Commission Regulation (EC) No 1525/98 of 16 July 1998 amending Regulation (EC) No 194/97 of 31 January 1997 setting maximum levels for certain contaminants in foodstuffs (Text with EEA relevance)
Date: 1998-07-16
Institutions: European Commission
Subjects: chemical salt, food contamination, food standard, human nutrition, leaf vegetable, toxic substance

17. 7. 98

‹

EN

‹

Official Journal of the European Communities

L 201/43

COMMISSION REGULATION (EC) No 1525/98

of 16 July 1998

amending Regulation (EC) No 194/97 of 31 January 1997 setting maximum levels
for certain contaminants in foodstuffs

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

as well as proper functioning of the single market with
regard to such products;

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

Whereas some Member States have adopted, or plan to
adopt, maximum levels for aflatoxins in certain foodstuffs;

in view of

Whereas,
the disparities between Member
States and the consequent risk of distortion of competi-
tion, Community measures are necessary in order to
ensure market unity while abiding by the principle of
proportionality;

Whereas consequently Commission Regulation (EC) No
194/97 of 31 January 1997 setting maximum levels for
certain contaminants in foodstuffs (2) has to be added to;

Whereas aflatoxins are mycotoxins produced by certain
species of Aspergillus, which develop at high temper-
atures and humidity levels; whereas aflatoxins may be
present in a large number of foods;

Whereas aflatoxins, in particular aflatoxin B1, are geno-
toxic carcinogenic substances; whereas for substances of
this type there is no threshold below which no harmful
effect is observed; whereas no admissible daily intake can
therefore be set; whereas current scientific and technical
knowledge and improvements in production and storage
these
techniques do not prevent
moulds and consequently do not enable the presence of
the aflatoxins in food to be eliminated entirely; whereas it
is, therefore, advisable to set limits as low as possible;

the development of

Whereas rules have to be set concerning the maximum
limits which are acceptable in single dried and/or
processed agricultural products and in compound food-
stuffs in order to ensure proper human health protection

(1) OJ L 37, 13. 2. 1993, p. 1.
(2) OJ L 31, 1. 2. 1997, p. 48.

Whereas efforts to improve production, harvesting and
storage methods in order to reduce the development of
moulds should be encouraged;

Whereas the aflatoxins group includes a number of
compounds of varying toxicity and frequency in food;
whereas aflatoxin B1 is by far the most toxic compound;
whereas it is advisable, for safety reasons, to limit both the
total aflatoxin content of food (compounds B1, B2, G1
and G2) and aflatoxin B1 content;

Whereas aflatoxin M1 is a metabolic product of aflatoxin
in milk and milk products from
B1, and is present
animals which have
consumed contaminated feed;
whereas even if aflatoxin M1 is regarded as a less dan-
gerous genotoxic carcinogenic substance than aflatoxin
B1, it is necessary to prevent the presence thereof in milk
and milk products intended for human consumption and
for young children in particular;

Whereas it is recognised that the sorting or other physical
treatment methods make it possible to reduce the afla-
toxin content of the groundnuts, nuts and dried fruit; that
in order to minimise the effects on trade, it is advisable
consequently to admit higher aflatoxin contents for those
products which are not
intended for direct human
consumption or as an ingredient in foodstuffs; that, in
these cases, the maximum limits for aflatoxins were fixed
by taking at the same time into consideration the known
possible effects of the abovementioned treatments respec-
tively for the groundnuts, the nuts and the dried fruit and
the need to comply after treatment with the maximum
limits fixed for these products intended for direct human
consumption or to be used as an ingredient in foodstuffs.
That according to the progress of scientific and technolo-
gical knowledge, the limits for the raw nuts and dried
fruit could be reconsidered within a defined period of
time;

Whereas in the case of the cereals, it cannot be excluded
that sorting methods or other physical treatments can
reduce the level of contamination of aflatoxins; that in
order to be able to check the real effectiveness of these
methods and, if necessary, to fix specific maximum limits

L 201/44

‹

EN

‹

Official Journal of the European Communities

17. 7. 98

for the unprocessed cereals, it is foreseen for a limited
period to apply the maximum limits as laid down in the
Annex only for the cereals and processed products thereof
intended for direct human consumption or as an ingre-
dient in foodstuffs; that in the absence of data justifying
the fixing of a specific maximum limit for unprocessed
cereals, after a well-defined period of time, the maximum
limit laid down for the cereals and the processed products
thereof intended for direct human consumption or as an
ingredient of food, will also apply to the unprocessed
cereals;

either as such, after mixture with other foodstuffs or as an
ingredient in other foodstuffs;

Whereas under Article 5 of Regulation (EEC) No 315/93,
Member States may maintain their national provisions
concerning the maximum limits for aflatoxins in certain
foodstuffs for which no Community provisions have been
adopted;

Whereas it suffices for the moment to lay down general
provisions
for processed and compound foodstuffs;
in
whereas
processed and compound foodstuffs could be fixed in case
of need;

specific maximum limits

aflatoxins

for

Whereas to allow effective control of the respect of the
it is
various limits fixed for the products in question,
appropriate to know the exact destination by suitable
labelling;

Whereas the Scientific Committee for Food has been
consulted,
in accordance with Article 3 of Regulation
(EEC) No 315/93, on the provisions liable to affect public
health;

Whereas products with levels of aflatoxin exceeding the
into circulation,
maximum limit may not be brought

Whereas the measures provided for in this Regulation are
in accordance with the opinion of
the Standing
Committee on Foodstuffs,

HAS ADOPTED THIS REGULATION:

Article 1

Regulation (EC) No 194/97 is amended as follows:

1. Article 2(1) is replaced by the following:

‘1.

