Commission Regulation (EC) No 641/2004 of 6 April 2004 on detailed rules for the implementation of Regulation (EC) No 1829/2003 of the European Parliament and of the Council as regards the application for the authorisation of new genetically modified food and feed, the notification of existing products and adventitious or technically unavoidable presence of genetically modified material which has benefited from a favourable risk evaluation (Text with EEA relevance)
Date: 2004-04-06
Institutions: European Commission
Subjects: animal nutrition, environmental risk prevention, foodstuff, genetically modified organism, health risk, market approval

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COMMISSION REGULATION (EC) No 641/2004

of 6 April 2004

on detailed rules for the implementation of Regulation (EC) No 1829/2003 of the European Parlia-
ment and of the Council as regards the application for the authorisation of new genetically modi-
fied food and feed, the notification of existing products and adventitious or technically unavoid-
able presence of genetically modified material which has benefited from a favourable risk evalua-
tion

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(5)

Having regard to the Treaty establishing the European
Community,

Having regard to Regulation (EC) No 1829/2003 of the Euro-
pean Parliament and of the Council of 22 September 2003 on
genetically modified food and feed (1), and in particular Articles
5(7), 8(8), 17(7), 20(8) and 47(4) thereof,

After consulting the European Food Safety Authority in accord-
ance with Articles 5(7) and 17(7) of Regulation (EC) No 1829/
2003,

Whereas:

(1)

(2)

(3)

(4)

Regulation (EC) No 1829/2003 lays down Community
procedures for the authorisation and supervision of
genetically modified food and feed and for the labelling
of such food and feed.

It is necessary to provide detailed rules concerning appli-
cations for authorisations submitted in accordance with
Regulation (EC) No 1829/2003.

In addition, Regulation (EC) No 1829/2003 provides
that the European Food Safety Authority (the Authority)
is to publish detailed guidance to assist the applicant in
the preparation and the presentation of the application,
concerning notably the information and data to be
provided in order
the product
complies with the criteria referred to in Articles 4(1) and
16(1) of that Regulation.

to demonstrate that

In order to ensure a smooth transition to the regime
provided by Regulation (EC) No 1829/2003 transitional
regards
laid down in that Regulation as
measures
requests and notifications of products falling within the
scope of other Community legislation, should be subject
to implementing rules.

(1) OJ L 268, 18.10.2003, p. 1.

It is also necessary to provide detailed rules on the
preparation and presentation of notifications of existing
products submitted to the Commission under Regulation
(EC) No 1829/2003 as regards products placed on the
market in the Community before 18 April 2004.

Such rules should facilitate the task of operators,
in
preparing applications for authorisations and in the
preparation of notifications of existing products, and the
Authority in evaluating such applications and verifying
such notifications.

The scope of Regulation (EC) No 1829/2003 includes
food which consists of, contains or is produced from
genetically modified organisms (GMOs) such as geneti-
cally modified plants and micro-organisms. Therefore, in
the interests of consistency of Community legislation,
the scope of the present Regulation should also cover
existing food consisting of, containing or produced from
genetically modified plants and micro-organisms.

The scope of Regulation (EC) No 1829/2003 covers
including feed additives as defined in Council
feed,
Directive 70/524/EEC of 23 November 1970 concerning
additives in feeding-stuffs (2) consisting of, containing or
produced from GMOs such as genetically modified
plants and micro-organisms. Therefore, the scope of the
present Regulation should also cover existing feed,
including feed additives consisting of, containing or
produced from genetically modified plants and micro-
organisms.

(6)

(7)

(8)

(9)

The scope of Regulation (EC) No 1829/2003 does not
cover processing aids, including enzymes used as proces-
sing aids. Therefore, the scope of the present Regulation
similarly should not cover existing processing aids.

(2) OJ L 270, 14.12.1970, p. 1. Directive as last amended by Regu-

lation (EC) No 1756/2002 (OJ L 265, 3.10.2002, p. 1).

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(10)

(11)

(12)

Regulation (EC) No 1829/2003 provides that detailed
rules are to be adopted for implementing the transitional
measures for the adventitious or technically unavoidable
presence of genetically modified material which has
benefited from a favourable risk evaluation. In the inter-
ests of consistency of Community legislation those rules
should in particular clarify which genetically modified
material
is covered by such transitional measures and
how the 0,5 % threshold is to be applied.

