EU Perspective Wojciech Dziworski First Secretary EU Delegation to - - PowerPoint PPT Presentation

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EU Perspective Wojciech Dziworski First Secretary EU Delegation to - - PowerPoint PPT Presentation

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


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SLIDE 1

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

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SLIDE 2

The EU at a glance

The World's largest economy

Although growth is slowing, the EU remains the World's largest economy with a GDP per head

  • f €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 Import s

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SLIDE 3

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
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SLIDE 4

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

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SLIDE 5

BELGIUM SUFFERS EU3BIL DUE TO DIOXIN SCARE

Softdrink Company in Belgium recalls 2.5m bottles

Olive oil contamination: 600 death, 25,000 disabled

British eggs contain Salmonella! Minister resigns Listeria in Mexican style cheese: 142 ill, 47 death

Hamburgers infected with E.coli O157.H7 Salmonella enteridis in egg sandwiches

RAZOR BLADES IN BABY FOOD

Pesticide poisoning killed 203

Chilli paste maker jailed, fined for Food Act offence

Goods from 60 dirty stalls seized in ops Woman bites on mouse in MARS bar Snow brand factory closes in Okinawa prefecture Mad Cow Disease Strikes Europe Heinz recalls its baby foods

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SLIDE 6

6 Plant Health Animal health and welfare Biological hazards Chemical contaminants Nutrition Plant Protection Genetically modified

  • rganisms

Animal feed Food additives Food packaging

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SLIDE 7

7

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

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SLIDE 8

White Paper on Food Safety (2000)

 Structural reforms:

  • Reorganization of Commission services (DG SANCO/SANTE)
  • Creation of FVO (Food and Veterinary Office)
  • Creation of EFSA (European Food Safety Authority)
  • Reform of regulatory committees
  • Creation of advisory group of the food chain

 Procedural reforms:

  • RASFF (Rapid Alert System for Food and Feed)
  • Crisis management structure
  • Emergency procedures

 Legislative reforms:

  • New regulatory framework
  • New legislation enacted (Regulations)
  • Recasting (simplification) of existing legislation (Regulations)
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SLIDE 9

Regulation (EC) No 178/2002

 Completed in record time!  Based on a coherent and comprehensive approach:

  • Traceability ("from farm to table")
  • Functional separation between:
  • Risk assessment
  • Risk management
  • Risk assessment (EFSA):
  • Based on available scientific proof
  • Conducted in an independent,
  • bjective and transparent manner
  • Risk management:
  • Based on risk assessment
  • Precautionary principle
  • Other legitimate factors
  • Transparency
  • Consultation of stakeholders
  • Access to information
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SLIDE 10

 New emphasis on:

  • Enforcement
  • Communication:
  • Risk/crisis communication
  • Website
  • Guidance documents
  • Training (“Better Training for Safer Food”)

 New legal framework for food business operators:

  • Equal treatment of:
  • Domestic producers
  • Importers from non-EU countries
  • Clearly assigned responsibilities:
  • Producers, wholesalers, retailers
  • Officials

Regulation (EC) No 178/2002

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SLIDE 11

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.

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Human data ECDC EFSA: risk assessment EC: impact assessment, consultation of stakeholders Risk management: legal requirements, targets, trade restrictions Member States and businesses: Implementation, Verification incl. sampling and analysis

A coordinated risk analysis approach on food safety

Food/animal data EFSA Burden

  • f disease

EURL & NRL: QA of analyses Evaluation of

monitoring

Evaluation of monitoring

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EU/MS Food Safety structures

EMA SANTE Parliament Council

FVO

Commission Risk assesment Authorities Control Authorities Political Authorities

EU

Member States Risk management <-> Risk assessment Regulatory Authorities

RASFF

ECDC EFSA

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SLIDE 14

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)

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SLIDE 15

08 December 2015 15

food safety

CODEX

plant health

IPPC

animal health

OIE

Harmonisation at international level

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SLIDE 16

 Key obligations of food business operators:

  • Safety
  • Operators may not place on the market unsafe food

Regulation (EC) No 178/2002

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SLIDE 17

 Key obligations of food business operators:

  • Safety
  • Responsibility
  • Operators are responsible for the safety of the food

which they produce, transport, store or sell

Regulation (EC) No 178/2002

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 Key obligations of food business operators:

  • Safety
  • Responsibility
  • Traceability
  • Operators shall be able to rapidly identify any

supplier or consignee

Regulation (EC) No 178/2002

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 Key obligations of food business operators:

  • Safety
  • Responsibility
  • Traceability
  • Transparency
  • Operators shall immediately inform competent

authorities if they have a reason to believe that their food is not safe

Regulation (EC) No 178/2002

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 Key obligations of food business operators:

