WORLD TRADE  
ORGANIZATION   
G/SPS/GEN/1095 
23 June 2011 
 (11-3112) 
Committee on Sanitary and Phytosanitary Measures Original:   English 
  
 
THE EUROPEAN UNION'S APPROACH TO SPS AUDITS 
AND INSPECTIONS IN THIRD COUNTRIES 
 
Communication from the European Union 
 
 
 The following communication, received on 22 June 2011, is being circulated at the request of 
the Delegation of the European Union. 
 
_______________ 
 
  The European Union is pleased to share its experience on its systems-based approach to 
audits and/or inspections in the assessment of expor ting partners' control systems.  This approach is 
built on recognition of the ability of exporting countries to provide sufficient guarantees to demonstrate that their exports meet the EU's leve l of sanitary protection.  The system promotes the 
idea that establishments in third countries can be lis ted as being eligible for export to the European 
Union on the basis of these guarantees, with a view to facilitate trade flows and to avoid undue delays 
or overly burdensome costs.  It applies pre dominantly to imports of animal products. 
I. INTRODUCTION 
1. In general, to have access to markets for animal s, plants and their products, it is necessary to 
provide guarantees that the appropriate level of sanitary protection (ALOP) set by the importing 
country is satisfied.  Importing countries often verify these guarantees by carrying out spot audits and/or inspections in exporting countries. 
2. While significant human, material and financial resources are needed to perform such audits 
and/or inspections, the use of these resources must be  balanced with other considerations such as the 
need to facilitate market access, to avoid unjustif ied delays and to avoid exorbitant costs.  
3. Parameters for audits and/or inspections are set out by the Codex Alimentarius which gives 
clear preference to the evaluation of official insp ection and certification systems rather than specific 
commodities or establishments.
1 
4. In keeping with this, the European Union reli es on an audit system that seeks to provide full 
confidence in the exporting country's competent auth orities and their ability to provide guarantees that 
meet the appropriate level of sanitary protecti on (ALOP) set by the European Union for those 
products they are seeking to export to the European Union. 
5. This audit system relies on the official controls performed by the competent authorities of 
exporting countries.  By building confidence in the inspection and certification systems of these third 
                                                      
1 Principles and Guidelines for the Conduct of A ssessment of foreign Inspection and Certification 
systems, Annex to CAC/GL 26-1997. G/SPS/GEN/1095 
Page 2  
 
  countries, the European Union does not engage in the overly burdensome task of inspecting each and 
every establishment seeking to expo rt to the European Union. 
6. The system mainly applies to animal products which are perceived to pose the highest risks. 
II. DESCRIPTION OF THE EU SYSTEM 
7. To be authorized to export a certain commodity  to the European Union, an exporting country 
first has to demonstrate that its offi cial controls fulfil EU requirements.
2  Once this is proven to be the 
case and after the European Union has verified  the guarantees including where necessary an on-the-
spot audit - the country is formally approved to export to the European Union. 
8. The competent authority of the exporting country is subsequently able to set in motion a 
process of assessing the eligibility of establishments within its territory to export to the European 
Union.  If the exporting country's competent author ity sees that an establishment meets the relevant 
EU import conditions, it can place the establishment on a list (often termed a " pre-list ") of exporting 
establishments that meet relevant EU conditions.  Th is list is subsequently proposed to the European 
Union and thereon serves as a list of establishments  from which EU member States are authorised to 
import.  The list is also published on the Internet.3 
9. The competent authority of the exporting country  is responsible for keeping the list updated 
by adding or deleting establishments or by modifying information pertaining to an approved 
establishment, as appropriate.  
10. Subsequent audits to the exporting country are carried out by the European Union on a regular 
basis to check if the exporting country's official  control systems continue to provide the necessary 
guarantees for export. 
11. This system is informally referre d to in the European Union as the "pre-listing system"  which 
underlines the recognition of the competence and au thority of a third country to list its own 
establishments eligible to export to the European Unio n.  It is applicable to all trading partners.  
III. CONFORMITY TO INTERNATIONAL STANDARDS 
12. EU audits follow international standards laid  down by the Codex Alimentarius which give a 
clear preference to the evaluation of official insp ection and certification systems rather than specific 
commodities or establishments.4 
13. EU audits also include inspections of a sa mple of the establishments involved.  These 
inspections are planned, open to scrutiny, and pe rformed on the basis of internationally recognised 
audit methodologies (in line with ISO 19011).  
14. They are carried out by the EU's audit and inspection service:  the Food and Veterinary 
Office.  The costs of travelling and the accommodati on of EU auditors are fully paid for by the 
European Union.  There are no audit fees to be paid - before, during or after the audits - by the visited 
                                                      
2 The EU import conditions referred to in this note  correspond to the general conditions as described 
under Article 11 of Regulation (EC) No: 178/2002, including the equivalence principle of the WTO SPS 
Agreement. 
3 Third country establishments lists - http://ec.europa.eu/food/international/trade/third_en.htm . 
4 Principles and Guidelines for the Conduct of A ssessment of foreign Inspection and Certification 
systems, Annex to CAC/GL 26-1997.  G/SPS/GEN/1095 
 Page 3 
 
