EU legislation concerning
mycotoxins in Food and Feed
Dr. Amelia Moreno
ainia, Spain
EU-China Seminar on Control of Aflatoxin in Peanuts
Workshop on Mycotoxins – 29-30 May 2012 – Qingdao, China
Health and
Consumers
Scope
• ■ Introduction to mycotoxins:
•
what are they?, importance, toxicity,
contamination pathway…
• ■ EU legislation concerning mycotoxins
• ■ Annexes
Tables summary of legislation, links of interest…
Health and
Consumers
what are they?
Toxin
■ Mycotoxins are the secondary metabolites
produced by several fungi
■ Many fungi are not well studied and not all
the species have been identified
■ > 300 mycotoxins are known, but many of
these are poorly studied or information about
their toxicity is lacking. Only around 30
mycotoxins have true toxic properties which
raise concerns
Health and
Consumers
Total Nº
(Regulated)
Aflatoxins
20
(B1,B2,G1,G2,M1)
(5)
Ochratoxins
9
(A)
(1)
Patulin
1
Fungi genera
Aspergillus
Aspergillus
Penicillium
Aspergillus
Penicillium
(1)
Fumonisins
15
(B1, B2)
(2)
Trichothecenes
Hundreds
(DON, T-2, HT-2)
(3)
Zearalenone
6
(ZEA)
(1)
Fusarium
Alternaria
Byssochlamys
Fusarium
Fusarium
what are they? (cont.)
■ Most of them are chemically stable therefore, they can survive
during storage and processing of foods and even at high
temperatures (i.e. most are not destroyed in normal cooking
procedures)
■ They are relatively small molecules (MW <700) with a diverse
chemical structure and activity
Health and
Consumers
Type A-trichothecenes: T-2:
(R1 = OAc) HT-2 (R1 = OH)
Type B-trichothecenes: DON
ZEA
Fumonisin B1, B2
Health and
Consumers
Ochratoxin
Aflatoxin B1
what are they? (cont.)
■There is no confirmed reason for the existence of mycotoxins
■ The presence of the fungus does NOT automatically imply
the presence of the toxin, as there are several factors involved
in its production. …
■ The absence of mould doesn’t imply the absence of
mycotoxins, as mycotoxins may remain even if the moulds are
gone
Health and
Consumers
Why are they important?
■ Public Health:
Mycotoxins are toxic chemicals that cause a wide
variety of harmful effects. They can cause cancer, birth
defects, liver damage, nervous tissue damage, etc
■ Economy:
Mycotoxins can infest growing or stored crops and
cause economic losses at all levels of food and feed
production (25% of the world’s food crops are affected
by mycotoxin contamination annually).
Health and
Consumers
Toxicity
■ Diseases caused by ingestion of mycotoxins are called
mycotoxicoses. There is a wide variety of human
diseases ranging from gastroenteritis to cancer.
PESTICIDES
ADDITIVES
MICROBIOLOGY
■ The toxicity of these substances can be
acute or chronic for humans and animals.
PHYCOTOXINS
DIET
PHYTOTOXINS
■ They are considered as the
contaminants with higher risk to
MYCOTOXINS
produce chronic toxicity
(Kuipper Goodman 1999)
Health and
Consumers
Chronic effects
Contamination pathway
■ Mycotoxins are widely spread in the food chain and the
complete elimination is not achievable at this time.
■ Its presence has been confirmed in almost all areas of
the world and to a greater or lesser extent, in almost all
staple foods
Food chain contamination pathway:
Health and
Consumers
FIELD
PROCESSED
STORE
FOOD
ANIMAL
FEED
RUMINANTS
BIRDS
PIGS
MILK
MEAT PRODUCTS
Health and
Consumers
SPICES
Main products affected
■ Products of Plan Origin:
Nuts, cereals and derivatives, dried fruit,
vegetables (Oil-bearing seeds, beans, raisins)
,spices, coffee, cocoa and fermented juices
and products (apple juice, grape juice, beer,
wine and cider).
■ Products Animal Origin:
Milk, eggs, meat, offal and all products
derived from them
Health and
Consumers
2. EU legislation concerning mycotoxins
Health and
Consumers
more holistic
Analytes to be controlled?
■ Reg 178/2004 General food Law
■Reg 882/2004. Global point of view on official control
■ Reg 1881/2006 and amending. Maximum levels for
contaminants
■ Reg 401/2006 and amending. Sampling and analysis for
more specific
Mycotoxins
■ Reg 669/2009 and amending. Increased level of official
controls on imports of certain feed and food of non
animal origin (FFNAO)
■ Reg 1152/2009. Special condition governing certain
foodstuffs imported from certain third countries
Health and
Consumers
Use the relevant
regulation!!!!!!
