Proposal for a Council Regulation amending Regulation (EEC) No 2092/91 on organic production of agricultural products and indications referring thereto in agricultural products and foodstuffs
Date: 2005-12-21
Institutions: European Commission
Subjects: agricultural product, animal feedingstuffs, animal production, crop production, organic farming, organic product

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 21.12.2005 
COM(2005) 671 final 

2005/0278 (CNS) 
2005/0279 (CNS) 

Proposal for a 

COUNCIL REGULATION 

on organic production and labelling of organic products 

Proposal for a 

COUNCIL REGULATION 

amending Regulation (EEC) No 2092/91 on organic production of agricultural products 
and indications referring thereto in agricultural products and foodstuffs 

(presented by the Commission) 

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EXPLANATORY MEMORANDUM 

POLICY FRAMEWORK 

Organic production 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

In 1991 the Council created with Council Regulation (EEC) No 2092/91 the first ever 
Community framework for organic farming and food production. More than a decade 
later and having seen a strong development of organic farming, the Commission has 
started the process of reviewing this framework on the basis of the experience gained. 

Organic  production  has  seen  an  impressive  growth  since  the  adoption  of  the 
Regulation in 1991 and the contribution of the organic  agricultural sector  is still on 
the  increase  in  most  Member  States.  According  to  the  most  recent  statistical  data, 
149 000  holdings are  certified as  organic or in conversion to organic production. In 
2003  these  holdings  represent  1,4%  of  the  total  of  agricultural  holdings  in  the 
25 Member  States.  The  certified  organic  and  in-conversion  area  covered  5,7 mio ha 
and represented 3,6% of the Utilised Agricultural Area in 2003. 

In  2001,  the  Council  under  Swedish  Presidency,  taking  this  development  and  the 
conferences on organic food and farming in Austria in 1999 and in Denmark in 2001 
into account, invited the Commission to propose a European Action Plan for Organic 
Food and Farming (EAP). The action plan was asked to formulate the basis for policy 
development for the organic sector in the coming years, thereby providing an overall 
strategic vision for organic farming’s contribution to the common agricultural policy. 

In the run-up to the Action Plan, extensive consultations were held including expert 
panel  meetings,  an  internet  consultation  of  the  wider  public  and  finally  a  public 
hearing in January 2004. 

From  these  consultations  the  most  important  conclusions  in  the  regulatory  domain 
were  the  need  to  lay  down  more  explicitly  the  principles  and  objectives  of  organic 
farming,  the  importance  of  safeguarding  the  integrity  of  the  inspection  system,  the 
need to  overcome dysfunctions of  the internal market caused by national an private 
logo’s  and  standards,  the  need  to  complete  and  improve  standards  and  the  need  to 
make import provisions more efficient. 

The Commission adopted the Communication on the EAP in June 2004. The EAP put 
forward  21  actions  to  facilitate  the  ongoing  development  of  organic  farming  in  the 
EU.  In  its  conclusions  of  October  2004,  the  Council  invited  the  Commission  to 
advance on the implementation of the EAP on the basis of concrete measures with the 
view to assure simplification and overall coherence and to bring forward proposals in 
this  regard  in  the  course  of  2005.  In  fact,  several  of  the  actions  imply  introducing 
amendments to Council Regulation (EEC) No 2092/91 on organic farming. 

The proposal takes account of the wide public consultation, which took place prior to 
the  adoption  of  the  EAP  and  responds  to  the  Council  conclusions.  It  also  takes 
account  of  subsequent  responses  and  numerous  written  submissions  by  Member 
States and stakeholders on a Commission staff working paper titled “information and 
consultation  on  key  ideas  to  reform  Council  Regulation  (EEC)  No 2092/91”.  This 
consultation took place in the framework of meetings of the standing committee and 
advisory group on organic farming on respectively 26 September and 5 October 2005. 

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Research 

8. 

The  proposal  has  taken  into  account  the  initial  findings  of  the  Research  project 
“Research  to  support  revision  of  the  EU  Regulation  on  organic  agriculture”1  when 
developing  objectives  and  principles  in  current  proposal.  When  at  a  later  stage  the 
Commission  will  draft  the  detailed  implementation  rules,  the  Commission  will  take 
into account the end results of Research projects “Research to support revision of the 
EU Regulation on organic agriculture” and “Development of criteria and procedures 
for the evaluation of the EAP”2. 

Sustainable development of European aquaculture 

9. 

As regards to aquaculture the proposal achieves one of the actions of the Commission 
Communication  to  the  Council  and  the  European  Parliament  of  2002  on  the 
sustainable  development  of  European  aquaculture3,  namely  “harmonisation  of  the 
rules on organic aquaculture under Regulation (EEC) No 2092/91”. 

Simplification and better regulation 

10. 

11. 

Defining  and  bringing  together  objectives,  principles  and  basic  labelling,  control, 
import  and  production  rules  in  a  simpler,  clearer  and  more  transparent  Council 
Regulation,  represents  a  simplification  of  the  current  legal  framework  on  organic 
production. It reduces considerably the level of detail in the Council Regulation and 
will  allow  for  a  further  reduction  of  detail  of  the  implementing  rules.  The  proposal 
also  replaces  the  current  practice  of  ‘legislation  by  derogation’  by  a  transparent 
strictly regulated mechanism allowing less strict rules (see under flexibility).  

The  essential  requirements  defining  organic  production  and  labelling  of  organic 
products  are  laid  down  by  the  principles  and  production  rules  formulated  in  this 
proposal.  The  application  of  these  principles  will  require  further  detailed  rules,  the 
management  of  which  necessitates  frequent  decisions,  such  as  on  the  approval  of 
ingredients  and  substances  that  may  be  used  in  organic  products.  Furthermore,  the 
recent reform of the Common Agricultural Policy (CAP) has placed the production of 
quality  products  that  protect  the  environment  and  animal  welfare  and  respond  to 
societal  concerns  at  its  heart.  This  legislation  thus  is  an  important  factor  in  the 
framework  of  the  Common  Agricultural  Policy.  It  is  also  closely  related  to  the 
developments  on  the  agricultural  markets.  In  order  to  facilitate  the  decision  making 
process and to further integrate quality into the Common Agricultural Policy and its 
management  systems,  a  Management  Committee  should  replace  the  current 
'Regulatory Committee'. 

12. 

Finally, the control provisions are kept simple by referring to the common framework 
of Regulation (CE) No 882/20004 ‘on official food and feed controls’4 (OFFC). Only 

1 

2 

3 

4 

EEC/2092/91  (Organic)  Revision SSPE-CT-2004-502397:  Research  to  support  revision  of  the  EU 
Regulation on organic agriculture. 
ORGAP SSPE-CT-2005-006591: European Action Plan of Organic Food and Farming, Development of 
criteria and procedures for the evaluation of the EU Action Plan for Organic Agriculture 
Communication from the Commission to the Council and the European Parliament “A strategy for the 
sustainable development of European aquaculture” - COM(2002) 511. 
Regulation  (EC)  No  882/20004  of  the  European  Parliament  and  of  the  Council  of  29  April  2004  on 
official controls performed in to ensure the verification of compliance with feed and food law, animal 
health and animal welfare rules. 

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the  provisions  specific  to  organic  farming  are  maintained  in  the  text  at  hand.  The 
application  of  the  risk  based  approach  of  the  OFFC  will  allow  for  reducing  the 
administrative burden on operators. It is expected that this new approach will allow 
for a better targeting of controls to the areas presenting the highest risks. It will also 
allow  operators  that  run  risk  based  internal  control  systems  to  benefit  from  the  risk 
based approach.  

13. 

The  proposal  at  hand  thus  contributes  to  the  actions  mentioned  in  various 
simplification  initiatives  of  the  Commission.  It  achieves  the  first  action  of  the 
Simplification  Rolling  Programme  for  the  agricultural  and  foodstuff  industry 
mentioned  in  the  Communication  of  the  Commission  on  ‘implementing  the 
Community  Lisbon  programme:  A  strategy  for  the  simplification  of  the  regulatory 
environment’5. It is also mentioned as a policy related action in the Communication 
from  the  Commission  on  simplification  and  better  regulation  for  the  Common 
Agricultural Policy6. 

THE PROPOSAL 

Subject matter, scope and definitions 

14. 

15. 

16. 

The  proposal  explicitly  covers  “organic  production”  and  not  just  labelling.  The 
proposal  does  not  cover  the  preparation  and  sale  to  the  final  consumer  of  meals  in 
large scale kitchens; for example in restaurants, hotels, hospitals and canteens, or in 
bars and coffeeshops. 

As  regards  products,  the  proposed  scope  covers  unprocessed  agricultural  products 
regardless  of  their  final  use;  namely  livestock,  unprocessed  plant  and  livestock 
products  and  live  or  unprocessed  aquaculture  products.  Processed  agricultural 
products  are  proposed  to  be  covered  for  as  far  as  they  are  intended  for  human  or 
animal  consumption;  namely  feed,  processed  plant,  livestock  and  aquaculture 
products.  It  thus  provides  for  objectives,  principles  and  production  rules  for  all 
products including for organic wines, aquaculture products and processed foodstuffs. 
Detailed  rules  for  all  products  may  be  laid  down  by  a  comitology  procedure.  The 
latter  is  particularly  relevant  for  the  adoption  of  detailed  rules  on  organic  wine 
production  as  that  is  excluded  under  the  current  rules.  Production  rules  for 
aquaculture will also be established at a later date. 

No  extension  of  the  scope  is  foreseen  at  this  stage.  It  is  not  proposed  to  include 
products  of  hunting  and  fishing  of  wild  animals;  as  they  are  not  obtained  from 
farming practices inclusion would not be coherent with the proposed objectives and 
principles. The scope will also not be extended to the following products not covered 
by  Annex  I  to  the  Treaty  establishing  the  European  Community;  namely  minerals, 
waters, non-food processed agricultural products such as textiles, cosmetics and other 
industrial products. 

5 
6 

COM(2005) 535, 25.10.2005. 
COM(2005) 509, 19.10.2005. 

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Objectives and principles for organic production 

17. 

As stated in the EAP, an appropriate definition of objectives and principles is needed 
to  strengthen  the  Regulation.  In  this  regard,  the  proposal  formulates  the  following 
objectives for organic production: 

– 

– 

– 

– 

protection  of consumers’  interest, ensuring consumer confidence and  avoiding 
misleading labelling; 

the  development  of  organic  production  while  taking  account  of  regional 
differences  in  climate,  farming  conditions  and  the  stage  of  development  of 
organic farming; 

a  high  level  of  protection  of  the  environment,  biodiversity  and  natural 
resources; 

respect  of  high  animal  welfare  standards  that  fully  meet  animals’  species-
specific needs. 

