Commission Recommendation of 25 January 2002 concerning a coordinated programme for the official control of foodstuffs for 2002 (Text with EEA relevance) (notified under document number C(2002) 290)
Date: 2002-01-25
Institutions: European Commission
Subjects: action programme, food inspection, genetically modified organism, product safety, quality control of agricultural products

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(Acts whose publication is not obligatory)

COMMISSION

COMMISSION RECOMMENDATION

of 25 January 2002

concerning a coordinated programme for the official control of foodstuffs for 2002

(notified under document number C(2002) 290)

(Text with EEA relevance)

(2002/66/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

HEREBY RECOMMENDS:

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 89/397/EEC of 14 June
1989 on the official control of foodstuffs (1), and in particular
Article 14(3) thereof,

After consultation of the Standing Committee for Foodstuffs,

Whereas:

It is necessary, with a view to the sound operation of the
internal market, to arrange for coordinated food inspec-
tion programmes at Community level designed to
improve the harmonised implementation of the official
controls by the Member States.

1. During 2002 Member States should carry out inspections
and controls including, where indicated, taking samples and
analysing such samples in laboratories, with the aim of:

— monitoring compliance with the Community rules on
labelling of certain foodstuffs that may contain ingredi-
ents, which may themselves contain, consist of or may
be produced from genetically modified organisms
(GMOs),

— assessing the bacteriological safety of pre-cut fresh fruits

and vegetables and of sprouted seeds,

— assessing the bacteriological safety of fruit and vegetable

juices.

Such programmes place emphasis on compliance with
Community legislation, the protection of public health,
consumer interests and fair trade practices.

2. Although sampling and/or inspection rates have not been
set in this recommendation, Member States should ensure
that they are sufficient to provide an overview of the subject
under consideration in each Member State.

Article 3 of Council Directive 93/99/EEC of 29 October
1993 on the subject of additional measures concerning
the official control of foodstuffs (2) requires the labora-
tories referred to in Article 7 of Directive 89/397/EEC to
in European Standard
comply with the
EN
EN 45000
ISO 17025:2000.

criteria
now

replaced

series,

by

results

from simultaneous

The
implementation of
national programmes and coordinated programmes may
provide information and experience on which to base
future control activities,

(1) OJ L 186, 30.6.1989, p. 23.
(2) OJ L 290, 24.11.1993, p. 14.

3. Member States should provide information as requested
following the format of the record sheets provided in the
Annex to this Recommendation to help enhance the
comparability of results. This information should be sent to
the Commission by 1 May 2003 accompanied by an expla-
natory report.

4. Foodstuffs submitted for analysis under this programme
should be submitted to laboratories complying with the
provisions of Article 3 of Directive 93/99/EEC. However, if
such laboratories do not exist in Member States for certain
analysis included in this Recommendation, Member States
may also nominate other laboratories providing the capacity
to carry out these analyses.

(1)

(2)

(3)

(4)

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5. Labelling of genetically modified foodstuffs

contamination (during cultivation, harvest, transport or
processing).

5.1. Scope of the programme

Genetically modified foodstuffs and in particular the
proper labelling of such products, are very much the
subject of consumer concerns. The coordinated control
of the labelling of food that may contain ingredients,
which may themselves contain, consist of or may be
produced from GMOs, will contribute to build up
consumer confidence.

Regulation (EC) No 258/97 of the European Parliament
and of the Council of 27 January 1997 on novel foods
and novel food ingredients (1) provides for the manda-
tory labelling of
foods and food ingredients which
contain or consist of a GMO without prejudice to the
other labelling requirements of Community law.

Council Regulation (EC) No 1139/98 of 26 May 1998,
concerning the compulsory indication of the labelling
of certain foodstuffs produced from genetically modi-
fied organisms of particulars other than those provided
for in Directive 79/112/EEC (2), lays down the compul-
sory labelling of foods and food ingredients produced
from genetically modified soya (Glycine max L.) covered
by Commission Decision 96/281/EC (3) and genetically
modified maize (Zea mays L.) covered by Commission
Decision 97/98/EC (4). These products were approved
before the entry into force of Regulation (EC) No 258/
97, according to Council Directive 90/220/EEC of 23
April 1990 on the deliberate release into the environ-
ment of genetically modified organisms (5). The label-
ling provisions are based on the presence of DNA or
protein resulting from genetic modification.

