worldwide and european regulations for ... -...

Worldwide and European regulationsfor mycotoxins & analytical methods

expected from Biocop

Hans van Egmond & Marco Jonker, Brussels, 22 October 2004

RENational Institutefor Public Health

and the EnvironmentResearch for man and environment

2Mycotoxin regulations & BioCop / Van Egmond & Jonker, Brussels 2004

r

“It can be measured, so it must exist”

Quote of first speaker at conference: “Measurements, a key to competitiveness”, 25th anniversary of BCR, November 1998


r

“A well-known mycotoxin, such as aflatoxin B1 is 33 million times more dangerousthan the dangerous solvent carbon tetrachloride – itsthreshold is 0.000001 gramper kg per day”

Naresh Magan, RTD Info 42, August 2004


r

“There is no point imposingconstraining regulations ifonly a few individuals and laboratories are able to monitor their applicationthroughout the continent”

Naresh Magan, RTD Info 42, August 2004


r

Outline of presentation

• Introduction• Factors influencing mycotoxin regulations• International inquiries on mycotoxin regulations• “Tour-du-monde“ 2003 & focus on the EU• Worldwide limits for aflatoxins in food and feed• Worldwide limits for other mycotoxins in food• BioCop work package mycotoxins• Summary


r




r

Factors influencing mycotoxin regulations

• Availability of toxicity data• Availability of survey analytical data• Availability of methods of sampling and analysis• Trade contacts with other countries• Sufficiency of food supply


r

Weighing the various factors: not trivial


r




r

Inquiries on mycotoxin regulations

• Worldwide inquiries in 1981, 1987, 1995 and 2002/2003, resulting in various publications

• Inquiry 1995 published as FAO FNP Paper 64 (1997)


r

International inquiry 2002/2003

Questionnaire February 2002For an Update of

“Worldwide regulations for mycotoxins 1995”FAO Food and Nutrition Paper 64

• Inquiry 2002/2003: FAO-contracted activity of RIVM• Information: Dutch Embassies and personal contacts • Details asked a.o. about tolerance limits, legal bases,

responsible authorities, methods of sampling and analysis• Results: regulations exist in 100 countries and for 13 toxins• FAO Food and Nutrition Paper: in print


r




r

Africa

• 15 nations with known regulations (59 % of inhabitants of the region)

• Majority of countries: regulations unknown or non-existent

• Several countries indicate regulations should be developed

• Regulations mainly for AFB1

• Most detailed: Morocco


r

Asia/Oceania


• Regulations for total aflatoxinsdominate in food, regulations for AFB1 dominate in feed

• Harmonized regulations in Australia & New Zealand

• Most detailed : China and Iran


r

Latin America


• Harmonized aflatoxin regulations in MERCOSUR

• Aflatoxin regulations mostly set for total aflatoxins

• Most detailed regulations: Uruguay


r

North America


• Canada: detailed tolerances forFusarium damaged kernels (% FDK) and for ergot (% by weight)

• USA: detailed tolerances forfumonisins (B1+B2+B3) in a widevariety of foods and feeds


r

Europe

• 39 nations with known regulations 99 % of inhabitants of the region)

• EU harmonized limits exist for: - total aflatoxins and AFB1 in various

foodstuffs and AFB1 in baby food- AFM1 in milk and baby food- ochratoxin A in various

foodstuffs and baby food- patulin in fruit products and baby food

• Low limits applied, especially for baby food


r

Europe - regulations in development

• EU guidelines limits for DON will be “upgraded” to regulated max. levels

• Expected: EU limits for ochratoxin A in coffee, wine and grape juice

• Expected: EU regulations for several Fusarium toxins in food and baby food

• Expected: EU regulations for various mycotoxins in feeds (apart from AFB1)- DON, zearalenone, fumonisins - ochratoxin A - ergot alkaloids


r

Europe: mycotoxins regulated in food (2003)

0 5 10 15 20 25 30 35 40

AFT

AFB1

AFB1/G1

AFM1

OTA

PAT

DON

T-2

ZEN

FUMB1/2

FUMB1

STEm

yco

toxi

ns

number of countries


r

Europe: mycotoxins regulated in feed (2003)

