Revision of permitted substances for use in organic production (2025)

Draft Implementing Regulation amending and correcting Implementing Regulation (EU) 2021/1165 authorising certain products and substances for use in organic production and establishing their lists

Draft Annex

Update

The European Union (EU) proposes to update the list of substances and products that can be used in the production of organic products for the EU market, with additions to the lists of authorised low-risk active substances, fertilisers, feed materials, feed additives, and food additives.

It also proposes to authorise certain substances that may only be used in products produced in non-EU countries due to specific conditions and needs in those countries: micro-organisms used as biological control agents and ethylene for flower induction in pineapple.

The European Commission has informed the World Trade Organization Technical Barriers to Trade (WTO TBT) of the proposed changes ( G/TBT/N/EU/1108). Comments can be submitted to the EU TBT Enquiry Point until 11 April 2025. There is also an opportunity to provide feedback on this proposal via the European Commission’s Have Your Say webpage until 4 March 2025.

Impacted Products

Organic products

What is changing?

The draft Regulation proposes to make a number of additions and amendments to the lists of substances authorised for use in organic products that are imported into the EU (Annexes to Regulation 2021/1165).

In particular, the following are added to the list of substances that may be used in organic production (Annex VI):

• micro-organisms including viruses, when used as biological control agents. These must not be from genetically modified organisms (GMOs) or produced using media of GMO origin
• ethylene for flower induction in pineapple.

Proposed additions to the lists of authorised low-risk active substances, fertilisers, feed materials, feed additives, and food additives are summarised in Table 1.

Those substances for which there has been an amendment to the description and/or conditions of use are summarised in Table 2.

Details of these changes can be found in the Annex to the draft Regulation.

Why?

The proposed changes to the list of low-risk substances reflect the renewal of approvals of these substances under Regulation 1107/2009.

The proposed changes to fertilisers, feed additives, and the use of micro-organisms and ethylene in non-EU countries’ organic production are based on recommendations from the European Commission’s Expert Group for Technical Advice on Organic Production (see EGTOP reports on organic production).

Timeline

The European Commission intends to adopt the proposed Regulation in the first quarter of 2025. The Regulation will apply within 20 days of its publication (expected to be in the second quarter of 2025).

What are the major implications for exporting countries?

Operators in non-EU countries are recommended to reconfirm with their certification body which substances are authorised for use under the new EU organic rules. Dossiers may need to be submitted to the EU in the case of some substances that were previously used under the old equivalence rules, but which now require specific EU authorisation for use on organic exports (provided they are registered for use in the country of origin).

Recommended Actions

Where countries are members of the WTO, comments on the proposal can be submitted via the National TBT notification authority of the country concerned to the EU TBT Enquiry Point until 11 April 2025. Comments can also be submitted via the Commission’s Have Your Say webpage until 4 March 2025.

Background

The Organic Regulation (EU) 2018/848 lays down the EU rules on organic production and labelling of organic products. It revised and strengthened the controls system, trade regime, and production rules that had been in place since 2007. The move from the principle of equivalence to the principle of conformity marked a fundamental change to the regulatory approach. The earlier Regulation (EC) 834/2007 recognised that organic goods could be produced in ways that were different, but equivalent in terms of their outcome and alignment with organic principles. Under the new Regulation, producers in non-EU countries that do not have equivalence recognised in a trade agreement with the EU, or are not recognised as an equivalent country under Regulation 834/2007, will have to conform with exactly the same set of rules as those in the EU.

In certain instances, farmers in non-EU countries, with specific conditions that are different from EU production conditions, will require different tools. Recognised control authorities/bodies can ask the Commission to evaluate and authorise additional substances in non-EU countries for use in the production of organic products for the EU market (Regulation 2021/1165, Art. 10).

For further information see New EU Organic Regulation Explained.

Resources

Sources

Tables & Figures

Source: based on Annex to the draft Regulation

Source: based on Annex to the draft Regulation