Health and
Consumers
General Food Law
Reg. (EC) 178/2002
Safety
› Food shall not be placed on the market if it
is unsafe.
Where any food which is unsafe is part of a batch, lot
or consignment of food of the same class or
description, it shall be presumed that all the food in
that batch, lot or consignment is also unsafe, unless
following a detailed assessment there is no evidence
that the rest of the batch, lot or consignment is
unsafe.
(Article 14)
Health and
Consumers
General Food Law
Reg. (EC) 178/2002
General Obligations
in the food and feed trade
■ Food and feed imported for placing on the market must
comply with the relevant requirements of EU food law
■ Food and feed exported or re-exported from the Community
for placing on the market of a Third Country shall comply with
the relevant requirements of EU Law
...with exemptions
(Article 11 and 12)
Health and
Consumers
General Food Law
Reg. (EC) 178/2002
Responsibilities
Food and feed business operators
at all stages of production, processing and distribution
……
shall
ensure
that
foods
or
feed
satisfy
the
requirements of food law which are relevant to their
activities ……………
(Article 17)
Health and
Consumers
General Food Law
Reg. (EC) 178/2002
Responsibilities
Member States shall enforce food law, and monitor
and verify that the relevant requirements of food law
are fulfilled by food and feed business operators at all
stages of production, processing and distribution
…………………………..HOW?? OFFICIAL CONTROLS
(Article 17)
Health and
Consumers
Control of residues and contaminants
Regulation 882/2004
What are official controls?
Official controls are defined as
"any form of control performed by the Competent
Authority or by the Community for the verification of
compliance with feed and food law, as well as animal
health and animal welfare rules".
►The
official
controls
involve
audits, samplings and analysis…
Health and
Consumers
inspections,
verifications,
Reg. (EC) N° 669/2009
regarding
the
increased
level
of
official
controls on imports of certain food and feed
of non-animal origin
Health and
Consumers
Reg. (EC) N° 669/2009
The increased level of officials controls is compulsory
for F&FNAO listed in Annex I
Reg. (EU) № 294/2012
of 3 April 2012
amending Annex I to Regulation (EC) No 669/2009
Review: quarterly (at least)
Health and
Consumers
Increased levels
Reg. (EC) 669/2009 and amend.
Food
Intended use Country
Mycotoxin
Hazelnut
Feed & Food
Azerbaijan
Aflatoxins
10
Peanuts
Feed & Food
Brazil
Aflatoxins
10
Peanuts
Feed & Food
Ghana
Aflatoxins
50
India
Aflatoxins
20
India
Aflatoxins
20
Capsicum
Curry
Nutmeg
Mace
Ginger
Curcuma
Peanuts
Peanut butter
Food
Feed & Food
Health and
Consumers
Frequency(%)
Applies 1st January
2012
BEFORE: 10
(2009/2010)
Increased levels
Reg. (EC) 669/2009 and amend.
Food
Intended use
Country
Mycotoxin
Frequency(%)
Watermelon
seeds
Food
Nigeria
Aflatoxins
50
Capsicum
Food
Peru
Aflatoxins
Ochratoxin A
10
Dried grapes
Food
Uzbekistan
Ochratoxin A
50
South Africa
Aflatoxin
10
Peanuts
Feed & Food
Health and
Consumers
Reg. (EC) № 1152/2009
imposing special conditions governing the
import of certain foodstuffs from certain
Third Countries due to contamination risk by
aflatoxins
Health and
Consumers
Special conditions
Reg. (EC) 1152/2009 and amend.
Food
Country
Mycotoxin
Brazil nuts
Brazil
Aflatoxins
100
Groundnuts
China
Aflatoxins
20
Groundnuts
Egypt
Aflatoxins
20
Pistachios
Iran
Aflatoxins
50
Almonds
(covered by
VASP)
United States
of America
Aflatoxins
random
Almonds
(not covered by
VASP)
United States
of America
Aflatoxins
100
Health and
Consumers
Frequency(%)
Increased levels
Reg. (EC) 1152/2009
Food
Country
Mycotoxin
Frequency(%)
Hazelnuts
Nuts
Turkey
Aflatoxins
10
Dried figs
Turkey
Aflatoxins
20
Pistachios
Turkey
Aflatoxins
50
■ The Regulation applies also to processed and compound
foodstuffs derived from or containing (>20%) the foodstuffs
referred to above
Health and
Consumers
Major Differences between Reg 1152 and 669
■The frequency in Reg 1152/2009 is considered as a
minimum in the sense that the competent authority can
decide to increase the frequency of controls (other
difference with Reg 669/2009 where the CA can not
increase the frequency.
