The National Reference Laboratory
The national reference laboratory is the leading laboratory in the state which in the specific area official testing has been nominated in accordance with the requirements of EU and national legislation.
Articles 92 and 93 of Regulation (EC) No 2017/625 on official controls replacing Regulation (EC) No 882/2004 from 14.12.2019 require the establishment of European Union reference laboratories and the procedures for their designation. Article 94 sets out the duties and tasks of these laboratories, where cooperation with EU national reference laboratories plays an important role.
Pursuant to Article 147 of Regulation (EC) No 2017/625, the designation of all European Union reference laboratories referred to in Annex VII to Regulation (EC) No 882/2004 shall remain in force until the designation of the European Union reference laboratory in the same field in accordance with Article 93 of this Regulation.
Article 100 of Regulation (EC) No 2017/625 provides that Member States shall designate one or more national reference laboratories for each EU reference laboratory designated in accordance with Article 93(1). Member States may also designate a national reference laboratory where there is no relevant EU reference laboratory.
The tasks and duties of the national reference laboratory are laid down in Article 101 of the Regulation. National reference laboratories shall, in their area of competence:
- collaborate with the European Union reference laboratories, and participate in training courses and in inter-laboratory comparative tests organised by these laboratories;
- coordinate the activities of official laboratories with a view of harmonising and improving the methods of laboratory analysis, test or diagnosis and their use;
- where appropriate, organise inter-laboratory comparative testing or proficiency tests between official laboratories, ensure an appropriate follow-up of such tests and inform the competent authorities of the results of such tests and follow-up;
- ensure the dissemination to the competent authorities and official laboratories of information that the European Union reference laboratory supplies;
- provide within the scope of their mission scientific and technical assistance to the competent authorities for the implementation of Multi-annual national control plans and of coordinated control programmes;
- where relevant, validate the reagents and lots of reagents, establish and maintain up-to-date lists of available reference substances and reagents and of manufacturers and suppliers of such substances and reagents;
- where necessary, conduct training courses for the staff of official laboratories
- assist actively in the diagnosis of outbreaks of foodborne, zoonotic or animal diseases.
Regulatory provisions of Latvia that regulate the functions of the national reference laboratories
- The Law on the Supervision of the Handling of Food;
- The Veterinary Medicine Law;
- The Law on Circulation of Genetically Modified Organisms.
Regulations of Cabinet of Ministers and European Union Regulations:
- Regulation of Cabinet of Ministers No. 864 of 4th August 2009 “Regulation on granting the status of reference laboratory and order of accreditation, functions and duties as well as the requirements determined for the equipment and appliances in the areas of food, animal feed and veterinary”
- Commission Regulation (EC) No 543/2008 of 16 June 2008 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 as regards the marketing standards for poultrymeat
Laboratories of the Institute of Food safety, Animal health and Environment “BIOR” (further on – Institute “BIOR”) have partly been performing the functions of the leading laboratory already since establishment of the Institute. Regulation of Cabinet of Ministers No.834 of 4th December 2007 “Regulation on granting the status of reference laboratory and order of accreditation, functions and duties as well as requirements determined for the equipment and appliances of reference laboratory” listed the area, for which the National Diagnostic Centre of Food and Veterinary Service (now Institute “BIOR”) is nominated as national reference laboratory.
In accordance with the authorisation, the Institute "BIOR" has been nominated as the National Reference Laboratory in the following areas:
- Food, materials and objects intended to come into contact with foodstuffs, animal proteins in feedingstuffs, residues including pesticide residues, and anti-microbial resistance of the agents of diseases – 25 areas
- Diagnostics of animal diseases - 18 areas and control and supervision over the standards and methods of diagnosis – 3 areas
Having regard to the fact that laboratory diagnostics is the area in which technological development happens rapidly, the national reference laboratory must ensure immediate fulfilment of all newest requirements and their implementation in official control. In addition to the aforementioned, such a laboratory must be able to develop, optimize and validate the methods of laboratory examinations, as well as to maintain the bank of agent stems and samples, the bank of antigens of agents, a stock of the set of diagnostic regents, specific bank of immunoglobulin and serum, as well as to perform laboratory examinations in the granted area of reference and, in case of disputes, to confirm or refuse the results of laboratories authorized or accredited by the state in the granted area of reference.
The national reference laboratory is the only state laboratory which constantly - 24h per day – maintain the readiness of their technologies and personnel for extraordinary situations and outbreaks of animal infection diseases.
As the official control is performed by taking into account also the results of examinations performed by the companies dealing with the circulation of animal feed and food in accordance with HACCP programs, it is important to ascertain about the competence of the laboratories of the company which might be achieved by involving these laboratories in the training organized by the national reference laboratory and by participation in inter-laboratory comparative testing organized by it.
In accordance with the legislation the member states must ensure the functions of reference in all appointed areas because in the opposite case the competence of laboratories involved in official control will be disputed at the level of the European Commission, and consequently – the credibility of the official control to be performed in the state. The fulfilment of the reference functions in a full scale will provide a possibility to make a considerable improvement of the ability of Latvia as EU member state, as well as its competence to justify the opinion with regard to the perfection of supervision and control mechanisms of various infection disease agents and food pollutants, as well as its regulatory values, which in turn will foster the export capability of the sector.