What Regulatory Documents Are Needed for Importing Plant Oils into the U.S.?

Essential documents and regulatory compliance for successful plant oil imports

TL;DR: Importing plant oils into the U.S. requires 5 essential documents: Phytosanitary Certificate, Certificate of Analysis (COA), Customs Entry Forms, TSCA Certification (for non-food oils), and FDA Prior Notice (for food-grade oils). The specific requirements depend on your oil’s intended use.

Quick Reference Table – Essential Documents at a Glance

Document	Required For	Issuing Authority	Timeline
Phytosanitary Certificate	Unprocessed/minimally processed oils	National Plant Protection Organization (NPPO)	14-21 days
Certificate of Analysis (COA)	All plant oils	Third-party laboratory	5-10 days
Customs Entry Forms (CBP 7501)	All imports	U.S. Customs and Border Protection	Day of arrival
TSCA Certification	Non-food oils (industrial/aromatherapy)	Environmental Protection Agency	Immediate
FDA Prior Notice	Food-grade oils	Food and Drug Administration	2-15 days before arrival

Quick Answer – The 5 Essential Documents You Need

Successfully importing plant oils into the United States requires careful preparation and documentation. Here are the 5 must-have documents every importer needs:

✅ Document Checklist

1. Phytosanitary Certificate – Proves your oils are pest-free
2. Certificate of Analysis (COA) – Verifies purity and composition
3. Customs Entry Forms – Declares shipment details to CBP
4. TSCA Certification – Required for non-food oils
5. FDA Prior Notice – Mandatory for food-grade oils

Key Insight: The U.S. essential oils market is valued at $12.47 billion in 2024 and projected to reach $27.82 billion by 2032, according to Fortune Business Insights. This massive growth makes proper documentation absolutely critical for importers.

Understanding Plant Oil Categories and Their Requirements

Not all plant oils face the same regulatory scrutiny. Understanding your oil’s classification is the first step toward compliance success.

Food-Grade Plant Oils (FDA Requirements)

Food-grade plant oils, including popular options like evening primrose oil for dietary supplements, face the strictest regulations under FDA oversight.

Primary Requirements:

• FDA Prior Notice through the Prior Notice System Interface (PNSI)
• Good Manufacturing Practices (GMP) compliance (21 CFR Part 111)
• Facility Registration under the Bioterrorism Act of 2002
• Proper labeling with common ingredient names

FDA Prior Notice system interface for food-grade oil imports

Industry Data: According to USA Customs Clearance, the U.S. imported over $3 billion in olive oil in 2024 alone, demonstrating the massive scale of food-grade oil imports.

Cosmetic Plant Oils (FDA Requirements)

Cosmetic oils follow FDA regulations but with different compliance pathways than food-grade oils.

Key Requirements:

• Common or usual names on labels (not Latin names)
• No therapeutic claims (avoid terms like "treats," "cures," "prevents")
• Fair Packaging and Labeling Act compliance
• Voluntary Cosmetic Registration Program (VCRP) participation recommended

Pro Tip: Many eucalyptus essential oil applications fall under cosmetic use, requiring careful attention to labeling requirements.

Industrial/Aromatherapy Plant Oils (EPA Requirements)

Industrial and aromatherapy oils fall under EPA jurisdiction through the Toxic Substances Control Act (TSCA).

Critical Requirements:

• TSCA Certification (positive or negative) via CBP’s ACE system
• Chemical substance compliance verification
• Environmental impact assessment for certain oils

EPA TSCA certification process for industrial plant oils

Step-by-Step Document Checklist

Before You Ship – Supplier Documentation

Phase 1: Verify Supplier Credentials (30-45 days before shipping)

1. Request Certificate of Analysis (COA)

   • Verify third-party laboratory certification
   • Check for heavy metals, pesticides, and contaminant testing
   • Confirm GMP compliance documentation

2. Obtain Phytosanitary Certificate

   • Contact exporting country’s National Plant Protection Organization
   • Allow 14-21 days for processing
   • Ensure certificate covers your specific oil type

Quality Assurance Note: According to Eurofins USA, up to 17.5% of certain supplements may be adulterated, making COA verification absolutely critical.

