REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the application of Council Regulation (EC) No 834/2007 on organic production and labelling of organic products
Date: 2012-05-11
Institutions: European Commission
Subjects: cosmetic product, genetically modified organism, import (EU), labelling, market approval, marketing standard, organic farming, textile product

EUROPEAN COMMISSION 

Brussels, 11.5.2012  
COM(2012) 212 final 

REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND 
THE COUNCIL 

on the application of Council Regulation (EC) No 834/2007 on organic production and 
labelling of organic products 

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TABLE OF CONTENTS 

1. 

2. 

2.1. 

2.2. 

3. 

3.1. 

3.2. 

3.3. 

3.4. 

4. 

5. 

Introduction .................................................................................................................. 3 

The scope of the Regulation......................................................................................... 4 

Mass caterers................................................................................................................ 4 

Textiles and cosmetics ................................................................................................. 5 

Prohibition on the use of GMOs in organic production............................................... 6 

General experience with the prohibition on the use of GMOs..................................... 7 

Availability of products not produced by GMOs......................................................... 8 

The vendor declaration................................................................................................. 8 

Feasibility of specific tolerance thresholds (for the adventitious or technically 
unavoidable presence of GMOs) and their impact on the organic sector .................... 9 

Functioning of the internal market and control system................................................ 9 

Application of the import regime............................................................................... 10 

5.1. 

Imports under the equivalence regime ....................................................................... 10 

5.1.1.  Recognition of third countries as providing equivalent guarantees ........................... 11 

5.1.2.  Recognition of control bodies and control authorities as providing equivalent 

guarantees................................................................................................................... 11 

5.2. 

5.3. 

6. 

Imports under the compliance regime........................................................................ 12 

Certificate of inspection ............................................................................................. 13 

Conclusions ................................................................................................................ 13 

ANNEX.................................................................................................................................... 15 

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REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND 
THE COUNCIL 

on the application of Council Regulation (EC) No 834/2007 on organic production and 
labelling of organic products 

1. 

INTRODUCTION 

Organic agriculture occupies 8.6 million hectares in the EU in 2009, which represents 4.7 % 
of EU-27 utilised agricultural area. In the period 2006-2009, its average annual rate of growth 
was 7.7 % in the EU-15 and 13 % in the EU-12 (EU-15 represented 81 % of all EU organic 
area in 2009). There were about 197.000 holdings involved in organic agriculture in 2008, i.e. 
1.4 % of all EU-27 holdings. It is estimated that the organic sector represented 2 % of total 
food expenses in the EU-15 in 2007.1 

Council  Regulation  (EC)  No  834/20072  and  its  implementing  Regulations,  Commission 
Regulations (EC) No 889/20083 and (EC) No 1235/20084 constitute the legal framework on 
organic food and farming at EU level. 

Already when conceiving Regulation (EC) No 834/2007 - hereafter named "the Regulation" -, 
the  Council  pointed  at  the  dynamic  evolution  of  the  organic  sector  and  asked  for  a  future 
review  of  a  number  of  issues  for  which  it  was  considered  that  experience  gained  from  the 
application  of  the  new  rules  should  be  taken  into  account.  The  Regulation  specified  in  its 
Article 41 which particular issues must be reviewed: 

(a) 

(b) 

(c) 

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the scope of the Regulation itself, in particular as regards organic food prepared by 
mass caterers; 

the  prohibition  on  the  use  of  GMOs,  including  the  availability  of  products  not 
produced  by  GMOs,  the  vendor  declaration,  the  feasibility  of  specific  tolerance 
thresholds and their impact on the organic sector; 

the functioning of the internal market and controls system, assessing in particular that 
the  established  practices  do  not  lead  to  unfair  competition  or  barriers  to  the 
production and marketing of organic products. 

More data and factual information concerning organic agriculture is provided in the publication by the 
Commission in 2010: "An analysis of the EU organic sector" available at: 
http://ec.europa.eu/agriculture/organic/files/eu-policy/data-statistics/facts_en.pdf 

Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic 
products and repealing Regulation (EEC) No 2092/91, OJ L 189, 20.7.2007, p. 1 

Commission  Regulation  (EC)  No 889/2008  of  5 September  2008  laying  down  detailed  rules  for  the 
implementation  of  Council  Regulation  (EC)  No 834/2007  on  organic  production  and  labelling  of 
organic products with regards to organic production, labelling and control, OJ L 250 of 18.9.2008, p.1 

Commission  Regulation  (EC)  No 1235/2008  of  8 December  2008  laying  down  detailed  rules  for 
implementation  of  Council  Regulation  (EC)  No 834/2007  as  regards  the  arrangements  for  imports  of 
organic products from third countries, OJ L 334, 12.12.2008, p. 25 

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With this report the Commission takes stock of the experience gained by the application of the 
Regulation from 1st January 2009, when it started to apply. 

This report will focus on the three main subjects set out above. In addition, it will highlight 
some other important issues under discussion with the Member States and stakeholders. 

