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Exporting food supplements from the EU

Food supplements are marketed as food in the EU, so supplements exported from the EU must meet EU food law unless the destination says otherwise. The Commission pages read describe no EU export certificate for supplements; the destination's certification requirements apply. The exporter lodges an export declaration with an EORI number, and proves origin to claim a lower tariff.

Updated · Each section links to the official source it comes from

Food law on exports
Article 12 of Regulation (EC) No 178/2002
Destination certificates
Checked in Access2Markets' My Trade Assistant
Restricted exports
Drugs and medicines are among restricted product types
Declaration
Electronic export declaration in AES, with an EORI number
Origin
REX statements on origin or EUR.1, by agreement

Before the goods leave

The questions to answer, in the order they usually come up.

  1. 1Does the supplement meet EU food law, or has the destination asked for something different? Read more
  2. 2Is the product treated as a medicine anywhere on the route, or otherwise restricted? Read more
  3. 3Which certificates and test reports does the destination accept? Read more
  4. 4Does the product meet the agreement's list rule, and what proof of origin goes with it? Read more
  5. 5Who lodges the export declaration, and are the documents ready? Read more

The rules, by area

What each area covers, the texts that set it, and what the official pages say.

EU food law on exported supplements

Food supplements are food, and Article 12 of the general food law covers food made for export.

  • In the EU, food business operators market food supplements, concentrated sources of nutrients or other substances in dose form, under Directive 2002/46/EC.
  • Food exported or re-exported from the EU for a third country's market must comply with the relevant requirements of EU food law, unless the importing country's authorities ask otherwise or its laws set different requirements (Article 12 of Regulation (EC) No 178/2002).
  • Food that cannot be placed on the EU market may be exported only where the destination's competent authorities have expressly agreed, after being fully informed of the reasons; food injurious to health may not be exported.
  • Where a bilateral agreement between the EU or a member state and the destination applies, exported food must meet its provisions.
  • Directive 2002/46/EC lists the vitamins and minerals, and their permitted sources, that supplements may contain; trade in products with vitamins and minerals not listed in Annex II has been prohibited since 1 August 2005.

How we help: Compliant Always keeps the destination's stated requirements beside your formulation and label, so a departure from EU rules is documented with the shipment. Ask about this

Export restrictions, licences and sanctions

Goods and destinations that need an export licence or cannot be exported at all.

  • Access2Markets says the export of some goods, or exports to certain destinations, may be prohibited or restricted and need a licence; check TARIC for export licences and the EU Sanctions Map for restrictions.
  • Restricted or prohibited types include some live animals, meat and plants, certain food products, dangerous chemicals, drugs and medicines, dual-use goods, waste, cultural goods and counterfeit goods.
  • Member states may exceptionally have national restrictions, which are checked with their competent authorities.
  • The export procedure includes presenting export licences, and an oral declaration is not allowed for goods subject to prohibitions or restrictions.
  • EU sanctions on Russia (Regulation (EU) No 833/2014) prohibit exports of listed goods and oblige operators to contractually prohibit the re-export of certain sanctioned goods.

How we help: Compliant Always keeps any licence with the shipments it covers and shows when it is near its end, before the next shipment is declared. Ask about this

Documents for the destination

What the importing country may ask the EU exporter to supply, as Access2Markets sets it out.

    • The destination's health, safety and technical requirements usually fall to the buyer as importer, who will need the exporter's help to show compliance. Access2Markets advises assuming only what the exporter can fulfil.
    • The destination may ask for certificates showing the product meets its health and safety rules, which may differ from the EU's.
    • Check in My Trade Assistant's Procedures and Formalities section which certificates the destination accepts, and whether testing can be done by an accredited laboratory in the EU or must be done in the destination.
    • Destination authorities may also ask for a commercial invoice, packing list, import licence, proof of preferential origin, or a certificate of non-preferential origin.

    How we help: Compliant Always reads your test reports and certificates against what the destination asks for, and answers importers' questions from the record. Ask about this

    Origin and proof of origin

    Preferential origin under EU trade agreements, how it is proved, and certificates of non-preferential origin.

    • To get a lower or zero tariff under a trade agreement, goods must be wholly obtained in the EU or sufficiently worked or processed there under the product-specific 'list rules' of the agreement's origin protocol, read by HS heading.
    • The Commission's Rules of Origin Self-Assessment tool (ROSA), in Access2Markets' My Trade Assistant, helps check a product against the rules and explains which proof of origin to prepare.
    • Proof can be a movement certificate EUR.1 or EUR-MED issued by customs, or a self-declaration by the exporter on a commercial document: a statement on origin, or an invoice or origin declaration.
    • EU exporters must be registered in REX, with their national competent authorities, to make out statements on origin under agreements including those with Canada, Japan, Vietnam, Singapore, the UK, New Zealand and Chile, and the EU-MERCOSUR Interim Agreement.
    • Without a REX number, an exporter may make out statements on origin for consignments of originating products worth up to EUR 6 000 (EUR 10 000 for trade with the OCTs).
    • Suppliers' declarations let an exporter rely on the originating status of materials bought in the EU. Exporters keep copies of proofs of origin and related records for at least three years.
    • A Binding Origin Information (BOI) decision from customs fixes the origin of goods for up to three years, but does not replace the proof of origin.
    • A certificate of non-preferential origin may be required by the destination; Access2Markets says these are usually issued by the local chamber of commerce, and in some countries by ministries or customs.