18. 

19. 

With  regard  to  the  underlying  principles,  most  of  them  already  exist  in  the  current 
detailed  rules  in  the  Annexes  to  Regulation  (EEC)  No 2092/91.  The  proposal 
reformulates these principles in articles in line with the objectives. 

Further to objectives and principles and for the sake of comprehension, the proposal 
establishes the basic “production rules” in the reformed Regulation. These production 
rules should set the parameters of the detailed rules to be laid down by Commission 
Regulations. 

Flexibility 

20. 

The  proposal  aims  at  providing  the  conditions  in  which  the  sector  can  develop  and 
produce  in  an  economically  viable  manner,  in  line  with  production  and  market 
developments.  To  this  end  it  provides  for  a,  certain  strictly,  regulated  flexibility. 
Under  this  flexibility  provision  Member  States  will  be  allowed,  by  a  comitology 
procedure,  to  apply  less  strict  production  rules  to  account  for  variation  in  local 
climatic,  development  and  specific  production  conditions.  It  basically  provides  for 
transforming the current multitude of derogations into a general but strictly regulated 
system.  But,  contrary  to  the  current  system,  the  conditions,  scope  and  division  of 
competencies between the actors involved in granting exceptions is clearly laid down. 

Labelling 

21. 

22. 

In order to continue protecting the term “organic”, current rules on use or references 
to “organic”, derivatives, diminutives and translations should be maintained. 

The  EU  logo  should  continue  to  be  available  on  all  products  that  comply  with  the 
Regulation, including for all imported products. When preparing the EAP, as a result 
of  discussions  with  stakeholders  and  Member  States,  it  was  concluded  that  the  EU 
logo  should  not  be  compulsory  for  the  time  being,  as  it  may  be  viewed  as  an 
excessive  EC  interference  in  commercial  freedom  in  other  areas.  However,  it  is 
proposed in those cases where the product does not bear the EU logo, to make the use 
of  a  simple  standardised  text  fragment  EU-ORGANIC  on  labels  compulsory  for 
products produced within the Community. This aims at communicating efficiently to 
all operators in the production chain and to the consumer that the product conforms to 
a single EU standard. 

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23. 

24. 

In  order  to  maintain  consumer  confidence,  the  use  of  GMOs  and  of  products 
produced from or by GMOs should continue to be prohibited in organic farming, as it 
is the case in the current Regulation. Despite this, in cases where products have been 
accidentally  contaminated  by  GMOs,  the  current  organic  rules  do  not  prohibit  the 
simultaneous labelling as organic and GMO. As announced in the EAP, the proposal 
prohibits  the  use  of  the  term  'organic'  for  GMO  labelled  products.  Finally,  the 
labelling thresholds for organic and non-organic produce should be identical, unless 
detailed rules foresee specific thresholds for example possibly for organic seeds. 

The  current  provision  requiring  a  minimum  95%  of  the  agricultural  products  to  be 
‘organic’  should  be  maintained.  However,  the  category  allowing  references  to  the 
organic  production  method  on  the  list  of  ingredients  if  it  contains  between  70  and 
95%  of  the  agricultural  ingredients  from  organic  origin,  will  be  suppressed.  In  fact, 
due to the development of the organic sector in recent years, this category of products 
is not considered to be needed anymore. 

Controls 

25. 

26. 

27. 

28. 

29. 

With  regard  to  controls,  Regulation  (EC)  No 882/2004  of  the  European  Parliament 
and of the Council on official food and feed controls (OFFC) enters into application 
on  1  January  2006  which  covers  organic  farming.  The  specific  requirements  of 
organic farming need to be aligned with the OFFC. In this regard, the proposal recasts 
the  organic  control  provisions  using  the  OFFC  framework  as  far  as  possible  to 
achieve the desired reforms and updates. The detailed provisions specific to organic 
production remain under the new organic Regulation. 

As  provided  for  in  OFFC,  Member  States  will  have  to  include  all  production  and 
operations covered by the new Regulation in their multi-annual national control plans 
and  fulfil  the  requirements  of  mutual  assistance.  The  multi-annual  national  control 
plans have to be notified to the Commission who may ask for amendments and use 
them  to  guide  Community  inspections.  Moreover,  pursuant  to  the  OFFC  private 
control  bodies  will  have  to  be  accredited.  Finally,  the  proposal  requires  that 
competent  authorities  and  control  bodies  promote  and  do  not  undermine  the  EC 
organic  standard,  in  line  with  the  principle  of  a  “single  concept  of  organic 
production”. 

In order to guarantee the free movement of organic products within the Community, 
the  current  provisions  requiring  Member  States  to  uphold  the  single  market  will  be 
retained.  In  this  context  the  requirement  of  OFFC  on  compulsory  accreditation  of 
private  control  bodies,  impartiality  and  freedom  of  any  conflict  of  interest  of 
designated  control  bodies  is  particularly  relevant.  One  of  the  main  purposes  of  the 
reform of the organic regulatory framework is to reduce the trade hampering impact 
on  the  internal  market  of  multiple  public  and  private  certification.  The  instruments 
proposed  for  improving  impartiality  and  reducing  conflicts  of  interest  are  the 
integration  of  private  control  bodies  in  the  control  system,  a  healthy  competition 
between control bodies and recognition of prior certification decisions for equivalent 
standards. 

As  regards  access  to  national  logos  and  marks  of  conformity  the  proposal  foresees 
imposing full access for all products that comply with the Community rules. 

The issuing of certificates stating that a certain operator or a specific lot of products is 
found to comply with the principles and rules of organic farming is a well-established 

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tool in trade of organic products and often conditions access to marks of conformity. 
Certification  practices  used  by  competent  authorities  or  by  control  bodies  to  which 
the  competent  authority  has  delegated  control  tasks  should  not  have,  directly  or 
indirectly,  restrictive  effects  on  the  free  movement  of  organic  goods,  nor  on  the 
freedom of establishment and the free provision of services in the area of issuing of 
certificates. In this regard certification practices should be more strictly supervised, in 
particular  where  mutual  recognition  of  certificates  and  the  collection  of  fees  are 
concerned.  Such  supervision  should  be  undertaken  without  prejudice  to  the 
application of Articles 43 and 49 of the Treaty. As regards access to private logos and 
marks of conformity it foresees rules facilitating access for products that comply with 
equivalent  standards,  by  placing  the  burden  of  proof  for  not  complying  with 
equivalent  standards  on  the  control  body  which  logo  the  operator  wishes  to  use. 
Finally  it  provides  for  ensuring  that  the  fees  for  control  and  certification  tasks  are 
reasonable. 

Furthermore,  promoting  a  “single  concept”  of  what  constitutes  organic  production 
will contribute to consumer recognition and confidence, which in turn is expected to 
improve  the  free  movement  of  organic  produce.  To  this  end  general  claims  that  a 
certain set of standards will guarantee a “better, stricter or higher standard organic”, 
directly on organic products or in their advertising or in publicity material should be 
prohibited. However, non-misleading and true claims of fact will be allowed. 

A high harmonisation level further reduces the room for private logos and marks of 
conformity. The proposal therefore maintains the ambition for a high harmonisation 
level  expressed  in  the  EAP.  This  should  be  facilitated  by  the  already  discussed 
flexibility mechanism and the adoption of detailed rules by a management committee 
(see also flexibility). 

Finally,  the  guarantees  provided  by  the  control  system  are  based  on  verification  of 
documentary  checks,  inspections  of  organic  farms  and  businesses,  reconciliation  of 
trade flows and testing of products for absence of prohibited substances. No tests are 
commercially available to verify the  innate characteristics of organic products  in an 
unequivocal  and  reproducible  manner.  The  Institute  for  Reference  Materials  and 
Measurements in Geel of the Directorate General Joint Research Centre is conducting 
Research into the development of such tests. 

With  regard  to  trade  with  third  countries,  it  is  proposed  to  grant  access  to  the  EU 
market  either  on  the  basis  of  compliance  with  the  EU  rules  or  on  equivalent 
guarantees  provided  by  Third  Country  authorities  or  certified  EU  approved  control 
bodies. The equivalency assessments for the purpose of import will be based on the 
international  standard  (Codex  Alimentarius)  or  on  the  Community  regulation.  Third 
countries  may  add  their  own  arrangements  where  needed.  The  current  system  of 
‘community list of third countries’ will be maintained. Annual reporting and follow-
up control visits with Member States involvement are foreseen. Single product access 
to  the  EU  market  will  be  granted  either  on  the  basis  of  compliance  with  the  EU 
standards and submission to the EU system of controls, or on the basis of equivalent 
guarantees certified by control bodies that have been approved by the Community for 
that purpose. 

30. 

31. 

32. 

Imports 

33. 

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Entry into force and application of the new rules 

34. 

35. 

The proposal does not contain the detailed rules currently laid down in the Annexes to 
Regulation (EEC) No 2092/91. In order to permit  a  smooth  change  over  to  the  new 
system, it is therefore necessary to allow for a sufficiently long period before it will 
apply. This period is proposed to be set at 1 January 2009 allowing for the reworking 
and transposing of the existing detailed rules to the new Regulation.  

Part of the import provisions of the current Regulation (EEC) No 2092/91 run out on 
31  December  2006.  The  new  import  scheme  should  thus  apply  as  from  1  January 
2007.  However,  this  will  leave  little  time  for  its  implementation,  in  particular  as 
regards  the  recognition  of  control  bodies  competent  to  carry  out  control  in  those 
countries  which  are  not  on  the  list  of  recognised  third  countries.  In  order  not  to 
disrupt  international  trade,  it  is  considered  necessary  to  extend  the  possibility  for 
Member States to continue to grant import authorisations for individual products until 
the measures necessary for the functioning of the new import scheme have been put 
in  place  To  this  end  a  second  proposal  amending  Regulation  (EEC)  No 2092/91  is 
included. 

Budgetary implications 

36. 

The  present  proposal  does  not  entail  any  direct  financial  implications  for  the 
Community budget. 

