Risk Assessment Approach in Designing EU Food Regulatory Standards Wojciech Dziworski First Secretary EU Delegation to India 9th CII National Food Safety and Quality Summit New Delhi, 2 December 2014
The European Union • The EU is a Success Story • 60 years peace, shared values, compromise • Single Market with 507 Million citizens • Economic stability, 70% of trade intra-EU • Harmonisation of rules and standards • The EU is a nightmare • 28 countries, 22 Languages, • Diverse traditions expectations and economies, • 100.000s food businesses, • By far the biggest importer and exporter of food worldwide • Risks must be managed
A Single Market for goods • Member States may restrict the free movement of goods only in exceptional cases, for example when there is a risk resulting from issues such as public health, environment, or consumer protection. • Approximately half of the trade in goods within the EU is covered by harmonised regulations, while the other half is accounted for by the „non - harmonised‟ sector, which is either regulated by national technical regulations or not specifically regulated at all. • Once allowed into the EU, food commodities and animal products in particular, can be sold in any Member State
Risks to be managed: • Contagious animal and plant disease FMD, Avian Flu, Carnal Bunt, Citrus Canker • Zoonoses Salmonella, Listeria, BSE, Tb • General hygiene Enterobacteria, histamine • Contaminants Pharmaceuticals, pesticides, heavy metals • Fraud
The EU institutions European Council (summit) Council of Ministers European Commission (Council of the EU) European Parliament Court of Court of Economic and Social Committee of the Regions Justice Auditors Committee Agencies European Investment Bank European Central Bank
How EU laws are made Request from European Parliament Scientific advice e.g. EFSA opinion or Council (Member States) Citizens, interest groups, nat, experts: discussion, consultation by EC EC makes proposal Implementing act: EC drafts & adopts Delegated act: EC Basic act: e.g. Regulation of the after favourable vote drafts & adopts European Parliament and of the Council Standing Committee Business implement, national or local authorities verify 6
Why decision making at EU-level on food safety? • Same high level of protection of all consumers • Domestically produced • From other Member States • From Countries all over the world • One internal market without border controls • Facilitating import, as same condition in whole EU
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Standing Committee for Plants, Animals, Food and Feed (PAFF) Biological safety Animal Pesticides nutrition Animal Import PAFF health control and and welfare conditions Toxicological General food law safety GMO
Some European risk assessment bodies • European Food Safety Authority (EFSA) • European Centre for Disease Prevention and Control (ECDC, human aspects) • European Medicines Agency (EMA) Joint assessments/scientific opinions when needed e.g. antimicrobial resistance
“General Food Law” Regulation No 178/2002 • General principles for food safety: • High level of protection of human life and health and the protection of consumers' interests • Integrated approach: « from farm to fork » • Responsibility of operators • Precautionary principle • Transparency • Traceability • Risk analysis
“General Food Law” Regulation No 178/2002 Other elements: • Setting up the European Food Safety Authority (EFSA) • Setting up the Standing Committe of the Food Chain and Animal Health (SCOFCAH) • Setting up a Rapid Alert System (RASFF) • Setting up a procedure for managing crises 12
EU/MS Food Safety structures ECDC Parliament EWRS DG Commission EFSA SANCO RASFF FVO Council EMA EU Member States Political Risk assesment Regulatory Control Authorities Authorities Authorities Authorities Risk management <-> Risk assessment
Harmonisation at international level plant health food safety animal health OIE IPPC CODEX 14
The risk analysis process • three interconnected components: • „risk assessment‟ • „risk management‟ • „risk communication‟
The risk analysis process • ‘risk assessment’ : a scientifically based process consisting of four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation; • ‘risk communication’ : means the interactive exchange of information and opinions throughout the risk analysis process as regards hazards and risks, risk-related factors and risk perceptions, among risk assessors, risk managers, consumers, feed and food businesses,
Risk management • The process, distinct from risk assessment, of • weighing policy alternatives in consultation with interested parties, • considering risk assessment and other legitimate factors, • and, if need be, selecting appropriate prevention and control options;
Food Safety: EU risk management competences Animal Contaminants Additives Nutrition Hygiene Feed health Contact Food Animal Residues Training Plant health materials complements welfare Official Animal-by Pesticides Flavourings Labelling GMOs Controls products 18
Tools for enforcement • Primary responsibility of food/feed operators-HACCP- obligation to withdraw/recall and notify • MS control authorities shall enforce food law • Reg. on official controls 882/2004 : general framework for the national control authorities (obligations, multi-annual control plans, training, auditing role of FVO) • Border Inspection posts (live animal and food of animal origin). • Traces (TRAde Control and Expert System) is a trans- European network for veterinary health which notifies, certifies and monitors imports, exports and trade in animals and animal products
Tools for emergency/ crisis • RASFF (Rapid Alert for Food and Feed) • Notifications by MS control services • Follow-up of the measures taken • Emergency procedures • Safeguard measures (ban, reinforced controls etc) • Crisis procedures in place in the EU Commission and EFSA
EFSA Role = Scientific assessment, technical assistance, non legislative Collection and study of information Risk assessment Risk communication Network with other agencies Response to Food Crisis Principles applied • Independence, excellence, transparency
1. From RM to RA REQUEST for example (2006): Question N ° EFSA-Q-2006-174 EC request following discussions at the Codex Committee for Food Additives and Contaminants (CCFAC): EFSA is requested to provide an opinion on the potential increase of consumer health risk by a possible increase of the maximum levels from 4 to 8 and 10 μg/kg for total aflatoxins in “ready -to- eat” almonds, hazelnuts and pistachios and derived products.
2. From RA to RM OPINION Opinion of the Scientific Panel Statement of the Panel on on Contaminants in the Food Contaminants in the Food Chain (CONTAM) - 2007 Chain - 2009
3. From RM to RA INFORMATION FOLLOW-UP COMMISSION REGULATION LEGISLATION (EU) No 165/2010
4. Communication about risk: how it works? RISK ASSESSMENT OPINION COMMUNICATION RA COMMUNICATION RM MEASURES RISK RISK COMMUNICATION MANAGEMENT
Conclusions Food Safety is a domain almost exclusively addressed at EU level A scientific approach is aimed at with close collaboration between risk assessors, risk managers and risk communicators In addition, a "one health" approach is aimed at with close collaboration between the human and the veterinary/food safety sectors A number of quality assurance systems e.g. for laboratory testing and follow-up of implementation of food safety rules are in place 26
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