In the global food trade landscape, the US market, boasting vast consumption potential and stringent regulatory demands, captivates numerous food enterprises. However, US food export certifications stand as formidable hurdles on the path to this market. Only by thoroughly comprehending and successfully fulfilling these certification requirements can enterprises firmly establish themselves in the highly competitive US food market.

I. Introduction: Why US Food Export Certifications are the Lifeline of Exports

US regulations for imported food rank among the world’s strictest, resembling a robust fortress safeguarding the safety and standardization of the domestic food market. Relevant data indicates that annually, substandard products worth up to $2 billion are detained due to non – compliance with certification standards. Once food fails to pass certification, enterprises face the detention of goods by customs, substantial fines, and may even be blacklisted, forfeiting access to the US market indefinitely.

For instance, a well – known Chinese food enterprise once exported its meticulously – crafted specialty food to the US with high hopes. Yet, due to oversight of a crucial certification requirement, the products were unceremoniously detained by the US Customs. This not only led to a significant backlog of goods, imposing heavy economic losses on the enterprise, but also severely damaged its brand reputation, causing its market image to plummet.

For enterprises aspiring to export food to the US successfully, mastering and smoothly navigating the three major certification systems of FDA, USDA, and FSIS is the key to unlocking the US market. These three certification systems are like three indispensable keys. Only by obtaining and utilizing them correctly can the door to success in the US market be opened.

II. FDA Certification System: The Gatekeeper of Food Safety

Jurisdiction

Within the framework of US food export certifications, the FDA is tasked with regulating various processed foods, beverages, and dietary supplements, excluding meat and poultry. For these products, Food Facility Registration (FFR) and the Prior Notice System (PN) are two mandatory requisites.

Food Facility Registration mandates that all domestic and foreign facilities engaged in food production, processing, packaging, or storage in the US, regardless of scale, must register with the FDA. This initiative aims to enable the FDA to comprehensively grasp the detailed information of food production and business entities, thereby facilitating efficient and effective supervision. The Prior Notice System requires relevant enterprises to notify the FDA in detail of all information regarding the food prior to its arrival in the US, including but not limited to product name, quantity, ingredients, manufacturer, and transportation route, enabling the FDA to prepare for inspections and ensure food safety.

Key Certification Processes

Compliance with the FSMA (Food Safety Modernization Act) lies at the core of FDA certification. It encompasses seven key elements. Preventive controls oblige enterprises to use scientific methods to comprehensively identify and deeply evaluate potential hazards in the production process, whether biological, chemical, or physical. Thorough analysis should be conducted, and practical preventive measures formulated. For example, in response to the risk of microbial contamination during food processing, enterprises need to develop strict sanitary standard operating procedures, standardize employees’ operations, and enhance the cleaning and disinfection of the production environment.

Supply chain audits emphasize that enterprises must conduct a comprehensive review of all aspects of the supply chain, including raw material suppliers and logistics service providers. Enterprises not only need to ensure the quality and safety of raw materials but also closely monitor the operational conditions of each supply chain link, such as temperature control during transportation and storage conditions, to prevent food from being contaminated or spoiled during transit.

Regarding label specifications, food labels must contain accurate and detailed nutritional labeling, strictly adhering to the requirements of the NLEA (Nutrition Labeling and Education Act). Nutritional labeling should clearly indicate the content of key nutrients such as energy, protein, fat, carbohydrates, and sodium in the food, along with the percentage of these nutrients in the daily recommended intake, enabling consumers to understand the food’s nutritional information and make informed dietary choices. Additionally, for allergens that may trigger allergic reactions in some consumers, such as milk, eggs, peanuts, and nuts, clear and prominent labeling must be provided on the label to fully safeguard consumers’ right to know and health.

Additional Requirements for Special Categories

For low – acid canned foods, aside from meeting general food certification requirements, FCE (Factory Registration for Low – Acid Canned Foods) registration is also necessary. This is because the nature of low – acid canned foods gives rise to certain microbial risks during processing, packaging, and storage. If not properly managed, these risks can lead to food safety issues. Through FCE registration, the FDA can exercise more stringent oversight of the production process of low – acid canned foods, ensuring product safety.

