Dr Stuart A. Slorach

Dr Stuart A. Slorach

Deputy Director-General of the Swedish National Food Administration, 1991-2005

Chairman, Management Board of the European Food Safety Authority, 2002-2006

Chairperson of the Codex Alimentarius Commission 2003-2005

Please note that the views expressed in this presentation are the author’s own and not necessarily those of the Swedish National Food Administration, the Swedish Government, the

European Commission or any other organisation

Conference on Reforming Food Safety Regulations in Ukraine, Kiev, 18 May 2009 1

Some important principles of EU food law

Policy underpinned by a sound scientific basis.

Based on risk analysis, with a functional separation of risk

assessment and risk management. Precautionary principle

EU-wide free movement of human food and animal feed

Integrated approach covering all aspects of the food production

chain: primary production, processing, transport and

distribution. Applies to all foods.

Tackle problems at source, if possible

Responsibility for ensuring the safety of foodstuffs clarified

Openness and transparency


Some important triggers of the process

Desire for free movement of foods and feed within the EU

Need to restore confidence of consumers, trading partners, etc.

in the safety of the EU food supply and EU food safety system

following BSE crisis, dioxin incident in Belgium, etc.

Need to comply with the requirements of SPS Agreement and

have a risk-based system with a whole food chain approach

Need to clarify responsibilities of food business operators and

the authorities

Need to simplify and update the system and incorporate

flexibility to deal with differing conditions in Member States

Import control “moving offshore”


Important EU food safety legislationEC Regulations

178/2002: general food law, European Food Safety Authority (EFSA),etc.

882/2004: official controls

852/2004: the hygiene of foodstuffs

853/2004: the hygiene of foods of animal origin

854/2004: official controls on products of animal origin

1881/2006: maximum levels for contaminants in foodstuffs

2377/90: maximum residue levels for veterinary medicines

396/2005: maximum residue levels for pesticides

258/97: novel food

1333/2008: food additives

EC Directives

96/22: prohibition on certain substances; 96/23: monitoring of substances and residues; 97/78 veterinary checks on imported animal products


Reg. (EC)178/2002:General food law (1) Covers all stages of production, processing and distribution

Risk analysis

Precautionary Principle: provisional risk management measures may be taken when a risk assessment points to the likelihood of harmful health effects and there is a lack of scientific certainty

Protection of consumers’ interests

Transparency: public consultation, public information

General obligations of food trade: food and feed imported into the Community, food and feed exported from the community

International standards: contribute to development, consistency between international technical standards and food law


Reg. (EC)178/2002:General food law (2) Responsibilities: Food & feed business operators at all stages

of production, processing and distribution shall ensure that foods/feeds satisfy the legal requirements and verify that requirements are met. Member States shall enforce food law, and monitor and verify that relevant requirements are fulfilled.

The traceability of food, feed and food-producing animals and all substances incorporated into foodstuffs must be established at all stages of production, processing and distribution. Responsibility of operators - “one step forward, one step back”

Responsibility of operators to act and report when they have reason to believe that food is not in compliance with food safety requirements


Regulation (EC) 178/2002: EFSAEuropean Food Safety Authority (EFSA)

Risk assessment and risk communication (not risk management, which is the responsibility of the Commission, Parliament, Council and Member States)

Provides the scientific basis for Community legislation and scientific and technical support to the Commission

Management Board, Advisory Forum, Executive Director and staff (400+), Scientific Committee and 10 Scientific Panels

Strong emphasis on independence, competence and openness and transparency

Website: www.efsa.europa.eu


8

COM

RISK

ASSESSMENT

=

Science

RISK

MANAGEMENT

=

Policy

RISK

COMMUNICATION

=

Info Exchange

EC+EFSA+MS

Preliminary

activities

Options

identification

Options

selection

Implementation

Review

Monitoring

Risk analysis in EU food safety system

EFSAEC+EP+MS

www.efsa.europa.eu 9

EFSA organisation

10

EFSA’s Scientific Committee & Panels

Mainly generic opinions Mainly opinions on

applications

1. Panel on plant health (PLH)

2. Panel on plant protection products and their residues (PPR)

3. Panel on biological hazards (BIOHAZ)

4. Panel on animal health and welfare (AHAW)

5. Panel on contaminants in the food chain (CONTAM)

6. Panel on Genetically Modified Organisms (GMO)

7. Panel on additives and products or substances used in animal feed(FEEDAP)

8. Panel on food contact materials, enzymes, flavorings and processing aids (CEF)

9. Panel on food additives and nutrient sources added to food (ANS)

10. Panel on dietetic products, nutrition and allergies (NDA)

Scientific Committee

11

Scientific opinions of EFSA

Risk managementRisk assessment

European Commission

European Parliament

Member States

QuestionEFSA Secretariat

EFSA Panel

Panel Working Group

Opinion

Risk communication

Reg. (EC) 178/2002:Rapid Alert System

Rapid Alert System for Food & Feed (RASFF)

- System by which Member States are linked via the

Commission to provide rapid information exchange on

serious food safety problems. Obligation on Member

States to notify Commission of food safety problems.

