Food Regulatory Regime EU Perspective Wojciech Dziworski First Secretary EU Delegation to India 10th CII National Food Safety and Quality Summit New Delhi, 1 December 2015
The EU at a glance The World's largest economy Import Although growth is slowing, the EU remains the s World's largest economy with a GDP per head of € 25 000 for its 500 million consumers. The World's largest trader The EU is the world’s largest trader (17%) of manufactured goods and services. Unlike the USA (-5%) and Japan (-3%) which have most suffered from China's rise, the EU share of World trade has been stable over the last 10 years. The Worlds largest investor The EU ranks first in the World in both inbound and outbound international investments EU US China Japan
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
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
Snow brand Olive oil contamination: factory closes in 600 death, 25,000 disabled Softdrink Okinawa prefecture Company in BELGIUM SUFFERS EU3BIL Belgium recalls DUE TO DIOXIN SCARE 2.5m bottles RAZOR BLADES IN Salmonella enteridis BABY FOOD British eggs in egg sandwiches Pesticide poisoning contain killed 203 Salmonella! Chilli paste maker jailed, Minister fined for Food Act offence resigns Listeria in Goods from 60 Mexican style cheese: dirty stalls 142 ill, 47 death seized in ops Mad Cow Disease Strikes Europe Heinz recalls its Hamburgers infected with E.coli O157.H7 baby foods Woman bites on mouse in MARS bar
Plant Plant Health Genetically modified Protection organisms Animal feed Animal health and welfare Biological hazards Chemical Food Food contaminants additives packaging Nutrition 6
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 7
White Paper on Food Safety (2000) Structural reforms: Reorganization of Commission services (DG SANCO/SANTE) o Creation of FVO (Food and Veterinary Office) o Creation of EFSA (European Food Safety Authority) o Reform of regulatory committees o Creation of advisory group of the food chain o Procedural reforms: RASFF (Rapid Alert System for Food and Feed) o Crisis management structure o Emergency procedures o Legislative reforms: New regulatory framework o New legislation enacted (Regulations) o Recasting (simplification) of existing legislation (Regulations) o
Regulation (EC) No 178/2002 Completed in record time! Based on a coherent and comprehensive approach: Traceability ("from farm to table") o Functional separation between: o Risk assessment Risk management o Risk assessment (EFSA): Based on available scientific proof Conducted in an independent, objective and transparent manner o Risk management: Based on risk assessment Precautionary principle Other legitimate factors o Transparency Consultation of stakeholders Access to information
Regulation (EC) No 178/2002 New emphasis on: Enforcement Communication: o Risk/crisis communication o Website o Guidance documents Training (“Better Training for Safer Food”) New legal framework for food business operators: Equal treatment of: Domestic producers o Importers from non-EU countries o Clearly assigned responsibilities: Producers, wholesalers, retailers o Officials o
Starting from scientific advice: some European risk assessment bodies • European Food Safety Authority (EFSA) • European Centre for Disease Prevention and Control (ECDC, human aspects) • European Medicines Agency (EMA) The Commission has the obligations to consult the relevant risk assessment body before proposing legislation to ensure a science-based approach.
A coordinated risk analysis approach on food safety Human data Food/animal data EFSA ECDC Burden of disease Evaluation of Evaluation of EFSA: risk assessment monitoring monitoring EC: impact assessment, consultation of stakeholders Risk management: legal requirements, targets, trade restrictions Member States and businesses: Implementation, EURL & NRL: Verification incl. sampling and analysis 12 QA of analyses
EU/MS Food Safety structures ECDC Parliament RASFF Commission EFSA SANTE FVO Council EMA EU Member States Political Risk assesment Regulatory Control Authorities Authorities Authorities Authorities Risk management <-> Risk assessment
Standing Committee for Plants, Animals, Food and Feed (PAFF) Biological safety Animal Pesticides nutrition Animal Import PAFF health control and and welfare conditions General Toxicological food law safety GMO
Harmonisation at international level plant health food safety animal health OIE IPPC CODEX 08 December 2015 15
Regulation (EC) No 178/2002 Key obligations of food business operators: Safety o Operators may not place on the market unsafe food
Regulation (EC) No 178/2002 Key obligations of food business operators: Safety Responsibility o Operators are responsible for the safety of the food which they produce, transport, store or sell
Regulation (EC) No 178/2002 Key obligations of food business operators: Safety Responsibility Traceability o Operators shall be able to rapidly identify any supplier or consignee
Regulation (EC) No 178/2002 Key obligations of food business operators: Safety Responsibility Traceability Transparency o Operators shall immediately inform competent authorities if they have a reason to believe that their food is not safe
Regulation (EC) No 178/2002 Key obligations of food business operators: Safety Responsibility Traceability Transparency Emergency o Operators shall immediately withdraw food from the market if they have reason to believe that it is not safe
Regulation (EC) No 178/2002 Key obligations of food business operators: Safety Responsibility Traceability Transparency Emergency Prevention o Operators shall identify and regularly review the critical points in their processes and ensure that controls are applied at these points
Regulation (EC) No 178/2002 Key obligations of food business operators: Safety Responsibility Traceability Transparency Emergency Prevention Co-operation o Operators shall co-operate with the competent authorities in actions taken to reduce risks
The EU food safety legislation Official Controls Regulated Products Import Regime and Processes Hygiene Reg. 178/2002 General Food Law Procedures EFSA Plant health Claims Animal health Labelling Animal welfare Nutrition labelling
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
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