In  order  to  get  a  better  view  on  the  experience  gained  so  far  with  the  Regulation,  the 
Commission sent a questionnaire to all the Member States and to stakeholders, by distributing 
it to all the Members of the Advisory Group for Organic Farming. Twenty-six Member States 
replied  to  the  questionnaire  in  March  2011,  as  well  as  eleven  stakeholders.  Those  replies 
provided an essential input to this report. 

2. 

THE SCOPE OF THE REGULATION 

The Regulation created the basis for adopting detailed production rules on sectors which were 
not  yet  subject  to  harmonised  rules5.  So  far  implementing  rules  have  been  finalised  and 
published on organic aquaculture, including seaweed, and on organic yeast. Work on the rules 
on  organic  wine  making  and  on  feed  were  ongoing  when  this  report  was  drafted.  For  some 
other  sectors,  like  poultry  and  greenhouses,  the  existing  production  rules  have  not  been 
revised yet. 

This chapter concentrates on a review of the experience with mass caterers and the question of 
the  possible  inclusion  of  textiles  and  cosmetics.  Organic  certification  of  certain  products 
outside  Annex  I  of  the  Treaty  but  which  are  closely  linked  to  Annex  I  products  or  to  rural 
economy,  such  as  beeswax,  essential  oils,  or  maté  is  not  examined  in  detail  here,  but  the 
Commission  recognises  a  need  for  clarifying  whether  such  products  may  be  certified  in 
compliance with the Regulation where those products have been produced in accordance with 
the requirements laid down in the Regulation. 

2.1.  Mass caterers 

The preparation of organic products in restaurants, hospitals, canteens and other food business 
is  steadily  gaining  importance,  in  both  private  and  public  sectors.  The  catering  sector 
comprises very different types of enterprises, from small restaurants to large catering chains. 

At  the  time  of  conceiving  the  Regulation,  including  the  catering  sector  was  judged  to  be 
premature  and  the  protection  of  terms  referring  to  organic  production  considered  sufficient. 
Anyhow,  the  mass  catering  sector  is  already  subject  to  EU  rules  on  hygiene  and  food 
labelling, which provide that labels referring to production methods cannot be used in a way 
that could mislead the purchaser6. 

Currently,  seven  Member  States  have  introduced  national  rules,  while  private  standards  are 
applied  in  ten  other  Member  States.  These  rules  provide  certification  of  ingredients,  dishes, 
menus or complete catering operations. Member States with an established control system did 
not  report  particular  difficulties.  Several  Member  States  reported  that  projects  to  regulate 
mass catering are envisaged at national or regional level. 

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Such as organic wine, organic aquaculture, including seaweed, organic yeast 

Directive 2000/13/EC 

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Most  Member  States  are  of  the  opinion  that  mass  catering  operations  should  not  become 
subject  to  EU  Regulation  on  organic  production  in  the  short  term,  not  only  because  of 
possible  increased  complexity,  but  also  because  of  the  limited  impact  on  trade  due  to  their 
local  character.  The  Commission  concludes  that  there  is  currently  no  need  to  include  mass 
catering operations in the Regulation but will closely follow developments in this sector. 

2.2. 

Textiles and cosmetics 

During  the  last  years,  there  has  been  significant  market  growth  for  textiles  and  cosmetics 
bearing reference to organic production. Private certification schemes for these products have 
been  developed.  However  those  two  product  categories  are  not  included  in  the  EU  organic 
legal  framework,  which  is  limited  to  a  series  of  agricultural  products7  (in  particular,  non 
processed agricultural products or processed agricultural products for use as food). While it is 
widely recognised that textiles and cosmetics both constitute a valuable outlet for organically 
produced  raw  materials,  a  debate  has  generated  in  the  organic  production  sector  on  the 
question of whether the reference to organic production for agricultural products outside the 
scope of the current Regulation could pose a risk for the credibility of the term "organic", as 
applied to foodstuffs. Additionally, it should be recalled that in order to systematically include 
non-agricultural products, the Regulation would have to be fundamentally changed. 

The Union legislation on textiles deals with fibre names and labelling rather than production 
methods8.  It  has  recently  been  revised9  with  a  view  to  simplify  and  improve  the  legislative 
framework  in  that  sector.  Within  the  voluntary  EU  Ecolabel  scheme10  criteria  have  been 
established  for  textile  products11.  In  the  case  of  cotton,  if  95 %  of  the  product  is  made  of 
organic cotton, the denomination "organic cotton" is allowed under this scheme. 

Agricultural  raw  materials,  such  as  plant  oils  and  plant  extracts,  are  present  in  many 
cosmetics.  The  Union  legislation  on  cosmetics  regulates  the  use  of  claims  on  cosmetic 
products12.  Common  criteria  for  all  types  of  claims  used  with  respect  to  cosmetic  products, 
including ‘natural and organic’ claims, are being developed13. 

