3rd Countries approved for Export to EU
The legislation and procedures for control of food safety of products intended for export to EU shall provide guarantees at least equivalent to the EU regulation in different fields (Link to: Screen 2A, question 1 for details):
- establish the overall policy for control of food safety in compliance with the EU regulation (Reg. 178/2002 mainly articles 14, 17, 19 )
- designate the institution(s) responsible for official control (Competent Authority) (Reg. 882/2004, mainly article 4)
- give a clear mandate and responsibility (legal power) to the Competent Authority to set the relevant regulation, standards, guidelines etc. and to conduct the specified official controls for food, including coordination of different involved institutions (Reg 882/2004, mainly article 3, article 5, article 8, article 9, article 10).
- give a clear mandate (legal power) to the Competent Authority to take action against operators that fail to meet requirements Reg 854/2004 article 12)
- specify the responsibility and the general and specific hygiene requirements to all involved business operators (farmers, fishing vessels, aquaculture farms, transport and storage, processing units) (Ref. 852/2004 and 853/2004 )
- the applied health criteria for specific 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)
No. Each country decides how to build their legal framework and what to include in which types of documents. The stipulated requirements shall be equivalent to the EU requirements in the field which is relevant for the export to EU. For example, if the country does not want to export products originating from aquaculture or bivalve molluscs, it is of course not necessary to have all the regulations regarding this. Certain issues related specifically to EU member countries are not relevant to third countries, and shall also not be included.
Each country decides which kind of documents to include in their legal framework. Combination of laws, acts, decrees, decisions, standards, guidelines etc. may be used to the extent that the system is transparent, coherent, and clear in regard to the status of the documents (eg. whether each of the documents are mandatory or not mandatory to different involved parts).
It is important that the legal framework is operational in reality in the country and at the same time require and allow for all parts involved in export to EU to comply with relevant EU regulations.
It shall be mentioned that the Regulation (EC) 882/2004 and 854/2004 are developed in specific reference to the need for uniform and coordinated performance in member states and many details are not relevant or applicable for third countries. In their evaluation, the FVO inspections will evaluate if the system offer equivalence to the EU legislation (Regulation (EC) 882/2004 article 46).
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.
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.
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.
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.
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.
There is no fixed frequency. The official control activities shall be efficient and appropriate to ensure that the objectives of the regulation are met (Reg. 882/2004 art. 2 and 10). They must be risk-based. The Competent Authority may define different frequencies and different control activities depending of the type of company and the actual results of the official control activities.
No. The Competent Authority is expected to develop their own inspection tools based on available guidelines, training materials etc.
Yes. Specific product and process criteria required by the EU regulation may not be adequate addressed even if the HACCP system is already correctly certified to a commercial standard. The official control shall verify that all general and specific criteria laid down in the EU legislation are implemented within the frame of the certified system.
The Health Certificate (Reg. 1250/2008, Reg. 1664/2006 Annex II) can be signed only by an official of the Competent Authority who is able to respect the requirements of Directive 96/93/EC specifically article 1, article 3 points 1 and 2 and article 4 point 1. According to these requirements the "certifying officer" who sign the certificate shall be authorized by the competent authority, be informed and have satisfactory knowledge about the legislation and the rules linked with the specific certificate and be impartial in regard to the consignment and the data related to the certificate.
By signing and issuing the Health Certificate, the Competent Authority certifies that it is aware of the relevant EU requirements and that it has verified, through official control activities that the products in the consignment comply with the requirements (Reg. 1250/2008 and Reg. 1664/2006 Annex II). The official control referred to in the statement, as defined in the Reg. 882/2004 art. 10, includes inspection, sampling, testing etc. in the whole chain of production, processing and transport. The pre export verification should therefore include at least the review of the company's own monitoring and verification results related to the particular consignment, and results of official controls that may be relevant with regards to the consignment, eg. inspection results, freshness testing, monitoring result.
Pre-export testing is not mandatory, however it is imperative that the Competent Authority, prior to issuing of the Health Certificate, verifies that the particular consignment complies with requirements and criteria (See question above).
If deemed necessary or specifically required by the operator due to buyer requirements, the pre-export verification may also include official sampling and testing of the specific consignment.
If deemed necessary or specifically required by the operator due to buyer requirements, official sampling and testing of the specific consignment may be a part of the pre-export verification. It is however not mandatory to attach such test results to the Health Certificate.
If, due to specific requirements, the Health Certificate is accompanied by laboratory test results, these shall be from official sampling from the defined consignment and testing carried out in official laboratories only. No sample or test result provided by the operator or provided through other official control activities not specifically linked with the consignment, can be directly referred to or accompanied with the Health Certificate.