It is necessary for this Regulation to apply as a matter of
urgency as Regulation (EC) No 1829/2003 applies from
18 April 2004.

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:

CHAPTER I

Applications for authorisation

Article 1

This chapter provides detailed rules concerning applications for
authorisation submitted in accordance with Articles 5 and 17
of Regulation (EC) No 1829/2003,
including applications
submitted under other Community legislation which are trans-
formed or supplemented in accordance with Article 46 of that
Regulation.

In supplying the information required under Article
2.
5(3)(b) and Article 17(3)(b) of Regulation (EC) No 1829/2003,
the application shall clearly identify the products covered by it
in accordance with Articles 3(1) and 15(1) of that Regulation.
Where the application is limited to either food or feed use, it
shall contain a verifiable justification explaining why the
authorisation should not cover both uses in accordance with
Article 27 of Regulation (EC) No 1829/2003.

3.
The application shall clearly state which parts of the
application are considered to be confidential, together with a
verifiable justification in accordance with Article 30 of Regu-
shall be
lation (EC) No 1829/2003. Confidential parts
submitted in separate documents.

The application shall specify, in supplying the informa-
4.
tion required under Article 5(3)(c) and Article 17(3)(c) of Regu-
lation (EC) No 1829/2003, whether the information included
in the application may be notified as such to the biosafety
clearing house under the Cartagena Protocol on Biosafety to
the Convention on Biological Diversity (the Cartagena Protocol)
approved by Council Decision 2002/628/EC (1).

If the application may not be notified as such, it shall include
the information which complies with Annex II to the Cartagena
Protocol and which may be notified to the biosafety clearing
house by the Commission as provided in Article 44 of Regu-
lation (EC) No 1829/2003 in a separate and clearly identified
document.

Paragraph 4 shall not apply to applications concerning
5.
only food and feed produced from genetically modified organ-
isms (GMOs) or containing ingredients produced from GMOs.

SECTION 1

Article 3

R e q u i r e me nts for a ppli c at i ons for a ut h or i sa ti on of
g e ne ti c a l ly modi f i e d fo od a nd f e e d

1.

The application shall include the following:

Article 2

(a) the monitoring plan referred to in Article 5(5)(b) and
Article 17(5)(b) of Regulation (EC) No 1829/2003, taking
into account Council Decision 2002/811/EC (2);

the guidance of

1. Without prejudice to Article 5(3) and (5) and Article
17(3) and (5) of Regulation (EC) No 1829/2003, and taking
the European Food Safety
into account
Authority (the Authority) provided for in Articles 5(8) and
17(8) of
authorisation
submitted in accordance with Articles 5 and 17 of Regulation
(EC) No 1829/2003 (the applications) shall comply with the
requirements of paragraphs 1 to 4 of this Article and with Arti-
cles 3 and 4 of this Regulation.

that Regulation,

applications

for

(b) in supplying the information required under Article 5(5)(a)
and Article 17(5)(a) of Regulation (EC) No 1829/2003, a
proposal for labelling complying with the requirements of
Annex IV to Directive 2001/18/EC of the European Parlia-
ment and of the Council (3);

(1) OJ L 201, 31.7.2002, p. 48.
(2) OJ L 280, 18.10.2002, p. 27.
(3) OJ L 106, 17.4.2001, p. 1.

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(c) in supplying the information required under Article 5(5)(a)
and Article 17(5)(a) of Regulation (EC) No 1829/2003, a
proposal for a unique identifier for the GMO in question,
developed in accordance with Commission Regulation (EC)
No 65/2004 (1);

(d) a proposal for labelling in all official Community languages,
where a proposal for specific labelling is needed in accord-
ance with Article 5(3)(f) and Article (g) and 17(3)(f) and (g)
of Regulation (EC) No 1829/2003;

(e) a description of a method(s) of detection, sampling and
event specific identification of the transformation event, as
provided for in Article 5(3)(i) and Article 17(3)(i) of Regu-
lation (EC) No 1829/2003, in accordance with Annex I to
this Regulation;

(f) a proposal for post-market monitoring regarding the use of
the food for human consumption or the feed for animal
consumption, as provided for in Article 5(3)(k) and Article
17(3)(k) of Regulation (EC) No 1829/2003, and according
to the characteristics of the products concerned, or a verifi-
able justification to the effect that a post-market monitoring
is not necessary.

