Authorized Government Agency(s):

European Union (EU) Member States retain the authority to determine additional requirements for production within their country. They can also determine exceptions due to catastrophic circumstances, but cannot restrict access to products in compliance with EU regulations. In addition, the EC delegates most authority for the administration of organic programs to the Member States.

Agency Contact Information
Ministry for Agriculture, Food, Fisheries and Animal Rights
24 Old Bakery Street
Valletta

Division of Quality Schemes
Organic Agriculture
https://agrikoltura.gov.mt/en/ikeltakwalita/Pages/organicAgriculture.aspx
Agricultural Directorate
Email: ikeltakwalita.mafa@gov.mt​ 
Telephone: +356 22924460

Name(s) of Regulation and/or Standard:

The European Union has an Equivalency Agreement with the United States.

This consolidated version repeals and replaces previous organic regulations and contains the basic legislative act plus amendments and corrections that set the rules on organic production and labeling of organic products: EU 2018/848 (pdf in English) 

Key secondary acts not included in consolidated EU 2018/848 include: 

• Retroactive recognition for the purpose of conversion, the production of organic products and information to be provided by EU countries: EU 2020/464 (pdf in English)
• Conditions for authorization and lists of authorized products and substances for use in organic production: EU 2021/1165 (pdf in English)
• Supplemental rules on the official control, traceability and mass balance checks for operators and groups of operators: EU 2021/771 (pdf in English)

A full list of basic legislative act and secondary acts are available here.

Date of Implementation: 1992

Regulation and/or Standard Scope:

EU standards cover crop, livestock, processing, and certification of groups of operators. Farm and handling plans are required, as well as detailed record keeping and detailed livestock feed standards.  Specific standards are included for aquaculture, seaweed, yeast, bees, sprouted seeds, chicory heads, wine, mushrooms, and salt. Criteria for determining allowed materials include consistency with the objectives and principles of organic farming, and materials must be of plant, animal, microbial or mineral origin. Synthetic substances, however, may be used when they replicate the natural sources and when they are approved for organic production in the EU.

EU requires that imported organic products meet EU standards. Non-EU organic products must include country of origin labeling if they wish to use the EU organic logo. Use of the EU organic logo is not required for products from outside the EU. EU requires that imported products must be from countries that have been recognized by the EU (third-countries) and certified by recognized control bodies (certifiers); or countries with bilateral equivalency arrangements (Canada, Japan, Korea, New Zealand, U.S.); or countries with equivalency agreements (Chile, Switzerland, UK).

List of third countries and the list of control authorities and control bodies recognized for the purpose of importing organic products into the EU: EU 2021/2325 (pdf in English)

Requirements have been established for importers, operators responsible for the consignments, first consignees and consignees for the import of organic and in-conversion products into the EU.

Documents and notification required EU 2021/2307 (pdf in English)

Beginning February 3, 2020, port of entry health authorities will only endorse a certificate of inspection if the certifier issued it prior to export. Certain sections of the certificates (boxes 13, 16, and 17) may be filled in with provisional information, since certifiers can not verify all of the data before the product is exported. The provisional information must be confirmed/updated within 10 days, and before the certificate can be endorsed at the port of entry.

Exports from the U.S. to EU must adhere to the EU procedures and require an EU Certificate of Inspection (COI). A USDA-accredited certifying agent must complete an electronic COI through the European Union's Trade Control and Expert System (TRACES) link before the product leaves the U.S. Certain edits to the COI may only be made within 10 days of issuing the original COI.

EU Trade in Organics

The EU requires organic certification for all those involved in production and handling, including importers. EU requires ALL processing operations to be certified, even if those products are below the 95% threshold for the "Organic" label.

EU delegates the authority for investigations, non compliance, mediation, and testing, as well as reporting, exclusion from organic sale, emergency treatments and appeals to the Member States in accordance with their respective control system plans.

The EU allows private sector standards for the product categories, such as cosmetics and textiles, which are not fully regulated by the EU.  In the EU certifiers (control bodies) can require additional organic crop, livestock and processing standards in association with the use of their certification seal.

The EU has unified the control systems that Member States and control bodies implement for investigations, non-compliance, mediation, testing, reporting, exclusion from organic sale, emergency treatments and appeals.  Required reports, records and certificates are submitted in electronic format through the use of the Organic Farming Information System.  

In addition to the EU organic regulations for certification and accreditation procedures, the requirements of EN 45011 and ISO Guide 65 for accreditation must be met. 

Requirements for recognition of control authorities and control bodies: EU 2021/1698 (pdf in English)

Use of Organic Farming Information System and templates for annual reports: EU 2021/1935 (pdf in English)

Record keeping and declaration requirements from operators and groups of operators EU 2021/2119 (pdf in English)

List of control authorities and control bodies for equivalence 

Control bodies in the European Union

FiBL Country reports
U.S. International Trade Administration

USDA's GAIN Report Economic Woes Slows Growth in EU Organic Sales (2024)
USDA's GAIN Report EU 2024 Promotion Programs for Agricultural Products (2023)
USDA's GAIN Report EU Adopts New Rules for Organic Pet Food (2023)
USDA’s GAIN Report Food and Agricultural Import Regulations and Standards Country Report (2022)
USDA’s GAIN Report Food and Agricultural Import Regulations and Standards Export Certificate Report Annual (2022)
USDA’S GAIN Report Update on Changing EU Import Conditions for Composite Products (2022)
USDA’S GAIN Report COVID-19 Boosts Organic Food Sales in the EU (2022)
USDA’S GAIN Report European Commission Launches Public Consultation on the Revision of EU Food Labeling Requirements (2022)
USDA’S GAIN Report New EU Labeling Rules for Wines (2022)
USDA’S GAIN Report Continuing Good Prospects for US Organic Exports to the EU (2021)
USDA’S GAIN Report New EU Organic Regulation Entering Into Force in 2021 Regulatory Update (2020)
USDA’S GAIN Report EU Launches Consultation on Future Organics Action Plan (Sept. 2020)
USDA’S GAIN Report Food Labeling Initiatives in the EU Farm to Fork Strategy (2020)
USDA’S GAIN Report Pesticides Initiatives in the EU Farm to Fork Strategy (2020)
USDA’S GAIN Report Good Prospects for US Organic Exports in the EU (2020)