In Spain we apply the frequency of controls as set in the
Reg 1152/2009
Health and
Consumers
Major Differences between Reg 1152 and 669
■ Documentary differences:
Reg. 1152/2009
Reg. 669/2009
-CED
-Health certificate accompanied
by the results of sampling and
analysis
-CED
-Physical control at a
determined frequency
-Physical control at a
determined frequency
CED= Common Entry Document
Health and
Consumers
Major Differences between Reg 1152 and 669
■ Period of detention for sampling and analysis:
Reg. 1152/2009
Reg. 669/2009
15 working days
Does not provide any
timeframe
(however they must be
available as soon as technically
possible)
■Differences in the scope of products containing a
commodity or derived from a commodity listed in each
Regulation.
Health and
Consumers
Mycotoxins Maximum levels: Reg 1881/2006
■ Commission Regulation (EC) 1881/2006 of
19 December 2006 setting maximum levels for
certain mycotoxins in foodstuffs
■Scope:
• To provide the consumers with an increased level of
protection by setting maximum levels for certain
contaminants in those foodstuffs that are significant
contributors to total dietary exposure of the consumers to
those contaminants
Health and
Consumers
Principles:
Maximum Levels
Reg. (EC) 1881/2006
■ People should be protected from the toxic effects of contaminants
■ MLs are set for
-products with high consumption
-products with high concentration of contaminants
■ Maximum levels are set to reasonably achievable leves but as
low as possible (ALARA-principle). Aims to keep those
contaminants at levels that are toxicologically acceptable and to
exclude grossly contaminated food from entering the food chain.
■ ML is set for the EDIBLE part
■ It harmonises Member States’ existing measures to facilitate
trade.
Health and
Consumers
Principles:
Maximum Levels
Reg. (EC) 1881/2006
■ If ML exceeds, food can’t be placed on the market
-Dilution, mixing with clean products
contaminated material is forbidden
or
detoxificating
■ Food producers are encouraged to take preventive measures
-Good agricultural practices
-Good storage conditions
-Improved sorting procedures
-etc
Health and
Consumers
Maximum Levels
Reg. (EC) 1881/2006
AFLATOXINS (B1, M1, SUM of B1,B2,G1,G2)
Maximum Levels (µg/Kg) in Foodstuff
● Groundnuts (2/4)
● Almonds, pistachios and
apricot kernels
● Hazelnuts and Brazil
nuts
● Tree Nuts
● Dried fruit
● Cereals
● Maize and rice
● Milk
● Spices
● Infant formulae
● Processed cereal-based foods
for infants
● Dietary foods for special
medical purposes intended
specifically for infants
-Higher maximum levels for commodities subjected to sorting,
or other physical treatment. e.g. groundnuts 8/15
Health and
Consumers
Maximum Levels
Reg. (EC) 1881/2006
OCHRATOXIN A
Maximum Levels (µg/Kg) in Food stuff
●
●
●
●
●
●
Cereals
Dried wine fruit
Roasted Coffee
Soluble Coffee
Wine
Grape juice
● Processed cereal-based foods for
infants
● Dietary foods for special medical
purposes intended specifically for
infants
●Spices
●Liquorice
-Maybe in the future:
Dried fruit, cocoa and cocoa products, meat products, green
coffee, beer.
Health and
Consumers
Maximum Levels
Reg. (EC) 1881/2006
PATULIN
Maximum Levels (µg/Kg) in Food stuff
● Fruit juices
● Spirit drinks
● Solid apple products
● Apple Juice and solid apple
products
● Baby food
Health and
Consumers
Maximum Levels
Reg. (EC) 1881/2006
DEOXYNIVALENOL
Maximum Levels (µg/Kg) in Food stuff
● Cereals
● Durum wheat and oats
● Maize
● Pasta (dry)
● Bread, pastries, biscuits,
snacks, breakfast cereals
●Processed cereal-based foods
and baby foods
●Milling fractions of maize with
particle size > 500 micron
● Milling fractions of maize with
particle size < 500 micron
-Higher maximum levels for maize commodities not used for
direct human consumption
Overview legislation - Peter Steinbüchel
Health and
Consumers
Maximum Levels
Reg. (EC) 1881/2006
ZEARALENONE
Maximum Levels (µg/Kg) in Food stuff
● Cereals
● Maize
● Refined Maize oil
● Bread, pastries, biscuits,
cereal snacks, breakfast
cereals
●Maize snacks and maize
based breakfast cereals
● Processed cereal-based foods for
infants
●Milling fractions of maize with
particle size > 500 micron
● Milling fractions of maize with
particle size < 500 micron
-Higher maximum levels for maize commodities not used for
direct human consumption
Health and
Consumers
Maximum Levels
Reg. (EC) 1881/2006
FUMONISINS
Maximum Levels (µg/Kg) in Food stuff
● Maize
● Maize-based cereals and
snacks
● Processed maize-based foods
for infants
●Milling fractions of maize with
particle size > 500 micron
● Milling fractions of maize with
particle size < 500 micron
-Higher maximum levels for maize commodities not used for
direct human consumption
Health and
Consumers
Maximum Levels
Reg. (EC) 1881/2006
T-2 AND HT-2
Maximum Levels (µg/Kg) in Food stuff
● ???