Article 2(2) of Council Regulation (EC) No 1139/98, as
amended by Commission Regulation (EC) No 49/
2000 (6), introduces a 1 % de minimis threshold for the
adventitious presence of DNA or protein resulting
from the genetic modification of soya and maize in
conventional foodstuffs. This provision is in force since
10 April 2000. The threshold is applied on each ingre-
individually considered and not on the final
dient
product. It applies, as a combined maximum for genet-
ically modified material from abovementioned prod-
ucts together with any material placed on the market
pursuant to Regulation (EC) No 258/97.

In order to be able to benefit from this exemption to
the mandatory labelling requirement
for genetically
modified foods, operators have to supply documentary
evidence to satisfy the competent authorities that they
have tried to avoid the use of GMOs or products
thereof and that any genetically modified material
(DNA or protein) in their products is due to accidental

(1) OJ L 43, 14.2.1997, p. 1.
(2) OJ L 159, 3.6.1998, p. 4.
(3) OJ L 107, 30.4.1996, p. 10.
(4) OJ L 31, 1.2.1997, p. 69.
(5) OJ L 117, 8.5.1990, p. 15.
(6) OJ L 6, 11.1.2000, p. 13.

The aim of this element of the programme is to check
the compliance with Community law (7) regarding the
labelling of foods and food ingredients, which may
contain or consist of or may be produced from geneti-
cally modified soya and maize.

5.2. Sampling and method of analysis

Controls may have to be applied to both final products
and raw materials through inspections at the appro-
priate stages of placing on the market of ingredients or
products. Compliance with the 1 % threshold for label-
ling, in case of adventitious presence of modified DNA
or protein resulting from the genetic modification,
shall be established by checking documents provided
by the operators and taking samples for analysis. Labo-
ratories should use PCR or ELISA based methods for
qualitative and quantitative analysis in foodstuffs of
DNA or protein resulting from genetic modification.
Specific recommendations concerning methods of
analysis are included in Annex I.

The results of the controls should be recorded on the
record sheet model provided in Annex II to this recom-
mendation.

6. Bacteriological safety of pre-cut fresh fruits and vegetables

and of sprouted seeds

6.1. Scope of the programme

There is no Community legislation fixing specific
microbiological criteria for fresh fruits and vegetables.
Experience shows that there is potential for a wide
range of these products to become contaminated with
micro-organisms, including human pathogens. Most of
the reported outbreaks have been associated with
bacterial contamination, particularly members of Enter-
obacteriaceae (Salmonella spp., Escherichia coli O157:H7).

There are certain factors which contribute to the
microbiological contamination with pathogens, partic-
ularly when fruits and vegetables are eaten raw. These
pathogens can derive from agricultural practices or
from other processes along the production chain.
Another aspect contributing to the microbial risk for
consumers is the increasing consumption of new prod-
ucts (e.g. sprouted seeds) or fruits and edible plants
imported as a part of the globalisation of the trade in
these commodities. Additionally,
the application of
technologies such as cutting, slicing, skinning and
shredding, remove the natural protective barriers of the
intact plant and open the possibility for providing a
suitable medium for the growth of contaminants.

(7) This

recommendation is without prejudice to the Commission
for

‘food-feed’/‘traceability’ and their consequences

proposals of
labelling and testing.

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hygiene of foodstuffs requires juice to be manufactured
in a hygienic way and requests food operators to apply
the HACCP principles for ensuring the safety and
wholesomeness of their products. Food operators are
also encouraged to develop and implement on a volun-
tary basis a code of practice outlining ways to mini-
mise the contamination of
is being
grown, harvested, stored and processed to make juice
and to minimise the contamination of
juice
concentrate while it is being stored, transported or
restored into juice for consumption.

fruit while it

fruit

The experience in this sector shows that all juices (fruit
and vegetable) have the potential to be contaminated
with microbiological hazards, in particular juice that
has not undergone any form of heat treatment. While
it is recognised that there is a low probability for juice
being contaminated with dangerous pathogens,
the
consequences, if it is, can be severe for at-risk groups.
Most of the reported outbreaks have been associated
with pathogens such as Salmonella spp., Escherichia coli
O157: H7.

