Federal Agency for the Safety of the Food Chain

Vicky LEFEVREDG Control PolicyBelgian Food Safety AgencySciCom Symposium 2017-11-24

Managing chemical hazards in the food chain:

lessons learned from the fipronil incident

Federal Agency for the Safety of the Food Chain

Food Safety:general context and responsibilities

Food Business Operator

Member stateFASFC

EUDG SANTE

Implementing legislation and enforcement

Basic legislation (hygiene package,

animal & plant health)and surveillance

Implementation and self -checking

Federal Agency for the Safety of the Food Chain

Mission FASFC

Federal Agency for the Safety of the Food Chain

Cornerstones of FASFC food safety control policy

• Self-checking

• Notification requirement

• Traceability

• Monitoring food chain by official controls and inspections (MANCP)

Royal decree 14/11/2003 on self-checking, notification requirement and traceability

Federal Agency for the Safety of the Food Chain

Implementation of self-checking systems

With an independently certified self-checking system (SCS) (based on the guides)

No independent guarantees by ACB

SCS validated (with or without guide) SCS not validated

Business operator of the food chain

Accredited certification bodies

External audit/Testing/inspection

Information

FASFC

Audit

Audit

InspectionInspectionInspection

Federal Agency for the Safety of the Food Chain

Notification requirement

• To inform FASFC

• Applies to food business operators, laboratories and certifying bodies

• Implement measures: withdrawal from the market, recall, information to consumers

Federal Agency for the Safety of the Food Chain

Traceability

• 1 step back

• 1 step forward

Federal Agency for the Safety of the Food Chain

Monitoring the food chain MANCP

Federal Agency for the Safety of the Food Chain

Monitoring the food chain : chemical contaminants

Risk based methodology sampling programme:

• Legislation

• Detection of contaminationStatistical approach based on population, matrix, severity of adverse effects, occurrence of hazard in population, contribution of population to exposure, prevalence to control, level of confidence

• Estimation of prevalence• Statistical approach• Level of confidence

Federal Agency for the Safety of the Food Chain

• MRL is not a toxicological limit • Non-compliant products

• pesticide residues > MRL• may not be put on the market

• Measures depend on risk for the consumer• Risk assessment according to EU procedures

• PSTI & ARfD• Pesticide Residue Intake Model EFSA (PRIMo model)

• FASFC procedure in case of non-compliant products ‘Inventory of actions and action limits and proposals for harmonization of official

controls’

Management of non-compliant pesticide residues by FASFC:

Federal Agency for the Safety of the Food Chain

Risk assessment according to EU procedures

• No serious risk for consumers:• Upstream traceability withdrawal from the market • Inspection of food business operator and possibly additional analyses• Infringement report

• Serious risk for consumer:• Upstream and downstream traceability

• Withdrawal from the market• Recall at consumer level

• RASFF communication• Inspection of food business operator and additional analyses• Infringement report

Management of non-compliant pesticide residues by FASFC:

Federal Agency for the Safety of the Food Chain

Fipronil incident: from non-compliance to food scare

Federal Agency for the Safety of the Food Chain

Chronology Fipronil investigation

Federal Agency for the Safety of the Food Chain

Blocked

Laying hens 48 + 7

Breeders and rearing

38

Total 86 + 7

• 86 suspected poultry farms initially blocked based on information onpotential use of Fipronil

• 7 farms additionally blocked based on a monitoring of all non suspectedlayer farms

Release of farms only in case of analysis results compliant with MRLTests are required on new laying hens before production

BE: egg production under control

Measures on farm level

Federal Agency for the Safety of the Food Chain

• Egg processing plants: informed of non-compliant results at farm level.Measures on non-compliant eggs and egg products (destruction, withdrawal)based on analytical results or risk assessment (taking into account processingfactors). Traceability downstream.

• Slaughterhouses layers: 15 lots/5 days of slaughtering and controls at random.All were compliant.

