動物性食品中的動物用藥物殘留標準（MRL）

本報告已在2011年08月03日停止出版。

簡介

目錄

Abstract

Overview:

This essential management report offers a comprehensive, global overview of residue incidence by species and market. It details major causes, detection techniques and technology, and control and prevention methods.

Customers increasingly require objective information to ensure that what they put on their plates is safe. This phenomenon has fuelled the need for quality assurance upon which international food trade is dependent.

How do regulatory bodies around the world control and monitor veterinary drug residues?

• Identify the major causes of residues.
• Analyse the laws in place worldwide to ensure that residues are kept in check.
• Become an expert in detection and testing techniques

Executive Summary:

The monitoring and controlling of veterinary residues in animal food products is a result of the heightened awareness of consumers. They require objective information that what they put on their plates is safe. This phenomenon has fuelled the need for quality assurance upon which international food trade is dependent. A recent survey commissioned by the European Union (EU) found that food safety is a major concern of European consumers. More than 60 per cent of the 23,000 people taking part indicated that they were "very concerned about the safety of food" when it came to chemical contaminants, which include veterinary drugs.

This report provides an overview of how regulatory bodies around the world control and monitr veterinary drug residues in samples taken from food-producing animals. They include countries in Europe, North and South America, Asia and Australasia. The international framework - as established by the Codex Alimentarius (Codex) under the aegis of the World Health Organization (WHO) and the Food and Agriculture Organization (FAO) - for controlling residues is also discussed, as are detection techniques.

Country chapters include information on the laws in place to ensure that residuesare kept in check, with detailsof maximum residue limits(MRts) in force and data tables, where the most recent results of sample testing are summarised.

The countries covered in this report are:

• Argentina
• Australia
• Austria
• Brazil
• Canada
• China
• Germany
• India
• Ireland
• Japan
• Mexico
• New Zealand
• Switzerland
• Thailand
• United Kingdom
• United States and
• The EU

Table of Contents

CHAPTER 1 MAJOR CAUSES

• 1.1 Introduction
• 1.2 Withdrawal periods
• 1.3 Hygiene
• 1.4 Misuse
• 1.5 Veterinarian
• 1.6 Risky residues
  • 1.6.1 Hormonal growth promoters
  • 1.6.2 Beta-agonists
  • 1.6.3 Bovine somatotrophin
  • 1.6.4 Penicillins
  • 1.6.5 Cephalosporins
• 1.7 Selected macrolide antibiotics
  • 1.7.1 Spiramycin
  • 1.7.2 Tilmicosin
• 1.8 Aminoglycosides
  • 1.8.1 Adverse effects
• 1.9 Fluoroquinolones
• 1.10 Sulfadimidine (sulfamethazine)
• 1.11 Nitrofurans and nitroimidazoles
• 1.12 Chloramphenicol
• 1.13 Ivermectin
• 1.14 Tranquilisers
  • 1.14.1 Xylazine
  • 1.14.2 Azaperone
• 1.15 Carazolol

CHAPTER 2 DETECTION AND TECHNOLOGY

• 2.1 Introduction
• 2.2 Ante- and post-mortem inspection
• 2.3 Screening methods
  • 2.3.1 Rapid tests
  • 2.3.2 Microbiological inhibition tests
  • 2.3.3 Electrophoretic systems
  • 2.3.4 Investigating further with ELISA and RIA
  • 2.3.5 Receptor tests
  • 2.3.6 Confirming results
  • 2.3.7 Chromatography and spectrometry
  • 2.3.8 Validation
  • 2.3.9 Identification points
  • 2.3.10 Analytical methods in the EU
• 2.4 Emerging technologies
  • 2.4.1 Introduction
  • 2.4.2 Variations on a theme
    • 2.4.2.1 Old with the new
  • 2.4.3 Biosensors
    • 2.4.3.1 Surface plasmon resonance
    • 2.4.3.2 Electrochemical biosensors
    • 2.4.3.3 BioCop

CHAPTER 3 CONTROLS AND PREVENTION

• 3.1 Introduction
• 3.2 Registration and distribution
• 3.3 Veterinarian responsibilities
• 3.4 Farmer/producer responsibilities
  • 3.4.1 Hygiene
  • 3.4.2 Feed
  • 3.4.3 Monitoring
  • 3.4.4 Record keeping
• 3.5 Scrutiny

CHAPTER 4 INTERNATIONAL FOOD SAFETY AND THE CODEX ALIMENTARIUS

• 4.1 Introduction
• 4.2 Setting standards
• 4.3 Establishing ADIs
  • 4.3.1 Veterinary hypothetical diet
• 4.4 Disadvantages