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2005/0278 (CNS) 

Proposal for a 

COUNCIL REGULATION 

on organic production and labelling of organic products 

THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  establishing  the  European  Community,  and  in  particular 
Article 37 thereof, 

Having regard to the proposal from the Commission, 

Having regard to the opinion of the European Parliament7, 

Whereas: 

(1) 

(2) 

(3) 

Organic production is an overall system of farm management and food production that 
combines  best  environmental  practices,  a  high  level  of  biodiversity,  preservation  of 
natural resources, application of high animal welfare standards and production in line 
with  the  preference  of  certain  consumers  for  products  produced  using  natural 
substances  and  processes.  The  organic  production  method  thus  plays  a  dual  societal 
role, where it on the one hand provides for a specific market responding to a consumer 
demand for organic products, and on the other hand delivers public goods contributing 
to  the  protection  of  the  environment  and  animal  welfare,  as  well  as  to  rural 
development. 

The contribution of the organic agricultural sector is on the increase in most Member 
States.  Growth  in  consumer  demand  in  recent  years  is  particularly  notable.  Recent 
reforms  of  the  common  agricultural  policy,  with  its  emphasis  on  market-orientation 
and  the  supply  of  quality  products  to  meet  consumer  demands,  are  likely  to  further 
stimulate  the  market  in  organic  produce.  Against  this  background  the  legislation  on 
organic  production  plays  an  increasingly  important  role  in  the  agricultural  policy 
framework and is closely related to the developments on the agricultural markets. 

The  Community  legal  framework  governing  the  sector  of  organic  production  should 
pursue  the  objective  of  ensuring  fair  competition  and  a  proper  functioning  of  the 
internal  market  in  organic  products,  and  of  maintaining  and  justifying  consumer 
confidence  in  products  labelled  as  organic.  It  should  further  aim  at  providing 
conditions  under  which  this  sector  can  progress  in  line  with  production  and  market 
developments. 

7 

OJ C […], p. […]. 

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(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

The  Communication  from  the  Commission  to  the  Council  and  the  European 
Parliament  on  a  European  Action  Plan  for  Organic  Food  and  Farming8  proposes  to 
improve  and  reinforce  the  Community’s  organic  farming  standards  and  import  and 
inspection requirements. In its conclusions of 18 October 2004, the Council called on 
the Commission to review the Community legal framework in this field with a view to 
ensuring  simplification  and  overall  coherence  and  in  particular  to  establishing 
principles encouraging harmonisation of standards and, where possible, a reducing the 
level of detail. 

It is therefore appropriate to define more explicitly the objectives, principles and rules 
applicable to organic production, in order to contribute to transparency and consumer 
confidence as well as a harmonised perception of the concept of organic production. 

To  that  end,  Council  regulation  (EEC)  No  2092/91  on  organic  production  of 
agricultural  products  and  indications  referring  thereto  on  agricultural  products  and 
foodstuffs9 should be repealed and replaced by a new regulation. 

A  general  Community  framework  of  organic  production  rules  should  be  established 
with regard to plant and livestock production, including rules on conversion, as well as 
on production of processed food and of feed. Competence to determine the details of 
those  general  rules and to adopt Community production rules  for aquaculture  should 
be conferred on the Commission. 

The  development  of  organic  production  should  further  be  facilitated  in  particular  by 
fostering the use of new techniques and substances better suited to organic production. 

Genetically modified organisms (GMOs) and products produced from or by GMOs are 
incompatible  with  the  concept  of  organic  production  and  consumers’  perception  of 
organic products. They should therefore not be deliberately used in organic farming or 
in the processing of organic products. 

(10)  Organic  farming  should  primarily  rely  on  renewable  resources  within  locally 
organised  agricultural  systems.  In  order  to  minimise  the  use  of  non-renewable 
resources, wastes of plant and animal origin should be recycled to return nutrients to 
the land and for energy production. 

(11)  Organic plant production should contribute to maintaining and enhancing soil fertility 
as well as to preventing soil erosion. Plants should preferably be fed through the soil 
eco-system and not through soluble fertilisers added to the soil. 

(12)  The  essential  elements  of  the  organic  plant  production  management  system  are  soil 
fertility  management,  choice  of  species  and  varieties,  multi-annual  crop  rotation, 
recycling  organic  materials  and  cultivation  techniques.  Additional  fertilisers,  soil 
conditioners and plant protection products should only be used if they are compatible 
with the objectives and principles of organic production.  

8 
9 

COM(2004) 415, 10.6.2004. 
OJ  L  198,  22.7.1991,  p. 1.  Regulation  as  last  amended  by  Regulation  (EC)  No 1567/2005  (OJ L 252, 
28.9.2005, p. 1). 

EN 

10 

   EN 

 
                                                 
(13)  Livestock production is fundamental to the organisation of agricultural production on 
organic holdings in so far as it provides the necessary organic matter and nutrients for 
cultivated  land  and  accordingly  contributes  towards  soil  improvement  and  the 
development of sustainable agriculture. 

(14) 

In order to avoid environmental pollution, in particular of natural resources such as the 
soil and water, organic production of livestock should in principle provide for a close 
relationship  between  such  production  and  the  land,  suitable  multi-annual  rotation 
systems and the feeding of livestock with organic-farming crop products produced on 
the holding itself or on neighbouring organic holdings. 

(15)  As  organic  stock  farming  is  a  land-related  activity,  animals  should  have,  where 

possible, access to open air or grazing areas. 

(16)  Organic stock farming should respect high animal welfare standards and meet animals’ 
species–specific behavioural needs and animal-health management should be based on 
disease  prevention.  In  this  respect,  particular  attention  should  be  paid  to  housing 
conditions, husbandry practices and stocking densities. Moreover, the choice of breeds 
should favour slow growing strains and take account of their capacity to adapt to local 
conditions.  The  implementing  rules  for  livestock  production  and  aquaculture 
production  shall  ensure  compliance  with  at  least  the  provisions  of  the  European 
Convention  to  the  Protection  of  Animals  kept  for  Farming  purposes  (T-AP)  and  its 
subsequent recommendations. 

(17)  The  organic  livestock  production  system  should  aim  at  completing  the  production 
cycles  of  the  different  livestock  species  with  organically  reared  animals.  It  shall 
therefore  encourage  the  increase  of  the  gene  pool  of  organic  animals,  improve  self 
reliance and thus ensure the development of the sector. 

(18)  Pending the adoption of Community production rules for aquaculture, Member States 
should have the  possibility  to provide for the application of national standards, or in 
the  absence  thereof  private  standards  accepted  or  recognised  by  the  Member  States. 
However,  to  prevent  disturbances  on  the  internal  market,  Member  States  should  be 
required to recognise each other’s production standards in this field. 

(19)  Organic  processed  products  should  be  produced  by  the  use  of  processing  methods 
which  guarantee  that  the  organic  integrity  and  vital  qualities  of  the  product  are 
maintained through all stages of the production chain.  

(20)  The commercial availability of organic agricultural ingredients has increased over the 
past years and therefore the use of non-organic ingredients in organic processed food 
and feed can be further restricted. 

(21) 

It is appropriate to provide for flexibility as regards the application of production rules, 
so as to make it possible to adapt organic standards and requirements to local climatic 
or  geographic  conditions,  specific  husbandry  practices  and  stages  of  development. 
This should allow for the application of less restrictive standards, but only within the 
limits of specific conditions laid down in Community legislation. 

EN 

11 

   EN 

 
(22) 

It is important to maintain consumer confidence in organic products. Exceptions from 
the requirements applicable to organic production should therefore be strictly limited 
to cases where the application of less restrictive rules is deemed to be justified. 

(23)  For  consumer  protection  and  fair  competition,  the  terms  used  to  indicate  organic 
products should, throughout the Community and independently of the language used, 
be  protected  from  being  used  on  non-organic  products.  The  protection  should  also 
apply  to  the  usual  derivatives  or  diminutives  of  those  terms,  whether  they  are  used 
alone or combined.  

(24) 

(25) 

It  is  also  necessary  to  prevent  other  forms  of  misleading  general  labelling  and 
advertising claims. 

In  order  to  create  clarity  throughout  the  Community  market,  a  simple  standardised 
reference  should  be  made  obligatory  for  all  organic  products  produced  within  the 
Community,  at  least  where  such  products  do  not  bear  the  Community  organic 
production  logo.  The  possibility  to  use  this  reference  should  also  apply  to  organic 
products imported from third countries, but without any obligation to do so. 

(26)  The  Community  rules  should  promote  a  harmonised  concept  of  organic  production 
recognised,  defined  and  defended  by  all  stakeholders.  It  is  therefore  necessary  to 
prevent  the  use  of  general  label  claims  referring  to  higher,  better,  more  or  stricter 
organic,  since  claims  of  this  nature  are  confusing  and  undermine  the  harmonised 
approach. Indications referring to specific elements  of the production  method  should 
however  be  allowed,  provided  that  they  are  true  statements  of  fact  that  comply  with 
the  general  labelling  requirements  set  out  in  Directive 2000/13/EC  of  the  European 
Parliament and of the Council of 20 March 2000 on the approximation of the laws of 
the  Member  States  relating  to  the  labelling,  presentation  and  advertising  of 
foodstuffs10. 

(27)  The deliberate use of GMOs in organic production is prohibited. For the sake of clarity 
and  coherence,  it  should  not  be  possible  to  label  a  product  as  organic  where  it  is 
labelled as containing GMOs, consisting of GMOs or produced from GMOs. 

(28) 

In  order  to  ensure  that  organic  products  are  produced  in  accordance  with  the 
requirements laid down under the Community legal framework on organic production, 
all activities falling under the scope of this legislation should be controlled throughout 
the production chain and be in conformity with the rules laid down in Regulation (EC) 
No 882/2004  of  the  European  Parliament  and  of  the  Council  of  29 April  2004  on 
official controls performed to ensure the verification of compliance with feed and food 
law, animal health and animal welfare rules11. 

(29) 

It  might  in  some  cases  appear  disproportionate  to  apply  notification  and  control 
requirements  to  certain  types  of  retail  operators.  It  is  therefore  appropriate  to  allow 
Member States to exempt such operators from these requirements. 

10 

11 

OJ L 109, 6.5.2000, p. 29. Directive as last amended by Directive 2003/89/EC (OJ L 308, 25.11.2003, 
p. 15). 
OJ L 165, 30.4.2004, p. 1. Corrected version in OJ L 191, 25.5.2004, p. 1. 

