Key Export Certifications and Documents U.S Manufacturers are Required to Have

Manufacturers in the USA aiming to export products internationally must have key export certifications to meet specific requirements in target countries. 

In this article, we’re diving into the essential export certifications U.S. manufacturers need to successfully enter global markets, meet regulatory requirements, and ensure smooth cross-border trade.

Read More: 9 Food Manufacturing Certifications Every U.S Business Should Pursue

Essential Types of Export Certifications Required

Here are the key types of export certifications required for manufacturers: 

a. FDA Certification (for Food, Drugs, and Cosmetics)

 The Food and Drug Administration (FDA) issues certificates for products in its jurisdiction, such as food, beverages, supplements, drugs, medical devices, and cosmetics. –

 The main certifications include:

• Certificate of Free Sale: Confirms the product is legally sold in the U.S.
• Health Certificate: Specifically for dairy, meat, and other perishable items to verify safety and compliance.

How to Obtain? 

1. Compile required documentation, including product composition, ingredient sources, processing standards, and safety protocols. 
2. Ensure that your facility is registered with the FDA, a mandatory step for all manufacturers in regulated industries. This registration confirms your product’s compliance with U.S. standards, which is essential for the issuance of export certificates.
3. Apply for the necessary export certificates through the FDA’s Certificate Application Process. This involves submitting your product details, supporting documentation, and evidence of U.S. market compliance.
4. The FDA will review your application to verify that your product meets safety, labeling, and regulatory requirements. Once approved, the FDA will issue the requested certification, like the Certificate of Free Sale or Health Certificate.

b. USDA Certification (for Agricultural Products)

The U.S. Department of Agriculture (USDA) provides certification for meats, poultry, eggs, dairy, and other agricultural goods. 

Key certifications include:

• APHIS Phytosanitary Certification: For plants and plant products to prevent pest and disease spread. 
• FSIS Export Certificate: Required for meat and poultry.

How to Obtain? 

1. Engage with the USDA’s Animal and Plant Health Inspection Service (APHIS) for phytosanitary certification or Food Safety and Inspection Service (FSIS) for meat and poultry. These agencies conduct inspections to ensure your product meets export standards.

2. Gather necessary documents, including ingredient lists, processing details, and pest control measures. APHIS and FSIS will review these to verify compliance.

3. Arrange for a USDA-authorized inspector to visit your facility. They will assess your production practices, hygiene, and product handling to confirm compliance.

4. Complete the USDA export certificate application, providing all required documentation and inspection results. Once approved, you’ll receive the relevant certification to accompany your exports.

c. Halal Certification

Muslim-majority countries require halal certification for food, cosmetics, and pharmaceuticals. Manufacturers must acquire Halal certifications from recognized organizations (e.g., American Halal Foundation) to ensure it is recognized by the importing country.

Halal Certification Requirements for Export 

Manufacturers seeking halal certification must meet several key requirements, which typically include:

• Sourcing of Ingredients: Only halal-certified or suitable are permitted.
• Production Process: Halal certification bodies will inspect production facilities to confirm adherence to hygiene, sanitation, and segregation standards.
• Supply Chain Integrity: Certain countries require maintaining halal integrity through the supply chain, which can mean additional documentation for shipping and handling.

Interested in exploring halal certification? Start off by filling this online application in less than 5 minutes!

e. Good Manufacturing Practice (GMP) Certification

Many countries require proof that manufacturing practices comply with GMP standards, ensuring product quality and safety, especially for pharmaceuticals and food. The FDA issues GMP certificates in the U.S., but ISO 22716 certification is also commonly recognized.

How to Obtain? 

1. Hire an FDA-authorized auditor or a third-party auditing body to conduct a formal GMP inspection. The auditor will assess your facility, practices, and documentation to ensure full compliance with GMP standards.
2. After a successful audit, submit an application for GMP certification, along with the auditor’s report and other supporting documentation, to the relevant certifying body (e.g., FDA for U.S. standards or an accredited ISO body for ISO 22716).

