Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EU) 2018/848 as regards certain production, labelling and certification rules and certain rules on trade with third countries
Date: 2025-12-16
Institutions: Directorate-General for Agriculture and Rural Development, European Commission
Subjects: animal welfare, consumer protection, eco-label, food safety, harmonisation of standards, import, labelling, organic farming, organic product, third country

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   EUROPEAN COMMISSION  Brussels, 16.12.2025  COM(2025) 780 final 2025/0417 (COD)  Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EU) 2018/848 as regards certain production, labelling and certification rules and certain rules on trade with third countries  {SWD(2025) 424 final} (Text with EEA relevance)  
 
EXPLANATORY MEMORANDUM 

1. 

• 

CONTEXT OF THE PROPOSAL 

Reasons for and objectives of the proposal 

Organic farming is a key element of the Common Agricultural Policy (CAP) of the European 
Union.  The  share  of  land  farmed  organically  has  been  steadily  growing  to  11%  today. 
Consumers  increasingly  purchase  organic  food,  recognisable  through  an  EU  logo  and  a 
common label. The production and labelling of organic products are governed by Regulation 
(EU)  2018/848,  applicable  since  January  2022,  and  the  delegated  and  implementing 
Regulations adopted on its basis. These regulations establish the detailed rules that underpin 
organic production. 

In its judgment in Case C-240/23, the Court of Justice of the European Union concluded that, 
in light of the wording of Articles 30(2) and 33(1) of Regulation (EU) 2018/848, the context 
and  the  objectives  of  the  legislation  of  which  those  provisions  form  part,  neither  terms 
referring to organic production nor the EU organic production logo may be used by products 
that comply only with standards merely equivalent to the production rules in Regulation (EU) 
2018/848.  It  is  therefore  necessary  to  ensure  that  consumers  are  able  to  make  informed 
choices when purchasing products from third countries whose organic production and control 
systems  have  been  recognised  as  equivalent  to  those  of  the  Union,  as  well  as  to  ensure 
consumer  confidence  in  those  products  and  in  the  organic  production  logo  of  the  European 
Union whilst ensuring fair competition within the internal market between products that fully 
comply with Union production and control rules and those that comply with rules equivalent 
to those Union rules. 

Furthermore,  given  that  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  and  that  technical  exchanges  with  those  third  countries  with  a  view  to 
concluding  agreements  on  trade  in  organic  products  are  still  ongoing,  it  is  necessary  and 
urgent for those third countries to continue to be recognised until 31 December 2036 to avoid 
disruptions in the trade of organic products.  

Finally,  while  Regulation  (EU)  2018/848  provides  a  sound  basis  for  a  reliable  and  growing 
organic sector in the Union, it is necessary to make targeted adjustments to certain production 
rules to create a more efficient, effective, and user-friendly regulatory framework. 

• 

Consistency with existing policy provisions in the policy area 

This proposed regulation amends the current rules to facilitate organic production, labelling, 
controls and trade across the Union and in third countries. It will also ensure that consumers 
can make informed choices when buying organic products imported from third countries. 

• 

Consistency with other Union policies 

This proposal amends existing provisions of Regulation (EU) 2018/848, without altering their 
essence. As those existing provisions are consistent with other Union policies, the proposal is 
also consistent with those policies. 

The proposal ensures that consumers can make informed choices as regards organic products 
imported  from  third  countries  whose  organic  production  and  control  systems  have  been 
recognised  as  equivalent  to  those  of  the  Union,  in  particular  when  bearing  the  organic 
production logo of the European Union and the terms referring to organic production. It also 
extends the deadline for the expiry of the recognition of third countries that were recognised 

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for the purposes of equivalence under Article 33(2) of Regulation (EC) No 834/2007. Finally, 
in  reducing  complexities  in  the  regulatory  burden  on  organic  operators,  this  proposal  may 
facilitate investments and lead to the development of employment opportunities in the organic 
sector,  as  well  as  the  further  development  of  agricultural  practices  with  high  environmental 
standards. 

2. 

• 

LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY 

Legal basis 

Article 43(2) of the Treaty on the Functioning of the European Union. 

• 

Subsidiarity (for non-exclusive competence) 

This proposal amends provisions of Regulation (EU) 2018/848. That Regulation was adopted 
at EU level and is applicable in all Member States. 

The  proposal,  removes  burdens  on  Member  States,  operators  in  the  Union  and  in  third 
countries and avoids the disruption of trade in organic products, by: (i) allowing the use of the 
products  and  substances  available  on  the  market  for  cleaning  and  disinfection  for  use  in 
processing  and  storage;  (ii)  ensuring  that  consumers  get  appropriate  information  when 
purchasing products bearing the organic production logo of the European Union and the terms 
referring  to  organic  production;  (iii)  adapting  the  conditions  for  the  exemption  of  smaller 
operators selling  unpacked organic products  other than feed from  the obligation  of being  in 
possession  of  a  certificate  pursuant  to  Article  35(1)  of  Regulation  (EU)  2018/848;  (iv) 
adapting  the  requirements  for  the  composition  of  groups  of  operators;  (v)  postponing  the 
expiry  of  recognition  of  equivalent  third  countries;  and  (vi)  adapting  livestock  production 
rules. 

The amendments maintain the degree of harmonisation already achieved by Regulation (EU) 
2018/848  and  ensure  a  level-playing  field  between  operators  in  the  organic  sector.  It  is 
therefore considered that they cannot be implemented by Member States acting alone.  

• 

Proportionality 

The  proposal  amends  Regulation  (EU)  2018/848  only  to  the  extent  strictly  necessary  to 
achieve the objectives of that Regulation, while ensuring that the amendments remain targeted 
and  within  the  limit  of  what  is  necessary  to  achieve  those  objectives.  It  reduces  the 
administrative burden on Member States and operators, and it adds new elements only to the 
extent strictly necessary to adjust Regulation (EU) 2018/848 to the objectives outlined above. 

The proposal amends specific aspects of a limited number of provisions in Regulation (EU) 
2018/848: (i) it allows operators to use the products and substances available on the market 
for  cleaning  and  disinfection  for  use  in  processing  and  storage.  This  amendment  does  not 
change the objectives pursued by Regulation (EU) 2018/848 and only adjusts the provisions 
to  the needs of the sector and to  these  objectives;  (ii) it adapts  rules on labelling  of organic 
products imported from third countries. This  amendment ensures  that  consumers are able to 
make  informed  choices  when  purchasing  products  from  third  countries  whose  organic 
production and control systems have been recognised as equivalent to those of the Union, as 
well as to ensure consumer confidence in those products and in the organic production logo of 
the  European  Union  whilst  ensuring  fair  competition  within  the  internal  market  between 
products  that  fully  comply  with  Union  production  and  control  rules  and  those  that  comply 
with rules equivalent to those Union rules; (iii) it adapts the conditions for the exemption of 
smaller operators who sell unpacked organic products other than feed from the obligation of 
being  in  possession  of  a  certificate  pursuant  to  Article  35(1)  of  Regulation  (EU)  2018/848. 