The  Commission  considers  that  it  may  be  worth  exploring  the  opportunities  offered  by  the 
Union  legislation  to  extend  the  protection  of  the  use  of  the  word  "organic"  to  textiles  and 
cosmetics. 

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Listed in Article 1(2) of Council Regulation (EC) N° 834/2007 of 28 June 2007 on organic production 
and labelling of organic products (O.J. L 189, 20.07.2007, p.1) 

Directive 2008/121/EC 

Regulation (EU) No 1007/2011 of the European Parliament and of the Council of 27 September 2011 
on textile fibre names and related labelling and marking of the fibre composition of textile products. 

Regulation (EC) No 66/2010 of the European Parliament and of the Council of 25 November 2009 on 
the EU Ecolabel 

Commission Decision of 9 July 2009 (2009/567/EC) 

Article 20 of Council Regulation (EC) No 1223/2009, OJ L 342 of 22.12.2009 

ISO/NP 16128 

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3. 

PROHIBITION ON THE USE OF GMOS IN ORGANIC PRODUCTION 

One of the overall principles of organic production set out in the Regulation is the prohibition 
of the use of: 

–  genetically modified organisms or GMOs14, 

–  products produced from GMOs15, or 

–  products produced by GMOs16. 

These  products  are  considered  incompatible  with  the  concept  of  organic  production  and 
consumers' perception of organic products. 

In practice it means that GMOs and products produced from or by GMOs shall not be used as 
food,  feed,  processing  aids,  plant  protection  products,  fertilisers,  soil  conditioners,  seeds, 
vegetative  propagating  material,  micro-organisms  and  animals  in  organic  production.  One 
exception only is made for veterinary medicinal products (vaccines and others). 

However,  as  organic  systems  are  not  isolated  from  the  general  production  chain,  low  and 
accidental presence of GM crops in non-GM farming systems such as organic farming cannot 
be completely excluded during cultivation, harvest, transport, storage and processing. Sources 
of possible GMO admixture are seed impurities, cross-pollination, volunteers and harvesting 
and  storage  practices.  Another  potential  source  are  food  and  feed  additives,  which  are 
commonly produced from or by GMOs. 

The  former  Regulation  (EEC)  No  2092/9117  contained  the  same  prohibitions  on  GMOs  but 
did not address the issue of unintended presence of traces of GMOs. In the absence of specific 
rules, the horizontal rules of the EU Regulation on Genetically Modified Food and Feed18 thus 
applied  equally  to  products  used  in  organic  farming.  That  Regulation  lays  down  a  general 
labelling threshold of 0.9% for the adventitious or technically unavoidable presence of GMOs 
or products from GMOs19. 

14 

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16 

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19 

The definition of ‘Genetically modified organism (GMO)’ is given in Directive 2001/18/EC. 
Examples: plants and seeds from genetically modified soya and maize. 

‘Produced from GMOs’ means derived in whole or in part from GMOs but not containing or consisting 
of GMOs (Article 2.u). 

Examples:  oil,  starch  or  proteins  from  genetically  modified  soya  or  maize,  not  containing  any 
genetically modified DNA. 

‘Produced  by  GMOs’  means  derived  by  using  a  GMO  as  the  last  living  organism  in  the  production 
process, but not containing or consisting of GMOs nor produced from GMOs (Article 2.v). 
Examples:  food  and  feed  additives  (mainly  vitamins  and  amino-acids)  and  processing  aids  (mainly 
enzymes) produced by genetically modified micro-organisms (such as bacteria and fungi). 

Council  Regulation  (EC) N° 2092/91  of  24  June 1991  on  organic  production  of  agricultural  products 
and indications referring thereto on agricultural products and foodstuffs  

Regulation (EC) n° 1829/2003 of the European Parliament and of the Council of 22 September 2003 on 
genetically modified food and feed OJ L 268, 18.10.2003, p. 1–23, , article 12 (2) 

For seed no threshold is defined. 

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In this sense, the Regulation clarifies that the general rules on unavoidable presence of GMOs 
apply. Moreover it introduces specific provisions in its Article 9 (3) on the responsibility of 
the  organic  operator  for  avoiding  the  presence  of  GMOs  in  organic  products.  The  leading 
principles are to have the lowest possible adventitious presence of GMOs in organic products, 
as set out in recital 10, and at the same time to avoid undue constraints and additional burden 
on organic operators. 

3.1. 

General experience with the prohibition on the use of GMOs 

From the above mentioned questionnaire it appears that supervising the control system on the 
prohibition of the use of GMOs did not pose major problems to the Member States. However, 
feed  is  singled  out  as  a  risk  product  for  adventitious  presence  of  GMOs.  Some  very  low 
findings of authorised GMOs below 0.1% were reported in soya and maize. Operators make 
considerable  efforts  and  take  common  initiatives  to  keep  organic  products  free  from 
adventitious GMO presence. They bear the costs for these preventive actions. 

