Special Report No 9/2012 ‘Audit of the control system governing the production, processing, distribution and imports of organic products’
Date: 2012-06-27
Institutions: European Court of Auditors
Subjects: aid to agriculture, consumer information, labelling, market supervision, organic farming, organic product, regulation of agricultural production, tax system

EUROPEAN
COURT OF AUDITORS

4
3
8
0
-
1
3
8
1
N
S
S

I

2
1
0
2

9
o
N

t
r
o
p
e
R

l

a
i
c
e
p
S

AUDIT OF THE CONTROL SYSTEM GOVERNING 

THE PRODUCTION, PROCESSING, DISTRIBUTION 

AND IMPORTS OF ORGANIC PRODUCTS

EN

 
 
 
 
Special Report No 9 

 2012

AUDIT OF THE CONTROL SYSTEM 
GOVERNING THE PRODUCTION, 
PROCESSING, DISTRIBUTION AND 
IMPORTS OF ORGANIC PRODUCTS

(pursuant to Article 287(4), second subparagraph, TFEU)

EUROPEAN COURT OF AUDITORS

EUROPEAN COURT OF AUDITORS
12, rue Alcide De Gasperi
1615 Luxembourg
LUXEMBOURG

Tel. +352 4398-1
Fax +352 4398-46410
E-mail: eca-info@eca.europa.eu
Internet: http://eca.europa.eu

Special Report No 9 

 2012

A great deal of additional information on the European Union is available on the Internet.
It can be accessed through the Europa server (http://europa.eu).

Cataloguing data can be found at the end of this publication.
Luxembourg: Publications Office of the European Union, 2012

ISBN 978-92-9237-669-7
doi:10.2865/50111

© European Union, 2012
Reproduction is authorised provided the source is acknowledged.

Printed in Luxembourg

3

CONTENTS

Paragraph

GLOSSARY

ABBREVIATION	LIST

I–VII	

EXECUTIVE	SUMMARY

1–19	

INTRODUCTION

1–2	

3–4	

5–9	

ORGANIC	PRODUCTION	IN	THE	EU

FINANCIAL	SUPPORT	TO	ORGANIC	FARMING	IN	THE	EU

LEGAL	FRAMEWORK

10–14	

THE	CONTROL	SYSTEM	FOR	ORGANIC	PRODUCTION

15–19	

IMPORT	OF	ORGANIC	PRODUCTS	FROM	THIRD	COUNTRIES

20–24	

THE	AUDIT

20–22	

THE	AUDIT	SCOPE

23	

24	

THE	AUDIT	APPROACH

PREVIOUS	AUDITS

25–79	

OBSERVATIONS

25–54	

IMPLEMENTATION	OF	CONTROL	PROCEDURES	GOVERNING	THE	ORGANIC	PRODUCTION	WITHIN	THE	EU

25–37 

WEAKNESSES FOUND IN MEMBER STATES’ PRACTICES WHEN APPROVING AND SUPERVISING CONTROL BODIES

38–45 

 INSUFFICIENCIES FOUND IN THE EXCHANGE OF INFORMATION WITHIN MEMBER STATES, WITH THE 
COMMISSION AND WITH OTHER MEMBER STATES

46–49 

DIFFICULTIES ENCOUNTERED FOR ENSURING THE TRACEABILITY OF THE PRODUCTS

50–54 

 ACTION TAKEN BY THE COMMISSION TO ENSURE PROPER FUNCTIONING OF THE MEMBER STATES’ CONTROL 
SYSTEMS WAS FOUND TO BE INSUFFICIENT

55–79	

IMPLEMENTATION	OF	CONTROL	PROCEDURES	FOR	IMPORTING	PRODUCTS

55–64 

WEAKNESSES FOUND IN THE MANAGEMENT OF THE LIST OF EQUIVALENT THIRD COUNTRIES

65–77 

WEAKNESSES FOUND IN THE MANAGEMENT OF THE IMPORT AUTHORISATION REGIME

78–79 

 COMMON PROVISIONS ON IMPORTS — INCOMPLETE CHECKS CARRIED OUT BY CONTROL BODIES ON 
IMPORTERS

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

	
	
4

80–86	

CONCLUSIONS	AND	RECOMMENDATIONS

ANNEX	I	 —	 TRACEABILITY	EXERCISE	—	METHODOLOGY

ANNEX	II	 —	 LABORATORY	TESTS	—	METHODOLOGY

ANNEX	III	 —	

	OBSERVATIONS	CONTAINED	IN	SPECIAL	REPORT	NO	3/2005	CONCERNING	
MEMBER	STATES’	REPORTING	ON	ORGANIC	FARMING	TOGETHER	WITH	AN	
ASSESSMENT	OF	THE	CURRENT	SITUATION

REPLY	OF	THE	COMMISSION

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

	
	
	
GLOSSARY

5

Accreditation	body: A public or private body that gives a formal recognition that a control body is compe-
tent to carry out inspection and certification according to organic standards. In the European Union, organic 
control bodies have to be accredited to European Standard EN 45011 or ISO Guide 65. 

Additional	control	visit: Control visit by a control body of an operator in addition to the compulsory annual 
control visit for that operator.

Competent	authority: The central authority of a Member State competent for the organisation of official con-
trols in the field of organic production, or any other authority to which that competence has been conferred. 
It shall also include, where appropriate, the corresponding authority of a third country.

Control	body: An independent private third party carrying out inspection and certification in the field of 
organic production. 

Non-compliance: An instance where a particular standard or certification requirement is not being met.

Operator: An individual or business enterprise that is producing, storing, processing, transporting, exporting 
or importing organic products.

Organic	production: An overall system of farm management and food production that aims at sustainable 
agriculture, the production of high-quality products and the use of processes that do not harm the environ-
ment, human, plant or animal health and animal welfare. 

Recognised	control	body	for	the	purpose	of	compliance: Control body operating in a third country recog-
nised by the Commission as able to guarantee that the objectives and principles for organic production, and 
the production and labelling rules in the third country are the same as those applied to organic production 
and labelling in the EU. 

Recognised	control	body	for	the	purpose	of	equivalence: Control body operating in a third country rec-
ognised by the Commission as able to guarantee that the production and labelling rules in the third country, 
as well as the control measures applied to the operators in the third country are equivalent to those applied to 
organic production and labelling in the EU.

Recognised	equivalent	third	country: Third country recognised by the Commission as complying with pro-
duction rules and control standards equivalent to those applied to organic production in the EU, and thereby 
capable of meeting the same objectives and principles by applying rules which ensure the same level of assur-
ance of conformity.

Residue	testing: Laboratory analysis of organic products in order to test for the presence of substances not 
authorised for organic production or for checking production techniques not in conformity with the organic 
production rules, such as the use of synthetic pesticides and fertilisers, antibiotics, certain food additives and 
processing aids.

Stages	of	production,	preparation	and	distribution: Any stage from and including the primary production 
of an organic product up to and including its storage, processing, transport, sale or supply to the final con-
sumer, and where relevant labelling, advertising, import, export and subcontracting activities.

Traceability: The  ability  to  trace  and  follow  a  food,  feed,  food-producing  animal  or  substance  intended 
to  be,  or  expected  to  be  incorporated  into  a  food  or  feed,  through  all  stages  of  production,  processing 
and distribution.

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

ABBREVIATION LIST

6

EAFRD: European Agricultural Fund for Rural Development

FVO: Food and Veterinary Office of the European Commission

GMO: genetically modified organisms

MANCP: multiannual national control plan

OFIS: Organic Farming Information System

SCOF: Standing Committee on Organic Farming

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

7

EXECUTIVE SUMMARY 

I.
Organic production is an overall system of farm man-
agement and food production that aims at sustainable 
agriculture, the production of high-quality products 
and the use of processes that do not harm the envir-
onment, human, plant or animal health and animal 
welfare. The organic market has rapidly developed 
and experienced annual growth rates of more than 
10 % in the last two decades. The European market for 
organic food amounts to about 20 billion euro annu-
ally, representing an estimate of 1,5 % share of the 
entire food market.

II.
The  EU  legal  framework  governing  the  sector  of 
organic production aims at providing the basis for 
the sustainable development of organic production 
while guaranteeing fair competition, ensuring con-
sumer confidence and protecting consumer interests 
and ensuring the effective functioning of the internal 
market. To that end, a control system has been set up 
that covers all stages of the organic supply chain, such 
as production at farm level, food processing, distri-
bution, import and retailing activities. Each operator 
in this chain has to respect the same set of rules on 
organic production, processing, distribution, labelling 
and controls.

III.
The  Cour t ’s  audit  focused  on  the  effectiveness  of 
the control system and how the various institutions 
involved (the Commission and competent authorities, 
accreditation bodies and control bodies in Member 
States) have carried out their responsibilities both for 
the control system within the EU and when managing 
the import regimes currently in operation. 

IV.
The overall audit question addressed was: Does the 
control  system  for  organic  products  provide  suffi-
cient assurance that the key requirements for organic 
production,  processing,  distribution  and  impor ts 
are fulfilled?

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

8

EXECUTIVE SUMMARY

V.
The control system for organic products as set out in 
the EU regulations aims at guaranteeing the produc-
tion processes but not the organic character of the 
products themselves. This is because there is no sci-
entific way to determine whether a product is organic 
or not. The Court considers that, in order to provide 
sufficient assurance that the system is operating effec-
tively and to ensure that consumer confidence is not 
undermined, it would be appropriate to remedy the 
weaknesses highlighted by the Court’s audit. 

VII.
On the basis of the weaknesses found the Court makes 
the following recommendations: 

(a)  competent  authorities  should  strengthen  their 
supervisory role over control bodies by applying 
appropriate documented procedures for approv-
ing and supervising control bodies, by promoting 
harmonisation in the definition of infringements, 
irregularities and corresponding sanctions, and by 
promoting identified good practices;

VI.
Based on the results of this audit, the Court concluded 
that: 

(a)  a number of competent authorities do not suf-
ficiently fulfil their supervisory role over control 
bodies. As a result certain control bodies fail to 
satisfy a number of EU requirements and fail to 
take the opportunity to implement certain good 
practices;

(b)  the  exchange  of  information  within  Member 
States and from Member States to the Commis-
sion and other Member States is not yet adequate 
to ensure that the system is operating correctly;

(c)  competent authorities in Member States encoun-
ter difficulties in ensuring the traceability of the 
organic products within the territory for which 
they have authority. Traceability is even more dif-
ficult to achieve for products crossing borders;

(d)  the Commission has not given enough priority to 
supervision activities, including audits, to ensure 
the proper functioning of the Member States’ con-
trol systems; 

(e)  the Commission does not have sufficient informa-
tion  to  satisfy  itself  that  the  control  system  for 
organic production in third countries recognised 
as  equivalent  continues  to  fulfil  the  regulatory 
requirements  as  long  as  they  keep  this  status. 
The Court further notes that there is a significant 
backlog in assessing applications for equivalence 
from third countries;

(f )  weaknesses exist in the system used for granting 

import authorisations.

(b)  the  exchange  of  information  within  Member 
States,  between  Member  States  and  the  Com-
mission and between Member States should be 
improved in order to ensure high-quality controls 
and supervision;

(c)  controls should be strengthened to ensure that 
operators fulfil the regulatory requirements re-
garding traceability; in this regard the Commis-
sion should clarify the roles and responsibilities 
of the different actors;

(d)  the Commission should strengthen its monitoring 
of Member States’ control systems by undertaking 
audit missions and gathering and exploiting the 
necessary data and information; 

(e)  as regards imports, the Commission should ensure 
adequate supervision of the countries included in 
the list of those recognised as being equivalent 
for organic production and carry out a timely as-
sessment of the applications from third countries 
applying to be included in that list;

(f )  the Court welcomes the simplification implicit in 
the Commission initiative of phasing out the im-
port authorisations regime. However, as long as 
this regime is in operation Member States should 
ensure its correct application. Competent authori-
ties in Member States should reinforce the checks 
carried out on control bodies authorised to issue 
certificates of inspection.

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

INTRODUCTION

9

ORGANIC	PRODUCTION	IN	THE	EU

1. 

Organic production is an overall system of farm management and food 
production that aims at sustainable agriculture, the production of high-
quality products and the use of processes that do not harm the envi-
ronment, human, plant or animal health and animal welfare. Organic 
products are thus produced according to a specific set of rules, such as 
crop rotation, the prohibition of the use of genetically modified organ-
isms and very strict limits on chemical synthetic pesticide and synthetic 
fertiliser use, livestock antibiotics, food additives and processing aids. 
Organic products, being considered premium products, are generally 
sold at higher prices than conventional products.

FIGURE	1

EUROPEAN	MARKET	FOR	ORGANIC	FOOD	AND	DRINK:	THE	10	EU	
COUNTRIES	WITH	THE	HIGHEST	SALES	IN	2009	(BILLION	EURO)

5,80

3,04

2,07

1,50

Germany

France

United Kingdom

Italy

Spain

Austria

Denmark

Sweden

0,91

0,87

0,77

0,70

Netherlands

0,59

Belgium

0,35

0,00

1,00

2,00

3,00

4,00

5,00

6,00

Source: Willer, H., Organic agriculture in Europe 2009: production and market. 
http://orgprints.org/18365/2/willer-2011-european-market.pdf

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

2. 

The  organic  market  has  developed  rapidly  and  experienced  annual 
growth rates of between 10 and 15 % in the last two decades1. The EU 
is one of the main producers and consumers of organic products in the 
world. In the period 2000–08, the total organic area2 in the 27 Member 
States  of  the  EU  (EU-27)  increased  by  an  average  of  7,4  %  yearly.  In 
2008, it amounted to 4,3 % of the utilised agricultural area (UAA), i.e. an 
estimated 7,6 million ha of land. It is estimated that in the same year 
there were about 197 000 holdings involved in organic agriculture in 
the EU-273. Around 15 % of the organic products consumed in Europe 
are imported from non-EU countries, mainly products that are not or 
are rarely grown in the EU (coffee, bananas, cotton, etc.)4. The European 
market for organic food amounts to about 20 billion euro5 annually, rep-
resenting an estimate of 1,5 % share of the entire food market6. Figure 1 
shows the EU Member States with the highest sales of organic food and 
drink7 and Figure 2 shows the EU Member States with the most organic 
agricultural land.

FIGURE	2

THE	10	EU	MEMBER	STATES	WITH	THE	MOST	ORGANIC	
AGRICULTURAL	LAND	(IN	CONVERSION	AND	FULLY	
CONVERTED)	IN	2009	(1	000	HA)

10

1  Source: http://ec.europa.
eu/agriculture/organic/
consumer-confidence/
consumer-demand_en

2  Fully converted and in 
conversion.

3  Source: An analysis of the 
organic sector, June 2010, 
European Commission. Data 
are for 2008 and for the 
EU-27.

4  There is no consolidated 
statistical evidence 
supporting this since EU 
trade databases do not 
distinguish organic and 
conventional agricultural and 
food products.

5  Source: Willer, H., Organic 
agriculture in Europe 2009: 
production and market. 
http://orgprints.org/18365/2/
willer-2011-european-
market.pdf

6  Source: Research Institute 
of Organic Agriculture 
(FiBL), Agricultural Market 
Information Service (AMI) 
(Agrarmarkt Informations-
Gesellschaft), Bonn, Germany. 
Data are for 2008. 

7  Organic food is just one 
type of organic product. 
Other organic products 
are for instance organic 
cosmetics, organic textiles 
and organic pet food. 

1 331

1 107

947

1 400

1 200

1 000

800

600

400

200

0

722

678

519

398

392

367

326

Spain

Italy Germany United 
Kingdom

France Austria

Czech 
Republic

Sweden Poland Greece

Source: Willer, H., Organic agriculture in Europe 2009: production and market. 
http://orgprints.org/18365/2/willer-2011-european-market.pdf

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

11

8  According to the estimates 
based on monitoring data 
provided by Member States in 
the framework of the annual 
progress reports. 

9  Article 68 of 
Council Regulation  
(EC) No 73/2009 of 
19 January 2009 establishing 
common rules for direct 
support schemes for 
farmers under the common 
agricultural policy and 
establishing certain support 
schemes for farmers, 
amending Regulations 
(EC) No 1290/2005, 
(EC) No 247/2006, 
(EC) No 378/2007 and 
repealing Regulation 
(EC) No 1782/2003 
(OJ L 30, 31.1.2009, p. 16). As 
of 15 March 2012, 348 million 
euros were planned under 
this article for 2010–13. 
No available figures exist 
concerning the indirect 
EAFRD support. 

3. 

4. 

5. 

FINANCIAL	SUPPORT	TO	ORGANIC	FARMING		
IN	THE	EU

The EU financially supports organic farming practices through the agri-
environment payments under the European Agricultural Fund for Rural 
Development (EAFRD). The agri-environment payments are generally 
implemented through contracts between a public body in the Mem-
ber States and a beneficiary (farmer or land manager). These contracts 
commit the beneficiary to apply specific farming practices. One of the 
farming practices beneficiaries may opt for is organic farming. By the 
end of 2010, public support commitment for organic agriculture under 
the agri-environment measures amounted to more than 690 million euro 
(EU-27)8. EAFRD support represents 58 % of total public support while 
the remainder is comprised of national contributions. 

