Post on 25-Jun-2020
EFSA and RASFF
Ana Afonso
40 years of RASFF: “All you need is RASFF?” - smarter data = better analysis
13.12.2019. Brussels
EFSA role - scientific and technical support to RASFF
Rapid Assessment of Contaminant Exposure tool (RACE)
RASFF Data for Rapid Outbreak and Risk assessment
Next….
Overview
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• Consumer association X investigated the presence of potentially genotoxic processing contaminants in ready to eat food.
• The brand, batches of the products and positive analysis results were published in the association website, but no details on the analytical methodology used.
• A RASFF alert notification was issued by country Y. The level of risk was undecided.
Develop a tool to harmonise risk evaluation
Propose methodology for a risk-based classification of RASFF notifications on contaminants
Based on science but practical to use
Application areas :
Industrial and environmental contaminants
Heavy metals
Mycotoxins and other biotoxins
Migration from food contact materials
Residues of pharmacologically active substances
Mandate to EFSA
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3 Work Packages (WP):
WP1 Toxicological parameters
WP2 Estimating exposure
WP3 IT tool
Consultation with RASFF network
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https://efsa.onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2019.EN-1625
Technical report
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A chemical contaminant of concern was detected in a food sample…..
Is the compound Genotoxic and Carcinogenic?
Is there an Acute reference dose available?
Is there a Chronic health-based guidance value available?
Is there a Reference Point available?
WP1 Toxicological parameters
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WP1 Toxicological parameters
EFSA Comprehensive European Food Consumption Database
https://www.efsa.europa.eu/en/microstrategy/food-consumption-survey
WP2 Estimating exposure
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FoodEx2
Webinar: The FoodEx2 classification system
A common language
Developed and maintained by EFSA
Clearly defined groups
Parent-child structure
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WP3 IT tool
Overview
Example: 127.63 µg/kg PAH4 in dried garlic
0. Is the compound genotoxic and carcinogenic?
Yes Yes
2G. Exposure assessment Is BMDL10 / exposure
> 10,000?
1G. Is there a RP (e.g. BMDL)
available?
EFSA, 2008: BMDL10 340 µg/kg bw/day
FoodEx2: IT tool: summary outcome*
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Analytical results
Use of the tool
OUTCOME
Risk assessment vs Risk evaluation
No risk;
Low probability of adverse health effects;
Low concern for public health
No risk
Serious risk
Risk / Potential risk Not serious risk
Rate of exceedance;
Population categories exposed;
Severity of the effect;
Duration of exposure;
Characteristics of the food
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Published 15/5/19
RASFF network training 23/5/19
Crisis simulation exercise 28/8/19
Enquires and technical support
Next steps
229 registered users
93 of them run at least one analysis
452 analysis are now stored in the accounts of the users
RACE users’ stats
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50 cases of Listeria monocytogenes XXXX infections were reported from country A and B.
20 isolates from sliced ready-to-eat meat products, were found to be contaminated with strains matching the outbreak strain.
The exact points of contamination were not identified. Company A, is the only common manufacturing point of the contaminated products. Company A distributed products to several EU countries as well as to countries outside the EU.
Rapid outbreak assessment
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Notifications
Follow ups
Questions
Answers
Laboratory results
Trade documents
Distributions lists
Measures taken…..
RASFF
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iRASFF notification
Tracing identification,
LOTs, units, withdrawals from market, product
processing information
Document information, questions, answers
Analytical results, laboratory results,
methodology, serotyping results
(WGS data)
Tested product ID Product ID
Outbreak information
Data in RASFF
iRASFF
Which establishment?
Which product?
DETAILS
Data in RASFF
Information source
RASFF number (key) Follow-up number(key) Notifying country Type of notification Hazzard Dates
Company / FBO
Company name (key) Country (key) Register number / VAT… Position in the supply chain (key) Type of activities
Product
Product name (key) LOT number (key) BBD/UBD/Date of production (key) Storage information
Details - tracing
Back-/Forward-tracing (key) Company IN /Company OUT (key) Product Transportation Storage Dates of delivery
Details – Lab. results
Laboratory name (key) Samples product/environment (key) Stage of sampling Method (key) Results
WGS results
WGS methods (key) Matching with outbreak strain
Data model
Tools to support Rapid assessments
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structuring
• extracting information
reviewing
• combining information
consolidating
• clarifying inconsistencies
analysing
•reconstructing the food/feed supply chain
•identifying “hot spots” and hypothesis
summarizing
•reporting
Data extraction tool
Inhouse system (Distiller software)
Data consolidation tool
Inhouse system (SAS software, FoodChain-Lab [DE-BfR])
Data analysis tool
FoodChain-Lab (EFSA-BfR partnership)
Data reporting tool
Summary of affected countries, food items, lots, contamination
Inhouse system (SAS software)
[Data collection tool]
Guided local data collection (EFSA-BfR partnership)
Tools to support rapid assessments
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Sharing of tools and structured information
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RASFF - AAC – What changes?
IMSOC – What changes?
Rapid Outbreak assessments and Food incidents coordinated response, what is needed?
Next…
Improve data capture at the point of sampling and simplify reporting
Focus on data already collected by MS (interoperability)
Increase the quality of data reported (controlled terminologies and validation rules)
Engage with RASFF contact points and MS crisis coordinators
Next…
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