2.
Points (a), (b) and (c) of paragraph 1 shall not apply to
applications concerning only food and feed produced from
GMOs or containing ingredients produced from GMOs.

Article 4

Samples of the food and feed and their control samples
1.
which are to be submitted in accordance with Article 5(3)(j)
and Article 17(3)(j) of Regulation (EC) No 1829/2003 shall be
in accordance with the requirements set out in Annexes I and
II to this Regulation.

application shall be

The
information
concerning the place where the reference material developed in
accordance with Annex II may be found.

accompanied by

SECTION 2

Tr a nsfor ma ti on of
r e q u e sts and noti fi c ati ons i n to
a p p li c a t i on s i n a c c o r d a n c e w i t h R e g u l a t i on ( E C ) N o
1829/2003

Article 5

the European Parliament and of

1. Where a request submitted under Article 4 of Regulation
(EC) No 258/97 of
the
Council (2) is transformed into an application under Regulation
(EC) No 1829/2003, in accordance with Article 46(1) of that
Regulation, the national competent authority of the Member
State in which the request was submitted shall, without delay,
ask the applicant to submit a complete dossier in accordance
with Article 5 of Regulation (EC) No 1829/2003.

2.

The national competent authority shall:

(a) acknowledge receipt of the information supplied by the
applicant in accordance with paragraph 1 within 14 days
of the date of its receipt. The acknowledgement shall state
the date of receipt: of the information;

(b) inform the Authority without delay;

(c) make the request and the information supplied by the
applicant in accordance with paragraph 1 available to the
Authority;

(d) where applicable, make available to the Authority the
initial assessment report provided for in Article 6(3) of
Regulation (EC) No 258/97, as well as any comments or
objections which may have been made by Member States
or the Commission under Article 6(4) of that Regulation.

3.

The Authority shall:

(a) inform the other Member States and the Commission
without delay that the request under Article 4 of Regulation
(EC) No 258/97 has been transformed into an application
under Regulation (EC) No 1829/2003 and make the appli-
cation and any supplementary information supplied by the
applicant available to them;

(b) make the summary of the dossier referred to in Article
5(3)(l) of Regulation (EC) No 1829/2003 available to the
public.

The summary to be provided in accordance with Article
2.
5(3)(l) and Article 17(3)(l) of Regulation (EC) No 1829/2003
shall:

The date of receipt of the application for the purpose of
4.
Article 6(1) of Regulation (EC) No 1829/2003 shall be the date
of receipt by the Authority of the information referred to in
points (c) and (d) of paragraph 2 of this Article.

(a) be presented in an easily comprehensible and legible form;

(b) not contain parts which are considered to be confidential.

5.
The transformed application shall further be processed as
any other application under Article 5 of Regulation (EC) No
1829/2003.

(1) OJ L 10, 16.1.2004, p. 5.

(2) OJ L 43, 14.2.1997, p. 1.

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Article 6

1. Where a notification concerning a product including its
use as feed submitted under Article 13 of Directive 2001/18/
EC is transformed into an application under Regulation (EC) No
1829/2003,
in accordance with Article 46(3) of that Regu-
lation, the national competent authority, within the meaning of
Directive 2001/18/EC, of the Member State in which the notifi-
cation was submitted shall ask without delay the notifier to
submit a complete dossier in accordance with Article 17 of
Regulation (EC) No 1829/2003.

2.

The national competent authority shall:

(a) acknowledge receipt of the information supplied by the
notifier in accordance with paragraph 1 within 14 days of
the date of its receipt; the acknowledgement shall state the
date of receipt of the information;

(b) inform the Authority without delay;

(c) make the notification and the information supplied by the
notifier in accordance with paragraph 1 available to the
Authority;

(d) where applicable, make available to the Authority the
assessment report provided for in Article 14(2) of Directive
2001/18/EC.

3.

The Authority shall:

(a) inform the other Member States and the Commission
without delay that the notification under Article 13 of
Directive 2001/18/EC has been transformed into an appli-
cation under Regulation (EC) No 1829/2003 and shall
make the application and any supplementary information
supplied by the notifier available to them;

Regulation, the Commission shall ask the applicant without
delay to submit a complete dossier in accordance with Article
17 of Regulation (EC) No 1829/2003.

The applicant shall send the complete dossier to the Member
States and to the Commission.