Organic  production  can  also  be  suppor ted  indirectly  through  oth-
er  measures  from  the  EAFRD  (such  as  modernisation  of  agricultural 
holdings, training etc.) or through specific support9. Certain Member 
States have prioritised giving aid to holdings or projects developing 
organic production. 

LEGAL	FRAMEWORK

The  EU  legal  framework  governing  the  sector  of  organic  production 
aims at providing the basis for the sustainable development of organic 
production while guaranteeing fair competition, ensuring consumer 
confidence and protecting consumer interests and ensuring the effec-
tive functioning of the internal market. 

picture 1 — examples of organic production 

© European Union. 
Source: European Court of Auditors.

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

6. 

Organic production covers all stages of the supply chain, such as pro-
duction at farm level, food processing, distribution and retailing activi-
ties. Each operator in this chain has to respect the same set of rules on 
organic production, processing, distribution, labelling and controls. In 
the EU, these rules are laid down in several regulations: 

—  Council Regulation (EC) No 834/2007 of 28 June 2007 on organic 
production and labelling of organic products and repealing Regula-
tion (EEC) No 2092/9110;

—  Commission Regulation (EC) No 889/2008 of 5 September 2008 
laying down detailed rules for the implementation of Council Regu-
lation (EC) No 834/2007 on organic production and labelling of 
organic products with regard to organic production, labelling and 
control11;

—  Commission Regulation (EC) No 1235/2008 of 8 December 2008 
laying down detailed rules for implementation of Council Regula-
tion (EC) No 834/2007 as regards the arrangements for imports of 
organic products from third countries 12.

Moreover, organic food must comply with the General Food Law (Regula-
tion (EC) No 178/200213), and organic production falls within the scope 
of Regulation (EC) No 882/200414, which is the more general legislation 
on official food and feed controls15.

picture 2 — the eu organic farming logo

© European Union.
Source: Commission Regulation (EU) No 271/2010 of 24 March 2010 amending Regulation (EC) No 889/2008 
laying down detailed rules for the implementation of Council Regulation (EC) No 834/2007, as regards the 
organic production logo of the European Union (OJ L 84, 31.3.2010, p. 19).

12

10  OJ L 189, 20.7.2007, 
p. 1. The regulation was 
amended by Regulation 
(EC) No 967/2008 
(postponing the obligatory 
use of the EU organic logo)  
(OJ L 264, 3.10.2008, p. 1).

11  OJ L 250, 18.9.2008, 
p. 1. The regulation was 
amended by Regulation 
(EC) No 1254/2008 
(introducing new rules on 
organic yeast production) 
(OJ L 337, 16.12.2008, p. 80).

12  OJ L 334, 12.12.2008, 
p. 25. The regulation was 
amended by Regulation 
(EC) No 537/2009 
(OJ L 159, 20.6.2009, p. 6), 
Regulation (EU) No 471/2010 
(OJ L 134, 1.6.2010, p. 1) and 
Implementing Regulation 
(EU) No 590/2011 (OJ L 161, 
21.6.2011, p. 9).

13  Regulation (EC) 
No 178/2002 of the European 
Parliament and of the Council 
of 28 January 2002 laying 
down the general principles 
and requirements of food law, 
establishing the European 
Food Safety Authority and 
laying down procedures 
in matters of food safety 
(OJ L 31, 1.2.2002, p. 1).

14  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 165, 30.4.2004, p. 1).

15  Organic food must also 
comply with the specific 
legislation applicable to the 
relevant commodity, such as 
Regulation (EC) No 852/2004 
on the hygiene of foodstuffs, 
Regulation (EC) No 853/2004 
laying down specific hygiene 
rules for food of animal 
origin, or Regulation (EC) 
No 1760/2000 establishing 
a system for the identification 
and registration of bovine 
animals and regarding the 
labelling of beef and beef 
products, to name but a few.

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

 
7. 

8. 

9. 

10. 

13

In the EU, organic products can thus be certified ‘organic’ and labelled as 
such when the production rules are compliant with the requirements of 
the abovementioned EU regulations. The placement of the EU logo has 
been mandatory since 1 July 2010 for pre-packaged food. It is voluntary 
for imported products.

16  Version of 8 July 2011 — 
Presented in the SCOF on 
27 and 28 September 2011.

17  See also paragraphs 32 
and 33.

In line with Article 37 of Regulation (EC) No 834/2007, the Commission 
has set up the Standing Committee on Organic Farming (SCOF). The 
SCOF is the Commission’s regulatory committee on organic production, 
chaired  by  the  Commission  and  composed  of  representatives  of  the 
Member States. Its aim is to ensure that the European Commission’s re-
sponsibility for the implementation of secondary legislation is exercised 
in close consultation with the governments of the Member States.

The Commission, in cooperation with the Member States, has finalised 
the ‘Working document of the Commission services on official controls in 
the organic sector’16. This document, even though it is not legally bind-
ing, shows the Commission’s efforts to develop more concrete guidelines 
to Member States when implementing the regulations governing organic 
production.

THE	CONTROL	SYSTEM	FOR	ORGANIC	PRODUCTION

A control system has been put in place that verifies and certifies for 
each operator in the supply chain (farmers, processors, importers) the 
correct application of the production rules. The control system aims at 
guaranteeing the production processes and not the products themselves 
since there is no scientific way to determine whether a product is or-
ganic or not17. The market for organic products is highly dependent on 
consumers’ confidence and therefore upon this certification system to 
give a guarantee of genuine organic products. According to the Commis-
sion, consumers should be sure that, for example, every time they buy 
an organic apple or a piece of organic beef from their local supermarket, 
they were produced according to strict rules aimed at respecting the 
environment and animals.

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

14

The EU legal framework establishes that Member States set up a system 
of controls (see Figure 3). The Commission is responsible for auditing 
Member States’ control systems. 

Member States may opt for setting up a public, private or mixed control 
system and they designate one or more competent authorities respon-
sible for controls. The competent authority designates, depending on the 
system chosen: public control authorities; private control bodies; or a mix 
of the two. The majority of the Member States (18) have adopted a sys-
tem of private control bodies while five Member States have designated 
public control authorities and four have a mixed system of a designated 
public control authority and approved private control bodies. Competent 
authorities are responsible for approving and supervising control bodies 
and control authorities. Competent authorities are required to organise 
audits or inspections of control bodies as necessary and, where needed, 
withdraw approval of control bodies that fail to satisfy the requirements.

11. 

12. 

FIGURE	3

INSTITUTIONS	AND	BODIES	OPERATING	IN	THE	CONTROL	
SYSTEM	FOR	ORGANIC	PRODUCTS

European organic standard
Council Regulation (EC) No 834/2007 and
Commission Regulation (EC) No 889/2008

European Commission

National government/ministry (Member State)

Competent national authority/(federal) authorities

Accreditation body

Control body/control authority

Organic operator

Source: ‘Economic concepts of organic certification’ 29.7.2009, Certcost — Economic analysis of 
certification systems in organic food and farming.

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

15

13. 

14. 

Where a Member State chooses a system with private control bodies, 
these bodies need to be accredited 18. Each EU Member State has ap-
pointed a single national accreditation body. The checks performed by 
these accreditation bodies concern the technical competence, the inde-
pendence, the impartiality and the professional integrity of the control 
bodies. Public control authorities do not need to be accredited.

18  According to the 
most recent version of 
the European Standard 
EN 45011 or ISO Guide 65 
(General requirements for 
bodies operating product 
certification systems).

Control bodies (or control authorities as they are known in public sys-
tems)  are  the  central  element  of  the  control  system. They  carr y  out 
checks at the level of the individual operators. Consumers, Member State 
authorities and the Commission rely to a large extent on the work of 
these bodies. Typical checks performed on organic operators include 
physical inspections of the production or processing premises, verifica-
tion of the documentary accounts as well as sampling of final products, 
harvested products, leaves or soil for testing the use of non-authorised 
substances. The certificates issued by control bodies are paid for by the 
individual operators.

IMPORT	OF	ORGANIC	PRODUCTS	FROM	
THIRD COUNTRIES

15. 

For organic products produced outside the EU, four different import 
regimes are foreseen by Regulation (EC) No 834/2007 (see Table 1); how-
ever, only two of them were in operation at the time of the audit. 

TABLE	1

IMPORT	REGIMES	FORESEEN	BY	REGULATION	(EC)	NO	834/2007

Import regime

Managed by

In operation at the time  
of the audit

List of recognised equivalent 
third countries 

List of recognised control 
bodies/authorities for the 
purpose of equivalence

List of recognised control 
bodies/authorities for the 
purpose of compliance

the European Commission

Yes

the European Commission

the European Commission

No — First list of equivalent 
control bodies not published by the 
Commission at the time of the audit. 

No — Deadline for receiving 
applications to draw up the first list 
postponed until 31 October 2014.

Import authorisations 

Member States

Yes

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

16

19  Council Regulation (EEC) 
No 2083/92 (OJ L 208, 
24.7.1992, p. 15) allowed 
import authorisations 
until 31 July 1995; Council 
Regulation (EC) No 1935/95 
(OJ L 186, 5.8.1995, p. 1) 
extended the deadline until 
31 December 2002; Council 
Regulation (EC) No 1804/1999 
(OJ L 222, 24.8.1999, p. 1) 
extended the deadline 
until 31 December 2005; 
Council Regulation 
(EC) No 1567/2005 (OJ L 252, 
28.9.2005, p. 1) extended the 
deadline until 31 December 
2006; Council Regulation (EC) 
No 1991/2006 (OJ L 411, 
30.12.2006, p. 18) extended 
the deadline until 12 months 
after the publication of the 
first list of inspection bodies 
and inspection authorities 
recognised for the purpose 
of equivalence; Commission 
Regulation (EC) No 1235/2008 
(OJ L 334, 12.12.2008,  
p. 25) fixed the deadline at 
1 January 2013. 

16. 

17. 

18. 

Since production conditions in third countries can be very different from 
those in the EU, it may not be possible to apply exactly the same rules 
for production or control. The Commission therefore recognises third 
countries for which it considers the production and control system for 
organic products as being equivalent, which means that products certi-
fied as organic in that third country are accepted as organic in the EU. 
Countries that are currently on the list of recognised equivalent third 
countries are Argentina, Australia, Canada, Costa Rica, India, Israel, Japan, 
Switzerland, Tunisia, New Zealand and, with effect from 1 June 2012, the 
United States. 

In addition, two new import regimes are being put in place to ensure that 
organic products can be imported from third countries which have not 
yet attained recognition. These are the list of recognised control bodies/
authorities for the purpose of equivalence (not published at the time of 
the audit) and the list of recognised control bodies/authorities for the 
purpose of compliance (deadline for receiving applications postponed 
until October 2014). 

The  four th  regime,  the  impor t  authorisations  regime,  was  estab -
lished with only a transitional character by Council Regulation (EEC) 
No 2083/92. Since then the possibility to grant import authorisations has 
been extended several times19. The current Regulation (EU) No 1267/2011 
of 6 December 2011 stipulates that it will no longer be possible to grant 
import authorisations as from 1 July 2014. The  same regulation  pro-
vides that authorisations granted as from 1 July 2012 must expire after 
12 months at the latest. Nevertheless, this import regime is still exten-
sively used since approximately 4 000 import authorisations are delivered 
yearly by the different EU Member States (mainly by Germany, France, 
Italy, the Netherlands and the United Kingdom). 

19. 

The correct implementation of control procedures for imports (guaran-
teeing that imported products comply at least with equivalent produc-
tion and control conditions) is important in order to ensure a proper 
functioning of the internal market with fair competition between prod-
ucts produced outside and products produced inside the EU.

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

17

THE AUDIT

THE	AUDIT	SCOPE	

20. 

The audit focused on the effectiveness of the control system and how the 
institutions and bodies involved (Commission and competent authorities, 
accreditation bodies and control bodies in Member States) have carried 
out their responsibilities. The overall audit question addressed was: 

Does the control system for organic products provide sufficient as-
surance that the key requirements for organic production, process-
ing, distribution and imports are fulfilled?

20  Council Regulation (EEC) 
No 2092/91 of 24 June 1991 
on organic production of 
agricultural products and 
indications referring thereto 
on agricultural products and 
foodstuff (OJ L 198, 22.7.1991, 
p. 1).

21. 

More specifically the audit aimed at answering the following questions:

(a) 

Is the implementation of the control procedures governing the 
organic production within the EU adequate:

 — When Member States approve and supervise control bodies?

 — When Member States exchange information within Member 
States, with the Commission and with other Member States?

 — For guaranteeing the traceability of the products?

 — When  the  Commission  super vises  Member  States’  control 

systems?

(b) 

Is the implementation of control procedures for importing products 
adequate:

 — When the Commission manages the list of equivalent third 

countries?

 — When Member States grant import authorisations?

 — When  control  bodies  in  the  EU  check  specific  impor ters’ 

requirements?

22. 

As regards control procedures governing the organic production within 
the EU, the audit considered the period starting  from  the  entry  into 
force of Regulation (EC) No 834/2007, i.e. from January 2009. In rela-
tion to control procedures for importing products, the audit consid-
ered the period starting from the entry into force of Council Regulation 
(EEC) No 2092/9120 and amendments (i.e. from June 1991 for the list of 
recognised equivalent third countries and from July 1992 for import 
authorisations).

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

 
18

21  The Member States 
visited were selected for 
their relevance within the 
EU market (see paragraph 2). 
Ireland was selected for 
testing and optimising the 
audit methodology.

22  OJ C 279, 11.11.2005, p. 1.

23  http://eca.europa.eu

THE	AUDIT	APPROACH	

23. 

The audit evidence was collected through:

—  A review of Commission files, including the review of documenta-
tion received by the Commission from third countries in the context 
of the different import regimes, and meetings with the services of 
the Directorate-General for Agriculture and Rural Development and 
of the Directorate-General for Health and Consumers — Food and 
Veterinary Office.

—  Audit  visits  to  six  Member  States  (the  United  Kingdom  —  Eng-
land, Germany — North-Rhine-Westphalia, Italy — Emilia Romagna, 
Spain — Andalucía, France and Ireland21). These visits included doc-
umentary reviews, meetings with the competent authorities, with 
the accreditation bodies and with two private control bodies per 
Member State as well as on-the-spot visits to producers, processors 
and importers. For the on-the-spot visits the auditors accompanied 
the inspectors in order to evaluate the quality of the inspection 
and understand how they carry out documentary checks and the 
checks on production practices.

— 

Traceability checks on 85 products verifying (a) whether it was pos-
sible to identify the full chain of operators who had intervened in sup-
plying the products, (b) whether all of the operators hold an organic 
certificate, and (c) whether all of the operators had received an in-
spection visit during the previous year (find more details in Annex  I).

— 

Laboratory tests carried out on 73 products to check control bodies 
procedures when taking samples and interpreting laboratory results 
(find more details in Annex II).

—  An assessment report carried out by an internationally recognised 
expert contracted by the Court (focused on the quality of control 
bodies’ procedures when carrying out laboratory tests and on the 
interpretation of the laboratory results of the 73 products).

—  A  review  of  the  available  multiannual  national  control  plans 
(MANCPs) and the related annual reports sent by the 27 Member 
States to the Commission.

PREVIOUS	AUDITS

24. 

The Court issued its Special Report No 3/2005 concerning rural develop-
ment: the verification of agri-environment expenditure 22 which covered 
part of the control system for organic production (see paragraph 43) and 
its Special Report No 7/2011 concerning the design and management 
of the agri-environment support23.

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

OBSERVATIONS

19

IMPLEMENTATION	OF	CONTROL	PROCEDURES	
GOVERNING	THE	ORGANIC	PRODUCTION	WITHIN	
THE	EU

WEAKNESSES	FOUND	IN	MEMBER	STATES’	PRACTICES	WHEN	
APPROVING	AND	SUPERVISING	CONTROL	BODIES	

25. 

Competent authorities in Member States should have documented pro-
cedures for approving and supervising control bodies in order to en-
sure that the regulatory requirements are respected. They should also 
promote the application of good practices. Control bodies (or control 
authorities in public systems) are the central element of the control 
system. Control bodies, when checking organic operators, must comply 
with the EU regulations. 

BOX	1

EXAMPLES	OF	DELAYED	OR	INSUFFICIENTLY	DETAILED	COMPETENT	AUTHORITIES’	
APPROVAL	AND	SUPERVISION	PROCEDURES	

In the United Kingdom the competent authority’s procedures for approval and supervision of control bodies 
were formally adopted only on 18 October 2010, while Regulation (EC) No 834/2007 on organic production 
had entered into force in January 2009.

In France the competent authority had not laid down procedures or checklists to validate the control bodies’ 
control plans which is the key document submitted by the control bodies.

In Spain — Andalusia the competent authority had no verification checklists for supervising control bodies in 
accordance with Article 27(8) and (9) of Regulation (EC) No 834/2007 (such as, for example, verification that each 
operator is inspected at least once a year) or in accordance with other procedures which would constitute good 
practice such as verification of the sampling policy, of the results of analyses or of the exchange of information 
between the control body and other entities.

In Ireland procedures for approval of control bodies did not specify which checks should be carried out and 
referred only to administrative work required when treating new applications. No procedures existed for with-
drawing the approval of control bodies.

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

20

26. 

27. 

28. 