EN 

12 

   EN 

 
                                                 
(30)  The issuing of certificates stating that a certain operator or a specific lot of products is 
found to comply with the principles and rules of organic farming is a well-established 
tool in trade of organic products and often conditions access to marks of conformity. 
Certification practices used by competent authorities or by control bodies to which the 
competent authority has delegated control tasks should not have, directly or indirectly, 
restrictive  effects  on  the  free  movement  of  organic  goods.  Certification  practices 
should  therefore  be  subject  to  certain  conditions,  requiring  in  particular  mutual 
recognition of conformity assessment decisions as regards equivalent standards as well 
as  limitations  on  the  collection  of  fees,  in  order  to  avoid  hindering  the  smooth 
functioning of the internal market. 

(31)  Organic  products  imported  into  the  European  Community  should  be  allowed  to  be 
placed on the Community market labelled as organic, where they have been produced 
in  accordance  with  production  rules  and  subject  to  control  arrangements  that  are  in 
compliance with or equivalent to those laid down in Community legislation, meaning 
that they should be capable of meeting the same objectives and principles. In addition, 
the products imported  under  an equivalent system should be covered by a  certificate 
issued  by  the  competent  authority  or  recognised  control  body  of  the  third  country 
concerned. 

(32)  The  assessment  of  equivalency  with  regard  to  imported  products  should  take  into 

account the international standards laid down in Codex Alimentarius. 

(33) 

It  is  considered  appropriate  to  maintain  the  list  of  third  countries  recognised  by  the 
Commission  as  having  production  standards  and  control  arrangement  which  are 
equivalent to those provided for in Community legislation. For third countries which 
are  not  included  in  that  list,  the  Commission  should  set  up  a  list  of  control  bodies 
recognised  as  being  competent  for  the  task  of  ensuring  controls  and  certification  in 
those countries. 

(34)  Relevant  statistical  information  should  be  collected  in  order  to  obtain  reliable  data 
needed  for  the  implementation  and  follow-up  of  this  Regulation  and  as  tools  for 
producers,  market  operators  and  policy  makers.  The  statistical  information  needed 
should be defined within the context of the Community Statistical Programme. 

(35)  This  Regulation  should  apply  from  a  date  defined  in  order  to  give  the  Commission 
sufficient  time  to  adopt  the  measures  necessary  for  the  implementation  of  the 
Regulation. 

(36)  The measures necessary for the implementation of this Regulation should be adopted 
in  accordance  with  Council  Decision  1999/468/EC  of  28 June  1999  laying  down  the 
procedures for the exercise of  implementing powers conferred on the Commission12. 
Considering  that  the  legislation  on  organic  production  is  an  important  factor  in  the 
framework  of  the  Common  Agricultural  Policy,  as  it  is  closely  related  to  the 
developments  on  the  agricultural  markets,  it  is  appropriate  to  bring  it  in  line  with 
existing legislative procedures used to manage the this policy. The powers conferred 
on the Commission under this Regulation should therefore be exercised in accordance 
with the management procedure provided for in Article 4 of Decision 1999/468/EC, 

12 

OJ L 184, 17.7.1999, p. 23. 

EN 

13 

   EN 

 
                                                 
HAS ADOPTED THIS REGULATION: 

TITLE I 
SUBJECT MATTER, SCOPE AND DEFINITIONS 

Article 1 
Subject matter and scope 

1. 

This Regulation establishes objectives, principles and rules concerning: 

(a) 

(b) 

the  production,  placing  on  the  market,  import,  export  and  controls  of  organic 
products; 

the  use  of  indications  referring  to  organic  production  in  labelling  and 
advertising. 

2. 

This Regulation shall apply to the following products originating from agriculture or 
aquaculture, where such products are intended to be marketed as organic: 

(a) 

unprocessed plant and livestock products and livestock; 

(b)  processed  plant  and  livestock  products  which  are  intended  for  human 

consumption (hereinafter referred to as “processed food”); 

(c) 

live or unprocessed products of aquaculture; 

(d)  processed products of aquaculture which are intended for human consumption; 

(e) 

feed. 

However, it shall not apply to products of hunting and fishing of wild animals. 

3. 

This Regulation shall apply within the territory of the European Community to any 
operator involved in the following activities: 

(a) 

primary production; 

(b)  processing of food and feed; 

(c) 

packaging, labelling and advertising; 

(d)  warehousing, transport and distribution; 

(e) 

imports to and exports from the Community; 

(f) 

placing on the market. 

However,  it  shall  not  apply  to  catering  operations,  factory  canteens,  institutional 
catering, restaurants or other similar food service operations. 

For the purposes of this Regulation, the following definitions shall apply:  

Article 2 
Definitions 

EN 

14 

   EN 

 
(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

(g) 

(h) 

(i) 

(j) 

(k) 

(l) 

(m) 

(n) 

13 

14 

‘organic  production’  means  the  use  of  organic  production  methods  on  the  farm 
holding,  as  well  as  activities  involved  in  the  further  processing,  packaging  and 
labelling  of  a  product,  in  compliance  with  the  objectives,  principles  and  rules 
established in this Regulation; 

‘organic product’ means an agricultural product coming from organic production; 

‘plant production’ means production of agricultural crop products and harvesting of 
wild plant products for commercial purposes; 

‘livestock production’ means the production  of domestic  or domesticated terrestrial 
animals (including insects); 

‘aquaculture’ means the rearing or cultivation of aquatic organisms using techniques 
designed to increase the production beyond the natural capacity of the environment, 
where the organisms remain the property of a natural or legal person throughout the 
rearing or cultivation stage, up to and including harvesting; 

‘conversion’ means the transition from non organic to organic farming; 

‘preparation’  means  the  operations  of  preserving  and/or  processing  of  organic 
products (including slaughter and cutting for livestock products), and also packaging 
and/or alterations made to the labelling concerning the organic production method; 

‘placing  on  the  market’  has  the  meaning  given  by  Article  3,  point  8  of  Regulation 
(EC) No 178/2002 of the European Parliament and of the Council13; 

‘labelling’ means any words, particulars, trade marks, brand name, pictorial matter or 
label,  ring  or  collar 
symbol  placed  on  any  packaging,  document,  notice, 
accompanying  or  referring  to  a  product  referred  to  in  the  first  subparagraph  of 
Article 1(2); 

‘competent authority’ means the central authority of a Member State competent for 
the  organisation  of  official  controls  in  the  field  of  organic  production  or  any  other 
authority on which that competence has been conferred and, where appropriate, the 
corresponding authority of a third country; 

‘control  body’  means  an  independent  third  party  to  which  the  competent  authority 
has delegated certain control tasks; 

‘certificate’  means  a  written  confirmation  issued  by  a  competent  authority  or  a 
control body that an operator or a specific lot of products is found to comply with the 
principles and rules applicable to organic production; 

‘mark  of  conformity’  means  the  assertion  of  conformity  to  a  particular  set  of 
standards or other normative documents in the form of a mark; 

‘ingredients’  has  the  meaning  given  by  Article 6(4)  of  Directive 2000/13/EC  of  the 
European Parliament and of the Council14; 

OJ  L  31,  1.2.2002,  p. 1.  Regulation  as  last  amended  by  Regulation  (EC)  No 1642/2003  (OJ L 245, 
29.9.2003, p. 4). 
OJ L 109, 6.5.2000, p. 29. 

EN 

15 

   EN 

 
                                                 
(o) 

(p) 

(q) 

(r) 

(s) 

(t) 

(u) 

(v) 

‘plant protection products’ means products as defined in Article 2, point 1 of Council 
Directive 91/414/EEC15; 

‘genetically modified organism (GMO)’ means an organism  as defined  in Article 2 
of Directive 2000/18/EC of the European Parliament and of the Council16; 

‘produced  from  GMOs’  means  derived,  in  whole  or  in  part,  from  GMOs  but  not 
containing or consisting of GMOs; 

‘products produced by GMOs’ means food and feed additives, flavourings, vitamins, 
enzymes, processing aids, certain products used in animal nutrition (under Directive 
82/471/EEC17), plant protection products, fertilisers and soil conditioners, produced 
by nourishing an organism with materials that are in whole or in part GMOs; 

‘food’ has the meaning given by Article 2 of Regulation (EC) No 178/2002; 

‘feed’ has the meaning given by Article 3, point 4 of Regulation (EC) No 178/2002; 

‘feed  additives’  means  products  as  defined  in  Article  2(a)  of  Regulation  (EC) 
No 1831/2003 of the European Parliament and of the Council18; 

‘equivalent’ in describing different systems or measures, means that they are capable 
of meeting the same objectives and principles. 

TITLE II 
OBJECTIVES AND PRINCIPLES FOR ORGANIC PRODUCTION 

Article 3 
Objectives 

The organic production system shall pursue the following objectives: 

(a) 

It  shall  establish,  in  a  practical,  economically  viable  management  system  for 
agriculture, a production of a wide variety of products by methods that:  

(i)  minimise the negative effects on the environment; 

(ii)  maintain  and  enhance  a  high  level  of  biological  diversity  on  farms  and  their 

surrounding areas; 

(iii)  preserve  as  far  as  possible  the  natural  resources,  such  as  water,  soil,  organic 

matter and air; 

(iv) 

respect high animal welfare standards and in particular meet animals’ species-
specific behavioural needs. 

15 
16 
17 

18 

OJ L 230, 19.8.1991, p. 1. 
OJ L 106, 17.4.2001, p. 1. 
OJ  L  213,  21.7.1982,  p.  8.  Directive  as  last  amended  by  Directive 1999/20/EC  (OJ  L 80,  25.3.1999, 
p. 20). 
OJ L 268, 18.10.2003, p. 29. 

EN 

16 

   EN 

 
                                                 
(b) 

It shall establish a production of food and other agricultural products that responds to 
a consumer demand for goods produced by use of natural processes, or processes that 
are comparable to natural processes, and naturally occurring substances. 

Article 4 
Overall principles 

The following principles shall apply to all organic production: 

(a) 

(b) 

(c) 

(d) 

the use of living organisms and mechanical production methods shall be preferred to 
the use of synthetic materials; 

natural substances shall be used in preference to chemically synthesised substances, 
which may be used only where natural substances are not commercially available; 

GMOs and products produced from or by GMOs may not be used, with the exception 
of veterinary medicinal products; 

rules  of  organic  production  shall  be  adapted  to  local  conditions,  stages  of 
development  and  specific  husbandry  practices,  while  maintaining  the  common 
concept of organic production. 