Introduction of animal products to the EU market can take place only trough designated and approved Border Inspection Posts (BIP) located in the immediate vicinity of the point of entry in an EU Member Country. (Directive 97/78 art. 6). The Border Inspection Post's are subject to inspection by the DG Sanco Food and Veterinary Office and approval by the Commission, like production units (Directive 97/78 art. 6 and Annex II, Decision 2001/812 and Decision 2001/881).
Specific pre-export checks carried out for specific products by third countries may be approved by EU if the FVO audits to the country has proved that the official controls in the country are sufficient to ensure compliance with EU requirements and adequate to replace or reduce the checks laid down in the EU Border Inspection Points (Reg. 882/2004 art. 23). Link for more information (Screen 2B question 12, 13, 14).
Please consult the list of approved border inspection points and related regulation.
The regulation for the EU border inspection includes:
- the overall principles (Directive 97/98, consolidated version 01.01.2007),
- requirements to procedures to be used (Regulation 136/2004, consolidated version 01.01.2007),
- products subject to control (Decision 2007/275),
- methods to be used (Decision 2000/571)
- frequency of physical checks (decision 94/360, consolidated version of 02.09.2006).
The border inspection includes Documentary Check (correct certificates), Identity Check (correct Health Marks and labelling) and Physical Checks. The physical checks include may organoleptic control and sampling and laboratory testing according to a monitoring plan. The overall frequency of physical checks for different products are given in Decision 94/360, but if irregularities are found in the sampling and testing, at least the next 10 consignments of same origin shall be sampled for checks (Directive 97/78 article 24) .
All regulations and guidelines regarding border inspection are available through http://ec.europa.eu/food/animal/bips/legis_en.htm
Only laboratories specifically designated as official laboratories can be responsible for testing related to official control. The laboratories designated for official control by the competent authority, may be public, private, in country or outside country, if they comply with requirements for management and technical operation and if they are free of conflicting interest in regard to the testing they are designated to carry out. (Reg. 882/2004 Art. 12)
The technical and management criteria are those of ISO 17025 and only laboratories which are accredited to this standard and which apply and comply with the required analytical test methods and/or performance criteria can be designated as laboratory responsible for official control. A laboratory may be designated for some parameters only hence the need for official testing may be covered by a network of official laboratories.
In order to ensure uniform testing and decision criteria, the EC has stipulated specific analytical test methods to be used for testing of specific products and water. These are mainly ISO standards or other international standards and they are all listed in Regulation 2073/2005, 2074/2005 for food products and in Directive 98/83 for water. For most chemical parameters it is not comprehensive to stipulate specific analytical test methods, hence analytical principles that may be used (e.g. HPLC, Chromatographic, AAS, etc.) and specific performance criteria to comply with has been stipulated in other regulatory documents, of which Decision 2002/657, Regulation 1883/2006 and Regulation 333/2007 are the most important.
Harmonized criteria are those agreed by all EU member states and stipulated in EU regulation, directives or decisions. They shall apply mandatorily in all member states and to all food business operators willing to sell food or feed on the EU internal market. The microbiological criteria stipulated in Reg. 2073/2005 and the chemical criteria stipulated in Reg. 1881/2006 are all examples of most important harmonized criteria.
Member States are allowed to apply additional criteria to the extent that these are scientifically justified and not less strict than the harmonized criteria. Criteria for total bacteria count (TPC) and Vibrio species applied for fishery products in certain countries are example of such non-harmonized criteria, also called national criteria.
Any criteria not stipulated by EU regulation, decision or directive would be either a national criteria or a customer requirement.
MRL = Maximum Residue Limits refer to the actual limit of a substance in a product. MRL established for substances which is accepted to be present up to a certain limit in the product because scientific evaluation has proved that such level is safe for the consumers. This is the case for certain veterinary medicines which may be used with certain restrictions and certain environmental contaminants which can not be totally avoided. Any detected concentration below the MRL should be considered in compliance with requirements.
MRPL = Minimum Required Performance Limits refer to the performance of the analytical test method used to test for a substance. This criterion is applied to substances which are not accepted at all in the products, e.g. prohibited antibiotics. For such substances the level should be "0". But since "0" in reality depends of the performance of the analytical method (detection limit, uncertainty etc.) the MRPL's has been stipulated to ensure that the method used shall be able to detect at least the MRPL level, if the substance is present. Any positive finding, even lower than the MRPL, if the method allow so, shall be considered non-compliant with requirements, because it by definition is above 0 which is the real requirement.