Only vessels flying the flag of EU member states or third countries approved for export to EU (Decisions 2008/156(EC) and 2006/766 (EC)) shall be allowed to place product on the EU market or to companies that process and export to the EU market. In principle such vessel should be approved and under inspection of the competent authority in the country of which it carry the flag. The task of inspecting the vessel can however be delegated to another country which are either an EU member state or approved for export to EU.If a foreign flagged vessel is under long term charter by local companies and incorporated under local law, the competent authority may deal with the vessel as a local vessel. )In any case the vessel shall comply with the EU hygiene requirements in Regulation 853/2004 Annex III, section VIII. The approved vessel shall appear only on one list even if several competent authorities are involved in approval and inspection as per agreement.
2. What are the additional legal requirements if our country wants to export product of aquaculture origin?
A third country to be approved for export of food products originating from aquaculture shall further document compliance with EU regulations in regard to marketing, distribution and use of veterinary medicines, i.e. at least:1. have in place a legal document stipulating one or several list with active substances allowed/prohibited to use, at least equivalent to those for fishery products in Regulation (EC) 2377/90, Annex 1, 2 and 4 and requirements in Decision 2003/181, Decision2004/25(EC)and Directive 96/22 (EC).2.designate a competent authority and establish and implement regulations and procedures that ensure that all veterinary medical products for fish and crustaceans are authorized for use in compliance with EU regulations (both imported and local production) and are distributed only by organizations and persons authorized or approved to do so. (Directive 2001/82 (EC) and 2004/28(EC), specifically articles 5, 6, 65, 66, 67, 68)3.establish and implement regulations and administrative procedures to ensure that labeling of all authorized products are adequate for correct use by the farmer and veterinarian and in compliance with relevant EU regulations (Directives 2001/82 (EC) and 2004/28(EC), specifically articles 9, 11, 58, 59, 60, 61).Further the requirements to production, distribution, use and official control of feed shall be implemented, specifically1. The Competent authority shall have procedures to register all (relevant) feed producers in the country and further to approve producers of feed additives, pre-mixtures or compound feedstuffs by the competent authority. This includes also the maintenance of a list of establishments abroad from which import of feed for aquaculture to farms that supply to EU approved establishments (Regulation (EC) 183/2005 Article 9and Art 11and Annex IV.2.The feed producers shall be required to apply Good Hygiene Practices, apply HACCP (specifically Regulation (EC) 183/2005 articles 5, 6, 7, 13, 20, Annex I and Annex II).3. The feed producers shall be required to comply with EU Register on Feed Additives (Regulation (EC) 1831/2003 and Community Register on Feed Additives Rev. 5, 2005).The Program for monitoring of residues of veterinary medicines and environmental contaminants shall be implemented (see questions below).If the export of animals from aquaculture includes certain defined species subject to defined diseases, it shall be justified and signed for on the certificate that the species are free from the mentioned diseases or have been subject to quarantine (Directive 2006/88, Regulation (EC) 1664/2006 and Regulation (EC)1250/2009). Regulations and Guidance for movement of aquaculture animals are available here.
3. Do we need to have a monitoring program for residues of environmental contaminants in products of wild caught origin?
The development of monitoring plans for environmental residues in wild caught species is not mandatory to export to the EEC. However maximum tolerated residue levels stipulated in Regulation (EC) 1881/2006, Regulation (EC) 1883/2006 and Regulation (EC) 333/2007 must be complied with. It is up to each country to define how to ensure compliance (Regulation (EC) 854/2004 Annex III). While raw material testing and pre-export testing may be the only solution for insurance and verification of compliance in the short term, the development of monitoring plans, which will help to build up knowledge about contamination levels in most sensitive species from specified areas, may be a more comprehensive long term strategy for most countries.
4. Do we need to have a monitoring program for residues of veterinary medicines and environmental contaminants in products of aquaculture origin?
If the country wants to export fishery products based on raw materials from any kind of aquaculture, it needs to apply for approval of a residue monitoring program and subsequently to be listed in Decision 2004/432(EC) (consolidated version of 2008).Countries that want to export only fishery products based on raw materials other than any kind of aquaculture do not need the monitoring program.
5. What are the requirements to the monitoring program for residues veterinary of medicines and environmental contaminants in products of aquaculture origin?