2.

The Commission shall:

(a) acknowledge receipt of the information supplied by the
applicant in accordance with paragraph 1 within 14 days
of the date of its receipt; the acknowledgement shall state
the date of receipt of the information;

(b) inform the Authority without delay;

(c) make the request and the information supplied by the
applicant in accordance with paragraph 1 available to the
Authority;

(d) where applicable, make available to the Authority the
dossier provided for in Article 7(1) of Directive 82/471/
EEC.

3.

The Authority shall make:

(a) any supplementary information supplied by the applicant

available to the Member States and the Commission;

(b) the summary of the dossier referred to in Article 17(3)(l) of
Regulation (EC) No 1829/2003 available to the public.

4.
The date of receipt of the application for the purpose of
Article 18(1) of Regulation (EC) No 1829/2003 shall be the
date of receipt by the Authority of the information referred to
in points (c) and (d) of paragraph 2 of this Article.

(b) make the summary of the dossier referred to in Article
17(3)(l) of Regulation (EC) No 1829/2003 available to the
public.

5.
The transformed application shall further be processed as
any other application under Article 17 of Regulation (EC) No
1829/2003.

4.
The date of receipt of the application for the purpose of
Article 18(1) of Regulation (EC) No 1829/2003 shall be the
date of receipt by the Authority of the information referred to
in points (c) and (d) of paragraph 2 of this Article.

The transformed application shall further be processed as
5.
any other application under Article 17 of Regulation (EC) No
1829/2003.

SECTION 3

Su p p l e me nta t i on of
r e q u e sts u n de r Di r e c t i v e 7 0 /
52 4 / E E C b y a n a p p l i c a ti o n u nde r R e g u la t i on ( E C) N o
1829/2003

Article 7

1. Where a request submitted under Article 7 of Council
Directive 82/471/EEC (1), concerning products produced from
GMOs,
is transformed into an application under Regulation
(EC) No 1829/2003, in accordance with Article 46(4) of that

(1) OJ L 213, 21.7.1982, p. 8.

Article 8

1. Where a request submitted under Article 4 of Directive
70/524/EEC, concerning products referred to in Article 15(1)
of Regulation (EC) No 1829/2003,
is supplemented by an
application under Regulation (EC) No 1829/2003, in accord-
ance with Article 46(5) of that Regulation, the Member State
acting as rapporteur shall ask the applicant without delay to
submit a separate application for authorisation in accordance
with Article 17 of Regulation (EC) No 1829/2003.

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The application shall further be processed as any other
2.
application under Article 17 of Regulation (EC) No 1829/2003.

(ii) information as to the place where the reference mate-
rial, which shall be developed in accordance with
Annex II to this Regulation, may be found.

CHAPTER II

The notifications referred to in paragraph 1 shall be

2.
submitted to the Commission before 18 October 2004.

Notification of existing products

SECTION 2

Article 9

Addi t i ona l r e qu i r e me nts f or no ti f i c a ti on s o f c e r t a i n
p r o du c t s p l a c e d on t h e ma r k e t b e f or e 18 A p r i l 2 0 0 4

This chapter provides the requirements concerning the prepara-
tion and presentation of notifications of existing products
submitted to the Commission in accordance with Articles 8
and 20 of Regulation (EC) No 1829/2003 and applies to
existing products covered by the scope of that Regulation and
placed on the market in the Community prior to 18 April
2004.

SECTION 1

G e ne r a l
for not i fi c a t i ons of c e r t a i n
produ cts place d on the marke t b efor e 18 A pril 2004

r e q u i r e me nts

Article 10

Notifications submitted in accordance with Articles 8(1)

1.
and 20(1) of Regulation (EC) No 1829/2003 shall:

(a) clearly identify the products covered by the notification,
taking account of Articles 3(1) and 15(1) of Regulation (EC)
No 1829/2003;

(b) include relevant information and studies, including, where
available,
independent and peer-reviewed studies, which
demonstrate that the product complies with the require-
ments provided for in Articles 4(1) or 16(1) of Regulation
(EC) No 1829/2003;

(c) clearly indicate which parts of the notification are consid-
ered to be confidential, together with a verifiable justifica-
tion, and those parts shall be submitted in separate docu-
ments;

(d) include a method(s) of detection, sampling and identifica-
tion of the transformation event in accordance with Annex
I to this Regulation;

(e) in accordance with Articles 5(3)(j) and 17(3)(j) of Regu-

lation (EC) No 1829/2003 provide:

Article 11

1.
In addition to the requirements of Article 10, notifica-
tions of GMOs which have been placed on the market in
accordance with part C of Council Directive 90/220/EEC (1) or
part C of Directive 2001/18/EC shall include a copy of the rele-
vant consent granted under those directives.