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This  amendment  facilitates  the  exemption  of  smaller  operators  and  therefore  facilitates  the 
achievement of the objective of Regulation (EU) 2018/848 of encouraging short distribution 
channels and local production in the various areas of the Union; (iv) it adapts and simplifies 
the requirements for the composition of groups of operators. This  amendment facilitates the 
implementation  of  the  existing  provisions  and  the  development  of  organic  farming  in 
accordance with Regulation (EU) 2018/848; (v) it postpones the expiry of the recognition of 
equivalent  third  countries.  This  amendment  avoids  any  disruption  in  the  trade  of  organic 
products  and  ensures  a  smooth  transition  to  the  scheme  of  recognition  of  third  countries 
through  international  agreements;  and  (vi)  it  adapts  production  rules  for  livestock.  This 
amendment,  which  aims  to  simplify  the  current  rules  and  adapt  them  to  the  needs  of  the 
operators, is proportionate in so far as the new elements added to the EU organic legislative 
framework  (such  as  the  specific  conversion  period  and  the  minimum  age  at  slaughter  for 
quails)  are  limited  to  the  extent  strictly  necessary  to  adjust  the  existing  provisions  to  the 
objectives outlined above. 

• 

Choice of the instrument 

The rules that need to be amended are laid down in a Regulation of the European Parliament 
and of the Council. Therefore, the chosen instrument must also be a Regulation of European 
Parliament and of the Council. 

3. 

• 

RESULTS 
CONSULTATIONS AND IMPACT ASSESSMENTS 

EX-POST 

EVALUATIONS, 

OF 

STAKEHOLDER 

Ex-post evaluations/fitness checks of existing legislation  

No evaluation or fitness check was performed on Regulation (EU) 2018/848. However, since 
January  2022  and  the  entry  into  application  of  Regulation  (EU)  2018/848,  the  Commission 
consulted Member States and stakeholders on the implementation of the regulation. 

• 

Stakeholder consultations 

The Commission regularly exchanges information with Member States through the Group of 
Experts  on  Organic  Production  (GREX)  and  with  stakeholders,  through  the  Civil  Dialogue 
Group  on  organic  farming  (CDG).  In  these  meetings,  the  Commission  gathers  views  on 
various aspects related to the implementation of Regulation (EU) 2018/848 and the delegated 
and implementing Regulations adopted on its basis. 

In  2024,  the  Fit  For  Future  Platform,  the  high-level  expert  group  set  up  to  help  the 
Commission simplify existing legislation and reduce administrative burden, issued an opinion 
on how Regulation (EU) 2018/848 and the delegated and implementing Regulations adopted 
on its basis could be simplified1. The opinion was discussed in the AGRIFISH Council of 27 
January 2025. 

The Commission consulted the GREX and the CDG in the first half of 2025 to follow up on 
the  opinion  of  that  platform.  It  was  concluded  that  some  elements  of  Regulation  (EU) 
2018/848  and  the  delegated  and  implementing  Regulations  adopted  on  its  basis  could  be 
simplified.  

Furthermore,  on  24  September  2025,  a  combined  GREX-CDG  meeting  was  held  to  discuss 
how Regulation (EU) 2018/848 could be simplified without lowering its objectives, principles 
and standards. 

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https://commission.europa.eu/document/download/25d40cdf-9e5e-4a8b-8da6-
7a72efad04ed_en?filename=fo_2024_8_organic_production_and_labeling_en.pdf&prefLang=mt   

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An Implementation Dialogue on the organic policy2 was held on 10 November 2025, chaired 
by  the  Commissioner  for  Agriculture  and  Food  and  attended  by  several  agri-food  organic 
operators  and  other  stakeholders.  Discussions  focused  on  their  experience  of  the  rules  on 
organic  production  and  the  labelling  of  organic  products  and  how  certain  aspects  of 
Regulation  (EU)  2018/848  and  the  delegated  and  implementing  Regulations  adopted  on  its 
basis could be simplified. 
Finally, a Call for evidence was open from 21 October to 18 November 20253. A total of 720 
submissions  were  received  from  EU  citizens  (44.9%),  companies/businesses  (31.3%), 
business  associations  (11%),  Non-Governmental  Organisations  (NGOs)  (2.8%),  public 
authorities (1.5%), trade unions (1.3%), and others (7.4%). The feedback concerned possible 
amendments  to  Regulation (EU) 2018/848  and the delegated  and implementing Regulations 
adopted on its basis. 

• 

Collection and use of expertise 

The  Commission  regularly  exchanges  views  with  Member  States  and  stakeholders  on  the 
implementation  of  Regulation  (EU)  2018/848  and  the  delegated  and  implementing 
Regulations adopted on its basis, including gathering feedback on difficulties they encounter. 
In addition, the Commission collected evidence through the targeted consultations mentioned 
above.  The  expertise  gathered  through  all  these  consultations  constitute  the  expertise  the 
Commission relied on for this initiative. 

• 

Impact assessment 

In light of the need to urgently: (i) ensure that consumers are able to make informed choices 
when purchasing products from third countries whose organic production and control systems 
have  been  recognised  as  equivalent  to  those  of  the  Union,  as  well  as  to  ensure  consumer 
confidence in those products and in the organic production logo of the European Union whilst 
ensuring fair competition within the internal market between products that fully comply with 
Union  production  and  control  rules  and  those  that  comply  with  rules  equivalent  to  those 
Union  rules;  (ii)  avoid  any  disruption  of  trade  in  organic  products  with  third  countries 
recognised as equivalent; (iii) address, in a targeted way, the challenges that the organic sector 
is  facing,  removing burdens and enhancing  its competitiveness, no impact assessment could 
be conducted. 

However,  the  proposed  amendments  to  Regulation  (EU)  2018/848  have  been  developed  on 
the basis of the evidence gathered through consultations described in the section ‘Stakeholder 
consultations’  above.  The  proposed  amendments  are  targeted  and  will  not  alter  the  overall 
objectives of the policy.  

The  full  impact  of  the  proposal  will  depend  on  the  adherence  to  the  proposed  measures  by 
organic operators. Beyond reduction of monetary costs, removing barriers for operators in the 
Union  and  in  third  countries  is  expected  to  stimulate  the  maintenance  and  the  uptake  of 
organic farming, thus enhancing its environmental and social benefits. 

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https://agriculture.ec.europa.eu/media/events/implementation-dialogue-eu-organic-policy-2025-11-
10_en  
https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/15273-Organic-production-
targeted updates-and-simplification_en  

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The Commission will present the reduction of burden,  including an assessment of costs and 
benefits  and  how  the  inputs  from  the  consultations  have  been  taken  into  account,  in  an 
analytical Staff Working Document to be published along with this proposal.  

Given  that  the  proposed  measures  are  expected  to  result  in  no  increase  in  greenhouse  gas 
emissions,  this  proposal  is  consistent  with  the  climate-neutrality  objective  set  out  in  Article 
2(1) of Regulation (EU) 2021/1119 of the European Parliament and of the Council (European 
Climate  Law),  as  well  as  the  Union  20304  and  20405  climate  targets.  Moreover,  as  organic 
farming  practices  can  strengthen  resilience  to  climate  change6,  the  proposed  measures 
contribute  to  the  EU’s  efforts  in  climate  change  adaptation,  provided  for  in  Article  5  of 
Regulation (EU) 2021/1119. 