Article 5 
Principles applicable to farming 

In addition to the overall principles set out in Article 4, the following principles shall apply to 
organic farming: 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

(g) 

(h) 

(i) 

(j) 

farming  shall  maintain  and  enhance  soil  fertility,  prevent  and  combat  soil  erosion, 
and minimise pollution; 

farming  shall  aim  at  producing  products  of  high  quality  instead  of  maximising 
production; 

the use of non-renewable resources and off-farm inputs shall be minimized; 

wastes and by-products of plant and animal origin shall be recycled as input in plant 
and livestock production and for energy production; 

production decisions shall take account of the local or regional ecological balance; 

plants shall be primarily fed through the soil ecosystem; 

maintenance  of  animal  and  plant  health  shall  be  based  on  preventative  techniques 
including selection of appropriate breeds and varieties; 

feed for livestock shall come primarily from the holding where the animals are kept 
or shall be produced in cooperation with other organic farms in the same region; 

the highest level of animal welfare shall be observed; 

products of organic livestock production shall come from animals that since birth or 
hatching and throughout their life have been raised on organic holdings; 

EN 

17 

   EN 

 
(k) 

(l) 

(m) 

(n) 

(o) 

breeds  shall  be  chosen  favouring  slow  growing  strains  and  having  regard  to  the 
capacity of animals to adapt to local conditions, their vitality and their resistance to 
disease or health problems; 

organic livestock feed shall be composed essentially of agricultural ingredients from 
organic farming and of natural non-agricultural substances; 

husbandry  practices  which  enhance  the  immune  system  and  strengthen  the  natural 
defence against diseases shall be used; 

aquaculture  production  shall  minimise 
environment; 

the  negative  effect  on 

the  aquatic 

feed used in aquaculture shall be from sustainable fisheries or composed essentially 
of  agricultural  ingredients  from  organic  farming  and  of  natural  non-agricultural 
substances; 

(p) 

polyploid animals may not be used. 

Article 6 
Principles applicable to processing 

In addition to the overall principles set out in Article 4, the following principles shall apply to 
the production of processed organic feed and food: 

(a) 

(b) 

organic  food  and  feed  shall  be  produced  essentially  from  agricultural  ingredients 
which  shall  be  organic,  except  where  an  organic  ingredient  is  not  commercially 
available; 

additives and processing aids shall be used to a minimum extent and only in case of 
essential technological need; 

(c) 

ionising radiation may not be used. 

TITLE III 
PRODUCTION RULES 

CHAPTER 1 
FARM PRODUCTION 

Article 7 
General farm production rules 

1. 

The  entire  commercial  part  of  a  holding  shall  be  managed  in  compliance  with  the 
requirements applicable to organic production or conversion to organic production. 

However, in accordance with specific conditions to be laid down in accordance with 
the  procedure  referred  to  in  Article  31(2),  a  holding  may  be  split  up  into  clearly 
separated units which are not all managed under organic production. 

Where,  in  accordance  with  the  second  subparagraph,  not  all  of  a  farm  is  used  for 
organic  production,  the  farmer  shall  keep  the  land,  animals,  and  products  used  for 

EN 

18 

   EN 

 
organic  production  separate  from  the  rest  and  keep  adequate  records  to  show  the 
separation. 

2. 

Farmers are required not to use GMOs or products produced from GMOs where they 
should  have  knowledge  of  their  presence  due  to  information  on  any  label 
accompanying the product or from any other accompanying document. 

Where farmers use products purchased from third parties to produce organic food or 
feedstuffs,  they  shall  require  the  vendor  to  confirm  that  the  products  supplied  have 
not been produced by GMOs. 

Article 8 
Plant production rules 

1. 

In addition to the general rules laid down in Article 7, the following rules shall apply 
to organic plant production: 

(a) 

(b) 

(c) 

organic plant production shall be based on tillage and cultivation practices that 
maintain  or  increase  soil  organic  matter,  enhance  soil  stability  and  soil 
biodiversity, and prevent soil compaction and soil erosion; 

fertility and biological activity of the soil shall be maintained and increased by 
multi-annual crop rotation including green manure, application of manure and 
organic material from organic farms; 

in addition, fertilisers and soil conditioners compatible with the objectives and 
principles of organic production may be used if they have been approved under 
Article 11; 

(d)  mineral nitrogen fertilisers shall not be used; 

(e) 

(f) 

(g) 

(h) 

(i) 

all plant production techniques used shall prevent or minimise any contribution 
to contamination of the environment; 

prevention of damage caused by pests, diseases and weeds shall rely primarily 
on the choice of species and varieties, crop rotation and cultivation techniques; 

in  the  case  of  threat  to  a  crop,  plant  protection  products  compatible  with  the 
objectives and principles of organic production may be used if they have been 
approved under Article 11; 

the use of any approved synthetic substances shall be subject to conditions and 
limits as regards the crops that they can be applied to, the application method, 
the dosage, the time limits for use and the contact with crop; 

only organically produced seed and propagating material may be used. To this 
end,  the  mother  plant  in  the  case  of  seeds  and  the  parent  plant  in  the  case  of 
vegetative  propagating  material  shall  have  been  produced  in  accordance  with 
the rules laid down in this Regulation for at least one generation, or, in the case 
of perennial crops, two growing seasons. 

2. 

The collection of edible plants and parts thereof, growing naturally in natural areas, 
forests and agricultural areas, is considered an organic production method provided 
that: 

EN 

19 

   EN 

 
(a) 

(b) 

those areas have not, for a period of three years before the collection, received 
treatments with products other than those approved under Article 11; 

the  collection  does  not  affect  the  stability  of  the  natural  habitat  or  the 
maintenance of the species in the collection area. 

Article 9 
Livestock production rules 

In  addition  to  the  general  rules  laid  down  in  Article  7,  the  following  rules  shall  apply  to 
livestock production: 

(a) 

with regard to the origin of the animals: 

(i) 

organic livestock shall be born and raised on organic holdings; 

(ii) 

for  breeding  purposes,  non-organically  raised  animals  may  be  brought  onto  a 
holding  under  specific  conditions  to  be  established  in  accordance  with  the 
procedure referred to in Article 31(2);  

(b) 

with regard to husbandry practices and housing conditions: 

(i) 

personnel  keeping  animals  shall  possess  the  necessary  knowledge  and 
competence as regards the health and the welfare needs of the animals; 

(ii)  husbandry practices, including stocking densities, and housing conditions shall 
ensure that developmental, physiological and ethological needs of animals are 
met; 

(iii) 

the  livestock  shall  have  permanent  access  to  a  free-range  area,  preferably 
pasture, whenever weather conditions and the state of the ground allow this; 

(iv) 

the  number  of  livestock  shall  be  limited  with  a  view  to  minimising 
overgrazing, poaching of soil, erosion, or pollution caused by animals or by the 
spreading of their manure; 

(v)  organic  livestock  shall  be  kept  separate  or  readily  separable  from  other 

livestock; 

(vi) 

tethering  or  isolation  of  livestock  shall  be  prohibited,  unless  for  individual 
animals  for  a  limited  period  of  time  and  justified  for  safety,  welfare  or 
veterinary reasons; 

(vii)  duration of transport of livestock to slaughterhouses shall be minimised; 

(viii)  any suffering, including mutilation, shall be kept to a minimum; 

(ix)  apiaries  must  be  placed  in  areas  which  ensure  nectar  and  pollen  sources 
consisting  essentially  of  organically  produced  crops  and/or  spontaneous 
to 
vegetation  and  must  keep  enough  distance  from  sources 
contamination of products from beekeeping; 

leading 

(x)  hives and materials used in beekeeping must be made of natural materials; 

EN 

20 

   EN 

 
(xi) 

the destruction of bees in the combs as a method associated with the harvesting 
of beekeeping products is prohibited; 

(c) 

with regard to breeding: 

(i) 

reproduction  shall  not  be  induced  by  hormone  treatment,  unless  in  order  to 
treat reproduction disorders; 

(ii) 

cloning and embryo transfer shall not be used; 

(iii)  an  appropriate  choice  of  breed  shall  contribute  to  the  prevention  of  any 

suffering and to avoiding the need for mutilation of animals; 

(d) 

with regard to feed: 

(i) 

livestock shall be fed with organic feed, which may include proportions of feed 
from  farm  units  which  are  in  conversion  to  organic  farming,  that  meet  the 
animal’s nutritional requirements at the various stages of its development; 

(ii) 

animals shall have permanent access to pasture or roughage; 

(iii)  feed additives may be used only if they have been approved under Article 11; 

(iv)  growth promoters and synthetic amino-acids may not be used; 

(v) 

suckling mammals shall be fed with natural, preferably maternal, milk; 

(e) 

with regard to disease prevention and veterinary treatment: 

(i) 

disease  prevention  shall  be  based  on  breed  and  strain  selection,  husbandry 
management  practices,  high  quality  feed  and  exercise,  appropriate  stocking 
density  and  adequate  and  appropriate  housing  maintained  in  hygienic 
conditions; 

(ii)  disease outbreaks shall be treated immediately to avoid suffering to the animal; 
allopathic  products  including  antibiotics  may  be  used  where  necessary,  when 
the use of phytotherapeutic, homeopathic and other products is inappropriate. 

Article 10 
Production rules for aquaculture 

1. 

2. 

The Commission shall in accordance with the procedure referred to in Article 31(2), 
and subject to the objectives and principles laid down in Title II, establish production 
rules, including rules on conversion, applicable to organic aquaculture. 

Pending the adoption of the rules referred to in paragraph 1, national rules, or in the 
absence thereof private standards accepted or recognised by the Member States, shall 
apply,  provided  that  they  pursue  the  same  objectives  and  principles  as  those  laid 
down in Title II. 

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Article 11 
Use of certain products and substances in farming  

1. 

The Commission shall in accordance with the procedure referred to in Article 31(2), 
and  subject  to  the  objectives  and  principles  laid  down  in  Title II,  establish  specific 
criteria  for  the  approval  of  products  and  substances  that  may  be  used  in  organic 
farming as follows: 

(a) 

plant protection products; 

(b) 

fertilisers and soil conditioners; 

(c) 

plant, animal and mineral feed material; 

(d) 

feed additives; 

(e) 

cleaning materials; 

(f) 

other substances. 

2. 

The Commission shall, in accordance with the procedure referred to in Article 31(2), 
decide on approval of the products and substances referred to in paragraph 1 and fix 
the conditions and limits for their use. 