2.
The date of publication in the Official Journal of the Euro-
pean Union of the Decision to grant consent under Directive
90/220/EEC or Directive 2001/18/EC shall be considered to be
the date on which the product was first placed on the market,
unless the notifier provides verifiable proof that it was first
placed on the market at a later date

Article 12

In addition to the requirements of Article 10, notifica-
1.
tions of food produced from GMOs which have been placed on
the market in accordance with Article 5 of Regulation (EC) No
258/97 shall include a copy of the original notification letter to
the Commission.

2.
The date of the letter from the Commission forwarding
the original notification to the Member States shall be consid-
ered to be the date on which the product was first placed on
the market, unless the notifier provides verifiable proof that it
was first placed on the market at a later date.

Article 13

1.
In addition to the requirements of Article 10, notifica-
tions of genetically modified food which have been placed on
the market in accordance with Articles 6 and 7 of Regulation
(EC) No 258/97 shall include a copy of the authorisation of
that food.

(i) samples of the food and feed and their control samples

in accordance with Annex I to this Regulation;

(1) OJ L 117, 8.5.1990, p. 15.

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The date the authorisation of the product took effect
2.
under Regulation No (EC) 258/97 shall be considered to be the
date on which it was first placed on the market, unless the noti-
fier provides verifiable proof that the product was first placed
on the market at a later date.

(b) include a declaration that the product was placed on the

market before 18 April 2004.

Article 14

1.
In addition to the requirements of Article 10, notifica-
tions of feed produced from GMOs which have been placed on
the market in accordance with Articles 3 and 4 of Directive
82/471/EEC shall include a copy of the authorisation at Com-
munity level or, where applicable, the authorisation granted by
a Member State.

2.
The date the authorisation of the product took effect in
accordance with Directive 82/471/EEC shall be considered to
be the date on which it was first placed on the market, unless
the notifier provides verifiable proof that the product was first
placed on the market at a later date.

Article 17

In addition to the requirements of Article 10, notifications of
food and feed produced from GMOs which have been lawfully
placed on the market in the Community and which are not
covered by Articles 11 to 16 shall include a declaration that
the product was placed on the market before 18 April 2004.

CHAPTER III

Transitional measures
technically
unavoidable presence of genetically modified material
which has benefited from a favourable risk evaluation

for adventitious or

Article 15

Article 18

In addition to the requirements of Article 10, notifica-
1.
tions of feed containing, consisting of or produced from GMOs
which have been authorised in accordance with Directive 70/
524/EEC shall include:

(a) the identification of the feed additive(s) to be covered by
the number or the EC number, where applicable, as laid
down in Article 9(l) of Directive 70/524/EEC;

(b) a copy of the authorisation.

2.
The date the authorisation of the product took effect
under Directive 70/524/EEC shall be considered to be the date
on which it was first placed on the market, unless the notifier
provides verifiable proof that the product was first placed on
the market at a later date.

Article 16

In addition to the requirements of Article 10, notifications of
feed produced from GMOs which have been lawfully placed on
the market in the Community, which are not covered by Arti-
cles 11, 14 and 15, and for which the GMO(s) has been noti-
fied for authorisation for use as animal feed under part C of
Directive 2001/18/EC shall:

For the purpose of implementing Article 47 of Regulation
1.
(EC) No 1829/2003, the Commission shall, on 18 April 2004,
publish a list of the genetically modified material that has bene-
fited from a favourable opinion from the Community Scientific
Committee(s) or the Authority before that date and for which
an application for authorisation has not been rejected in
accordance with the relevant Community legislation.

2.

This list shall distinguish between:

(a) material

in respect of which the Commission has been
informed, by any interested party, that a detection method
is publicly available; an indication of where the detection
method has been made available shall be included;

(b) material in respect of which the Commission has not yet
been informed that a detection method is publicly available.

Any interested party may, at any time, inform the Commission
that a detection method for material referred to in point (b) of
the first subparagraph is publicly available, with an indication
of where the detection method is available.

