usage of data in efsa’s work and risk assessment...usage of data in efsa’s work and risk...

Usage of data in EFSA’s work and risk assessment

Enikő Varga EFSA Evidence Management Unit (DATA) Food, Health and the Role of National Reference Laboratories Backweston, Celbridge, Co. Kildare, Ireland 3/4 February 2016


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Why? What?

How?

Summary: Data collections at EFSA

EFSA was established in 2002 as an independent source of scientific advice on risks associated with the food chain to:

Improve EU food safety

Help ensure a high level of consumer protection

Restore and maintain confidence in the EU food supply

EFSA’S ORIGINS

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Risk assessment and risk communication but not risk management


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EFSA “shall search for, collect, collate, analyse and

summarise relevant scientific and technical data in

the fields within its mission. This shall involve in

particular the collection of data relating to food

consumption and the exposure of individuals to risks

related to the consumption of food”;

EFSA “shall work in close cooperation with all

organisations operating in the field of data collection,

including those from applicant countries, third countries

or international bodies”.

REGULATION (EC) NO 178/2002


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The Member States shall take the necessary

measures to enable the data they collect in the fields

referred to in paragraphs 1 and 2 to be transmitted

to the Authority.

The Authority shall forward to the Member States and

the Commission appropriate recommendations

which might improve the technical comparability of the

data it receives and analyses, in order to facilitate

consolidation at Community level.

REGULATION (EC) NO 178/2002

Article 33

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The Regulation covers all data collections This is the basis for the harmonisation initiatives


The Laboratories in the Member States are EFSA’s Laboratories

EFSA HAS NO LABORATORY

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RISK ASSESSMENT & SCIENTIFIC

ASSISTANCE

ANIMAL AND PLANT HEALTH (ALPHA)

ASSESSMENT AND METHODOLOGICAL

SUPPORT (AMU)

EVIDENCE MANAGEMENT

(DATA)

BIOLOGICAL HAZARD AND CONTAMINANTS

(BIOCONTAM)

WHO ARE EFSA’S DATA PROVIDERS?

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http://www.google.it/url?sa=i&source=imgres&cd=&cad=rja&uact=8&ved=0CAkQjRwwAGoVChMIs7WFpeeQyAIVQTUUCh2qugtT&url=http://www.escubes.com/2015/07/computer-network-systems-computer-network/&psig=AFQjCNEa4VyaPUI1ZGU0iiYya7phvpilJQ&ust=1443223138078140



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Why? What?

How?



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EUROPEAN DATA COLLECTIONS


Food consumption Contaminant

occurrence in food and feed

Pesticide residue

occurrence

Food additive usage &

occurrence

Zoonoses, antimicrobial resistance & food-borne outbreaks

Veterinary Medicinal Product Residues (VMPR)

Molecular Typing

Current data collections

Current data collections

Coming data collection


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Pesticide residue data collection

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Legislation background: Regulation 396/2005 requires that EFSA collate and analyse results of national controls on pesticide residues in food and feed

A consumer exposure assessment has to be carried out by EFSA before concluding on the safety of a maximum residue level

Annual summary report

Pesticide residue data collection and analysis


Up to 20 million data per year

Around 200-220 pesticides analysed every year

on 10-12 different food commodities


PESTICIDE RESIDUE DATA COLLECTION AND ANALYSIS

PESTICIDE RESIDUE DATA COLLECTION AND ANALYSIS

Lab1 Lab2 Lab3 Lab4 Lab5

Veterinary Authority

Agricultural / Health Protection Authority

Reporting Organisation

Collection of pesticide residues data in Member States and data transmission to EFSA



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Zoonoses data collection

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Annual EU summary reports on zoonoses and antimicrobial resistance based on data submitted to EFSA

Directive 2003/99/EC lays down the European Union (EU) system for monitoring and reporting of information on:

Zoonoses

Zoonotic agents

Antimicrobial resistance (AMR)

Food-borne outbreaks (FBO)

ZOONOSES DATA COLLECTION


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ZOONOSES DATA COLLECTION



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Chemical contaminants data collection

The EU Commission has gradually specified in regulations EFSA as data collection point for ‘raw’ occurrence data on chemical contaminants in food and feed. EFSA cannot substitute Member States in communicating to the Commission issues on risk management (aggregated or summarised data / results).