Article 12 
Conversion 

The following rules shall apply to a farm on which organic production is commenced:  

(a) 

(b) 

(c) 

(d) 

prior to the first growing season of crops which are to be grown according to organic 
production methods, products not permitted to be used in organic farming shall not 
have  been  applied  for  a  period  to  be  defined  in  accordance  with  the  procedure 
referred to in Article 31(2); 

livestock existing on the holding may be deemed organic after a transitional period to 
be defined in accordance with the procedure referred to in Article 31(2); 

milk  and  milk  products  from  formerly  non  organic  dairy  animals  may  be  sold  as 
organic after a period to be defined in accordance with the procedure referred to in 
Article 31(2); 

on  single  farm  units  partly  under  organic  production  and  partly  in  conversion  to 
organic  production,  the  farmer  shall  keep  the  land,  animals,  and  products  separate 
and keep adequate records to show the separation. 

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CHAPTER 2 
FEED PRODUCTION 

Article 13 
Production rules for feed 

1. 

2. 

3. 

4. 

Production  of  organic  feed  shall  be  kept  separate  from  production  of  non  organic 
feed. 

Organic  feed  materials,  and/or  feed  materials  from  production  in  conversion,  shall 
not  enter  simultaneously  with  the  same  feed  materials  produced  by  non  organic 
means into the composition of the organic feed product. 

Hexane and other organic solvents may not be used. 

Feed manufacturers are required not to use GMOs or products produced from GMOs 
where they should have knowledge of their presence due to information on any label 
accompanying the product or from other accompanying documents. 

Where feed manufacturers use ingredients and additives purchased from third parties 
to produce feedstuffs for organic livestock, they shall require the vendor to confirm 
that the products supplied have not been produced by GMOs. 

CHAPTER 3 
PRODUCTION OF PROCESSED PRODUCTS 

Article 14 
General rules on the production of processed food 

1. 

The following criteria shall apply to the composition of organic processed food: 

(a) 

(b) 

(c) 

at least 95%, by weight, of the ingredients of agricultural origin of the product 
shall be organic; 

ingredients of non-agricultural origin and processing aids may be used only if 
they have been approved under Article 15; 

non-organic  agricultural  ingredients  may  be  used  only  if  they  have  been 
approved under Article 15. 

The extraction, processing and storage of organic food shall be conducted with care 
to  avoid  losing  the  properties  of  the  ingredients.  Substances  and  techniques  that 
reconstitute these properties or correct the results of negligence in the processing of 
these products shall not be used. 

Processors are required not to use GMOs  or  products  produced  from  GMOs  where 
they  should  have  knowledge  of  their  presence  due  to  information  on  the  label 
accompanying the product or from any other accompanying document. 

2. 

3. 

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1. 

2. 

3. 

1. 

2. 

Where processors use ingredients and processing aids purchased from third parties to 
produce organic food or feedstuffs, they shall require the vendor to confirm that the 
products supplied have not been produced by GMOs. 

Article 15 
Use of certain products and substances in processing 

The Commission shall in accordance with the procedure referred to in Article 31(2), 
and  subject  to  the  objectives  and  principles  laid  down  in  Title  II,  establish  specific 
criteria for the approval of ingredients of non-agricultural origin and processing aids 
that may be used in the production of organic processed food. 

The Commission shall in accordance with the procedure referred to in Article 31(2), 
and  subject  to  the  objectives  and  principles  laid  down  in  Title  II,  establish  specific 
criteria for the approval of agricultural ingredients which are not organic but which 
may be used in the production of organic processed food where organic agricultural 
ingredients are not commercially available. 

The Commission shall, in accordance with the procedure referred to in Article 31(2), 
decide on approval of the products and substances referred to in paragraphs 1 and 2 
and, where necessary, fix the conditions and limits for their use. 

CHAPTER 4 
FLEXIBILITY 

Article 16 
Less restrictive production rules 

The Commission may, in accordance with the procedure referred to in Article 31(2) 
and the conditions set out in paragraph 2 and subject to the objectives and principles 
laid down in Title II, provide for the granting of exceptions from the production rules 
laid down in Chapters 1 to 3. 

Exceptions as referred to in paragraph 1 shall be kept to a minimum and may only be 
provided for in the following cases: 

(a)  where  they  are  necessary  in  order  to  enable  farm  units  initiating  organic 
production to become viable, in particular for holdings located in areas in the 
early stages of development of organic production; 

(b)  where  they  are  necessary  in  order  to  ensure  that  organic  production  can  be 
maintained  on  holdings  confronted  with  climatic,  geographical  or  structural 
constraints;  

(c)  where  it  is  necessary  in  order  to  ensure  access  to  feed,  seed  and  vegetative 
propagating material, live animals and other farm inputs, where such inputs are 
not commercially available in organic form; 

(d)  where  it  is  necessary  in  order  to  ensure  access  to  ingredients  of  agricultural 
origin, where such ingredients are not commercially available in organic form; 

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(e)  where  they  are  necessary  in  order  to  solve  specific  problems  related  to  the 

management of organic livestock; 

(f)  where they are necessary in order to ensure continued production of traditional 

food products well known for at least a generation; 

(g)  where temporary measures are necessary in order to allow organic production 

to continue or recommence in the case of catastrophic circumstances; 

(h)  where  restrictions  and  obligations  related  to  the  protection  of  human  and 

animal health are imposed on the basis of Community legislation. 

3. 

The Commission may in accordance with the procedure referred to in Article 31(2) 
lay  down  specific  conditions  for  the  application  of  exceptions  provided  for  under 
paragraph 1. 

TITLE IV 
LABELLING 

Article 17 
Use of terms referring to organic production 

1. 

2. 

3. 

4. 

5. 

1. 

The terms listed in Annex I, their derivatives or diminutives, alone or combined, may 
be used throughout the Community and in any Community language for the labelling 
and  advertising  of  a  product  which  is  produced  and  controlled,  or  imported,  in 
accordance with this Regulation. 

The terms listed in Annex I, their derivatives or diminutives, alone or combined, may 
not  be  used  anywhere  in  the  Community  and  in  any  Community  language  for  the 
labelling and advertising of a product which has not been produced and controlled, or 
imported,  in  accordance  with  this  Regulation,  unless  these  terms  clearly  cannot  be 
associated with agricultural production. 

The terms listed in Annex I, their derivatives or diminutives, alone or combined, may 
not  be  used  for  a  product  which  bears  a  label  indicating  that  it  contains  GMOs, 
consists of GMOs or is produced from GMOs. 

Member  States  shall  take  the  measures  necessary  to  ensure  compliance  with  this 
Article. 

The Commission may in accordance with the procedure referred to in Article 31(2) 
adapt the list of terms set out in Annex I. 

Article 18 
Compulsory indications 

Where  a  term  referred  to  in  Article 17,  or  its  derivative  or  diminutive,  is  used  in 
labelling of products produced within the Community, the following indications shall 
also appear on the label:  

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25 

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(a) 

the  code  number  referred  to  in  Article 22(7)  of  the  body  competent  for  the 
controls to which the operator is subject; 

(b)  where  the  logo  referred  to  in  Article  19  is  not  used,  at  least  one  of  the 

indications listed in Annex II in capital lettering. 

2. 

3. 

4. 

The indications referred to in paragraph 1 shall be marked in a conspicuous place in 
such a way as to be easily visible, clearly legible and indelible. 

In  addition,  the  Commission  shall  in  accordance  with  the  procedure  referred  to  in 
Article 31(2)  lay  down  specific  criteria  as  regards  the  presentation  and  size  of  the 
indications referred to in paragraph 1. 

The Commission may in accordance with the procedure referred to in Article 31(2) 
adapt the list of indications set out in Annex II. 

For products imported from third countries, the use of the indications referred to in 
paragraph 1 shall be optional. 

Article 19 
Community organic production logo 

The Commission shall, in accordance with the procedure referred to in Article 31(2), define a 
Community logo which may be used in the labelling, presentation and advertising of products 
produced and controlled, or imported, in accordance with this Regulation. 

Article 20 
Label and advertising claims 

1. 

2. 

3. 

General claims that a particular set of private or national organic standards is stricter, 
more  organic  or  otherwise  superior  to  the  rules  laid  down  in  this  Regulation,  or  to 
any other set of organic standards, may not be used on labels or in advertising.  

However,  indications  referring  to  specific  elements  of  the  production  method  used 
for a certain product may only be used on labels or in advertising on condition that 
they  are  true  statements  of  fact  and  otherwise  in  conformity  with  the  general 
labelling requirements set out in Directive 2000/13/EC. 

Member  States  shall  take  the  measures  necessary  to  ensure  compliance  with  the 
conditions set out in this Article. 

The Commission may in accordance with the procedure referred to in Article 31(2) 
adopt measures in order to ensure compliance with this Article. 

Article 21 
Specific labelling requirements 

The Commission shall in accordance with the procedure referred to in Article 31(2) establish 
specific  labelling  requirements  applicable  to  organic  feed  and  to  products  originating  from 
holdings in conversion.  

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TITLE V 
CONTROLS 

Article 22 
Control system 

1. 

2. 

3. 

4. 

5. 

Member States shall in accordance with the provisions laid down in Regulation (EC) 
No 882/2004  set  up  a  system  of  controls  applicable  to  the  activities  referred  to  in 
Article 1(3) of this Regulation. 

In applying Article 3 of Regulation (EC) No 882/2004, the nature and frequency of 
the controls shall be determined on the basis of an analysis of the risk of irregularity 
in the field of each of the activities referred to in Article 1(3) of this Regulation. 

Member  States  shall  in  accordance  with  Article 4  of  Regulation  (EC)  No 882/2004 
designate the competent authority responsible for the controls to be carried out under 
the control system. 

The  competent  authority  may  in  accordance  with  Article 5  of  Regulation  (EC) 
No 882/2004 delegate certain control tasks to one or more control bodies. 

The  control  bodies  shall  fulfil  the  requirements  set  out  in  European  Standard  EN 
45011  or  ISO  Guide  65  ‘General  requirements  for  bodies  operating  product 
certification systems’ of the version as most recently notified by a publication in the 
Official Journal of the European Union, C series. 

Approved  control  bodies  shall  give  the  competent  authority  access  to  their  offices 
and  facilities  and  provide  any  information  and  assistance  deemed  necessary  by  the 
competent authority for the fulfilment of its obligations according to this Article. 

6. 

