Ausgangslage

1
Responsibility for Food Operators within the EUs
legal Framework for Food and the proposed
Mechnisms for Food and Feed Controls, including
the Rapid Alert System
Frerk Feldhusen Veterinary Institute for Fish and
Fishery Products Lower Saxony Federal State
Office for Consumer Protection and Food Safety
2
LAVES locations
LAVES locations
Schleswig-Holstein
Cuxhaven
Mecklenburg-West Pomerania
Hamburg
Stade
Oldenburg
Bremen
Lüneburg
Hannover
Saxony-Anhalt
Braunschweig
North Rhine-Westphalia
Thuringia
Hesse
3
LAVES institutes
Cuxhavenveterinary testing center for fish and
fishery products
Tasks

• Analysis and valuation of fishery products

• Supervision of EU - registrated
• fish factories

• EU border control station

• Measuring of radioactivity

• Diagnostics of diseases marine fish and mammals

4
Basic Regulations Food Hygiene
White Book of European Union
New EU-Regulations of Food Law

• Reg. 178/2002/EC about general principles and
  requirements of food law

• Common Positions EC - Hygiene
• Reg. EC on the hygiene of foodstuffs
• Reg. with specific hygiene rules for food of
  animal origin

• Common Positions EC - Hygiene
• - Reg. EC on feed and food controls
• - Reg. with specific rules for the organisation
  of official controls of
• products of animal origin intended for human
  consumption

5
Reg. (EC) 178/2002 Procedures in Matters of Food
Safety
Important Contents

• Definitions (Risk analysis etc.)
• Primary production included
• Risk analysis and precautionary principle
• Co-developement of internationl standards
• Food safety requirements
• Traceability
• Responsibility for food food business
  operators
• Responsibility for feed feed business
  operators
• Scientific organisations
• Rapid alert system

6
Food Safety
Different Responsibilities
Governments
Consumer
Industry / Market
Food chain! / Traceability
Research / Risk assessment
Information
constructive/criticalposition
HACCP-concept / self responsibility
Law making / Risk management
Advice/ Risk communication
Acceptance of hygienic guidelines
Training of personal
Manifestation of precautionary principle
Asking for advice
Labelling
mod. WHO 1991
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Government, Consumer, Industry, MarketFood chain
from farm to fork
Supplier
Primary producer
Food producer
Consumer

• storage in the household
• preparation of products

• specifications
• semi-finished
• product
• partnership

• recipe
• production process
• hygienic conditions
• controll of residues

• feed
• plant protection
• animal welfare
• residues

8
GovernmentConsequences of WTO/SPS-contract

• Definition of requirements on food
• by requirements to ensure human health
• by application of scientific principles of risk
  analysis
• Member states (WTO) take international standards
  in all food safety actions into account
• standards of Codex Alimentarius are relevant for
  food safety actions!

9
GovernmentRisk analysis Definitions (Codex
Alim. 1999)
1. Risk assessmenta scientific process of
systematic and objective evaluation of all
available information concerning to food
hazards hazard identification hazard
characterisation incl. evaluation of doses and
effects exposure assessment and risk
characterisation 2. Risk management 3. Risk
communication
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GovernmentRisk analysis (Codex Alim. 1997)

• General Principles
• actions to produce safe food must result from
  risk assessment
• risk assessment on scientific basis
• Risk assessment shall mostly be based on
  quantitative informations
• Functional separation of risk assessment and risk
  management
• No zero risk possible!

11
GovernmentRisk Analysis and Food Safety
Objectives (FSOs)

• Risk Assessment
• risk assessment describes food safety elements
• quantitative risk assessment no zero risk
• food safety aims comparable to Acceptable Level
  of Protection (ALOP)
• examples
• aflatoxin M1 in milk lt 10ppt
• L. monocytogenes max. 100 cfu/g
• MRL-values for veterinary drugs(4 ppb penicillin)

12
GovernmentPrinciples of analysis

• Developement of modern principles of
  investigation
• Identification und quantification of substances
  and microorganisms
• (Enlargement of investigation possibilities and
  reduction of quantification limit zero
  tolerance)
• Analysis of structures und sequences(e.g.
  PCR-analysis, antisera)
• Analysis of effects(e.g. cell culture tests)