PROCEDURES	FOR	THE	APPROVAL/WITHDRAWAL	OR	FOR	THE	SUPERVISION	OF	CONTROL	
BODIES	NOT	ADEQUATELY	DOCUMENTED

Competent authorities approve control bodies and delegate to them 
control tasks if they have sufficient assurance that control bodies func-
tion according to the requirements of the EU regulations. One of the 
basic requirements for control bodies is that they be accredited. Ac-
creditation bodies deliver initial accreditation and monitor the continued 
fulfilment of the requirements for accreditation. Nevertheless, competent 
authorities have the ultimate responsibility to supervise control bodies 
and monitor the continued fulfilment of the requirements of the EU 
regulations. 

The Court carried out the audit in six Member States with a system of 
private control bodies and found in three of them that the procedures 
for approving, withdrawing or supervising control bodies were not suf-
ficiently detailed (e.g. procedures describing in detail the checks to be 
carried out when validating the control bodies’ control plans or when 
performing on-the-spot checks at the level of the control bodies). In one 
case they had not been updated in a timely manner (see Box 1).

COMPETENT	AUTHORITIES	DO	NOT	HAVE	SUFFICIENT	INFORMATION	TO	ENSURE	THAT	
ALL	OPERATORS	ARE	INSPECTED	AT	LEAST	ONCE	A	YEAR	AS	THE	REGULATION	REQUIRES

Control bodies are responsible for inspecting the operators and for is-
suing organic certificates in conformity with the EU rules. One of the 
key requirements is that control bodies/authorities must inspect oper-
ators, be they producers, processors or importers, at least once a year 
(Article 27(3) of Regulation (EC) No 834/2007). The respect of this re-
quirement aims at guaranteeing consumers that operators continuously 
comply with the rules of organic production.

Regulation (EC) No 834/2007, Article 27 — Control system

‘3. [...] all operators with the exception of wholesalers dealing only with 
pre-packaged products and operators selling to the final consumer or 
user as described in Article 28(2), shall be subject to a verification of 
compliance at least once a year.’

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

21

29. 

Competent authorities are expected to supervise that control bodies 
comply with this obligation. However competent authorities do not have 
sufficient information to properly supervise this issue because: 

(a)  The information provided by the control bodies in application of 
Article 27(14) of Regulation (EC) No 834/2007 is inadequate to verify 
this requirement. For example, summary reports submitted to the 
competent authorities mention the total number of controls car-
ried out during the year. This does not take into account the fact 
that operators can enter or exit the control system during the year, 
and consequently it does not make it possible to verify that each 
individual operator has received one control visit in that year; and

Regulation (EC) No 834/2007, Article 27 — Control system

‘14. By 31 January each year at the latest the control author ities 
and control bodies shall transmit to the competent authorities 
a list of the operators which were subject to their controls on 
31 December of the previous year. A summary report of the con-
trol activities carried out during the previous year shall be pro-
vided by 31 March each year.’

(b)  Some competent authorities rely on the work carried out by the ac-
creditation body, but evaluation reports by the accreditation bodies 
do not contain sufficient information to confirm that the annual 
inspection requirement is complied with. The accreditation bodies 
frequently rely only on the description of procedures applied by the 
control bodies rather than checking whether such procedures are 
applied in practice. In addition, in the context of the accreditation 
cycle, which lasts four to five years, the EU requirement for an an-
nual inspection is not required to be verified every year. 

THE	CONTROL	BODIES’	PROCEDURES	AND	PRACTICES	WHEN	INSPECTING	OPERATORS	
COULD	BE	IMPROVED

30. 

In line with the provisions of Article 27(3) of Regulation (EC) No 834/2007 
and Article 65(4) of Regulation (EC) No 889/2008 control bodies should 
apply systematic risk assessment of their operators against risk factors 
linked to the nature of their operation (such as the quantity of the prod-
ucts concerned and the risk of exchanging organic with conventional 
products) in order to decide on additional control visits (i.e. in addition of 
annual control visits, see paragraph 28). A high incidence of irregularities 
in a particular product or business type should then lead to additional 
monitoring in the form of random control visits to operators with the 
same profile. However seven of the 12 control bodies visited during the 
audit do not take into account risk factors linked to the nature of the 
operators when deciding on additional control visits.

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

22

Regulation (EC) No 834/2007, Article 27 — Control system

‘3. In the context of this Regulation the nature and frequency of the 
controls shall be determined on the basis of an assessment of the risk 
of occurrence of irregularities and infringements as regards compli-
ance with the requirements laid down in this Regulation. [...]’.

Regulation (EC) No 889/2008, Article 65 — Control visits

‘4.  Moreover,  the  control  authority  or  control  body  shall  carr y  out 
random control visits, primarily unannounced, based on the general 
evaluation of the risk of non-compliance with the organic production 
rules, taking into account at least the results of previous controls, the 
quantity of products concerned and the risk for exchange of products.’

31. 

Although this is not required by the regulations, rotation of inspectors 
is a good management practice in control bodies which reduces the risk 
of over-familiarity between inspector and operator. The results of the 
audit, however, show that only four of the 12 control bodies visited had 
defined procedures for rotation of inspectors (see Box 2).

BOX	2

EXAMPLE	OF	A	CONTROL	BODY	NOT	APPLYING	ROTATION	OF	INSPECTORS

In Italy one of the control bodies visited did not impose an obligatory rotation of its inspectors after a certain 
number of years, despite the corrective action that it should have applied following a warning received in 2009 
from one of the competent authorities of the region concerned in the framework of its surveillance activities. 
The control body indicated that work is ongoing with the aim of establishing a rotation of inspectors e.g. every 
four years.

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

23

RESIDUE	TESTING	CAN	BE	BETTER	USED	AS	A	TOOL	FOR	CONTROLLING		
PRODUCTION	PROCESSES

32. 

Restrictions on the use of chemicals and other substances are a key re-
quirement of organic production methods. Residue testing can provide 
evidence, in case of doubt, about the use of unauthorised substances, 
such as prohibited pesticides, GMOs, food additives or pharmaceuticals. 
Residue testing is one of the tools to be used by control bodies to ensure 
that operators respect the production rules set out in the various regula-
tions. The applicable regulations do not foresee a minimum number of 
laboratory tests to be performed, but only require testing where the use 
of products not authorised for organic production is suspected. Conse-
quently control bodies have different interpretations of when suspicion 
occurs and use this tool differently. 

BOX	3

EXAMPLES	OF	CONTROL	BODIES	WITH	A	GOOD	SAMPLING	PLAN	FOR	LABORATORY	TESTS

In Italy, the two control bodies visited had a sampling plan for carrying out routine laboratory analysis of 
products. Their sampling plan was determined based on a risk analysis. When dealing with low-risk operators, 
samples are taken only in the case of suspicion. For medium-risk operators, a percentage of the total number 
of operators in this class is sampled, while for high-risk operators 100 % are sampled.

In France, one of the control bodies visited draws up a laboratory testing programme each year on the basis of 
a risk analysis, any alerts and the previous years’ results being taken into account. Since 2009 the certification 
board has drawn up a provisional testing programme specifying the minimum number of samples that are to 
be analysed and a minimum number of tests that are to be made on those samples. 

A second control body visited in France has a testing strategy, which is set out in the control plan, that estab-
lishes the circumstances in which an analysis can be instigated. These include specific circumstances, such as 
mixed operators (organic and conventional) and GMO risk. The officer in charge prepares an annual guide of 
recommendations for testing in the organic farming sector, which is used to improve the way the number and 
types of tests are defined. The decision to perform an analysis remains at the inspector’s discretion. The cer-
tification board sets an annual budget for testing, and each inspector/auditor is assigned his/her own annual 
budget depending on the typology for the sector.

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

24

24  In case of positive 
analytical results, it is 
important to identify 
the possible source of 
contamination and to 
develop measures to avoid 
contamination in the future. 

25  Modern pesticides 
have been developed to 
breakdown rapidly and 
recommendations for their 
use are designed to minimise 
pesticide residues. Most 
pesticide applications will not 
leave detectable residues in 
the final products.

33. 

In order to evaluate the residue testing system in the Member States 
visited, the Court purchased a range of products and had the Member 
States apply their normal tests for detecting non-allowed substances 
(see Annex II for more details). The results of the tests and the method-
ologies used were then evaluated by an independent expert. The Court 
observed that good practices in terms of residue testing are followed 
by a number of control bodies. Scope exists for other control bodies to 
apply them:

(a)  The procedures of the control bodies visited in two of the Member 
States visited can be considered as good practice as they define 
a risk-oriented annual or multiannual sampling plan for routine 
laboratory tests, even though the EU legislation on organic farming 
only requires sampling in case of suspicion (see Box 3). However, 
five control bodies visited do not have a sampling plan that defines 
a minimum number of analyses or that is based on a risk analysis.

(b)  All control bodies visited sample for pesticides and fertilisers, some 
of  the  substances  not  allowed  by  the  EU  legislation  on  organic 
production; however, one of them fails to test for other substances 
such as feed and food additives or processing aids.

(c)  Analytical results always need a qualified interpretation24. The Court 
has observed that the procedures of two control bodies visited do 
not adequately describe how to interpret analytical results, and 
what follow-up action needs to be taken in case of positive ana-
lytical results.

(d)  The type of samples taken (e.g. food, leaves, soil) and the timing 
must be related to the hypothesis of the use of prohibited sub-
stances at some stage of production or processing25. For example, 
the analysis of leaves or soil will often provide much better results 
than the analysis of the harvested crop or the processed product 
(e.g. jam). Most control bodies for which this issue was examined 
take into account the type of samples taken in order to maximise 
the use of the analysis. However, one of the control bodies visited 
in Spain confines its samples where possible to final products to 
the detriment of checks to test production processes.

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

25

34. 

The Court also found that two out of 10 control bodies where the issue 
was examined did not apply adequate procedures for sample taking 
and analysis. In Spain, the two control bodies visited do not take more 
than one sample from operators. This is not compliant with Article 11(5) 
and (6) of Regulation (EC) No 882/2004; furthermore it places the control 
body in a weak position should the operator decide to dispute the results 
as tests on a countersample are not possible. The Court considers that 
competent authorities could improve their approval and supervisory role 
by ensuring that EU requirements like the one mentioned are fulfilled 
by control bodies.

Regulation (EC) No 882/2004, Article 11 — Methods of sampling 
and analysis

‘5.  The  competent authorities  shall establish  adequate  procedures 
in order to guarantee the right of feed and food business operators 
whose products are subject to sampling and analysis to apply for a 
supplementary expert opinion, without prejudice to the obligation 
of competent authorities to take prompt action in case of emergency.

6. In particular, they shall ensure that feed and food business operators 
can obtain sufficient numbers of samples for a supplementary expert 
opinion, unless impossible in case of highly perishable products or 
very low quantity of available substrate.’

INFRINGEMENTS,	IRREGULARITIES	AND	CORRESPONDING	SANCTIONS	APPLIED	DIFFER	
BETWEEN	MEMBER	STATES,	WITHIN	MEMBER	STATES	AND	EVEN	WITHIN	CONTROL	BODIES

35. 

In several Member States, competent authorities have not defined detailed 
categories of non-compliances and corresponding sanctions (Germany, 
France and the United Kingdom). As a consequence, each control body 
within a Member State defines the non-compliances and applies sanctions 
in a different way. This leads to operators being sanctioned differently 
even within a Member State for having committed the same infringement.

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

26

36. 

37. 

Different control  bodies apply different  sanctions  for  the same  non-
compliance, do not apply the appropriate sanction (according to their 
control plan or according to the competent authority’s instructions) or 
apply sanctions that are not foreseen in their control plan (see Box 4).

Studies carried out by recognised academics have pointed out that con-
siderable differences in control results exist between control bodies 26. 
The  Court  observed  that,  in  2009,  one  control  body  in  one  Member 
State had not withdrawn any certificate and had decided upon only 
three suspensions (equivalent to 0,38 withdrawals or suspensions per 
1 000 operators) whereas another control body in a different Member 
State had decided in the same year 5,26 withdrawals or suspensions 
per 1 000 operators. Such differences in control results could usefully 
be  monitored  and  followed  up  by  competent  authorities  in  the  first 
instance, and by the Commission at EU level, when carrying out their 
supervision activities.

26  ‘Supervision of an 
organic control system 
in Europe — an analysis 
of German control data’, 
Certcost project, Presentation 
at Biofach Nürnberg, 19 
February 2010; Zorn et al., 
‘Monitoring of the organic 
control system in Germany 
— an opportunity to increase 
consumers’ trust’, Jahrbuch der 
Österreichischen Gesellschaft 
für Agrarökonomie, 2010, 
Band 19(1):71–80.

BOX	4

EXAMPLES	OF	DIFFERENT	SANCTIONS	APPLIED	

The non-respect of one specific requirement related to animal production27 in Italy leads to ‘withdrawal of or-
ganic labelling’, in one control body in France it would lead to a ‘warning’ whereas another control body in France 
would apply a ‘request for corrective action’. Examples were found by the auditors where, for this requirement, 
operators in Italy were sanctioned with ‘withdrawal of organic labelling’, meaning that they were not allowed 
to sell their products as organic while, for the same infraction, in France operators have had the possibility to 
continue selling their products as organic. 

One of the control bodies visited in Italy, in its inspection reports for producers, includes a section with ‘Recom-
mendations and measures for enforcement of the regulations’ in addition to the section listing the instances 
of non-compliance. An example was found by the auditors where a non-compliance had been reported in this 
section instead of having been classified and sanctioned according to the procedures. 

27  According to Article 24(5) of Regulation (EC) No 889/2008 the withdrawal period between the last allopathic veterinary treatment to 
an animal under normal conditions of use, and the production of organically produced foodstuffs from such animals, should be twice the 
legal withdrawal period or 48 hours in case the period is not specified.

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

27

28  Commission Regulation 
(EC) No 1975/2006 of 
7 December 2006 laying 
down detailed rules for 
the implementation 
of Council Regulation 
(EC) No 1698/2005, as 
regards the implementation 
of control procedures as 
well as cross-compliance in 
respect of rural development 
support measures (OJ L 368, 
23.12.2006, p. 74).

38. 

39. 

INSUFFICIENCIES	FOUND	IN	THE	EXCHANGE	OF	INFORMATION		
WITHIN	MEMBER	STATES,	WITH	THE	COMMISSION	AND	WITH		
OTHER	MEMBER	STATES

The flow of information is a vital part of the control system. Without 
proper information flow there is the risk that the control system does 
not work effectively. The following sections present the Court’s findings 
on two of the levels considered most relevant by the Court: the flow of 
information between the control system for organic production and the 
control system for agri-environment payments, and the flow of informa-
tion from Member States to other Member States and to the Commission. 

THE	INFORMATION	FLOW	BETWEEN	THE	CONTROL	SYSTEM	FOR	ORGANIC	PRODUCTION	
AND	THE	CONTROL	SYSTEM	FOR	AGRI-ENVIRONMENT	PAYMENTS	NEEDS	TO	BE	IMPROVED

In the framework of the rural development pillar of the common agricul-
tural policy, certain practices of organic farming are eligible for support 
through the European Agricultural Fund for Rural Development. Art-
icle 36(1) of Regulation (EC) No 1975/200628 provides for the exchange of 
information between the services and organisations involved in checks 
regarding the eligibility criteria for this support. 

Regulation (EC) No 1975/2006, Article 36 — Reporting of controls to 
the paying agency

‘1. Where controls are not carried out by the paying agency, the Mem-
ber State shall ensure that sufficient information on the controls car-
ried out is received by the paying agency. It is for the paying agency 
to define its needs for information.

[…].’

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

28

40. 

In two Member States visited, the information flow between the control 
system for organic production29 and the support scheme for rural de-
velopment measures30 concerning subsidies for organic farming under 
the agri-environment measures was insufficient. In France the results of 
the checks made by the control bodies are not communicated to the 
paying agency for the agri-environment subsidies. As a consequence, 
there is the risk that non-compliances affecting the conditions for re-
ceiving agri-environment payments, detected by a control body, do not 
result in a reduction or recovery of the payment. Likewise, in the United 
Kingdom there is no reverse flow of information and there is the risk that 
non-compliances concerning organic farming practices detected by the 
paying agency as a result of their inspections do not result in sanctions 
imposed by the control body. The Commission has also recognised weak-
nesses in this area (see paragraph 53).

29  Regulated by Regulation 
(EC) No 834/2007 and its 
implementing regulations.

30  Regulated by Council 
Regulation (EC) 1698/2005 
of 20 September 2005 
on support for rural 
development by the 
European Agricultural Fund 
for Rural Development 
(EAFRD) (OJ L 277, 21.10.2005, 
p. 1) and its implementing 
regulations.

MEMBER	STATES’	REPORTING	DOES	NOT	FULLY	COMPLY	WITH	THE	REGULATIONS

41. 

Member States have different reporting obligations to respect:

—  Annual reporting on the implementation of the multiannual na-
tional control plan, including information on controls and audits 
carried out, non-compliances and sanctions (Article 44(3) of Regula-
tion (EC) No 882/2004).

Regulation (EC) No 882/2004, Article 44 — Annual reports

‘3. Member States shall finalise their reports and transmit them 
to the Commission, within six months of the end of the year to 
which the reports relate.’