REGULATORY FRAMEWORK FOR CONTAMINANTS

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CALL FOR DATA: CONTAMINANT OCCURRENCE

Continuous annual call for data

Deadline 1st October each year

Main data providers are Member State competent authorities

Ad hoc calls for data when required


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DATA ANALYSIS: CONTAMINANT OCCURRENCE

Arsenic

Deoxynivalenol mycotoxin

Lead

Cadmium

3-MCPD esters


Scientific / Technical reports published

using data from the EFSA contaminant

occurrence database

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Chemical contaminants – published in 2015

DATA USED IN SCIENTIFIC OPINIONS AND REPORTS

Nickel in food http://www.efsa.europa.eu/en/efsajournal/doc/4002.pdf

Nickel in feed http://www.efsa.europa.eu/sites/default/files/scientific_output/files/main_documents/4074.pdf

Beauvericin and enniatins in food and feed http://www.efsa.europa.eu/en/efsajournal/doc/3802.pdf

Inorganic Arsenic in food http://www.efsa.europa.eu/en/efsajournal/pub/3597.htm

Chloramphenicol in food http://www.efsa.europa.eu/en/efsajournal/doc/3907.pdf

Tetrahydrocannabinol (THC) in food http://www.efsa.europa.eu/sites/default/files/scientific_output/files/main_documents/4141.pdf


http://www.efsa.europa.eu/en/efsajournal/doc/4002.pdf



http://www.efsa.europa.eu/sites/default/files/scientific_output/files/main_documents/4074.pdf





http://www.efsa.europa.eu/en/efsajournal/pub/3597.htm










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Chemical contaminants – published in 2015

Nitrofuran and its metabolites in food http://www.efsa.europa.eu/sites/default/files/scientific_output/files/main_documents/4140.pdf

Chlorate in food http://www.efsa.europa.eu/sites/default/files/scientific_output/files/main_documents/4135.pdf

Deoxynivalenol (DON) and masked deoxynivalenol in food and feed: http://www.efsa.europa.eu/sites/default/files/scientific_output/files/main_documents/3379.pdf

DATA USED IN SCIENTIFIC OPINIONS AND REPORTS













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Chemical contaminants - on-going

Nitrate in feed and food: on-going

3-MCPD esters in food: on-going

Erucic acid in feed and food: on-going

Fusarium toxins in feed: on-going

Copper in feed: on-going

New/foreseen mandates

Furan

Alternaria toxins

Pyrrolyzidine alkaloids

Dioxins and PCBs

DATA SELECTED FOR SCIENTIFIC OPINIONS AND REPORTS IN 2016


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EFSA JOURNAL

The EFSA Journal is an open-access, online scientific journal that publishes the scientific outputs of the European Food Safety Authority.

EFSA’s various output types are devoted to the field of risk assessment in relation to food and feed and include nutrition, animal health and welfare, plant health and plant protection.


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Call for chemical occurrence data: priorities for data collection

FORESEEN SCIENTIFIC OPINION AND REPORT

In view of a risk assessment or when reporting the data available at the European level, EFSA seeks to consider the most comprehensive overview of the existing data.

To achieve this aim, EFSA wishes to inform the data providers about the risk assessments and scientific reports being started and to give them the possibility to submit any additional data to those already submitted through the continuous call.

To help priorities for data collection: EFSA regularly sends Newsletter to the Chemical Occurrence Network Members


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Additive data collection


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CALL FOR DATA: FOOD ADDITIVES


Legislation background: Regulation (EC) No 1333/2008 on food additives requires that food additives are subject to a safety evaluation by EFSA before they are permitted for use in the European Union

In additional the programme for the re-evaluation of food additives that were already permitted in the European Union before 20 January 2009 has been set up under Commission Regulation (EU) No 257/2010

Call for food additives usage level and/or concentration data in food and beverages intended for human consumption - as needed

Main data providers: the food industry & Member State Competent Authorities

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DATA NEEDED FOR EXPOSURE CALCULATION


Analytical

results from

laboratory

analyses

Different

amounts eaten

by different

consumers

EXPOSURE ASSESSMENT ELEMENTS

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Exposure assessment

Occurrence of hazardous agent

in food

Food consumption



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Food consumption data

Small children (from 1 to 3)

Infants

Elderly

DISCRIMINATORS: AGE, CONSUMPTION…

Adult population

Special groups: vegetarians, diabetics, ethnic groups and different socio-economic strata …

Pregnant women

Regional habits

High consumers


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AGE CLASSES

Age class Age range Number of

surveys Number of countries

Infants 0 - 12 months 2 2

Toddlers 12 - 36 months 8 8

Children 3 - 10 years 16 14

Adolescents 10 - 18 years 14 12

Adults 18 - 65 years 21 20

Elderly 65 - 75 years 9 9

Very elderly > 75 years 8 8


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WHAT’S ON THE MENU IN EUROPE?