    How we help: Compliant Always keeps the REX number, suppliers' declarations and each statement on origin or certificate with the shipment it covers, and shows which proofs are missing or out of date. Ask about this

    EORI and the export declaration

    Who may export, the registration number every declaration carries, and the two stages of the export procedure: export and exit.

    • The export procedure (Article 269 UCC) is obligatory for EU goods leaving the EU customs territory, with very few exceptions, so that export measures such as restrictions are applied.
    • An EORI number is mandatory for customs operations in the EU, export included. It is assigned by the customs authority of the member state where the operator is established, and does not expire.
    • Access2Markets says an exporter normally needs to be established in the EU, including a VAT registration; a non-EU resident needs a person established in the EU, such as a logistics provider or customs agent, to act as exporter.
    • The export declaration is lodged electronically in the Automated Export System (AES), at the customs office for the place where the exporter is established or where the goods are packed or loaded (Article 221(2) UCC-IA).
    • It gives the origin of the goods, the destination country, commodity codes, customs procedure codes and the value. Customs may release the goods, ask for documents, or check them physically.
    • The goods and the Master Reference Number (MRN) are then presented at the customs office of exit, which supervises their departure. Goods stay under customs supervision until they leave.
    • Keep invoices, transport documents and packing lists for at least three years. Exports are exempt from EU VAT if records and the customs proof of export are kept.

    How we help: Compliant Always keeps the EORI, invoice, packing list, MRN and proof of exit with each shipment, dated, and shows what is missing before the goods are declared. Ask about this

    Who answers for what

    WhoWhat they answer forHow we help
    ExporterA product that meets EU food law or the destination's stated rules, the export declaration and proof of origin.The shipment's documents kept together and dated.
    ManufacturerThe formulation, test reports and suppliers' declarations the exporter and importer rely on.Test reports and declarations kept by batch and shown when they lapse.
    Buyer or importerUsually the destination's registration, labelling and import clearance, with the exporter's help.Importers' questions answered from the record.
    Customs representative or forwarderLodging the declaration and presenting the goods for export and exit.The documents behind the declaration, ready before it is lodged.

    Member states

    The export rules are EU law, but member states run them. The EORI number, the export declaration, origin registrations such as REX and approved exporter status, and dual-use licences go through the national authorities of the member state concerned.

    Export certificates for food, animal products and plants are issued by member states' competent authorities; the Commission supplies harmonised certificates through TRACES and guidance in its Export library. Certificates of non-preferential origin are usually issued by local chambers of commerce.

    Where are the goods going?

    Most of what food supplements have to meet is set where they are sold. Each guide sets out the rules on arrival, with the official source for each.

    Questions businesses ask

    Do EU food rules apply to supplements made only for export?
    Yes, as a rule. Food exported from the EU must meet EU food law unless the destination's authorities ask otherwise or its laws set different requirements.
    Can I export a supplement that is not allowed in the EU?
    Only where the destination's competent authorities have expressly agreed, after being fully informed why it cannot be sold in the EU, and never where it is injurious to health.
    Is there an EU certificate of free sale for food supplements?
    The Commission pages read for this guide describe no EU-wide certificate of free sale. Access2Markets advises checking the destination's certification requirements, and which certificates it accepts, in My Trade Assistant.
    Can I export a supplement with a vitamin source not on the EU list?
    Trade in products with vitamins and minerals not listed in Annex II of Directive 2002/46/EC has been prohibited since 2005. Under Article 12 of the general food law, such a product may be exported only where the destination's authorities or laws provide for it, or its authorities expressly agree.
    Can my supplements be tested in the EU for the destination?
    Sometimes. Access2Markets advises checking whether the destination accepts testing by an accredited laboratory in the EU, or requires certification in the destination itself.
    Do I need an export licence for supplements?
    Not as a rule. Access2Markets lists drugs and medicines, and certain food products, among restricted types, so check TARIC for a licence requirement and the EU Sanctions Map for the destination.
    Do I need an EORI number to export supplements from the EU?
    Yes. An EORI number is needed for every customs export declaration. It is assigned by the customs authority of the member state where you are established.
    Who is responsible for meeting the destination's supplement rules?
    Usually the buyer, as importer, under your contract, with your help to show compliance. Access2Markets advises the exporter to assume only the requirements it can fulfil.
    What proof of origin do supplements need for a lower tariff?
    The proof set by the trade agreement: usually a statement on origin by a REX-registered exporter, or an EUR.1 or EUR-MED certificate from customs.
    Is VAT charged on supplements exported from the EU?
    No. Exports are exempt from EU VAT, to businesses or consumers, provided you keep records of the export and the proof of export issued by customs.
    How does Compliant Always help with exporting from the EU?
    Our team reads the rules for the routes you ship. Compliant Always shows which export documents apply to your product, keeps them with the shipment beside what the destination asks for, and watches the sources for changes. It shows what the requirements say and what your documents show; you decide.

    Sources

    Compliant Always is a product of Lettuce Labs LLC. It shows what requirements say and what your documents show. It is not legal advice, and you decide.

    Tell us what you make, and we will show you the rules for it.

    Name the product and the markets you sell in. We will come back to you with what applies in the EU and what your paperwork needs to show.

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