Data handling: observatories/databases/data storage/legal framework: EFSA data collection

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1 Data handling: observatories/databases/data storage/legal framework: EFSA data collection Mary Gilsenan Head of Evidence Management Unit, EFSA Workshop: Food Safety Challenges for Mediterranean Products Zaragoza, Spain, June, 2014

2 OUTLINE Data collection of food-borne hazards: Data collections at EFSA Regulatory framework Data management 2

3 EVIDENCE MANAGEMENT (DATA) UNIT 3

4 DATA COLLECTION AT EFSA EFSA does not have laboratories Data are collated from European countries to EFSA 4

5 WHY WE NEED DATA: RISK ASSESSMENT PARADIGM (1) Hazard Identification What is the food borne hazard capable of doing? How much is likely to be consumed? (2) Hazard Characterisation (3) Exposure Assessment At what level is it likely to cause harm? (4) Risk Characterisation What level of intake could be allowed without appreciable health risk? 5

6 EUROPEAN DATA COLLECTIONS AT EFSA Food consumption Contaminant occurrence in food and feed Now Pesticide residue occurrence Food additive usage & occurrence Zoonoses, antimicrobial resistance & food borne outbreaks Veterinary drug residues Molecular typing Future Ad hoc data collections (e.g. Perchlorates) 6

7 DATA COLLECTION NETWORKS Zoonoses monitoring data National coordinators of data reporting + observers Chemical occurrence data Food consumption data Pesticide residue monitoring data 7

8 CALL FOR DATA: CONTAMINANT OCCURRENCE Continuous annual call for data Deadline 1 st October each year Main data providers are Member State competent authorities Instructions on how to submit data to EFSA Ad hoc calls for data when required 8

9 DATA USE: EXAMPLE REPORTS & RISK ASSESSMENTS 9

10 OUTLINE Data collection of food-borne hazards: Data collections at EFSA European regulatory framework Data management & use 10

11 REGULATORY FRAMEWORK Overarching legal obligation: EFSA shall search for, collect, collate, analyse and summarise relevant scientific and technical data... work in close cooperation with all organisations operating in the field of data collection... Article 33 of EFSA Founding Regulation 178/2002/EC 11

12 SECTOR SPECIFIC EUROPEAN LEGISLATION National monitoring & exchange of data to EFSA Food borne hazard Pesticide residues Legal basis Commission Regulation 396/2005/EC (Article 31) Zoonoses, zoonotic agents and antimicrobial resistance (AMR); foodborne outbreaks Flavourings Food additives Commission Directive 2003/99/EC (Articles 8 & 9) Commission Implementing Decision 2013/652/EU (Article 5) (AMR specific) Regulation 1334/2008/EC (Article 20) Regulation 1333/2008/EC (Article 27) 12

13 SECTOR SPECIFIC EUROPEAN LEGISLATION (CONTD./) Commission Regulation (257/2010/EC) Food additive safety re-evaluation programme All food additives permitted for use before January 2009 to be re-evaluated by EFSA EFSA collects data on food additive usage and occurrence from several stakeholders through calls for data 13

14 SECTOR SPECIFIC EUROPEAN LEGISLATION (CONTD./) Contaminants: Commission Regulation (EC) No. 1881/2006 Lays down maximum residue levels for contaminants in foodstuffs Requirement to monitor and report to the European Commission The Commission transferred task of collecting data on a continuous basis from Member State data providers to EFSA* in 2010 *EFSA mandate No

15 SECTOR SPECIFIC EUROPEAN LEGISLATION (CONTD./) Contaminant monitoring Contaminant Acrylamide Ergot alkaloids Ethyl carbamate Legal basis Commission Recommendation 2010/307/EU Commission Recommendation 2012/154/EU Commission Recommendation 2010/133/EU Perfluoroalkylated substances in food (PFAS) Cadmium Furan Commission Recommendation 2010/161/EC Commission Recommendation 2014/193/EU Commission Recommendation 2007/196/EC Recommendations on Member States to monitor and report data directly to EFSA 15

16 SECTOR SPECIFIC EUROPEAN LEGISLATION (CONTD./) Veterinary drug residues: Council Directive 96/23/EC Requires Member States to implement national residue monitoring plans & to report results to the Commission on a annual basis Monitoring data are reported in aggregated format EFSA assists the Commission in the preparation of an annual summary report on monitoring results EFSA received a mandate* from the Commission to set up a European data collection at sample based level 16

17 DATA COLLECTION: FOOD CONSUMPTION EFSA data collection regulatory framework covered by article 33 of EFSA founding Regulation EFSA has compiled the Comprehensive European Food Consumption Database 32 dietary surveys (different survey methodologies) 22 Member States Infants to elderly Summary statistics on EFSA website EFSA is supporting Member States to collect more harmonised food consumption data EU Menu project:

18 OUTLINE Data collection of food-borne hazards: Data collections at EFSA Regulatory framework Data management 18

19 DATA STANDARDISATION: SSD Standard Sample Description (SSD) EFSA standard for receipt of analytical occurrence data Pre SSD SSD No specified format Word / PDF files as attachments Standardised description & transmission of the data Legal obligation for pesticide data submission (Commission Implementing Regulation (EU) No. 788/2012) 19

20 DATA STANDARDISATION: SSD (CONTD./) SSD: Standard Sample Description MANDATORY Laboratory sample code Language Country of sampling Country of origin of the product EFSA product code Product treatment Year of sampling Sampling strategy Programme type Sampling method Sampling point Laboratory accreditation Result code Year of analysis Parameter code Type of parameter Result unit Type of result Evaluation of the result OPTIONAL Product full text description Expression of result Product comment Result LOQ Percentage of fat in the original sample Result value corrected for recovery Result value uncertainty Analytical method code Analytical method text Percentage of moisture in the original sample Area of origin for fisheries or aquaculture activities code and text Ingredient Comment of result Packaging Result LOD Month of sampling Day of sampling Area of sampling Area of origin of the product ~80 fields (data elements) ~20 mandatory fields In built business rules Guidance on the Standard Sample Description version 2 (2013) 20

21 EFSA DATA COLLECTION FRAMEWORK (DCF) Web-based interface for submitting occurrence data to EFSA System checks for correct completion of mandatory fields and business rules Automatic feedback to data providers 21

22 EFSA Data Warehouse Validation, aggregation, harmonisation Ongoing project; under development 22

23 DATA ACCESS ACCESS RULES Outlines proposed data access for different stakeholders ACCESS RULES TECHNICAL ASPECT 23

24 DATA COLLECTION AT EFSA EFSA has established a significant hub of European data for its risk assessments 24

25 EFSA DATA ROADMAP 2005 Focus on data collection Data Standardisation SSD* Data Warehouse DATA unit towards centralisation & streamlining of data collection at EFSA Draft Data Roadmap Open data Data quality Data 25

26 Thank you Mary Gilsenan, PhD Head of Evidence Management (DATA) Unit, EFSA 26