3rd Countries not approved for Export to EU

1. What are the requirements we shall comply with?

The country shall demonstrate that it has measures in place to ensure at least equivalence with key aspects of the EU regulation that apply to the products (Regulation (EC) 178/2002 article 11, Regulation (EC) 882/2004 article 47, Regulation (EC) (EC) 882/2004 article 48 point 3 and 4, Regulation (EC) 854/2004 article 11). Such equivalence shall be guaranteed only for establishments that want to be approved for export to EU and the part of the official administration which is assigned as competent authority for official control of this type of products and these establishments. Establishments and authorities not involved in export to EU can continue to operate in accordance with national regulations, even if these do not comply with EU requirements. For more details Link (to screen 2B). The key aspects in the EU regulation for which equivalence shall be demonstrated relates to:

policies and principles (Reg. 178/2002, mainly articles 14, 17, 19 )
hygiene requirements to all food business operators (Reg. 852/2004)
special product and process requirements to food of animal origin (Reg. 853/2004)
structure and organization of the Competent Authority and its control services (Reg. 882/2004, mainly chapter II and Chapter III, and 854/2004, mainly article 11)

the effective implementation of official controls (Reg. 882/2004, mainly chapter II and Chapter III, and 854/2004, mainly article 11)
the applied health criteria for certain products (Reg. 2073/2005, 2074/2005, 1881/2006, Reg. 396/2005 )
the applied analytical test methods and performance criteria (Reg. 1883/2006, 333/2007, 657/2002)

To be approved for export of products of animal origin it is further required to adopt equivalent legislation regarding authorization, distribution, use and control of veterinary medicines, production, distribution and use of feed, and specifically it is required to adopt the requirements to implement a monitoring program for residues of veterinary medicines and environmental contaminants. (Reg. 2377/90, Dec. 2003/181, Dec. 2004/25, Dir. 96/22, Dir. 2001/82, Dir. 2004/28, Reg. 183/2005 and Dir. 96/23). See also other questions with more specific information and references on this issue.

For import of live animal products specific requirements to control of animal health shall be complied with, see the web-site referred to below for details.

Please consult the Dg Sanco web-site for detailed information and access to documents.
For import of live animal products, please consult the link to the dedicated page on DG SANCO's web-site for detailed information and access to documents.

All legal documents can also be downloaded from EUR-LEX. To most of the regulations different amendments has been issued. The relevant amendments will be found under "Bibliographic Notes" for each document. At certain intervals "Consolidated version" of a document will be issued. The consolidated version includes all amendments. Latest consolidated version should always be studied for updated information about requirements.

Guidelines explaining the main requirements and listing all relevant regulations are available on Hygiene Requirements (you can also check the on-line interactive guidelines), Import Regulations and Pesticide Residues.

2. Do we need to have official control implemented before we apply?

The response on the questionnaire which is a part of the application Link (to question 5) shall reflect the situation being or in process to be implemented and in the first FVO mission it shall be proved that all documents and procedures are adequately implemented.

3. Do we need to have monitoring programs for residues of veterinary medicines and environmental contaminants in place before we apply?

If the country wants to export products of aquaculture origin, the adequate monitoring programs according to Directive 96/23 shall be implemented at the time of the first FVO inspection.

4. Do we need to approve all companies for export to EU before we apply?

No, only operators that want to export to EU and that comply with all criteria shall be on the list. The list can be extended with more companies when they want to change their market strategy and comply with requirements. When it is relevant, he competent authority shall submit a list of changes to the list of approved companies to DG Sanco and the web-page shall be updated accordingly.
Please consult the Guidance to request updating of the list of approved establishments and the list of approved countries and business operators.

5. How do we apply?

A letter should be sent from the National Official Authority for control of food safety, to the European Commission, Health and Consumer Protection Directorate-General, Directorate D/Animal health and Welfare, requesting the process of approval to start. The Directorate will recognize the receiving of the letter and request the Official Authority to fill in a questionnaire requesting detailed information about the system of official control, including legal framework, competent authority organization, official controls etc.
For more information, please consult the process of application and an example of the questionnaire.

6. How much time does the approval procedure take?

The DG Sanco Food and Veterinary Office (FVO) will plan the first inspection when satisfactory response has been provided to all questions in the questionnaire and, if relevant, an adequate plan for the residue monitoring has been submitted. The FVO mission plans their inspection missions one year ahead.Please consult the website of FVOto browse the plans and the reports from all visits.

7. How will the FVO Inspection take place and what will be the purpose?

The regulations for the FVO missions to third countries are in Regulation (EC) 882/2004 article 46. The FVO inspection team will include 2-4 experts from different fields as appropriate, e.g. laboratory testing, residue monitoring, official control in general etc. The team will conduct an audit of the system of official control.

The scope of the audit will be to evaluate if the competent authority and the system of official control is adequate to ensure safe products from the country. This will be done by interview and inspection of Competent Authority staff, resources and facilities. Specifically the competent authority's ability to conduct adequate official controls will be verified through visits to business operators (fishing vessels, landing sites, aquaculture farms, processing industry, veterinary medicines distribution etc.).

The FVO mission will not approve/reject individual companies, only evaluate if the Competent Authority has the legal power and capability to conduct official control, and specifically that Competent Authority have in place and use appropriately, the capability to register or approve the business operators that comply with EU requirements.