National Reference Laboratory for Marine Biotoxins
The National Reference Laboratory for Marine Biotoxins designated by the Competent Authority by resolution of the Executive Directorate of the AESAN of September 30th 2021, develops its activity in all aspects related to the control of marine biotoxins in bivalve molluscs and other food of marine origin described in articles 100 and 101 of Regulation (EU) 2017/625 of the European Parliament and of the Council (official Controls Regulation).
The Laboratory provides services to the official control laboratories of the national network. Its responsibilities and tasks as National Reference Laboratory are set out in article 101 of Regulation (EU) 2017/625 of the European Parliament and of the Council, of March 15, 2017.
Responsibilities and task of national reference laboratories
The functions of the LNRs, in their area of competence, are those provided for in article 101 of Regulation (EU) 2017/625 of the European Parliament and of the Council, of 15 March 2017:
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a) collaborate with the European Union reference laboratories, and participate in training courses and in inter-laboratory comparative tests organised by these laboratories;
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b) coordinate the activities of official laboratories designated in accordance with Article 37 (1) with a view of harmonising and improving the methods of laboratory analysis, test or diagnosis and their use;
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c) where appropriate, organise inter-laboratory comparative testing or proficiency tests between official laboratories, ensure appropriate follow-up of such tests and inform the competent authorities of the results of such tests and follow-up;
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d) ensure the dissemination to the competent authorities and official laboratories of information that the European Union reference laboratory supplies;
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e) provide, within the scope of their mission scientific and technical assistance to the competent authorities for the implementation of MANCPs referred to in article 109 and of coordinated control programmes adopted in accordance with article 112;
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f) where relevant, validate 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;
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g) where necessary, conduct training courses for the staff of official laboratories designated under Article 37 (1); and
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h) assist actively the Member State having designated them in the diagnosis of outbreaks of foodborne, zoonotic or animal diseases, or of pests of plants, and in case of non-compliance of consignments, by carrying out confirmatory diagnoses, characterization and epizootic or taxonomic studies on pathogen isolates or pest especimens.
Quality
Article 100, paragraph 2, of Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 establishes that the requirements provided for in point (e) of Article 37 (4) shall apply to national reference laboratories:
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The competent authorities may only designate as an official laboratory a laboratory which:
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e) operates in accordance with EN ISO/IEC 17025 and is accredited in accordance with that standard by a national accreditation body operating in accordance with Regulation (EC) No 756/2008.
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Quality is, therefore, a priority in the activities of the NRL for Marine Biotoxins, which establishes as a general objective the reliability of its tests and the constant improvement of its processes and activities, as well as the effectiveness of its management system.
Accreditation
Accreditation by ENAC (National Accreditation Entity) according with the standard EN ISO/IEC 17025: General requirements for the competence of testing and calibration laboratories. Scope of the accreditation defined in the corresponding Technical Annex: Accreditation 160/LE/394 for conducting tests on agri-food products.
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