—  Reporting on irregularities and infringements affecting the organic 
status of a product (Article 30(2) of Regulation (EC) No 834/2007).

Regulation (EC) No 834/2007, Article 30 — Measures in case of 
infringements and irregularities

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

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

[…].’

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

29

42. 

The majority of Member States report significantly later than the regula-
tory deadlines to the Commission on the implementation of the multi-
annual control plan. At the beginning of 2011, two Member States still 
had not provided the reports for 2009. As regards the reports’ content, 
Member States are required to follow the Commission guidelines31 on 
preparing the annual report and include a minimum of information re-
garding non-compliances detected, operators registered, inspection 
visits, samples analysed and sanctions applied. However, in practice, 
information relating to the organic control system in the annual reports 
is very limited. Most Member States did not provide an analysis of non-
compliances detected or basic data on the organic sector (see Figure 4).

31  Commission Decision 
2008/654/EC of 24 July 2008 
on guidelines to assist 
Member States in preparing 
the annual report on the 
single integrated multiannual 
national control plan 
provided for in Regulation 
(EC) No 882/2004 of the 
European Parliament and 
of the Council (OJ L 214, 
9.8.2008, p. 56).

FIGURE	4

NUMBER	OF	MEMBER	STATES	THAT	HAVE	INCLUDED,	IN	THEIR	LAST	ANNUAL	REPORT	
AVAILABLE 1,	INFORMATION	IN	RELATION	TO	THE	FOLLOWING	POINTS 2

0

3

6

9

12

15

18

21

24

Type and number of non-compliances identified

Occurrence of non-compliances

Risks arising from non-compliances

Root causes of non-compliances

Number of registered operators

Number of annual visits

Number of additional risk-based visits

Number of samples analysed

Number of sanctions applied

Yes

Partly

No

1  As at February 2011 the following reports had been made available to the Court: (i) 2009 annual report: Estonia (however, the report 
could not be analysed because of technical problems for reading the files); (ii) 2008 annual report: Austria, France, Latvia, Malta, Poland and 
Sweden; (iii) for 19 Member States the last annual report available was for the year 2007; however ,the annual report from Bulgaria could 
not be analysed because of technical problems for reading the files; (iv) for Portugal no report was available.

2  Annual reports for Bulgaria, Estonia and Portugal were not analysed (see endnote 1 of Figure 4).

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

30

43. 

In its Special Report No 3/2005 concerning rural development: the veri-
fication of agri-environment expenditure the Court identified several 
weaknesses related to the Member States’ reporting on organic farming32. 
At the time of the Court’s audit in 2005, Regulation (EEC) No 2092/91 
required Member States to provide a specific report on organic pro-
duction. However, this requirement was superseded by Regulation (EC) 
No 882/2004, which integrated organic farming in the overall reporting 
of official feed and food controls. Table 2 gives an overview of some of 
the findings in that report together with the Court’s assessment of the 
situation in 2011. However, the annual reporting by Member States is 
still unsatisfactory having taken into account the changed reporting 
requirements. 

32  Regulation (EC) 
No 1698/2005 includes 
organic farming as one of the 
agro-environment measures.

TABLE	2

OBSERVATIONS	CONTAINED	IN	SPECIAL	REPORT	NO	3/2005	
CONCERNING	MEMBER	STATES’	REPORTING	ON	ORGANIC	
FARMING	TOGETHER	WITH	AN	ASSESSMENT	OF	THE	CURRENT	
SITUATION	(SEE	COMPLETE	TABLE	IN	ANNEX III)

Findings contained in SR No 3/2005

Annual implementation reports

Not all Member States send the annual reports.

Annual reports do not conclude  
on the functioning of the system.

The Commission makes limited use  
of the reports.

Court’s assessment of the current situation  
in 2011

The majority of Member States report much too late 
on their control activities.

Information related to the organic control system  
in these annual reports is still very limited. 

The review of the annual reports by the Commission 
and its feedback focuses mainly on identifying 
missing information rather than on an analysis 
of them with respect to the design and functioning 
of the control system.

The quality is not always satisfactory and the 
reports include errors and inconsistencies.

Reports by Member States are still of  
unsatisfactory quality.

Even if these reports were complete and 
accurate, they would not give assurance about 
the objectiveness and effectiveness of the 
inspections carried out.

The Commission lacks basic information  
as regards the functioning of the control system  
in Member States. 

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

31

The applicable regulation requires immediate communication of Member 
States’ notifications of irregularities and infringements affecting the or-
ganic status of a product to other Member States and to the Commission. 
For the purpose of allowing a Member State to notify irregularities and 
infringements supposedly originated in another Member State, the Com-
mission has put in place the Organic Farming Information System (OFIS). 
Despite the fact that communication is required to be ‘immediate’, the 
time elapsed between identification of the irregularity or infringement 
and the date on which it was notified through OFIS differs significantly 
between cases, ranging from around 1 to 7 months. One of the reasons 
for these variations is that, in practice, the Member States have different 
interpretations as regards the moment from which the term ‘immediate’ 
applies. For instance in case of detection of non-allowed substances, 
it is not clear if the notification should be done (i) following the first 
laboratory results or (ii) following second laboratory results confirming 
the first ones. 

33  As established 
in ‘Procedure to 
follow-up notifications 
from Member States 
according to Article 92(2) 
of Regulation (EC) 
No 889/2008 on measures 
in case of infringements and 
irregularities’, agreed at SCOF 
on 28–29 January 2009.

34  http://ec.europa.eu/
agriculture/organic/the-farm/
farm-fork_en and  
http://www.trace.eu.org/doc/
TRACE_consumer-info-EA.pdf

Once a notification has been made in OFIS, the Commission expects the 
notified country to investigate the possible causes of the irregularity and 
to reply via OFIS within 30 days33. Member States’ replies to notifications 
are also not made in a timely manner. On 20 January 2011, there were 
38 notifications still open. For 36 of these notifications, this deadline for 
replying had not been respected. In total, 100 notifications on EU irregu-
larities were notified in OFIS in 2009 and 2010. For those cases where 
a reply was received from the notified Member State, the average time 
between notification and reply was 106 days.

DIFFICULTIES	ENCOUNTERED	FOR	ENSURING	THE	TRACEABILITY	OF	
THE	PRODUCTS

Member States should ensure traceability of organic products in line with 
Article 27(13) of Regulation (EC) No 834/2007. Traceability of foodstuffs 
is cited by the Commission as an important element for consumer con-
fidence34 and allows the verification that all the operators involved at all 
stages of production, preparation and distribution have applied the EU 
requirements on organic production. It allows, when a non- compliance 
has been identified, to trace it back to its source and isolate the problem, 
preventing the concerned products from reaching consumers (see Boxes 
5 and 6).

44. 

45. 

46. 

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

32

Regulation (EC) No 834/2007, Article 27 — Control system

‘13. Member States shall ensure that the control system as set up allows 
for the traceability of each product at all stages of production, prepa-
ration and distribution in accordance with Article 18 of Regulation (EC) 
No 178/2002, in particular, in order to give consumers guarantees that 
organic products have been produced in compliance with the require-
ments set out in this Regulation.’

47. 

In all the Member States visited, control bodies included checks on the 
identification of suppliers and customers in order to verify the operator’s 
obligations regarding the documentary accounts35. Supervisory checks 
are also carried out by competent authorities in Member States. Some 
competent authorities perform traceability checks themselves at the 
level of the final product (Spain, France, Italy); whereas, in other Member 
States, competent authorities include checks of mandatory traceability 
documentation as part of their surveillance activities at the level of the 
control bodies (Germany, Italy).

35  As defined by Article 66 of 
Regulation (EC) No 889/2008.

GOOD	PRACTICE:	ONLINE	DATABASES	FOR	IMPROVED	TRACEABILITY

In Italy several control bodies have developed online databases that allow consumers and companies acquiring 
organic products from operators certified by them to verify the veracity of the operator’s transaction documents 
or certificate of conformity. The Court considers such procedures to be good practice in terms of transparency 
and traceability.

BOX	5

BOX	6

FINDING	DISCOVERED	WHILE	CARRYING	OUT	THE	TRACEABILITY	EXERCISE

Through the traceability exercise carried out by the Court, one fraudulent organic transaction certificate was 
found. The Court purchased organic flour and the subsequent checks showed that the certificates were false, 
therefore the organic status of the product was not confirmed. The case is part of a larger investigation of al-
leged fraud made public at the end of 2011 which is being conducted by the responsible national authorities. 

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

33

36  Germany provided info 
after 9 weeks (13 products), 
Spain after 4 weeks 
(21 products), France after 
8 weeks (23 products), 
Italy after 9 weeks 
(15 products) and the United 
Kingdom after 13 weeks 
(15 products).

48. 

Despite the existence of control systems in place in the Member States 
visited to check traceability requirements, a traceability exercise carried 
out by the Court (see Annex I for more details) on 85 products from dif-
ferent origin and composition shows that traceability back to the pro-
ducer level is not ensured for all products. Within the initial time frame 
of the exercise (3 months)36, 40 % of the products could not be traced 
back to the producer level and the information requested (identifica-
tion of operators down to producer level and certificate of conformity 
for each of the operators identified) was complete for only 48 % of the 
products. Taking into account the additional information provided by 
some Member States after the end of the exercise, i.e. within a total time 
frame of 6 months, 32 % of the products still could not be traced down 
to producer level and for only 56 % of the products, the documentation 
provided was complete (see also Figure 5 for a summary of the results, 
split according to the origin of the product). One major explanation for 
this situation is that Member States do not have authority over operators 
outside their territory, in the case of products or product ingredients 
crossing intra- and extra-EU borders.

FIGURE	5

SUMMARY	RESULTS	OF	THE	COURT’S	TRACEABILITY		
EXERCISE	(PRODUCTS	FOR	WHICH	THE	INFORMATION	
REQUESTED	WAS	COMPLETE) 1

100 %

80 %

60 %

40 %

20 %

0 %

68 %

38 %

60 %

63 %

56 %

Products
produced and
consumed in
the same MS

Products
produced in
another MS

Products
imported
through import
authorisations

Full sample 
of 85 
products

Products
imported
through the
list of 
equivalent
countries

1  31 products were produced and sold in the same Member State, 26 products were produced in 
one Member State but sold in another Member State, 20 products contained at least one ingredient 
imported  through  the  import  authorisations  regime  and  eight  products  contained  at  least  one 
ingredient imported from a country considered as equivalent.

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

34

37  In Italy, control bodies 
deliver an ‘Enterprise 
Suitability Certificate’ 
(attestato di idoneità 
aziendale) certifying the 
inclusion of the operator 
in the control system. In 
France, control bodies deliver 
a ‘licence’, a declaration 
of a commitment by the 
operators to adhere to 
organic production methods 
concerning their organic 
activities as a whole. These 
documents do not include 
the list of products subject to 
certification.

49. 

In addition, the traceability exercise has revealed a number of factors 
that are detrimental to the reliability of the control system, such as no 
clear reference to producers or producer groups on group certificates, 
group certification for countries other than developing countries, or the 
existence of documents that are similar to the certificate of conformity 
but that do not have the same value37.

picture 3 — example of a specialised shop in england selling organic products

© European Union.
Source: European Court of Auditors.

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

35

38  Before 2001 audits 
carried out by the Food 
and Veterinary Office (FVO) 
highlighted important 
shortcomings in the 
control system for organic 
production.

39  The FVO is a service of the 
Health and Consumer DG.

40  One of the weaknesses 
identified by the Commission 
concerns the lack of a proper 
exchange of information 
between the system for 
organic production and the 
support scheme for agri-
environment payments.

50. 

51. 

52. 

53. 

ACTION	TAKEN	BY	THE	COMMISSION	TO	ENSURE	PROPER	
FUNCTIONING	OF	THE	MEMBER	STATES’	CONTROL	SYSTEMS		
WAS	FOUND	TO	BE	INSUFFICIENT

Article 45 of Regulation (EC) No 882/2004 requires the Commission to 
carry out audits of Member States’ official controls. The Commission has 
a general responsibility for the supervision and coordination of the con-
trol system for organic production and it should ensure Member States 
comply with their responsibilities. A first condition for enforcing a control 
system is to have access to information about its functioning. A second 
condition is the availability of proportionate enforcement measures that 
can be applied to Member States.

As mentioned in paragraphs 41 to 45, Member States’ reporting to the 
Commission is very limited, often incomplete and subject to major de-
lays. As a consequence, the Commission does not have the basic data 
available that it would need to improve its own monitoring, inform to 
the public or to reply to Parliamentary questions and to provide a reliable 
basis for the policy-making process. Concerning the multiannual national 
control plans and the related annual reports, the Commission services 
have not taken any action in order to obtain from Member States the 
annual reports in a timely manner. Once the reports are received, the 
Agriculture and Rural Development DG reviews them, identifies miss-
ing information, analyses them and, where necessary, comments on the 
content of the information provided.

Since 2001, the Commission has not carried out audits in Member States38 
to verify that official checks regarding organic production are being 
undertaken in accordance with the EU regulations. According to the 
Commission, working arrangements between the Agriculture and  Rural 
Development DG and the Health and Consumers DG continue to be dis-
cussed and, as of 2012, organic farming should be a regular part of the 
FVO39 annual inspection programme. However, the prioritisation of the 
FVO audit programme is risk based and the main risk factor considered 
continues to be ‘food safety’. At the time of the audit organic production 
issues were not included in the annual inspection programme.

The Commission (the Agriculture and Rural Development DG) does carry 
out audit visits to Member States when auditing rural development ex-
penditure. However, the review of the corresponding audit reports 40 
shows that the information obtained is not comparable between Mem-
ber States.

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

36

41  Four letters concerned 
the accreditation of control 
bodies. A fifth letter 
concerned the number and 
results of performed controls, 
the follow-up of detected 
irregularities, the follow-
up of a particular case of 
suspension and the follow-up 
of an audit mission by the 
FVO in 2000. A further letter 
was sent in July 2011, while 
the Court’s audit was taking 
place.

42  As defined in Article 8(2) 
of Regulation (EC) 
No 1235/2008. 

54. 

55. 

56. 

In case of non-application of EU legislation applicable to organic produc-
tion the Commission has the general possibility to send pre-infringement 
letters to Member States or to initiate an infringement procedure. How-
ever, the regulations pertaining to organic production do not provide 
for any specific enforcement measures that the Commission could apply 
when Member States do not comply with their responsibilities. The Com-
mission addressed six pre-infringement letters to four Member States41. 
However this procedure is very cumbersome and time consuming. 

IMPLEMENTATION	OF	CONTROL	PROCEDURES	FOR	
IMPORTING	PRODUCTS

WEAKNESSES	FOUND	IN	THE	MANAGEMENT	OF	THE	LIST	OF	
EQUIVALENT	THIRD	COUNTRIES

According to Article 33(2) of Regulation (EC) No 834/2007, the Com-
mission may recognise third countries whose system of production is 
equivalent to the principles and production rules laid down in Regula-
tion (EC) No 834/2007 and whose control measures are of equivalent 
effectiveness to those laid down in this same regulation, and establish a 
list of these countries. The countries currently recognised as equivalent 
are Argentina, Australia, Canada, Costa Rica, India, Israel, Japan, Switzer-
land, New Zealand, Tunisia and, with effect from 1 June 2012, the United 
States. The organic products certified as organic in these third countries 
are therefore accepted as organic in the EU.

The Commission has overall responsibility for managing this  list but 
partly shares this responsibility with the Member States, who assist the 
Commission in the recognition and supervision process. Correct manage-
ment of the list should include the appropriate implementation of clear 
procedures for inclusion of third countries in line with the aim and scope 
of the EU regulation as well as the provision of sufficient guarantees to 
ensure that third countries once recognised as equivalent keep fulfilling 
the requirements. 

COMMISSION’S	CAPACITY	FOR	TREATING	REQUESTS	OF	INCLUSION	IN	THE	LIST	OF	
EQUIVALENT	THIRD	COUNTRIES	IS	INADEQUATE	

57. 

When examining requests for recognition, the Commission has to as-
sess the information42 provided by the third country and may decide to 
examine on-the-spot the rules of production and the control measures 
of the third country concerned.

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

58. 

59. 

60. 

37

In practice, the Commission assesses equivalence of applicant countries 
generally in line with the provisions of the regulation. The Commission 
uses a standardised ‘comparison table’ to document the checks carried 
out when assessing the equivalence of the production standards and 
the effectiveness of the control system applied in the third countries. In 
addition, except for Argentina, Australia, New Zealand and Switzerland 
(see Table 4), it has carried out at least one visit to each applicant coun-
try before including it in the list. Since 2010, for the visits to third coun-
tries, the Commission has adopted the use of standardised checklists.

43  Article 12(1)(b) 
of Regulation (EC) 
No 1235/2008.

44  Article 16(2) of Regulation 
(EC) No 1235/2008.

45  Article 33(2) of Regulation 
(EC) No 834/2007.

The number of third countries applying for inclusion in the list of equiva-
lent third countries is increasing. Twenty-five applications have been 
received between 2000 and 2011, of which the Commission has been 
able to examine only eight. In addition, several of the countries already 
listed have requested an extension of the scope of the equivalence. The 
widespread and growing range of responsibilities the Commission has to 
fulfil in a situation where limited resources are available has resulted in 
very long delays when managing specific applications (e.g. Bolivia sent 
its application in 2006, and Chile sent its first application in 2000 and 
additional information in 2009, but the Commission has not yet finalised 
the examination of the information provided).