Baby formula, as a specialized food category, must not only adhere to GMP (Good Manufacturing Practice) to ensure the hygiene, standardization, and quality control of the production process but also meet extremely strict nutritional standards. Baby formula is the primary source of nutrition for infants during their growth, and the rationality and safety of its nutritional components are directly related to infants’ healthy development. Consequently, the FDA has explicit regulations regarding the content and proportion of nutrients such as protein, fat, carbohydrates, vitamins, and minerals in baby formula, and enterprises must produce in strict accordance with these standards.

III. USDA Certification System: The Pass for Agricultural and Organic Products

Regulatory Agency Division

The USDA has a well – defined division of regulatory agencies within the US food export certification system. The AMS (Agricultural Marketing Service) under its purview is primarily responsible for organic certification. Products that pass rigorous review are eligible to use the USDA Organic Seal, a mark that commands high recognition and credibility in the market, significantly enhancing product competitiveness.

Conversely, the FSIS (Food Safety and Inspection Service) focuses its supervision on meat, poultry, and egg products. It conducts strict supervision and inspection of every stage from breeding and slaughtering to processing and sales to ensure the safety and quality of these products.

Core Processes for Meat Exports

The Equivalence of Slaughter Establishments Audit (EQS certification) is the primary and critical step for meat exports to the US. Its objective is to ensure that the facilities, operational processes, and hygiene standards of foreign slaughterhouses are on par with those of US domestic slaughterhouses, guaranteeing that US consumers can access equally safe and high – quality meat products. This necessitates that the slaughterhouses of exporting enterprises meet the strict standards set by the US FSIS in aspects such as building layout, equipment, personnel operation specifications, and hygiene management.

The product traceability system is implemented through Lot Numbering. Each batch of meat products is assigned a unique number, and enterprises are required to meticulously record the entire process information of the batch, from the breeding origin, slaughtering process, processing steps, to the sales channels. In the event of a product quality issue, the root cause can be quickly and accurately traced through the batch number, allowing for the implementation of effective recall and handling measures to minimize harm to consumers.

The mandatory filing of the HACCP (Hazard Analysis and Critical Control Points) plan is another vital requirement for meat exports. Enterprises must conduct a comprehensive hazard analysis of all stages of the meat production process, identify potential biological, chemical, and physical hazards, determine critical control points, and formulate corresponding monitoring measures and corrective actions to ensure that potential hazards are detected and eliminated promptly during production, safeguarding the safety of meat products.

Key Points of Organic Certification

To obtain USDA organic certification, products must meet the strict criterion of 95% organic ingredients. This implies that at least 95% of the product’s ingredients must stem from organic production methods, eschewing the use of chemically synthesized pesticides, fertilizers, growth regulators, and genetically modified technology, and instead following natural laws and ecological principles.

Furthermore, farms and processing plants are subject to unannounced inspections annually. This unannounced inspection approach can accurately reflect the production status of enterprises. The inspection scope encompasses all aspects of organic production, including soil management, crop cultivation, breeding processes, processing links, and product labeling, ensuring that enterprises consistently meet organic standards and maintain the quality and reputation of organic products.

IV. FSIS Special Certification: The Technical Barrier for Meat Products

Three – step Factory Registration

First is the country list equivalence assessment. The FSIS conducts a comprehensive evaluation of the food safety system of the exporting country. Only when the food safety system of the exporting country is deemed equivalent to that of the US can enterprises in that country be eligible to apply for exporting meat products to the US. This assessment process involves scrutinizing various aspects of the exporting country, such as laws and regulations, regulatory agency set – up, and inspection and quarantine standards.

Subsequently, enterprises need to register. They should submit detailed enterprise information to the FSIS, including factory address, production process, product types, and quality control systems, enabling the FSIS to comprehensively understand and oversee the enterprises.

Finally, sampling inspection authorization is required. The FSIS conducts sampling inspections on enterprise products. Only when the products pass stringent inspection and meet US food safety standards can enterprises obtain export qualifications, allowing their products to enter the US market.

