1. New data collection-State of play Residues of Veterinary Medicinal Products in live animals and animal products Anca Stoicescu, Scientific Officer Zagreb, 9-10 February 2015

2. OUTLINE  Background  Mandate received from the European Commission  Status of progress o Data model o Drafting the “Reporting guidelines”  Next steps New data collection-State of play

3. BACKGROUND  European Food Safety Authority (EFSA) are getting a steady increase in risk assessment questions for veterinary drug residues (e.g. chloramphenicol, nitrofurans) and the current aggregated data collection system is not fit for purpose.  Annual reports on the results from the monitoring of veterinary medicinal product residues and other substances in live animals and animal products underline the limitations of collection of the aggregated data. New data collection-State of play

4. BACKGROUND  On February 2013, the European Commission (EC) asked EFSA and the European Medicines Agency (EMA) for a joint statement regarding a risk assessment on residues of phenylbutazone in horse meat, from direct consumption of horse meat as well as from other products adulterated with such food.  The current data in aggregated form were of little value to EFSA to perform risk assessment and this prompted the EC to send EFSA the mandate to set up a European sample-based data collection. New data collection-State of play

5. 5 MANDATE RECEIVED FROM EUROPEAN COMMISSION Term of reference as described in EC mandate: 1. To collect information on all samples analysed within the framework of residue monitoring. 2. To allow the MSs to provide information on follow- up actions directly linked to the respective non-compliant results. 3. To allow differentiated access to the data: for Commission services for MSs New data collection-State of play

6. 6 MANDATE RECEIVED FROM EUROPEAN COMMISSION The data collection system should allow the extraction of: 1. Reports on the implementation of the residue monitoring plan. Each MS shall be able to extract a report containing only their national data. 2. An annual compilation of the monitoring data of all MSs. EFSA annually extracts such a compilation containing data submitted by the MSs for the past year. 3. A summary overview of the actions taken by the MSs as follow-up to non-compliant results. The Commission services shall be the only party that can extract such data for all MSs. The MSs shall be able to extract their own respective data. New data collection-State of play

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8. 8 Zoonoses Molecular typing Pesticide residues Chemical contaminants Food consumption Food additives Food contact materials EFSA's DATA COLLECTION DATA UNIT is in charge to collect data: New data collection-State of play

9. 9 STATUS OF PROGRESS EFSA has set up a Working Group: Objectives: To define the data model for sample-based data collection and to draft a Technical Report ‘Reporting guidelines’. Experts from: Austria Cyprus Denmark Ireland Luxemburg Lithuania WG Meetings: 6 meetings held New data collection-State of play

10. 10 EFSA EXPERT WG ON VDR: TASKS Tasks: 1. To draft Data Model Structure at sample level: - decide for each data element: mandatory/optional /not applicable - create new data elements if needed 2. To draft Data Model Catalogues: select appropriate terms from catalogues propose new terms if needed 3. To draft Data Model Business rules: - define quality criteria for each data element - EFSA implements them 4. To draft a EFSA expert WG Technical Report ‘Reporting guidelines’ New data collection-State of play

11. DATA MODEL Data should be provided at result-based level according to the Standard Sample Description* version 2 (SSD2). * SSD is the EFSA standard model for receipt of analytical occurrence data from several data domains (e.g. pesticides, food additives, contaminants etc.). New data collection-State of play

13. WHAT IS SSD2? A harmonised model for 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 used by both data providers and data receivers to fully describe samples and analytical parameters for assessment purposes. The SSD2 includes controlled terminologies and validation rules to guarantee data quality (in data export, transmission and storage). New data collection-State of play

14. Data element: it is a unique element name, referenced by a sequential alphanumeric code. The data elements are also described by a label. E.g. Data element: sampStrategy Data label: Sampling strategy DATA MODEL New data collection-State of play

15. Controlled terminology: finite and numerated set of terms code: identifier to the term name: preferred name of the term scopeNote: definition of the term E.g. Data element ‘Programme legal reference’ (progLegalRef) must contain codes from the catalogue ‘LEGREF’. DATA MODEL New data collection-State of play

18. Validation rules (Business rules): the rules to verify the validity of a value reported in an individual data element. There are: - General business rules - Specific business rules DATA MODEL New data collection-State of play

20. SPECIFIC BUSINESS RULES New data collection-State of play

21. 21 REPORTING GUIDELINES New data collection-State of play

22. 22 2015 - Pilot project - Specific EFSA SCIENTIFIC NETWORK 2016 – Pilot study (all MSs) 2017 – All data to be collected at sample- based level 2018 – All data to be transmitted at result- based level NEXT STEPS New data collection-State of play

23. 23 The role of the Network would be: to advise and assist EFSA in cooperation with the European Commission on all scientific and practical matters related to the collection, analysis and reporting of data on veterinary medicinal products residues. to ensure the exchange of information and data between EFSA and Member States. to review the reporting guidelines, data collected etc. EFSA SCIENTIFIC NETWORK New data collection-State of play

24. The data model and the guidelines will be published: www.efsa.europa.eu www.efsa.europa.eu Contacts in EFSA: Anca.STOICESCU@efsa.europa.eu data.collection@efsa.europa.eu http://www.efsa.europa.eu/en/contact/askefsa.htm New data collection-State of play