Commission Regulation (EC) No 856/2005 of 6 June 2005 amending Regulation (EC) No 466/2001 as regards Fusarium toxins   (Text with EEA relevance)
Date: 2005-06-06
Institutions: European Commission
Subjects: consumer protection, food contamination, food standard, foodstuff, public health, toxic substance

7.6.2005

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COMMISSION REGULATION (EC) No 856/2005

of 6 June 2005
amending Regulation (EC) No 466/2001 as regards Fusarium toxins

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(5)

Having regard to the Treaty
Community,

establishing the European

Having regard to Council Regulation (EEC) No 315/93 of 8
February 1993 laying down Community procedures
for
contaminants
and in particular Article 2(3)
thereof,

in food (1),

The SCF considered that
the available data did not
support the establishing of group Tolerable Daily Intake
(TDI) for the evaluated trichothecenes and established

— a TDI of 1 μg/kg body weight/day for deoxynivalenol

(DON),

— a

temporary TDI
weight/day for nivalenol,

(t-TDI) of 0,7 μg/kg

body

Whereas:

— a combined temporary TDI of 0,06 μg/kg body

weight/day for T-2 and HT-2 toxin.

(1)

(2)

(3)

(4)

Commission Regulation (EC) No 466/2001 (2) provides
for maximum levels for certain contaminants in food-
stuffs.

For the other Fusarium toxins the SCF established

Certain Member States have adopted or plan to adopt
maximum levels for Fusarium toxins, such as deoxyni-
(DON), zearalenone (ZEA) and fumonisins in
valenol
certain foodstuffs.
the disparities between
the level authorised in Member States and the consequent
risk of distortion of competition, Community measures
are necessary in order to ensure market unity while
complying with the principle of proportionality.

In view of

A variety of Fusarium fungi, which are common soil
fungi, produce a number of different mycotoxins of the
class of trichothecenes such as deoxynivalenol
(DON),
nivalenol
(NIV), T-2 toxin and HT-2 toxin and some
other toxins (zearalenone and fumonisins). The Fusarium
fungi are commonly found on cereals grown in the
temperate regions of America, Europe and Asia. Several
of the toxin producing Fusarium fungi are capable of
producing to a variable degree two or more of these
toxins.

The Scientific Committee for Food (SCF) has evaluated in
a set of opinions the Fusarium toxins: deoxynivalenol
in December 1999, zearalenone in June 2000,
(DON)
fumonisins in October 2000, updated in April 2003,
nivalenol in October 2000 and T-2 and HT-2 toxin in
May 2001 and a group evaluation of the trichothecenes
in February 2002.

— a

temporary TDI

(t-TDI) of 0,2 μg/kg

body

weight/day for zearalenone,

— a TDI of 2 μg/kg bodyweight/day for the total of
fumonisin B1, B2 and B3, alone or in combination.

(6)

In the framework of Council Directive 93/5/EEC of 25
February 1993 on assistance to the Commission and
cooperation by the Member States in the scientific exam-
ination of questions relating to food (3), a scientific coop-
eration (SCOOP) task 3.2.10 ‘Collection of occurrence
data on Fusarium toxins in food and assessment of
dietary intake by the population of EU Member
States’ (4) was performed and finalised in September
2003.

The results of that task demonstrate that Fusarium myco-
toxins are widely distributed in the food chain in the
Community. The major sources of dietary intake of
Fusarium toxins are products made from cereals,
in
particular wheat and corn. While the dietary intakes of
Fusarium toxins for the entire population and adults are
often less than the TDI’s for the respective toxin, for risk
groups like infants and young children, they are close or
even exceed the TDI in some cases.

(1) OJ L 37, 13.2.1993, p. 1. Regulation as amended by Regulation (EC)
No 1882/2003 of the European Parliament and of the Council
(OJ L 284, 31.10.2003, p. 1).

(2) OJ L 77, 16.3.2001, p. 1. Regulation as last amended by Regulation

(EC) 208/2005 (OJ L 34, 8.2.2005, p. 3).

(3) OJ L 52, 4.3.1993, p. 18. Directive as amended by Regulation (EC)

No 1882/2003.

(4) Report available on the website of the European Commission, DG

Health and Consumer Protection
(http://europa.eu.int/comm/food/fs/scoop/task3210.pdf).