Microbial Zero – Tolerance Items

Take ready – to – eat meat products as an example. The FSIS enforces a zero – tolerance policy for microorganisms like Salmonella and Escherichia coli. Ready – to – eat meat products are directly consumed by consumers, and microbial contamination can pose a serious threat to consumers’ health. Therefore, the FSIS has established extremely strict detection standards. If Salmonella or Escherichia coli is detected above the permitted level in a product, it will be categorically rejected from entering the US market to safeguard consumers’ health.

Packaging and Labeling Specifications

The packaging and labeling of meat products must clearly and accurately convey product information. The ingredient statement should list all components of the product in detail, enabling consumers to clearly understand its composition. Net content labeling must comply with relevant regulations to ensure consumers receive accurate product weight information. Additionally, the proper use of the USDA inspection logo is an essential specification. This logo indicates that the product has passed the FSIS’s strict inspection, enhancing consumer trust in the product.

V. Other Mandatory Certification Scenarios

State – level Additional Requirements

Proposition 65 in California imposes special requirements on food exports to the US. This proposition aims to protect California residents from chemicals potentially causing cancer or reproductive toxicity. For foods containing harmful substances such as heavy metals, enterprises must affix clear warning labels on product packaging to inform consumers of potential risks. This requirement further raises the bar for food exports to California, compelling enterprises to pay close attention to harmful substance content and label products accordingly.

Religious Certifications

Kosher and Halal certifications respectively meet the special dietary needs of Jewish and Islamic consumers. For enterprises seeking to penetrate these specific religious consumer markets, obtaining the relevant religious certifications is of great significance. Kosher certification requires that food production, processing, storage, and transportation adhere to Jewish dietary laws. Halal certification demands that products comply with Islamic doctrines and regulations, such as animal slaughter methods. Through these certifications, enterprises can better meet the needs of specific religious consumers and expand their presence in the US market.

Third – party Certifications

Third – party certifications such as SQF (Safe Quality Food) and BRCGS (British Retail Consortium Global Standards), while not mandatory by the US government, enjoy high international recognition. Through these certifications, enterprises can showcase their outstanding food safety management capabilities and strict standards to consumers and partners, enhancing their international competitiveness. These certifications typically cover the entire process from raw material procurement to production, processing, and sales, imposing comprehensive and detailed requirements on the enterprise’s quality management system.

VI. Certification Pitfall – Avoidance Guide: Frequently Asked Questions for Enterprises

How to Determine the Product Classification (FDA/USDA/FSIS)?

For enterprises engaged in US food export certifications, accurately determining product classification is the initial step in the certification process. Enterprises can initially assess product classification based on product ingredients, processing techniques, and intended use. Generally, pure meat products, whether fresh or processed, typically fall under FSIS supervision. Processed foods without meat or poultry are mostly regulated by the FDA, while agricultural and organic products may be subject to USDA certification.

However, the actual situation can be complex, with some products having multiple attributes and thus being difficult to classify simply. In such cases, enterprises can consult professional certification agencies. These agencies possess extensive experience and expertise, enabling them to make accurate judgments based on product characteristics. Alternatively, enterprises can directly consult relevant departments like the FDA, USDA, or FSIS for authoritative classification guidance.

How Can Small and Medium – sized Enterprises Reduce Certification Costs? (Joint Audits/Simplified Processes)

For small and medium – sized enterprises, joint audits offer an effective means of reducing certification costs. Multiple such enterprises can collaborate and jointly hire a certification agency for auditing. This not only allows for cost – sharing, reducing the financial burden on each enterprise, but also provides an opportunity for them to exchange experiences during the audit, facilitating mutual improvement. Simultaneously, enterprises can streamline internal processes, establish a comprehensive quality management system, and ensure that all documentation is prepared thoroughly and in line with standards.

Before applying for certification, enterprises should carefully study the certification requirements, prepare all necessary documents and records in advance, and avoid unnecessary costs incurred from repeated rectifications due to incomplete or non – compliant materials. Moreover, enterprises can keep an eye on the preferential policies and training programs offered by certification agencies. Some agencies provide preferential packages or free training courses for small and medium – sized enterprises, assisting them in better understanding certification requirements, improving certification efficiency, and ultimately reducing costs.