0 5 10 15 20 25 30 35 40

AFT

AFB1

AFB1/G1

OTA

DON

T-2

DAS

ZEN

myc

oto

xin

s

number of countries


r

AFRICA

EUROPE

ASIA

&

OCEANIA

NORTH AMERICA

LATIN AMERICA


r

Number of mycotoxin regulations per country

Food

1,53,6

1,8

5,519,6

ASIA / OCEANIA

LATIN AMERICA

AFRICA

EUROPE

NORTH AMERICA


r


Feed1,3

1,71,0

13,5

8,5

EUROPE

NORTH AMERICA

LATIN AMERICA

ASIA / OCEANIAAFRICA


r




r

Aflatoxin B1 in food

1

29

21

5

2

3

1 µg/kg

2 µg/kg

5 µg/kg

10 µg/kg

15 µg/kg

20 µg/kg

number of countries


r

Total aflatoxins in food

23

129

388

173

2

0 µg/kg

1 µg/kg

3 µg/kg

4 µg/kg

5 µg/kg

10 µg/kg

15 µg/kg

20 µg/kg

30 µg/kg

35 µg/kg

number of countries


r

Aflatoxin M1 in milk

1

34

1

22

1

1

not detectable

0.05 µg/kg

0.2 µg/kg

0.5 µg/kg

5 µg/kg

15 µg/kg

number of countries


r

Aflatoxin B1 in feed for dairy cattle

27

5

1

3

1

2

5 µg/kg

10 µg/kg

15 µg/kg

20 µg/kg

25 µg/kg

50 µg/kg

number of countries


r




r

Patulin in fruits and fruit juices

1

1

1

44

1

5 µg/kg

25 µg/kg

30 µg/kg

50 µg/kg

100 µg/kg

number of countries


r

Ochratoxin A in cereals and cereal products

1

29

1

1

1

1

3

3 µg/kg

5 µg/kg

10 µg/kg

15 µg/kg

20 µg/kg

30 µg/kg

50 µg/kg

number of countries


r

DON in wheat(flour) and other cereals

1

4

19

9

1

2

1

300 µg/kg

700 µg/kg

750 µg/kg

1000 µg/kg

1100 µg/kg

1200 µg/kg

2000 µg/kg

number of countries


r

Zearalenone in maize and other cereals

1

1

2

5

8

50 µg/kg

60 µg/kg

100 µg/kg

200 µg/kg

1000 µg/kg

number of countries


r

Fumonisins in maize

4

1

1

1000 µg/kg

2000 µg/kg

3000 µg/kg

number of countries


r

Techniques used in mycotoxin regulatory analysis

TLC

minicolumn

LC

GC

GC/MS ELISA

fluorometry

frequency of techniques


r


• Introduction• Factors influencing mycotoxin regulations• International inquiries on mycotoxin regulations• “Tour-du-monde“ 2003 & focus on the EU• Limits for aflatoxins in food and feed• Limits for other mycotoxins in food• BioCop work package mycotoxins• Summary


r

An Integrated Project proposal submitted to the EC on the subject of chemical contaminant monitoring


r

Broad Spectrum Contaminant Analysis

In their wise & far sighted approach to the subject the European Commission published in the FP6 Food Quality Work Programme:

“New methods to prevent & monitor occurrence of multiple contaminants such as pesticides, toxins, drugs and endocrine disrupters in foods.

This should be achieved through use of advanced sample preparation techniques & emerging biotechnological screening approaches based on development of novel biomarkers.”


r

Question…….

How can such a radical set of requirements be met?

The birth of the consortium (32 partners)

The BioCop principles:The fundamental scientific objective is to utilise emerging lifescience technologies to create a powerful new approach to detect & control chemical contaminants in foods.


r

BioCop: the science…..

Veterinary drugs, heavy metals, mycotoxins, endocrine disrupters,

shellfish toxins, pesticides

Transcriptomics, proteomics, biosensors, molecular engineering


r

The BioCop matrixWP1 WP2 WP3 WP4

Binding moleculesTranscriptomics Proteomics Biosensors

WP5 Shellfish toxins

WP10 Mycotoxins

WP6 Pesticides

WP8 Therapeutic drugs

WP7 Endocrine disrupters

WP9 Heavy metals


r

Work package mycotoxins

• 8 partners involved • Links with CEN and AOAC International• Focus on trichothecenes (DON, NIV, T-2, HT-2)• Techniques explored:

- new analyte isolation techniques (e.g. pressurized liquid extraction, slurrying techniques, microwave hydrolysis)

- transcriptomics (identification of chemical residues through genomic fingerprints)

- electrochemical biosensors (low cost portable devices)


r

Phase 1: Research, e.g. Development of binders, surface chemistry, chip production, equipment design, test materials

Phase 2: Research, e.g. Development of assays, technology coupling, sample preparation

Phase 3: Comparison and validationCompare new assays with state of the art & fully validate