In  some  Member  States  specific  risk  analysis  and  risk  management  tools  have  been 
developed, which offer a systematic approach for deciding on additional sampling and control 
visits. The Commission will monitor the development of these tools and propose them for EU 
wide application if appropriate. 

Regarding coexistence, the Commission's report to the Council and the European Parliament 
of  2009  on  the  coexistence  of  genetically  modified  crops  with  conventional  and  organic 
farming20  concluded  that  GM  crops  have  not  caused  any  demonstrable  damage  to  existing 
non-GM  farming.  Further,  on  13  July  2010  the  Commission  issued  a  Commission 
Recommendation21  on  guidelines  for  the  development  of  national  co-existence  measures  to 
avoid the unintended presence of GMOs in conventional and organic crops, which recognises 
that  the  potential  loss  of  income  for  producers  of  particular  agricultural  products  such  as 
organic  products  may  occur  as  a  result  of  the  presence  of  GMO  traces  at  levels  even  lower 
than  the  GM  labelling  threshold  set  out  in  EU  legislation  at  0.9 %.  Moreover,  the 
Recommendation  acknowledges  that  the  admixture  of  GMOs  has  specific  implications  for 
producers of particular products such as organic farmers, impacting also the final consumer, 
since such production is often more costly, as it requires stricter segregation efforts to avoid 
GMO  presence  to  guarantee  the  associated  price  premium.  In  this  same  context,  the 
Commission  has  submitted  a  Regulation  proposal  to  the  European  Parliament  and  to  the 
Council which, once adopted, would allow Member States to restrict or prohibit cultivation of 
GMOs on their territory22. 

Recently, the European Court of Justice in joint cases C-58/10 to C-68 Monsanto provided an 
interpretation  of  Regulation  (EC)  No  1829/2003  on  genetically  modified  food  and  feed 
indicating  that  for  a  Member  State  to  adopt  safeguard  measures,  only  Art.  34  of  that 

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COM  (2009)  153  final  of  2.4.2009  Report  from  the  Commission  to  the  Council  and  the  European 
Parliament on the coexistence of genetically modified crops with conventional and organic farming 
http://ec.europa.eu/agriculture/gmo/coexistence/index_en.htm 

Commission Recommendation 2010/C/200/01, OJUE C 200 of 22 July 2010, page 1. 
http://ecob.jrc.ec.europa.eu/documents/CoexRecommendation.pdf 
COM (2010) 375 final of 13.7.2010 Proposal for a Regulation of the European Parliament and of the 
Council amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or 
prohibit the cultivation of GMOs in their territory. 

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Regulation  is  applicable  to  existing  products  previously  authorised  under  Directive 
2001/18/EC. Also, the European Court of Justice (Case 442-09) provided an interpretation of 
Regulation  (EC)  No  1829/2003  as  regards  GM  pollen  in  honey.  The  Commission,  together 
with the Member States, is evaluating the ruling and its impacts, including on co-existence. 

3.2. 

Availability of products not produced by GMOs 

Vitamins,  enzymes  and  amino-acids  used  in  food  processing  are  nowadays  very  often 
produced by genetically modified micro-organisms and can therefore not be used in organic 
production. 

The  Regulation  has  foreseen  within  the  exceptional  production  rules  the  possibility  for  the 
Commission  to  provide  exceptions  to  the  prohibition  of  using  products  produced  by  GMOs 
when it would  be  necessary to  use food  and  feed additives and other  substances that would 
not  be  available  on  the  market  other  than  produced  by  GMOs.  The  Commission  has  not 
granted such exceptions so far. 

However, some substances such as vitamins B2 (riboflavin)  and B 12 (cobalamine) and  the 
enzymes  chymosin  (for  cheese  making)  and  phytase  (for  feed)  are  regularly  reported  as 
available  only  produced  by  GMOs.  Therefore  the  Commission  will  closely  monitor  this 
situation and propose appropriate action if necessary. 

3.3. 

The vendor declaration 

When organic operators buy inputs needed for their production processes, they need to make 
sure that these inputs are not GMOs or products produced from or by GMOs. The Regulation 
stipulates  in  its  article  9  (2)  that  operators  can  rely  on  the  labels  accompanying  products  or 
any other accompanying document, affixed or provided pursuant to Directive 2001/18/EC23, 
Regulation  (EC)  No  1829/200324  or  Regulation  (EC)  No  1830/200325  unless  they  have 
obtained  information  indicating  that  the  labelling  of  the  product  in  question  is  not  in 
conformity  with  those  Regulations  for  instance  when  the  labelling  threshold  of  0,9%  of 
adventitious presence of GMOs is exceeded.  

Products produced by GMOs and products produced from GMOs which are not food or feed 
are  not  covered  by  the  GMOs  legislation  and  therefore  no  labelling  and  traceability 
obligations are imposed on them. Therefore the Regulation provided in its article 9 (3) that the 
organic  operator  has  to  request  in  such  cases  a  confirmation  or  vendor  declaration26  to  be 
signed  by  the  supplier  of  the  products.  In  this  document,  the  vendor  must  declare  that  his 
product has not been produced from or by GMOs. 