Contact Point in each Member State.

- Example: Dioxins in Irish pork in December 2008.

Emergency preparation

Crisis management


Reg.(EC) 882/2004: Official controls

Risk-based official controls of all food, feed and live

animals

National competent authorities control the correct

implementation of legislation by operators

The Commission’s Food and Veterinary Office (FVO)

controls verify the correct implementation of EU

legislation in Member States. FVO also inspects

establishments in countries exporting products to EU.

Principles and general requirements: documented

procedures, training, enforcement


Reg. (EC) 852/2004: Hygiene Regulation

Hygiene requirements for all food, including primary

production – general and specific hygiene requirements,

microbiological criteria, temperature control requirements, cold

chain, sampling and analysis. Annex I for primary production,

Annex II for other stages

Food business operators shall put in place, implement and

maintain a permanent procedure(s) based on Hazard Analysis

and Critical Control Point (HACCP) principles. (Does not

apply to primary production)

Registration of all food businesses

National and Community guides to good practice


Reg. (EC) 853/2004: Hygiene rules for

foods of animal origin Directed to food business operators

Approval or registration of establishments

Identification mark required

Health mark only on carcases

HACCP-based systems

Detailed rules in guidelines

Possibility for national measures – traditional methods, remote areas

For import from countries outside EU products must come from establishments approved and listed and must fulfil requirements of the Regulation


Regulation (EC) 854/2004. Official

controls on products of animal origin Responsibilities of competent authorities

Approval of establishments

Meat inspection: ante- and post mortem

Health mark for red meat, large wild and farmed game meat

Implementation of hygiene package

Reg. (EC) No 2073/2005: microbiological criteria

Reg. (EC) No 2074/2005: implementing measures

Reg. (EC) No 2075/2005: Trichinella testing

Reg. (EC) No 2076/2005: transitional measures

Directive 96/23/EC: measures to monitor certain substances and residues in live animals and animal products


Swedish National Food Administration

The National Food Administration (NFA), an autonomous

government agency under the Ministry of Agriculture, Food

and Fisheries is the central administrative authority for matters

concerning all types of food, including drinking water.

In the interests of consumers, the NFA is working towards three

goals – safe foods, fair practices in the food trade and healthy

eating habits.

The NFA issues food standards and other food regulations,

leads and coordinates food control in Sweden, assists the

Government with and participates in EU work and other

international activities in the food area.



Office of the DG

Communications division

DG

DDG

R&D

Department

Divisions:

Chemistry 1

Chemistry 2

Microbiology

Toxicology

Food Standards

DepartmentFood Control

Department

Divisions:

Inspection

International Trade

Local Authority

Support

Control

Programme

Meat Inspection

Nutrition

DepartmentAdministration

Department

Divisions:

Finance

IT

Personnel

Service

Organisation of the Swedish National Food Administration

Board

Food legislation in Sweden

Sweden has been a member of the EU since 1995 and its food

legislation is harmonised with that of the EU

NFA takes an active part in the development of new legislation

in cooperation with other EU Member States & Commission

The Food Act (made by the Swedish Parliament) complements

EC Regulations. It also designates the authorities responsible

for food control and contains provisions on penalties & appeals

EC Directives are transposed into NFA regulations and

published in the NFA’s own Code of Statutes. The authority of

the NFA to issue legislation is primarily laid down in the Food

Act and the Food Decree (made by the Government)


Food control in Sweden (1) The NFA is responsible at the national level, the County

Administrative Boards (CABs) at the regional level and the municipal Environment and Health Protection Committees at the local level. NFA provides advice to the regional and local control bodies

NFA inspects slaughterhouses, cutting establishments, dairies, egg product establishments, export-controlled establishments & other very large food-producing establishments (ca. 650 in all)

NFA organises control of residues of pesticides and veterinary drugs in various foods and is the RASFF Contact Point.

NFA is responsible for import control at Border Inspection Posts and has overall responsibility for export control


Food control in Sweden (2) 21 County Administrative Boards (CABs) responsible for

coordinating food control at the regional level and for controls of food in primary production.

290 Municipal Environment & Health Protection Committees carry out food control at all food handling establishments except those under the supervision of the NFA or CABs, including food production establishments, wholesalers, retailers, catering establishments and waterworks, altogether some 65000 establishments.

