Commission Regulation (EC) No 1126/2007 of 28 September 2007 amending Regulation (EC) No 1881/2006 setting maximum levels for certain contaminants in foodstuffs as regards Fusarium toxins in maize and maize products (Text with EEA relevance)
Date: 2007-09-28
Institutions: European Commission
Subjects: cereal product, food contamination, food safety, foodstuff, maize, toxic substance

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Official Journal of the European Union

29.9.2007

COMMISSION REGULATION (EC) No 1126/2007

of 28 September 2007

amending Regulation (EC) No 1881/2006 setting maximum levels for certain contaminants in
foodstuffs as regards Fusarium toxins in maize and maize products

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(4)

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 in food (1), and in particular Article 2(3) thereof,

Whereas:

(5)

(6)

(7)

(1)

(2)

(3)

Commission Regulation (EC) No 1881/2006 of 19
for certain
December 2006 setting maximum levels
contaminants in foodstuffs (2) sets maximum levels for
Fusarium toxins in certain foodstuffs.

Maximum levels should be set at a strict level which is
reasonably achievable by following good agricultural and
manufacturing practices and taking into account the risk
related to the consumption of the food.

in particular at
Climatic conditions during the growth,
flowering, have a major influence on the Fusarium toxin
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.
Commission Recommendation 2006/583/EC of 17
August 2006 on the prevention and reduction of
Fusarium toxins
and cereal products (3),
including maize and maize products contains general
principles for the prevention and reduction of Fusarium
toxin contamination
and
trichothecenes)
in cereals to be implemented by the
development of national codes of practice based on
these principles.

(zearalenone,

fumonisins

in cereals

(1) OJ L 37, 13.2.1993, p. 1. Regulation as amended by Regulation
the

the European Parliament and of

(EC) No 1882/2003 of
Council (OJ L 284, 31.10.2003, p. 1).

(2) OJ L 364, 20.12.2006, p. 5.
(3) OJ L 234, 29.8.2006, p. 35.

Maximum levels were established in 2005 for Fusarium
toxins in cereals and cereal products,
including maize
and maize products. For maize, not all factors involved
in the formation of Fusarium toxins, in particular zeara-
lenone and fumonisins B1 and B2, were precisely known.
the maximum levels in maize and maize
Therefore,
products were foreseen to apply only from 1 July
2007 for deoxynivalenol ad zearalenone and from 1
October 2007 for fumonisins B1 and B2,
in case no
changed maximum levels based on new information on
occurrence and formation are set before that time. This
time period enabled food business operators in the cereal
chain to perform investigations on the sources of the
formation of these mycotoxins and on the identification
of the management measures to be taken to prevent their
presence as far as reasonably possible.

Taking into account new information since 2005,
it
appears necessary to amend the maximum levels in
maize and maize products as well as the date of appli-
cation of these levels.

Recent
information has been provided demonstrating
that for the harvest 2005 and 2006 higher levels have
been observed in maize than for the harvest 2003 and
2004 of mainly zearalenone and fumonisins and to a
linked to the weather
lesser extent deoxynivalenol,
for zearalenone and
conditions. The foreseen levels
certain weather
fumonisins
are
conditions not
even when
applying prevention measures to the extent possible.
Therefore the maximum levels need to be amended in
order to avoid a disruption of the market whilst main-
taining a high level of public health protection by
ensuring that human exposure will remain significantly
below the health based guidance value.

under
for maize,

therefore
achievable

In order to ensure a correct and smooth application of
these maximum levels,
it is also appropriate that they
apply to all maize and maize products harvested in a
season and therefore the date of application should
reflect
the
next harvest year. As the harvest of maize in Europe
starts usually mid-September and runs until the end of
October, it is appropriate to take 1 October 2007 as date
of application.

the marketing season of

the beginning of

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(8)

(9)

(10)

(11)

In the light of the foregoing this Regulation should apply
from 1 July 2007.

(12)

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

opinion

the

the

of

In addition, a number of minor technical changes should
also be made.

HAS ADOPTED THIS REGULATION:

It is appropriate to provide that the maximum level does
not apply to the unprocessed maize intended to be
processed by wet milling (starch production).
Indeed,
scientific data have shown that regardless the levels of
Fusarium toxins present in unprocessed maize, Fusarium
toxins were not detected or only at very low levels in
in order to
starch produced from maize. Nevertheless,
protect public
food business
operators in the wet milling sector should intensively
monitor the by-products from the wet milling process
destined for animal feeding to check compliance with
the guidance values referred in Commission Recommen-
dation 2006/576/EC of 17 August 2006 on the presence
of deoxynivalenol, zearalenone, ochratoxin A, T-2 and
HT-2 and fumonisins in products intended for animal
feeding (1).

animal health,

and

The dry milling process results in milling fractions with
different particle size from the same batch of unpro-
cessed maize. Scientific data show that
the milling
fractions with smaller particle size contain a higher
level of Fusarium toxins than the milling fractions with
a larger particle size. Maize milling fractions are classified
according to the particle size in different headings in the
Combined Nomenclature based upon a rate of passage
through a sieve with an aperture of 500 microns.
Different maximum levels for milling fractions smaller
and larger than 500 microns should be set to reflect
the contamination level of the different fractions.

