April 2026 – TOS issue 206 Article 3

Changes, decisions & roadmaps in the EU

Changes include harmonisation of rules on withdrawal periods for veterinary medicines

by Marian Blom, Project Officer with Bionext, Netherlands

In January we briefly reported in TOS on the EU Commission proposal for changes to Regulation 2018/848 on organic production and labelling and the EU’s ‘Roadmap’ for the sector. We asked Marion Blom of Bionext, Netherlands to explain the proposed changes in more detail and the process of decision-making that the Commission is undertaking.


Fit for the future, simpler said than done

The organic production, trade and control system in the European Union is regulated by a European Law, EU Regulation 2018/848. This is called the basic regulation. With numerous delegating and implementing acts, together called secondary legislation, topped up with guidelines and guidance from the organic unit DG Agri, this constitutes an impressive and complex structure. In the course of 2025, the probability that some rules would be revised became increasingly obvious and on December 17, 2025, the European Commission published their proposal. In this article we will explore the reasons for this, describe the most important proposals and explain the process for decision-making.


Three reasons why the European regulation for organic production is being revised

There are at least three reasons why the EU regulation 2018/848 is currently being revised. First, there is an EU court ruling that impacts the relation with important trading countries outside the EU. The European Commission is trying to mitigate the effect of this ruling. Secondly, there is an unrealistic deadline for renewal of the equivalency agreements in the Basic Regulation that needs to be postponed. The third reason is the new political direction of the EU calling for simplification and less bureaucracy that was launched in 2025 which applies to the EU Organic Regulation as well as other horizontal legislation.


Court of Justice ruling on the use of the EU logo

In Case C-240/23 Herbaria Kräuterparadies II, the Court of Justice of the European Union (ECJ) ruled that Regulation (EU) 2018/848 must be interpreted as meaning that a product imported from a third country whose organic production and control systems have been recognised as equivalent to those of the Union may not have on its labelling either the organic production logo of the European Union or, in principle, terms referring to organic production. The organic production logo of the third country from which such product comes should be permitted on the product, even where that logo contains terms identical to those referring to organic production.


It would mean for example that you can sell a box of blueberries produced in the US in the EU, even if it is produced out of soil. But you cannot put the EU logo on it. You can put the NOP logo on it.  As this would be a change of the current practise, the European Commission has proposed a change in Regulation (EU) 2018/848 to try and solve this.


The deadline for concluding organic trade agreements is too soon

The recognition of third countries whose organic production and control systems have been recognised as equivalent to those of the Union will expire on 31 December 2026. The idea was that by the end of 2026 a new system would be in place. It will be a system of trade agreements.  The European Commission started work to conclude such agreements. They have conducted technical exchanges with those third countries, but the deadline of end of this year is not feasible. The basic regulation needs to be reopened to change the deadline.


Simplification of organic production rules

In February 2025, the European Commission adopted ‘A Vision for Agriculture and Food’. The document called for reducing unnecessary burdens on the farming sector and the entire agri-food value chain as a key step towards boosting their competitiveness. The focus on simplification and boosting EU competitiveness is in line with the new strategic direction the European Commission has taken after the European elections in 2024. Following several consultations of Member States and stakeholders, DG Agri made a list of proposals for change in the basic regulation and a work agenda which is called “Roadmap” with topics to address in the secondary legislation or through guidelines.

So, in mid-December 2025, the European Commission proposed a targeted revision. The following changes are proposed.


Extra conditions for equivalent regimes before the organic logo can be used

To resolve the Herbaria case, it is proposed that the use of the organic production logo of the European Union should be allowed on products imported from equivalent third countries, provided that, in addition to the equivalent rules, those products comply with certain additional production rules. These additional rules are considered fundamental to what European consumers may expect from organic products. Those rules include living soil, animal welfare standards and processing of food using minimum artificial inputs.


 So, if we take the example of blueberries again: if you have a statement accompanying your box of blueberries, that they are produced in the soil in the US, you can put the EU organic logo on the box. The European Commission has not made clear in their proposal how such a statement would look. Also, there is some flexibility suggested: if 5% or less of the ingredients that you use in producing an organic product in the EU is equivalent-but-not-compliant with the additional production rules, you can use the EU-logo on your product. If the non-compliant ingredient is more than 5% of the weight, you cannot use the EU logo on your finished product.


The question is whether the solution suggested by the European Commission is an improvement. The impact of these additional production rules is not clear. It may be little, but as no assessment is available, this remains open. And of course, the talks on equivalence agreements will be impacted. Furthermore, it can be heard from the side of the control bodies that the 5% proposal cannot be controlled.

   

Extension of negotiating time for trade agreements until 2036

To give themselves more time to conclude the discussion on the new trade agreements for organic trade, it is proposed that the 11 equivalent third countries continue to be recognised until 31 December 2036 to avoid disruptions in the trade of organic products. 


No rules for cleaning and disinfection in processing and storage facilities

For many years a positive list has existed for cleaning and disinfection substances for milking parlours and fishponds that are used for organic production. For plant production facilities like mushroom tunnels and greenhouses such a list could also be made, but until recently that was left to the Member states. Regulation 2018/848 introduced the possibility to make a list of cleaning and disinfection substances for processing and storage facilities. The European Commission attempted over several years to draw up such a list. But this proved to be nearly impossible. Many processing facilities process conventional and organic products. And complex machinery can only be cleaned following strict procedures and substances dictated by the machine builder. So, the barriers were so high that the European Commission now proposes to delete this whole idea.