• Food processing plants: informed of non-compliant results through traceabilityexercise. Measures on non-compliant products (destruction, withdrawal) basedon analytical results or risk assessment (taking into account the eggincorporation rate and processing factors). Traceability downstream. On thespot visit to verify if appropriate measures have been taken. Verification ofown-checks, records.

• Retail: informed of non-compliant results through traceability exercise.Screening based on random sampling of foodstuffs for analysis on fipronil.More then 5600 on the spot checks to verify if appropriate measures have beentaken in case of contaminated products (destruction, withdrawal).

• NC eggs, animals, products: animal by-products of category 1 (destruction).

Measures in processing plants, retail and with regard to animal by-products

Federal Agency for the Safety of the Food Chain

- Use of PRIMo model: safety threshold in eggs and meat- 0,72 mg fipronil / kg eggs- 0,77 mg fipronil / kg meat

- Worst case scenario (children 8,7 kg, meal 500 g) for safety threshold* in processed products

- 0,15 mg fipronil / kg processed products

- MRL 0,005 mg fipronil / kg for all products to assess compliance

- Use of measurement uncertainty - Recalculation for egg yolk taking into account of the fat solubility of

fipronil : 0,016 mg fipronil/ kg egg yolk- Recalculation for egg products as powder using standard processing

factor- Whole egg powder : 0,021 mg fipronil / kg (dehydration factor of 4,28)- Egg white powder : 0,041 mg fipronil / kg powder (dehydration factor of 8,23) - Egg yolk powder : 0,036 mg fipronil / kg powder (dehydration factor of 2,26)

Risk assessment and risk management

* Threshold for notification to the FASCF which will carry out a risk assessment in view of a recall in case of acute risk.

Federal Agency for the Safety of the Food Chain

Raw materials Analysis result ≤ MRL(0.005 mg/kg)

MRL (0.005 mg/kg) < Analysisresult ≤ Safety threshold

Analysis result > Safety threshold

Eggs No action Withdrawal(safety threshold: 0.72 mg/kg)

Recall(safety threshold: 0.72 mg/kg)

Egg products No action Withdrawal(safety threshold: 0.72 mg/kg)

Recall(safety threshold: 0.72 mg/kg)

Poultry Meat No action Withdrawal(safety threshold: 0.77 mg/kg)

Recall(safety threshold: 0.77 mg/kg)

Processed Foodstuffs

No action Withdrawal(safety threshold: 0.15 mg/kg)

Withdrawal or Recall*(safety threshold: 0.15 mg/kg)

Use of a measurement uncertainty to verify compliance analytical result with MRL

Risk assessment and management

Federal Agency for the Safety of the Food Chain

Communication on non-compliant products in case of fipronil incident

BE has mainly applied normal procedures in case of withdrawal/recall of products

In case of recall• Information to consumers (normal way of working)

In case of withdrawal from the market• No information to consumers (normal way of working)• Food business operator needs to inform FASFC of

withdrawn products (exceptional procedure)

Federal Agency for the Safety of the Food Chain

• Confidentiality in case of judicial investigation versus transparentcommunication

• Need for EU harmonised approach between MS on risk analysis, action levelsand measures taken on processed products

• Need for EC clarity and coherence on use of communication channels

RASFF AAC-FF

• EC goes beyond RASFF SOP (PSTI > ARfD) in case of this incident

• BE RASFF notification on 20/07/2017 (2017.1065) - over 400 follow-up on 29/08/2017 and also new initial notifications from MS - difficult to manage!

Encountered difficulties

Federal Agency for the Safety of the Food Chain

• 100 % control of the food chain is impossible to achieve :fipronil was not included in control programmes in EU MS…

• Maintain a high level of alertness by all players of the food chain

• Specific policy on food fraud

• Need for better control of biocide use by service providers

• Transparent risk communication even in case of ongoingcriminal investigations

• Better harmonisation of risk assessment, risk management andrisk communication on EU level in case of cross-borderincidents

Lessons learned

Federal Agency for the Safety of the Food Chain

Thanks for your attention