• 

Regulatory fitness and simplification 

Several  elements  in  the  proposal  contribute  to  simplification,  reducing  bureaucracy  and 
administrative burden for organic operators and Member States’ administrations (i) allowing 
the use of the products and substances available on the market for cleaning and disinfection 
for  use  in  processing  and  storage;  (ii)  adapting  the  conditions  for  the  exemption  of  smaller 
operators selling  unpacked organic products  other than feed from  the obligation  of being  in 
possession  of  a  certificate  pursuant  to  Article  35(1)  of  Regulation  (EU)  2018/848;  (iii) 
adapting  the  requirements  for  the  composition  of  groups  of  operators;  and  (iv)  adapting 
livestock production rules. Moreover, they benefit Member States’ administration in relation 
to  the  adaptation  of  the  conditions  for  the  exemption  of  smaller  operators  selling  unpacked 
organic  products  other  than  feed  from  the  obligation  of  being  in  possession  of  a  certificate 
pursuant to Article 35(1) of Regulation (EU) 2018/848. 

These  elements  therefore  adapt  the  provisions  of  Regulation  (EU)  2018/848  to  the  practical 
needs  of  operators,  preserving  objectives  and  principles  of  that  Regulation,  maintaining  its 
high standards and avoiding one-size-fits-all approaches that might prove to be burdensome to 
implement and less effective. 

In particular, these elements may entail annual direct administrative cost savings for a total of 
EUR  47.8  million,  of  which  EUR  45.9  million  for  businesses  and  EUR  1.9  million  for 
administrations.  In  addition,  these  elements  may  entail  for  businesses  direct  one-off 
adjustment  cost  savings of  EUR  109.2  million  and  annual  direct  adjustment  cost  savings  of 
EUR 90.2 million. 

Following the digital assessment,  the current  proposal  does  not  include any requirements of 
digital relevance. Digital means or data exchange are not under the scope of this proposal. 

• 

Fundamental rights 

The  proposal  respects  the  fundamental  rights  and  observes  the  principles  recognised,  in 
particular, by the Charter of Fundamental Rights of the European Union. 

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https://climate.ec.europa.eu/eu-action/climate-strategies-targets/2030-climate-targets_en 
Proposal  for  a  Regulation  of the  European  Parliament  and of  the  Council  amending  Regulation  (EU) 
2021/1119  establishing  the  framework  for  achieving  climate  neutrality  (COM/2025/524  final) 
https://climate.ec.europa.eu/document/download/e1b5a957-c6b9-4cb2-a247-bd28bf675db6_en 
N.  Scialabba,  M.  Müller-Lindenlauf,  Organic  agriculture  and  climate  change,  Renewable  Agriculture 
and Food Systems, 25 (2), pp. 158 – 169 (2010) 10.1017/S1742170510000116 

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4. 

BUDGETARY IMPLICATIONS 

This proposal has no budgetary implications. 

5. 

• 

OTHER ELEMENTS 

Implementation plans and monitoring, evaluation and reporting arrangements 

the 

implementation  of  Regulation  (EU)  2018/848  and 

The market observatories established by the Commission continuously monitor the supply and 
demand of organic products, as well as their prices, on the Union market. They will continue 
to  provide  an  insight  on  their  developments.  In  addition,  the  Commission  will  continue  to 
monitor 
the  delegated  and 
implementing Regulations adopted on its basis in the framework of its regular meetings with 
Member  States  and  stakeholders’  representatives.  Finally,  in  relation  to  third  countries 
recognised  for  the  purpose  of  equivalence  under  Regulation  (EC)  No  834/2007,  the 
Commission will continue to ensure their appropriate supervision as provided for in Article 48 
of Regulation (EU) 2018/848. 

• 

Explanatory documents (for directives) 

Not applicable. 

• 

Detailed explanation of the specific provisions of the proposal 

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,  either  through  an  international  agreement 
between the Union and those third countries or where the third countries were recognised for 
the purpose of equivalence under Regulation (EC) No 834/2007, may not have on its labelling 
either the organic production logo of the European Union or, in principle, terms referring to 
organic production. The ECJ further ruled that the use of 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, within the meaning of 
Article 30(1) of that Regulation (EU) 2018/848 and Annex IV thereto. 

The use, for  a product  imported from  a third country whose organic production and control 
systems have been recognised as equivalent to those of the Union, of the organic production 
logo  of  a  third  country  is  not  liable  to  harm  fair  competition  within  the  internal  market  in 
organic  products  or  to  give  rise  to  ambiguity  that  may  mislead  consumers.  This  is  because 
such a logo neither places the product concerned on the same level as Union organic products 
from  the  point  of  view  of  competition  nor  is  liable  to  give  the  impression  that  the  product 
concerned complies with all the requirements laid down by Regulation (EU) 2018/848. 

Terms  referring  to  organic  production,  including  their  derivatives  and  diminutives,  are  used 
both  in  the Union and in third countries to  suggest  to  the purchaser that the product  and its 
ingredients  have  been  produced  in  accordance  with  applicable  organic  production  methods. 
This is also the case in the Codex Alimentarius guidelines CAC/GL 32, where terms referring 
to organic production methods such as ‘organic’, ‘biological’, ‘ecological’ or words of similar 
intent  including  diminutives  are  used  to  suggest  to  the  purchaser  that  the  product  or  its 
ingredients  were  produced  in  accordance  with  organic  production  methods.  In  addition, 
certain  organic  production  rules  in  third  countries  require  terms  referring  to  organic 
production to be used for products and their ingredients product that have been produced in 
accordance with applicable organic production methods. 

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Not every third country whose organic production and control systems have been recognised 
as  equivalent  to  those  of  the  Union  has  its  own  organic  production  logo.  Consequently,  if 
products from such third countries could not bear terms referring to organic production, this 
would  deprive  operators  in  those  third  countries  of  the  possibility  to  indicate  the  organic 
status of such products and to suggest to consumers in the Union that those products originate 
from organic production and are produced in accordance with organic production methods in 
their countries of origin. This would also be difficult to reconcile with the Codex Alimentarius 
guidelines  CAC/GL  32  because  it  would  not  be  possible  to  refer  to  organic  production 
methods  in  the  labelling  of  such  products  despite  them  meeting  all  the  corresponding 
conditions set out in these guidelines. 

The recognition of the organic production and control systems of a third country as equivalent 
to  those  of  the  Union  means  that  such  a  system  has  been  assessed  as  meeting  the  same 
objectives and principles as those of the Union by applying rules which ensure the same level 
of assurance of conformity, even if that is achieved through different means.  

Differences  between  the  rules  applied  in  organic  production  and  control  systems  of  third 
countries  recognised  as  equivalent  and  those  applied  in  the  Union  are  intrinsic  to  the 
equivalence regime. The assessment of equivalency by the Commission has shown that while 
some of those differences  are  limited and do not translate into product  characteristics, other 
differences involve rules of organic production which play an important role in the structure 
of  organic  production  in  the  Union  and  contribute  to  achieving  the  objective  of  satisfying 
consumer expectations as regards organic products whilst ensuring fair competition within the 
internal market between products that fully comply with Union production and control rules 
and those that comply with rules equivalent to those Union rules. Those rules include living 
soil, animal welfare standards and processing of food using minimum artificial inputs.  
A  Eurobarometer  survey7  conducted  in  June  and  July  2024  and  entitled  ‘Europeans, 
Agriculture and the CAP’ indicated that the organic production logo of the European Union is 
the  food  product  logo  of  which  Europeans  are  the  most  aware.  It  is  essential  to  both 
consumers  and  producers  because  it  makes  it  easier  for  consumers  to  identify  organic 
products and helps producers to market them across the Union. 