-It is necessary to collect more data for T-2 and HT-2:
Maximum levels should be considered by 1 July 2008
Health and
Consumers
Sampling and analysis
Reg. (EC) 401/2006
•
Annex I:
■ Sampling
methods
for
official
control
of
mycotoxins
http://ec.europa.eu/food/food/chemicalsafety/contaminants/guidance2010.pdf
•
• Annex II:
■ Criteria for the analytical methods used for
official controls
■ Reporting results
Health and
Consumers
•Requirements for Official Control laboratories
•■ the Competent Authority designates laboratories
that may carry out the analysis of samples taken
during official controls.
•■ The laboratory must be accredited by ISO 17025 (FOR
ANALYSIS AND SAMPLING!!)
•(Reg. 882/2004 Article 12)
Health and
Consumers
Sampling and analysis
Reg. (EC) 401/2006
Mycotoxins Analysis Requirements
Contaminant
Concentration
Recovery
Presicion (RSDR)
level
It means that any analytical method
Aflatoxins (B1,
< 1.0 µg/Kg
50-120 %
2* Horwitz
that meets
these criteria
can be
B2, G1,G2)
equation
70-110 %
used!!! 1-10 µg/Kg
Ochratoxin
>10 µg/Kg
80-110 %
< 1.0 µg/Kg
50-120 %
≤60
1-10 µg/Kg
70-110 %
≤30
Health and
Consumers
Sampling and analysis
Reg. (EC) 401/2006
Mycotoxins Analysis Requirements
• … ….and the for interpretation of results
• ■ The results must be reported as:
XU
Where,
X= analytical result
U = Expanded uncertainty (95%)
…The expanded uncertainty should be subtracted from the analytical
result after correction for recovery:
Result= X-U
Health and
Consumers
Sampling and analysis
Reg. (EC) 401/2006
Mycotoxins Analysis Requirements
• ■ Acceptance if the laboratory sample conforms to the
maximum limit, taking into account the correction for
recovery and measurement uncertainty
• ■ Rejection if the laboratory sample exceeds the
maximum limit, taking into account the correction and
measurement uncertainty
Health and
Consumers
Health and
Consumers
14
11
8
6
10 ppb
Health and
Consumers
3. Annexes
Health and
Consumers
Table Summary of legislation (1)
Reg 1881/2006
Setting maximum levels for certain
contaminants in foodstuff
Reg 1126/2007
Amending Reg. 1881/006 setting maximum
levels for certain contaminants in foodstuffs as
regards Fusrium toxins in maize and maize
products
Reg 105/2010
Maximum levels
Food
Amending Reg. 1881/2006 setting maximum
levels for cetain contaminants in foodstuffs as
regards Ochratoxin A
Reg 165/2010
Amending Reg. 1881/2006 setting maximum
levels for cetain contaminants in foodstuffs as
regards Aflatoxins
Dir 2002/32
Setting maximum levels of contaminants in
Feed and amend.
Recommendation for further 5 mycotoxins
Recommendation
2006/576
Health and
Consumers
Maximum Levels
Feed
Overview legislation - Peter Steinbüchel
Table Summary of legislation (2)
Reg 669/2009
Reg 294/2012
Increased level of official controls on imports of
certain feed and food of non-animal origin
Amending Reg. Anexe I of Reg 669/2011
Reg 1152/2009
On special conditions governing certain foostuffs
imported from certain third countries due to
contamination risks of these products by
aflatoxins
Reg 401/2006
Laying down the methods and sampling and
analysis for the offical control of the levels of
mycotoxins in foodstuffs
Reg 178/2010
Amending Reg. 401/2010 as regards
groundnuts, other oilseeds, tree nuts, apricot
kenels, liquorice and vegetable oil
Health and
Consumers
Sampling
frequency
Sampling
Analysis criteria
Acceptance
criteria
WEB LINKS OF INTEREST
-European Mycotoxins Awareness NetworkEMAN
http://www.mycotoxins.org/
-European Commision Health and Consumers
(DG SANCO)
For EU legislation, general information
http://ec.europa.eu/food/food/chemicalsafet
y/contaminants/index_en.htm
- Access to European Union Law
http://eur-lex.europa.eu/es/index.htm
Health and
Consumers
THANK YOU!!!
Health and
Consumers