INADEQUATE	COMMISSION	PROCEDURES	TO	GUARANTEE	THAT	THIRD	COUNTRIES	
RECOGNISED	 AS	 EQUIVALENT	 CONTINUE	 TO	 FULFIL	 THE	 REQUIREMENTS	 OF	
THE REGULATION

Recognised equivalent third countries have  the  obligation  to report 
yearly to the Commission on the control activities carried out in the 
previous year43. The regulation foresees that Member States will assist 
the Commission in assessing the annual reports 44. Based on the informa-
tion in these annual reports, the Commission, assisted by Member States 
co-reporters, has to ensure appropriate supervision of the recognised 
third countries. The nature of the supervision has to be determined on 
the basis of an assessment of the risk of the occurrence of irregularities 
or infringements of the provisions set out in the EU regulation 45. How-
ever, the Commission lacks detailed procedures for the management and 
review of the list of equivalent third countries and a risk assessment of 
the third countries has not been formalised. 

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

38

The Commission’s analysis of annual reports is not standardised (e.g. no 
checklists or standard report formats are used) and the analysis does 
not lead to specific actions (e.g. a Commission written note). In some 
cases (e.g. Israel report 2008/09, Argentina) no evidence could be found 
that the Commission reviewed the report (e.g. no handwritten notes or 
other documentary evidence). Frequently no evidence could be found 
that the Member States co-reporters assigned assisted the Commission 
to ensure appropriate supervision (e.g. by giving feedback on annual re-
ports) as considered in the regulation. The Commission has not provided 
Member States co-reporters with guidelines on the expected content of 
their reports.

The Court analysed a sample of the annual reports of third countries 
currently recognised as equivalent. These annual reports are not com-
plete as they lack information about monitoring activities, about the 
number and type of inspections conducted by control bodies or about 
the number of laboratory tests carried out and the results. In two cases 
they do not include any explanation regarding corrective actions tak-
en following irregularities detected during the reporting period and 
for  which  there  has  been  communication  with  the  Commission  (see 
 Table 3). The Commission has only recently (2011) sent guidelines to 
third countries about the content of these annual reports.

61. 

62. 

TABLE	3

RESULTS	OF	THE	COURT’S	ANALYSIS	OF	THE	CONTENT	OF	THE	LAST	ANNUAL	REPORT	
AVAILABLE	AT	THE	TIME	OF	THE	AUDIT

Subject

Argentina

Israel

India

New 
Zealand

Tunisia1

Costa Rica

Monitoring and supervisory activities 
carried out by the competent authority 
in the third country

Corrective actions taken by the 
competent authority in the third country

Number of control bodies operating 
in the third country

Number and type of inspections 
conducted by control bodies

Number of laboratory tests carried out 
and results

Yes

Yes

Yes

No

No

No

No

Yes

No

Yes

Yes

Yes

Yes

No

No

Yes

Yes

Yes

No

No

n.a.

n.a.

n.a.

n.a.

n.a.

Yes

No

Yes

No

Yes

1  Tunisia was included in the list of equivalent countries in 2009 but had not submitted any annual report by September 2010. 
It provided the 2009 annual report in November 2010. 

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

39

63. 

64. 

Given  that  the  Commission  services  have  no  internal  procedures  on 
how the supervision of recognised third countries should be carried 
out, it is uncertain when the Commission on-the-spot visits should be 
conducted after third countries are included in the list. The Court notes 
in this regard that no regular on-the-spot visits have been conducted 
to third countries (e.g. last visit to Israel in 1999, last visit to Costa Rica 
in 2000) (see Table 4).

The fact that the information contained in the annual reports provided 
by the equivalent third countries is poor, together with the fact that the 
Commission does not regularly visit the equivalent third countries on 
the spot, does not allow the Commission to guarantee that the produc-
tion standards and the effectiveness of the control systems in the third 
countries included in the list remain equivalent.

TABLE	4

DETAILS	OF	THE	COMMISSION’S	ON-THE-SPOT	VISITS	TO	THIRD	COUNTRIES

Third countries  
recognised as 
equivalent

Date of inclusion  
in the list

On-the-spot visits carried out (year) 
before acceptance of the 
third country in the list of equivalent 
third countries

On-the-spot visits carried out (year) 
after acceptance of the 
third country in the list of equivalent 
third countries1

Argentina

Australia

Canada

Costa Rica

India

Israel

Japan

New Zealand

Switzerland

Tunisia

1996

1996

2011

2003

2006

1996

2010

2002

1996

2009

-

-

2010

2000

2004

1994 

2001 and 2009

-

-

2008

1999 and 2000

1999

-

-

-

1999

-

2003

2001

-

1  Marked in red the countries for which an on-the-spot visit has not taken place after their inclusion in the list or for which the last 
on-the-spot visit took place more than 7 years ago; marked in green the countries for which a recent on-the-spot visit has taken 
place after their acceptance as equivalent, or for which the date of inclusion in the list is recent.

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

40

WEAKNESSES	FOUND	IN	THE	MANAGEMENT	OF	THE	IMPORT	
AUTHORISATION	REGIME

65. 

Organic products produced outside the EU can be imported through 
the import authorisation regime. Import authorisations are issued for 
specified periods by the competent authority of each individual Mem-
ber  State;  they  are  valid  for  a  maximum  of  one  year 46,  for  a  specific 
importer and for well-identified products and can be withdrawn if the 
requirements referred to in Article 33(1)(a) and (b) of Regulation (EC) 
No 834/2007 are no longer satisfied.

46  Recently, the maximum 
period of validity has been 
limited to 12 months 
(Regulation (EU) 
No 1267/2011). Previously, 
the exact length of validity 
of import authorisations 
was not specified in the 
EU regulations.

Regulation (EC) No 834/2007, Article 33 — Import of products providing 
equivalent guarantees

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

(a)  the product has been produced in accordance with production rules 

equivalent to those referred to in Titles III and IV;

(b)  the operators have been subject to control measures of equivalent 
effectiveness to those referred to in Title V and such control meas-
ures have been permanently and effectively applied;

[…].’

66. 

67. 

The Commission has a supervisory role and may require a Member State 
which granted an authorisation to withdraw it when it considers that 
those requirements are not satisfied (see Box 8). 

Around 4 000 import authorisations are granted yearly by the 27 Member 
States of the EU. It is extremely difficult to ensure a harmonised approach 
by the competent authorities of the 27 Member States when issuing 
import authorisations. Due to these difficulties the import authorisation 
regime system is meant to be phased out by the end of June 2015. The 
Court’s visits to Member States in the context of this audit have shown 
the following weaknesses both at the level of the checks carried out by 
the competent authorities and at the level of the Commission.

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

41

68. 

69. 

70. 

71. 

INSUFFICIENT	CHECKS	CARRIED	OUT	BY	MEMBER	STATES	WHEN	GRANTING		
IMPORT	AUTHORISATIONS	

Each consignment of organic products imported through this regime 
must be accompanied by a certificate of inspection. This certificate of 
inspection should be issued by a control body in the third country. The 
control body should be accepted by the competent authority of the 
Member State granting the import authorisation. When granting an im-
port authorisation, the competent authority of the authorising Member 
State has therefore to accept the control body proposed by the importer 
that applies for the import authorisation as competent to issue certifi-
cates of inspection. However, the EU regulations do not define on what 
basis this acceptance may be made. 

In practice most competent authorities base the decision of accept-
ing a control body in a third country as competent to issue certificates 
of inspection by checking if the concerned control body is accredit-
ed. However competent authorities in Member States do not actively 
check whether control bodies charged with issuing the certificates of 
inspection keep their accreditation up to date and whether the scope 
of the accreditation provided is pertinent to ensure equivalence with 
EU standards. 

The Court observed that only some Member States (Ireland, Spain, Italy) 
carry out additional checks and require importers applying for import 
authorisations to provide inspection reports issued by the concerned 
control bodies in the third countries in order to check if control practices 
are equivalent to the ones requested by the EU regulation. All Member 
States’ checks rely solely on documentary checks, none of the Member 
States visited carry out on-the-spot inspections.

Once an import authorisation is granted, the concerned operators in 
the EU rely on the certificate of inspection accompanying each con-
signment  of  imported  products  which  states  (in  box  15  of  the  men-
tioned certificate, and in accordance with Article 13(4) of Regulation (EC) 
No 1235/2008) that equivalent production rules and equivalent control 
measures have been applied in the third country.

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

42

Regulation (EC) No 1235/2008, Article 13 — Certificate of inspection

‘4. The authority or body issuing the certificate of inspection shall only 
issue the certificate of inspection and endorse the declaration in box 
15 of the certificate, after:

(a)  it has carried out a documentary check on the basis of all relevant 
inspection documents, including in particular the production plan 
for the products concerned, transport documents and commercial 
documents; and

(b)  it has either made a physical check of the consignment, or it has re-
ceived an explicit declaration of the exporter declaring that the con-
signment concerned has been produced and/or prepared in accord-
ance with Article 33 of Regulation (EC) No 834/2007; it shall carry 
out a risk-oriented verification of the credibility of this declaration.

It shall furthermore give a serial number to each issued certificate and 
keep a register of the delivered certificates in chronological order.’

72. 

Notably the endorsement of box 15 in this certificate is in effect a self-
declaration, by the same control body, in the third country issuing the 
certificate of inspection. Competent authorities in Member States do 
not perform any checks to assess the reliability of this declaration. This 
highlights why the verifications carried out by the competent authorities 
of the authorising Member States about the competence of the control 
body issuing this certificate before granting an import authorisation are 
of extreme importance. 

THE	COMMISSION	DOES	NOT	HAVE	ACCESS	TO	SUFFICIENT	RELIABLE	DATA	TO	BE	ABLE	
TO	ASSESS	WHETHER	IMPORT	AUTHORISATIONS	GRANTED	BY	MEMBER	STATES	SATISFY	
THE	CONDITIONS	ESTABLISHED	BY	THE	REGULATION

73. 

The Commission guidelines about the content of the annual reports sent 
by Member States to the Commission do not foresee the inclusion of 
information regarding import authorisations granted by Member States.

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

43

74. 

OFIS provides for the transmission of information concerning import 
authorisations between Member States and the Commission, as required 
according to Article 19(2) of Regulation (EC) No 1235/2008. Results from 
the Member States’ visits carried out in the context of this audit have 
shown examples where the information communicated by the Member 
States in OFIS concerning the import authorisations is not reliable and 
complete (see Box 7).

Regulation  (EC )  No  1235/20 08,  Ar ticle  19  —  Transitional  rules  on 
equivalent import of products not originating in listed third countries

‘2. Each Member State shall inform the other Member States and the 
Commission of each authorisation granted pursuant to this Article, 
including information on the production standards and control ar-
rangements concerned.’

75. 

A review of the minutes of the Standing Committee on Organic Farming 
(years 2010 and 2011) has shown that this committee does not adequate-
ly perfom its role for exchanging information regarding the functioning 
of the import authorisation regime.

BOX	7

INFORMATION	ON	IMPORT	AUTHORISATIONS	IN	OFIS	IS	NOT	RELIABLE	

The audit showed that, of the 26 import authorisations withdrawn by Germany in 2009, only 11 appeared cor-
rectly in OFIS, 11 had been labelled ‘expired’ instead of ‘withdrawn’ and four had not been entered in OFIS at all.

In 2009, Germany temporarily suspended eight import authorisations due to detection of pesticide residues 
in certain consignments. However, the current EU regulation does not provide for the possibility to suspend 
an import authorisation. Therefore, as OFIS does not provide for encoding the status ‘suspended’, four of the 
authorisations had been labelled ‘expired’ and one had been labelled ‘withdrawn’. Three of the import authorisa-
tions were not encoded in OFIS at all.

One import authorisation from Italy for 2009 was erroneously labelled as ‘withdrawn’ when it should have re-
mained active.

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

44

76. 

77. 

Since 2001 the Commission has not carried out any audits in Member 
States to verify that they grant import authorisations only when the 
conditions of the regulation are complied with. In the absence of any 
on-the-spot visits to Member States in the last 10 years, the Commission 
has no up-to-date information to assess whether import authorisations 
could and should be granted. 

47 Article 33(1)(a) and (b) of 
Regulation (EC) No 834/2007.

48 Article 19(3) of Regulation 
(EC) No 1235/2008.

Regarding import authorisations, when an examination finds that the 
equivalent production rules and equivalent control measures have not 
been applied in the third country 47, the Commission can request the 
authorising Member State to withdraw the import authorisation48. The 
Commission, in the almost 20 years of existence of this import regime, 
has never used this procedure. In one case, however, the Commission 
has recommended (but not requested) the Member States to withdraw 
import authorisations for a certain product; however, this recommenda-
tion was not followed by all Member States (see Box 8).

BOX	8

A	PRODUCT	IMPORTED	FROM	A	THIRD	COUNTRY

In October and November 2009, following an increased number of findings of unauthorised substances in a cer-
tain product imported from one third country, the Commission issued two communications to the competent 
authorities of Member States through the SCOF. In these communications, the Commission recommended the 
withdrawal of import authorisations for this product from the concerned third country. Most Member States 
followed the recommendation and withdrew the import authorisations concerned. The Court identified three 
Member States that did not follow it. On 1 March 2010 the Commission issued a communication to SCOF dele-
gates allowing new authorisations for the products concerned. Some Member States had at that time already 
started to grant new import authorisations for the same products.

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

45

COMMON	PROVISIONS	ON	IMPORTS	—	INCOMPLETE	CHECKS	CARRIED	
OUT	BY	CONTROL	BODIES	ON	IMPORTERS

78. 

For imported products the first stages of the production chain are re-
quired to be checked in the third country in accordance with equivalent 
production rules and equivalent control measures (see paragraphs 55 
to 77). Once these products arrive to the EU, the control system operat-
ing within the EU has only the possibility to check the last part of the 
production chain, i.e. the importer. The Court has observed that the 
checks carried out in this sense are often not complete.

CHECKS	MADE	BY	CONTROL	BODIES	ON	IMPORTERS	AND	IMPORTED	PRODUCTS	ARE	
OFTEN	INCOMPLETE

79. 

The Court’s visits to Member States in the context of this audit have 
shown the following results in relation to control bodies respecting their 
obligations as established in Articles 82 and 84 of Commission Regula-
tion (EC) No 889/2008: 

— 

for three out of eight control bodies where the issue was exam-
ined, control bodies did not ensure importers provide a complete 
description of the unit together with an undertaking committing 
themselves to submit to control any facility used for the storage of 
the products (Article 82 of Regulation (EC) No 889/2008); 

Regulation (EC) No 889/2008, Article 82 — Control arrangements

‘1. In the case of the importer, the full description of the unit re-
ferred to in Article 63(1)(a) shall include the importer’s premises 
and of his import activities, indicating the points of entry of the 
products  into  the  Community  and  any  other  facilities  the  im-
porter intends to use for the storage of the imported products 
pending their delivery to the first consignee. 

In addition, the declaration referred to in Article 63(2) shall in-
clude an undertaking by the importer to ensure that any facilities 
that the importer will use for storage of products are submitted 
to control [...].’

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

46

— 

for five out of seven control bodies where the issue was examined, 
control bodies did not require importers to notify them of each 
imported consignment (Article 84 of Regulation (EC) No 889/2008).

Regulation (EC) No 889/2008, Article 84 — Information on import-
ed consignments

‘The importer shall, in due time, inform the control body or con-
trol authority of each consignment to be imported into the Com-
munity [...]’.

picture 4 — example of an impor ted product labelled organic sold in the eu

© European Union.
Source: European Court of Auditors.

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

CONCLUSIONS AND RECOMMENDATIONS

47

80. 

81. 

The control system for organic products as set out in the EU regula-
tions aims at guaranteeing the production processes but not the or-
ganic character of the products themselves. This is because there is no 
scientific way to determine whether a product is organic or not. In order 
to provide sufficient assurance that the system is operating effectively 
and to ensure that consumer confidence is not undermined, it would be 
appropriate to remedy the weaknesses highlighted by the Court’s audit. 

The Court found examples where competent authorities do not suffi-
ciently fulfil their supervisory role over control bodies. As a result certain 
control bodies fail to satisfy a number of EU requirements and fail to take 
the opportunity to implement certain good practices (paragraphs 27, 
29 to 31, 33 to 37 and 79). The Court recommends that:

RECOMMENDATION	1

Competent authorities should strengthen their supervisory role over 
control bodies by applying appropriate documented procedures for 
approving and supervising control bodies, by promoting harmonisa-
tion in the definition of infringements, irregularities and corresponding 
sanctions, and by promoting identified good practices.

82. 

The exchange of information within Member States and from Member 
States to the Commission and other Member States is not yet adequate 
to  ensure  that  the  system  is  operating  correctly  (paragraphs  40  and 
42 to 45). The Court recommends that: 

RECOMMENDATION	2

Member States should ensure a direct flow of all relevant information 
on infringements and irregularities from the control bodies to the pay-
ing agencies and vice versa; and the Commission should specif y the 
form and timing of communications of infringements and irregularities, 
introduce appropriate measures to ensure that Member States respect 
their reporting obligations and revise the information system provided 
for the communication of infringements and irregularities and consider 
including communications affecting third countries.