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(7)

(8)

(9)

(10)

In particular for deoxynivalenol, the dietary intake for the
group of young children and adolescents is close to the
TDI. For T-2 and HT-2 toxin, the estimated dietary intake
exceeded in most of the cases the t-TDI. However, it has
to be noted that for T-2 and HT-2 toxin most occurrence
data were obtained by making use of methods of analysis
with a high limit of detection and taking into consid-
eration that the amount of samples above the limit of
detection was lower than 20 %, the dietary intake was
strongly influenced by the limit of detection of the used
analytical methods. For nivalenol all
intakes were far
below the t-TDI. As regards the other trichothecenes
considered in the abovementioned SCOOP-Task, such
as
15-acetyldeoxynivalenol,
fusarenon-X, T2-triol, diacetoxyscirpenol, neosolaniol,
monoacetoxyscirpenol and verrucol, as far as the infor-
mation is available all dietary intakes are low.

3-acetyldeoxynivalenol,

For zearalenone, the average daily intake is significantly
lower than the TDI but attention should be paid to
population groups not
identified in the task which
might have regularly high consumption of products
with high incidence of zearalenone contamination and
to food aimed for consumption among children, since
is among young children is
the diversity of
limited.

the diet

fumonisins
are

increases
considered. Nevertheless,

For fumonisins, the estimated dietary intake for most
population groups is far below the TDI. The dietary
significantly when
intake of
consumers only
the
dietary intake is also for
that group of consumers
below the TDI. However, monitoring control results of
the harvest 2003 indicate that maize and maize products
It is
can be very highly contaminated by fumonisins.
appropriate that measures are taken to avoid that such
unacceptably highly contaminated maize and maize
products can enter the food chain.

infect

grain pre-harvest.

Fusarium species
In
the
connection with Fusarium infection and Mycotoxin
risk factors have been identified.
formation several
Climatic conditions during the growth,
in particular at
flowering, have a major influence on the mycotoxin
content. However, good agricultural practices, whereby
the risk factors are reduced to a minimum, can prevent
to a certain degree the contamination by Fusarium fungi.

food chain and to encourage and ensure that all
measures are taken during the field, harvest and storage
stage of the production chain (by applying good agri-
cultural, harvest and storage practices). It is appropriate
to apply the maximum level on unprocessed cereals to
cereals placed on the market for first stage processing as
the intended use (for food,
feed or industrial) of the
cereals is known at this stage. Cleaning, sorting, drying
procedures are not considered as first-stage processing
insofar no physical action is exerted on the grain
kernel itself while scouring is to be considered as first-
stage processing.

(12) Maximum levels are set at a level taking into account the
current human exposure in relation with the tolerable
the toxin in question and which can be
intake of
reasonably achieved by following good practices at all
stages
an
and
approach ensures that food business operators apply all
possible measures to prevent/reduce the contamination
as far as possible in order to protect public health.

distribution.

production

Such

of

(13)

(14)

For maize, not all factors involved in the formation of
Fusarium toxins, in particular zearalenone and fumonisins
B1 and B2 are yet precisely known. Therefore, a time
period is granted to enable food business operators in
the cereal chain to perform investigations on the sources
of the formation of these mycotoxins and on the identi-
fication of the management measures to be taken to
prevent their presence as much as reasonably possible.
Maximum levels based currently available occurrence
data are proposed to apply from 2007 in case no
specific maximum levels based on new information on
occurrence and formation are set before that time.

Through cleaning and processing the content of Fusarium
toxins in raw cereals can be reduced at a varying degree
in processed cereal products. Given the varying degree of
reduction, it is appropriate to set a maximum level for
final consumer cereal products to protect the consumer
In
and necessary to have an enforceable legislation.
setting maximum levels
cereal
for
products, a pragmatic approach has to be followed.
Furthermore the setting of a maximum level for major
food ingredients derived from cereals is appropriate in
order to ensure an efficient enforcement in the interest of
ensuring public health protection.

consumer

final

(11)

It is important for the protection of public health that
maximum levels are set on unprocessed cereals in order
to avoid that highly contaminated cereals can enter the

(15) Given the low contamination levels of Fusarium toxins
found in rice, no maximum levels are proposed for rice
or rice products.

