The Ministry of Health designated Istituto Superiore di Sanità as the National Reference Laboratory (NRL) for the residue of veterinary drugs in products of animal origin.
The designation of the NRL arises from the need to identify a structure that has the necessary expertise and carries out activities in accordance with art. 100 of Regulation EU 625/2017 which provides for the appointment of one or more National Reference Laboratories (NRLs) for each Member State to support activities of EURL (European Union Reference Laboratories).
The NRL for residues is involved in the Quality Management System of the Food, Nutrition and Veterinary Health Department, which is accredited in accordance with the UNI CEI EN ISO/IEC 17025 standard (accreditation n. 0779 L). Accreditation is regulated by a specific agreement and is the recognition of the technical competence of the laboratory to carry out specific tests (accreditation for fixed accreditation field) or test techniques (accreditation for flexible accreditation field), but does not imply responsibility on the part of ACCREDIA with regard to the results of the tests or any interpretation that may arise from them.
European Regulation 625/2017 - art.101 states the tasks of NRL as follow:
- 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 designated in accordance with Article 37 paragraph 1 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 MANCPs referred to in Article 109 and of coordinated control programmes adopted in accordance with Article 112;
- 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 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 designated under Article 37 paragraph 1