Aims to collect food consumption data at EU level: • in different age classes (from infants to elderly) • in all Member States (minimum 80,000 subjects in

total) • using methods allowing the comparison of the results

from different Member States • using the EPIC soft, or comparable software • including anthropometric measurements


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Why? What?

How?



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Networks on:

Zoonoses & AMR

Chemical occurrence

Food consumption

Pesticides

Veterinary medicinal product residues

SHP* discussion group on food chemical occurrence data

COLLABORATION WITH DATA PROVIDERS

*http://www.efsa.europa.eu/en/foodchemicaloccurrence%20/docs/tor_shp_dg_food_chemical_occurence_data.pdf

SHP: Stakeholder platform; AMR: antimicrobial resistance


Analytical

results from

laboratory

analyses


Different

amounts eaten

by different

consumers

Different

amounts eaten

by different

consumers

FROM CHAOS ....TO ORDER

Consumption data Concise data Comprehensive data Pan-European data

Contaminant data Legislated activities Ad hoc activities Total Diet Studies

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Different structures,

Varying protocols,

Different meaning, e.g. cup of coffee…

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Market data EuroMonitor GEMS/Food Household surveys

Other data Commercial data International data Research project data

Data management Different structures Varying protocols Incompatible storage

Literature data Searches Submissions Official reports

Data management

Uniform structure Standard protocol Compatible storage


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Guidance on data exchange (DCF)

EFSA receiving electronically sent data in a standard

format with automatic check of the formal correctness

during transmission

Data access system (DWH)

Standard sample description

Uniform structure Standard protocol Compatible

storage

Input

Output

DATA COLLECTION FLOW…

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Standard data management

Data Collection and Validation

Data transfer in SSD

DCF

Automatic data

validation

No validation error

Validation error

Data rejection

Data acceptance

Data Correction

Second data validation and standardisation

Storage final data:

Data warehouse Validation error

Data provider approval


Web portal for data submission (DCF) & storage original data Report on

the outcome of the

validation process & feedback

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Data warehouse

Access and

Reporting

Input into Risk Assessment &

Risk management


Statistical Analysis and Reporting

Corrective actions on the database if

needed

DCF

Data validations & standar-disation

Standard data management

WHAT IS SSD?

A model harmonising the collection of a wide range of analytical results in several domains of EFSA activity

A list of data elements that are standardised and can be conveniently used by both data providers and data receivers to fully describe samples and analytical parameters for assessment purposes. The SSD includes controlled terminologies and validation rules to guarantee data quality (in data export, transmission and storage) Standard terminologies are maintained and kept up to date

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Parameter code Parameter code

Acrylamide 4-[2-Chloro-4-

(trifluoromethyl)phenoxy-2-fluorobenzenamine

acrylamide 4 - (2-Chloro-4-

(trifluoromethyl) phenoxy-2-fluorobenzenamine

PARAMCODE PARAMCODE

RF-00000410-CHE RF-00001594-PAR

Data in SSD

format

Data not in SSD format

Data transformation into SSD format

DCF


What is SSD?