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(16)

to in particular

is not necessary due to co-occurrence to consider
It
specific measures for 3-acetyl deoxynivalenol, 15-acetyl
deoxynivalenol and Fumonisin B3, as possible measures
with regard
and
Fumonisin B1 + B2 would also protect the human popu-
lation from an unacceptable exposure from 3-acetyl
deoxynivalenol, 15-acetyl deoxynivalenol and Fumonisin
B3. The same applies to nivalenol for which to a certain
degree
can be
co-occurrence with deoxynivalenol
observed and human exposure to nivalenol is estimated
to be significantly below the t-TDI.

deoxynivalenol

(17) Data on the presence of T-2 and HT-2 toxin are for the
time being limited. There is also an urgent need for the
development and validation of a sensitive method of
analysis. However intake estimates indicate clearly that
the presence of T-2 and HT-2 can be of concern for
public health. Therefore, the development of a sensitive
method, collection of more occurrence data and more
investigations/research in the factors involved in the
and cereal
presence of T-2 and HT-2 in cereal
products,
is
necessary and of high priority.

in oats and oat products,

in particular

(18)

(19)

Regulation (EC) No 466/2001 should therefore be
amended accordingly.

The measures provided for in this Regulation are in
accordance with
Standing
Committee on the Food Chain and Animal Health,

opinion

the

the

of

HAS ADOPTED THIS REGULATION:

Article 1

Regulation (EC) No 466/2001 is amended as follows:

(1) In Article 2, paragraph 3 is replaced by the following:

‘3. Without prejudice to Articles 3(1) and 4(3),
following shall be prohibited

the

(a)

to use products, which do not comply with the
maximum levels set out in Annex I, as food ingredients
for the production of compound or other foodstuffs;

(b) to mix products complying with the maximum levels
with products exceeding the maximum levels set out in
Annex I;

(c)

to deliberately detoxify products by chemical treatments
in the case of contaminants listed in section 2 (Myco-
toxins) of Annex I.’

(2) In Article 5, the following paragraph 5 is added:

‘5.
The Commission shall review points 2.4, 2.5, 2.6 and
2.7 of section 2 of Annex I by 1 July 2008 as regards the
maximum limits
and
fumonisin B1+B2
view to including a
for T-2 and HT-2 toxin in cereals and
maximum level
cereal products.

for deoxynivalenol, zearalenone
and with a

For that purpose, the Member States and interested parties
shall communicate each year to the Commission the results
of investigations undertaken including occurrence data and
the progress with regard to the application of prevention
measures to avoid contamination by deoxynivalenol, zear-
alenone, T-2 and HT-2 toxin and fumonisin B1+B2.’

(3) Annex I is amended in accordance with the Annex to this

Regulation.

Article 2

This Regulation shall enter into force on the twentieth day
following that of its publication in the Official
Journal of the
European Union.

It shall apply from 1 July 2006. This Regulation shall not apply
to products which were placed on the market before 1 July
2006 in conformity with the provisions applicable. The
burden of proving when the products were placed on the
market shall be borne by the food business operator.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 6 June 2005.

For the Commission

Markos KYPRIANOU
Member of the Commission

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ANNEX

In Section 2 Mycotoxins of Annex I to Regulation (EC) No 466/2001, the following points 2.4, 2.5, 2.6, and 2.7 are
added:

‘Product (1)

Maximum level
(μg/kg)

Sampling method

Reference analysis method

2.4. DEOXYNIVALENOL (DON)

2.4.1. Unprocessed cereals (2) other than durum wheat, oats

1 250

Directive 2005/38/EC (*)

Directive 2005/38/EC

and maize

2.4.2. Unprocessed durum wheat and oats

2.4.3. Unprocessed maize

1 750

— (3)

Directive 2005/38/EC

Directive 2005/38/EC

Directive 2005/38/EC

Directive 2005/38/EC

2.4.4. Cereal flour,

including maize flour, maize grits ands

750

Directive 2005/38/EC

Directive 2005/38/EC

maize meal (4)

2.4.5. Bread, pastries, biscuits, cereal snacks and breakfast

500

Directive 2005/38/EC

Directive 2005/38/EC

cereals

2.4.6. Pasta (dry)

2.4.7. Processed cereal-based food for infants and young

children and baby food (5)

750

200

Directive 2005/38/EC

Directive 2005/38/EC

Directive 2005/38/EC

Directive 2005/38/EC

(1) For the purpose of the application of maximum levels of deoxynivalenol, zearalenone, fumonisins B1 and B2, T-2 and HT-2 toxin established in points 2.4, 2.5, 2.6 and

2.7 only, rice is not included in “cereals” and rice products not included in “cereal products.”

