Promotion and protection of public health through the development, evaluation and application of knowledge, tools and strategies aimed at ensuring food safety, the fight against zoonoses and the adoption of appropriate eating styles.
Audit activity to biosecurity management systems
The Department carries out, on behalf of the Ministry of Health, audit activities to biosecurity management systems. The activity is regulated by a collaboration agreement between the Istituto Superiore di Sanità (ISS) and the Ministry of Health. This agreement regulates the procedures for implementing the technical and scientific support of the ISS for the surveillance activity on the laboratories that hold the etiological agents referred to in the former list A of the OIE, which is the responsibility of the Ministry of Health. In order to ensure the effectiveness of the activity, methods and procedures have been defined according to which to plan and implement periodic audits at the facilities identified by the Ministry of Health.
The Audit activity refers to the functional area "Audit to biosecurity management systems" included in the Quality Management System of the SANV Department, and is carried out on the basis of procedures, developed in accordance with the UNI CEI EN ISO / IEC 17021: 2015 standard "Conformity assessment - Requirements for bodies that provide audit and certification of management systems - Part 1: Requirements".
Reserved area ai Laboratori oggetto di audit.
QMS – Quality Management and Accreditation System
The Quality Management System (QMS) applied in the Department has been developed in accordance with ISO/IEC 17025 "General requirements for the competence of testing and calibration laboratories". The Department's laboratories engaged in official control activities, the NRL and the EURL belonging to it, carry out their activities within the departmental QMS (Document "Quality Policy").
Since 2007 the Department is accredited ISO/IEC 17025 (ACCREDIA accreditation number 0779 L). Accreditation, which is regulated by a special agreement stipulated between the Department and ACCREDIA, represents the recognition of the compliance of the management system and the technical skills of the laboratory with internationally recognized regulatory requirements, as well as with the mandatory legislative requirements, not implying however responsibility on the part of ACCREDIA with regard to the results of the tests or any interpretation that may derive from them. Accreditation also cannot be used for the purposes of product certification. (Document " Meaning and value of accreditation").
Since July 2011, the Department also has been credided for flexible accreditation. The flexible accreditation field allows the laboratory, on the basis of skills already evaluated, to directly manage the inclusion among the accredited test methods of new methods based on the same analytical technique, and implies on the part of the Laboratory, not only the technical competence but also its ability to manage the process of application of the flexible accreditation field and its commitment to offer accredited activities in this area. (Document "Meaning and Value of Flexible Accreditation").
Lists of accredited tests with fixed accreditation field and flexible accreditation field are available on the ACCREDIA website.
The Department has also obtained accreditation according to ISO/IEC 17043 (ACCREDIA accreditation no. 0002 P) providing for the creation of a special functional area dedicated to the activity of the organization of evaluation tests for food safety. This area is able to interact with the different departmental structures, thus assuming the responsibility of ensuring that the requirements, both technical and managerial, specified in the reference standard ISO / IEC 17043, are met. Thanks to the organization of interlaboratory evaluation tests with flexible accreditation field, the Department is able to guarantee a prompt and qualified service whose users are mainly the Ministry of Health, the Regions, the Local Health Units (LHUs) and the laboratories responsible for the official control of food (IZS, LHUs and ARPA).
The full list of accredited schemes is available on the Accredia website.
However, the Department does not exclude that laboratories outside this network may participate in the tests. (Document "Meaning and Value of ISO/IEC 17043 Accreditation").
Annually the program of Proficiency Tests (PT program according to the requirements of ISO/IEC 17043) organized by the Department is published on this site. Laboratories interested in participating can contact the Operational Manager of the Functional Proficiency Tests Area Dr. Angela Sorbo (e-mail: firstname.lastname@example.org, phone (+39) 06 4990 2349/2492) to know how and costs, described on the page: https://www.iss.it/tariffe-dei-servizi-a-terzi. ISO/IEC 17043 accreditation also represents an added value for customers themselves as it allows them to provide evidence of participation in accredited schemes. This is a guarantee that these schemes are planned and managed in accordance with the provisions of the relevant legislation.
How to submit complaints
The Department handles feedback information from users as well as complaints for the purpose of continuous improvement. Complaints can only be submitted using the"Complaints and Appeals Form"which, duly completed, must be sent only to the following e-mail address: RAQ-DSPVSA.