The requirements to this national monitoring are stipulated in Directive 96/23(EC). In short it is required that a central public department or body shall be assigned to be responsible for planning, coordination of implementation and reporting of the results. Annual plans and annual reports on results shall be submitted to the European Commission for approval every year by 31 March. Together with the plans, shall be submitted information about the national legislation and criteria in use in the field, list of assigned laboratories as well as information about infrastructure and work procedures of the involved public departments. The purpose of the monitoring of aquaculture products shall be to detect the possible illegal use of prohibited substances, the possible misuse of allowed substances and to create ground to take specific actions to minimize the recurrence of cases of unwanted residues in animal food. Detailed Guidance and support documents, including templates for planning and reporting are available on the dedicated DG Sanco web-page. The annual plan and report from each third country shall provide guarantee that the measures in place are at least equivalent to those in the EU regulations. It is therefore imperative that the guidance and support documents are studied and adhered to in the whole process of preparing and implementing.
No. The plan shall cover at least all animals/raw materials/products originating from aquaculture and being or intended to be exported to EU. In member countries the program shall be a national program. For many third countries exporting aquaculture products to EU it is relevant to make a split program, including only animals/materials intended for export to EU. A split program may typically be linked with specified raw materials and/or regions of relevance for export to EU. For a split program to be approved, the EC Commission will require justified clarifications and documentation as to how the segregation of the products for the EU market is ensured. In this context it is crucial requirements to documented traceability of all lots of raw materials from EU-registered primary producers to EU-approved processors/exporters are enforced and adhered to and further that regular official verification of this aspect takes place.
No. There are very specific requirements to the sampling strategy in the monitoring program (Directive 96/23(EC) article Annex III and Annex IV). Please also consult the specific guidance and support documents in this issue, specifically section 6 on the dedicated DG Sanco web-site.
Annex I to Decision 96/23(EC) provides the groups of substances to be included in the monitoring plan. An excel sheet with a Plan Template and instructions for planning of the sampling and testing can be downloaded from section 6 on the dedicated DG Sanco web-site. In the Instruction to the Plan Template, it can be seen how the substances to be monitored are grouped according to their characteristic effects, and for each group/substance and product it is decided by guidance if the monitoring is mandatory (E= Essential) or highly desirable (HD). Groups of substances considered mandatory or “E” are those of particular concern for the Community (i.e. prohibited substance such as chloramphenicol, Nitrofuran metabolites, hormones and hormone like substances) and those which are of concern because they are frequently detected in different commodities (e.g. antibacterial substances). Substances or groups of substances considered “HD” are those to be tested in the different commodities because MRL’s exist for certain substances in certain products. Detailed decision on which substances to include within each group shall be taken by each third country based on justified evidence and knowledge about what is allowed/prohibited to use by national regulation and experience and risk assessment in regard to possible violence of the regulation. Decisions to omit “HD” substances/substance groups from the plan shall be justified and supported by appropriate documentary evidence.
If the screening test is validated and proven to have a detection limit well below than the MRPL or the MRL of the substance tested for, it is not required to confirm a negative finding with a confirmatory method. If there is a positive finding with the same screening method it should be considered suspect and further testing with a confirmatory method shall be conducted before the finding is considered positive to which the competent authority take final action.In this context it should be reminded, that in the European point of view, the objective for the validation of a screening method, is to prove that the method produce less than 5% of false compliant results at a level well (e.g. around 50%) below the MRPL or MRL . The objective for the validation of the confirmatory method is to prove that the compound is well identified, that the compound is really present (forbidden substances) or over the tolerated concentration (MRL) and that the performance characteristics of the method allow its use for the purpose.
Positive findings shall be addressed with recalls or prohibition to place the involved products on the market until proved free from residues and with actions that will contribute to minimize the recurrence of cases of unwanted residues in animal food. This means that investigations to identify the causes to the finding shall be conducted and appropriately addressed.
11. Shall non-compliant results found in the aquaculture residue monitoring program be included in the annual report?
Yes the template for table of results to be downloaded from section 6 in the dedicated DG Sanco web-site shall be included in the annual report. The text in the annual report shall include detailed information about investigation of cases of positive findings and the results of actions taken to minimize the recurrence.