Commission Regulation (EC) No 1981/2006 of 22 December 2006 on detailed rules for the implementation of Article 32 of Regulation (EC) No 1829/2003 of the European Parliament and of the Council as regards the Community reference laboratory for genetically modified organisms   (Text with EEA relevance)
Date: 2006-12-22
Institutions: European Commission
Subjects: agro-industry, animal feedingstuffs, food inspection, food safety, genetically modified organism, quasi-fiscal charge, research body

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COMMISSION REGULATION (EC) No 1981/2006

of 22 December 2006

on detailed rules for the implementation of Article 32 of Regulation (EC) No 1829/2003 of the
European Parliament and of the Council as regards the Community reference laboratory for
genetically modified organisms

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

to charge a financial contribution to applicants for new
authorisations, for renewal of authorisations and in the
case of modification of authorisations where appropriate.

Having regard to the Treaty
Community,

establishing the European

the
Having regard to Regulation (EC) No 1829/2003 of
European Parliament and of
the Council of 22 September
2003 on genetically modified food and feed (1), and in
particular Article 32, fifth sub-paragraph, thereof,

Whereas:

(EC) No

1829/2003

a
Regulation
to carry out
Community reference laboratory (CRL)
It
certain duties and tasks set out in that Regulation.
also provides that the CRL is to be assisted by national
reference laboratories.

provides

for

Methods of detection and identification which have to be
tested and validated by the CRL and samples and control
samples have to meet the requirements laid down in
Commission Regulation (EC) No 641/2004 of 6 April
2004 on detailed rules for the implementation of Regu-
lation (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 adven-
titious or technically unavoidable presence of genetically
modified material which has benefited from a favourable
risk evaluation (2).

(5)

(6)

(7)

(8)

The determination of the amount of the financial contri-
bution should take into account the burden of work to
be carried out by the CRL in each case, depending on the
level of method testing and validation already carried out
prior to the submission of the application for authori-
sation.

Applicants should be encouraged to provide data that
refer to modules which have already been validated and
published by the CRL in order to facilitate both the
establishment of the application dossier and the vali-
dation of the detection method.

A financial contribution should be levied on a flat-rate
basis in order to contribute to supporting the costs
incurred in the comprehensive data analysis and in-
the method and
verification of
house
samples received to be carried out by the CRL in all
cases where a new method is submitted.

laboratory

An additional financial contribution should be charged to
applicants where the validation of the proposed method
requires
study
to
involving national
comply with the criteria referred to in Annex I of Regu-
lation (EC) No 641/2004.

reference laboratories in order

the performance of

collaborative

a

It is necessary to provide detailed rules for implementing
Article 32 of Regulation (EC) No 1829/2003.

(9)

The financial contribution to be paid by applicants in
accordance with Article 32 of Regulation (EC) No
1829/2003 should be used only towards supporting
the costs of
in the
Annex to that Regulation. The CRL should be authorised

the duties and tasks as set out

(1) OJ L 268, 18.10.2003, p. 1.
(2) OJ L 102, 7.4.2004, p. 14.

to members of

The amount of the financial contributions should cover
the costs directly associated with the validation tasks to
be performed. Those include in particular the manpower,
the reagents and other associated disposable material, the
distribution of material
the European
Network of GMO laboratories (ENGL) where appropriate
and the administrative costs. They should be calculated
the
on the basis of
Commission’s Joint Research Centre in carrying out vali-
dations of detection methods,
including collaboration
with members of
the ENGL where appropriate, and
should not exceed the actual costs incurred in carrying
out that validation.

gained by

experience

the

(1)

(2)

(3)

(4)

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(10) Where the validation costs for a specific application for
authorisation exceeds substantially the amount of
the
financial contributions provided for in this Regulation,
the CRL should be able to charge an additional contri-
bution to the applicant. In that case, the applicant should
have the right to be exempted from the payment of the
additional contribution if he withdraws its application
within a set time limit.

