to include both in the APHIS Core Message Set. Failure to submit required APHIS Core Message Set data may result in agriculture holds being placed on shipments, subjecting the shipment to entry delays or refusal.
Shipments arriving in the United States without a veterinary health certificate, either original or copy uploaded into ACE-DIS, will be refused entry, or held until the required documents are received. If there is reason to believe a certificate uploaded into ACE-DIS is fraudulent, CBP retains the shipment on hold until the original hard copy veterinary health certificate is reviewed and verified.
For any questions regarding import of animal products and by-products, please contact Animal Product Imports at and select option 4, or send via e-mail to [email protected]
Please share the following link with others who may be interested in these updates. Click here to subscribe to the VS Animal Health Stakeholder Registry. This link will also allow you to change or cancel your subscriptions.
Guidance on the Lacey Act Declaration
The Lacey Act (16 U.S.C. et seq., the Act) as amended makes it unlawful to import, export, transport, sell, receive, acquire, or purchase in interstate or foreign commerce any plant, with some limited exceptions, taken or traded in violation of the laws of the United States, a U.S. State or a foreign country. Since , the U.S. Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS) has been phasing in the Lacey Act declaration requirement. The products that require a Lacey Act declaration are listed by Harmonized Tariff Schedule (HTS) Chapter or Heading on the APHIS Lacey Act program website.
APHIS continues to evaluate products to include in future phases and publishes notices in the Federal Register to keep stakeholders and the public informed. The most recent Notice of Phase VI enforcement schedule was published on March 31 for public comment.
PPQ Form Plant and Plant Product Declaration
The Lacey Act requires an import declaration upon importation. Customs and Border Protection (CBP) has automated the process for collecting the PPQ Form data elements. Data will be transmitted to CBP's Automated Commercial System (ACS) through the Automated Broker Interface (ABI) in the cargo release and entry summary modules. A declaration is required to obtain release of most products if filing in ACE. Electronic filing of the PPQ declaration will not preclude remote location filing. Additional information on how to electronically file the PPQ data can be found in the Participating Government Agencies chapter in the Customs and Trade Automated Interface Requirements (CATAIR) page. An importer has the option to complete and present a paper Plant and Plant Product Declaration Form PPQ for each line. If a paper form is used, the importer must mail the form to USDA at the address on the form. Importers may also file electronically in USDA, APHIS’ web-based system, “Lacey Act Web Governance System (LAWGS). Contact APHIS for information about this option.
For All Importers
CBP expects and urges most importers to use ACE to file the declaration. CBP also advises importers not to use the PPQ Form if they intend to file the declaration in ACE. If an entry package is presented to CBP to obtain release, the CBP form will be annotated in Box 29 to indicate "PPQ Paper" if the declaration is presented in paper or "PPQ ABI" if the declaration information was submitted electronically. If an original, signed paper form is submitted to CBP as part of the entry package, the paper form will be returned to the importer (or importer's representative) for mailing to USDA. CBP will not mail forms to USDA. As a reminder, providing false or misleading information to the U.S. government can result in civil or criminal actions against any involved party and may result in the seizure and forfeiture of the merchandise.
APHIS has been designated the lead regulatory agency for these requirements and CBP is assisting APHIS with the electronic collection of data to fulfill the import declaration requirement. CBP will continue to work as part of the interagency working group, consulting with trading partners, importers, exporters, and other interested groups as the provisions of the Act are fully implemented. The most current information on implementation of the amended Lacey Act and additional information about electronically filing the declaration can be found on the USDA website at https://www.aphis.usda.gov/plant_health/lacey_act.
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Common Export Documents
When it comes to selling and shipping your products outside of the United States, there are standard documents used for exporting. To know which documents are needed for an export shipment, the best place to start is your foreign customer/importer or a freight forwarder. By obtaining correct information, you are helping your customer efficiently clear the goods with customs in the target market.
Commonly Used Export Documents
Pro Forma Invoice
A pro forma invoice is an important document used as a negotiating tool between the seller and the buyer prior to an export shipment. This document should be used by the seller to quote at the beginning of an export transaction and it will eventually become the final commercial invoice used when goods are cleared through customs in the importing country. The document contains a description of goods (e.g., quantity, price, weight, kind and other specifications) and is a declaration by the seller to provide the products and services to the buyer at the specified date and price.