The competent authority may not delegate the following tasks to the control bodies: 

(a) 

the supervision and audit of other control bodies; 

(b) 

the competence to grant exceptions, as referred to in Article 16, unless this is 
provided  for  in  the  specific  conditions  laid  down  by  the  Commission  in 
accordance with Article 16(3). 

Member  States  shall  attribute  a  code  number  to  each  body  competent  to  carry  out 
controls under this Regulation. 

The approved control bodies shall by 31 January each year at the latest transmit to 
the competent authority a list of the operators which were subject to their controls on 
31 December of the previous year, accompanied by a summary report of the control 
activities carried out during the previous year. 

Article 23 
Adherence to the control system 

Any  operator  who  produces,  prepares,  stores  or  imports  from  or  exports  to  a  third 
country products as specified in the first subparagraph of Article 1(2) with a view to 
the subsequent marketing thereof, or who markets such products, shall: 

7. 

8. 

1. 

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27 

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2. 

3. 

4. 

1. 

2. 

3. 

(a) 

notify  this  activity  to  a  competent  authority  of  the  Member  State  where  the 
activity is carried out; 

(b) 

submit his undertaking to the control system. 

Member  States  may  exempt  from  the  application  of  this  Article  operators  who  sell 
such  products  directly  to  the  final  consumer  or  user  provided  they  do  not  produce, 
prepare, store other than in connection with the point of sale, or import such products 
from a third country. 

Member  States  shall  ensure  that  any  operator  who  complies  with  the  rules  of  this 
Regulation, and who pays a reasonable fee as a contribution to the control expenses, 
is entitled to be covered by the control system. 

The  competent  authority  shall  keep  an  updated  list  containing  the  names  and 
addresses of operators subject to the control system. 

Article 24 
Certification 

The  competent  authority  and  the  approved  control  bodies  may  grant  certificates, 
including  the  right  to  use  their  marks  of  conformity  with  organic  standards,  to 
operators which are subject to the control system. 

A competent authority may not refuse to grant certificates or the use of its mark of 
conformity for any product that meets the requirements laid down in this Regulation. 

A  control  body  may  not  refuse  to  grant  certificates  or  the  use  of  its  mark  of 
conformity for any product that has been certified by another approved control body, 
where  the  latter  control  body  has  assessed  and  certified  conformity  with  organic 
standards equivalent to those of the first control body. 

A  control  body  which  refuses  to  grant  a  certificate  or  the  use  of  its  mark  of 
conformity,  shall  provide  proof  that  the  organic  standards  under  which  the  product 
concerned has already been certified are not equivalent to its own standards. 

Fees collected for the granting of the certificate or the mark of conformity shall be 
reasonable. 

Article 25 
Measures in case of infringements and irregularities 

1. 

The competent authority shall: 

(a)  where an irregularity is found as regards compliance with the requirements laid 
down in this Regulation, ensure that the indications and the logo provided for 
in  Articles 17,  18  and  19  are  not  used  on  the  entire  lot  or  production  run 
affected by this irregularity; 

(b)  where  a  manifest  infringement  or  an  infringement  with  prolonged  effect  is 
found,  prohibit  the  operator  concerned  from  marketing  products  with 

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28 

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indications  referring  to  the  organic  production  method  for  a  period  to  be 
determined by the competent authority. 

2. 

Information on cases of irregularities or infringements affecting the organic status of 
a product shall be immediately communicated between the concerned control bodies, 
competent authorities, Member States and, where appropriate, to the Commission. 

The  level  of  communication  shall  depend  on  the  severity  and  the  extent  of  the 
irregularity or infringement found. 

The Commission may in accordance with the procedure referred to in Article 31(2) 
lay down specifications regarding the form of such communications. 

Article 26 
Exchange of information 

Upon request duly justified by the necessity to guarantee that a product has been produced in 
accordance  with  this  Regulation,  the  competent  authorities  and  the  control  bodies  shall 
exchange  with  other  competent  authorities  and  control  bodies  relevant  information  on  the 
results of their controls. They may also exchange such information on their own initiative. 

TITLE VI 
TRADE WITH THIRD COUNTRIES 

Article 27 
Imports from third countries 

1. 

2. 

3. 

A product imported from a third country may be placed on the Community market 
labelled as organic where it complies with the provisions set out in Titles II, III and 
IV of this Regulation. 

A third country operator who wishes to place his products labelled as organic on the 
Community  market,  under  the  conditions  provided  for  in  paragraph 1,  shall  submit 
his  activities  to  any  competent  authority  or  control  body  as  referred  to  in  Title V, 
provided that the authority or body concerned perform controls in the third country 
of production, or to a control body approved in accordance with paragraph 5. 

A  product  imported  from  a  third  country  may  also  be  placed  on  the  Community 
market labelled as organic provided that: 

(a) 

(b) 

the  product  has  been  produced  in  accordance  with  production  standards 
equivalent  to  those  applied  to  organic  production  in  the  Community,  or  in 
accordance with the internationally  recognised standards set out in the Codex 
Alimentarius guidelines; 

the producer has been subject to control arrangements which are equivalent to 
those  of  the  Community  control  system,  or  which  comply  with  the  Codex 
Alimentarius guidelines; 

(c) 

the third country operator who wishes to place his products labelled as organic 
on the Community market under the conditions of this paragraph has submitted 

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29 

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4. 

5. 

his activities to a control system recognised in accordance with paragraph 4 or 
a control body recognised in accordance with paragraph 5; 

(d) 

the  product  is  covered  by  a  certificate  issued  by  the  competent  authorities  or 
control bodies of a third country recognised in accordance with paragraph 4, or 
by a control body recognised in accordance with paragraph 5, which confirms 
that the product satisfies the conditions set out in this paragraph. 

The Commission shall in accordance with the procedure referred to in Article 31(2) 
recognise  the  third  countries  whose  production  standards  and  control  arrangements 
are  equivalent  to  those  applied  in  the  Community,  or  are  in  accordance  with  the 
internationally  recognised  standards  set  out  in  the  Codex  Alimentarius  guidelines, 
and establish a list of these countries. 

When  examining  requests  for  recognition,  the  Commission  shall  invite  the  third 
country  to  supply  all  the  necessary  information.  The  Commission  may  entrust 
experts with the task of examining on-the-spot the rules of production and the control 
arrangements of the third country concerned. 

For  products  imported  from  a  third  country  which  is  not  recognised  under 
paragraph 4, and where the operator has not submitted his activities to a competent 
authority  or  control  body  as  referred  to  in  Title V,  the  Commission  shall  in 
accordance  with  the  procedure  referred  to  in  Article 31(2)  recognise  the  control 
bodies competent to carry out controls and issue certificates in that third country for 
the purpose of paragraph 3, and establish a list of these control bodies. 

The  Commission  shall  examine  any  request  for  recognition  lodged  by  a  public  or 
private control body in a third country. 

When  examining  requests  for  recognition,  the  Commission  shall  invite  the  control 
body  to  supply  all  the  necessary  information.  The  Commission  may  also  entrust 
experts with the task of examining on-the-spot the rules of production and the control 
activities carried out in the third country by the control body concerned. 

TITLE VII 
FINAL AND TRANSITIONAL RULES 

Article 28 
Free movement of organic products 

Member States may not, on grounds relating to the method of production, to labelling or to 
the  presentation  of  that  method,  prohibit  or  restrict  the  marketing  of  organic  products  that 
meet the requirements of this Regulation. 

Article 29 
Transmission of information to the Commission 

Members States shall annually transmit the following information to the Commission:  

(a) 

the names and addresses of the competent authorities; 

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(b) 

lists of control bodies and their code numbers and, where appropriate, their marks of 
conformity with standards. 

Article 30 
Statistical information 

Member  States  shall  transmit  to  the  Commission  statistical  information  necessary  for  the 
implementation and follow-up of this Regulation This statistical information shall be defined 
within the context of the Community Statistical Programme. 

Article 31 
Management Committee on organic production 

1. 

2. 

3. 

4. 

The  Commission  shall  be  assisted  by  the  Management  Committee  on  organic 
production (hereinafter “the Committee”). 

Where  reference  is  made  to  this  paragraph,  Articles  4  and  7  of  Decision 
1999/468/EC19 shall apply. 

The period provided for in Article 4(3) of Decision 1999/468/EC shall be set at three 
months. 

The Committee shall adopt its rules of procedure. 

Article 32 
Implementing rules 

The  Commission  shall  in  accordance  with  the  procedure  referred  to  in  Article  31(2)  and 
subject  to  the  objectives  and  principles  laid  down  in  Title II  adopt  detailed  rules  for  the 
application of this Regulation. They shall include in particular the following: 

(a) 

(b) 

(c) 

(d) 

detailed rules as regards the production rules laid down in Title III, in particular as 
regards the specific requirements and conditions to be respected by farmers and other 
producers of organic products; 

detailed rules as regards the labelling rules laid down in Title IV; 

detailed rules as regards the control system established under Title V, in particular as 
regards the specific criteria for delegation of tasks to private control bodies and the 
criteria for approval of such bodies; 

detailed  rules  as  regards  the  rules  on  imports  from  third  countries  laid  down  in 
Title VI,  in  particular  as  regards  the  criteria  and  procedures  to  be  followed  with 
regard  to  the  recognition  under  Article  27  of  third  countries  and  control  bodies, 
including the publication of lists of recognised third countries and control bodies, and 
as regards the certificate referred to in Article 27(3), point (d). 

19 

OJ L 184, 17.7.1999, p. 23. 

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Article 33 
Repeal of Regulation (EEC) No 2092/91 

1. 

2. 

Regulation (EEC) No 2092/91 is hereby repealed from 1 January 2009. 

References  to  the  repealed  Regulation  (EEC)  No 2092/91  shall  be  construed  as 
references to this Regulation. 

Article 34 
Transitional measures 

Measures  to  facilitate  the  transition  from  the  rules  established  by  Regulation  (EEC) 
No 2092/91 to this Regulation may be adopted in accordance with the procedure referred to in 
Article 31(2).  

Article 35 
Entry into force and application 

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

It shall apply as from 1 January 2009. 

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

Done at Brussels,  

For the Council 
The President 

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ANNEX I 

Terms referred to in Article 17(1) 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

ES:  ecológico, 

CS:  ekologické, 

DA:  økologisk, 

DE:  ökologisch, biologisch, 

ET:  mahe, ökoloogiline, 

EL:  βιολογικό, 

EN:  organic, 

FR:  biologique, 

GA:  orgánach, 

IT:  biologico, 

LV:  bioloģiskā, 

LT:  ekologiškas, 

HU:  ökológiai, 

MT:  organiku, 

NL:  biologisch, 

PL:  ekologiczne, 

PT:  biológico, 

SK:  ekologické, 

SL:  ekološki, 

FI: 

luonnonmukainen, 

SV:  ekologisk. 