In  order  to  ensure  a  fair  competition  within  the  internal  market  between  products  that  fully 
comply with Union production and control rules and those that comply with rules equivalent 
to those Union rules, and in order to respond to consumer expectations that products imported 
from third countries whose organic production and control systems have been recognised as 
equivalent to those of the Union meet standards as high as those of the Union, the use of the 
organic  production  logo  of  the  European  Union  should  be  allowed  in  the  labelling, 
presentation and advertising of products imported from those third countries, provided that, in 
addition  to  those equivalent  rules,  those products  comply with  certain  additional  production 
and control requirements. 

In order to preserve the effectiveness of Regulation (EU) 2018/848 as regards trade with third 
countries, such additional requirements should correspond to production and control rules that 
play an important  role in the structure of organic production in  the Union and contribute to 
achieving the objective of satisfying consumer expectations as regards organic products whilst 
ensuring fair competition within the internal market.  

Where there are changes to the production rules in the EU or in third countries whose organic 
production  systems  have  been  recognised  as  equivalent  to  those  of  the  Union,  the  power  to 

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https://europa.eu/eurobarometer/surveys/detail/3226 

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adopt  certain  acts  should be delegated to  the Commission in respect  of  adding  or amending 
the additional production and control requirements with which products imported from those 
third  countries  must  comply  in  order  to  use  the  organic  production  logo  of  the  European 
Union. 

Operators  in  the  Union  that  produce  organic  food  and  feed  rely  on  the  use  of  ingredients 
imported  from  third  countries  whose  organic  production  and  control  systems  have  been 
recognised  as  equivalent  to  those  of  the  Union.  Such  ingredients  are  used  in  variable 
proportions  during  the  processing  of  organic  products  in  the  Union  and  are  necessary  for  a 
large variety of organic products processed in the Union. 

Processing operations in the Union, when using  those ingredients, take place in compliance 
with  the  production  rules  set  out  in  Regulation  (EU)  2018/848.  The  use  of  the  organic 
production logo of the European Union should therefore be allowed by products processed in 
the  Union  and  that  contain  organic  ingredients  either  produced  in  accordance  with  this 
Regulation  or  imported  from  third  countries  whose  organic  production  and  control  systems 
have been recognised as equivalent to those of the Union and where those ingredients account 
for 5% or less of the agricultural ingredients of the product (by weight for food and in general 
for feed). 

Where  those  ingredients  account  for  more  than  5%  of  the  agricultural  ingredients  of  the 
product (by weight for food and in general for feed), and in order to ensure a fair competition 
between processed products containing ingredients that fully comply with Union production 
and  control  rules  and  those  that  comply  with  rules  equivalent  to  those  Union  rules,  and  in 
order to respond to consumer expectations in relation to the use of the organic production logo 
of  the  European  Union,  that  logo  should  be  allowed  in  the  labelling,  presentation  and 
advertising of processed products containing ingredients imported from those third countries, 
provided  that,  in  addition  to  those  equivalent  rules,  those  ingredients  comply  with  certain 
additional production and control requirements.  

Regulation  (EU)  2018/848  provides  that  the  use  of  the  organic  production  logo  of  the 
European Union is obligatory for all organic prepacked food produced within the Union. It is 
therefore  necessary  to  exclude  from  that  obligation  prepacked  food  produced  within  the 
Union with  ingredients  imported from  third countries whose organic production and control 
systems have been recognised as equivalent to those of the Union and where those ingredients 
account for more than 5% of the agricultural ingredients of the product by weight and do not 
comply with certain additional production and control requirements. 

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. On 28 June 
2021,  the  Council  authorised  the  Commission  to  open  negotiations  with  the  third  countries 
recognised for the purpose of equivalence under Regulation (EC) No 834/2007 with a view to 
concluding  agreements  on  trade  in  organic  products.  On  that  basis,  the  Commission  is 
conducting  technical  exchanges  with  those  third  countries.  Those  exchanges  show  different 
levels  of  progress  due  to  the  diversity  of  legal  and  regulatory  frameworks  and  complexities 
linked  to  varying  consumer  perceptions  of  organic  production  from  one  organic  production 
system to the other. It is therefore necessary and urgent for those third countries to continue to 
be recognised until 31 December 2036 to avoid disruptions in the trade of organic products. 

Regulation (EU) 2018/848 provides that products for cleaning and disinfection in processing 
and  storage  facilities  for  use  in  organic  production  should  be  authorised  and  included  in 
restrictive  lists  by  the  Commission.  However,  there  are  a  number  of  challenges  associated 
with the establishment of such lists. Those challenges have been confirmed by several reports 
from the Expert Group for Technical Advice on Organic Production (EGTOP). First, there are 

EN 

8 

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a  large  number  of  products  and  substances  for  cleaning  and  disinfection  of  processing  and 
storage facilities currently available on the Union market. Second, the processing and storage 
of organic products takes place in many different types of establishments and involves the use 
of a wide range of equipment, machinery and buildings. Third, the equipment and machinery 
for  processing  and  storage  must  be  cleaned  and  disinfected  in  accordance  with  the 
manufacturers’  specifications  in  order  to  ensure  its  appropriate  maintenance  and  operation. 
With  a  view  to  allowing  organic  operators  to  use  products  and  substances  for  cleaning  and 
disinfectants  available  on  the  market,  the  requirement  for  the  Commission  to  authorise 
products  for cleaning  and disinfection in  processing  and storage facilities for use in  organic 
production and include them in restrictive lists should be deleted. 

Regulation  (EU)  2018/848  entitles  Member  States  to  exempt  smaller  operators  that  sell 
unpacked  organic  products  other  than  feed  from  the  obligation  to  be  in  the  possession  of  a 
certificate  pursuant  to  Article  35(1)  of  Regulation  (EU)  2018/848.  However,  the  current 
conditions  may  act  as  a  barrier  to  growth.  Furthermore,  increasing  costs  experienced  by 
smaller operators since the entry into application of Regulation (EU) 2018/848 have increased 
their  turnover  in  relation  to  unpacked  organic  products  other  than  feed.  This  has  created  a 
barrier  to  the  fulfilment  of  the  conditions  relating  to  their  turnover  in  order  to  be  exempted 
from  the  obligation  of  being  in  possession  of  a  certificate  pursuant  to  Article  35(1).  Those 
conditions  should  therefore  be  abolished.  In  addition,  the  condition  relating  to  annual  sales 
should be revised upwards in order not to hinder smaller operators from being exempted from 
the obligation of being in possession of a certificate pursuant to Article 35(1). 

Regulation (EU) 2018/848 lays down provisions on the composition of groups of operators in 
the  Union  and  in  third  countries.  Evidence  in  relation  to  the  implementation  of  those 
provisions  shows  significant  difficulties  in  setting  up  groups  of  operators  that  fulfil 
requirements as regards the composition of members, in particular the annual turnover, and as 
regards  their  legal  personality.  These  difficulties  prevent  smaller  operators  from  becoming 
part of groups of operators. In third countries, the reorganisation of the producers’ activities 
can  also  result  in  difficulties  in  supplying  the  Union  with  products  originating  from  them, 
with the consequent risk of trade disruptions. The requirements relating to the annual turnover 
of  the  members  of  the  groups  of  operators  should  therefore  be  abolished.  In  addition,  the 
requirement relating to the maximum eligible surface areas of members’ holdings should be 
revised upwards in order to allow the integration into groups of operators of smaller operators. 