The commercial invoice is a legal document between the exporter and the buyer (in this case, the foreign buyer) that clearly states the goods being sold and the amount the customer is to pay. The commercial invoice is one of the main documents used by customs in determining customs duties. A commercial invoice is a bill for the goods from the seller to the buyer. These documents are often used by governments to determine the true value of goods when assessing customs duties. Governments that use the commercial invoice to control imports will often specify its form, content, number of copies, language to be used and other characteristics.
Considerably more detailed and informative than a standard domestic packing list, an export packing list lists seller, buyer, shipper, invoice number, date of shipment, mode of transport, carrier, and itemizes quantity, description, the type of package, such as a box, crate, drum, or carton, the quantity of packages, total net and gross weight (in kilograms), package marks and dimensions, if appropriate. Both commercial stationers and freight forwarders carry packing list forms. A packing list may serve as conforming document. It is not a substitute for a commercial invoice. In addition, U.S. and foreign customs officials may use the packing list to check the cargo so the commercial invoice should reflect the information shown on the packing list.
Air freight shipments require airway bills. An air way bill accompanies goods shipped by an international air carrier. The document provides detailed information about the shipment and allows it to be tracked. Air waybills are shipper-specific and are not negotiable documents (as opposed to “order” bills of lading used for vessel shipments).
Bill of Lading
A bill of lading is a contract between the owner of the goods and the carrier (as with domestic shipments). For ocean shipments, there are two common types: a straight bill of lading, which is non-negotiable, and a negotiable, or shippers order bill of lading. The latter can be used to buy, sell or trade the goods while in transit. The customer usually needs an original bill of lading as proof of ownership to take possession of the goods from the ocean carrier.
Export Compliance Documents
Electronic Export Information Filing (EEI) is the electronic export data as filed in the Automated Export System (AES). This data is the electronic equivalent of the export data formerly collected as Shippers Export Declaration (SED) information. The EEI must be electronically filed via the Automated Export System online, which is a free service from Census and Customs. It is required for any shipments with items per Schedule B number exceeding $2,* in value and for shipments of any value requiring an export license.
A complete guide to filing electronic export information in the Automated Commerce Environment (AESDirect) is an excellent resource. See EEI and AESDirect. To sign up and log into the ACE system directly, visit the portal at U.S. Customs and Border Protection.
*Note: The EEI is required for shipments to Puerto Rico, the U.S. Virgin Islands and the former Pacific Trust Territories (unless each “Schedule B” item in the shipment is under $2,) even though they are not considered exports. Shipments to Canada do not require an EEI except in cases where an export license is required. (Shipments to third countries passing through Canada do need an EEI.)
U.S. Principal Party in Interest (USPPI)
The USPPI, a required field in the EEI as defined in the Foreign Trade Regulations (“FTR”), is the person in the United States that receives the primary benefit, monetary or otherwise, of the export transaction. The attached article describes responsibilities of the USPPI, and offers a handy checklist to assure compliance with U.S. export regulations.
An export license is a government document that authorizes the export of specific goods in specific quantities to a particular destination for a particular end-use. This document may be required for most or all exports to some countries or for other countries only under special circumstances. Examples of export-license certificates include those issued by the U.S. Department of Commerce’s Bureau of Industry and Security (dual use articles), the State Department’s Directorate of Defense Trade Controls (defense articles), the Nuclear Regulatory Commission (nuclear materials), and the U.S. Drug Enforcement Administration (controlled substances and precursor chemicals).
Destination Control Statement
A Destination Control Statement (DCS found in part of the BIS Export Administration Regulations, or EAR) is required for exports from the United States for items on the Commerce Control List that are outside of EAR99 (products for which no license is required) or controlled under the International Traffic in Arms Regulations (ITAR). A DCS appears on the commercial invoice, ocean bill of lading, or airway bill to notify the carrier and all foreign parties that the item can be exported only to certain destinations. For more information, visit the Bureau of Industry and Security website.
Depending on the type of product, nature of transaction (i.e. standard or temporary shipment), and destination country, you may be required to submit additional export documentation. This could include a generic or FTA certificate of origin, ATA Carnet, letter of credit, or other documentation. For more information, see Special Documents Used in Export Transactions.
Also, visit the Country Commercial Guides prepared by our in-country trade exports at U.S. embassies abroad. Each guide includes chapters on how to do business with a particular country. Among the chapters are “Selling U.S. Goods and Services,” and ”Customs Regulations and Standards” section which highlights the requirements and documentation for a particular country of interest. See an example for shipment to China.