DATA Management,

analysis and exposure

DATA LIFE CYCLE WITHIN THE UNIT

Data management team Dietary exposure team

Receipt of data Data Storage in EFSA Estimation of

from Member management & scientific data dietary exposure
State competent validation warehouse in EFSA opinions
authorities, and reports
academia,
industry…
Export of raw
data, maps,
graphs, reports,
dashboards..
 DATA MANAGEMENT AND EXPOSURE ROLES

Interfaces and Reference Data collection Data operation Data access Data quality Data modelling
tools for data terminologies, (Bionumerics, (data (Business and design
reporting organisation DCF) validation, ETL, intelligence, Exposure
and users storage) ArcGIS, R, SAS assessment
identities, EG)
metadata,
terminology
management
system

INTERIM
INTERIM

3
DATA MANAGEMENT PROCESSES
Data collection and data stewarding
• Chemical contaminants
• Additive usage and occurrence
• Veterinary medicinal product residues

Data collection and data stewarding

• Pesticide residues

Data Data collection and data stewarding

Zoonoses prevalence, animal diseases

processes
•
• Zoonoses foodborne outbreaks
• Zoonoses animal population
• Antimicrobial resistence

and Data collection and data stewarding

• Molecular typing

content Data collection and data stewarding

stewarding
• Consumption
• Food composition

Exposure
Exposure team
team

Data support
• Service desk support
• Quality assurance support
• MS Network meeting support
• Stakeholder platform support

Contracts and partnership management

• SSD2 pilot implementation
• Framework Partnership Agreement with MSs
• Framework contract to outsource some data management activities

4
 Data providers
EFSA has no laboratories

The Laboratories in the Member States are EFSA’s Laboratories

5
 DATA MANAGEMENT AND EXPOSURE

Collection,
management and Exposure
validation of data assessment
SOP08 SOP40
Chemi-
cals

Exposure

Data files Data Warehouse Consum- Opinion

from data ption

providers

6
DATA MANAGEMENT AND EXPOSURE

Data management

Exposure assessment

7
DATA MANAGEMENT AND EXPOSURE

Example: Data collection chemical contaminants

8
DATA MANAGEMENT
• Chartering
• Preparing calls for data
• Planning
and set up data
• Objective setting collections
(scientifically and
technically)
• Support data providers
during data
transmission
• Process and validate
data

Plan Do
Records are in
next slides 

Act Check
• Non conformities
• IT system enhancements
• Team meetings and
• Process enhancements (e.g. new
monitoring
WINs) • One to one bilaterials
• Data enhancement (Data quality
• Intermediate dialogues
KPIs)
• KPIs from objective
• Suppliers enhancements
setting

9
PLAN (RECORDS)
 Mandate M-2010-0374 (RoQ)
 Charter (Resources/Budget) DMS
 Planning
 Team baseline (inputs: SPD 2016-2018, ABB, Sciforma, CII-
DB, Team leader objectives though
performance dialogue application, output: team base planning
)
 Team monitoring (input: Team base planning output:
team management monitoring)

10
DO (RECORDS)
 SOP40 and WINs
 Preparation of data collection
 Call for data, Refined data collection requirements [SOP8.record2]
 DCF configuration (Metadata and business rules) [SOP8.record3.1]
 Master record in DCF data collection configuration
 Configuration of S-DWH and Web DAS (Metadata and business rules)
[SOP8.record3.2] Delivery and Editorial
 Submitted data/revised submission [SOP8.4.1]
 Data Collection Framework System (DCF),
 file tracking (link to SAS file server),
 functional mailbox (data.collection@efsa.europa.eu)
 Support to data providers ->Mail correspondence [SOP8 4.4]Functional
mailbox (data.collection@efsa.europa.eu)
 SAS program [SOP8 5.1]
 Validation reports [SOP8 5.2] 4.4 Functional mailbox,
validation reports inbound folder, validation report outbound folder

11
CHECK (RECORDS)
• Team meetings (DMS) & monitoring & team KPIs dashboard (
team management monitoring)
• One to one bilateral meetings (DMS)
• Intermediate dialogues (DMS)
• KPIs from objective setting (Performance dialogue application)
• Team internal audits for SOPs records (DMS)
• EFSA internal audit plan (DMS)

12
ACT (RECORDS)
• Non-conformities management (see non-conformity slide)
• Suppliers management (warning letter1&2, reduced payments, draft final deliverable –
paper copy)
• Continuous improvements:
• IT System enhancements (P-DATA-05 Scientific data warehouse project – charter)
• DCF enhancements DCF
• Organisational enhancements:
• Introducing service catalogue (P-DATA-17 Data collection services – charter, slides)
• Process enhancements:
• New/revised SOPs and WINs: (Catalogue annual revisions, Clarifications and Criteria files)
• Process Output (Data) enhancements:
• Data quality KPIs (technical document)
• Enhance suppliers management:
• Data providers (National competent organisations)
• Data Quality Framework partnership agreement with MSs (Scoping document)
• IT suppliers - activities already agreed (hyper-care during reporting season and
data collection calendar, list of checks)
• Data Management outsourcing: New framework contract for data management services
• Team lessons learned (DMS)
13
RISK BASED THINKING

 Risk listed in a section of the charters

 Risk listed in team meetings (here)

14
NON CONFORMITIES

List and result

 DMS

15
Annex 1 – Data validation
process
 Data management flow
Data Correction

Data Collection Data transfer DCF

and Validation in SSD
Data providers
Web portal for data
submission (DCF) &
Report on the storage original data
outcome of the Automatic
validation data
process &
Data provider feedback
validation
approval No validation Validation
error error
Second data
Storage final Data Data
data: validation and
Data standardisation acceptance rejection
warehouse
Validation error
17
Annex 2 – Legal
background
 REGULATION (EC) NO 178/2002

 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”.