(16)

The relationship between the national reference labora-
tories assisting the CRL for testing and validation of
detection methods and between them and the CRL
should be defined by a written agreement.

(17)

The Annex to Regulation (EC) No 1829/2003 should be
amended accordingly.

(11) Due consideration should be given to the specific case of
biotechnological
in developing
research originating
countries. A reduction of the amount of the financial
contribution should therefore be provided where the
head office of the applicant for authorisation is estab-
lished in a developing country.

(18)

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

opinion

the

the

of

(12)

(13)

(SMEs)

to facilitate the participation of small and
In order
to the Community
medium-sized enterprises
authorisation of genetically modified
procedure
for
it is appropriate to provide for a
(GM) food and feed,
reduced financial contribution where applicants are SMEs.
The model declaration on the information relating to the
qualification of an enterprise as an SME (1) could serve
for the written evidence to be provided by applicants as
to their SME status.

Regulation (EC) No 1829/2003 already lays down the
rule that applicants should make a financial contribution,
so any applicants who have lodged applications before
the entry into force of this Regulation will be aware of
this rule. Consequently, the financial contribution should
authorisation
also be
submitted before the date of entry into force of this
Regulation.

required for

applications

for

(14) National reference laboratories assisting the CRL for the
duties and tasks set out in the Annex to Regulation (EC)
No 1829/2003 should be part of the European Network
of GMO Laboratories (ENGL), whose members represent
the state-of-the-art in GMO detection, including expertise
in method development, performance and validation,
sampling and management of biological and analytical
uncertainties.
specific
should
requirements where they have to assist the CRL speci-
fically for testing and validation of detection methods in
the context of collaborative studies according to interna-
tional standards.

also meet

They

HAS ADOPTED THIS REGULATION:

Article 1

Subject matter and scope

This Regulation lays down detailed rules for the implementation
of Article 32 of Regulation (EC) No 1829/2003 as regards:

(a)

the contribution to the costs of the tasks of the Community
reference laboratory (CRL) and of
the national reference
laboratories, as referred to in the Annex to the said Regu-
lation; and

(b) the establishment of national reference laboratories.

Article 2

Definitions

For the purposes of this Regulation, the following definitions
apply:

(a)

‘full validation procedure’ means the assessment through a
involving national reference laboratories of the
ring trial
criteria set by the applicant as
method performance
entitled ‘Definition of
compliant with the document
minimum performance
analytical
methods of GMO testing’ referred to in point 1(B) of
Annex I
to Regulation (EC) No 641/2004, and the
assessment of the repeatability and trueness of the method
provided by the applicant;

requirements

for

(15)

In the interests of stability and efficacy and in order to
make the validation procedure operational in accordance
is necessary to designate the
with this Regulation,
national reference laboratories apt to assist the CRL for
testing and validation of detection methods.

it

(b) ‘small and medium-sized enterprise (SME)’ means small and
medium-sized enterprises as defined in Commission Recom-
mendation 2003/361/EC (2);

(1) Commission communication 2003/C 118/03 (OJ C 118, 20.5.2003,

p. 5). Corrigendum published in OJ C 156, 4.7.2003, p. 14.

(2) OJ L 124, 20.5.2003, p. 36.

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(c)

countries’ means beneficiary
‘developing
as
referred to in Article 2 of Council Regulation (EC) No
980/2005 of 27 June 2005 applying a scheme of gener-
alised tariff preferences (1);

countries

The contributions provided for in paragraphs 1 and 2

4.
remain due in case of withdrawal of the application.