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

48

83. 

Competent authorities in Member States encounter difficulties in en-
suring the traceability of the organic products within the territory for 
which they have authority. Traceability is even more difficult to achieve 
for products crossing borders (paragraphs 48 to 49). The Court recom-
mends that:

RECOMMENDATION	3

Controls should be strengthened to ensure that operators fulfil the regu-
latory requirements regarding traceability; in this regard the Commis-
sion should clarify the roles and responsibilities of the different actors.

84. 

The Commission has not given enough priority to supervision activities, 
including audits, to ensure the proper functioning of the Member States’ 
control systems (paragraphs 51 to 54). The Court recommends that: 

RECOMMENDATION	4

The Commission should strengthen its monitoring of Member States’ 
control systems by undertaking audit visits and gathering and exploit-
ing the necessary data and information.

85. 

The Commission does not have sufficient information to satisfy itself that 
the control system for organic production in third countries recognised 
as equivalent continues to fulfil the regulatory requirements as long as 
they keep this status. The Court further notes that there is a significant 
backlog in assessing applications for equivalence from third countries 
(paragraphs 59 to 64). The Court recommends that: 

RECOMMENDATION	5

The Commission should ensure adequate supervision of the countries 
included in the list of those recognised as being equivalent for organic 
production and carry out a timely assessment of the applications from 
third countries applying to be included in that list.

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

49

86. 

The Court found weaknesses in the system used for granting import 
authorisations (paragraphs 68 to 77). The Court welcomes the simplifi-
cation implicit in the Commission initiative of phasing out the import 
authorisations regime and recommends that:

RECOMMENDATION	6

As long as the import authorisations regime is in operation Member 
States should ensure its correct application. Competent authorities in 
Member States should reinforce the checks carried out on control bod-
ies authorised to issue certificates of inspection. 

This report was adopted by Chamber I, headed by Mr Ioannis SARMAS, 
Member  of  the  Cour t  of  Auditors,  in  Luxembourg  at  its  meeting  of 
28 March 2012.

For the Court of Auditors

Vítor Manuel da SILVA CALDEIRA
President

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

50

ANNEX	I

TRACEABILITY	EXERCISE	—	METHODOLOGY

1. 

Article 27(13) of Regulation (EC) No 834/2007 establishes that:  

‘13. Member States shall ensure that the control system as set up allows for the traceability 
of each product at all stages of production, preparation and distribution in accordance with 
Article 18 of Regulation (EC) No 178/2002, in particular, in order to give consumers guaran-
tees that organic products have been produced in compliance with the requirements set 
out in this Regulation.’

2. 

3. 

The traceability exercise carried out by the Court in the context of this audit consisted of requesting 
a number of documents for 85 products bought during the Member States’ visits to trace the products 
back to their origin. The information requested was:

 ο

 ο

 ο

identification details of all operators having intervened in supplying the product (back to the pro-
ducer level) — for products composed of more than one ingredient this information was requested 
for the two most important organic ingredients (in terms of weight);

the organic certificate for each of the operators identified in the previous point; and

the last inspection report for each of the operators identified.

Different types of products were selected to be included in the exercise for the purpose of covering 
several risks associated to the following variables:

 ο

 ο

 ο

different composition (products composed of one single ingredient of vegetable origin, composed 
of one single ingredient of animal origin, composed of more than one ingredient);

different origin (products produced in the same Member State where they are bought, pro-
duced in a different Member State than the Member State where they are bought, produced in 
a third country);

different system used for importing the products (products imported through national import 
authorisations, imported through the list of equivalent third countries).

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

 
51

4. 

To carry out this exercise the Court’s auditors, for each Member State visited:

 ο

 ο

 ο

prepared a list of products to be bought (taking into account the coverage mentioned in para-
graph 3), which included products certified by the control bodies operating in the Member State 
visited or operating in the Member States of the remaining Court’s audit visits, and bought the 
products;

requested, from the competent authority of the Member State visited, the traceability records for 
the products bought during the audit visit and for which the control body appearing in the label 
of the product was operating in that Member State;

requested, from the competent authority of the Member State visited, the traceability records for 
the products bought in other Member States during previous audit visits but for which the control 
body appearing in the label was a control body operating in that Member State.

5. 

The following tables give an overview of the distribution of the products included in the exercise:

TABLE	1	—	DISTRIBUTION	OF	THE	PRODUCTS	PER	ORIGIN	AND	TYPE	OF	IMPORT	REGIME

Country the 
product was 
bought in

Produced and 
consumed in the 
same Member 
State

Produced in 
another Member 
State

Produced in 
a country listed 
on the list of 
equivalent third 
countries

Produced 
in a country 
exporting through 
national import 
authorisations

Total number of 
products bought 
per country

DE

ES

FR

IT

LU

UK

3

15

7

2

0

4

31

Total 

5

5

7

4

1

4

26

3

0

0

2

0

3

8

5

3

2

4

0

6

20

16

23

16

12

1

17

85

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

52

TABLE	2	—	COUNTRIES	COVERED	BY	THE	TRACEABILITY	EXERCISE

EU Member States (14)

Third countries from the equivalent 
third-country list (6)

Other third countries (14)

Canada

Costa Rica

India

Japan

Tunisia

Switzerland

Denmark 

Germany

Ireland

Greece

Spain

France

Italy

Hungary

Netherlands

Austria

Poland

Romania

Sweden

United Kingdom

Bolivia

Brazil

China

Dominican Republic

Ecuador

Kazakhstan

Paraguay

Peru

Philippines

South Africa

Sri Lanka

Turkey

Ukraine

Uruguay

TABLE	3	—	DISTRIBUTION	OF	THE	PRODUCTS	BY	COMPOSITION

Products composed of 
one single ingredient 
of vegetable origin

Products composed of 
one single ingredient 
of animal origin

Products composed 
of more than one 
ingredient

Number of products

37

11

37

Total

85

TABLE	4	—	DISTRIBUTION	OF	THE	PRODUCTS	ACCORDING	TO	THE	MEMBER	STATE	THEY	
HAVE	BEEN	BOUGHT	IN

Traceability  
information requested in

Bought in the same  
Member State

Bought in a different  
Member State

DE

ES

FR

IT

UK

12

20

16

11

13

72

1 (UK)

1 (DE)

3 (ES), 1 (IT), 2 (DE), 1(UK)

1 (DE), 2 (UK), 1 (LU)

-

13

Total

Total

13

21

23

15

13

85

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

 
 
53

TABLE	5	—	PRODUCTS	WITH	AT	LEAST	ONE	INGREDIENT	IMPORTED	FROM	COUNTRIES	
LISTED	IN	THE	EQUIVALENT	THIRD-COUNTRY	LIST

Traceability  
information requested in

Bought in the same  
Member State

Bought in a different  
Member State

DE

ES

FR

IT

UK

3

-

-

2

2

7

Total 

-

-

1 (UK)

-

-

1

Total

3

0

1

2

2

8

TABLE	6	—	PRODUCTS	WITH	AT	LEAST	ONE	INGREDIENT	IMPORTED	THROUGH	IMPORT	
AUTHORISATIONS	GRANTED	BY	MEMBER	STATES

Traceability  
information requested in

Bought in the same  
Member State

Bought in a different  
Member State

DE

ES

FR

IT

UK

4

2

2

4

6

18

Total 

-

-

1 (ES)

1 (DE)

-

2

Total

4

2

3

5

6

20

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

54

ANNEX	II

LABORATORY	TESTS	—	METHODOLOGY

1. 

2. 

The Court commissioned laboratory tests for 73 products that were bought during the Member States’’ 
visits. In each Member State, one of the control bodies visited was asked to carry out laboratory tests on 
the products bought by the Court. Sampling and testing had to be done following the control bodies’ 
own procedures and practices. The Court’s auditors selected and bought the products, and the control 
body was asked to (1) choose the substances for which each product had to be tested; (2) choose 
the laboratory/laboratories it usually works with; (3) take the samples following its normal procedures; 
(4) send the laboratory results to the Court. The interpretation of the analytical results was carried out 
by an expert contracted by the Court for this purpose. 

From the 73 samples analysed, 67 samples were subject to a single type of analysis while six samples 
were subject to two different types of analysis. This resulted in a total of 79 analyses including tests for 
pesticides, antibiotics, GMO, heavy metals and conservation agents. 

TABLE	—	OVERVIEW	OF	ALL	PRODUCTS	FOR	WHICH	LABORATORY	TESTS	WERE	
COMMISSIONED	AND	CORRESPONDING	TESTS

Product code Court

Country

DE-01

DE-02

DE-03

DE-04

DE-05

DE-06

DE-07

DE-08

DE-09

DE-10

DE-11

DE-12

DE-13

DE-14

DE-15

DE-16

DE-17

DE-18

DE-19

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Product

Shrimps

Bilberries

Manouri cheese

Paprika

Eggs

Plums

Banana chips

Lemonade

Cereal muesli

Green tea

Tea

Olive oil

Olive oil

Fig jam

Linseed

Wheat bran

Plums with chocolate

Dates

Cane sugar

Type of analysis

Heavy metals, conservation agents

Pesticides

Cow milk

Pesticides

Roll marks

Pesticides

Pesticides

GMO

Pesticides

Pesticides

Pesticides

Pesticides

Pesticides

Pesticides

Pesticides, GMO

Pesticides, GMO

Pesticides

Pesticides

Heavy metals

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

55

Product

Soy beans

Type of analysis

Pesticides, GMO

Blue poppy seeds

Heavy metals, pesticides

Honey

Ginger

Neck chops

Mayonnaise

Olive oil

Baguette

Manzanilla olives

Eggs

Courgette garnish

Olive oil bread sticks

Mandarine jam

Paraguay tea

Fried potatoes

Chocolate

Cane sugar

Quince spread

Fresh goats’ cheese

Grapefruit

Fresh milk

Apples

Pumpkin seeds

Tomato soup

Hibiscus juice

Sushi rice

Oat drink

Pears

Milk

Apples

Maize oil

Fruit pulp

Potatoes

Bacon

Prawns

Avocado

Lamb mince

GMO

Pesticides

Conservation agents

Pesticides

Pesticides

Pesticides

Pesticides

Conservation agents

Pesticides

Pesticides

Pesticides

Pesticides

Pesticides

Pesticides

Pesticides

Pesticides

Pesticides

Pesticides

Pesticides

Pesticides

Pesticides

Pesticides

Pesticides

Pesticides

Pesticides

Pesticides

Antibiotics

Pesticides

Pesticides, GMO

Pesticides

Pesticides

Antibiotics

Antibiotics

Pesticides

Antibiotics

Product code Court

DE-20

DE-21

DE-22

DE-23

ES-01

ES-02

ES-03

ES-04

ES-05

ES-06

ES-07

ES-08

ES-09

ES-10

ES-11

ES-12

ES-13

ES-14

ES-15

ES-16

FR-01

FR-04

FR-05

FR-07

FR-08

FR-09

FR-10

FR-12

IT-01

IT-02

IT-03

IT-04

UK-01

UK-02

UK-03

UK-04

UK-05

Country

Germany

Germany

Germany

Germany

Spain

Spain

Spain

Spain

Spain

Spain

Spain

Spain

Spain

Spain

Spain

Spain

Spain

Spain

Spain

Spain

France

France

France

France

France

France

France

France

Italy

Italy

Italy

Italy

United Kingdom

United Kingdom

United Kingdom

United Kingdom

United Kingdom

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

56

Type of analysis

Antibiotics

Pesticides

Antibiotics

Pesticides

Pesticides

Pesticides

Pesticides

Pesticides

Pesticides

Pesticides

Pesticides

Pesticides

Pesticides

Pesticides

Pesticides

Pesticides

Pesticides

Product

Chicken breast

Oranges

Cheddar

Muesli

Walnut pieces

Sultanas

Honey

Sugar

Wild rice

Fruit-T-loaf

Radish

Fusilli

Baby food — Lancashire hotpot

Vinegar

Yerba mate

Green tea

Sweet potatoes

Product code Court

Country

UK-06

UK-07

UK-08

UK-09

UK-10

UK-11

UK-12

UK-13

UK-14

UK-15

UK-16

UK-17

UK-18

UK-19

UK-20

UK-21

UK-22

United Kingdom

United Kingdom

United Kingdom

United Kingdom

United Kingdom

United Kingdom

United Kingdom

United Kingdom

United Kingdom

United Kingdom

United Kingdom

United Kingdom

United Kingdom

United Kingdom

United Kingdom

United Kingdom

United Kingdom

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

57

ANNEX	III

OBSERVATIONS	CONTAINED	IN	SPECIAL	REPORT	NO	3/2005	CONCERNING		
MEMBER	STATES’	REPORTING	ON	ORGANIC	FARMING	TOGETHER	WITH		
AN	ASSESSMENT	OF	THE	CURRENT	SITUATION

Findings contained in SR 3/2005

Commission’s replies given to SR 3/2005

Court’s assessment of the current 
situation in 2011

Annual implementation reports

47. (a) Not all Member States send these  
supervision reports. 

There were no reports from Austria, for example. 
At the end of the audit (November 2004), of 
the 48 reports due over the period 2000–03 in 
respect of the 12 Member States obliged to file 
such reports, 15 had not been sent. The missing 
reports in respect of Austria, France, Ireland, 
Portugal, Spain and the United Kingdom have 
since been received.
47. (b) The reports are composed of a table 
with the number of visits carried out by the 
various private inspection bodies, the number 
of samples taken for analysis and the number of 
irregularities found and penalties applied. 

There is no conclusion on the functioning  
of the system.

47. (c) The Commission makes limited use  
of the reports.

47. (d) The quality is not always satisfactory and 
the reports include errors and inconsistencies. 
The Commission guidance states that ‘the reports 
submitted to the Commission so far have been a 
very mixed bag, making it difficult for the Com-
mission to have an overall view of implementa-
tion’. This situation still remained at the time of 
the Court’s audit.
48. Although Member States communicate the 
list of inspection bodies, not all send details of 
their standard inspection procedure annually.

49. The Court concludes that, even if these 
reports were complete and accurate, they would 
not give assurance about the objectiveness and 
effectiveness of the inspections carried out.

As of 1 January 2006 organic farming falls under 
the scope of Regulation (EC) No 882/2004 on 
official food and feed controls and should be 
covered by the MANCP and its related general 
annual report. Member States send these reports 
very late (see paragraph 42).

Completion of the standardised table is the 
minimum reporting requirement, though the 
‘guidance document’ states that ‘further informa-
tion may be submitted as Member States feel fit’. 

Information related to the organic control system 
in these annual reports is very limited. Most 
Member States do not provide an analysis of 
non-compliances detected nor basic data on the 
organic sector (see paragraph 42).

Some Member States also send a written report 
giving a description of their inspection system 
and drawing up conclusions on the inspections 
carried out.
These reports were of limited use for the 
evaluation of supervision by Member States’ 
authorities, but were nevertheless helpful to 
show whether all operators were submitted to 
inspections (see also paragraph 49).

This document aimed at giving some guidance 
to the Member States on the type and format 
of information they have to submit. The reports 
have since then been written in a more uniform 
format. The Commission has now embarked on a 
process of improving the format and the content 
of the supervision report, in cooperation with the 
Member States.
These reports give a number of indications on 
the inspection system in place such as confirma-
tion of the number of inspection visits carried 
out, which is at the least very close to, and in 
most cases exceeds, the number of operators, 
and the number of infringements notified. 

The Commission identified in the European 
a ction plan on organic food and farming the 
need to improve the quality of the supervision 
reports.

The review of the annual reports by the  
Commission and its feedback focuses mainly on 
identifying missing information rather than on 
remarks with respect to content regarding design 
and functioning of the control system  
(see paragraph 51).
See assessment under finding 47. (b) in this 
table.

The Commission lacks basic information as 
regards the functioning of the control system in 
Member States (see paragraphs 51 and 52). 

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

58

REPLY OF THE 
COMMISSION

EXECUTIVE SUMMARY

V.
The Commission is aware of certain weaknesses in the con-
trol system and the risk of undermining consumer confi-
dence. Improving the supervision and control system is at 
the core of the Commission’s current action in the organic 
sector. The Commission is currently assessing the EU legal 
framework governing organic production. The issue of con-
trols is one of the main items covered by this assessment. 
The  legislation  may  subsequently  be  amended,  where 
necessary. 

VI. (a)
The Commission is making constant efforts to assist the 
Member States in exercising their supervisory role, mainly 
by providing them with relevant information on the proper 
functioning of the control system.

The Commission has recently made public a ‘Working doc-
ument of the Commission services on official controls in 
the organic sector’1 to assist Member States in implement-
ing the regulatory provisions regarding the organic farm-
ing  control  system.  Member  States  were  also  invited  to 
participate in training on organic farming that is currently 
ongoing  under  the ‘Better  training  for  safer  food’  initia-
tive. Both the working document and the training contain 
a section on the supervision of control bodies.

VI. (b)
Provisions stipulating exchange of information are con-
tained  in  the  EU  regulations  on  organic  produc tion. 
There are several channels through which Member States 
communicate with each other and the Commission: the 
Organic  Farming  Information  System  (OFIS),  an  IT  tool 
operated by the Commission; the organic farming page 
of the Communication and Information Resource Centre 
Administrator  (CIRCA);  and  the  Standing  Committee  on 
Organic Farming (SCOF). 2 The Commission is aware that 
improvements can be made and will further reflect upon 
this.