The aim of this element of the programme is to assess
the bacteriological safety of fruit and vegetable juices
and to monitor possible risks for human health. In
view of this it is recommended to verify the applica-
tion of the HACCP principles by food operators and to
test for some pathogens such as Salmonella spp., toxi-
genic E. coli (in particular E. coli O157:H7) and Listeria
monocytogenes.

7.2. Sampling and method of analysis

The verifications should concern fruit and vegetable
juices, in particular apple and citrus juices, that have
not been pasteurised.

The competent authorities of
the Member States
should carry out controls at the level of establishments
of production and/or at retail level in order to verify
the HACCP principles including,
the application of
where indicated,
for
taking samples of products
analysis. For the sampling and methods of analysis it is
recommended to apply the same criteria as indicated in
point 6.2 for fresh fruits and vegetables.

The results of
should be
recorded on the record sheet model provided in Annex
IV to this recommendation.

the following controls

Done at Brussels, 25 January 2002.

For the Commission

David BYRNE

Member of the Commission

Good agricultural practices and good manufacturing
practices can help control microbial hazards associated
with all stages of the production of fresh fruits and
vegetables from primary production to packing and
trade. The effective implementation of
the HACCP
(Hazard analysis and critical control points) principles,
where applicable, according to Council Directive 93/
43/EEC on the hygiene of foodstuffs (1),
is another
important element to ensure safety of fruits and veget-
ables.
The aim of this element of the programme is to assess
the microbiological safety of pre-cut fresh fruits and
vegetables and of sprouted seeds to monitor possible
risks for human health. In view of this it is recom-
mended to verify the application of the HACCP princi-
ples by food operators and test for some pathogens
such as Salmonella spp, toxigenic E. coli (in particular E.
coli O157:H7) and Listeria monocytogenes.

6.2. Sampling and method of analysis

The verifications should concern ready to eat fresh
fruits and vegetables that have been peeled, cut or
otherwise physically altered from their original form
intended to be consumed raw, and sprouted seeds.
the Member States
The competent authorities of
should carry out controls at the level of establishments
of production and/or at retail level in order to verify
the HACCP principles including,
the application of
where indicated,
for
taking samples of products
analysis. These samples shall be of one hundred grams
minimum each and the product shall be kept in its
original packaging. Samples should be placed in refri-
gerated containers and sent immediately to the labora-
tory for analysis.
The overall level of sampling is left to the judgement of
the competent authorities of Member States.
Laboratories are allowed to use a method of their
choice provided that its level of performance matches
the aims to be achieved. However, the most recent
version of standard ISO 6579 is recommended for the
detection of Salmonella, the most recent version of
standard EN/ISO 16654 is recommended for the detec-
tion of toxigenic E. coli and the most recent versions of
standards EN/ISO 11290-1 and EN/ISO 11290-2 are
recommended for detection and enumeration of Listeria
monocytogenes. Additional equivalent methods recog-
nised by competent authorities may also be used.
The results of the controls should be recorded on the
to this
record sheet model provided in Annex III
recommendation.

7. Bacteriological safety of fruit and vegetable juices

7.1. Scope of the programme

As for fresh fruits and vegetables, there are no specific
microbiological standards for juices in Community
legislation. Council Directive 93/43/EEC on the

(1) OJ L 175, 19.7.1993, p. 1.

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RECOMMENDATIONS CONCERNING ANALYSIS OF FOODSTUFFS FOR COMPLIANCE WITH LABELLING OF
GMO

ANNEX I

This annex is to provide a list of methods that have been submitted to ring trial evaluation and that could be used for the
scope of this programme. These studies have been performed according to harmonised international protocols (e.g.
IUPAC, AOAC, ISO), and cover a wide range of laboratories, usually no fewer than eight. An essential criterion for
consideration is the performance of the method and the quality of the data presented in the final report. The testing
method should produce acceptably accurate, precise, and reproducible results for the given analyte. At least seven
methods meet these criteria and could be considered as possible references for regulatory compliance.