SSD is implemented for…

Chemical contaminants

Currently implemented for:

Pesticide residues

Additives

Food contact materials

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Veterinary drug residues

Implementation in progress (from 2018)

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BACKGROUND

VMPR data collection

Increasing number of request for risk assessment for

veterinary drug residues (e.g. chloramphenicol,

nitrofurans)

The current aggregated data collection system is not fit

for purpose

http://www.google.it/url?sa=i&source=imgres&cd=&cad=rja&uact=8&ved=0CAkQjRwwAGoVChMI1Y6Uoc6ayQIVRmAPCh2M8Afb&url=http://www.hrmonline.co.nz/news/rising-number-of-jobs-nationwide-129922.aspx&psig=AFQjCNEA53TaWsfBDF7tpcCvkXLqnu1DBw&ust=1447958062978174

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BACKGROUND


The European Commission sent a mandate to EFSA to set up a European

sample-based data collection

http://www.google.it/url?sa=i&source=imgres&cd=&cad=rja&uact=8&ved=0CAkQjRwwAGoVChMI1Y6Uoc6ayQIVRmAPCh2M8Afb&url=http://www.hrmonline.co.nz/news/rising-number-of-jobs-nationwide-129922.aspx&psig=AFQjCNEA53TaWsfBDF7tpcCvkXLqnu1DBw&ust=1447958062978174

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MANDATE RECEIVED FROM THE EUROPEAN COMMISSION

Term of reference as described in the EC mandate


To collect information on all samples analysed

within the framework of residue monitoring.

To allow the MSs to provide information on follow-up

actions directly linked to the respective non-compliant

results.

To allow differentiated access to the data:

• for the European Commission services

• for the Member States

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DATA MODEL

Data should be provided at sample-based level according to the Standard Sample Description* version 2: SSD2


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PROCUREMENT FOR DATA MODEL IMPLEMENTATION


The objectives of the contract resulting from the procurement procedure are:

Design the data extraction process

Define the automatic conversion in SSD2-XML data file by:

• improving the reporting guidelines documents;

• improving the SSD2 data model;

• improving the SSD2 catalogues;

• improving the specific requirements and the business rules.

Test the data extraction process using data transmissions in 2016 (2015 data)

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Next Steps


Developing a reporting tool for sample-based veterinary medicinal product residues

Setting up a Specific EFSA Scientific Network on VMPR

Organising training

Setting criteria for data aggregation for reports displayed in DWH

http://vignette3.wikia.nocookie.net/ravemaster/images/4/47/Done.png/revision/latest?cb=20120326201341

http://www.google.it/url?sa=i&source=imgres&cd=&cad=rja&uact=8&ved=0CAkQjRwwAGoVChMIv6eiuJScyQIVQ1wUCh0rrgfw&url=http://www.brothersconstruction.in/ongoing_projects.html&psig=AFQjCNF0JhJuHrPUYUVJIJZdUNfKh75lpw&ust=1448011261662388



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Next Steps


2015 Pilot project with 11 MSs – including Ireland

2016 First meeting of Scientific Network on VMPR

23-24 February 2016 Parma

2016 Pilot study (all MSs)

2017 All data to be collected at sample-based level

2018 All data to be transmitted at sample-based level to EFSA

No nominated NW member from Ireland!

http://img1.wikia.nocookie.net/__cb20110705195119/lego/images/c/cd/Warning_sign.png

Aggregated data of any type

Animal diseases

SSD is NOT implemented for…

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SSD IS ONLY THE BASIS…

SSD is a model harmonising the collection of analytical results…

However doesn’t guarantee good quality data

Harmonisation should start as early as possible in the data production chain

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Food composition

Exposure assessment


in food

Food consumption

Precise description of the food


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Maybe there was also an omelette inside Chicken egg with Omega III

DIFFERENT CONSCIOUSNESS

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Analytical technique

Food description

Exposure assessment


in food

Precise description: Aflatoxins or Afla. B1

Product treatment

Moisture content of the sample

Sampling year (season >month)

Method of production (organic,

greenhouse?)

Food consumption

Very Precise description of the food


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Which data are used in the reports on chemical

contaminants?

?

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Data elements for reporting chemical contaminants data

Data elements

Mandatory Optional

Missing information?

- essential information - value must be

reported

- important information - value is recommended

to be reported

Data transmission

rejected

Data transmission

accepted, but

information might be

requested


http://img1.wikia.nocookie.net/__cb20110705195119/lego/images/c/cd/Warning_sign.png

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Example: acrylamide level in food


Product Acrylamide levels mg/kg

French fries < LOQ

French fries 312

French fries 1250

French fries 7900

Statistical analysis? Average, median, standard deviation…

Measuring unit?