1  Version 8 July 2011 — presented to the SCOF on 27–28 September 2011 
(http://ec.europa.eu/agriculture/organic/files/eu-policy/data-statistics/
control_guidelines_version_08072011_en.pdf ).

2 

In 2011, nine 2-day SCOF meetings took place in Brussels.

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

VI. (c)
The assessment of traceability is part of the audits to be 
conducted as from this year (2012) by the Food and Veteri-
nary Office (FVO).

VI. (d)
The  Commission  is  mak ing  constant  effor ts  to  ensure 
that the control system functions properly. Some recent 
ex amples are: the Commission working document on con-
trols in the organic sector, made public mid-2011; specific 
audits of control systems put in place for organic farming 
both in Member States and third countries as from 20123; 
and  the  ongoing  assessment  of  the  EU  legal  framework 
governing organic production.

VI. (e)
Annual reports by the respective authorities in charge are 
the main source of information on recognised third-coun-
tries’ control systems. The Commission also collects, shares, 
and checks, with Member States, information on irregu-
larities concerning products from third countries and the 
results of their investigation.

The Commission is strengthening its supervision of recog-
nised third countries by improving the information flow 4 
and organising audits5.

As regards the existing backlog in assessing equivalence 
requests from third countries, the Commission has made 
progress and recently included two third countries in the 
list (Canada in 2011 and the United States in 2012).

3  The FVO has included in its programme of audits for 2012 two audits 
in Member States (Portugal and Poland) and one in a third country 
(India). The programme is made public at: http://ec.europa.eu/food/fvo/
inspectprog/index_en.htm.

4  Through providing a template for the annual report and formalising the 
internal supervision procedure.

5 

In 2012, the FVO will audit organic farming control systems in India.

59

REPLY OF THE  
COMMISSION

VI. (f )
The  Commission  ack nowledges  cer tain  weak nesses  in 
the system of import authorisations. Therefore, between 
June  2012  and  July  2015,  the  system  of  import  authori-
sations granted by Member States is going to be phased 
out and replaced by a system of recognised control bod-
ies, which will be directly managed and supervised by the 
Commission, thereby ensuring harmonised application of 
the import regime at the EU borders. This new system will 
enter into force as from 1 July 2012.

VII. (a)
The Commission agrees with this recommendation and is 
making constant efforts to facilitate Member States’ super-
visory role by providing them with relevant information 
and training on supervision.

See also the reply to point VI (a) above.

VII. (b)
In addition to the several existing communication channels 
referred to in the reply to point VI (b), new IT modules are 
being developed6. The Commission is aware that improve-
ments can be made and will further reflect upon this.

VII. (c)
The roles and responsibilities of actors are spelled out in 
the general food law 7, Regulation (EC) No 882/2004 and 
the EU regulations on organic production8. Nevertheless, 
better coordination between stakeholders and authorities 
in charge of controls in the food chain would improve the 
application  of  general  and  organic  traceability  require-
ments. The development of other tools, such as electronic 
certification or databases, could also improve traceability. 
The Commission will consider the need for improvement in 
the ongoing assessment of the EU legal framework govern-
ing organic production.

6  The  Commission  is  currently  developing  new  OFIS  modules  for 
communicating irregularities concerning imported products and for 
exchanging information with third countries and control bodies recognised 
as equivalent for certification of imports.

7  Traceability requirements laid down by the general food law apply to 
all food operators. The roles and responsibilities of the different actors are 
already clarified in Regulation (EC) No 178/2002 on the general principles 
and requirements of food law.

8  EU regulations on organic production do impose a number of additional 
traceability requirements on organic operators (e.g. specific record keeping).

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

60

REPLY OF THE  
COMMISSION

VII. (d)
The Commission has resumed specific audits on organic 
production in Member States (see the reply to point VI (d )
above). The purpose of these audits is to verify the imple-
mentation of EU regulations on organic production, with a 
specific focus on the implementation and functioning of 
the control system. In order to gather the necessary data 
and information, Member States’ reporting to the Commis-
sion could be improved.

VII. (e)
The Commission is making constant efforts to strengthen 
the supervision of equivalent third countries 9. Regarding 
the timely assessment of equivalence requests from third 
countries, the Commission has made progress recently (see 
the reply to point VI (e) above).

VII. (f )
The Commission agrees with the Court’s recommendation. 
The main challenge of the system of import authorisations 
is to ensure that the competent authorities of the 27 Mem-
ber States adopt a harmonised approach10. However, com-
munication  and  exchange  of  information  between  the 
main  impor ting  Member  States  is  improving:  Member 
States  meet  regularly  in  an  informal  impor t  group  and 
information is exchanged via CIRCA and OFIS. Furthermore, 
where necessary, the Commission coordinates the action 
taken by Member States in respect of import authorisa-
tions  granted  for  a  particular  product/operator/control 
body/third country if problems arise.

9  These efforts include the audits planned as from 2012 to third countries, 
providing the third countries with a template for the annual report, 
formalising internal procedures for supervision, and inviting third countries 
to participate in the training on organic farming organised under the ‘Better 
training for safer food’ initiative.

10  The Commission will verify the checks carried out by Member States 
on control bodies during the audits planned in the Member States as 
from 2012.

INTRODUCTION

15.
The Commission published the first list of recognised con-
trol bodies and authorities for the purpose of equivalence 
in Regulation (EU) 1267/2011 of 6 December 2011, applic-
able as from 1 July 2012. 

OBSERVATIONS

25.
In the ‘Working document of the Commission services on 
official controls in the organic sector’ 11, the Commission 
highlighted  the  need  for  documented  procedures  con-
cerning the supervision of control bodies (Chapter 6 — 
Super vision  of  control  bodies).  In  the  same  document, 
the Commission reminded Member States of the general 
requirement  for  competent  authorities  to  have  docu-
mented  procedures  (Chapter  4  —  Requirements  of  the 
Competent Authority responsible for official controls in the 
organic sector).

27.
The weaknesses reported by the Court in relation to this 
point pertain to the documentation of procedures rather 
than to their implementation. The information at the Com-
mission’s disposal does not allow it to conclude that the 
approval,  withdrawal  and  supervision  of  control  bodies 
in the Member States does not take place in line with EU 
regulation. See also the reply to points 30–37.

Box 1
The existence and quality of competent authorities’ pro -
cedures for the approval and supervision of control bodies 
was checked by the Commission as part of the pilot audit 
on organic farming in Austria in 2011 and will be system-
atically checked in all subsequent organic farming audits 
as from 2012. For more information on the audits, please 
see the reply to point 52.
See also the reply to point 25.

11  See footnote to the reply to point VI (a).

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

29. (a)
The list of operators and the summary report requested 
from the control bodies in accordance with Article 27(14) 
is not provided with the purpose of enabling the compe-
tent authority to verify that all operators were inspected 
at least once per year. Its main purpose is to inform the 
competent authority of which operators were certified as 
organic and provide it with a general overview of the activ-
ities of the control body in the given year.

A  practicable  way  for  the  competent  authority  to  verify 
compliance with the requirement for an annual inspection 
per operator is to verify the control body’s procedure upon 
its approval and then to verify its application by checking a 
sample of operator files during the annual supervision. Per-
forming a simple comparison between the number of con-
trols and the number of certified operators is not possible 
because some operators do not need to be visited every 
year whereas some operators, which have been identified 
as more risk-prone in the framework of a risk assessment, 
may require more frequent control visits.

29. (b)
Competent authorities may have cooperation agreements 
with the accreditation bodies regarding the supervision of 
control bodies. The main reason is to avoid duplication of 
work. However, the overall responsibility for the supervi-
sion of control bodies lies with the Member State’s compe-
tent authority for organic production.

Article 5 of Regulation (EC) No 882/2004 requires compe -
tent  authorities  who  delegate  a  control  task  to  audit  or 
inspect the control body, but the frequency of such audits 
or inspections is not specified.

61

REPLY OF THE  
COMMISSION

30. and 37. Joint reply 
Each Member State is responsible for verifying that a con-
trol  body  has  appropriate  procedures  and  that  they  are 
correctly implemented. A constant effort is made by the 
Commission  to  assist  Member  States  in  exercising  their 
responsibility. This assistance mainly consists in providing 
Member States with information on how the control sys-
tem should work. To this end, the Commission published 
a  working  document  on  official  controls  in  the  organic 
sector,  which  assists  Member  States  in  implementing 
regulatory provisions regarding the organic farming con-
trol  system.  A  specific  recommendation  is  made  to  the 
Member  States  concerning  the  risk  assessment  and  the 
risk-based approach (Chapter 8 — Risk-based approach). 
Furthermore, Member States may participate in the train-
ing on organic farming which is currently ongoing under 
the  Commission’s ‘Better  training  for  safer  food’  (BTSF) 
initiative. 

31.
The Commission agrees with the Court that the rotation of 
inspectors, although not specifically required by the regu-
lations, is a good practice to be followed by control bod-
ies. The Commission will include this recommendation in a 
future version of its working document on official controls 
in the organic sector. 

Box 2 
See the reply to point 31.

32.
The EU regulations on organic production consider sam-
pling  as  a  supplementar y  control  tool  that  becomes 
obliga tory in cases where the use of non-authorised sub-
stances is suspected. Control bodies and control authori-
ties  are  required  to  act  on  any  kind  of  suspicion.  In  its 
working document on controls, the Commission recom-
mends  the  sampling  policy  and  its  result  as  one  of  the 
areas to be verified by the competent authorities as part 
of the supervision of control bodies. The same document 
requires the competent authorities to report the number 
of  samples  analysed  to  the  Commission.  Sampling  and 
residue testing is one of the areas that was checked by the 
Commission as part of the pilot audit on organic farming 
in Austria in 2011 and will be systematically checked in all 
subsequent organic farming audits as from 2012.

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

33.
Please see the reply to point 32.

34.
See the reply to point 32.

35.
Sanctions policy is one of the areas that was checked by 
the Commission as part of the pilot audit on organic farm-
ing in Austria in 2011 and will be systematically checked in 
all subsequent organic farming audits as from 2012. 

36. and Box 4 - Joint reply 
Although further harmonisation might be sought, sanc-
tions are determined by Member States in line with the 
principles of subsidiarity and proportionality (as laid down 
in Article 55 of Regulation (EC) No 882/2004 on sanctions). 
Since a case-by-case assessment is required, the fact that 
an  identical  non-compliance  has  led  to  different  sanc-
tions is not automatically questionable: whether the oper-
ator ’s behaviour was intentional or mere negligence, or 
whether the non-compliance was a repeat or first occur-
rence might, inter alia, constitute aggravating or mitigat-
ing circumstances.

37.
In its supervisory role, the Commission monitors all cases 
of  irregularities  that  are  communicated  by  the  Member 
States in accordance with Article 92(2) of Regulation (EC) 
No 889/2008. However, such communication is limited to 
cases of irregularities concerning products traded between 
Member States.

As  from  2012,  the  FVO  will  carr y  out  specific  audits  on 
organic  production,  which  will  include  verification  that 
Member States apply appropriate enforcement measures 
and sanctions.

62

REPLY OF THE  
COMMISSION

38.
The  Commission  recognises  the  impor tance  of  proper 
exchange  of  information  between  the  control  system 
for  organic  production  and  the  control  system  for  agri- 
environmental payments. The need to set up a functioning 
communication system between the competent authority 
for organic production and competent authorities in other 
(horizontal) fields is also stressed by the Commission in the 
recently published working document on official controls 
in the organic sector, which underlines that irregularities 
found in organic farming should be systematically com-
municated to the relevant authorities in charge of EU rural 
development or the EU Fisheries Fund. 

39.
Although control bodies are not delegated bodies for the 
purposes  of  agri- environment  measures,  the  Commis-
sion  endorses  the  good  practice  of  sharing  information 
between different services and organisations involved in 
controls. The paying agencies have to perform their own 
controls on organic farming beneficiaries. Following the 
audits it carries out, the Commission gives recommenda-
tions and, if appropriate, applies financial corrections, in 
particular  when  exchanges  of  information  between  the 
services and organisations involved in checks are found 
insufficient  or  when  it  is  considered  that  controls  per-
formed by the paying agencies are not exhaustive and not 
independent from the controls carried out by the control 
bodies on their own.

40.
In the framework of the conformity audits on measure 214, 
the  Commission  ser vices  verify  the  flow  of  information 
between the competent authority for organic farming and 
the paying agency for rural development, and, if needed, 
recommend  setting  up  a  functioning  cross-notification 
system. The paying agencies assess whether beneficiar-
ies respect the EU regulations on organic production by 
checking the certificates provided by the control bodies in 
accordance with the relevant and regular controls for every 
beneficiary who is part of the scheme.

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

42.
Regarding the transmission of reports, the situation has 
improved significantly from 2010 onwards. The Commis-
sion has also specified, in its working document on offi-
cial controls in the organic sector, the minimum amount 
of  information  regarding  organic  controls  that  should 
be  included  in  the  annual  repor t.  Member  States  were 
reminded  of  their  obligation  to  include  information  on 
controls in the organic sector in the annual report at vari-
ous  meetings  organised  by  the  Commission  (Standing 
Committee on Organic Farming and multiannual national 
control  plan  (MANCP)  and  annual  repor t  (AR)  network 
meetings).

44.
As  the  wording  of  the  regulation  is  sufficiently  precise 
(‘immediately ’),  there  is  no  need  to  set  any  other  time 
frame. On the contrary, the establishment of such a time 
frame would imply that some delay would be tolerated. 
Member  States  were  reminded  at  the  SCOF  meeting  of 
7 July 2011 of their obligation to notify cases of irregulari-
ties immediately.

The regulation also states very clearly that ‘where a Mem-
ber State finds irregularities …’ (Article (92(2) of Regula-
tion  (EC)  No  889/2008),  implying  that  the  obligation  to 
notify irregularities applies at the time they are detected. 
In the example given by the Court, should the subsequent 
la borator y  results  prove  that  the  first  result  was  a  false 
posi tive,  the  Member  State  still  has  the  option  of  with-
drawing its notification and informing the other Member 
States of the reasons.

45.
Several  measures  have  been  taken  by  the  Commission 
with a view to ensuring that Member States reply to noti-
fications of irregularities in a timely manner. First of all, in 
January 2009 the Commission shortened the deadline for 
replying from 4 months to 30 calendar days. Furthermore, 
notifications of irregularities are discussed at each meet-
ing of the SCOF, at which the Commission indicates all the 
open  cases  for  which  the  30-day  deadline  for  reply  was 
not met and asks the Member States concerned to reply. 
The Commission also regularly sends written reminders to 
Member States.

63

REPLY OF THE  
COMMISSION

Box 5 
The  Commission  agrees  with  the  Court  that  such  data-
bases are a useful tool for strengthening the transparency 
and effectiveness of the organic farming control system. 
Control bodies in other Member States have developed 
similar databases. In order to allow the wider public to find 
out about operators and their products which are subject 
to  the  organic  farming  control  system,  the  Commission 
required  the  Member  States  to  publish  on  the  Internet 
updated lists of operators and their documentary evidence 
(Regulation (EU) No 426/2011).

48.
The Commission takes account of the Court’s comment. 
The assessment of traceability is part of the audits to be 
conducted by the FVO as from this year (2012).

49.
In order to standardise the appearance of the certificate 
issued by control bodies to operators who comply with 
the EU regulations on organic production, the Commis-
sion published a model of documentary evidence to be 
used throughout the EU in Annex XII to Regulation (EC) 
No 889/2008.

At  the  initiative  of  the  Commission,  Regulation  (EC ) 
No 889/2008 was amended in May 2011 in order to include 
a provision on publication of the list of organic farming 
operators in each Member State, including updated infor-
mation on their documentary evidence (Regulation (EC) 
No 426/2011).

Box 6 
The Commission closely follows cases of fraud occurring in 
the EU and makes sure that the relevant authorities carry 
out a thorough analysis and investigation. The Commission 
also actively participates in the anti-fraud initiative, a joint 
private  initiative  founded  in  2007  that  brings  together 
stakeholders from the organic sector with the aim of dis-
cussing common approaches to ensuring organic integ-
rity. The Commission is making ongoing efforts to improve 
the effectiveness of the organic farming control system12. 
The Commission confirms that the case referred to by the 
Court in Box 6 is being investigated at national level.

12  A case in point is its recent initiative of requiring Member States to 
publish lists of organic farming operators, including updated information 
on their documentary evidence (Regulation (EC) No 426/2011).

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

50. and 51. Joint reply
The  Commission  considers  that  the  timeliness  of  Mem-
ber States’ reporting has improved since the time of the 
audit. However, the extent of coverage of official controls 
on organic farming is still limited and the Commission will 
encourage Member States to improve timely and substan-
tial reporting. This issue will be considered in the ongoing 
assessment of the EU legal framework governing organic 
production.

Apart  from  the  annual  reports,  the  Commission  obtains 
information on the functioning of the control system via 
other channels. A continuous exchange of information on 
infringements and irregularities takes place between the 
Member States and the Commission through OFIS. These 
issues are also regularly discussed by the SCOF, as are, on 
an ad hoc basis, other control-related matters. Recently, 
the  SCOF  had  an  extensive  exchange  of  information  on 
the control system in the context of the preparation of the 
working document on official controls13.