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ANNEX II 

Indications referred to in Article 18(1)(b) 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

UE-ECOLÓGICO, 

EU-EKOLOGICKÉ, 

EU-ØKOLOGISK, 

EU-ÖKOLOGISCH, 

EL-MAHE, 

EL-ÖKOLOOGILINE, 

EE-ΒΙΟΛΟΓΙΚΌ, 

EU-ORGANIC, 

UE-BIOLOGIQUE, 

AE-ORGÁNACH, 

UE-BIOLOGICO, 

ES-BIOLOĢISKĀ, 

ES-EKOLOGIŠKAS, 

EU-ÖKOLÓGIAI, 

EU-ORGANIKU, 

EU-BIOLOGISCH, 

UE-EKOLOGICZNE 

EU-EKOLOGICKE, 

EU-EKOLOSKI, 

EU-LUONNONMUKAINEN, 

EU-EKOLOGISK.

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2005/0279 (CNS) 

Proposal for a 

COUNCIL REGULATION 

amending Regulation (EEC) No 2092/91 on organic production of agricultural products 
and indications referring thereto in agricultural products and foodstuffs 

THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  establishing  the  European  Community,  and  in  particular 
Article 37 thereof, 

Having regard to the proposal from the Commission, 

Having regard to the opinion of the European Parliament20, 

Whereas: 

(1) 

(2) 

(3) 

Given  the  need  to  advance  on  the  implementation  of  the  European  Action  Plan  for 
Organic Food and Farming21 on the basis of concrete measures with a view to assuring 
simplification and overall coherence, Council Regulation (EEC) No 2092/9122 will be 
repealed on [1 January 2009] and replaced by Council Regulation (EC) No …./2006 of 
[…] on organic production and labelling of organic products23. 

Under  the  new  scheme  established  by  Regulation  (EC)  No  …./2006  for  imports  of 
organic produce from third countries, organic products imported into the Community 
should be allowed to be placed on the Community market labelled as organic, where 
they  have  been  produced  in  accordance  with  production  rules  and  subject  to  control 
arrangements that are in compliance with or equivalent to Community legislation.  

To this end, third countries whose production standards and control arrangements are 
equivalent to those applied in the Community should be recognised and a list thereof 
should  be  published.  The  control  bodies  competent  to  carry  out  control  in  countries 
which are not on the list of recognised third countries should also be recognised and 
listed.  Third  country  operators  who  produce  in  direct  compliance  with  Community 
rules  should  be  allowed  to  choose  to  submit  their  activities  to  the  competent 
authorities and control bodies designated by the Member States. 

(4) 

Article 11(6) of Regulation (EEC) No 2092/91 provides for the possibility for Member 
States to grant until 31 December 2006 import authorisations for individual products 
under certain conditions. It is thus appropriate to amend that Article, so as to allow for 

20 
21 
22 
23 

OJ C […], p. […]. 
COM(2004) 415. 
OJ L 198, 22.7.1991, p. 1. Regulation as last amended by …. 
OJ L [ …, ….2006, p. …]. 

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35 

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a  replacement  of  the  current  import  scheme  by  the  new  import  scheme  as  from  that 
date. 

(5) 

The new import scheme should thus apply as from 1 January 2007. However, this will 
leave  little  time  for  its  implementation,  in  particular  as  regards  the  recognition  of 
control bodies competent to carry out control in those countries which are not on the 
list  of  recognised  third  countries.  In  order  not  to  disrupt  international  trade,  it  is 
considered necessary to extend the possibility for Member States to continue to grant 
import  authorisations  for  individual  products  until  the  measures  necessary  for  the 
functioning of the new import scheme have been put in place. 

(6) 

Regulation (EEC) No 2092/91 should be amended accordingly, 

HAS ADOPTED THIS REGULATION: 

Article 1 

Regulation (EEC) No 2092/91 is amended as follows: 

(1) 

In Article 10(1), point (b) is replaced by the following: 

“(b)  have  been  subject  to  the  inspection  system  referred  to  in  Article  9  or,  in  the 
case of products imported under Article 11(3) and (6), to equivalent measures;”  

(2) 

Article 11 is replaced by the following: 

“Article 11 

1.  A  product  imported  from  a  third  country  may  be  placed  on  the  Community 
market  labelled  as  organic  where  it  complies  with  the  production  rules  laid 
down in this Regulation. 

2.  A third country operator who wishes to place his products labelled as organic 
on the Community market, under paragraph 1, shall submit his activities to any 
inspection authority or inspection body as referred to in Article 9, provided that 
the  authority  or  body  concerned  perform  controls  in  the  third  country  of 
production,  or  to  a  control  body  approved  in  accordance  with  paragraph  5  of 
this Article. 

3.  A product imported from a third country may also be placed on the Community 

market labelled as organic provided that: 

(a) 

(b) 

the product has been produced in accordance with  production  standards 
equivalent to those applied to organic production in the Community, or in 
accordance  with  the  internationally  recognised  standards  set  out  in  the 
Codex Alimentarius guidelines; 

the  producer  has  been  subject  to  control  arrangements  which  are 
equivalent to  those of  the Community control system, or which comply 
with the Codex Alimentarius guidelines; 

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36 

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4. 

5. 

6. 

(c) 

(d) 

the  third  country  operator  who  wishes  to  place  his  products  labelled  as 
organic on the Community market under the conditions of this paragraph 
has submitted his activities to a control system recognised in accordance 
with  paragraph 4  or  a  control  body  recognised  in  accordance  with 
paragraph 5; 

the product is covered by a certificate issued by the competent authorities 
or  control  bodies  of  a  third  country  recognised  in  accordance  with 
paragraph 4,  or  by  a  control  body  recognised  in  accordance  with 
paragraph 5, which confirms that the product satisfies the conditions set 
out in this paragraph. 

The  Commission  shall,  in  accordance  with  the  procedure  referred  to  in 
Article 14(2),  recognise  the  third  countries  whose  production  standards  and 
control arrangements are equivalent to those applied in the Community, or are 
in  accordance  with  the  internationally  recognised  standards  set  out  in  the 
Codex Alimentarius guidelines, and publish a list of these countries. 

When  examining  requests  for  recognition,  the  Commission  shall  invite  the 
third  country  to  supply  all  the  necessary  information.  The  Commission  may 
entrust experts with the task of examining on-the-spot the rules of production 
and the control arrangements of the third country concerned. 

For  products  imported  from  a  third  country  which  is  not  recognised  under 
paragraph 4,  and  where  the  operator  has  not  submitted  his  activities  to  an 
inspection  authority  or  inspection  body  as  referred  to  in  Article 9,  the 
Commission  shall, 
in 
Article 14(2), recognise the control bodies competent to carry out controls and 
issue certificates in that third country for the purpose of paragraphs 2 or 3 of 
this Article, and publish a list of these control bodies. 

the  procedure  referred 

in  accordance  with 

to 

The Commission shall examine any request for recognition lodged by a public 
or private control body in a third country. 

When  examining  requests  for  recognition,  the  Commission  shall  invite  the 
control  body  to  supply  all  the  necessary  information.  The  Commission  may 
entrust experts with the task of examining on-the-spot the rules of production 
and  the  control  activities  carried  out  in  the  third  country  by  the  control  body 
concerned. 

For a period ending six months after the publication of the first list of control 
bodies  recognised  pursuant  to  paragraph  5,  the  competent  authority  of  a 
Member  State  may  authorise  importers  in  that  Member  State  to  place  on  the 
market  products  imported  from  third  countries  which  are  not  included  in  the 
list  referred  to  in  paragraph  4,  provided  that  the  importer  provides  sufficient 
evidence  showing  that  the  conditions  referred  to  in  points  (a)  and  (b)  of 
paragraph  3  are  satisfied.  If  those  conditions  are  no  longer  satisfied,  the 
authorisation shall be immediately withdrawn. 

The imported product shall be covered by a certificate issued by the competent 
authority of the authorising Member State or by a control body recognised in 
accordance  with  paragraph  5,  which  confirms  that  the  product  satisfies  the 
conditions set out in this paragraph.  

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Each Member State shall inform the other Member States and the Commission 
of each authorisation granted pursuant to this paragraph, including information 
on the production standards and control arrangements concerned. 

At  the  request  of  a  Member  State  or  at  the  Commission’s  initiative,  an 
authorisation  granted  pursuant  to  this  paragraph  shall  be  examined  by  the 
Committee  set  in  Article 14.  If  it  emerges  from  this  examination  that  the 
conditions referred to in points (a) and (b) of paragraph 3 of this Article are not 
satisfied,  the  Commission  shall  request  the  Member  State  which  granted  the 
authorisation to withdraw it. 

7. 

The  Commission  may,  in  accordance  with  the  procedure  referred  to  in 
Article 14(2),  adopt  detailed  rules  for  the  application  of  this  Article,  and  in 
particular: 

(a) 

as  regards  the  criteria  and  procedures  to  be  followed  with  regard  to  the 
recognition  of  third  countries  and  control  bodies  under  paragraphs 4 
and 5 of this Article, including the publication of lists of recognised third 
countries and control bodies, 

(b) 

as  regards  the  certificate  referred  to  in  paragraphs 3(d)  and  6  of  this 
Article.” 

(3) 

(4) 

The second subparagraph of Article 16(3) is deleted. 

Point C of Annex III is amended in accordance with the Annex to this Regulation. 

Article 2 

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

It shall apply from 1 January 2007. 

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

Done at Brussels,  

For the Council 
The President 

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ANNEX 

Point C of the Specific Conditions in Annex III to Regulation (EEC) No 2092/91 is amended 
as follows: 

(1) 

In the first paragraph, the second indent is replaced by the following: 

“– 

the  first  consignee  shall  mean  the  natural  or  legal  person  to  whom  the 
consignment is delivered and who will receive it for further preparation and/or 
marketing.” 

(2) 

In point 5, the first subparagraph is replaced by the following: 

“The  inspection  body  or  authority  shall  inspect  the  stock  and  financial  records 
mentioned  in  section  C,  point  2  and  the  certificate  referred  to  in  Article 11(3)(d)  or 
Article 11(6).” 

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