(d) ‘application’ where used without further specification, means
an application for authorisation submitted in accordance
with Article 5 or 17 of Regulation (EC) No 1829/2003,
including applications submitted under other Community
supplemented in
legislation which are transformed or
accordance with Article 46 of
It also
refers
authorisations
to applications
according to Article 11 or 23 of Regulation (EC) No
1829/2003 and modifications of authorisations according
to Articles 9(2), 10, 21(2) or 22 of that Regulation, where
the CRL is requested to test and validate a method of
detection and identification.

that Regulation.

renewal of

for

Article 3

Contributions

For

1.
EUR 30 000 shall be paid by the applicant to the CRL.

application,

flat-rate

contribution

each

a

of

2. Where a full validation procedure of a method of
detection and identification for a single GMO event according
to the requirements laid down in Annex I of Regulation (EC) No
641/2004 is required, the CRL shall request the applicant to pay
an additional contribution of EUR 60 000.

This amount shall be multiplied by the number of GMO events
to be fully validated.

The CRL shall reduce the amount of the additional contribution,
in proportion of the costs saved:

(a) where the material needed to perform the full validation

procedure is supplied by the applicant; and/or

(b) where the applicant provides data that refer to modules,
such as DNA extraction protocols and species specific
reference systems, already validated and published by the
CRL.

3. Where the costs of the validation of the detection method
proposed by the applicant exceed substantially the amount of
the financial contributions mentioned under paragraphs 1 and
2, an additional contribution shall be requested.

Article 4

Reductions and exemptions

1. Where the applicant is a SME or has its head office estab-
lished in a developing country,
the financial contributions
referred to in Article 3(1) and (2) shall be reduced by 50 %.

2. Where the same method of detection and identification
has already been included in a previous application by the same
applicant
for products related to the same GMO and that
method has been validated and published by the CRL or its
validation is pending, that applicant shall be exempted from
the payment of the financial contributions referred to Article 3.

validation tasks

However, where costs are incurred by the CRL in carrying out
the
laid down in Regulation (EC) No
1829/2003, the CRL may charge the applicant a maximum
contribution of EUR 30 000.

Article 3(3) shall not apply where the applicant is a SME
3.
or has its head office established in a developing country, nor to
applications submitted before the entry into force of this Regu-
lation.

Article 5

Procedure

The applicant shall provide evidence that

1.
the flat-rate
contribution of EUR 30 000 referred to in Article 3(1) has
been paid to the CRL when it submits the samples of the
food and feed and their control samples to the CRL in
accordance with Article 5(3)(j) or Article 17(3)(j) of Regulation
(EC) No 1829/2003.

2. Where, as provided for in Article 3(2), a full validation
procedure is required, the CRL shall notify the applicant in
writing of this fact and require the payment of the amount
due in accordance with that provision.

The additional contribution shall cover 50 % of the part of the
costs exceeding the amount of the contributions referred to in
paragraphs 1 and 2.

(1) OJ L 169, 30.6.2005, p. 1.

3. Where, as provided for in Article 3(3), the CRL expects
the costs of the validation of the detection method proposed by
the applicant to exceed substantially the amount of the financial
contributions referred to in Article 3(1) and (2), it shall notify
the applicant in writing of the estimated amount of the addi-
tional costs.

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If, within one month of the date of receipt of the notification,
the applicant withdraws its application, the additional contri-
bution referred to in Article 3(3) is not due.

After completion of the validation of the detection method, the
CRL shall notify the applicant in writing the actual and duly
justified costs incurred in carrying out the validation of the
detection method and require payment of
the contribution
due in accordance with Article 3(3).

Article 6

National
reference laboratories assisting the CRL for
testing and validating the methods of detection and
identification

1.
Laboratories which assist the CRL in testing and validating
the method of detection and identification, as provided for in
Articles 6(3)(d) and 18(3)(d) of Regulation (EC) No 1829/2003,
shall fulfil the minimum requirements laid down in Annex I to
this Regulation.

4. Where, as provided for in Article 4(2), costs are incurred,
the CRL shall notify the applicant in writing of the amount of
the contribution due, including a justification of that amount.

laboratories

listed in Annex II,

The
are meeting those
requirements, and are hereby appointed as national reference
laboratories under Regulation (EC) No 1829/2003 to assist
the CRL for testing and validating the method of detection.