13
Government/Market/IndustryResidues

• Problems with zero tolerance residues
• Importing countries have to show residue control
  plans to ensure residue control garantees
• Border inspection Cecks and investigations of a
  percentage of the consignments of the food (e.g.
  on hormones, contaminants, residues etc.)
• Substances with zero- tolerance, independent to
  the ability of being a human risk at very low
  concentrations (e.g. CAP, Nitrofuranes)
• Rejected consignments
• Prawns and honey from China (CAP)
• Turkey breasts fom Chile (CAP)
• Milk powder from Russia (CAP)
• Eels from China (Nitrofuranes)
• Fish from Vietnam (Nitrofuranes)

14
GovernmentInvestigation of samples

• Potential Analysis Problems
• Zero Tolerance Compounds
• (Annex IV of EWG No. 2377/90)
• Aristolochia
• Ronidazol
• Chloroforme
• Chlorpromazine
• Colchicine
• Dapson
• Dimetridazole
• Metronidazole
• Nitrofuran
• Chloramphenicol

15
Goverment/IndustryFeed
Unwanted Ingredients in Feed

•  ? mushroom toxins, e.g. aflatoxine B1, ergot
•  ? heavy metals, e.g. lead, mercury, arsenic,
  cadmium
•  ? chlorinated hydrocarbons, e.g. chlordane,
  DDT, dieldrine, endosulfane, endrine, heptachlor,
  hexachlorbenzene (HCB), ?- und ? - HCH, ? - HCH
  (lindane), dioxins
•  ? special ingredients of plants, e.g.
  hydrocyanic acid, mustard oil, gossypol,
  theobromine
•  ? weed seeds and fruits, which contain
  alcaloides, glucosides or other toxic substances
• (Annex 5 of Feed Regulation)

16
GovernmentInvestigation of samples

• Potential Analysis Problems
• Zero Tolerance Compounds
• (Annex IV of EWG No. 2377/90)
• Chloramphenicol (CAP)
• Minimum Required Performance Level (MRPL) is
  0.3 µg/kg
• requires LC-MS/MS or GC-MS
• limit of detection 0.05 µg/kg
• toxicological relevance?
• reclamation ?

17
Market/IndustryEC-Regulations

• New concepts
• including the whole food chain
• increase of autonomy
• direction to self control with HACCP-concept
  control of self control
• priority to process control (compared to
  control of final product)
• increase of competence by self responsibility
  (possibility for deregulation)

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Industry/MarketReg. (EC) 178/2002 Art. 18

• Traceability
• Implementation for food, feed, food-producing
  animals or any substance incorporated into the
  stages of production, processing and distribution
  
• Identification of every supplier
• Implementation of systems and procedures
• Labelling has to ensure traceability in
  combination with documentation etc.
• More specific provisions possible

19
IndustryRequirements for official controls (H 3
Art. 4)

• Food business operators apply procedures
  continuously and properly at least
• checks on food chain information
• the design and maintenance of premises and
• equipment
• pre-operational, operational and post
  operational hygiene
• personal hygiene
• training in hygiene and in working procedures
• pest control
• water quality
• temperature control
• controls on food entering and leaving the
  establishment and
• any accompanying documentation

20
IndustryHACCP based Procedures (H 3, Art. 4)

• Procedures should guarantee, as far as possible,
  that products of animal origin
• comply with microbiological criteria of EC
• comply with community legislation on residues,
• contaminants and prohibited substances
• do not contain physical hazards, such as
  foreign bodies

21
Government/IndustryReg. (EC) about
Microbiological Criteria

• General Concept
• Microbiological criteria defining acceptance of
  products
• Sampling and investigation International
  standards
• L. monocytogenes (max. 100 cfu/g) in RTE
• Meat/ meat products (Salmonella, E. coli, total
  viable count etc.)
• Milk/ milk products (Salmonella, Staph. aureus,
  E. coli, Enterobacteriaceae)
• Criteria for egg products, fishery products etc.
• Hints for sampling

22
Consumer in Germany
Niedersächsisches Landesamtfür Verbraucherschutz
und Lebensmittelsicherheit
International Food Issues Monitor August 2002,
Germany
Average values on a scale from 1 absolutely
not to 4 very much concerned
23
Government/Consumer/Industry/MarketRapid Alert
System (RASFF)