CHAPTER 5 THE EUROPEAN UNION

• 5.1 Legislation and Regulation
• 5.2 Setting MRLs
• 5.3 National monitoring
  • 5.3.1 Sampling
  • 5.3.2 Infringements
  • 5.3.3 Residue categories
• 5.4 Third countries
  • 5.4.1 Monitoring
  • 5.4.2 Inspections
• 5.5 Residue incidence rates
  • 5.5.1 Latest results
  • 5.5.2 Non-compliant results
    • 5.5.2.1 Hormones
    • 5.5.2.2 Corticosteroids
    • 5.5.2.3 Beta-agonists
    • 5.5.2.4 Prohibited substances
    • 5.5.2.5 Antibacterials
    • 5.5.2.6 Anthelmintics
• 5.6 Incidence rate tables
  • 5.6.1 Country codes
  • 5.6.2 Bovines: non-compliant results
  • 5.6.3 Pigs: non-compliant results
  • 5.6.4 Poultry: non-compliant results
  • 5.6.5 Sheep and goats: non-compliant results

CHAPTER 6 UNITED KINGDOM

• 6.1 Legislation and Regulation
• 6.2 Statutory surveillance
• 6.3 Non-statutory surveillance
• 6.4 Surveillance results 2005
  • 6.4.1 Statutory results
    • 6.4.1.1 Emamectin and malachite green in fish
    • 6.4.1.2 Coccidiostats
    • 6.4.1.3 Phenylbutazone in cattle and horse
    • 6.4.1.4 Nitrofuran and Nortestosterone
  • 6.4.2 Non-statutory results
    • 6.4.2.1 Farmed fish and crustaceans
    • 6.4.2.2 Retailer results

CHAPTER 7 IRELAND

• 7.1 Legislation and Regulation
• 7.2 Results 2005
  • 7.2.1 Banned substances
  • 7.2.2 Antibiotics
  • 7.2.3 Anticoccidials
  • 7.2.4 Aquaculture
  • 7.2.5 Follow-up actions

CHAPTER 8 GERMANY

• 8.1 Legislation and Regulation
• 8.2 Non-compliant results
• 8.3 Results 2004
• 8.4 Results by substance group
  • 8.4.1 Anabolic and unauthorised substances
  • 8.4.2 Antibacterials

CHAPTER 9 SWITZERLAND

• 9.1 Legislation and regulation
  • 9.1.1 Testing
    • 9.1.1.1 Sample collection
• 9.2 Results
• 9.3 Infringement

CHAPTER 10 AUSTRIA

• 10.1 Legislation and regulation
• 10.2 Results 2005

CHAPTER 11 AUSTRALIA

• 11.1 Legislation and Regulation
• 11.2 Sampling
• 11.3 Tracing back
• 11.4 Results
  • 11.4.1 Anthelmintics
  • 11.4.2 Antibacterials
  • 11.4.3 Hormones
  • 11.4.4 Steroids
• 11.5 Incidence rates

CHAPTER 12 NEW ZEALAND

• 12.1 Legislation and regulation
  • 12.1.1 Risk management
• 12.2 Results

CHAPTER 13 JAPAN

• 13.1 Legislation and regulation
  • 13.1.1 Establishing MRLs
  • 13.1.2 Imports
• 13.2 Incidence rates
  • 13.2.1 Imported food results 2003-4
  • 13.2.2 Imported food results 2004-5
  • 13.2.3 Latest imported food data
  • 13.2.4 Domestic food results 2003-4
  • 13.2.5 Domestic food results 2004-5

CHAPTER 14 CHINA

• 14.1 Legislation and regulation
  • 14.1.1 Non-compliant results
• 14.2 MRLs
• 14.3 EU relations
  • 14.3.1 Chinese exports to EU
  • 14.3.2 On-site inspections
    • 14.3.2.1 Background
    • 14.3.2.2 NRMP 2006

CHAPTER 15 HONG KONG

• 15.1 Legislation and Regulation
  • 15.1.1 Inspections
• 15.2 Non-compliance consequences
• 15.3 Results

CHAPTER 16 THAILAND

• 16.1 Legislation and Regulation
• 16.2 Setting MRLs
• 16.3 Results

CHAPTER 17 INDIA

• 17.1 Legislation and Regulation
• 17.2 Exports and MRLs
• 17.3 EU certification

CHAPTER 18 ARGENTINA

• 18.1 Legislation and Regulation
• 18.2 Results

CHAPTER 19 MEXICO

• 19.1 Legislation and Regulation
• 19.2 MRLs
• 19.3 Results
• 19.4 EU relations

CHAPTER 20 BRAZIL

• 20.1 Legislation and Regulation
  • 20.1.1 Banned substances
• 20.2 Results
  • 20.2.1 Milk results
    • 20.2.1.1 Antimicrobials
    • 20.2.1.2 Avermectins
• 20.3 EU relations