 
  countries or establishments.  Both the audit body  and audit process are independent in order to 
guarantee objective and un-biased results.  Audit re ports are made publicly available on the Internet.5 
15. By developing a system to manage audits and inspections and the authorization of 
establishments in this manner, the European Union not only guarantees a high level of safety of traded 
agri-food commodities, it also respects its appropriate  level of sanitary protection in a resource and 
trade-friendly manner. 
IV. THE SITUATION TO DATE AMONGST WTO MEMBERS 
16. According to the experience of the European Union, audit and inspection approaches which 
do not follow the Codex Alimentarius  guidelines result in unjustified delays, create discriminatory 
treatment between trading partners and are not in lin e with WTO requirements, in particular as set in 
Annex C of the WTO SPS Agreement.  
17. The European Union notes with regularity that many of its trading partners do not follow 
these guidelines with the negative consequences outlined below. 
18. There are also differences in the import pro cedures and the frequency of audits/inspections 
from country to country. 
19. While there are a number of trading partners applying "best practice" in their import control 
systems, there are also a wide range of  trade-prohibitive practices, which the EU "pre-listing" system 
was specifically designed to avoid.  In particular: 
(a) Unclear and cumbersome audit/inspection procedures - some audits and/or 
inspections lack planning:  they are not systematic, poorly communicated, or not reported at all to the competent authority of the visited country. 
(b) Long delays for export approval to be gran ted - countries seeking to export to another 
country often have to wait a very long period of time for an inspection that will potentially allow market access.  This is often due to a lack of - or the improper use of - human and/or financial resources.  In some cases, it can take up to ten years for an exporting country to receive a visit from an importing country. 
(c) Excessive costs – costs that do not necessarily reflect the real cost of the 
audit/inspection are often charged to inspect  establishments or competent authorities, 
or both;  
(d) Temporary approval granted - exporting est ablishments are often only approved on a 
temporary basis, many years after the original application. 
(e) Lists of establishments are updated only after long delays. 
(f) Differentiated treatment - trading partners in  a similar situation are treated differently. 
(g) Lack of reciprocity - there is little, if any, reciprocity from trading partners despite the 
fact that the European Union app lies its system equally to all. 
20. Some WTO Members do manage imports and the authorization of establishments on the basis 
of an evaluation of official inspection and certification systems in a manner similar to that of the 
                                                      
5 The Food and Veterinary Office - http://ec.europa.eu/food/fvo/index_en.cfm . G/SPS/GEN/1095 
Page 4  
 
  European Union.  This results in an efficient and effective use of human resources, facilitation of 
trade and is able to deliver the appropria te level of sanitary protection required. 
V. ADVANTAGES OF THE EU SYSTEM 
21. Rights and obligations of the WTO SPS Agreem ent - The European Un ion manages imports 
in general, and the lists of exporting establishments in particular, respecting the rights and obligations 
of the WTO SPS Agreement. 
22. International standards - The EU appr oach recognizes, in line with the Codex Alimentarius 
(cf. CAC/GL 20-1995, CAC/GL 26-1997), that official and officially recognized inspection and 
certification systems are fundamentally important to build and maintain the necessary confidence in the inspection and certification system of an expor ting country and to facilitate fair trade, taking 
account of the expectations of consumers. 
23. Non-discrimination - The EU audit-based principles and the management of establishments 
are non-discriminatory as they apply equally to all the EU's trading partners. 
24. Minimal disruptions to trade - The EU system is designed to minimize disruptions to trade 
while maintaining an appropriate level of sanitary protection. 
25. Risk based approach - The audit system target s those commodities that pose the highest risk.  
This means that it is not imposed on all animals, plants and their products imported into the European 
Union.  When a particular commodity or country, on the basis of an identifiable risk, requires an audit 
in order to verify that it meets the relevant EU  import conditions, the procedures and objectives of the 
evaluation are communicated to the exporting compet ent authority in advance.  This is an ongoing 
relationship which must be constantly assessed a nd maintained.  Confidence in the competent 
authority of exporting countries is not only assessed by  audits and/or inspection but also on the basis 
of controls at EU borders.  The frequency of foll ow-up audits is limited to what is considered 
necessary to maintain confidence. 
26. Transparency - The EU import conditions and lists  of authorised establishments are publicly 
available, and on-the-spot inspections/audits are planned, systematic, consistent, fully-documented 
and well-communicated to trading partners. 
27. Equivalence – The principle of equivalence is  recognized whereby an exporting country may 
choose either to implement specific EU measures or to demonstrate that their own sanitary measures 
provide, at least, equivalent guarantees to achieve th e EU's appropriate level of sanitary protection. 
28. Efficiency and efficacy - The European Union a pplies a flexible, efficient and swift working 
system to manage lists of third countries and e xporting establishments.  The EU approach focuses on 
the performance of competent authorities, who ar e responsible to guarantee compliance with EU 
import requirements for exported products, including h ealth verifications where necessary, rather than 
evaluating each and every exporting establishment.  Th e EU approach makes the best possible use of 
limited human and financial resources and avoi ds unnecessary costs and unjustified delays. 
29. Independence - To guarantee the independence of the audit body and the audit process, 
ensuring that it is sufficiently detached from entities which have a direct trade or commercial interest, 
the audit body is located in the European Commis sion's Directorate General responsible for Health 
and Consumers.  All the costs of audits are also  covered by the EU budget, to avoid any potential 
conflict of interest.  G/SPS/GEN/1095 
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  30. Evidence-based - The confidence n eeded for a swift listing of establishments is largely based 
on evidence collected during audits which rely on th e examination of a sample of system procedures, 
documents or records and, where required, a selection of sites (including a representative sample of exporting establishments, i.e. not necessarily all establishments) within the scope of the system under 
audit.  This is distinct from the necessity to insp ect all procedures, records and production sites.  The 
main objective of these audits is to build confid ence in the competent authority of the exporting 
country and on-site verification is used only to the extent necessary to achieve that objective.  
31. In conclusion, the European Union not only guar antees a high level of safety in traded agri-
food commodities, it does this in a resource and trade-friendly manner . 
 
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