Presentation of ANSES

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Presentation of ANSES French Agency for Food, Environmental and Occupational Health & Safety Role and activities 20 november 2015 1

Creation and origins ANSES was created on 1 st of July 2010 under the 2009 law Hôpital Patients Santé et Territoires Through merging the agency in charge of food safety (AFSSA) with the agency in charge of occupational and environmental health (AFSSET) ANSES reports to five ministries (state goals and performance contract) & Parliament National plans Ministry for ecology and sustainable development Ministry for labour Ministry for health Ministry for agriculture Ministry for consumer affairs 2

Missions ANSES contributes to ensuring: -human health andsafety in the fields of environment, work and food as well as -protecting animal health and welfare - protecting plant health Recommend public health measures Assess nutritional and health risks and benefits Conduct laboratory reference missions Conduct public health monitoring missions Conduct, coordinate and initiate research projects 2 assessment departments 11 laboratories ANMV Provide training and information and contribute to public debate Authorise marketing of veterinary medicinal products Collaborate with European and international agencies (EFSA, ECHA, EEA, EU-OSHA, ECDC and EMA) 3

Organisation chart 11 laboratories, conducting reference & research activities on food safety, animal health & plant health Marketing authorisations for veterinary medicinal products Monitoring & control of veterinary drugs Inspection of the entire sector Risk assessment through collective expertise involving external experts Different kinds of groups of experts (includes 16 Expert committees) Around 350 requests/year Opinions published on the website 4

Broad and all-embracing competencies Biological agents Chemical agents Physical agents Food Water Soil Air Animals Nutrition Environment Work Occupational activities Plants Animals Humans 5

Risk assessment through collective expertise 6

Who can make requests to ANSES? Approved associations Trade unions and employers associations Ministries Professional associations Internal requests State organisations 7

Risk assessment through collective expertise Principles (laid down in founding texts) ANSES provides independent and multidisciplinary scientific expertise ANSES providesexpert assessment in its fields of competency through its Expert Committees Objectives Requirements Expert Groups Scientific excellence Independent and impartial scientific opinions Competence and a multidisciplinary approach Comparing viewpoints, collegial debate Diverging opinions considered Prevention of conflicts of interest Code of conduct for Expert Assessment, NFX 50-110 standard, traceability, transparency Expert Committees Working Groups Emergency Collective Assessment Groups 8

18 permanent ANSES Expert Committees Assessment of risks related to biocidal substances and products Assessment of risks related to chemicalsubstances within the framework of the implementation of REACH and CLP regulations Plant protection products: chemical substances and preparations Micro- and macro-organisms beneficial to plants Fertilisersand growing media Veterinary medicinal products Characterisation of substance hazards and toxicity reference values Assessment of risks related to air environments Assessment of risks related to physical agents, new technologiesand development areas Assessment of chemical risks of consumer items and products Recommendation of occupational exposure limits for chemical agents Water Human nutrition Assessment of physical and chemical risks in food Assessment of biological risks in food Animal feed Animal health Biological risks to plant health Regulated products Veterinary medicinal products Environmental and occupational risks Water, food and nutritional risks (human ) Animal health & feed Plant health Also thematic working groups (GT) 9

Examples 10

Reference and research 11

11 laboratories Reference and research Conducting reference and research activities on food safety, animal health, and plant health Contributing to animal health surveillance and expert assessment in food safety, animal health, and plant health Ensuring a territorial presence of the laboratories & their units which allows them to be close to the field (anticipation & detection of emergencies & health problems) Maintaining a position in the main regions of production corresponding to the sectors concerned by the reference activities of the laboratories 12

Plant Health: 1 Laboratory / 6 sites Rennes-Le Rheu Nematodes Nancy- Malzeville Mycology Angers (HQ) GMO, virology, bacteriology Clermont Virology & quarantine Montpellier Arthropods La Réunion Tropical pathogens ANSES Visit to FERA, York, UK 18 th March, 2015 13

Food safety Boulogne Fishery and aquaculture products Maisons- Alfort Food safety ANSES Visit to FERA, York, UK 18 th March, 2015 14

Food and drinking-water safety Fougères Veterinary drug residues Nancy Hydrology Lab. Drinking-water ANSES Visit to FERA, York, UK 18 th March, 2015 15