Article 1

Regulation (EC) No 1881/2006 is amended as follows:

1. Article 11, point (b) is replaced by the following:

‘(b) 1 October 2007 as regards the maximum levels for
deoxynivalenol and zearalenone laid down in points
2.4.3, 2.4.8, 2.4.9, 2.5.2, 2.5.4, 2.5.6, 2.5.8, 2.5.9 and
2.5.10 of the Annex;’

2. The Annex, Section 2 is amended as follows:

(a) The entries for Deoxynivalenol (2.4), Zearalenone (2.5),
and Fumonisins (2.6) are replaced by the entries in the
Annex to this Regulation.

(b) The text of footnote 20 is replaced by ‘Maximum level

shall apply from 1 October 2007.’

(c) The footnote 21 is deleted.

Article 2

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

It shall apply from 1 July 2007.

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

Done at Brussels, 28 September 2007.

For the Commission

Markos KYPRIANOU
Member of the Commission

(1) OJ L 229, 23.8.2006, p. 7.

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‘2.4

2.4.1

2.4.2

2.4.3

2.4.4

2.4.5

2.4.6

2.4.7

2.4.8

2.4.9

2.5

2.5.1

2.5.2

2.5.3

2.5.5

2.5.6

2.5.7

ANNEX

Deoxynivalenol (17)

Unprocessed cereals (18) (19) other than durum wheat, oats and maize

Unprocessed durum wheat and oats (18) (19)

1 250

1 750

Unprocessed maize (18), with the exception of unprocessed maize intended to be
processed by wet milling (*)

1 750 (20)

Cereals intended for direct human consumption, cereal flour, bran and germ as end
product marketed for direct human consumption, with the exception of foodstuffs
listed in 2.4.7, 2.4.8 and 2.4.9

Pasta (dry) (22)

Bread (including small bakery wares), pastries, biscuits, cereal snacks and breakfast
cereals

750

750

500

Processed cereal-based foods and baby foods for infants and young children (3) (7)

200

Milling fractions of maize with particle size > 500 micron falling within CN code
1103 13 or 1103 20 40 and other maize milling products with particle size > 500
micron not used for direct human consumption falling within CN code 1904 10 10

Milling fractions of maize with particle size ≤ 500 micron falling within CN code
1102 20 and other maize milling products with particle size ≤ 500 micron not used
for direct human consumption falling within CN code 1904 10 10

Zearalenone (17)

Unprocessed cereals (18) (19) other than maize

Unprocessed maize (18) with the exception of unprocessed maize intended to be
processed by wet milling (*)

Cereals intended for direct human consumption, cereal flour, bran and germ as end
product marketed for direct human consumption, with the exception of foodstuffs
listed in 2.5.6, 2.5.7, 2.5.8, 2.5.9 and 2.5.10

750 (20)

1 250 (20)

100

350 (20)

75

400 (20)

50

100 (20)

2.5.4

Refined maize oil

Bread (including small bakery wares), pastries, biscuits, cereal snacks and breakfast
cereals, excluding maize-snacks and maize-based breakfast cereals

Maize intended for direct human consumption, maize-based snacks and maize-based
breakfast cereals

Processed cereal-based foods (excluding processed maize-based foods) and baby
foods for infants and young children (3) (7)

20

2.5.8

Processed maize-based foods for infants and young children (3) (7)

20 (20)

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2.5.9

2.5.10

2.6

2.6.1

2.6.2

2.6.3

2.6.4

2.6.5

2.6.6

Milling fractions of maize with particle size > 500 micron falling within CN code
1103 13 or 1103 20 40 and other maize milling products with particle size > 500
micron not used for direct human consumption falling within CN code 1904 10 10

Milling fractions of maize with particle size ≤ 500 micron falling within CN code
1102 20 and other maize milling products with particle size ≤ 500 micron not used
for direct human consumption falling within CN code 1904 10 10

200 (20)

300 (20)

Fumonisins

Sum of B1 and B2

Unprocessed maize (18), with the exception of unprocessed maize intended to be
processed by wet milling (*)

Maize intended for direct human consumption, maize-based foods for direct human
consumption, with the exception of foodstuffs listed in 2.6.3 and 2.6.4

Maize-based breakfast cereals and maize-based snacks

4 000 (23)

1 000 (23)

800 (23)

Processed maize-based foods and baby foods for infants and young children (3) (7)

200 (23)

Milling fractions of maize with particle size > 500 micron falling within
CN code 1103 13 or 1103 20 40 and other maize milling products with particle
size > 500 micron not used for direct human consumption falling within CN code
1904 10 10

Milling fractions of maize with particle size ≤ 500 micron falling within CN code
1102 20 and other maize milling products with particle size ≤ 500 micron not used
for direct human consumption falling within CN code 1904 10 10

1 400 (23)

2 000 (23)

(*) The exemption applies only for maize for which it is evident e.g. through labelling, destination, that it is intended for use in a wet

milling process only (starch production).’