As part of general audit and general follow-up missions, 
Member States are reminded of the requirement to submit 
their annual reports in a timely manner. Similar remind-
ers  may  be  made  in  the  context  of  more  specific  audit 
missions.

Publication of the first Commission report under Article 44 
of Regulation (EC) No 882/2004, which includes comments 
on the Member States’ annual reports, has also increased 
the  pressure  on  all  parties  to  present  their  reports  in  a 
timely  manner. The  Commission  also  encourages  Mem-
ber States to present executive summaries of their annual 
reports, following agreed criteria, to allow more consistent 
understanding of the report and to overcome translation 
difficulties (some reports are several hundred pages long).

13  The document was discussed at SCOF meetings on 14–15 December 2009, 
1 March 2010, 26 April 2010, and 16–17 June 2010.

64

REPLY OF THE  
COMMISSION

52.
Working arrangements between the Agriculture and Rural 
Development DG and the Health and Consumers DG were 
agreed in the form of a memorandum of understanding 
signed in December 2011 and, as a result, the FVO included 
specific audits on organic production in its regular annual 
inspection programme as from 2012.

The audits performed before 2001, mentioned in the first 
footnote to point 52, were subject to specific follow-up by 
the Commission. 

53.
The information received by the Member States can vary; 
it depends on the variety and number of the agri-environ-
mental sub-measures present in the Member State/region. 

54.
Apart from the infringement procedure, which is to be ini-
tiated for all cases of persistent, overall non-application 
of  EU  law,  the  Commission  currently  does  not  have  any 
other enforcement measures specific to the organic sec-
tor. Its duration notwithstanding, the infringement pro-
cedure generally has a positive impact on Member State 
compliance.

58.
In  2011,  the  Commission  ser vices  prepared  an  internal 
procedure regarding the inclusion of third countries. The 
procedure provides for a detailed description of the rec-
ognition  process  and  contains  standardised  check lists 
and  working  papers  for  documentar y  and  on-the -spot 
assessment.

59.
The  Commission  has  recently  made  progress  with  the 
assessment of some third countries, resulting in the inclu-
sion of Tunisia in 2009, Japan in 2010, Canada in 2011 and 
the United States in 2012. Intensive work on several other 
applications is ongoing.

60. and 61. Joint reply
The Commission services are developing an internal pro-
cedure for the supervision, management and review of the 
list of equivalent third countries in order to formalise and 
standardise the work. In 2011, the Commission introduced 
a  standardised  template  for  the  assessment  of  annual 
reports referring to the year 2010. Where appropriate, the 
analysis prompted the Commission to send a request for 
additional  information  to  the  concerned  countries.  All 
replies have been received.

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

65

REPLY OF THE  
COMMISSION

62.
The analysis performed by the Court related to the 2009 
annual reports. In 2011, the Commission sent to the listed 
third countries a detailed template explaining the type of 
information that needs to be contained in the report. As 
a result, the quality of the 2010 reports improved. Where 
necessary, the Commission sent a request for additional 
information (see the reply to point 61)14.

63.
The Commission services are developing an internal pro-
cedure for the supervision, management and review of the 
list of equivalent third countries. As from 2012, the FVO 
will carry out on-the-spot audits in listed third countries as 
part of its annual auditing. The FVO programme of audits 
for 2012 includes an audit of organic farming in India15. 

64.
The Commission has recently taken steps to strengthen the 
supervision of listed third countries, including the devel-
opment of a detailed internal procedure, a template for the 
annual report and its assessment and audits in listed third 
countries. For details see replies to points 60–63.

67.
In order to overcome the intrinsic weaknesses of the sys-
tem of import authorisations, the system is being phased 
out and replaced by a system of recognised control bod-
ies for the purpose of imports, which enters into force as 
from  1  July  2012  and  is  under  the  Commission’s  direct 
management.

14  For example, at the request of the Commission, Israel has sent detailed 
information about its 2009/10 annual report. Details about the scope of the 
assessment, the evaluation, the findings (non-compliance), corrective action 
and the status of corrective actions of each approved control body have 
been provided. The report also stated that, where pesticide residues were 
found, the operator was immediately suspended. Thorough investigations 
were conducted by the control bodies and corrective actions were taken 
by the administration.

15  Please see the footnote to reply to point VI (d).

68–70. Joint reply
Member  States  can  issue  an  impor t  authorisation  only 
if there is (1) sufficient evidence that the products were 
produced in accordance with equivalent production rules 
and (2) the operators were subject to control measures of 
equivalent effectiveness (Article 19(1) of Regulation (EC) 
No 1235/2008). Member States can accept a certificate of 
inspection only if it is issued by a control body that can 
guarantee that the abovementioned two conditions were 
met for the products and operators in question. The sys-
tem for issuing import authorisations was checked by the 
Commission as part of the pilot audit on organic farming in 
Austria in 2011 and will be systematically checked during 
all subsequent organic farming audits as from 2012.

72.
It is the responsibility of the competent authority of the 
Member  State  to  verify  the  competence  of  the  control 
body to issue a certificate of inspection, and in particu-
lar  the  evidence  that  the  conditions  referred  to  in  Art-
icle 19(1) of Regulation (EC) No 1235/2008 are met, before 
granting an import authorisation. The system for issuing 
import authorisations was checked by the Commission as 
part of the pilot audit on organic farming in Austria in 2011 
and will be systematically checked during all subsequent 
organic farming audits as from 2012.

73.
T h e   g u i d e l i n e s   r e f e r r e d   t o   ( C o m m i s s i o n   D e c i s i o n 
2008/654/EC) specify the information which Member States 
are required to report in accordance with Article 44(1) of 
Regulation (EC) No 882/2004.

While Member States are not expected to include infor-
mation on import authorisations they have granted in the 
annual  reports,  they  are  required  to  enter  each  import 
authorisation in the specific module of OFIS. The module 
gives the Commission and the Member States access to 
up-to-date, standardised information on all import author-
isations granted across the EU.

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

66

REPLY OF THE  
COMMISSION

77.
Member States should have the relevant information and 
expertise  necessar y  for  granting  import  authorisations: 
the requests and all supporting documents are submitted 
by an importer directly to them. Withdrawing an import 
authorisation as provided for by Article 19 of Regulation 
(EC) No 1235/2008 has not proved necessary so far. The 
Commission has made use of Article 19 in order to facili-
tate harmonisation in the approaches developed individu-
ally by each of the 27 Member States’ competent authori-
ties, and to force the Member States to re-examine some 
specific cases where necessary.

Box 8 
The  communications  issued  by  the  Commission  to  the 
Member States constituted only a recommendation and 
cannot be considered as an official request for withdrawal 
pursuant to Article 19(3) of Regulation (EC) No 1235/2008.

79.
The Commission considers proper controls on imported 
products a high priority. It convened a specific meeting 
of the SCOF on 22 June 2011 in order to discuss the new 
system of recognised control bodies and related controls 
on imported products. At the meeting, the Commission 
reminded Member States of the basic architecture of the 
EU control system and their control obligations regarding 
imported  products.  Furthermore,  checks  on  controls  of 
imports are included by the Commission in the scope of 
the specific audits on the Member States’ control systems.

74.
The Commission systematically requests Member States 
to use OFIS 16. The Commission also provided training for 
Member States on the uses of OFIS in response to remarks 
concerning difficulties in using the system expressed by 
some Member States.

75.
Regarding  imports,  the  work  of  the  SCOF  concentrated 
mainly  on  implementation  of  the  new  impor t  regime 
(Regulation  (EC )  No  1235/2008). The  system  of  impor t 
authorisations is a transitional measure that is going to be 
phased out and replaced by a system of recognised control 
bodies, which will be directly managed and supervised by 
the Commission, ensuring harmonised application of the 
import regime at the EU borders. Cases presenting diffi-
culties under the system of import authorisations are dis-
cussed with a view to ensuring that Member States adopt 
a harmonised approach, such as in the case mentioned by 
the Court in Box 8.

76.
As  from  2012,  the  FVO  will  carr y  out  specific  audits  on 
organic  production  (see  the  reply  to  point  52) 17. These 
audits  will  include  the  system  of  import  authorisations. 
During  the  pilot  audit  carried  out  in  Austria  in  2011, 
the Commission found that the Member State itself had 
decided to take action in order to improve the quality of 
import authorisations issued. In that Member State, the 
issuing of import authorisations, which was previously car-
ried out at regional level, had been centralised to a single 
point in order to harmonise the system.

16  In 2011, the Commission requested Member States to use OFIS at every 
SCOF meeting.

17  The FVO has included in its programme of audits for 2012 one audit of 
a third country (India).

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

CONCLUSIONS AND RECOMMENDATIONS

80.
The Commission is aware of certain weaknesses in the con-
trol system and the risk of undermining consumer confi-
dence. Improvement of the supervision and control sys-
tem is at the core of the Commission’s current action in the 
organic sector.

81.
The  Commission  is  making  constant  efforts  to  help  the 
Member States in exercising their supervisory role, mainly 
by providing them with relevant information on the proper 
functioning of the control system.

The  Commission  recently  made  public  a  working  docu-
ment on official controls in the organic sector 18 to assist 
Member  States  in  implementing  the  regulator y  provi-
sions regarding the organic farming control system. Mem-
ber States were also invited to participate in training on 
organic farming that is currently ongoing under the ‘Better 
training for safer food’ initiative. Both the working docu-
ment and the training contain a section on the supervision 
of control bodies.

Recommendation 1
The Commission agrees with this recommendation and is 
making constant efforts to facilitate Member States’ super-
visory role by providing them with relevant information 
and training on supervision.

See also the reply to point 81 above. In addition, the Com-
mission  is  currently  assessing  the  EU  legal  framework 
governing organic production. The legislation may subse-
quently be amended, where necessary.

18  Please see the footnote to reply to point VI (a).

67

REPLY OF THE  
COMMISSION

82.
Provisions stipulating exchange of information are con-
tained in the EU regulations on organic production.

The Commission regularly reminds Member States of these 
provisions and makes every effort to provide them with 
tools facilitating exchange of information. There are several 
channels through which Member States communicate with 
each other and the Commission.

Recommendation 2
There are several channels through which Member States 
communicate with each other and the Commission: OFIS, 
an IT tool operated by the Commission; the organic farm-
ing  page  of  CIRCA;  and  the  SCOF 19. The  Commission  is 
currently  developing  new  OFIS  modules  for  communi-
cating  irregularities  concerning  imported  products  and 
for exchanging information with third countries and con-
trol  bodies  recognised  as  equivalent  for  certification  of 
imports.

83.
The assessment of traceability is part of the audits to be 
conducted as from this year (2012) by the FVO.

Recommendation 3
The roles and responsibilities of actors are spelled out in 
the general food law20, Regulation (EC) No 882/2004 and 
the EU regulations on organic production 21. Nevertheless, 
better coordination between stakeholders and authorities 
in charge of controls in the food chain would improve the 
application  of  general  and  organic  traceability  require-
ments. The development of other tools, such as electronic 
certification or databases, could also improve traceability. 
The Commission will consider the need for improvement in 
the ongoing assessment of the EU legal framework govern-
ing organic production.

19  In 2011, nine 2-day SCOF meetings took place in Brussels.

20  Traceability requirements laid down by the general food law apply to 
all food operators. The roles and responsibilities of the different actors are 
already clarified in Regulation (EC) No 178/2002 on the general principles 
and requirements of food law.

21  EU regulations on organic production do impose a number of additional 
traceability requirements on organic operators (e.g. specific record keeping).

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

68

REPLY OF THE  
COMMISSION

Recommendation 5
The Commission is making constant efforts to strengthen 
the supervision of equivalent third countries 23. Regarding 
the timely assessment of equivalence requests from third 
countries, the Commission has made progress recently. 

86.
The Commission acknowledges certain weaknesses in the 
system of import authorisations. Therefore, between June 
2012 and July 2015, the system of import authorisations 
granted by Member States is going to be phased out and 
replaced by a system of recognised control bodies, which 
will  be  directly  managed  and  super vised  by  the  Com-
mission, ensuring harmonised application of the import 
regime at the EU borders. This new system will enter into 
force as from 1 July 2012.

Recommendation 6
The  Commission  agrees  with  the  recommendation  of 
the  Court. The  main  challenge  of  the  system  of  import 
authoris ations is to ensure that the competent authorities 
of the 27 Member States adopt a harmonised approach24.

However,  communication  and  exchange  of  information 
between  the  main  importing  Member  States  is  improv-
ing. Member States meet in an informal import group and 
information is exchanged via CIRCA and OFIS. Furthermore, 
where necessary, the Commission coordinates the action 
taken by Member States in respect of import authorisa-
tions  granted  for  a  particular  product/operator/control 
body/third country if problems arise.

23  These efforts include the planned audits as from 2012 to third countries, 
providing the third countries with a template for the annual report, 
formalising internal procedures for supervision, and inviting third countries 
to participate in the training on organic farming organised under the ‘Better 
training for safer food’ initiative.

24  The Commission will verify the checks carried out by Member States 
on control bodies during the audits planned in the Member States as 
from 2012.

84.
The  Commission  is  mak ing  constant  effor ts  to  ensure 
that the control system functions properly. Recent exam-
ples are the Commission working document on controls 
in the organic sector, made public mid-2011, or the spe-
cific audits planned of the control systems put in place for 
organic farming in both Member States and in third coun-
tries as part of the FVO programme of audits for 201222. 

Recommendation 4
The Commission has resumed specific audits on organic 
production in Member States. The purpose of these audits 
is  to  verify  the  implementation  of  EU  regulations  on 
organic production, with a specific focus on the implemen-
tation and functioning of the control system. Additionally 
the Commission has worked with the Member States to 
improve both the quality and timeliness of reporting on 
control activities in order to gather the necessary data and 
information, and the situation regarding reporting is now 
much improved.

85.
Annual  reports  submitted  by  the  respective  authorities 
in charge are the main source of information at the Com-
mission’s disposal on control systems of recognised third 
countries. In addition, the Commission collects, informs 
and checks, with all Member States, information on irregu-
larities concerning products from third countries and the 
results of their investigation.

The Commission is strengthening its supervision of recog-
nised third countries by improving the information flow 
(through providing a template for the annual report and 
formalising the internal supervision procedure) and organ-
ising  audits  (the  FVO  has  included  in  its  programme  of 
audits 2012 one audit in a third country (India)).

As regards the existing backlog in assessing equivalence 
requests from third countries, the Commission has made 
progress with the assessment and recently included two 
third  countries  in  the  list  (Canada  in  2011  and  United 
States  in  2012).  For  fur ther  details  see  the  replies  to 
points 58–64.

22  Please see the footnote to reply to point VI (d).

Special Report No 9/2012 – Audit of the control system governing the production, processing, distribution and imports of organic products

European Court of Auditors

Special Report No 9/2012
Audit of the control system governing the production, processing, distribution and imports of organic products

Luxembourg: Publications Office of the European Union

2012 — 68 pp. — 21 × 29.7 cm

ISBN 978-92-9237-669-7
doi:10.2865/50111

HOW	TO	OBTAIN	EU	PUBLICATIONS

Free	publications:

• 

• 

via EU Bookshop (http://bookshop.europa.eu);

at the European Union’s representations or delegations. You can obtain their contact details 
on the Internet (http://ec.europa.eu) or by sending a fax to +352 2929-42758.

Priced	publications:

• 

via EU Bookshop (http://bookshop.europa.eu).

Priced	subscriptions	(e.g.	annual	series	of	the	Official Journal of the European Union	
and	reports	of	cases	before	the	Court	of	Justice	of	the	European	Union):

• 

via one of the sales agents of the Publications Office of the European Union 
(http://publications.europa.eu/others/agents/index_en.htm).

 
 
Q
J
-
A
B
-
1
2
-
0
0
7
-
E
N

-
C

THE MARKET FOR ORGANIC PRODUC TS IS HIGHLY DEPENDENT ON CON-

SUMER  CONFIDENCE.  ACCORDINGLY,  EU  LEGISLATION  WAS  DESIGNED 

TO ENSURE THAT CONSUMERS CAN BE SURE THEY ARE BUYING ORGANIC 

PRODUCTS WHEN THEY ARE LABELLED AS SUCH. THE SYSTEM OF CHECKS 

LAID  DOWN  IN THE  LEGISLATION  AIMS  AT VERIFYING  AND  CERTIFYING 

THAT EACH OPERATOR IN THE SUPPLY CHAIN (E.G. FARMERS, PROCESSORS,  

IMPORTERS) APPLIES THE ORGANIC PRODUCTION RULES CORRECTLY. THE 

COURT AUDITED THE APPLICATION OF THE EU RULES THAT APPLY TO THIS 

SYSTEM OF CHECKS. 

IN ORDER TO GAIN SUFFICIENT ASSURANCE THAT THE SYSTEM IS OPERAT-

ING EFFECTIVELY AND TO PROTECT CONSUMER CONFIDENCE, THE WEAK-

NESSES THE COURT HAS IDENTIFIED SHOULD BE REMEDIED  BOTH AT THE 

LEVEL OF THE EUROPEAN COMMISSION AND IN THE MEMBER STATES.

EUROPEAN COURT OF AUDITORS