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Directive  2001/18/EC  of  the  European  Parliament  and  of  the  Council  of  12  March  2001  on  the 
deliberate  release  into  the  environment  of  genetically  modified  organisms  and  repealing  Council 
Directive 90/220/EEC - Commission Declaration OJ L 106, 17.4.2001, p. 1–39 

Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 
on genetically modified food and feed ; OJ L 268, 18.10.2003, p. 1–23 
Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 
concerning the traceability and labelling of genetically modified organisms and the traceability of food 
and feed products produced from genetically modified organisms and amending Directive 2001/18/EC 
OJ L 268, 18.10.2003, p. 24–28 

The model of the declaration is referred to in article 69 of Regulation (EC) No 889/2008 and included 
in Annex XIII thereof. 

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The vendor declaration represents a commitment of the supplier with legal value. However, 
stakeholders  signal  that  many  companies  do  not  fully  understand  its  function,  may  refuse 
using it, or, on the contrary, sign it very easily. Some Member States also indicate that they 
have  difficulties  to  verify  whether  a  given  declaration  is  reliable  because  of  technical  and 
analytical constraints. 

The  Commission  therefore  considers  that  the  reliability  and  effectiveness  of  the  vendor 
declaration raises some concern and needs to be further examined. 

3.4. 

Feasibility  of  specific  tolerance  thresholds  (for  the  adventitious  or  technically 
unavoidable presence of GMOs) and their impact on the organic sector 

In  their  answers  to  the  above  mentioned  questionnaire,  almost  all  Member  States  and  most 
stakeholders  judge  the  current  legislative  framework  as  providing  sufficient  guarantees 
regarding the prohibition of GMOs in the organic production system. It ensures that products 
marketed without references to GMOs on the label only contain adventitious and unavoidable 
levels  below  0.9 %.  A  few  Member  States,  making  reference  to  the  level  of  detection,  do 
prefer  a  specific  threshold  for  products  used  in  organic  production,  going  from  a  0.1 % 
quantification limit27 up to 0.3 %. 

In about five Member States, there are private certification schemes certifying adventitious or 
technically  unavoidable  presence  of  GMOs  in  organic  products  below  the  general  level  of 
0.9 %. The controls are reported to focus on soya, maize, rapeseed, rice and flax. 

It can be retained that there is a majority of opinions in favour of keeping the same threshold 
of  0.9%  for  the  adventitious  presence  of  GMOs  in  organic  products.  A  specific  threshold 
would increase complexity and costs to be borne by producers and consumers.  

4. 

FUNCTIONING OF THE INTERNAL MARKET AND CONTROL SYSTEM 

A new element of the Regulation that could influence the functioning of the internal market, 
is the obligatory use of the EU logo on all organic products28 produced in the EU applicable 
from 1st July 2010, with a transition period ending by 30 June 2012. Although it is fair to say 
that  its  introduction  was  quite  successful,  with  an  increasing  visibility  on  a  wide  range  of 
products, it is however impossible to assess its impact at this stage. 

The  Member  States  indicate  that  the  control  system  as  applied  in  2009  and  2010  does  not 
cause  significant  problems  to  the  smooth  functioning  of  the  internal  market  for  organic 
products. However,  several Member States and stakeholders  pointed  out that varied reading 
and  interpreting  of  the  EU  legislation  reveal  a  need  for  harmonisation,  and  sometimes 
simplification,  of  the  actual  implementation  of  the  organic  rules  throughout  the  Union.  In 
2010,  there  were  199  Control  Authorities  and  Control  Bodies  in  the  EU  in  charge  of  the 
organic farming control system. 

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Currently 0.1% is the lowest level at which the presence of GMO can reliably be quantified 

Introduced by Commission Regulation (EU) n° 271/2010, OJ L 84 of 31.03.2010 

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In  order  to  improve  transparency  the  Commission  has  adopted  Regulation  (EU)  No 
426/201129 which obliges the Member States to draw up a publicly available updated list of 
operators,  as  from  1  January  2013.  As  regards  cases  of  infringements  and  irregularities,  the 
Commission considers that, although Member States generally take adequate measures, there 
is  room  for  improvement  on  the  exchange  of  information  in  such  cases,  in  particular  as 
regards timeliness and completeness of the notifications. 

Group  certification  for  small  organic  producers  in  tight  cooperation  inside  the  Union  raised 
some  interest  from  Member  States  and  stakeholders,  as  it  facilitates  the  placing  of  their 
products on the market. But all respondents underlined the need to guarantee its capacity to 
safeguard or improve the reliability and the efficiency of the controls. 

