in Designing EU Food Regulatory Standards Wojciech Dziworski First - - PowerPoint PPT Presentation

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
• f 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

• ther 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

• 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

Risks to be managed:

European Parliament

The EU institutions

Court of Justice Court of Auditors Economic and Social Committee Committee of the Regions Council of Ministers (Council of the EU) European Commission European Investment Bank European Central Bank Agencies European Council (summit)

6

How EU laws are made

Scientific advice e.g. EFSA opinion Citizens, interest groups, nat, experts: discussion, consultation by EC EC makes proposal Basic act: e.g. Regulation of the European Parliament and of the Council Implementing act: EC drafts & adopts after favourable vote Standing Committee Delegated act: EC drafts & adopts Business implement, national or local authorities verify

Request from European Parliament

• r Council (Member States)

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

8

Animal nutrition Animal health and welfare General food law GMO Toxicological safety Import control and conditions Pesticides Biological safety

PAFF

Standing Committee for Plants, Animals, Food and Feed (PAFF)

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

12

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

“General Food Law” Regulation No 178/2002

EU/MS Food Safety structures

EMA DG SANCO Parliament Council

FVO

Commission Risk assesment Authorities Control Authorities Political Authorities

EU

Member States Risk management <-> Risk assessment Regulatory Authorities

EWRS RASFF

ECDC EFSA

14

food safety

CODEX

plant health

IPPC

animal health

OIE Harmonisation at international level

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
• f 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;

18

Food Safety: EU risk management competences

Additives Contact materials Flavourings Nutrition Contaminants Residues Pesticides Food complements Labelling Hygiene Training Official Controls Animal health Animal welfare Animal-by products Feed Plant health GMOs

Tools for enforcement

• Primary responsibility of food/feed operators-HACCP-
• bligation 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
• rigin).
• 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

• n Contaminants in the Food

Chain (CONTAM) - 2007 Statement of the Panel on Contaminants in the Food Chain - 2009

• 3. From RM to RA

INFORMATION FOLLOW-UP LEGISLATION

COMMISSION REGULATION (EU) No 165/2010

• 4. Communication about risk: how it works?

OPINION MEASURES COMMUNICATION RA COMMUNICATION RM RISK COMMUNICATION RISK ASSESSMENT RISK 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