3.
The list referred to in paragraph 1 shall be maintained by
the Commission. Amendments to the list may result, in particu-
lar, from:

(a) contain a reference to the notification under evaluation
submitted according to Article 13 of Directive 2001/18/EC;

(a) the granting of an authorisation or the rejection of an
included in the
application for authorisation for material
list, in accordance with the relevant Community legislation;

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(b) notifications to the Commission, in accordance with Arti-
cles 8 or 20 of Regulation (EC) No 1829/2003, that mate-
rial
included in the list has been lawfully placed on the
market in the Community before 18 April 2004, or adop-
tion by the Commission of a measure in accordance with
Article 8(6) or 20(6) of Regulation (EC) No 1829/2003;

(c) information received by the Commission that a detection
method in respect of material included in the list is publicly
available.

Information about amendments brought to the list shall be
compiled in an Annex to the list.

Article 19

18(2) of the present Regulation. Where a lower threshold has
been established in accordance with Article 47(3) of Regulation
(EC) No 1829/2003, it shall be specified in that list.

2.
The thresholds provided for in Article 47 of Regulation
(EC) No 1829/2003 shall apply to food ingredients considered
individually or food consisting of a single ingredient and to
feed and each feed of which it is composed.

CHAPTER IV

Final provision

Article 20

1.
The 0,5 % threshold provided for in Article 47(1) of
Regulation (EC) No 1829/2003 shall apply to genetically modi-
fied material included in part (a) of the list referred to in Article

This Regulation shall enter into force on the day of its publica-
tion in the Official Journal of the European Union.

It shall apply from 18 April 2004.

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

Done at Brussels, 6 April 2004.

For the Commission

David BYRNE

Member of the Commission

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ANNEX I

METHOD VALIDATION

1.

INTRODUCTION

A. For the purpose of implementing Articles 5(3)(i) and 17(3)(i) of Regulation (EC) No 1829/2003, this Annex
provides technical provisions on the type of information on detection methods that shall be provided by the
applicant and that is needed to verify the preconditions for the fitness of the method. This includes information
about the method as such and about the method testing carried out by the applicant. All guidance documents
referred to in this Annex or produced by the Community Reference Laboratory (CRL) shall be made available by
the CRL.

B. The method acceptance criteria and method performance requirements have been compiled by the European
Network of GMO Laboratories (ENGL) in a document entitled ‘Definition of minimum performance requirements
for analytical methods of GMO testing’, which shall be made available by the CRL. ‘Method acceptance criteria’
are criteria, which should be fulfilled prior to the initiation of any method validation by the CRL. The ‘method
performance requirements’ define the minimum performance criteria that the method should demonstrate upon
completion of a validation study carried out by the CRL according to internationally accepted technical provisions
and this in order to certify that the method validated is fit for the purpose of enforcement of Regulation (EC) No
1829/2003.

C. The CRL, established under Regulation (EC) No 1829/2003 and assisted by ENGL, will evaluate the provided
information for its completeness and fitness for the purpose. Here, the method acceptance criteria recommended
by ENGL, which are described under 1(B), will be taken into account.

D. If the information provided about the method is considered adequate and fulfils the method acceptance criteria,

the CRL will initiate the validation process for the method.

E. The validation process will be carried out by the CRL according to internationally accepted technical provisions.

F. The CRL, together with ENGL, shall provide further information about the operational procedures of the valida-

tion process and shall make the documents available.

G. The CRL, assisted by ENGL, shall evaluate the results obtained in the validation study for the fitness for the

purpose. Here, the method performance requirements as described under 1(B) shall be taken into account.

2.

INFORMATION ABOUT THE METHOD

A. The method shall refer to all the methodological steps needed to analyse the relevant material in accordance with

Articles 5(3)(i) and 17(3)(i) of Regulation (EC) No 1829/2003.

For a particular material this must include the methods for DNA extraction and the subsequent quantification in
a polymerase chain reaction (PCR) system. In such a case, the whole process from extraction up to the PCR-tech-
nique (or equivalent) constitutes a method. The applicant shall provide information about the whole method.

B. As described in the document referred to under 1(B), ENGL recognises the modularity of a method. According to
this principle, the applicant is allowed to refer to existing methods for a certain module(s), if available and appro-
priate. This could be, for instance, a DNA extraction method from a certain matrix. In such a case, the applicant
shall provide experimental data from an in-house validation in which the method module has been successfully
applied in the context of the application for authorisation.

