1. FOOD AND VETERINARY OFFICE
Paul Peeters Weem

2. 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

3. 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

4. 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
staff
auditors
+ 250 audits per year (221 in 2015 )

5. 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.

6. 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)

7. 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

8. 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

9. 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.

10. 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:
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

11. 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?

12. 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.

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

14. Useful links FVO main page FVO reports Videos
FVO reports
Videos
FVO introduction
Food, 500 Million Reasons to keep it safe" (video)