Food samples collected by the food control authorities are analysed by accredited, mainly private, laboratories

Annual and multi-annual food control programmes developed


Food control in Sweden (3) The work of the NFA is financed mainly by annual government

appropriation (180 MSEK) and by fees paid by food business

operators (FBOs) (185 MSEK). NFAs meat inspection and

inspection of other establishments is financed entirely by fees

collected from FBOs. All CAB activities are financed by annual

government appropriation. Municipal control is financed by fees

collected from FBOs. Fees are based on control needs, assessed risk

and compliance history.

The NFA participates actively in the training of food inspectors,

including training in HACCP principles, and of veterinarians.

NFA’s laboratories develop methods for food control, in particular

methods for chemical and microbiological analysis.



Structure of Swedish food control

NFAlegislation, support

coordination, audit, control

(500-600 establishments),

National Ref Lab, R&D, etc. CABs (21)

Coordination, support, audit, etc.

From 2009, control in primary production

(80 000 establishments)

Municipalities (290)

Control

(65 000 establishments

Control staff 500 fte.)

Cooperation with other govt. agenciesOn food safety issues the NFA cooperates closely with a large

number of other government agencies in Sweden, including:

Board of Agriculture (primary production, animal feed, animal

health and welfare)

National Veterinary Institute (zoonoses, animal feed, laboratories)

Institute for Infectious Disease Control (zoonoses)

National Chemicals Inspectorate (pesticides, etc.)

Medical Products Agency (veterinary drugs, etc.)

Environmental Protection Agency (environmental pollution, water)

National Board of Health & Welfare (health services and statistics)

Board for Accreditation and Conformity Assessment (accreditation)


NFA’s international contact network

The NFA is the

Swedish Codex Contact Point

Swedish Focal Point for EFSA

Swedish Contact Point for RASFF

main Swedish contact with FAO and WHO on food safety

issues

The NFA has an extensive network of international contacts,

established through its work in the EU, Codex, FAO/WHO,

etc., with authorities, research institutes, laboratories, scientists,

etc in the Nordic countries, Europe and other parts of the world


Reform of the Swedish system

A report in February 2009 proposed that the National Food

Administration, the National Veterinary Institute and part of the

National Board of Agriculture be amalgamated to form a single

Food Safety Authority, responsible for the whole food chain.

Proposal currently out for comment and may well result in the

formation of a new authority next year. That would make

organisation more in line with organisation at the Commission.

A weakness of current Swedish system is that some of the 290

local authorities have very small resources and coordinating

such a large number of independent organisations is difficult.

Better to have a central authority with regional/local offices.


Changes in Sweden following EU

membership Legislation now developed together with Commission, the other 26

EU Member States, European Parliament.

Some food-producing establishments had to be upgraded to meet EU requirements

Sweden now more reliant on the food control carried out in other EU Member States, including control of foods coming from third countries. Salmonella guarantees instead of Swedish border control.

Operation of Swedish food control system subject to regular inspection by Commission’s Food and Veterinary Office

Annual and multi-annual control programmes now developed

Farm-to-table control principle emphasised

Some more restrictive Swedish regulations were withdrawn

Improved scientific and other cooperation and coordination with other EU Member States via EFSA, EU research projects, etc.


Advantages of the EU food safety system Modern approach applying Codex risk analysis principles, with a

clear functional separation of risk assessment (EFSA) and risk

management (Commission, Parliament, Council/Member States),

covering all foods and the whole of the food chain.

Risk-based control system based on HACCP principles

Clear assignment of responsibilities for food safety

Strong scientific base provided by EFSA’s independent Scientific

Committee/Panels. Improved scientific cooperation between MS.

Combining the resources of the Member States, Commission, etc.

enables development of food safety legislation, etc. that would be

very difficult/impossible for a single country to achieve and

strengthens position in dealing with food, chemical, etc. industries.


Advantages of the EU food safety system Food & Veterinary Office (FVO) inspections provide external

audit of the operation of food safety controls in all EU Member States and in countries exporting to the EU and inspection results are available on the FVO website

EU-wide rapid alert system and emergency planning in place

Coordination of EU position at meetings of international organisations (e.g. Codex Alimentarius Commission, OIE, SPS Committee) gives added weight to EU Member States’ views.

Free circulation within EU means domestic food producers have direct access to a market of ca. 500 million consumers, but are also more exposed to competition from producers in other EU Member States

Open and transparent system


Disadvantages of the EU food safety

system

Process to develop and adopt new/amended food safety

legislation is complicated and often slow, since it involves 27

Member States (Council), the European Commission and the

European Parliament. Need to compromise to reach agreement.

Free circulation of foodstuffs within the EU, without border

controls between Member States, means that countries are

dependent on the correct functioning of the food control system

in all Member States, including controls carried out on foods

from third countries at Border Inspection Posts (system is only

as strong as the weakest link)


Documents

Dr Stuart A. Slorach