During Import – Government Forms

Phase 2: Government Documentation (2-15 days before arrival)

3. Submit FDA Prior Notice (Food-grade oils only)

   • Use FDA’s Prior Notice System Interface (PNSI)
   • Include manufacturer details, arrival port, and product specifications
   • Submit 2-15 days before shipment arrival

4. Complete TSCA Certification (Non-food oils)

   • File through CBP’s Automated Commercial Environment (ACE)
   • Declare positive or negative TSCA compliance
   • Required for industrial and aromatherapy applications

5. Prepare Customs Entry Forms

   • Complete CBP Form 7501 (Entry Summary)
   • Determine correct HTS code (e.g., 1515.90 for Evening Primrose Oil)
   • Arrange customs bond for food-grade oils

CBP customs clearance process for plant oil imports

After Arrival – Compliance Verification

Phase 3: Port Clearance (Day of arrival)

• USDA APHIS inspection for pest verification
• CBP review of all documentation
• FDA inspection (if selected for examination)

Agency-Specific Requirements Made Simple

FDA Requirements (Food & Cosmetic Oils)

The FDA’s regulatory framework ensures consumer safety through comprehensive oversight.

Food Oil Requirements:

• Prior Notice: Submit via PNSI 2-15 days before arrival
• GMP Compliance: Follow 21 CFR Part 111 for dietary supplements
• Labeling: Use FDA-approved common names
• Facility Registration: Required under Bioterrorism Act

Cosmetic Oil Requirements:

• Ingredient Declaration: Common names only
• No Drug Claims: Avoid therapeutic language
• VCRP Registration: Voluntary but recommended

External Resource: The FDA Import Program provides comprehensive guidance for food-grade oil imports.

USDA APHIS Requirements (Pest Control)

APHIS protects U.S. agriculture from invasive pests and diseases.

Documentation Required:

• Phytosanitary Certificate from exporting country’s NPPO
• Import Permits for certain high-risk oils
• Inspection Clearance at U.S. ports

Contact Information:

• APHIS PPQ Permit Unit: (301) 851-2046 or (877) 770-5990
• Online Applications: APHIS eFile System

USDA APHIS inspection process at U.S. ports of entry

CBP Requirements (Customs Clearance)

CBP oversees all import clearance procedures and duty collection.

Essential Forms:

• CBP Form 7501 (Entry Summary)
• Commercial Invoice with accurate valuation
• Bill of Lading for shipment tracking
• Customs Bond for food-grade oils (regardless of value)

Duty Information:

• HTS Code 1515.90 for Evening Primrose Oil
• Typical Duties: 3.4¢ to 5¢ per kilogram
• Processing Time: Same-day clearance with proper documentation

EPA Requirements (Industrial Oils)

The EPA regulates chemical substances under TSCA to protect human health and the environment.

TSCA Certification Process:

1. Determine Oil Classification – Chemical substance vs. excluded category
2. Submit Certification via CBP’s ACE system
3. Declare Compliance Status – Positive (compliant) or negative (exempt)

Important Note: Many aromatherapy and industrial plant oils require TSCA certification, often overlooked by first-time importers.

Common Import Mistakes to Avoid

❌ Top 5 Costly Import Errors

1. Incomplete COA Documentation

   • Mistake: Accepting supplier COAs without third-party verification
   • Solution: Always request independent laboratory analysis

2. Wrong FDA Classification

   • Mistake: Treating cosmetic oils as food-grade (or vice versa)
   • Solution: Clearly define intended use before import

3. Missing TSCA Certification

   • Mistake: Assuming all plant oils are TSCA-exempt
   • Solution: Verify classification for non-food oils

4. Late Prior Notice Submission

   • Mistake: Submitting FDA Prior Notice after shipment departure
   • Solution: Submit 2-15 days before U.S. arrival

5. Incorrect HTS Code Declaration

   • Mistake: Using generic codes instead of specific plant oil classifications
   • Solution: Verify correct HTS code with customs broker

Common documentation errors that delay plant oil imports

💡 Pro Tips for Smooth Imports

• Build Supplier Relationships: Work with GMP-compliant manufacturers who understand U.S. requirements
• Use Customs Brokers: Professional brokers reduce documentation errors
• Maintain Documentation: Keep all certificates for FDA/USDA audits
• Plan Lead Times: Allow 45-60 days for first-time imports

Frequently Asked Questions

What documents are required to import plant oils into the U.S.?

The five essential documents include:

• Phytosanitary Certificate (pest-free verification)
• Certificate of Analysis (purity and composition)
• Customs Entry Forms (CBP Form 7501)
• TSCA Certification (non-food oils only)
• FDA Prior Notice (food-grade oils only)

Does the FDA regulate plant oils?

Yes, the FDA regulates plant oils for food and cosmetic uses. Food-grade oils require Prior Notice, GMP compliance, and proper labeling. Industrial oils fall under EPA’s TSCA regulations instead.

Are permits required for importing plant oils?

Permits may be required for:

• Unprocessed oils from certain countries
• High-risk plant materials (seeds, unrefined oils)
• Protected plant species derivatives

Contact APHIS PPQ at (301) 851-2046 for specific permit requirements.

What is a phytosanitary certificate, and when is it needed?