We inform you that:
- messages forwarded anonymously or in ways other than those indicated above will not be accepted
- the truthfullness of the data entered will be checked, before starting the complaint resolution procedure
- the protection of the personal data of all subjects who use the service is guaranteed
- the Department undertakes to provide a first response regarding the processing of the complaint within 30 working days from the date of receipt
Nutrition and health
Director: Dr. Marco Silano
phone: (+39) 06 4990 6001
The Unit is an innovative, multidisciplinary structure that integrates medical, nutritional, chemical, biomolecular and toxicological skills to develop research, study, evaluation, training and communication activities on the benefits and risks for human health associated with food consumption. It is the national scientific reference for information on correct eating styles, the training of operators of the National Health Service (NHS) on the prevention of nutritional diseases and basic, translational and clinical research on nutrition. It is a scientific reference on the nutritional aspects of products for the food industry. The Unit responds to the need to update the technical-scientific reference framework for targeted support to national and European institutions in the definition of strategies and programs for the prevention of diseases related to incorrect nutritional regimens and exposure to risk factors of a chemical nature. The activities: obesity and chronic-degenerative diseases, evaluation of nutrient intake and exposure to xenobiotics, irradiated foods,allergies and food intolerances, food supplements, mineral waters, risk-benefit assessment, maternal-fetal nutrition, infant (0-3 years) and in the reproductive age, endocrine disruptors, LIFE-EDESIA Project.
Chemical food safety
Director: Dr. Paolo Stacchini
phone: (+39) 06 4990 2533
In the context of food safety, the control of chemical hazards is a prerequisite for ensuring the health of the population. Globalisation has changed the way food is produced, processed and distributed, leading on the one hand to an increasing diversification of food supply and, on the other, to an increase in potential health risks linked to the presence of harmful chemicals. The presence of involuntary contaminants or substances intentionally added to the different food supply chains for different technological purposes therefore requires a study and research activity that allows to identify, evaluate and manage the health criticalities related to food consumption.
The research activity – focused on the search for strategies and methodological approaches aimed at reducing/eliminating the risks related to the presence of chemical hazards in food products and to assess their impact on the general population and vulnerable population segments – takes place within different thematic areas concerning chemicals voluntarily used in food production and contaminating chemicals also in the context of reasearch of food fraud.
- chemical contamination of environmental, technological and natural origin of food and feed products and their effects on health
- assessment of dietary exposure to contaminants and voluntarily added substances
- safety of food supplements and food intended for vulnerable population groups
- food fraud in relation to the possible voluntary use of potentially harmful substances
- influence of climate change on food security
- GMOs in food production chains
The Unit inludes National coordination laboratory structures in the context of the activities of official control of food and feed.
- National Reference Laboratory (LNR) for Polycyclic Aromatic Hydrocarbons (PAHs)
- National Reference Laboratory (NRL) for feed additives
- National Reference Laboratory (NML) for veterinary drug residues in products of animal origin
- National Reference Laboratory (NRL) for metals and nitrogen compounds in food
- National Reference Laboratory (NRL) for mycotoxins and plant toxins
- National GMO reference laboratory according to EU Regulation 1981/2006
These structures coordinate the control activities carried out at national level through the use of tools indicated in Community legislation (evaluation tests, scientific meetings, development of analytical methods, advice to the NHS, training, support for monitoring plans on chemical hazards).
The Unit includes the technical-scientific coordination of the National Food Additives Plan. The activities of revision analysis of food and feed are carried out, as required by current legislation, regarding the presence of chemical substances.
Microbiological food safety and foodborne diseases
Director: Dr. Stefano Morabito
phone: (+39) 06 4990 3081
The Unit carries out scientific and institutional research on the subject of foodborne diseases, with particular reference to the microbiological safety of food.
The activities are carried out on food-borne microorganisms and related infections, in particular on Escherichia coli, viral contamination of bivalve molluscs, botulism and Listeria monocytogenes and includes the following laboratories and reference centers for various microbiological hazards:
- European Union Reference Laboratory for Escherichia coli, including Verotoxigenic E. coli (EURL-VTEC)
- National Reference Laboratory for Escherichia coli
- National Reference Laboratory for Food-Borne Viruses
- National Reference Centre for Botulism
- Listeria monocytogenes
In addition, the department is also entrusted with the development and maintenance of both the Italian Registry of Hemolytic-Uremic Syndrome and the ARIES public server for the analysis of mainly genomic data.
Director: Dott. Umberto Agrimi
phone: (+39) 06 4990 3420
The Unit carries out research on emerging infectious diseases of animals, studies etiopathogenesis, develops possible management strategies and identifies risks to humans. It develops diagnostic methods for the identification and characterization of different etiological agents (Prions, Norovirus, Rotavirus, Sapovirus, Hepatitis E, Brucella spp., Mycobacterium spp., Bacillus anthracis, Salmonella spp., Bacillus cereus), as well as animal models for the evaluation of possible prophylactic and therapeutic interventions. The Unit includes the Reference Laboratory (LR) for the characterization of strains and genetics of transmissible Spongiform Encephalopathies (TSEs) of animals.
In 1999, the Unit started its activity on noroviruses interspersed with the European FBVE (Food-borne Viruses in Europe) network, which then merged into the European surveillance network of gastroenteritis caused by norovirus, NoroNet.
The Unit coordinates the laboratories of the surveillance network of rotavirus infections in paediatric patients, by molecular typing of viral strains. The network is part of international collaboration, with the European Network EuroRotaNet (European Rotavirus Strain Surveillance Network), which deals with providing detailed information on rotavirus genotypes co-circulating at European level.