These methods are listed below, grouped per type of method and type of organism (soybean, maize). The categories are:

— Qualitative PCR methods for screening of foodstuffs containing soybean

— Qualitative PCR methods for screening of foodstuffs containing maize

— Qualitative PCR methods for screening of foodstuffs containing maize and soybean

— Real-time PCR method for the quantification of GM-soybean

— Real-time PCR method for the quantification of GM-maize

— Immunoassay for detection and semi-quantification of GM-soybean

The methods listed are at present being used world-wide in a large number of proficiency tests and either have been
annexed to the CEN standards on GMO testing that are under development (elaborated by CEN/TC275/WG11) or will be
submitted before long. Therefore, they can be considered as consistent with the highest international performance criteria.

Recommended validated methods

Table 1: Qualitative PCR methods for screening of foodstuffs containing soybean

Matrix

Authorised GMO that can be
detected in the assay

GMO concentrations analysed

Target

Coordinator
(Reference)

Soy flour
Soybeans

Soy meal

GTS 40-3-2
(Roundup Ready soybean)

0 %, 0,1 %, 0,5 %, 2 %

35S promoter nos termi-
nator

JRC, (Lipp et al., 1999) (1)
BgVV (2)

GTS 40-3-2
(Roundup Ready soybean)

0 %, 0,1 %, 0,5 %, 2 %

Herbicide tolerance gene
epsps

DMIF-GEN, 1999 (3)

Processed foods:
Acidified soybeans

GTS 40-3-2
(Roundup Ready soybean)

0 %, 2 %, 100 %

35S promoter nos termi-
nator

JRC, (Lipp et al., 2001) (4)

Table 2: Qualitative PCR methods for screening of foodstuffs containing maize

Matrix

Authorised GMO that can be
detected in the assay

GMO concentrations analysed

Target

Coordinator
(Reference)

Maize flour

Bt-176

0 %, 0,1 %, 0,5 %, 2 %

35S promoter

JRC, (Lipp et al., 1999) (1)

Maize flour

Bt-176 (construct-specific)

0 %, 0,1 %, 0,5 %, 2 %

Maize flour

Bt-176 (construct-specific)

0 %, 100 %

Overlap between insect
resistance gene cryIAb and
CDPK promoter

DMIF-GEN, 1999 (3)

Overlap between insect
resistance gene cryIAb and
CDPK promoter

BgVV (2)

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Matrix

Authorised GMO that can be
detected in the assay

GMO concentrations analysed

Target

Coordinator
(Reference)

Maize flour

Bt-11 (construct-specific)

0 %, 100 %

Maize flour

T25 (construct-specific)

0,1 %, 1 %, 100 %

Maize flour

MON810 (event-specific)

0,1 %, 1 %, 100 %

Junction region of adh 1S-
Intron2 (IVS2) and pat
gene

BgVV (2)

CaMV 35S terminator and
the pat gene

BgVV (2)

fragment

Edge
covering
genomic maize DNA to
CaMV promoter

BgVV (2)

Processed foods:
polenta

Bt-176

0 %, 2 %, 100 %

35S-promoter

JRC, (Lipp et al., 2001) (4)
BgVV (2)

Table 3: Qualitative PCR methods for screening of foodstuffs containing maize and soybean

Matrix

Authorised GMO that can be
detected in the assay

GMO concentrations analysed

Target

Coordinator
(Reference)

Processed foods:
Baby food;
Biscuits

Bt-176
GTS 40-3-2
(Roundup Ready soybean)

0 %, 2 %, 100 %

35S promotor nos termi-
nator (for soybean only)

JRC, (Lipp et al ., 2001) (4)

Table 4: Real-time PCR method for the quantification of GM-soybean

Matrix

Authorised GMO that can be
detected in the assay

GMO concentrations analysed

Target

Coordinator
(Reference)

Soybean meals and textur-
ised vegetable protein

GTS 40-3-2
(Roundup Ready soybean)

0,1 %, 0,5 %, 1 %, 2 %, 5 % Herbicide tolerance gene

(Roundup Ready)