Regulation (EU) 2018/848 does not lay down any specific conversion  period or a minimum 
age at slaughter for quails, hindering their production. It is therefore appropriate to lay down 
such  rules.  In  the  Member  States  where  organic  quails  are  currently  raised  for  meat 
production, they are slaughtered from 42 days of age, with a conversion period of five weeks. 
This  corresponds  to  one  week  less  than  the  minimum  age  of  slaughter  for  these  species. 
Hence,  the  current  period  of  conversion  of  10  weeks  for  poultry  for  meat  production  is  not 
appropriate for quails and should be shortened taking into account their age at slaughter. It is 
therefore appropriate to set a minimum age of 42 days at slaughter and a conversion period of 
five weeks for quails for meat production. 

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 provide that the withdrawal period after the use of veterinary medicinal products is 
twice  the  normal  withdrawal  period,  or  a  minimum  duration  of  48  hours  if  no  period  is 

EN 

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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. 

Regulation  (EU)  2018/848  requires  that  poultry  must  be  provided  with  continuous  daytime 
open air access from as early an age as practically possible. Such a requirement 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.  Those  requirements 
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. 

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 maximum usable surface area for fattening poultry should 
therefore be defined at the level of the poultry houses. 

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2025/0417 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

amending Regulation (EU) 2018/848 as regards certain production, labelling and 
certification rules and certain rules on trade with third countries  

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  on  the  Functioning  of  the  European  Union,  and  in  particular 
Article 43(2) thereof, 

Having regard to the proposal from the European Commission, 

After transmission of the draft legislative act to the national parliaments, 
Having regard to the opinion of the European Economic and Social Committee8, 
Having regard to the opinion of the Committee of the Regions9, 

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

(1) 

8 
9 
10 

Regulation (EU) 2018/848 lays down provisions for the authorisation of products and 
substances for use in organic production. In particular, the Commission may authorise 
products  for  cleaning  and  disinfection  in  processing  and  storage  facilities  for  use  in 
organic production and include them in restrictive lists. However, there are a number 
of challenges associated with the establishment of such lists, as confirmed by several 
reports  from  the  Expert  Group  for  Technical  Advice  on  Organic  Production 
(EGTOP)10.  First,  there  are  a  large  number  of  products  and  substances  for  cleaning 
and disinfection of processing and storage  facilities currently available on the Union 
market.  Second,  the  processing  and  storage  of  organic  products  takes  place  in  many 
different types of establishments and involves the use of a wide range of equipment, 
machinery  and  buildings.  Third,  the  equipment  and  machinery  for  processing  and 
storage  must  be  cleaned  and  disinfected  in  accordance  with  the  manufacturers’ 
specifications  in  order  to  ensure  its  appropriate  maintenance  and  operation.  With  a 

OJ C, … 
OJ C, … 
EGTOP,  ‘Final  report  on  the  criteria  for  evaluation  of  products  for  cleaning  and  disinfection’, 
8 December 
2021, https://agriculture.ec.europa.eu/document/download/2cd40421-9a7e-432c-9818-
947cc97358c4_en?filename=egtop-report-on-criteria-cleaning-and-disinfection_en.pdf;  EGTOP,  ‘Final 
2025, 
14 
disinfection 
report 
https://agriculture.ec.europa.eu/document/download/bc0480a6-d269-468b-97df-
3da3216f0d4d_en?filename=final-report-egtop-on-cleaning-disinfectant-iii_en.pdf;  EGTOP, 
report 
https://agriculture.ec.europa.eu/farming/organic-farming/co-operation-and-expert-advice/egtop-
reports_en  

‘Final 
2025, 

disinfection 

November 

cleaning 

cleaning 

(III)’, 

April 

(IV), 

and 

and 

on 

on 

6 

EN 

11 

  EN 

 
(2) 

(3) 

(4) 

(5) 

view  to  allowing  organic  operators  to  use  products  and  substances  for  cleaning  and 
disinfectants available on the market, the requirement for the Commission to authorise 
products  for  cleaning  and  disinfection  in  processing  and  storage  facilities  for  use  in 
organic production and include them in restrictive lists should be deleted. 

Regulation  (EU)  2018/848  lays  down  rules  for  the  import  of  products  from  third 
countries for the purpose of placing such products on the Union market as organic or 
in-conversion  products.  Under  those  rules,  organic  products  can  have  access  to  the 
Union market where they comply with the Union rules on organic production or where 
they  come  from  third  countries  whose  organic  production  and  control  systems  have 
been  recognised  as  equivalent  to  those  of  the  Union,  either  through  an  international 
agreement  between  the  Union  and  those  third  countries  or  where  the  third  countries 
were recognised for the purpose of equivalence under Regulation (EC) No 834/2007. 

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,  either  through  an 
international agreement between the Union and those third countries or where the third 
countries  were  recognised  for  the  purpose  of  equivalence  under  Regulation  (EC)  No 
834/2007,  may  not  have  on  its  labelling  either  the  organic  production  logo  of  the 
European  Union  or,  in  principle,  terms  referring  to  organic  production.  The  ECJ 
further ruled that, in order to ensure the effectiveness of Regulation (EU) 2018/848, as 
well as to preserve the powers which that Regulation confers on the Commission, the 
use of 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,  within  the  meaning  of  Article  30(1)  of  that 
Regulation (EU) 2018/848 and Annex IV thereto. 

The  use  for  a  product  imported  from  a  third  country  whose  organic  production  and 
control systems has been recognised as equivalent to those of the Union of the organic 
production  logo  of  a  third  country  is  not  liable  to  harm  fair  competition  within  the 
internal  market  in  organic  products  or  to  give  rise  to  ambiguity  that  may  mislead 
consumers.  This  is  because  such  a  logo  neither  places  the  product  concerned  on  the 
same  level  as  Union  organic  products  from  the  point  of  view  of  competition  or  is  it 
liable  to  give  the  impression  that  the  product  concerned  complies  with  all  the 
requirements laid down by Regulation (EU) 2018/848. 

Terms referring to organic production, including their derivatives and diminutives, are 
used  both  in  the  Union  and  in  third  countries  to  suggest  to  the  purchaser  that  the 
product and its ingredients have been produced in accordance with applicable organic 
production  methods.  This  is  also  the  case  in  the  Codex  Alimentarius  guidelines 
CAC/GL 3211, where terms referring to organic production methods such as ‘organic’, 
‘biological’, ‘ecological’ or words of similar intent including diminutives are used to 
suggest  to  the  purchaser  that  the  product  or  its  ingredients  were  produced  in 
accordance with organic production methods.  In  addition,  certain organic production 
rules  in  third  countries  require  terms  referring  to  organic  production  to  be  used  for 
products and their ingredients that have been produced in accordance with applicable 
organic production methods. 

11 

Guidelines  for  the  production,  processing,  labelling  and  marketing  of  organically  produced  foods  GL 
32–1999: https://www.fao.org/input/download/standards/360/cxg_032e.pdf  

EN 

12 

  EN 

 
(6) 

(7) 

(8) 

(9) 

Not  every  third  country  whose  organic  production  and  control  systems  have  been 
recognised  as  equivalent  to  those  of  the  Union  has  its  own  organic  production  logo. 
Consequently, if products from such third countries could not bear terms referring to 
organic  production,  this  would  deprive  operators  in  those  third  countries  of  the 
possibility to indicate the organic status of such products and to suggest to purchasers 
in the Union that those products originate from organic production and are produced in 
accordance with organic production methods in  their countries of origin.  This  would 
also  be  difficult  to  reconcile  with  the  Codex  Alimentarius  guidelines  CAC/GL  32 
because  it  would  not  be  possible  to  refer  to  organic  production  methods  in  the 
labelling  of  such  products  despite  them  meeting  all  the  corresponding  conditions  set 
out in those guidelines. 

