• The Acheson Group

Food Export Certification: Simplified and Clarified

It was just a brief announcement put out last week by FDA – you may have even missed it. But if you export food, FDA’s expansion of its electronic export system and launch of the Export Listing Module could make life simpler for you – but also may require resubmission of your forms. If you don’t yet export your food product, you may not have realized that FDA has an electronic export system or know what else is required. So we thought we’d take the opportunity to ride the tails of FDA’s announcement and talk a bit about food export certification – relevant to those who do and those who don’t yet export food. 

To start with FDA’s announcement: The Export Listing Module (ELM) is an electronic portal for receiving and processing requests from establishments that seek to be included on all export lists for FDA-regulated food products. The newly expanded module improves FDA’s ability to efficiently process requests to be added, monitor listed establishments, and generate updates for foreign regulatory agencies.

But because FDA, itself, does not require written certification for exports, why would a producer seek to be included on FDA export lists? Because foreign customers or governments will often ask firms exporting FDA-regulated products from the United States to supply a written export certification for those products.

With the authorization to provide this in a form it determines appropriate, FDA provides written certification for food exports in the form of certificates and lists of eligible exporters for specific products or destinations. CFSAN issues “certificates of export” for seafood, food additives, and food contact substances and “certificates of free sale” for landfood, dietary supplements, infant formula, medical foods, and foods for special dietary use. But while the certificate gives the agency’s official attestation concerning a product’s regulatory or marketing status, FDA’s issuance of an export certificate does not preclude it from taking appropriate regulatory action against a product covered by the certificate.

Some foreign food safety authorities also require certification in the form of publicly available lists of eligible exporters for certain food products, and use FDA-provided information to identify and publish their own lists of approved firms. The importing countries' criteria for inclusion on these lists vary depending on the product or the destination. With the expansion of the ELM, FDA can now receive and process requests and updates for the exportation of seafood and infant formula to China and collagen and gelatin products to the European Union.

As such, following are examples of products for which importing country listing is required as a precondition for market access for U.S. exporters of:

  • Dairy products to the European Union (EU), China, and Chile. Note: Because importing authorities definition of dairy/milk product may differ from that of FDA, you may wish to consult the regulatory authorities in the country to which you intend to export to determine whether your products are subject to listing requirements.

  • Collagen and gelatin products to the EU. To be eligible for the EU collagen and gelatin export lists, establishments must provide a laboratory report from an accredited, private laboratory demonstrating that the products do not exceed certain criteria related to bacterial and other counts. Industry may apply for inclusion on these lists via the ELM. 

  • Seafood products to the EU and China. Once listed, U.S. exporters may contact the National Oceanic and Atmospheric Administration (NOAA) Seafood Inspection Program to request export certificates for U.S. seafood exports to the EU and China. 

  • Infant formula products to China. Note: While U.S. regulations define infant formula as food intended for children up to 12 months of age, the China Certification and Accreditation Administration (CNCA) defines infant formula as food intended for children up to 36 months of age, known as “infant and young children formula.” Refer to the Implementation Catalogue for Registration of Overseas Manufacturers of Imported Food released by the General Administration of Quality Supervision, Inspection and Quarantine of the People’s Republic of China (AQSIQ) for more information. Establishments manufacturing these products should apply to be listed as infant formula manufacturers.

  • Additionally, for both seafood and infant formula to China, the CNCA requires that firms obtain third-party certification of compliance with Chinese laws and standards prior to being listed. All currently listed establishments that wish to remain on the China seafood export list should provide evidence of third-party certification through the ELM by June 15, 2019, as the CNCA intends to remove firms that have not provided the information from its lists. Once listed, applicants are required to reapply with FDA and submit a new third-party certification report every two years. CNCA also requires that infant formula manufacturers/processors submit an Establishment Registration Application with additional information to CNCA.

To ensure a successful transition to the electronic system, establishments that are currently listed for these products are strongly encouraged to submit a new request via the ELM. Establishments that previously submitted requests for inclusion on the dairy exports lists via the DLM will have continued access to these requests via the ELM. Establishments that wish to be added to an applicable list can submit the third-party certification when they submit a new request for these lists in the ELM.

Although you can request to be added to FDA’s export lists at any time, the agency generally transmits list updates on a quarterly basis, and final listing decisions are made by the competent authority of the importing country. Thus, products produced or shipped prior to a firm's official listing by the importing country may be detained or rejected.

For more information from TAG on exporting and importing, see:

About The Acheson Group (TAG)

Led by Former FDA Associate Commissioner Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG's team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com