BgVV (EU Tender Report,
2000) (5)

Table 5: Real-time PCR method for the quantification of GM-maize

Matrix

Authorised GMO that can be
detected in the assay

GMO concentrations analysed

Target

Coordinator
(Reference)

Maize flour

Bt-176 (construct-specific)

0,1 %, 0,5 %, 1 %, 2 %

Overlap between insect
resistance gene cryIAb and
CDPK promoter

BgVV, (Broll et al ., in prepa-
ration) (6)

Table 6: Immunoassay for detection and semi-quantification of GM-soybean

Matrix

Authorised GMO that can be
detected in the assay

GMO concentrations
analysed

Antibody

Target GMO

Coordinator
(Reference) Date

Dried soybean
powder

GTS 40-3-2
(Roundup Ready soybean)

0 %, 0,5 %, 1 %, 2 %

Ab against
CP4EPSPS

Herbicide tolerance
protein
(Roundup
Ready)

JRC, (Lipp et al .,
2000) (6)

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Recommendations

— It is recommended to follow precisely the protocols referred to above. Changes (for example in primer sequences) to

the protocol may adversely affect the quality of results.

— It is recommended to use the appropriate protocols for the range of GMO percentages for which the method has been

validated.

— It is recommended to use the appropriate protocols in conjunction with the matrices listed. It is further recommended
to pick from the lists above the best method of choice if no validated method is available for a particular matrix to be
analysed, or for a threshold which is being applied. For example the method provided by producers of analytical
instruments that deliver probes to quantify cry1AB (present in Bt-11, MON-810, MON-809 and Bt-176), the 35S
promoter (present in all five authorized maizes) and for the nos terminator (present in Bt-11, MON-809 and T25)
have not yet been internationally validated but
they can be considered as having a high degree of method
performance.

— Following these recommendations it should be possible to utilise reliable methods that should allow the detection
and/or quantification of Roundup Ready soybean GTS 40-3-2 as well as all five authorised GM maize varieties Bt-11,
MON-810, MON-809, Bt-176 and T25 in the following food matrices:

Foodstuffs derived from soy: soy bean, soy flower (all types), soy meal, tofu, soy bean bakery products

Foodstuffs derived from maize: maize, maize flour (all types), maize snacks, maize chips, maize bakery products, polenta

Foodstuffs derived from soy and maize: baby food, raw material for food supplements, biscuits.

— For further information, it is advised to consult the compendium of validated methods that do not meet the criteria as
stipulated above but that nonetheless may provide good analytical guidance. This compendium, compiled by the
European Commission Joint Research Centre can be downloaded from http://biotech.jrc.it/documents.

References

1. Lipp M, Brodmann P, Pietsch K, Pauwels J, Anklam E (1999) IUPAC Collaborative Trial Study of a Method To Detect

Genetically Modified Soy Beans and Maize in Dried Powder. J AOAC Int 82:923–928.

2. Collection of official methods under article 35 of the German Federal Foods Act; Methods of sampling and analysis of
foods, tobacco products, cosmetics and commodity goods/Federal Health Office, Loose leaf edition as of November
1999, Berlin, Köln, Beuth Verlag GmbH, No L 00.00-31.

3. DMIF-GEN Final Project (1999), DMIF-GEN-Project: Development of Methods to Identify Foods Produced by Means of

Genetic Engineering. EU-Project SMT4-CT96-2072, Final Report 12/1999.

4. Lipp, M., Bluth, A., Eyquem, F., Kruse, L., Schimmel, H., Van den Eede, G., and Anklam, E. (2001) Validation of a
method based on polymerase chain reaction for the detection of genetically modified organisms in various processed
foodstuffs. Eur Food Res Technol 212:497-504.

5. EU Tender Report (2000). Development of qualitative as well as quantitative detection methods to identify a genetic

modification in soybean and maize products. Report of the EU tender No. XXIV/98/A3/001.

6. Broll et al.,

in preparation.

7. Lipp M., Anklam E. and Stave J: ‘Validation of an immunoassay for the detection and quantification of Roundup-

Ready soy beans in food and food fractions’, J. AOAC 83, 919 (2000).

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