Commission Regulation (EC) No 2174/2003 of 12 December 2003 amending Regulation (EC) No 466/2001 as regards aflatoxins (Text with EEA relevance)
Date: 2003-12-12
Institutions: European Commission
Subjects: consumer protection, food contamination, food standard, foodstuff, public health, toxic substance

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Official Journal of the European Union

13.12.2003

COMMISSION REGULATION (EC) No 2174/2003

of 12 December 2003

amending Regulation (EC) No 466/2001 as regards aflatoxins

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

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:

(1)

(2)

(3)

Commission Regulation (EC) No 466/2001 of 8 March
2001 setting maximum levels for certain contaminants
in foodstuffs (2), as last amended by Regulation (EC) No
1425/2003 (3), establishes maximum levels for aflatoxin
B1 and aflatoxin total in certain foodstuffs.

Regulation (EC) No 466/2001 provides that in so far as
no specific level was fixed for maize to be subjected to
sorting, or other physical
treatment, before human
consumption or use as an ingredient in foodstuffs before
1 July 2003, the levels established for cereals intended
for direct consumption would apply thereafter. The
reason for this was that, in the case of maize, it cannot
be excluded that sorting methods or other physical treat-
ments reduce the level of contamination of aflatoxins
but the real effectiveness of these methods remains to be
demonstrated. It was also provided that, in the absence
of data justifying the fixing of a specific maximum level
for unprocessed cereals, the levels of 2 µg/kg aflatoxin
B1 and 4 µg/kg aflatoxin total were to apply.

it

In that connection, data with regard to maize have been
submitted. On the basis of the submitted data,
is
evident that through the various sorting and physical
treatments the aflatoxin content of unprocessed maize
can be significantly reduced after cleaning in the final
consumer product (flaking grits, other grits). The afla-
toxin contamination was mainly concentrated in the
screenings (waste) and in maize germ, bran meal and
broken maize (products for animal feed). While it is not
possible to assess precisely quantitatively and with
certainty to what extent this reduction can be achieved,
it is evident from the data available that the different
cleaning and processing steps are sufficiently effective in
removing aflatoxins from maize products destined for

(1) OJ L 37, 13.2.1993, p. 1.
(2) OJ L 77, 16.3.2001, p. 1.
(3) OJ L 203, 12.8.2003, p. 1.

human consumption whereby raw maize containing
levels of aflatoxin B1 of 5 µg/kg and aflatoxin total of
10 µg/kg will result
in maize products destined for
human consumption complying with the maximum
levels of aflatoxin B1 of 2 µg/kg and aflatoxin total of
4 µg/kg, providing a high level consumer protection.

(4)

(5)

(6)

It appears that some food control enforcers and analysts,
when reporting the analytical
result, use the same
number of significant figures in which the maximum
level in legislation is expressed.

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

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

HAS ADOPTED THIS REGULATION:

Article 1

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

1. In Article 4, paragraph 3 is replaced by the following:

‘3.
Groundnuts, nuts and dried fruit not complying with
the maximum levels of aflatoxins laid down in point 2.1.1.1
of Annex I and maize not complying with the maximum
levels laid down in point 2.1.2.1 of that Annex can be
placed on the market provided that these products:

(a) are not intended for direct human consumption or used

as an ingredient in foodstuffs;

(b) comply with the maximum levels laid down in point
2.1.1.2 of Annex I for groundnuts, in point 2.1.1.3 of
Annex I for nuts and dried fruit and in point 2.1.2.3 of
Annex I for maize;

(c) are subjected to a secondary treatment involving sorting
or other physical treatment and that after this treatment
the maximum limits laid down in points 2.1.1.1 and
2.1.2.1 of Annex I are not exceeded, and this treatment
does not result in other harmful residues;

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(d) are labelled clearly showing their destination, and bearing the indication “product must be
subjected to sorting or other physical treatment to reduce aflatoxin contamination before
human consumption or use as an ingredient in foodstuffs”.’

2. Annex I is amended as set out in the Annex to this Regulation.

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

Article 2

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

Done at Brussels, 12 December 2003.

For the Commission

David BYRNE

Member of the Commission

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Official Journal of the European Union

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

ANNEX

1. In Section 2 (Mycotoxins), point 2.1 (Aflatoxins) is replaced by the following:

Maximum level aflatoxin (µg/kg)

B1

(B1 + B2 +
G1 + G2)

M1

Sampling
method

Performance
criteria for
methods of
analysis

Product

‘2.1.

AFLATOXINS

2.1.1. Groundnuts, nuts and dried fruit

2.1.1.1. Groundnuts, nuts and dried fruit
and processed products thereof,
intended
human
consumption or use as an ingre-
dient in foodstuffs

direct

for

2,0 (6)

4,0 (6)

—

Directive
98/53/EC

Commis-
sion Direc-
tive 98/53/
EC (7)

2.1.1.2. Groundnuts to be subjected to
treat-
sorting, or other physical
ment, before human consumption
or use as an ingredient in food-
stuffs

8,0 (6)

15,0 (6)

—

Directive
98/53/EC

Directive
98/53/EC

2.1.1.3. Nuts

and

fruit

dried

to be
subjected to sorting, or other
physical treatment, before human
consumption or use as an ingre-
dient in foodstuffs

2.1.2.

Cereals
Fagopyrum sp)

(including

buckwheat,

2.1.2.1. Cereals

(including

buckwheat,
processed
Fagopyrum sp)
products
intended for
direct human consumption or use
as an ingredient in foodstuffs

thereof

and

2.1.2.2. Cereals

to be

(including

buckwheat,
Fagopyrum sp), with the exception
subjected to
of maize,
sorting, or other physical
treat-
ment, before human consumption
or use as an ingredient in food-
stuffs

5,0 (6)

10,0 (6)

—

Directive
98/53/EC

Directive
98/53/EC

2,0

4,0

—

Directive
98/53/EC

Directive
98/53/EC

2,0

4,0

—

Directive
98/53/EC

Directive
98/53/EC

2.1.2.3. Maize to be subjected to sorting,
or
treatment,
physical
before human consumption or
use as an ingredient in foodstuffs

other

5,0

10,0

—

Directive
98/53/EC

Directive
98/53/EC

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Maximum level aflatoxin (µg/kg)

B1

—

(B1 + B2 +
G1 + G2)

—

M1

0,05

Sampling
method

Performance
criteria for
methods of
analysis

Directive
98/53/EC

Directive
98/53/EC

5,0

10,0

—

Directive
98/53/EC

Directive
98/53/EC

Product

2.1.3. Milk (raw milk, milk for

of milk

the
manufacture
based
products and heat-treated milk as
defined by Council Directive 92/
46/EC (10) as
last amended by
Regulation (EC) No 806/2003 (11)

2.1.4.

Following species of spices:
— Capsicum spp.

(dried fruits
ground,
thereof, whole or
including
chilli
chillies,
powder, cayenne and paprika)
thereof,
and black

spp.
including white
pepper)

(fruits

— Piper

— Myristica fragrans (nutmeg)
— Zingiber officinale (ginger)
— Curcuma longa (turmeric)

(6) The maximum levels apply to the edible part of groundnuts, nuts and dried fruits. If nuts “in shell” are analysed, it is assumed

when calculating the aflatoxin content all the contamination is on the edible part.

(7) OJ L 201, 17.7.1998, p. 93.
(10) OJ L 268, 14.9.1992, p. 1.
(11) OJ L 122, 16.5.2003, p. 1.’

2. Footnote 9 is deleted.