  • Safety
  • Responsibility
  • Traceability
  • Transparency
  • Emergency
  • Operators shall immediately withdraw food from the

market if they have reason to believe that it is not safe

Regulation (EC) No 178/2002

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 Key obligations of food business operators:

  • Safety
  • Responsibility
  • Traceability
  • Transparency
  • Emergency
  • Prevention
  • 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

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SLIDE 22

 Key obligations of food business operators:

  • Safety
  • Responsibility
  • Traceability
  • Transparency
  • Emergency
  • Prevention
  • Co-operation
  • Operators shall co-operate with the competent

authorities in actions taken to reduce risks

Regulation (EC) No 178/2002

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SLIDE 23
  • Reg. 178/2002

General Food Law Procedures EFSA Official Controls Import Regime Hygiene Claims Labelling Nutrition labelling Plant health Animal health Animal welfare Regulated Products and Processes

The EU food safety legislation

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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

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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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Organization of official controls

 Legislation on official controls:

  • Regulation (EC) 882/2004:
  • To prevent or eliminate risks which may arise for human beings and

animals

  • To guarantee fair practices and the protection of consumers' interests,

including labelling of food and feed

 Official controls are in the hands of Member States

  • Official controls must:
  • enable Member States to verify and ensure compliance with national and EU

rules on feed and food

  • be carried out at any stage of production, processing and distribution of

feed and food

  • Official controls are defined as a function of:
  • the identified risks,
  • the experience and knowledge gained from previous controls,
  • the reliability of the controls already carried out by the business operators

concerned, and

  • a suspicion of possible non-compliance.
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Organization of official controls

 National Control Plans:

  • The Member States must prepare an integrated multi-annual

national control plan which

  • sets out the national control system and activities in a global and

comprehensive way

  • is developed along the lines that are contained in guidelines established by

the Commission

  • The Member States must submit to the Commission an annual

report indicating updates their control plan.

  • The Commission must:
  • establish a general report on the overall operation of the official control

systems on the basis of the national reports and the results of the audits which it has carried out

  • pass this report on to the European Parliament and the Council and

publishes it.

 EU controls in the Member States

  • Audits by the Food and Veterinary Office (FVO)
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Imports from non-EU countries

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Imports from non-EU countries

 Food imported from non EU-countries must conform with EU requirements

  • No recognition of equivalence

 Responsibility of the producers

  • To know and understand EU requirements
  • To implement them

 Compliant with the requirements of the SPS agreement of the WTO / international standards  Role of the competent authorities of exporting country varies:

  • Products of animal origin
  • Products of non-animal origin

and…

  • Composite products: products containing both ingredients of non-animal
  • rigin and processed products of animal origin.
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Products of animal origin

 Imports of products of animal origin into the European Union are subject to official certification.  Official certification is based on the recognition of the competent authority of the non-EU country by the European Commission.  The competent authority of a non-EU country will only be recognised if:

  • It has the necessary legal powers and resources;
  • It is able to ensure credible inspection and controls throughout the

production chain.

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Products of animal origin

 Non-EU countries are only authorized to export for certain categories of products – on a case-by-case basis, e.g.:

  • Poultry
  • Milk and milk products
  • Honey

 Non-EU countries have to apply for each category:

  • Questionaire:
  • Legislation
  • Organization of controls
  • Animal health status
  • FVO audit
  • National residue monitoring plan (if applicable)
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Destination after border inspection

 Consignments which are found to be compliant with EU legislation are “in free circulation” in the EU. They may be:

  • Placed on the market as food or feed, or used for food or feed

production

  • Used for industrial purpose
  • Re-exported to a 1/3 country

 Consignments which are found not to be compliant with EU legislation shall be:

  • either destroyed
  • or, under certain conditions, re-dispatched within 60 days
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Products of non-animal origin

 Most food products may be imported into the EU without restriction (e.g. certification).  However, specific plant-health rules apply to plants or plant products which could introduce harmful organisms

  • nto EU territory.
  • Long list of approximately 250 harmful organisms whose introduction into the EU

is prohibited.

  • Short list of plants and plant products whose introduction into the EU is

prohibited when they originate in certain non-EU countries.

  • Extensive list of specific technical requirements which certain plants and plant

products must meet before being imported into the EU (e.g. inspections must be carried out in the country of origin during the growth period)

  • List of plants and plant products which are subject to specific technical

requirements and must be accompanied by a 'plant health certificate'issued by the official plant protection body in the exporting country.

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Yet…

 The EU is the largest importer of agricultural products in the World.  The EU imports more agricultural products from developping countries than the US, Canada, Australia, Japan and New Zealand together.  The EU imports 65 % of its consumption of fish and fishery products, from more than 90 countries around the World.

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SLIDE 35

Thank you!