A phytosanitary certificate is issued by the exporting country’s National Plant Protection Organization (NPPO). It confirms the oil is pest-free and disease-free. Required for unprocessed or minimally processed oils that may harbor agricultural pests.

How do I comply with FDA regulations for food-grade plant oils?

Follow these steps:

1. Submit Prior Notice via FDA’s PNSI system
2. Ensure GMP compliance (21 CFR Part 111)
3. Use proper labeling with common ingredient names
4. Register facilities under the Bioterrorism Act

What are the customs requirements for importing plant oils?

CBP requires:

• CBP Form 7501 (Entry Summary)
• Customs bond for food-grade oils
• Correct HTS code declaration (e.g., 1515.90 for EPO)
• Commercial invoice with accurate valuation

CBP Form 7501 completion process for plant oil imports

Are there specific requirements for cosmetic plant oils?

Cosmetic plant oils must:

• Use common ingredient names (not Latin names)
• Avoid therapeutic claims (no medical benefits)
• Comply with Fair Packaging and Labeling Act
• Consider VCRP registration (voluntary but recommended)

Do I need a TSCA certification for plant oils?

Yes, for non-food oils classified as chemical substances. Submit certification via CBP’s ACE system, declaring either:

• Positive TSCA (compliant with regulations)
• Negative TSCA (exempt from requirements)

What are the risks of non-compliance when importing plant oils?

Non-compliance can result in:

• Shipment detention at ports
• Product rejection and return to origin
• Financial penalties from CBP, FDA, or APHIS
• Import license suspension for repeat violations

How can I verify the quality of imported plant oils?

Quality verification requires:

• Third-party COA from accredited laboratories
• GMP certification from manufacturing facilities
• Traceability documentation from source to shipment
• Contaminant testing for heavy metals and pesticides

External Resource: The American Herbal Products Association provides additional quality standards for botanical imports.

Working with Reliable Suppliers

Choosing the Right Manufacturing Partner

Success in plant oil imports often depends on your supplier’s regulatory expertise and documentation capabilities.

Essential Supplier Qualifications:

• GMP Certification with international standards compliance
• Full Documentation Support including COAs, MSDS, and traceability
• Regulatory Experience with U.S. import requirements
• Quality Control Systems with batch tracking capabilities

Red Flags to Avoid:

• Suppliers unwilling to provide third-party COAs
• Lack of GMP or ISO certifications
• Inability to explain U.S. regulatory requirements
• No experience with phytosanitary certificates

GMP-compliant manufacturing facility with quality control systems

Documentation Support Services

Professional suppliers should provide comprehensive documentation support, including:

• Rapid COA Generation from accredited laboratories
• Phytosanitary Certificate assistance through proper channels
• Regulatory Consultation for FDA and EPA compliance
• Custom Formulation support for specific applications

For example, experienced manufacturers often maintain over 1000 tons of essential oils in inventory, enabling fast delivery while ensuring complete documentation compliance.

External Resource: Learn more about essential oil manufacturing processes and quality control standards.

Building Long-Term Partnerships

Successful plant oil imports require reliable, long-term supplier relationships. Look for partners who offer:

• Consistent Quality with batch-to-batch reliability
• Scalable Production from small samples to large orders
• Technical Support for formulation and compliance questions
• Responsive Service with guaranteed response times

Industry Insight: The bulk essential oils wholesale market continues expanding as businesses recognize the value of working with established, compliant suppliers.

Conclusion

Importing plant oils into the United States requires navigating complex regulatory requirements across multiple federal agencies. However, with proper documentation and planning, the process becomes manageable and profitable.

Key Takeaways:

• Five essential documents cover most import scenarios
• Oil classification determines specific regulatory pathways
• Early planning prevents costly delays and rejections
• Supplier selection significantly impacts compliance success

The U.S. plant oils market’s projected growth to $27.82 billion by 2032 represents tremendous opportunity for prepared importers. Success depends on understanding regulatory requirements, maintaining proper documentation, and working with experienced suppliers who prioritize compliance.

Ready to Start Importing Plant Oils?

Whether you’re sourcing evening primrose oil for dietary supplements, eucalyptus oil for cosmetic applications, or industrial oils for manufacturing, proper documentation ensures smooth customs clearance and regulatory compliance.

Take Action Today:

1. Assess your oil classification and regulatory pathway
2. Contact qualified suppliers with proven U.S. import experience
3. Prepare your documentation checklist based on intended use
4. Connect with customs brokers for professional import support

For businesses seeking reliable, compliant plant oil suppliers with comprehensive documentation support, consider exploring PhytoEx’s industries page to learn how GMP-certified manufacturers can streamline your import process.

Start your plant oil import journey today – the growing U.S. market awaits your premium products.