Commission Directive 2003/121/EC of 15 December 2003 amending Directive 98/53/EC laying down the sampling methods and the methods of analysis for the official control of the levels for certain contaminants in foodstuffs (Text with EEA relevance)
Date: 2003-12-15
Institutions: European Commission
Subjects: food inspection, foodstuff, foodstuffs legislation, human nutrition, toxic substance

L 332/38

EN

Official Journal of the European Union

19.12.2003

COMMISSION DIRECTIVE 2003/121/EC

of 15 December 2003

amending Directive 98/53/EC laying down the sampling methods and the methods of analysis for
the official control of the levels for certain contaminants in foodstuffs

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

HAS ADOPTED THIS DIRECTIVE:

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 85/591/EEC of 20
December 1985 concerning the introduction of Community
methods of sampling and analysis for the monitoring of food-
stuffs intended for human consumption (1), and in particular
Article 1 thereof,

Whereas:

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), fixes specific maximum limits for maize
to be subjected to sorting, or other physical treatment,
before human consumption or use as an ingredient in
foodstuffs.

Sampling plays a crucial part in the precision of the
determination of the levels of aflatoxins, which are very
heterogeneously distributed in a lot. Commission Direc-
tive 98/53/EC (4), as amended by Directive 2002/27/
EC (5), should be amended to include specific provisions
for maize to be subjected to sorting, or other physical
treatment, before human consumption or use as an
ingredient in foodstuffs.

It
is of major importance that analytical results are
reported and interpreted in a uniform way in order to
ensure a harmonised enforcement approach across the
Union. These interpretation rules should be of applica-
tion for the analytical result obtained on the sample for
official control. In case of analysis for defence or referee
purposes, the national rules apply.

(1)

(2)

(3)

(4)

(5)

Article 1

Annex I to Directive 98/53/EC is amended as set out in Annex
I to this Directive.

Annex II to Directive 98/53/EC is amended as set out in Annex
II to this Directive.

Article 2

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
Directive by 31 October 2004 at the latest. They shall forth-
with communicate to the Commission the text of those provi-
sions and a correlation table between those provisions and this
Directive.

When Member States adopt those provisions, they shall contain
a reference to this Directive or be accompanied by such a refer-
ence on the occasion of their official publication. Member
States shall determine how such reference is to be made.

2. Member States shall communicate to the Commission the
texts of the provisions of national law which they adopt in the
field governed by this Directive.

Article 3

This Directive shall enter into force on the 20th day following
that of its publication in the Official Journal of the European
Union.

This Directive is addressed to the Member States.

Article 4

Directive 98/53/EC should therefore be amended accord-
ingly.

Done at Brussels, 15 December 2003.

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

For the Commission

David BYRNE

Member of the Commission

(1) OJ L 372, 31.12.1985, p. 50.
(2) OJ L 77, 16.3.2001, p. 1.
(3) OJ L 203, 12.8.2003, p. 1.
(4) OJ L 201, 17.7.1998, p. 93.
(5) OJ L 75, 16.3.2002, p. 44.

19.12.2003

EN

Official Journal of the European Union

L 332/39

Annex I to Directive 98/53/EC is amended as follows:

1.

in point 5.2.1, the fourth indent is replaced by the following:

ANNEX I

‘— weight of the aggregate sample = 30 kg which has to be mixed and to be divided into three equal subsamples
of 10 kg before grinding (this division into three subsamples is not necessary in the case of groundnuts, nuts,
dried fruit and maize intended for further sorting or other physical treatment, however, this will depend upon
the availability of equipment which is able to homogenise a 30 kg sample). In cases where the aggregate sample
weights are under 10 kg, the aggregate sample must not be divided into three subsamples. In the case of spices
the aggregate sample weighs not more than 10 kg and therefore no division in subsamples is necessary.’;

2. point 5.2.2 is replaced by the following:

‘5.2.2. Acceptance of a lot or sublot

— For groundnuts, nuts, dried fruit and maize subjected to a sorting or other physical treatment and spices:

— acceptance if the aggregate sample or the average of the subsamples conforms to the maximum limit,

taking into account the measurement uncertainty and correction for recovery,

— rejection if the aggregate sample or the average of the subsamples exceeds the maximum limit beyond

reasonable doubt taking into account the measurement uncertainty and correction for recovery.

— For groundnuts, nuts, dried fruit and cereals intended for direct human consumption and cereals, with the

exception of maize, to be subjected to a sorting or other physical treatment:
— acceptance if none of the subsamples exceeds the maximum limit, taking into account the measure-

ment uncertainty and correction for recovery,

— rejection if one or more of the subsamples exceeds the maximum limit beyond reasonable doubt

taking into account the measurement uncertainty and correction for recovery,

— where the aggregate sample is under 10 kg:

— acceptance if the aggregate sample conforms to the maximum limit, taking into account the

measurement uncertainty and correction for recovery,

— rejection if the aggregate sample exceeds the maximum limit beyond reasonable doubt taking into

account analytical uncertainty and correction for recovery.’;

3. point 5.4.2 is replaced by the following:

‘5.4.2. Acceptance of a lot or sublot

— acceptance if the aggregate sample conforms to the maximum limit, taking into account the measurement

uncertainty and correction for recovery,

— rejection if the aggregate sample exceeds the maximum limit beyond reasonable doubt taking into account

the measurement uncertainty and correction for recovery.’;

4. point 5.5.1.2 is replaced by the following:

‘5.5.1.2. Acceptance of a lot or sublot

— acceptance if the aggregate sample conforms to the maximum limit, taking into account the measure-

ment uncertainty and correction for recovery,

— rejection if the aggregate sample exceeds the maximum limit beyond reasonable doubt taking into

account the measurement uncertainty and correction for recovery.’;

5. point 5.5.2.3 is replaced by the following:

‘5.5.2.3. Acceptance of a lot or sublot

— acceptance if the aggregate sample conforms to the maximum limit, taking into account the measure-

ment uncertainty and correction for recovery,

— rejection if the aggregate sample exceeds the maximum limit beyond reasonable doubt taking into

account the measurement uncertainty and correction for recovery.’

L 332/40

EN

Official Journal of the European Union

19.12.2003

In Annex II to Directive 98/53/EC, point 4.4 is replaced by the following:

‘4.4. Recovery calculation and reporting of results

ANNEX II

The analytical result is to be reported corrected or uncorrected for recovery. The manner of reporting and the level
of recovery must be reported. The analytical result corrected for recovery is used for checking compliance (see
Annex I, points 5.2.2, 5.3.2, 5.4.2, 5.5.1.2 and 5.5.2.3).

The analytical result has to be reported as x +/- U whereby x is the analytical result and U is the expanded measure-
ment uncertainty, using a coverage factor of 2 which gives a level of confidence of approximately 95 %.’