Applied analytical technique…?

http://www.google.it/url?sa=i&source=imgres&cd=&cad=rja&uact=8&ved=0CAkQjRwwAGoVChMIneDryeOyyAIVBIosCh0Y0gaU&url=http://cliparts.co/question-mark-gif&psig=AFQjCNENmge2j_hgYksDUJskHjjOydABmA&ust=1444390372616406

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Example: acrylamide level in food


Time for frying: 3.5 min

Acrylamide level: 1250 mg/kg

French fries prepared in the lab from pre-fried, frozen potato

Time for frying: 7 min


Time for frying: unprepared Acrylamide level: < LOQ

Time for frying: n.a. (restaurant)


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For a reliable risk assessment the chemical occurrence data must be:

accurate, complete, compliant to the standards, well described;

Provide sufficient geographical coverage;

Represent all the food groups significant for consumption;

Reasonably represent the real food market share in each food group;

Provide in each food group sufficient number of samples to allow robust statistical treatment.


Reliable data for risk assessment

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Reduce set of data for report/opinion might base on:

Sampling year

Analytical method used – adequate / precise enough?

Analytical method validation

Data selected only from certain matrices,

Descrepencies in sample descriptors,

High-level catalogue terms, etc.

Not used data can be used later!


Reliable data for risk assessment

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Cascading requirements

EFSA

National Competent Authorities

Local Authorities

Laboratories Sampling officers

Data should fit requirements

when recorded


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EFSA risk assessment and EC risk management are using European data:

Provided by National Competent Authorities

Generated by Member States laboratories

Data requirements are established to fulfill data analysis requirements for exposure assessment and EC data requirements

All data required is proposed to data analysts in the EFSA Scientific Data Warehouse

Data requirements are best fulfilled at time of data entry

Harmonisation should start as early as possible in the data production chain

Conclusion


Thank you for your attention!

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Questions

http://www.google.it/url?sa=i&source=imgres&cd=&cad=rja&uact=8&ved=0CAkQjRwwAGoVChMI7Pv-xu2QyAIVx-0UCh2rEAuF&url=http://www.global-english.com/news/tips-for-tefl-discussion-classes/&psig=AFQjCNHqyHa2pI1wm-XTxMY1XplksJp-Tg&ust=1443224819912642

http://www.google.it/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&ved=0CAcQjRxqFQoTCMuAy6fnssgCFYsKGgodSasCbg&url=http://www.clipartpanda.com/categories/question-mark-clip-art&psig=AFQjCNEXzbkNP1zskZIzxQJ5-6jJxOFlwg&ust=1444390353172240

DWH access policy


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DWH allows differentiated access to the data for the

different parties (described in the DWH access policy):

Data providers, EFSA’s data managers and scientific

officers working on the data: access to raw data at

individual level

European Commission services

Participants of the project of “Circle of trust” (CoT)

Others: only aggregated level (Dashboards)

EXPOSURE ASSESSMENT ELEMENTS IN DWH

Precise description: Aflatoxins

Data analyst searches for

specific substances


ANALYSIS IN DWH - EXAMPLE

Output precise description of the food

Output to the level of detail e.g. needed to combine with consumption

data

Output to the level of detail e.g. needed to set possible ML


ANALYSIS IN DWH - EXAMPLE

Grains for human consumption


DWH Dashboard – Chemical Occurrence - 2012


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DWH Dashboard – Chemical Occurrence – 2012 - IE


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DWH Dashboard – Chemical Occurrence - 2012

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Granted access to the participants for data at individual, raw data level with some restriction

Advantages:

The CoT pilot study allows access to many data and the possibility of comparison with other countries on levels and trends

Might promote better co-operation between countries both in risk management and laboratory practices by promoting direct dialogue

Might improve the understanding of the observed levels thus driving a better management of the risk;

Laboratories can gather information on limit of quantification (LOQ) and limit of detection (LOD), and analytical methods used in other Member State laboratories to improve their current practice

Circle of Trust: Scientific database for MSs


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Through the CoT the members may access data for areas (e.g. food groups, analytes) not included in their national datasets. These data can be used for example in modelling exposure and risk assessment;

With the DWH tools it is possible to obtain statistics on own data;

For defining the national monitoring plan, it is possible to get useful insights from monitoring programmes in other countries; for example, substances with high occurrence levels in some countries may be considered in the monitoring plans of other MSs

Circle of Trust: Scientific database for MSs


usage of data in efsa’s work and risk assessment...usage of data in efsa’s work and risk...

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