The  Commission  recognises  that  the  control  system  can  be  further  improved,  and  will 
continue its work in this direction with the Member States. Given that the Court of Auditors 
has  performed  a  recent  audit  in  respect  of  organic  production  and  labelling  of  organic 
products, of which a report is expected to be published early 2012, the Commission will also 
base itself on the findings of this audit to guide its work on the matter. Commission services 
and Member States are in the process of developing a common understanding of all elements 
of the control system, in particular on the linkage between the specific legislation on organic 
production and the general legislation on official food and feed controls Regulation (EC) No 
882/200430,  and  a  more  active  supervision  of  competent  authorities  both  in  Member  States 
and  in  recognised  third  countries  including  audits  carried  out  by  the  Food  and  Veterinary 
Office.  The  Commission  will  not  hesitate  to  launch  infringement  procedures  when  control 
systems are not complying with the EU legislation. 

5. 

APPLICATION OF THE IMPORT REGIME 

Together with the USA, the EU is the world's leading organic market attracting exports from 
many  third  countries,  representing  together  around  95 %  of  the  world's  organic  sales.  The 
Regulation includes provisions and harmonised procedures for importing organic products on 
the EU market through two possibilities: either in compliance with the EU organic legislation, 
or based on equivalence between standards and control systems. 

Outside  this  import  regime,  other  imports  of  equivalent  organic  products  into  the  EU  are 
based  on  import  authorisations31,  which  are  granted  by  the  Member  States  authorities 
consignment by consignment for a limited period of time. This possibility is transitional and 
to be phased out progressively32. 

5.1. 

Imports under the equivalence regime 

Equivalent,  in  describing  different  systems  or  measures,  means  that  they  are  capable  of 
meeting the same objectives and principles by applying rules which ensure the same level of 

29 
30 

31 
32 

EN 

OJ L 113 of 3.5.2011, p. 1 

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 rules, OJ L 191, 30.4.2004, p. 1–141 

Member States granted 2440 authorisations in 2009 and 3754 in 2010. 

Article 19 of Commission Regulation (EC) n° 1235/2008. 

10 

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assurance  of  conformity33.  Equivalence  agreements  can  encourage  the  development  of 
standards and controls adapted to local conditions. They are encouraged by the World Trade 
Organisation. 

The  specific  Codex  Alimentarius  guidelines34  on  organic  food  constitute  the  international 
point  of  reference  intended  to  facilitate  the  harmonization  of  requirements  for  organic 
products worldwide. 

5.1.1.  Recognition of third countries as providing equivalent guarantees 

The  list  of  recognized  third  countries  comprised  eleven  countries  at  the  moment  of  drafting 
this report. Another seventeen requests are pending. The recognition process is initiated by an 
official  application  lodged  by  the  national  authorities  to  the  Commission.  It  includes  the 
detailed  assessment  of  the  third  country's  organic  standard  and  control  system  to  determine 
whether  they  are  equivalent  to  the  ones  of  the  EU.  This  assessment  requires  significant 
resources. Minor differences may be accepted, but too divergent rules may impose restrictions 
on  the  imports.  Control  measures  must  be  proved  to  be  as  effective  as  inside  the  EU.  The 
Commission also carries out on-the-spot examinations and reviews the list of recognised third 
countries regularly. 

The  Commission  considers  that  once  the  initial  assessment  has  been  successfully  finalised, 
this list of third countries offers the most stable and reliable approach to organic imports, and 
also contributes to stimulate developing countries to engage in setting up their own rules and 
control system. It is the Commission's intention to continue examining the existing requests 
and possible new ones with a view to promote the equivalence concept at world level. 

However,  the  time  needed  for  the  assessments  performed  so  far  shows  that  this  task  is 
complex  and  requires  highly  technical  expertise.  While  the  Commission  can  call  on  co-
reporting  Member  States  to  help  perform  assessments  and  on-the-spot  visits,  it  is  however 
clearly  not  sufficient  to  meet  the  resources  needed  to  cover  the  whole  process  and  for  the 
subsequent  monitoring  of  the  list.  The  Commission  will  study  further  streamlining  of  the 
procedures  used  and  may  propose  ways  of  simplification  and  reinforcement  of  the 
supervision. In the meantime, the Commission is intensifying its efforts to treat the pending 
requests. It must be noted that imports from the third countries in question, are not affected 
because  they  now  take  place  via  import  authorisations  granted  by  the  Member  States  (see 
above)  and  in  future  they  will  be  possible  via  the  recognition  of  control  bodies  and  control 
authorities in third countries, as described below. 

5.1.2.  Recognition  of  control  bodies  and  control  authorities  as  providing  equivalent 

guarantees 

Regarding  imports  of  organic  products  from  third  countries  that  are  not  recognised,  the 
Commission started to implement the recognition of equivalence for control bodies with the 
opening of applications from 2008. By the first deadline of 31 October 2009 the Commission 
received  73 applications from  control bodies and control authorities all over the world. The 
Commission  assessed  the  technical  dossiers  prepared  by  the  applicants;  in  most  cases  it 

33 
34 

EN 

Regulation (EC) No 834/2007, article 2(x) 

Codex  CAC/GL  32  -  1999  Guidelines  for  the  production,  processing,  labelling  and  marketing  of 
organically produced foods. 

