Honey and Other Apiculture Export Lists
The European Union (EU) has implemented a new requirement (Regulation (EU) 2023/2652) for all apiculture products imported into the EU, including those in composite products. Effective November 29, 2024, the EU is requiring establishments that import apiculture products into the EU to appear on the EU’s list of approved establishments eligible to export such products. The EU will include establishments on these lists that have been found to comply with applicable food safety requirements by the competent authority of the exporting country. “Establishment” is defined as the unit in the business where the honey (or other apiculture product) is being produced, and if an apiculture product business has multiple production units, each unit is considered an “establishment” and requires approval and listing. These requirements do NOT apply to primary producers and businesses involved only in transporting and storing honey, and therefore, these establishments do not have to be listed (Regulation 2022/2292, Art. 14).
The EU requirement is for apiculture product 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 to be registered in EU’s Trade Control and Expert System (TRACES). This registration requirement applies to all apiculture products, which includes the following products: honey, beeswax, royal jelly, propolis or pollen, intended for human consumption. The legislation specifically references the following product HS Code headings: 0409, 0410, 1212, 1521, and 1702.
TRACES is the European Commission's online platform for animal and plant health certification required for the importation of animals, animal products, food and feed of non-animal origin and plants into the EU, and the intra-EU trade and EU exports of animals and certain animal products.
To be registered in TRACES as an approved establishment, the EU requires apiculture product exporters or their suppliers, as applicable, to first successfully complete an on-site assessment by the Agricultural Marketing Service (AMS). After successful completion of the on-site assessment, the EU further requires exporters or their suppliers to submit an application to the Food and Drug Administration (FDA) for inclusion on the relevant export list via FDA’s Export Listing Module (ELM).
AMS On-Site Assessment
To satisfy EU Establishment requirements, exporters or their suppliers must successfully complete an on-site assessment. The on-site assessment will consist of a USDA Hazard Analysis and Critical Control Point (HACCP) Verification Survey, Plant Survey, and Food Defense System Survey.
To schedule an on-site assessment, exporters or their suppliers must should the Specialty Crops Inspection Division (SCI). Requests for service or additional questions can be sent to 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 sciinspectionoperations@usda.gov.
FDA Application for Inclusion on Food Export List
After successful completion of a USDA Agricultural Marketing Service (AMS) on-site assessment, establishments may apply for inclusion on the food export lists via the Export Listing Module (ELM). Please 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) as well as in good regulatory standing with FDA for the products intended for export.
The FDA will maintain a list of establishments that have expressed interest in exporting apiculture products to the EU and that we have found to comply with applicable U.S. requirements. We intend to transmit an initial list of such establishments to the EU by December 31, 2024. Establishments that wish to be included in the initial list should request to be added to the list by December 23, 2024, using the ELM. Going forward, the FDA will send updates to these lists on a quarterly basis as described on the Food Export Lists webpage.
For general inquiries about export certification for FDA-regulated food products, please contact the FDA Human Foods Program Export Certification Team at hfpexportcertification@fda.hhs.gov.
EU TRACES Listing
Once the registration is finalized in EU TRACES and the receiving entity in the EU, DG SANTE, has completed the upload process, it will be publicly available on the TRACES website. View the EU TRACES list of Honey and Apiculture approved facilities.
U.S. Composite Products Containing Apiculture Products as the Only Animal-Based Ingredients
Manufacturers using apiculture products as ingredients will also be subject to this rule, but the process for compliance is different. The following pertains to composite products containing apiculture products as an ingredient (e.g., breakfast cereals, baked goods, beverages containing honey as a sweetener).
Starting November 29, 2024, apiculture-based ingredients will have to be sourced from an EU- approved establishment listed in TRACES, as described above. Under the EU requirement, the importer must file a private attestation in TRACES where they will enter the traceability information required by the EU for the apiculture ingredient/s. Importers have in the past been able to use an FDA registration number on this attestation, but it is our understanding that the EU approval number will be required after November 29, 2024.
An example of the private attestation form can be found in Annex V of the regulation 2023/2744.
There is additional information on exporting honey to the EU in a recently released EU Guidance: Exporting Honey to the European Union - An Introduction to Evolving EU Regulations.