Simplify the exemption from certificate for small operators

In the current regulation, small operators that sell a limited amount of unpacked goods can be exempt from the obligation to have a certificate. The current requirements for these operators are the certification cost as a percentage of their output; the annual sales of products sold in kilos and turnover. But inflation can increase the turnover without changing the real amount sold and this does not help the small operator.  Therefore, the proposal is to abolish the criteria for the turnover and certification cost and double the amount of maximum annual sales criterion from 5,000 to 10,000 kg.


Simplify the rules for groups of operators

Groups of farmers can produce and sell under one certificate. This option is mainly used by producer groups in third countries. Since 2022 very strict provisions are set for these producer groups. Evidence in relation to the implementation of those provisions shows significant difficulties in setting up groups of operators that fulfil requirements for the composition of members, in particular the annual turnover, and for their legal personality. There are high administrative costs and the need to reorganise the economic activities of groups of producers. Such difficulties prevent smaller operators from becoming part of groups of operators, since provisions in place do not appropriately reflect the needs and resource capacity of small farmers and operators, at the disadvantage of the development of organic farming both in the Union and in third countries. In third countries, the reorganisation of the producers’ activities can also result in difficulties in supplying the EU market with products originating from them, with the consequent risk of trade disruptions. To resolve some of these issues, the proposal is that requirements relating to the annual turnover of the members of the groups of operators are abolished. In addition, the requirement relating to the maximum eligible surface areas of members’ holdings should be revised upwards to allow the integration into groups of operators by smaller operators. Lastly, an organic group of operators can also be part of a larger group with a legal personality.


Poultry production – quail

The current period of conversion of 10 weeks for poultry for meat production is not appropriate for quail. In the Member States where organic quail are raised for meat production, their production cycle is shorter than the one applicable to other species of poultry for meat production, since they are slaughtered from 42 days of age. The conversion period should be five weeks. This corresponds to one week less than the minimum age of slaughter for these species.


Poultry production – housing of young birds

The Regulation lays down rules on housing and husbandry practices for poultry, including that poultry must be provided with continuous daytime open-air access from as early an age as practically possible. However, such rule can put at risk the safety of young, unfeathered birds in the period of their production cycle when they need, among other elements, stable temperatures to develop their feeding and drinking behaviours, their immunisation against infections, and shelter from any predators. That rule should therefore be amended to require access to open air areas only to birds that are sufficiently feathered to regulate their body temperature when exposed to outdoor climatic conditions.


Poultry production – fattening

Regulation (EU) 2018/848 provides that the total usable surface area for fattening poultry in poultry houses of any production unit must not exceed 1 600 m2. This limits the further development of organic fattening poultry production by limiting the size of any fattening poultry house in an organic production unit without bringing additional benefit to animal welfare and the environment. The proposal is to define the maximum usable surface area for fattening poultry at the level of the poultry houses.


Withdrawal period of the veterinary medicinal product

Regulation (EU) 2018/848 lays down rules on veterinary treatments. Those rules provide that, for terrestrial animals, the withdrawal period after the use of chemically synthesised allopathic medicinal products as defined in Regulation (EU) 2019/6 of the European Parliament and of the Council is twice the normal withdrawal period and with a minimum duration of 48 hours. This means that, even if the applicable normal withdrawal period of the veterinary medicinal product is zero days, the withdrawal period must be a minimum of 48 hours. For aquaculture, those rules require that the withdrawal period after the use of allopathic veterinary medicinal products must be twice that of an authorised veterinary medicinal product, or a minimum of 48 hours if no period is specified. To avoid a burden for the production of terrestrial animals, particularly in cases where the withdrawal period specified in the veterinary medicinal product is zero days, the provisions for terrestrial animals and aquaculture should therefore be aligned.


Decision making

The decision-making procedure for a change in a basic regulation in the EU is quite complex and can take several years. The European Commission presents a legal proposal to the Member States, united in the Council and the European Parliament. Both parties determine their position and then the institutions start negotiating until they reach an agreement. The ambition of the European Commission is that before the end of 2026 the revision is completed. This can only be done if there are not too many big changes and new topics put on the table.


So, following the system described above, after the legal proposal was published by the European Commission on December 17, the European Parliament has collected amendments from MEPs (members of the European Parliament). They have handed in 228 amendments. The next stage is that the rapporteur and shadow rapporteurs will analyse the amendments and seek convergence. The hope is that a compromise proposal can be voted upon by September.

In the meantime, the council is working too. The hope is to have a council position by the end of July.

  

To speed up the process, the European Commission already proposed that the new provisions should enter into force, as a matter of urgency, on the day following that of its publication in the Official Journal of the European Union.


Roadmap

As mentioned in the beginning of this article, alongside the change in the Basic Act, the European Commission also announced a simplification of production rules via a ‘roadmap’. This is the work agenda of the European Commission in the discussion with Member States for the next two years. On the list of topics on the work agenda there is for example a discussion on the possibility to correct the Certificate of Inspection if clear mistakes are made that do not affect the integrity of the organic product involved. Provisions on plant reproductive material are also on that agenda. This is welcome, as the rules for plant reproductive material have become very complex. A link to the whole list can be found at the bottom of the article. Apart from the work agenda, the European Commission promises to make the regulation more transparent, to invest in harmonisation through better cooperation and exchange of best practices.

 

Links:

A vision for agriculture and food

Proposal for changes in regulation 2018/848

The Roadmap to reduce the burden on organic operators and national administration


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