11 

   EN 

 
                                                 
needed to request additional information from the applicants, which made the process longer. 
The  first  list  of  recognised  control  bodies  adopted  by  the  Commission35  will  be  regularly 
updated. It will be applicable from 1st July 2012. 

The  Commission  considers  that  the  list  of  control  authorities  and  control  bodies  could  also 
offer a reliable approach to imports, provided adequate supervision is ensured to guarantee the 
correct functioning of the regime. In particular, whereas Member States competent authorities 
are  responsible  for  the  controls  on  all  imported  organic  products  from  their  release  for  free 
circulation in the EU territory, it will become essential that the Commission reacts in a timely 
manner to  possible deficiencies in the functioning of a  listed control body and withdraws it 
from the list if the requirements are no longer met. 

This  regime  being  new  and  not  yet  operational  no  conclusion  can  be  drawn  at  this  stage. 
However, from the experience gained with the functioning of the Regulation, it is clear that 
implementing this part of the import regime and ensuring appropriate supervision will create a 
substantial additional workload for the Commission. 

As  regards  the  supervision  of  the  import  regime  in  general,  the  feasibility  of  applying 
precautionary measures by the Commission to allow known or emerging risks to be countered 
more effectively should be explored,  taking account of measures foreseen in the Regulation 
itself, and in other parts of European law applicable to controls36. 

5.2. 

Imports under the compliance regime 

Under  the  compliance  regime  a  non-EU  operator  has  to  fulfil  all  the  requirements  of  EU 
legislation, including all detailed production rules and labelling. In contrast to the equivalence 
regime, the rules followed must be identical, and not merely equivalent, to the ones applicable 
in the EU. The operator must be subject to controls by a control body or a control authority 
recognised for the purpose of compliance by the Commission. 

The compliance regime has not been activated yet. The Commission fixed the deadline for the 
receipt  of  first  applications  from  control  authorities  and  control  bodies  at  31  October  2014, 
thus giving time to the equivalence regime to develop. 

Based on the experience gained so far, it is doubtful that the compliance regime will provide 
for  better  access  to  the  EU  market  and  will  bring  additional  benefit  to  the  EU's  trading 
partners compared to what is already provided by the equivalence regime. It will neither bring 
significant benefit for the consumers regarding the corresponding imported organic products, 
which  cannot  be  distinguished  on  the  market.  Moreover,  the  system  creates  an  additional 
administrative workload comparable to the equivalence system without any additional benefit. 
The  Commission  therefore  prefers  concentrating  its  efforts  on  equivalence  rather  than  on 
compliance,  whose  usefulness  and  efficiency  need  to  be  reconsidered  together  with  trading 
partners, in the light of current and future organic trade activities. 

35 

36 

Commission implementing Regulation (EU) n° 1267/2011 of 6 December 2011, OJ L 324, 7.12.2011, 
p. 9 

Regulation  (EC)  No  882/2004  and  Commission  Regulation  (EC)  No  669/2009  of  24  July  2009 
implementing Regulation (EC) No 882/2004 of the European Parliament and of the Council as regards 
the  increased  level  of  official  controls  on  imports  of  certain  feed  and  food  of  non-animal  origin  and 
amending Decision 2006/504/EC, OJ L 194, 25.7.2009, p. 11–21 

EN 

12 

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5.3. 

Certificate of inspection 

The  release  for  free  circulation  in  the  EU  of  a  consignment  of  organic  products  under  the 
equivalence  regime  is  conditional  on  the  submission  of  an  original  certificate  of  inspection 
delivered  by  a  control  body  or  a  control  authority  supervised  either  by  a  recognised  third 
country  or  the  Commission  or  a  Member  State's  competent  authority  (under  the  regime  of 
import  authorisations).  At  importation  into  the  EU,  the  consignment  is  checked  against  the 
information  contained  in  the  certificate  of  inspection,  in  particular  markings  and  batch 
numbers  identifying  the  organic  products,  and  the  certificate  is  endorsed  by  Customs.  The 
certificate  of  inspection  thus  constitutes  a  key  element  in  the  traceability  of  each  batch  of 
organic products from the third country producer to the EU importer, traceability that can be 
used to track the onwards distribution of the product in the EU in case the withdrawal from 
the market becomes necessary. 

Operators  consider  the  obligation  to  submit  an  original  certificate  of  inspection  as 
burdensome due to the potential delays caused by the time needed for forwarding the original 
certificate and call for the possibility of submitting electronic certificates of inspection. Some 
Member States who clear a large percentage of all EU imports have signalled their interest in 
investigating  the  feasibility  of  electronic  certificates  made  available  through  a  secured 
database for control, clearance and supervision purposes to Member State authorities and the 
Commission.  The  Commission  intends  to  examine  the  feasibility  of  introducing  such  a 
system,  which  would  offer  faster  clearance  to  operators  and  provide  key  data  on  import 
transactions  to  the  Commission  for  its  supervision  of  control  bodies  in  third  countries. 
Importantly, such a system would also facilitate quick response by Member States in cases of 
infringement by blocking non compliant products. 

