The EU approach to systems-based audits
John McEvoy European Commission, DG Health and Food Safety
Safe food, healthy animals and plants
• EU consumers have a right to safe food – regardless of origin
• Legislation in place (EU food law) • Primary responsibility lies with the producer • Role for competent authorities
Hierarchy of Official Controls in the EU
Commission
National Authorities
Operators
carry out official controls to enforce EU standards
apply EU standards (primary responsibility)
verifies how the competent authorities ensure enforcement of EU standards, and their functioning in practice
What about non-EU countries?
• Audited by Commission • Listed in order to
export to the EU • Animal health, • Public health, • Residues
• Certification of compliance with EU rules
Commission audits: Why?
• Assess competent authority performance
- Official controls to ensure that standards are met and in their effective enforcement
• Verify that EU Member States are compliant with EU law
• Assess if non-EU countries can provide reliable guarantees that commodities intended for export meet EU requirements (certification)
Commission audits: How?
Can it work?
Why not?
NO Is there a control system in place?
!
Consequences
NO
Does it work?
NO
Why not?
Why not?
YES
YES
YES
Commission audits – systems-based
• Evaluate official control (inspection) and certification systems
• Audits are planned, open to scrutiny, and performed on the basis of internationally-recognised audit methodologies (e.g. ISO 19011)
• Undertaken by Commission officials and national experts (impartiality)
• Costs paid for by Commission
Commission audits – systems-based
• 'Sampling' of establishments • Reporting structure
- Objectives/scope - Findings (factual/objective evidence) - Conclusions (judgement) - Recommendations (non-prescriptive)
• Draft and final reports • Action plans
System components
Example:
Residue control system
Resi
due
Surv
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nce
(Mon
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Plan
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Bord
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spec
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po
sts
in t
he E
U
Mem
ber
Stat
es
Lice
nsin
g an
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ntro
ls o
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m
edic
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Commission scrutiny
On-the-spot
Desk study
Resi
due
test
ing
labo
rato
ries
9
Commission audits - outputs
• Annual audit programme and planning cycle
• ~ 230 audits per year - 67% in Member States; 33% non-EU
• Transparency! Reports are published and available at: http://ec.europa.eu/food/audits-analysis/audit_reports/index.cfm
• Follow-up and closure of recommendations – country profiles for Member States
http://ec.europa.eu/food/audits-analysis/audit_reports/index.cfmhttp://ec.europa.eu/food/audits-analysis/audit_reports/index.cfm
Audit follow-up - address each
recommendation - be verifiable - be realistic and achievable
- Assessment - on paper or by audit
Summary • The EU Commission's systems audit approach:
- Allows balanced judgement on the performance of competent authorities in delivering official controls, based on objective evidence
- Encourages improvements in the implementation and effectiveness of control systems
- Underpins trade in food, animals, plants and feed – both intra-Union and from non-EU countries
- Is transparent giving stakeholders confidence in the safety of food from farm to fork
mailto:[email protected]
The EU approach to systems-based auditsSafe food, healthy animals and plantsHierarchy of Official Controls in the EUWhat about non-EU countries?Commission audits: Why?Commission audits: How?Commission audits – systems-basedCommission audits – systems-basedSystem components Commission audits - outputsAudit follow-upSummarySlide Number 13