CHAPTER 21 CANADA

• 21.1 Legislation and Regulation

CHAPTER 22 UNITED STATES

• 22.1 Legislation and Regulation
• 22.2 National residue monitoring
  • 22.2.1 Domestic sampling
  • 22.2.2 Testing results
    • 22.2.2.1 Monitoring sampling results
    • 22.2.2.2 Enforcement results
  • 22.2.3 Import sampling
  • 22.2.4 Non-compliance

CHAPTER 23 HORIZON ISSUES

• 23.1 Geographical and knowledge divide
  • 23.1.1 Capacity building in developing countries
• 23.2 Technical considerations
  • 23.2.1 Injection site residues
  • 23.2.2 Residue depletion
  • 23.2.3 Genotoxic and carcinogenic substances
  • 23.2.4 Development of new techniques

REFERENCES

LIST OF TABLES

• Table 1.1 Benzylpenicillin MRLs as set in Codex Alimentarius
• Table 1.2 Ceftiofur MRLs as set in Codex Alimentarius
• Table 1.3 Spiramycin MRLs as set in Codex Alimentarius
• Table 1.4 Tilmicosin MRLs as set in Codex Alimentarius
• Table 1.5 Neomycin MRLs as set in Codex Alimentarius
• Table 1.6 Gentamicin MRLs as set in Codex Alimentarius
• Table 1.7 Dihydrostreptomycin/Streptomycin MRLs as set in Codex Alimentarius
• Table 1.8 Danofloxacin MRLs as set in Codex Alimentarius
• Table 1.9 Flumequine MRLs as set in Codex Alimentarius
• Table 1.10 Ivermectin MRLs as set in Codex Alimentarius
• Table 1.11 Azaperone MRLs as set in Codex Alimentarius
• Table 1.12 Carazolol MRLs as set in Codex Alimentarius
• Table 2.1 Typical signs indicating probable residues of growth-promoting substances identified during ante-mortem and post-mortem inspections of animals at the slaughterhouse
• Table 2.2 Analyte testing profile for some banned substances (with no MRL or established tolerance limit) in the EU
• Table 3.1 Principal factors to be considered when improving the monitoring and policing of unauthorised substances in animals or products of animal origin
• Table 4.1 Codex MRLs for cattle
• Table 4.2 Codex MRLs for pigs
• Table 4.3 Codex MRLs for chicken
• Table 4.4 Codex MRLs for poultry
• Table 4.5 Codex MRLs for turkey
• Table 4.6 Codex MRLs for duck
• Table 4.7 Codex MRLs for sheep
• Table 4.8 Codex MRLs for goat
• Table 4.9 Codex MRLs for horses
• Table 4.10 Codex MRLs for fish and aquaculture products
• Table 5.1 EU MRPLs for banned substances
• Table 5.2 EU sampling levels
• Table 5.3 Residue groups in EU Directive 96/23/EC
• Table 5.4 Bovines, pigs, sheep and goats slaughtered and target samples taken in EU, 2004
• Table 5.5 Poultry production and targeted samples taken in EU, 2004
• Table 5.6 Steroid residues in bovines, EU, 2004
• Table 5.7 Resorcylic acid lactone residues in bovines, EU, 2004
• Table 5.8 Corticosteroid residues in bovines, EU, 2004
• Table 5.9 Beta-agonist residues in bovines, EU, 2004
• Table 5.10 Prohibited substances in bovines, EU, 2004
• Table 5.11 Antibacterial residues in bovines, EU, 2004
• Table 5.12 Other veterinary drugs residues in bovines, EU, 2004
• Table 5.13 Steroid residues in pigs, EU, 2004
• Table 5.14 Resorcylic acid lactone residues in pigs, EU, 2004
• Table 5.15 Beta-agonist residues in pigs, EU, 2004
• Table 5.16 Prohibited substances in pigs, EU, 2004
• Table 5.17 Antibacterial residues in pigs, EU, 2004
• Table 5.18 Other veterinary drug residues in pigs, EU, 2004
• Table 5.19 Steroid residues in poultry, EU, 2004
• Table 5.20 Beta-agonist residues in poultry, EU, 2004
• Table 5.21 Prohibited substances in poultry, EU, 2004
• Table 5.22 Antibacterial residues in poultry, EU, 2004
• Table 5.23 Other veterinary drug residues in poultry, EU, 2004
• Table 5.24 Steroid residues in sheep and goats, EU, 2004
• Table 5.25 Resorcylic acid lactone residues in sheep and goats, EU, 2004
• Table 5.26 Beta-agonist residues in sheep and goats, EU, 2004
• Table 5.27 Prohibited substances in sheep and goats, EU, 2004
• Table 5.28 Antibacterial residues in sheep and goats, EU, 2004
