FDA Announces European Union (EU) Requirements for All Honey and Other Apiculture Products Imported into the EU
Constituent Update
December 17, 2024
The European Union (EU) has implemented Regulation (EU) 2023/2652, effective November 29, 2024. This regulation requires that all establishments importing apiculture products into the EU, including honey, beeswax, royal jelly, propolis, and pollen, be registered in the EU’s Trade Control and Expert System (TRACES). These products, intended for human consumption, fall under HS headings 0409, 0410, 1212, 1521, and 1702.
TRACES Registration
TRACES is the EU's online platform for health certification required for the importation of animals, animal products, food, and feed of non-animal origin into the EU, and for intra-EU trade and exports of certain animal products. All establishments that import into the EU or supply honey or other apiculture products to food manufacturers that import products that contain honey or other apiculture products (i.e., composite products) into the EU must be registered in TRACES. This includes producers of honey, beeswax, royal jelly, propolis, and pollen, which fall under HS headings 0409, 0410, 1212, 1521, and 1702, intended for human consumption. To be eligible for importation into the EU, the EU requires that establishments successfully complete an on-site assessment by the USDA Agricultural Marketing Service (AMS) before applying for registration through the FDA’s Export Listing Module (ELM). For more details on TRACES, visit: TRACES.
AMS On-Site Assessment
To satisfy EU Establishment requirements, exporters or their suppliers must successfully complete an on-site assessment. This assessment includes a USDA Hazard Analysis and Critical Control Point (HACCP) Verification Survey, Plant Survey, and Food Defense System Survey. For detailed procedures on how to proceed with this assessment, including AMS public updates, please refer to the USDA's GAIN report which provides comprehensive guidelines on new EU market access rules effective from November 29, 2024.
To schedule an on-site assessment or for additional questions, producers should contact the Specialty Crops Inspection Division (SCI) at sciinspectionoperations@usda.gov.
After successful registration in TRACES, certification of honey and other apiculture exports may still be required prior to shipping to the EU. To arrange for additional product certification or other related inspection services, please contact SCI at the same email address. AMS has published additional information on these requirements, please refer to their latest update.
FDA Application for Inclusion on Food Export List
Upon successful completion of the AMS on-site assessment, applicants should apply for inclusion on the export lists via the FDA’s ELM. As part of this application process, the FDA verifies that the applicant maintains good regulatory standing. Visit Online Applications for Export Lists for a link to this electronic system and step-by-step instructions.
As part of the application process, FDA will verify the applicant is an FDA-regulated manufacturer of honey, apiculture, and/or composite product (and other establishments as applicable) in good regulatory standing with FDA for the products intended for export.
The FDA will maintain and update a list of establishments in good standing, intending to transmit an initial list to the EU by December 31, 2024. Establishments wishing to be included in this initial list should apply by December 23, 2024. Subsequent updates will be sent quarterly, as detailed on the Food Export Lists webpage.
For additional product certification after registration in TRACES, contact SCI at sciinspectionoperations@usda.gov. For general inquiries about export certification, contact the FDA Human Foods Program Export Certification Team at hfpexportcertification@fda.hhs.gov.
EU TRACES Listing
Once the registration is finalized and uploaded by DG SANTE, it will be publicly available on the TRACES website. To view the list of approved Honey and Apiculture facilities, click here: EU TRACES List.