Food Regulatory Regime EU Perspectiveface-cii.in/sites/default/files/presentation/Summit2015/...100.000s food businesses, By far the biggest importer and exporter of food worldwide

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 Although growth is slowing, the EU remains the 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

Import

s

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

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

6

Plant Health

Animal health and welfare Biological

hazards

Chemical

contaminants

Nutrition

Plant

Protection Genetically modified

organisms

Animal feed

Food

additives

Food

packaging

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

White Paper on Food Safety (2000)

Structural reforms: o 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

Procedural reforms: o RASFF (Rapid Alert System for Food and Feed)

o Crisis management structure

o Emergency procedures

Legislative reforms: o New regulatory framework

o New legislation enacted (Regulations)

o Recasting (simplification) of existing legislation (Regulations)

Regulation (EC) No 178/2002

Completed in record time!

Based on a coherent and comprehensive approach:

o Traceability ("from farm to table")

o Functional separation between:

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

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:

o Domestic producers

o Importers from non-EU countries

Clearly assigned responsibilities:

o Producers, wholesalers, retailers

o Officials


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.

12

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

of disease

EURL & NRL:

QA of analyses

Evaluation of

monitoring

Evaluation of

monitoring

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

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)

08 December 2015 15

food safety CODEX

plant health IPPC

animal health OIE

Harmonisation at international level

Key obligations of food business operators:

Safety

o Operators may not place on the market unsafe food



Safety

Responsibility

o Operators are responsible for the safety of the food which they produce, transport, store or sell



Safety

Responsibility

Traceability

o Operators shall be able to rapidly identify any supplier or consignee



Safety

Responsibility

Traceability

Transparency

o Operators shall immediately inform competent authorities if they have a reason to believe that their food is not safe



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



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



Safety

Responsibility

Traceability

Transparency

Emergency

Prevention

Co-operation

o Operators shall co-operate with the competent authorities in actions taken to reduce risks


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

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

Organization of official controls

Legislation on official controls: Regulation (EC) 882/2004:

o To prevent or eliminate risks which may arise for human beings and animals

o 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:

o enable Member States to verify and ensure compliance with national and EU rules on feed and food

o be carried out at any stage of production, processing and distribution of feed and food

Official controls are defined as a function of:

o the identified risks,

o the experience and knowledge gained from previous controls,

o the reliability of the controls already carried out by the business operators concerned, and

o a suspicion of possible non-compliance.

Organization of official controls

National Control Plans: The Member States must prepare an integrated multi-annual

national control plan which

o sets out the national control system and activities in a global and comprehensive way

o 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:

o 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

o 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)

Imports from non-EU countries

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 origin and processed 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.


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:

o Legislation

o Organization of controls

o Animal health status

FVO audit

National residue monitoring plan (if applicable)

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

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 onto 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.

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.

Thank you!

Documents

Food Regulatory Regime EU Perspectiveface-cii.in/sites/default/files/presentation/Summit2015/...100.000s food businesses, By far the biggest importer and exporter of food worldwide