• Table 5.29 Other veterinary drug residues in sheep and goats, EU, 2004
• Table 6.1 Fish results, UK, 2005
• Table 6.2 Poultry - broiler results, UK, 2005
• Table 6.3 Eggs' results, UK, 2005
• Table 6.4 Cattle results, UK, 2005
• Table 6.5 Calf results, UK, 2005
• Table 6.6 Horse results, UK, 2005
• Table 6.7 Pig results, UK, 2005
• Table 6.8 Sheep results, UK, 2005
• Table 6.9 Imported food results, UK, 2005
• Table 6.10 British Retailer 1 results 2005
• Table 6.11 British Retailer 2 results 2005
• Table 7.1 Positive results Ireland 2005
• Table 7.2 Overall results by substance group 2005 - bovines, pigs and sheep/goats, Ireland
• Table 7.3 Overall results by substance group 2005 - poultry, eggs, milk, Ireland
• Table 8.1 Number of samples by species, Germany, 2004
• Table 8.2 Cattle results for antimicrobial residues, Germany 2004
• Table 8.3 Pig, sheep and honey results for antimicrobial residues, Germany 2004
• Table 8.4 Positive samples by substance group, Germany 2004
• Table 8.5 Comparison of positive residue results for antibacterials in 2004 to 2002 and 2003, Germany
• Table 9.1 Results for all commodities, tested off-farm, 2005
• Table 9.2 Results for selected commodities, tested on-farm, 2005
• Table 9.3 Selected MRLs in Switzerland
• Table 10.1 Selection of results of Group A testing in Austria
• Table 10.2 Selection of results of Group B testing in Austria
• Table 11.1 Total testing results 2004-5
• Table 11.2 Beef results
• Table 11.3 Pig results by substance class
• Table 12.1 Domestic results, 2002-2003
• Table 12.2 Imported results, 2004-2005
• Table 12.3 Selected MRLs from New Zealand
• Table 13.1 Results for imported foods 2003-4
• Table 13.2 Results for imported food 2004-5
• Table 13.3 Results for domestic food 2003-4
• Table 13.4 Results for domestic food 2004-5
• Table 14.1 MRLs in force in China
• Table 14.2 Chinese food exports to the EU (tonnes) in 2005
• Table 15.1 Live Food Animals Inspection and Testing
• Table 15.2 No. of local and imported food animals inspected in 2005
• Table 16.1 MRLs set by Department of Livestock Development
• Table 16.2 Comparison of percentage of food and agricultural commodities detained before export, 2002 and 2004.
• Table 17.1 Tolerance limits for antibiotics in seafood and fish
• Table 17.2 MRLs for exports
• Table 18.1 Testing results for bovines
• Table 18.2 Testing results for pigs
• Table 18.3 Testing results for sheep
• Table 18.4 Testing results for poultry
• Table 18.5 Testing results for eggs
• Table 18.6 Testing results for eggs
• Table 18.7 Testing results for aquaculture
• Table 19.1 MRLs (mg/kg) for bovines and equidae
• Table 19.2 MRLs (mg/kg) for pigs and sheep
• Table 19.3 Testing results for bovines, 2005
• Table 19.4 Testing results for pigs, 2005
• Table 19.5 Testing results for poultry, 2005
• Table 19.6 Testing results for eggs, 2005
• Table 19.7 Exports to the EU in 2004
• Table 20.1 Number of milk samples analysed, 2004-5
• Table 20.2 Antimicrobial residues in milk samples, 2004-5
• Table 20.3 Avermectin residues in milk samples, 2004-5
• Table 20.4 Exports to the EU in 2004 and 2005
• Table 21.1 Domestic results for beef
• Table 21.2 Domestic results for cow
• Table 21.3 Domestic results for veal
• Table 21.4 Domestic results for mutton
• Table 21.5 Domestic results for pork
• Table 21.6 Domestic results for chicken
• Table 21.7 Domestic results for turkey
• Table 21.8 Domestic results for eggs and egg products
• Table 21.9 Domestic results for raw milk
• Table 22.1 Antibiotics testing results - domestic monitoring
• Table 22.2 Sulfonamides testing results - domestic monitoring
• Table 22.3 Avermectins and milbemycin testing results - domestic monitoring
• Table 22.4 STOP testing results - domestic enforcement
• Table 22.5 FAST testing results - domestic enforcement

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