In  order  to  ensure  the  effectiveness  of  Regulation  (EU)  2018/848,  as  well  as  to 
preserve  the  powers  which  that  Regulation  confers  on  the  Commission,  products 
imported  from  third  countries  whose  organic  production  and  control  systems  have 
been  recognised  as  equivalent  to  those  of  the  Union,  either  through  an  international 
agreement  between  the  Union  and  those  third  countries  or  where  the  third  countries 
were recognised for the purpose of equivalence under Regulation (EC) No 834/2007, 
which  have  access  to  the  Union  market  as  organic  products,  should  therefore  be 
allowed to bear terms referring to organic production.  

The  recognition  of  the  organic  production  and  control  systems  of  a  third  country  as 
equivalent  to  those  of  the  Union  means  that  such  a  system  has  been  assessed  as 
meeting  the  same  objectives  and  principles  as  those  of  the  Union  by  applying  rules 
which  ensure  the  same  level  of  assurance  of  conformity,  even  if  that  is  achieved 
through different means.  

Differences  between  the  rules  applied  in  organic  production  and  control  systems  of 
third countries recognised as equivalent and those applied in the Union are intrinsic to 
the equivalence regime. The assessment of equivalence by the Commission has shown 
that  while  some  of  those  differences  are  limited  in  scope,  other  differences  involve 
rules  of  organic  production  which  play  an  important  role  in  the  structure  of  organic 
production  in  the  Union  and  contribute  to  achieving  the  objective  of  satisfying 
consumer  expectations  as  regards  organic  products  whilst  ensuring  fair  competition 
within the internal market between products that fully comply with Union production 
and  control  rules  and  those  that  comply  with  rules  equivalent  to  those  Union  rules. 
Those rules include living soil, animal welfare standards and processing of food using 
minimum artificial inputs.  

(10)  A  Eurobarometer  survey  conducted  in  June  and  July  2024  and  entitled  ‘Europeans, 
Agriculture and the CAP’ indicated that the organic production logo of the European 
Union is the food product logo of which Europeans are the most aware. It is essential 
to both consumers and producers because it makes it easier for consumers to identify 
organic products and helps producers to market them across the Union. 

(11) 

In  order  to  ensure  fair  competition  within  the  internal  market  between  products  that 
fully comply with Union production and control rules and those that comply with rules 
equivalent to those Union rules, and in order to respond to consumer expectations that 
products imported from third countries whose organic production and control systems 
have  been  recognised  as  equivalent  to  those  of  the  Union  meet  standards  as  high  as 
those  of  the  Union,  the  use  of  the  organic  production  logo  of  the  European  Union 
should be allowed in the labelling, presentation and advertising of products imported 

EN 

13 

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from  those  third  countries,  provided  that,  in  addition  to  those  equivalent  rules,  those 
products comply with certain additional production and control requirements. 

(12) 

In  order  to  preserve  the  effectiveness  of  Regulation  (EU)  2018/848  as  regards  trade 
with third countries, such additional requirements should correspond to production and 
control rules that play an important role in the structure of organic production in the 
EU  and  contribute  to  achieving  the  objective  of  satisfying  consumer  expectations  as 
regards organic products whilst ensuring fair competition within the internal market. 

(13)  Where  there are changes to  the production and control  rules in  the  Union or in  third 
countries  whose  organic  production  and  control  systems  have  been  recognised  as 
equivalent to those of the Union, the power to adopt certain acts should be delegated to 
the  Commission  in  respect  of  adding  or  amending  the  additional  production  and 
control  requirements  with  which  products  imported  from  those  third  countries  must 
comply in order to use the organic production logo of the European Union. 

(14)  Operators  in  the  Union  that  produce  organic  food  and  feed  rely  on  the  use  of 
ingredients  imported  from  third  countries  whose  organic  production  and  control 
systems  have  been  recognised  as  equivalent  to  those  of  the  Union.  Such  ingredients 
are used in variable proportions during the processing of organic products in the Union 
and  are  necessary  for  a  large  variety  of  organic  products  processed  in  the  Union. 
Processing  operations  in  the  Union,  when  using  those  ingredients,  take  place  in 
compliance with the production rules set out in Regulation (EU) 2018/848. The use of 
the  organic  production  logo  of  the  European  Union  should  therefore  be  allowed  by 
products processed in the Union and that contain organic ingredients either produced 
in  accordance  with  this  Regulation  or  imported  from  third  countries  whose  organic 
production  and  control  systems  have  been  recognised  as  equivalent  to  those  of  the 
Union  and  where  those  ingredients  account  for  5%  or  less  of  the  agricultural 
ingredients of the product (by weight for food and in general  for feed). Where those 
ingredients account for more than 5% of the agricultural ingredients of the product (by 
weight  for  food  and  in  general  for  feed),  and  in  order  to  ensure  a  fair  competition 
within  the  internal  market  between  processed  products  containing  ingredients  that 
fully comply with Union production and control rules and those that comply with rules 
equivalent to those Union rules, and in order to respond to consumer expectations  in 
relation  to  the  use  of  the  organic  production  logo  of  the  European  Union,  that  logo 
should be allowed in the labelling, presentation and advertising of processed products 
containing ingredients imported from those third countries, provided that, in addition 
to those equivalent rules, those ingredients comply with certain additional production 
and control requirements. 

(15)  Regulation (EU) 2018/848 provides that the use of the organic production logo of the 
European  Union  is  obligatory  for  all  organic  prepacked  food  produced  within  the 
Union.  It  is  therefore  necessary  to  exclude  from  that  obligation  prepacked  food 
produced  within  the  Union  with  ingredients  imported  from  third  countries  whose 
organic production and control systems have been recognised as equivalent to those of 
the  Union  and  where  those  ingredients  account  for  more  than  5%  of  the  agricultural 
ingredients  of  the  product  by  weight  and  do  not  comply  with  certain  additional 
production and control requirements. 

(16)  Regulation  (EU)  2018/848  lays  down  provisions  on  the  conditions  under  which 
Member  States  can  exempt  smaller  operators  from  the  obligation  to  be  in  the 
possession of a certificate pursuant to Article 35(1) of that Regulation. The increasing 
costs experienced by smaller operators since the entry into application of Regulation 

EN 

14 

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(EU) 2018/848 have increased their turnover in relation to unpacked organic products 
other than feed. This has created a barrier to the fulfilment of the conditions relating to 
their turnover in order to be exempted from the obligation of being in possession of a 
certificate  pursuant  to  Article  35(1).  Such  a  barrier  in  turn  results  in  increased  costs 
due  to  that  obligation.  The  conditions  relating  to  the  annual  turnover  under  which 
Member States can exempt smaller operators from being in possession of a certificate 
pursuant to Article 35(1) of that Regulation should therefore be abolished. In addition, 
the condition relating to annual sales should be revised upwards in order not to hinder 
smaller operators from being exempted from the obligation of being in possession of a 
certificate pursuant to Article 35(1) of that Regulation. 