C. The applicant shall demonstrate that the method fulfils the following requirements.

1. The method shall be event-specific and thus must only be functional with the GMO or GM based product
considered and shall not be functional if applied to other events already authorised; otherwise the method
cannot be applied for unequivocal detection/identification/quantification. This shall be demonstrated with a
selection of non-target transgenic authorised events and conventional counterparts, in the case of GM plants.
This testing shall include closely related events, where relevant, and cases where the limits of the detection are
truly tested. The same specificity principle must be applied for products that consist of or contain GMOs
other than plants.

2. The method shall be applicable to samples of the food or feed, to the control samples and to the reference

material, which is referred to in Articles 5(3)(j) and 17(3)(j) of Regulation (EC) No 1829/2003.

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3. The method shall be developed taking the following documents in consideration as appropriate:

— General requirements and definitions: draft European standard prEN ISO 24276:2002,

— Nucleic acid extraction prEN ISO 21571:2002,

— Quantitative nucleic acid based methods: draft European standard prEN ISO 21570:2002,

— Protein based methods: adopted European standard EN ISO 21572:2002,

— Qualitative nucleic acid based methods: draft European standard prEN ISO 21569:2002.

D. For the purpose of implementing Articles 5(3)(i) and 17(3)(i) of Regulation (EC) No 1829/2003, the applicant

shall provide:

(a) in the case of an application for authorisation covering a GMO, products consisting of or containing a GMO
or products produced from a GMO, the event-specific quantitative detection method of the GM material;

(b) in addition, in the case of an application for authorisation covering products produced from a GMO where
the genetically modified material is detectable, the event-specific quantitative detection method in the foods
or feeds produced from the GMO.

E. The applicant shall provide a complete and detailed description of the method. The following points shall be

clearly addressed.

1. Scientific basis: An overview of the principles of how the method works, such as DNA molecular biology
based (e.g. for real-time PCR) information must be provided. It is recommended to provide references to rele-
vant scientific publications.

2. Scope of the method: Indication of the matrix (e.g. processed food, raw materials), the type of samples and the

percentage range to which the method can be applied.

3. Operational characteristics of the method: The required equipment for the application of the method shall be
clearly mentioned, with regard to the analysis per se and the sample preparation. Further information of any
specific aspects crucial for the application of the method shall also be mentioned here.

4. Protocol: The applicant shall provide a complete optimised protocol of the method. The protocol shall present
all the details as required to transfer and apply the method independently in other laboratories. It is recom-
mended to use a protocol template, which can be obtained from the CRL. The protocol shall include details
of:

— analyte to be tested,

— working conditions, instructions and rules,

— all the materials needed, including an estimation of their amounts and storage and handling instructions,

— all the equipment needed, including not only the main equipment such as a PCR system or centrifuge but
also small items such as micropipettes and reaction tubes with an indication of their appropriate sizes,
etc.,

— all the steps of the operative protocol, clearly described,

— instructions for the data recording (e.g. the programme settings or parameters to be included).

5. The prediction model (or alike) needed to interpret results and to make inferences must be described in full

details. Instructions for the correct application of the model should be provided.

3.

INFORMATION ABOUT THE METHOD TESTING CARRIED OUT BY THE APPLICANT

A. The applicant shall provide all the available and relevant data of the method optimisation and testing carried out.
These data and results shall be presented, where possible and appropriate, by using the performance parameters
recommended by the ENGL as referred to under 1(B). A summary of the testing carried out and the main results
as well as all the data including the outliers shall be provided. The CRL, together with ENGL, shall continue to
provide further technical provisions about the appropriate formats for these data.

B. The information provided shall demonstrate the robustness of the method for inter-laboratory transferability.
This means that the method should have been tested by at least one laboratory that is independent from the
laboratory which has developed the method. This is an important pre-condition for the success of the validation
of the method.

C.

Information required about the method development and the method optimisation:

1. primer pairs tested (in the case of a PCR-based test): justification shall be given of how and why the proposed

primer pair has been selected;

2. stability testing: experimental results from testing the method with different varieties shall be provided;

3. specificity: the applicant shall submit the full sequence of the insert(s), together with the base pairs of the host
flanking sequences needed to establish an event-specific detection method. The CRL shall enter these data in a
molecular database. By running homology searches, the CRL will thus be in a position to assess the specificity
of the proposed method.