(2) The maximum levels set for “unprocessed cereals” applies to cereals placed on the market for first-stage processing. However, the maximum levels do apply for the cereals
harvested and taken over, as from the 2005/2006 marketing year,
in accordance with Commission Regulation (EC) No 824/2000 of 19 April 2000 establishing
procedures for the taking-over of cereals by intervention agencies and laying down methods of analysis for determining the quality of cereals (OJ L 100, 20.4.2000,
p. 31), as last amended by Regulation (EC) No 777/2004 (OJ L 123, 27.4.2004, p. 50).
“First-stage processing” shall mean any physical or thermal treatment, other than drying, of or on the grain.
Cleaning, sorting and drying procedures are not considered to be “first stage processing” insofar as no physical action is exerted on the grain kernel itself and the whole
grain remains intact after cleaning and sorting.
If no specific level is fixed before 1 July 2007, the level of 1 750 μg/kg will apply thereafter to maize referred to in this point.

(3)
(4) This category includes also similar products otherwise denominated such as semolina.
(5) Processed cereal-based foods for infants and young children and baby food as defined in Article 1 of Commission Directive 96/5/EC of 16 February 1996 on processed
cereal-based foods and baby foods for infants and young children (OJ L 49, 28.2.1996, p. 17) as last amended by Directive 2003/13/EC (OJ L 41, 14.2.2003, p. 33).
The maximum level for processed cereal-based foods for infants and young children and baby food refers to the dry matter.

(*) See page 18 of this Official Journal.

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Product (1)

Maximum level
(μg/kg)

Sampling method

Reference analysis method

2.5. ZEARALENONE

2.5.1. Unprocessed cereals (2) other than maize

2.5.2. Unprocessed maize

2.5.3. Cereal flour except maize flour

2.5.4. Maize flour, maize meal, maize grits and refined maize

oil (4)

2.5.5. — Bread, pastries, biscuits

— maize snacks and maize-based breakfast cereals
— other cereal snacks and breakfast cereals

2.5.6. — processed maize-based foods for infants and young

children

100

— (3)

75

— (3)

50
— (3)

50

— (3)

— other processed cereal-based foods for infants and

20

young children and baby food (5)

Directive 2005/38/EC

Directive 2005/38/EC

Directive 2005/38/EC

Directive 2005/38/EC

Directive 2005/38/EC

Directive 2005/38/EC

Directive 2005/38/EC

Directive 2005/38/EC

Directive 2005/38/EC

Directive 2005/38/EC

Directive 2005/38/EC

Directive 2005/38/EC

(1) For the purpose of the application of maximum levels of deoxynivalenol, zearalenone, fumonisins B1 and B2, T-2 and HT-2 toxin established in points 2.4, 2.5, 2.6 and

2.7 only, rice is not included in “cereals” and rice products not included in “cereal products.”

(2) The maximum levels set for “unprocessed cereals” applies to cereals placed on the market for first-stage processing. However, the maximum levels do apply for the cereals
harvested and taken over, as from the 2005/2006 marketing year, in accordance with Commission Regulation (EC) No 824/2000 establishing procedures for the taking
over of cereals by intervention agencies and laying down methods of analysis for determining the quality of cereals (OJ L 100, 20.4.2000, p. 31), as last amended by
Regulation (EC) No 777/2004 (OJ L 123, 27.4.2004, p. 50).
“First-stage processing” shall mean any physical or thermal treatment, other than drying, of or on the grain.
Cleaning, sorting and drying procedures are not considered to be “first-stage processing” insofar no physical action is exerted on the grain kernel itself and the whole
grain remains intact after cleaning and sorting.
If no specific level is fixed before 1 July 2007, the level of
— 200 μg/kg will apply thereafter to unprocessed maize
— 200 μg/kg will apply thereafter to maize flour, maize meal, maize grits and refined maize oil
— 50 μg/kg will apply thereafter to maize snacks and maize-based breakfast cereals
— 20 μg/kg will apply thereafter to processed maize-based foods for infants and young children.