• Rapid Alert System for Food and Feed (RASFF)
• Legal Basis
• Regulation (EC) No 178/2002 laying down the
  general principles and requirements of food law,
  establishing the European Food Safety Authority
  and laying down procedures in matters of food
  safety (Article 50)
• Operated by the European Commission (Health and
  Consumer Protection DG)
• established as a network consisting of national
  competent authorities, the EFSA and the European
  Commission
• Aims
• To protect the consumer against any danger or
  potential danger arising from the consumption of
  foodstuffs
• To exchange rapidly information between Member
  States and the Commission
• Objective
• The pricipal objective is to prevent the
  placement on or the recall from the community
  market of foodstuffs (or feed), which pose a
  serious risk to the health of the consumer
• Scope
• The system is limited to those food products,
  which pose a risk to health that goes beyond the
  territory of a single Member State

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GovernmentRapid Alert System for Food and Feed
(RASFF) - Criteria for Notifications -

• Rapid Alert System Criteria for Notifications
• Basic criteria
• A foodstuff poses a serious risk to the health
  and safety of consumers, and
• The probability that the foodstuff is on the
  market in another Member State
• Risk is assessed on case by case basis by the
  national authorities (BVL / Federal States)
• Evaluation of information (Germany Federal
  Office for Consumer Protection and Food Safety)
• Seriousness / plausibility
• Sufficiency of the documents / completeness

25
GovernmentRapid Alert System for Food and Feed
(RASFF) - Criteria for Notifications -

• Rapid Alert System Criteria for Notifications
• Alert notifications
• Alert notifications (food and feed) are sent when
  the food or feed presenting the rsik is on the
  market and when immediate action is required
• Member States should take the necessary measures
• Information notifications
• Risk has been identified, Member States take no
  immediate action, because the products has not
  reached the market
• Mostly concerned consignments that have been
  tested and rejected at the external borders of
  the EU

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Government/Consumer/Industry/Market RASFF

• Informations of notification
• Definition of danger
• Results of the tests
• Methods
• Persons affected
• Types of illness
• Origin of product (e.g. address manufacturer,
  veterinary approval number etc.)
• Data for traceability (e.g. health certificate,
  identification of the lot etc.)
• Measures adopted (voluntary and compulsory
  measures, justification)
• Other informations (e.g. persons to contact)
• More RASFF-Vademecum

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Government/Consumer/Industry/MarketRapid Alert
System for Food and Feed (RASFF) - Upstream -
European Commission
Federal Ministry for Consumer Protection, Food
and Agriculture
Federal Office for Consumer Protection and Food
Safety
Federal States
l
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Government/Consumer/Industy/MarketRapid Alert
System for Food and Feed (RASFF) - Downstream -
European Commission
FederalMinistries
statistics (daily)
Verification implementation of measures
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GovernmentRapid Alert System for Food and Feed
(RASFF) Statistical Evaluation -
30
RASFF 2003
Bulgaria
Philippines
Origin of product
USA
Marokko
Chile
Malaysia
Indonesia
Netherlands
Vietnam
Countries of origin with more than 20
notifications
Egypt
Taiwan
Alert
Great Britain
Information
Argentina
France
Message
Singapur
Spain
Italy
Thailand
Germany
Brasil
India
China
Turkey
Iran
0
50
100
150
200
250
300
350
400
450
500
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RASFF 2003
Europe
Notifying Member States
Sweden
Luxembourg
Portugal
Finland
Message
Austria
Information
Belgique
Danmark
Alert
Norway
France
Greece
Netherlands
Great Britain
Spain
Italy
Germany
0
50
100
150
200
250
300
350
400
450
500
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RASFF 2003
Alerts groups of products
Fish
Meat
25
Milk
Fruit and vegetable
Grain
32
Nuts
Spices
Others
33
RASFF 2003
Reasons of Alerts 2003
Bacteria
17
Mildew
Mycotoxins
10
Heavy metals
Org. environ. contaminants
14
33
Pestizides
Veterinary drugs
8
Additives
Others
34
Thank you very much for your attention !