FOOD AND VETERINARY OFFICE Paul Peeters Weem

The FVO … in the Commission context Economic and Financial Affairs Environment Agriculture and Rural Development Communication Energy European Union civil service Trade Budget Others ….. Employment, Social Affairs and Inclusion Health and Food Safety Highlight our context: We are an integral part of SANTE Directorate A Directorate B Directorate C Directorate D Directorate E Directorate F Directorate G DG SANTE

SANTE Give A4 organigrams FVO structure 5 audit units organised on a sectorial/thematic basis: F2: Food of animal origin: mammals F3: Food of animal origin: birds and fish F4: Plant health, food of plant origin and food quality F5: Animal nutrition, import controls, health protection F6: Animal health, animal welfare 2 horizontal units: F1: Country profiles, co-ordination of follow-up F7: Operational and administrative affairs

The FVO - Areas of activity Farm to Fork Food and feed safety Food quality Animal health and welfare Plant health In Member States, candidate countries and third countries since 2013: Medical devices and active pharmaceutical ingredients Video covered most of these activities DG SANTE: Directorate F - FVO + 170 staff + 90 auditors + 250 audits per year (221 in 2015 )

What does the FVO do? Carries out audits of Member States, candidate countries and third countries. Reports on its findings (publicly). Makes recommendations to competent authorities (CA) to address identified shortcomings. Follows up on the recommendations and corrective actions announced/undertaken by CAs. Contributes to policy development and management within the Commission.

Controls - where are we in the process? carry out official controls to enforce EU standards Controls - where are we in the process? FVO verifies how the competent authorities ensure enforcement of EU standards, and their functioning in practice National Authorities UNION controls Operators apply EU standards (primary responsibility)

Looking at Control Systems: Purpose of FVO audits To assess the CA's performance both in the delivery of systems to ensure that standards are met and in their effective enforcement To assess the operation of these systems in practice and on-the-spot To assess the animal/plant health situation and related controls, as appropriate To verify that Member States are compliant with EU law To determine whether third countries can provide reliable guarantees that commodities intended for export to the EU meet the EU requirements [Time permitting ] Looking at Control Systems: Legal framework: Are legal/administrative measures in place to ensure that producers apply the standards and for the CA to enforce them? Competent authority organisation & controls: Responsibilities and tasks Co-operation and coordination Personnel and facilities (e.g. Laboratories) Control systems and records Enforcement Sites: production establishments, handling and storage sites, laboratories: to verify on-the-spot delivery

Is there a system in place? How do we do it?  System audits ! WHY? Is there a system in place? NO So what? WHY? YES NO WHY? Can it work? YES NO These are the main questions to be asked for system audits Are the necessary elements of the system in place PDCA cycle (Plan-Do-Check-Act) Legal basis Are the resources, procedures, etc available to implement it In practice does the system work, achieves results, If not do we know why and what is the impact in the overall capacity to meet requirements Does it work ? YES

Administrive Preparation Audit cycle Pre-audit activities Audit Post-audit activities END Planning Project planning (Unit & Cross-Unit) Audit Performance Intra-Unit Follow-up F1 Follow-up FVO Programme BTO Technical Preparation Draft Report Final Report END Administrive Preparation FVO programme (see next presentation) Technical preparation Includes preparing Evaluation plans, Pre-mission Questionnaires and report templates Sending to the CA Evaluation plans, Pre-mission Questionnaires Assessing the responses Establishing the audit itinerary BTO Back to the office note, internal document mainly to highlight significant issues Draft report Draft reports sent to CAs for comments (Comments are published) Final reports to CAs Commission Services, European Parliament/Council, stakeholders Follow up = Important!! Intra-Unit Follow up Competent authority Action Plan to address report recommendations Assessment of Action Plan Close-out: overall assessment of adequacy of the Action Plan Follow up Systematic follow-up (correspondence, General or specific follow-up audits, etc.) Enforcement action as appropriate.

Reporting on the results Types of reports Individual audit reports Overview reports (interim/end) on series of audits Principles According to procedures Regulation (EC) No 882/2004 and FVO Manual of Procedures In a transparent manner Draft reports sent for comments Publication of reports on internet: http://ec.europa.eu/food/fvo/index_en.htm SOP and WI " Guidance documents Procedures Previous slide Top level correspond to Standard Operating Procedures (SOP) Lower level to Work instructions and reference documents (WI) + many other Commission rules

Other activities Fact Finding Missions Conclusions To gather information regarding control systems In 2013/2014 five missions on Food Supplements in MS Implementation of Directive 2002/46/EC Overview Report Conclusions Variation in level of controls between MS Internet Sales difficult to control No harmonised approach to botanicals No harmonised levels of vitamins and minerals Medicine or Food Supplement?

Other activities Good Practices Exhaustive review of notified food supplements in some MS. Some MS cooperate to create list of safe botanicals. One MS reviewed safety of > 600 plants and plant parts.

Food and Veterinary Office Grange, Dunsany, Co. Meath, Ireland Thank You European Commission Food and Veterinary Office Grange, Dunsany, Co. Meath, Ireland

Useful links FVO main page FVO reports Videos http://ec.europa.eu/food/food_veterinary_office/index_en.htm FVO reports http://ec.europa.eu/food/fvo/audit_reports/index.cfm Videos FVO introduction https://www.youtube.com/watch?feature=player_embedded&v=c0J_3wIz6Qg Food, 500 Million Reasons to keep it safe" (video) http://www.youtube.com/watch?v=MYt_FRwNu7w