Download - 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
Conference on Reforming Food Safety Regulations in Ukraine, Kiev, 18 May 2009 2
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”
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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
Conference on Reforming Food Safety Regulations in Ukraine, Kiev, 18 May 2009 4
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
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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
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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
Conference on Reforming Food Safety Regulations in Ukraine, Kiev, 18 May 2009 7
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
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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
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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
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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
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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
Conference on Reforming Food Safety Regulations in Ukraine, Kiev, 18 May 2009 16
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.
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Conference on Reforming Food Safety Regulations in Ukraine, Kiev, 18 May 2009 18
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)
Conference on Reforming Food Safety Regulations in Ukraine, Kiev, 18 May 2009 19
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
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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
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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.
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Conference on Reforming Food Safety Regulations in Ukraine, Kiev, 18 May 2009 23
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)
Conference on Reforming Food Safety Regulations in Ukraine, Kiev, 18 May 2009 24
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
Conference on Reforming Food Safety Regulations in Ukraine, Kiev, 18 May 2009 25
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.
Conference on Reforming Food Safety Regulations in Ukraine, Kiev, 18 May 2009 26
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.
Conference on Reforming Food Safety Regulations in Ukraine, Kiev, 18 May 2009 27
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.
Conference on Reforming Food Safety Regulations in Ukraine, Kiev, 18 May 2009 28
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
Conference on Reforming Food Safety Regulations in Ukraine, Kiev, 18 May 2009 29
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)
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