(17)  Regulation  (EU)  2018/848  lays  down  provisions  on  the  composition  of  groups  of 
operators  in  the  Union  and  in  third  countries.  Evidence  in  relation  to  the 
implementation of those provisions shows significant difficulties in setting up groups 
of  operators  that  fulfil  requirements  as  regards  the  composition  of  members,  in 
particular the annual turnover, and as regards their legal personality. Such difficulties 
include  administrative  costs  and  the  need  to  reorganise  the  economic  activities  of 
groups  of  producers  that  are  currently  in  cooperative  associations,  operator 
cooperatives,  associations,  federations  or  organisations.  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  Union  with  products 
originating from them, with the consequent risk of trade disruptions. The requirements 
relating  to  the  annual  turnover  of  the  members  of  the  groups  of  operators  should 
therefore be abolished. In addition, the requirement relating to the maximum eligible 
surface  areas  of  members’  holdings  should  be  revised  upwards  in  order  to  allow  the 
integration into groups of operators of smaller operators. 

(18)  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. 
On  28  June  2021,  the  Council  authorised  the  Commission  to  open  negotiations  with 
the eleven third countries recognised for the purpose of equivalence under Regulation 
(EC) No 834/2007 with  a view to concluding international  agreements with them on 
trade  in  organic  products.  On  that  basis,  the  Commission  has  been  conducting 
technical exchanges with these third countries. Those exchanges show different levels 
of progress, due to the diversity of legal and regulatory frameworks and complexities 
linked  to  varying  consumer  perceptions  of  organic  production  from  one  organic 
production  system  to  the  other.  It  is  therefore  necessary  and  urgent  for  those  third 
countries to continue to be recognised until 31 December 2036 to avoid disruptions in 
the trade of organic products.  

(19)  Regulation  (EU)  2018/848  lays  down  a  conversion  period  for  poultry  for  meat 
production  and  a  minimum  age  at  slaughter,  in  cases  where  slow-growing  poultry 
strains are not used. Such provisions do not lay down any specific conversion period 
or a minimum age at slaughter for quails. In the Member States where organic quails 
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.  Hence,  the  current 
period of conversion of 10 weeks for poultry for meat production is not appropriate for 

EN 

15 

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quails and should be shortened taking into account their age at slaughter. It is therefore 
appropriate to set a conversion period of five weeks for quails for meat production and 
a minimum age of 42 days at slaughter. 

(20)  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 Council12 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 provide 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. 

(21)  Regulation  (EU)  2018/848  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. 

(22)  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.  Regulation  (EU)  2018/848  should 
therefore be amended to define the maximum usable surface area for fattening poultry 
at the level of the poultry houses. 

(23)  Since  the  objectives  of  this  Regulation,  in  particular  fair  competition  and  the  proper 
functioning  of the internal  market  in  organic products,  as  well as  ensuring consumer 
confidence  in  those  products  and  in  the  organic  production  logo  of  the  European 
Union, cannot be sufficiently achieved by the Member States but can rather, by reason 
of the required harmonisation of the rules on organic production, be better achieved at 
Union  level,  the  Union  may  adopt  measures,  in  accordance  with  the  principle  of 
subsidiarity  as  set  out  in  Article  5  of  the  Treaty  on  European  Union.  In  accordance 
with the principle of proportionality, as set out in that Article, this Regulation does not 
go beyond what is necessary in order to achieve those objectives. 

(24)  Regulation (EU) 2018/848 should therefore be amended accordingly. 

12 

Regulation  (EU)  2019/6  of  the  European  Parliament  and  of  the  Council  of  11  December  2018  on 
veterinary  medicinal  products  and  repealing  Directive  2001/82/EC  (OJ  L  4,  7.1.2019,  p.  43,  ELI: 
http://data.europa.eu/eli/reg/2019/6/oj). 

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(25) 

In view of the need to avoid unnecessary disruptions in the trade of organic products 
and  to  ensure  a  smooth  transition  to  the  scheme  of  recognition  of  third  countries 
through  international  agreements,  as  well  as  to  remove  unnecessary  burdens  on 
organic operators, this Regulation 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, 

HAVE ADOPTED THIS REGULATION: 

Article 1 

Regulation (EU) 2018/848 is amended as follows: 

(1) 

(2) 

in Article 24(1), point (g) is deleted; 

Article 30 is amended as follows: 

(a) 

paragraph 1 is replaced by the following: 

‘1. For the purposes of this Regulation, a product shall bear terms referring to 
organic production where, in the labelling, advertising material or commercial 
documents,  such  a  product,  its  ingredients  or  feed  materials  used  for  its 
production are described in terms suggesting to the purchaser that the product, 
ingredients  or  feed  materials  have  been  produced  in  accordance  with  this 
Regulation. In particular, the terms listed in Annex IV and their derivatives and 
diminutives, such as ‘bio’ and ‘eco’, whether alone or in combination, may be 
used  throughout  the  Union  and  in  any  language  listed  in  that  Annex  for  the 
labelling and advertising of products referred to in Article 2(1) which comply 
with this Regulation or are imported from a third country under the conditions 
laid down in Article 45(1), points (b)(ii) or (iii), for the purpose of placing such 
products on the market within the Union as organic products.’; 

(b) 

in paragraph 2, the first subparagraph is replaced by the following: 

‘For the products referred to in Article 2(1), the terms referred to in paragraph 
1 of this Article shall not be used anywhere in the Union, in any language listed 
in Annex IV, for the labelling, advertising material or commercial documents 
of  a  product  which  does  not  comply  with  this  Regulation  or  is  not  imported 
from a third country under the conditions laid down in Article 45, points (b)(ii) 
or (iii), for the purposes of placing that product on the market within the Union 
as an organic product.’; 

(3) 

in Article 32(1), point (b) is replaced by the following: 

‘(b)  In  the  case  of  prepacked  food,  the  organic  production  logo  of  the  European 
Union  referred  in  Article  33  shall  also  appear  on  the  packaging,  except  in  the 
following cases: 

- in the case referred to in Article 30(3); 

- in the cases referred to in points (b) and (c) of Article 30(5); 

- in the cases where the processed food as referred to in point (a) of Article 30(5) is 
made  with  ingredients  imported  in  accordance  with  Article  45(1),  points  (b)(ii)  or 
(iii) and where such ingredients account for more than 5% of the organic agricultural 
ingredients of the product by weight of the processed food and  do not comply with 
the requirements set out in Annex VII.’; 

(4) 

Article 33 is replaced by the following: 

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‘Article 33 

Organic production logo of the European Union 

1. 

The  organic  production  logo  of  the  European  Union  may  be  used  in  the  following 
cases: 

(a) in  the labelling,  presentation  and advertising of products  which are produced in 
accordance with the rules laid down in Chapters II, III and IV; 

(b)  in  the  labelling,  presentation  and  advertising  of  products  that  are  imported  in 
accordance  with  of  Article  45(1),  points  (b)(ii)  or  (iii),  and  that  comply  with  the 
requirements set out in Annex VII; 

(c)  for  processed  food  referred  to  in  Article  30(5),  point  (a),  and  processed  feed 
referred  to  in  Article  30(6),  with  ingredients  that  are  imported  in  accordance  with 
Article 45(1), points (b)(ii) or (iii), provided that those ingredients comply with the 
requirements  set  out  in  Annex  VII  or  represent  less  than  5%  of  the  organic 
agricultural ingredients of the product by weight for processed food or less than 5% 
of  the  organic  ingredients  of  agricultural  origin  that  are  contained  in  the  processed 
feed; 

(d) for information and educational purposes related to the existence and advertising 
of  the  logo  itself,  provided  that  such  use  is  not  liable  to  mislead  the  consumer  as 
regards  the  organic  production  of  specific  products,  and  provided  that  the  logo  is 
reproduced  in  accordance  with  the  rules  set  out  in  Annex  V.  In  such  case,  the 
requirements of Article 32(2) and point 1.7 of Annex V shall not apply. 