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D. Testing report. Besides the values obtained for the performance indices, the following information regarding the

testing shall be provided, as appropriate:

— participating laboratories, time of the analysis and outline of the experimental design, including the details

about the number of runs, samples, replicates etc.,

— description of the laboratory samples (e.g. size, quality, date of sampling), positive and negative controls as

well as reference material, plasmids and alike used,

— description of the approaches that have been used to analyse the test results and outliers,

— any particular points observed during the testing,

— references to relevant literature or technical provisions used in the testing.

4. SAMPLES OF THE FOOD AND FEED AND THEIR CONTROL SAMPLES

In view of implementing Articles 5(3)(j) and 17(3)(j) of Regulation (EC) No 1829/2003, the applicant shall, together
with the information specified under sections 1, 2 and 3 of this Annex, also provide samples of the food and feed
and their control samples of a type and amount to be specified by the CRL for the specific application for authorisa-
tion.

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ANNEX II

REFERENCE MATERIAL

The reference material as referred to in Articles 5(3)(j) and 17(3)(j) of Regulation (EC) No 1829/2003 shall be produced
in accordance with internationally accepted technical provisions such as ISO Guides 30 to 34 (and more particularly
ISO Guide 34, specifying the general requirements for the competence of reference material producers). The reference
material shall be preferably certified and, if such is the case, certification shall be done in accordance with ISO Guide 35.

For verification and value assignment, a method that has been properly validated (see ISO/IEC 17025:5.4.5) shall be
used. Uncertainties have to be estimated according to GUM (ISO Guide to the Expression of Uncertainty in Measure-
ment: GUM). Major characteristics of these internationally accepted technical provisions are given below.

A. Terminology:

reference material (RM): material or substance, one or more of whose property values are sufficiently homogenous
and well-established to be used for calibration of an apparatus, the assessment of a measurement method, or for
assigning values to materials;

Certified reference material (CRM): reference material, accompanied by a certificate, one or more of whose property
values are certified by a procedure which establishes its traceability to an accurate realisation of the unit in which the
property values are expressed, and for which each certified value is accompanied by an uncertainty at a stated level
of confidence.

B. GM RM containers:

— GM RM container (bottles, vials, ampoules, etc.) must be tight and contain not less than the stated amount of

material,

— samples must have appropriate homogeneity and stability,

— the commutability of the GM RM has to be assured,

— packaging must be appropriate to the purpose,

— labelling must be of good aspect and quality.

C. Homogeneity testing:

between-bottle homogeneity must be examined;

any possible between-bottle heterogeneity must be accounted for in the overall estimated RM uncertainty. This
requirement applies even when no statistically significant between-bottle variation is present. In this case, the
method variation or the actual calculated between-bottle variation (whichever is larger) must be included in the
overall uncertainty;

D. Stability testing:

stability must be positively demonstrated by appropriate statistical extrapolation for the GM RM shelf-life to be
within the stated uncertainty; the uncertainty related to this demonstration is normally part of the estimated RM
uncertainty;

assigned values are valid only for a limited time and must be subject to a stability monitoring.

E. Batch characterisation:

the methods used for verification and for certification must:

— be applied under metrologically valid conditions,

— have been properly technically validated before use,

— have precision and accuracy compatible with the target uncertainty;

each set of measurements must:

— be traceable to the stated references, and

— be accompanied by an uncertainty statement whenever possible;

participating laboratories must:

— have the required competence for the execution of the task,

— be able to achieve traceability to the required stated references,

— be able to estimate its measurement uncertainty,

— have in place a sufficient and appropriate quality assurance system.

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F. Final storage:

— to avoid a posterior degradation, all samples are best stored under conditions designated for the final storage of

the GM RM before measurements are started,

— otherwise, they must be transported from door to door keeping them at all times under such storage conditions

for which it has been demonstrated that there is no influence on the assigned values.

G. Establishment of a certificate for CRMs:

— a certificate complemented by a certification report has to be established, containing all information relevant to
and needed by the user. The certificate and report must be made available when the GM CRM is distributed,

— certified values must be traceable to stated references and be accompanied by an expanded uncertainty statement

valid for the entire shelf-life of the GM CRM.