Europe is together with the US the biggest market for organic products in the world. In 2023, the retail sales in Europe were valued with more than 50 billion euros. The largest market in Europe is Germany. Globally, European countries accounted for the highest share of organic food sales as a percentage of their respective food markets. Denmark had the highest share worldwide, with 13 percent in 2021. Updated data about organic import volumes to the EU can be search on TRACES, an European database.

In all member states of the European Union, the Organic Regulation (EU) 2018/848 sets out the rules of the production and labelling of organic products. The new Regulation (EU) 2018/848 is in force within the EU since 01 January 2022, but transitionary rules are provided for implementation of certain provisions, in particular on trade.

The regulation defines the rules for import of organic products into the union and has significant implications for Third Countries outside the EU, who wish to export organic products to any EU country beyond the end of the transitionary period for import from most countries on 31 December 2024. The transition period for organic imports from “recognized third countries” (13 countries, as per 08/2023) is until 31 December 2026 with less direct implications for operators.

The most significant change for operators and control bodies in Third countries is that the current import system of «equivalence» with the EU rules, in replaced by the system of «compliance», i.e. operators in third countries must comply with exactly the same organic rules as EU operators. Also, there are significant changes with regard to certification of small farmers as a grower group.

The Regulation (EU) 2018/848 replaces the previous organic Regulation (EC) 834/2007. It was agreed by the European parliament in 2017, after several years of intense negotiations. The stated aim of the new Regulation is to encourage the sustainable development of organic production in the EU, guaranteeing fair competition for farmers and operators, preventing fraud and unfair practices, and improving consumer confidence in organic products. 

The “Basic Act” published in 2018 is amended and supplemented by a large number of delegated acts. The consolidated version of 2018/848 is a recommended version to use and available in all EU languages, integrating provisions from «amending » regulations. However, there is also a large number of «implementing» or «supplementing» delegated acts, which remain separate regulations on specific topics.  

The EU Commission’s «Legislation for the Organic Sector» site provides access and information on all legal acts on organic production. Please note that not all acts apply to or are directly relevant for operators in Third countries outside the EU.

The EU Commission’s «Organics at a glance» provides up to date information on EU organic policy, the organic logo and legislation on organic production, distribution and marketing, including Guidelines on Import of organic products into the EU, and the Commission’s Frequently Asked Question Document.

For exporters in low and middle income countries, the Agrifo.eu site on the Regulation 2018/848 provides up-to-date simplified explanations of the new regulation, and links to a selection of key secondary acts of relevance for operators and exporters outside the EU with easy to read summaries and background information. 

The Organic Regulation (EU) 2018/848 brings in fundamental changes to the EU’s organic import system, moving from the principle of equivalence to the principle of compliance.

Earlier organic EU regulations recognized that organic production in countries outside Europe was different but could be considered equivalent in terms of meeting the EU’s organic principles. Under the new regulation, this changes to a system of compliance for imported products. Producers and traders in third countries have to comply with exactly the same rules as those in the EU, with no possibility to adapt the rules to local conditions in an “equivalent” way.

The rules for certification of smallholder farmer groups change in a fundamental way. The new definition and procedures for control of «groups of operators» have significant implications for the many certified groups in Third countries. Many currently certified smallholder groups do not meet the EU’s definition of a “group of operators” (Art. 36) in their current legal form and organizational set-up. A new maximum dimension of a group of operators (2000 members), and a new maximum farm size or organic turnover limit for members are introduced, as well as detailed rules for the Internal Control System (ICS). The control procedures for groups have become stricter and more concise, in response to concerns about the quality of group certification:  5% of members shall be inspected by the CB each year, and 2% of members are subject to sampling each year.

The IFOAM guidance for smallholder groups certification according to the new EU regulation provides a simplified explanation of the new rules, including an overview of organic production rules and requirements for the Internal Control System (ICS).

Another important change for Third Countries is that the EU will define a future list of high risk countries and value chains, subject to on-site control twice a year and intense sampling requirements (Regulation 2021/1698 Art 8-12). Until the new regulation is applied fully, the Commission publishes annual “Additional Measures” instructions to recognized control bodies in selected countries (see EU Commission “Trade in organics” site).

Organic products from countries outside the European Union (so-called third countries) can be imported into the EU and labelled with reference to organic agriculture and the EU organic logo, if they comply with the legal requirements of EU legislation for organic production and labelling and have been controlled and certified at all levels of production, processing, storage and marketing.

The procedure for the import of organic products into any country of the European Union depends on the country of origin. Once imported into any member state, organic products can be marketed freely in all Member States of the EU.

Organic Products from third countries can be exported to any EU member state depending on the country of origin:

Option 1: Import from “recognized third countries“

Argentina, Australia, Canada, Chile, Costa Rica, India, Israel, Japan, Republic of Korea, Switzerland, Tunisia, USA and New Zealand (status: 08/2023)  

Until 31 December 2026, During the transitionary period, the country must either be listed in the EU directory of recognized third countries (Annex I of Regulation 2021/2325) or have a trade agreement with the EU in place for organic products (See Agreements on trade in organic products).

From 1.1. 2027 onwards, a trade agreement for organic products must be in place, or the products will need to be certified under Option 2, which also applies to products not covered by the trade agreement.

Option 2: “Recognized control bodies” (import from all other third countries)  

The products must be certified by a Control Body (CB) recognized by the EU to control and certify organic products in the respective Third Country.

Until 31.12.2024: During the transition from the equivalence to the new compliance system, recognized equivalent CBs are listed in Annex I of Regulation 2021/2325 and continue to certify in according to the equivalence rules of the previous regulation. Third country CBs need to re-apply to the EU to be recognized for certification in compliance with Regulation 2018/848.

From 1.1.2025 onwards, only CBs recognized for certification in compliance with 2018/848 in the Annex of Regulation 2021/1378 can certify products to be imported into the EU as organic.

Customs clearance and import notification

Each batch of organic products imported into the EU has to be accompanied by an electronic certificate of inspection (COI) This electronic certificate of inspection has to be generated via TRACES (Trade Control and Expert System). Each company involved in the export and import procedure has to register in the TRACES database.

Consignments intended for import into the EU are subject to official control by the control body in the Third country. The relevant CB needs to verify the consignment by means of systematic documentary checks and risk based physical checks before the consignment leaves the Third country. The CB issues the COI in TRACES according to the model in the Annex (see Regulation (EU) 2021/2306)

There are new rules regarding documents and notifications required for EU import of organic products, which are important for exporters. This includes amended provisions for the COI; rules for prior notification before arrival (via TRACES)  min. 1 working day before arrival. Since June 2022 COIs can no longer be issued on paper and are issued bearing a qualified electronic seal. The COI must be issued before the consignment leaves the Third Country. (see Regulation (EU) 2021/2307)

The import company notifies its control body (or control authority) about its imports through TRACES. At the point of entry, the competent authority at the border control performs official control on consignment for verification of compliance with 2018/848, including an examination of the COI and other supporting documents as well as, where required, results of residue tests or analysis (see Regulation (EU) 2021/2306).

Organic produce that requires a phytosanitary certificate have to pass through Border Control Points (as opposed to “Border Control Posts”), with stricter controls and a limited number of EU ports of entry (see Regulation (EU) 2021/2305)

After customs clearance, the imported lots can be traded freely in all member states of the EU.

European Commission: Information on TRACES
The website of the European Commission provides general information on TRACES as well as detailed instructions. en

EU-Login
Website to create an EU-Login, which is a requirement to register with TRACES. 

TRACES - Trade Control and Expert System - Login
Website to register with TRACES.