(a) The products indicated in the Annex to this Regulation must not, when placed
on the market, contain higher contaminant levels than those specified therein.

(b) The maximum limits applicable to the products, as laid down in points I.2.1.1.1
and I.2.1.2.1 of the Annex shall also be applicable to processed products thereof
in so far as no specific maximum limits are fixed for such processed products.

(c) For milk products which are dried, processed or composed of more than one
ingredient, the maximum limit applicable shall be that laid down in point
I.2.1.3 of the Annex for milk, taking into account respectively the concentration
caused by the drying process, by processing or the relative concentrations of the
ingredients in the product, in so far as no specific maximum limits are fixed for
these dried, processed or compound milk products.’

2. In Article 2, paragraphs 4 and 5 are added as follows:

‘4. With regard to the products mentioned at point I.2.1 of the Annex, it is pro-
hibited:

— to mix products complying with the maximum limits laid down in the Annex with
products exceeding these maximum limits or to mix products to be subjected to a
sorting technique or physical treatment with products intended for direct human
consumption or as an ingredient in foodstuffs,

— to use products which do not comply with the maximum limits laid down in point
I.2.1.1.1, I.2.1.2.1 and I.2.1.3 as an ingredient for the manufacture of other food-
stuffs,

— to detoxify products by chemical treatments.

17. 7. 98

‹

EN

‹

Official Journal of the European Communities

L 201/45

5.
Groundnuts, nuts and dried fruit not complying with the maximum limits laid
down in point I.2.1.1.1 of the Annex and cereals not complying with the maximum
limits laid down in point I.2.1.2.1 can be placed on the market provided that:

(a) these products:

— are not intended for direct human consumption or use as an ingredient in food-

stuffs,

— comply with the maximum limits laid down in point I.2.1.1.2 of the Annex for
groundnuts and point I.2.1.1.3 of the Annex for nuts and dried fruit, and

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

(b) the destination of these products is demonstrated clearly by labelling comprising
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”’.

3. The following text is inserted under point I ‘Agricultural contaminants’ of the Annex:

‘2.

Mycotoxins

2.1.

Aflatoxins

Products

2.1.1.

Groundnuts, nuts and dried fruit

2.1.1.1. Groundnuts, nuts and dried fruit and
processed products thereof, intended for
direct human consumption or as an
ingredient in foodstuffs

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

2.1.1.3. Nuts and dried fruit to be subjected to
treatment,
sorting, or other physical
before human consumption or use as
an ingredient in foodstuffs

Aflatoxins: maximum admissible
levels (1)
(lg/kg)

B1

B1 + B2 + G1 + G2

M1

Sampling
method

Reference
analysis method

2 (4)

4 (4)

—

Directive 98/53/EC
(*)

Directive 98/53/EC

8 (4)

15 (4)

—

Directive 98/53/EC Directive 98/53/EC

5 (4) (5)

10 (4) (5)

—

Directive 98/53/EC Directive 98/53/EC

L 201/46

‹

EN

‹

Official Journal of the European Communities

17. 7. 98

Products

Aflatoxins: maximum admissible
levels (1)
(lg/kg)

B1

B1 + B2 + G1 + G2

M1

Sampling
method

Reference
analysis method

2.1.2.

Cereals
pyrum sp.)

(including buckwheat, Fago-

2

4

—

Directive 98/53/EC Directive 98/53/EC

— (6)

— (6)

—

Directive 98/53/EC Directive 98/53/EC

—

—

0,05

Directive 98/53/EC Directive 98/53/EC

2.1.2.1. Cereals

(including buckwheat, Fago-
and processed products
intended for direct human
in

pyrum sp.)
thereof
consumption or as an ingredient
foodstuffs

2.1.2.2. Cereals

(including buckwheat, Fago-
pyrum sp.) to be subjected to sorting, or
other physical treatment, before human
consumption or use as an ingredient in
foodstuffs

2.1.3.

Milk (raw milk, milk for the manufac-
ture of milk-based products and heat-
treated milk as defined by Council
Directive 92/46/EEC of 16 June 1992
laying down the health rules for the
production and placing on the market
of
raw milk, heat-treated milk and
milk-based products)

(4) The maximum limits apply to the edible part of groundnuts, nuts and dried fruits. If nuts ‘in shell’ are analysed, it is assumed when calculating the afla-

toxin content, all the contamination is on the edible part.

(5) The maximum limits shall be reconsidered before 1 July 1999 according to the progress of scientific and technological knowledge.
(6)

In as far as no specific limit will be fixed before 1 July 1999, the limits laid down in point 2.1.2.1 of the table will apply thereafter to the cereals referred
to in this point.

(*) See page 93 of this Official Journal.’

Article 2

This Regulation shall enter into force on the 20th day following its publication in the
Official Journal of the European Communities.

It shall apply from 1 January 1999.

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

Done at Brussels, 16 July 1998.

For the Commission

Franz FISCHLER

Member of the Commission