Maisons-Alfort Animal Health Laboratory (Zoonoses, epizootic diseases, epidemiology) Maisons-Alfort Animal Health ANSES Visit to FERA, York, UK 18 th March, 2015 16

Dozulé Laboratory (Equine diseases) Dozulé Equine diseases Mandate shared with Maisons-Alfort Lab. ANSES Visit to FERA, York, UK 18 th March, 2015 17

Niort (Ruminants) Sophia (Bees/Q Fever) Nancy (Rabies/Wildlife) Nancy Rabies Wildlife diseases Niort Ruminants Non-Priority 1 diseases Sophia Bees Q Fever ANSES Visit to FERA, York, UK 18 th March, 2015 18

Ploufragan (Pigs, Poultry) Plouzané (Fish) Ploufragan Pigs, poultry & rabbits, Health, Welfare & Food safety Plouzané Fish health ANSES Visit to FERA, York, UK 18 th March, 2015 19

Lyon Laboratory (Virology, Mycoplasma, AB-resistance, Neurodegenerative diseases, Plant-protective agent resistance, epidemiology) Lyon Animal and Plant Health (+ resistances) ANSES Visit to FERA, York, UK 18 th March, 2015 20

Missions and their recent developments Reference Development and validation of methods Networking and training of official labs Inter-laboratory proficiency tests (ILPT) Data compilation & synthesis EURL NRL Official Labs ILPT Technology transfer Laboratory approval Provide scientific & technical support Self-checks Maintain a scientific watch A fixed framework for the reliability of official controls Agri-food Industry Labs Primary production Epidemiologic al surveillance (Animal health, Plant health, etc.) ANSES Visit to FERA, York, UK 18 th March, 2015 21

Reference and research 65 national reference mandates (Animal & Plant Health / Food safety) 9 EU and 17 international reference mandates (OIE, WHO, FAO) National, EU and international partnerships EU networks (MedVetNet / Epizone / CoVetLab ) Projects funded through national and EU sources: In 2014, 32 on-going EU-funded research projects (Horizon 2020, COST, EFSA ) 22

Main missions include: Reference and research To conduct expertise, epidemiological surveillance, early warning, and scientific and technical support to Ministries To develop and validate analytical methods To coordinate networks of laboratories (in France and/or in the EU member states): training, inter-laboratory proficiency tests, etc. To provide confirmation of results to competent authorities To provide support for laboratory certification To perform epidemiological monitoring and modelling For biological and chemical agents of concern, to improve knowledge regarding identification, pathogenicity, toxicity, prevention, prevalence and distribution 23

Veterinary medicinal products 24

Veterinary medicinal products ANSES-ANMV (French agency for veterinary medicinal products) Delivers, suspends and withdraws marketingauthorisations for veterinary medical products based on collective assessment Monitors and controls veterinary drugs: quality, adverse effects, consumption, advertising, etc. Inspects the entire sector: production, distribution and export Represents France on veterinary drugs at the EU level at EMA Active at the international level (mandate of OIE collaborative centre) 25

Surveillance, alerts, monitoring and vigilance in ANSES 26

Surveillance, alerts, monitoring and vigilance ANSES is in charge of schemes that produce health alerts: Nutritional vigilance (health monitoring system for potential adverse effects associated primarily with food supplements or novel foods) Biotox plan (germs that could be used in the event of biologicalattacks) Pharmacovigilance for veterinary drugs Reference laboratory mandates in food safety and animal health ANSES contributes to activities on health surveillance and alerts that originate outside the agency, for example: Toxicovigilance for regulated products such as plant protection products National Network for Monitoring and Prevention of Occupational Diseases (RNV3P) National animal health epidemiological surveillance platform ANSES fulfils its mission also by: Setting up observatories for products and processes (e.g. Pesticide residues, food quality) Participating in European and international alert networks Maintaining a watch oninternational scientific publications and on trends in the media and society 27

About 1350 staff ANSES in brief Around 800 external experts solicited Annual budget: 130 million Euros More than 8000 Opinions issued since 1999 (AFSSA + AFSSET) 11 laboratories in 16 locations 65 National Reference Laboratory mandates, 9 EU-RL mandates, 17 international mandates 5 million Eurosper year to support calls for research projects 28

For more information www.anses.fr Twitter: Over 2550 followers in December 2014! 29