Emergency Plan for Sudden Detention: Process for Removing FDA Import Alert

If an enterprise’s products are detained by the FDA with an import alert issued, the first step is to promptly and comprehensively understand the reasons for detention. The enterprise can clarify the product issues by communicating with the FDA and reviewing relevant documents. In response to specific problems, the enterprise should immediately formulate and implement corrective measures to ensure the products meet FDA requirements. For example, if the product label is non – compliant, the enterprise should promptly revise the label content and resubmit it for review. If it’s a product quality issue, the enterprise should adjust the production process, strengthen quality control, and retest the products to ensure they meet the standards.

After rectification, the enterprise should gather relevant evidence demonstrating that the products meet the requirements, such as product test reports, corrective action reports, and production records, and submit an application to the FDA to lift the import alert. In the application, the enterprise should elaborate on the rectification measures taken and the resulting improvements, demonstrating its commitment and ability to ensure product quality.

Concurrently, the enterprise should maintain active communication with the FDA, cooperate fully with its investigation, and provide additional information or materials as required. By taking proactive steps, the enterprise can strive to have the import alert removed as soon as possible, enabling its products to enter the US market smoothly.

2025 New Regulation Warning: Pilot Requirements of the US Food Traceability System (FTT)

With the continuous evolution of food safety management, the US will implement the pilot requirements of the Food Traceability System (FTT) in 2025. Enterprises planning US food export certifications should plan ahead and actively respond to this new regulation. Firstly, enterprises should establish a comprehensive product traceability system. Starting from the raw material procurement stage, they should record in detail the origin, supplier details, and procurement date of each batch of raw materials.

During production, information such as production batch, production date, production process, and quality inspection results should be logged. In the sales phase, details like sales recipients, sales dates, and quantities should be documented. By establishing such a full – chain traceability system, enterprises can quickly identify the root cause of product issues and take effective corrective actions.

To enhance the accuracy and efficiency of the traceability system, enterprises can adopt advanced information technologies such as blockchain. Blockchain’s features of decentralization, immutability, and traceability ensure the authenticity and reliability of traceability information. Enterprises can upload product – related information to the blockchain platform for real – time sharing and transparent management. Additionally, enterprises should strengthen communication and collaboration with suppliers and partners to jointly establish unified traceability standards and processes, ensuring the integrity and accuracy of supply – chain – wide traceability information to meet future regulatory requirements.

VII. Conclusion: The Strategic Value behind the US Food Export Certification System

From an ROI (Return on Investment) perspective of certification, products of enterprises that pass certification often command a 30% access premium in the market. This indicates that the investment in certification can yield significant economic benefits for enterprises, not only covering certification costs but also generating additional profit margins. This is because certified products are perceived by consumers as having higher quality and safety assurances, thus justifying a higher price.

Building “certification assets” is crucial for enterprises to gain greater influence in the international supply chain. Enterprises with multiple authoritative certifications can secure more favorable cooperation terms in negotiations with suppliers, distributors, and partners, leveraging their certification advantages. For example, when procuring raw materials, enterprises can demand higher – quality products due to their certification – driven quality control requirements.

When collaborating with distributors, they can negotiate more favorable sales terms as certified products are more competitive. This enhanced influence in the international supply chain enables enterprises to optimize supply chain management, reduce operating costs, and further enhance their overall competitiveness.

In terms of global food compliance management, tools such as the TRACES and FAIRS platforms can assist enterprises in more efficiently managing certification processes and compliance matters. The TRACES platform, mainly used for the EU food and feed rapid alert system, allows enterprises to stay informed about EU food safety regulation changes and early – warning information, enabling them to prepare in advance.

The FAIRS platform offers a range of compliance management solutions, including regulation querying, certification process guidance, and risk assessment, helping enterprises comprehensively understand global food compliance requirements, optimize certification processes, and mitigate compliance risks. In summary, emphasizing and actively addressing US food export certifications is a strategic imperative for food enterprises aiming to expand globally and achieve sustainable development.