6. 

CONCLUSIONS 

This report has reviewed the limited experience gained with the application of the Regulation 
since 2009, from which the Commission draws the following conclusions: 

(a) 

(b) 

There  is  currently  no  objective  need  to  extend  the  scope  of  the  Regulation  to  mass 
caterers. The organic labelling of textiles and cosmetics could possibly be given an 
adequate protection of consumers and producers interest through other instruments. It 
is  preferable  to  deepen  the  regulatory  and  control  aspects  for  agricultural  products 
rather than to expand the scope to more products and sectors. 

While  the  prohibition  on  the  use  of  GMOs  in  organic  production  is  correctly 
implemented,  the  vendor  declaration  needs  to  be  further  re-examined  and  the 
availability  of  some  products  in  non-GM  version  to  be  followed  up.  Preventive 
measures  and  harmonised  actions  are  preferred  to  a  specific  GMO  threshold  for 
organic  products,  which  does  not  seem  to  be  justified  under  current  circumstances. 
On  co-existence,  further  guidance  to  Member  States  has  been  provided  on  13  July 
2010,  when  the  Commission  issued  a  Commission  Recommendation  on  guidelines 
for  the  development  of  national  co-existence  measures  to  avoid  the  unintended 
presence  of  GMOs 
in  conventional  and  organic  crops.  However,  recent 
developments need to be analysed. 

EN 

13 

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(c) 

The  control  system  in  most  cases  suited  the  functioning  of  the  internal  market; 
however it still shows some weaknesses in its application. Further work needs to be 
undertaken in order to make it more performing. 

Moreover,  while  progress  has  been  made  in  the  implementation  of  the  new  import  regime 
based  on  equivalence,  some  streamlining  is  desirable  and  the  usefulness  of  activating  the 
compliance regime is put into question. 

The Commission believes that it is too early to add proposals to change the Regulation to this 
Report, especially at the time when the corresponding proposal for its alignment to the Lisbon 
Treaty37 is still discussed in the Parliament and the Council. With this report, the Commission 
aims  at  providing  factual  elements  which  can  guide  a  constructive  debate  on  the  organic 
farming  Regulation.  Following  up  on  this  debate,  the  Commission  may  come  forward  with 
legal proposals at a later stage. 

For making such debate most constructive, and with a view to facilitate citizens' involvement, 
the  Commission  considers  that  topics  like  the  simplification  of  the  legislative  framework  -
while  at  the  same  time  ensuring  that  the  standards  are  not  watered  down-,  coexistence  of 
genetically modified crops in particular with organic farming, the improvement of the control 
system  and  of  the  equivalence  regime  in  trade of  organic  products  are  key  issues  for  future 
reflections about organic agriculture.  

The  Commission  invites  the  European  Parliament  and  the  Council  to  discuss  the  issues 
highlighted in this Report and welcomes feedback from other stakeholders. 

37 

COM(2010) 759 final of 17.12.2010 

EN 

14 

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ANNEX 

Suggestion  of  issues  to  address  in  the  framework  of  the  discussion  on  the  Report  from  the 
Commission  to  the  European  Parliament  and  the  Council  on  the  application  of  Council 
Regulation (EC) No 834/2007 on organic production and labelling of organic products 

1. 

2. 

3. 

4. 

5. 

Could  the  legislative  framework  be  simplified  and  how,  at  the  same  time  ensuring 
that the standards are not watered down? 

What measures should be taken in order to ensure that co-existence is respected and 
that the standards of organic production can be fulfilled by any farmer who opts for 
this sector? 

Is  there  a  need  to  revise  current  production  standards  and  go  for  stricter  rules,  for 
instance in relation to  the availability  of  organic  young  animals,  feed  and  seed  and 
other elements? If yes, what to propose to farmers or regions not able to fulfil such 
new conditions? Would regionalised flexibility be compatible with fair competition 
conditions? Would controls be feasible? 

Controls are based on physical inspections of each operator along the food chain at 
least  once  a  year.  Operators  must  be  attested  by  independent  certifiers.  How  could 
the control system be improved? 

In line with the European Action Plan38, the Commission has promoted equivalence 
in  trade  of  organic  products,  recognising  either  third  countries  or  control  bodies. 
Should  equivalence  be  the  unique  concept  for  trading  organic  products?  In  recent 
years the Commission has also achieved reciprocal recognition from third countries 
recognised equivalent by the EU. Should this approach be enhanced with a view to 
better defend offensive interest of the EU? 

38 

COM  (2004)  415  final  of  10.06.2004,  COMMUNICATION  FROM  THE  COMMISSION  TO  THE 
COUNCIL  AND  THE  EUROPEAN  PARLIAMENT  European  Action  Plan  for  Organic  Food  and 
Farming 

EN 

15 

   EN