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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