Phase 4: Demonstration Technology transfer events, e.g. workshops

YEAR

1

2

3

4

5

Decision Points Decision Points



BioCop phases


r

Current status of the BioCop proposal

Submitted February 2004

First phase of evaluation: Passed

Second phase evaluation: Passed

Contract negotiations ongoing since June 2004

Completion of contracts: November 2004

Five year project from January 2005, 32 partners from 16 countries, EC contribution approx. 10M €


r


• Introduction• Factors influencing mycotoxin regulations• International inquiries on mycotoxin regulations• “Tour-du-monde“ 2003 & focus on the EU• Limits for aflatoxins in food and feed• Limits for other mycotoxins in food• BioCop work package mycotoxins• Summary


r

Summary

• Various factors involved in establishing mycotoxin regulations • Mycotoxin regulations exist in 100 countries and for 13 toxins• Regulations in 2003: more diverse and detailed than in 1995• Harmonisation takes place, yet regulatory limits remain

substantially different across countries• Details of 2002/2003 inquiry: FAO FNP in 2004• BioCop: new technologies (transcriptomics, biosensors)

explored for determination of trichothecenes

Thank you for your attention!

Worldwide and European regulationsfor mycotoxins & analytical methods

expected from Biocop

Hans van Egmond & Marco Jonker, Brussels, 22 October 2004

RENational Institutefor Public Health

and the EnvironmentResearch for man and environment


r


r

Africa: mycotoxins regulated in food

0 2 4 6 8 10 12

AFT

AFB1

AFM1

AFG1

OTA

PAT

ZENm

ycot

oxin

s

number of countries


r

Africa: mycotoxins regulated in feed

0 2 4 6 8 10 12

AFT

AFB1

AFB1/G1

OTA

ZEN

myc

otox

ins

number of countries


r

Asia/Oceania: mycotoxins regulated in food

0 5 10 15 20

AFT

AFB1

AFM1

OTA

PAT

DON

T-2

ZEN

FUMB1/2

FUMB1

AGA

PHOm

yco

toxi

ns

number of countries


r

Asia/Oceania: mycotoxins regulated in feed

0 5 10 15 20

AFT

AFB1

OTA

DON

T-2

DAS

ZEN

myc

oto

xin

s

number of countries


r

Latin America: mycotoxins regulated in food

0 5 10 15 20

AFT

AFB1

AFB1/G1

AFM1

OTA

PAT

DON

ZEN

FUMB1m

yco

toxi

ns

number of countries


r

Latin America: mycotoxins regulated in feed

0 5 10 15 20

AFT

AFB1

DON

ZEN

ERG

myc

oto

xin

s

number of countries


r

North America: mycotoxins regulated in food

0 2 4 6 8 10

AFT

AFM1

PAT

DON

FUMB1/2/3

myc

oto

xin

s

number of countries


r

North America: mycotoxins regulated in feed

0 2 4 6 8 10

AFT

DAS

DON

ERG

FUMB1/2/3

HT-2

OTA

T-2

ZEN

myc

oto

xin

s

number of countries


r

Information in draft table of FAO document

status ref. status ref

FOODGroundnuts, nuts, dried fruit

Aflatoxin B1 2 [EU 1] Min. Health official [EU 2] official [EU 2]

DAIRYMilk Aflatoxin M1 0.05 [EU 1] Min. Health official [EU 2] official [EU 2]

FEEDgrain (products) incorporated in feed for pigs

DON 5000 [NL 1] Commodity Board Animal

Feedstuffs

Sampling method

Analytical method

The Netherlands <NL> 2002:

Legal basis

Responsible authority

Commodity Mycotoxin Limit (ng/g)


r

AFRICA

EUROPE

ASIA

&

OCEANIA

NORTH AMERICA

LATIN AMERICA


r


r


Dairy

0,3

0,7

0,60,5

1,2

AFRICA

ASIA / OCEANIA

LATIN AMERICANORTH AMERICA

EUROPE


r

Total aflatoxins in feed for dairy cattle

2

4

7

3

5

zero/0.01 µg/kg

10 µg/kg

20 µg/kg

30 µg/kg

50 µg/kg

number of countries


r

Ranges of limits for total aflatoxins in food

0 5 10 15 20 25 30 35 40 45 50

µg/kg

2002

North America 1995

2002

Latin America 1995

2002

Europe 1995

2002

Asia/Oceania 1995

2002

Africa 1995


r

Typical limits for total aflatoxins in food

0 5 10 15 20 25 30 35 40 45 50

µg/kg

2002

North America 1995

2002

Latin America 1995

2002

Europe 1995

2002

Asia/Oceania 1995

2002

Africa 1995


r


r

The BioCop matrixWP1 WP2 WP3 WP4

Binding moleculesTranscriptomics Proteomics Biosensors

WP5 Shellfish toxins

WP10 Mycotoxins

WP6 Pesticides

WP8 Therapeutic drugs

WP7 Endocrine disrupters

WP9 Heavy metals

worldwide and european regulations for ... -...

Documents