(3)

(4) This category includes also similar products otherwise denominated such as semolina.
(5) Processed cereal-based foods for infants and young children and baby food as defined in Article 1 of Commission Directive 96/5/EC of 16 February 1996 on processed
cereal-based foods and baby foods for infants and young children (OJ L 49, 28.2.1996, p. 17) as last amended by Directive 2003/13/EC (OJ L 41, 14.2.2003, p. 33).
The maximum level for processed cereal-based foods for infants and young children and baby food refers to the dry matter.

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Product

Maximum level
FB1 + FB2
(μg/kg)

Sampling method

Reference analysis method

2.6. FUMONISINS (1)

2.6.1. Unprocessed maize (2)

2.6.2. Maize grits, maize meal and maize flour (4)

2.6.3. Maize-based foods for direct consumption with the

exception of 2.6.2 and 2.6.4

2.6.4. Processed maize-based foods for infants and young

children and baby food (5)

— (3)

— (3)

— (3)

— (3)

Directive 2005/38/EC

Directive 2005/38/EC

Directive 2005/38/EC

Directive 2005/38/EC

Directive 2005/38/EC

Directive 2005/38/EC

Directive 2005/38/EC

Directive 2005/38/EC

(1) The maximum level applies to the sum of Fumonisin B1 (FB1) and Fumonisin B2 (FB2).
(2) The maximum level set for “unprocessed maize” applies to maize placed on the market for first-stage processing. However, the maximum levels do apply for the maize
harvested and taken over, as from the 2006/2007 marketing year, in accordance with Commission Regulation (EC) No 824/2000 establishing procedures for the taking
over of cereals by intervention agencies and laying down methods of analysis for determining the quality of cereals (OJ L 100, 20.4.2000, p. 31), as last amended by
Regulation (EC) No 777/2004 (OJ L 123, 27.4.2004, p. 50).
“First-stage processing” shall mean any physical or thermal treatment, other than drying, of or on the grain.
Cleaning, sorting and drying procedures are not considered to be “first stage processing” insofar as no physical action is exerted on the grain kernel itself and the whole
grain remains intact after cleaning and sorting.
If no specific level is fixed before 1 October 2007, the level of
— 2 000 μg/kg will apply thereafter to unprocessed maize
— 1 000 μg/kg will apply thereafter to maize flour, maize meal, maize grits and refined maize semolina
— 400 μg/kg will apply thereafter to maize based foods for direct consumption
— 200 μg/kg will apply thereafter to processed maize based foods for infants and young children and baby food.

(3)

(4) This category includes also similar products otherwise denominated such as semolina.
(5) Processed cereal-based foods for infants and young children and baby food as defined in Article 1 of Commission Directive 96/5/EC of 16 February 1996 on processed
cereal-based foods and baby foods for infants and young children (OJ L 49, 28.2.1996, p. 17) as last amended by Directive 2003/13/EC (OJ L 41, 14.2.2003, p. 33).
The maximum level for processed cereal-based foods and baby food for infants and young children refers to the dry matter.

Product (2)

Maximum level
(μg/kg)

Sampling method

Reference analysis method

2.7. T-2 AND HT-2 TOXIN (1)

2.7.1. Unprocessed cereals (3) and cereal products

— (4)

Directive 2005/38/EC

Directive 2005/38/EC

(1) The maximum level refers to the sum of T-2 and HT-2 toxin.
(2) For the purpose of the application of maximum levels of deoxynivalenol, zearalenone, fumonisins B1 and B2, T-2 and HT-2 toxin established in points 2.4, 2.5, 2.6 and

2.7 only, rice is not included in “cereals” and rice products not included in “cereal products”.

(3) The maximum levels set for “unprocessed cereals” applies to cereals placed on the market for first-stage processing.

“First-stage processing” shall mean any physical or thermal treatment, other than drying, of or on the grain. Cleaning, sorting and drying procedures are not considered to
be “first stage processing” insofar as no physical action is exerted on the grain kernel itself and the whole grain remains intact after cleaning and sorting.

(4) A maximum level will be fixed, if appropriate, before 1 July 2007.

Data on the presence of T-2 and HT-2 toxin are for the time being limited. However, intake estimates indicate clearly that the presence of T-2 and HT-2 can be of
concern for public health. Therefore, the development of a sensitive method, collection of more occurrence data and more investigations/research in the factors involved
in the presence of T-2 and HT-2 in cereal and cereal products particularly in oats and oat products is necessary and of high priority.’