The organic production logo of the European Union shall not be used for processed 
food referred to in Article 30(5), points (b) and (c), and for in-conversion products as 
referred to in Article 30(3).  

Except where used in accordance with paragraph 1, point (d), the organic production 
logo of the European Union is an official attestation in accordance with Articles 86 
and 91 of Regulation (EU) 2017/625. 

The use of the organic production logo of the European Union shall be optional for 
products imported from  third countries. Where that logo appears in the labelling of 
such  products  in  accordance  with  paragraph  1,  the  indication  referred  to  in  Article 
32(2) shall also appear in the labelling. 

The organic production logo of the European Union shall follow the model set out in 
Annex V, and shall comply with the rules set out in that Annex. 

National  logos  and  private  logos  may  be  used  in  the  labelling,  presentation  and 
advertising of products which comply with this Regulation. 

The Commission is empowered to adopt delegated acts in accordance with Article 54 
amending  Annex  V  as  regards  the  organic  production  logo  of  the  European  Union 
and the rules relating thereto. 

The Commission is empowered to adopt delegated acts in accordance with Article 54 
amending  Annex  VII  on  the  use  of  the  organic  production  logo  of  the  European 
Union for products imported in accordance Article 45(1), with points (b)(ii) or (iii), 
by  adding  requirements  that  need  to  be  met  to  fulfil  consumers’  expectations  and 
maintain fair competition on the Union market of organic products, or by amending 
those added requirements, as regards in particular the use of sustainable systems for 

2. 

3. 

4. 

5. 

6. 

7. 

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plant  production,  of  livestock  production  systems  ensuring  animal  welfare  and 
sustainable  nutrition,  of  food  processing  methods  using  minimum  artificial  inputs, 
while at the same time taking into account third countries’ specificities for products 
not grown or processed in the Union.’; 

(5) 

in Article 35(8), the first subparagraph is replaced by the following:  

‘Member  States  may  exempt  from  the  obligation  to  be  in  the  possession  of  a 
certificate  referred  to  in  paragraph  2  operators  that  sell  unpacked  organic  products 
other than feed directly  to  the final  consumer, provided that those operators do not 
produce, prepare, store other than in connection with the point of sale, or import such 
products  from  a  third  country,  or  subcontract  such  activities  to  a  third  party,  and 
provided that such sales do not exceed 10 000 kg per year.’; 

(6) 

in Article 36, paragraph 1 is amended as follows: 

(a) 

point (b) is replaced by the following: 

‘(b) only be composed of members who each have holdings of maximum: 

— (i) 10 hectares,  

— (ii) one hectare, in the case of greenhouses, or  

— (iii) 30 hectares, exclusively in the case of permanent grassland;’; 

(b)  point (d) is replaced by the following: 

‘(d)  have  legal  personality  or  be  part  of  a  farmer  cooperative  association, 
operator  cooperative,  association,  federation  or  organisation  that  has  legal 
personality;’; 

(7) 

in  Article 48(1),  second subparagraph,  the date ‘31 December 2026’ is  replaced by 
‘31 December 2036’ 

(8) 

Annex II is amended as follows: 

(a)  Part II is amended as follows: 

(a) 

in point 1.2.2., points (c) and (d) are replaced by the following: 

‘(c)  10  weeks  for  poultry  for  meat  production,  except  for  Peking  ducks 
and quails, brought in before they are three days old; 

(d)  seven  weeks  for  Peking  ducks  and  five  weeks  for  quails  brought  in 
before they are three days old;’; 

(b)  point 1.5.2.5. is replaced by the following: 

‘1.5.2.5.  The  withdrawal  period,  as  defined  in  Article  4,  point  (34),  of 
Regulation (EU) 2019/6 of the European Parliament and of the Council*, 
of  a  chemically  synthesized  allopathic  veterinary  medicinal  product, 
including of an antimicrobial veterinary medicinal product, shall be twice 
the withdrawal period referred to in: 

(a) 

the  product  information  for  veterinary  medicinal  products  used 
within the terms of their marketing authorisation; or 

(b)  Article 115 of that Regulation,  where a medicinal  product  is  used 
outside  of  the  terms  of  the  marketing  authorisation  in  accordance 
with Article 113 of that Regulation.’ 

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* Regulation (EU) 2019/6 of the European Parliament and of the Council 
of  11  December  2018  on  veterinary  medicinal  products  and  repealing 
Directive 
43,  ELI: 
4, 
http://data.europa.eu/eli/reg/2019/6/oj).’; 

2001/82/EC 

7.1.2019, 

(OJ  L 

p. 

(c) 

in point 1.9.4.1, in the third subparagraph, the following point is added: 

‘(j) 42 days for quails.’; 

(d)  point 1.9.4.4. is amended as follows: 

(i) point (e) is replaced by the following: 

‘(e) continuous daytime open air access shall be provided from  as early 
an  age  as  birds  are  sufficiently  feathered  to  regulate  their  body 
temperature when exposed to outdoor climatic conditions and whenever 
physiological  and  physical  conditions  allow,  except  where  temporary 
restrictions have been imposed pursuant to Union legislation;’; 

(ii) point (m) is replaced by the following: 

‘(m) the total usable surface area for fattening poultry in poultry houses 
shall not exceed 1 600 m2 in any poultry house;’; 

(b) 

in Part III, point 3.1.4.2(f) is replaced by the following: 

‘The withdrawal period, as defined in Article 4, point (34), of Regulation (EU) 
2019/6,  of  an  allopathic  veterinary  medicinal  product shall  be  twice  the 
withdrawal period referred to in: 

(a) 

the product information for veterinary medicinal products used within the 
terms of their marketing authorisation; or 

(b)  Article 115 of that Regulation, where a medicinal product is used outside 
the terms of the marketing authorisation in accordance with Article 114 
of that Regulation.’; 

(c) 

in part IV, point 2.2.3. is deleted; 

(d) 

in part V, point 2.4. is deleted; 

(e) 

(f) 

in part VII, point 1.4. is deleted; 

in Annex III, point 7.5. is deleted; 

(g)  The following Annex is added: 

‘ANNEX VII 

Requirements  referred  to  in  Article  32(1),  point  (b)  and  Article  33(1),  points 
(b) and (c): 

(1) 

(2) 

(3) 

(4) 

point 1.2 of Part I of Annex II; 

point 1.7.5 of Part II of Annex II; 

point 1.7.11 of Part II of Annex II; 

point 2.2.2(f) of Part IV of Annex II’. 

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This  Regulation  shall  enter  into  force  on  the  day  following  that  of  its  publication  in  the 
Official Journal of the European Union. 

Article 2 

This Regulation shall be binding in its entirety and directly applicable in all Member States. 

Done at Brussels, 

For the European Parliament 
The President 

For the Council 
The President 

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