19 19
 REGULATION (EC) NO 178/2002

Article 33
 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.

The Regulation covers all data collections

This is the basis for the harmonisation initiatives 20
20 20
REGULATORY FRAMEWORK FOR CONTAMINANTS

Regulation (EC) No 882/2004

http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32004R0882R(01)&fro
m=EN

Covers annual reports, control and audits, cases of

non-compliance, enforcement actions + timelines
Regulation (EC) No 669/2009
Covers import of certain foods with quarterly report
to the EC

Regulation (EC) No 1152/2009

Covers import from third countries
21
21
Regulations/Recommendations for CONTAMINANTS
 Commission Regulation (EC) No 1881/2006 of 19
December 2006 setting maximum levels for certain
contaminants (Nitrate, Aflatoxins, Ochratoxin A, Patulin,
Fumonisins, Lead, Cadmium, Mercury, Tin (inorganic),
Benzo(a)pyrene) in foodstuffs.
 http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32006R1881
&from=en

 Regulation (EC) No 1258/2011

 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:320:0015:0
017:EN:PDF

 amending Regulation (EC) No 1881/2006 as regards maximum levels for

nitrates in foodstuffs

22
22
Regulations/Recommendations for CONTAMINANTS

 Regulation (EU) No 420/2011 amending Regulation (EC)

No 1881/2006 setting maximum levels for certain
contaminants (lead, cadmium, mercury, dioxin, PAH,) in
foodstuffs
 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:111:0003:0
006:EN:PDF

 Commission Regulation (EC) No 333/2007 of 28 March

2007 laying down the methods of sampling and analysis
for the official control of the levels of lead, cadmium,
mercury, inorganic tin, 3-MCPD and benzo(a)pyrene
in foodstuffs
 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2007:088:0029:0
038:EN:PDF
23
23
Regulation for mycotoxins
 Regulation (EC) No 401/2006 of 23 February 2006
laying down the methods of sampling and analysis for
the official control of the levels of mycotoxins in
foodstuff
 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2007:088:0029:
0038:EN:PDF

24
24
Recommendations for Acrylamide

 Commission Recommendation 2010/307/EU

of 2 June 2010 on the monitoring of acrylamide
levels in food
 http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?
uri=CELEX:32010H0307&from=EN…

 Commission Recommendation 2013/647/EU

of 8 November 2013 on investigations into the
levels of acrylamide in food
 http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELE
X:32013H0647&from=EN

25
25
Recommendations for Dioxins

 Commission Regulation (EC) No 1883/2006 of 19 December

2006 laying down methods of sampling and analysis for the
official control of levels of dioxins and dioxin-like PCBs in
certain foodstuffs
 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?
uri=OJ:L:2006:364:0032:0043:EN:PDF
 Commission Regulation (EU) No 252/2012 of 21 March 2012
laying down methods of sampling and analysis for the official
control of levels of dioxins, dioxin- like PCBs and non-
dioxin-like PCBs in certain foodstuffs and repealing Regulation
(EC) No 1883/2006
 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:084:0001:0022:EN:P
DF

26
26
Recommendations for Dioxins

 Commission Regulation (EU) No 278/2012 of 28 March

2012 amending Regulation (EC) No 152/2009 as regards
the determination of the levels of dioxins and
polychlorinated biphenyls.
 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:091:0008:0022:
EN:PDF

 Council Regulation (EC) No 2187/2005 of 21 December

2005 for the conservation of fishery resources through
technical measures in the Baltic Sea, the Belts and the
Sound, amending Regulation (EC) No 1434/98 and repealing
Regulation (EC) No 88/98
 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?
uri=OJ:L:2005:349:0001:0023:EN:PDF
27
27
Recommendations for Furan
 Commission Recommendation No
2007/196/EC of 28 March 2007 on the
monitoring of the presence of furan in
foodstuff
 http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:
32007H0196&from=EN

28
28
Recommendation for perchlorate and 3-MCPD esters

 Commission Recommendation (EU) 2015/682 of 29

April 2015 on the monitoring of the presence of
perchlorate in food
 http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?
uri=CELEX:32015H0682&from=EN

 Commission Recommendation (EU) of 10 September

2014 on the monitoring of the presence of 2 and 3-
monochloropropane-1,2-diol (2 and 3-MCPD), 2-
and 3-MCPD fatty acid esters and glycidyl fatty acid
esters in food
 http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?
uri=CELEX:32014H0661&from=EN

29
29
Annex 3 – Data collections
 DATA COLLECTIONS

Data collections operational project Mandate

Collection of chemical DATA-08 M-2010-0374
contaminants
Collection of zoonoses P-BIOCONTAM-01 M-2013-0063
data
Collection of pesticide PRAS-18 M-2014-0036 
residues data
Veterinary drug P-DATA-13 M-2014-0022
residues
Molecular typing data P-DATA-07 M-2013-0082

31
Annex 4 – Application
architecture
APPLICATION ARCHITECTURE

33