Check Out: GMP Checklist for Food Industry

Other Types of Export Certification Requirements

Here are some additional export certifications manufacturers can pursue: 

e. Organic Certification

For countries with stringent organic standards (like the EU or Japan), an organic certification compliant with the USDA Organic standard or equivalent is often required. This involves meeting specific farming, processing, and labeling standards.

f. ISO Certifications

 International Standards Organization (ISO) certifications demonstrate quality and environmental management compliance: 

• ISO 9001 (Quality Management)
• ISO 14001 (Environmental Management)
• ISO 22000 (Food Safety Management) – for food industry manufacturers

Key Documents Required for Exports

Here are key documents required for exports: 

#	Document	Description
1	Commercial Invoice	A detailed invoice specifying goods being exported, including product description, quantity, price, and payment terms. It is the primary document for customs duties.
2	Packing List	Lists contents of each package or container, including weight, dimensions, and packaging type, used by customs to verify shipment contents.
3	Bill of Lading (BOL)	A transport document issued by the carrier that serves as a shipment receipt and includes shipping terms and destination details; can be “straight” or “order.”
4	Certificate of Origin (COO)	Issued by a chamber of commerce, verifies the manufacturing country of goods. Often required to determine tariffs under trade agreements.
5	Export License	Required for certain restricted goods (e.g., pharmaceuticals, electronics). Issued by government agencies like the U.S. Department of Commerce.
6	Insurance Certificate	Proof of insurance for the shipment, protecting against loss or damage during transit, providing security for both exporter and importer.
7	Pro Forma Invoice	A preliminary invoice often requested by importers for quotation and pre-payment, including estimated costs, terms, and goods details.
8	Certificate of Analysis (COA)	Required for chemicals, pharmaceuticals, and ingredients, showing lab testing results to verify specifications, potency, and purity.
9	Certificate of Inspection	Required for certain goods to verify quality and compliance, often provided by third-party inspection agencies after product review.
10	Export Packing List	A more detailed packing list specifying how goods are packed for export, including container numbers and specifications.
11	Customs Declaration (SED)	Filed with customs in the exporting country, providing shipment details; often mandatory for shipments above specific value thresholds.
12	Dangerous Goods Declaration	Required for hazardous goods (e.g., chemicals, batteries), detailing the nature of goods and handling precautions necessary for safe transit.
13	Letter of Credit (LC)	A financial document issued by a bank, guaranteeing payment to the exporter upon meeting shipment terms; widely used in international trade.

Reach Out to AHF

Ensuring each essential certification is in place can make all the difference in avoiding delays, meeting international regulations, and safeguarding the value of your shipments. 

If you’re interested in exploring halal certification for exports, reach out to AHF at +1-(630)-759-4981 or simply mail us at info@halalfoundation.org!   

Frequently Asked Questions (FAQs) 

Q1. What are the essential export certifications for U.S. manufacturers?

A: U.S. manufacturers often need key export certifications such as FDA certification for food, drugs, and cosmetics, USDA certification for agricultural products, Halal certification for products entering Muslim-majority countries, GMP certification for quality assurance, and organic or ISO certifications, depending on target market requirements.

Q2. Why is Halal certification important for U.S. manufacturers exporting to Muslim-majority countries?

A: Halal certification is required in many Muslim-majority countries to ensure that food, cosmetics, and pharmaceuticals meet Islamic dietary and ethical standards. This certification builds trust with Muslim consumers and enables access to growing halal markets worldwide.

Q3. What are the essential documents needed for exporting products internationally?

A: To export internationally, key documents typically include a commercial invoice, packing list, bill of lading, certificate of origin, export license, insurance certificate, and, depending on the product, additional certificates like Certificate of Analysis (COA) or Certificate of Inspection.

Q4. What additional certifications might be required for exporting organic products?

A: For exporting organic products, an organic certification, often USDA Organic or an equivalent standard, may be required. This certification ensures that the product meets stringent organic farming, processing, and labeling standards in the target market.