5. Where an application has been submitted before the date
of entry into force of this Regulation, the CRL shall, within
three months of that date, notify in writing the applicant of
the amount of the financial contribution to be paid according
to Article 3(1) and (2) as appropriate.

2.
The CRL and the national reference laboratories listed in
Annex II shall enter into a written agreement to define the
In
relations between them, notably in financial matters.
particular, the written agreement shall provide that the CRL is
to distribute a share of the financial contributions it receives to
the national reference laboratories.

the contribution is claimed in
6. When a reduction of
accordance with Article 4(1), the application shall be accom-
panied by written evidence that the conditions laid down in that
Article are fulfilled. The CRL may require supplementary infor-
mation where appropriate.

Article 7

Reporting

The CRL shall be responsible for preparing an annual report on
each year’s activities carried out for the implementation of this
Regulation and shall submit it to the Commission. The national
reference laboratories under Regulation (EC) No 1829/2003
shall contribute to this annual report.

7.
The contributions mentioned in paragraph 2 to 5 shall be
payable by the applicant within 45 days of the date of reception
of the notification.

The CRL may also organise an annual meeting with the national
reference laboratories,
the
annual report.

the establishment of

in view of

Where the applicant has not provided proof of payment within
the set time limit, and where the evaluation report referred to in
point 3(e), of the Annex to Regulation (EC) No 1829/2003 has
not yet been sent to the European Food Safety Authority (the
Authority), the CRL shall not submit it to the Authority until
the reception of the due payment. The CRL shall immediately
notify the Authority that its report will be delayed, to enable the
Authority to inform the applicant and take any further steps
required under Articles 6(1) to (2) and 18(1) to (2) of Regu-
lation (EC) No 1829/2003.

Article 8

Amendment to Regulation (EC) No 1829/2003

The Annex to Regulation (EC) No 1829/2003 is amended in
accordance with Annex III to this Regulation.

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Article 9

Entry into force

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

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

Done at Brussels, 22 December 2006.

For the Commission

Markos KYPRIANOU
Member of the Commission

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ANNEX I

Requirements for laboratories assisting the Community reference laboratory for testing and validation of
methods for detection, as referred to in Article 6(1)

Laboratories assisting the Community reference laboratory for testing and validating the method for detection, as set out
in point 3(d) of the Annex to Regulation (EC) No 1829/2003, must:

(a) be accredited, or being in the process of accreditation according to EN ISO/IEC 17025 on ‘General requirements for
the competence of testing and calibration laboratories’ or an equivalent international standard which ensures that the
laboratories:

— have suitably qualified staff with adequate training in analytical methods used for the detection and identification

of GMOs and GM food and feed,

— possess the equipment needed to carry out the analysis of GMOs and GM food and feed,

— have an adequate administrative infrastructure,

— have sufficient data-processing capacity to produce technical reports and to enable rapid communication with the

other laboratories participating in the testing and validation of detection methods;

(b) provide assurance that their staff respect the confidential nature of subjects, data, results or communications involved
in the handling of applications for authorisation, for renewal of authorisations or for modification of authorisations
submitted in accordance with Regulation (EC) No 1829/2003 and in particular the confidential information referred
to in Article 30 of that Regulation.

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ANNEX II

National reference laboratories assisting the CRL for testing and validation of methods for detection, as referred
to in Article 6(1)

Belgique/België
— Centre wallon de Recherches agronomiques (CRA-W),

— Institut Scientifique de Santé Publique (ISP) — Wetenschappelijk Instituut Volksgezondheid (WIV),

— Instituut voor Landbouw- en Visserijonderzoek (ILVO);

Česká republika
— Státní veterinární ústav Jihlava (SVU Jihlava),

— Státní zdravotní ústav (SZÚ), Laboratoř pro molekulárně biologické metody (LMBM), Centrum hygieny potravinových

řetězců v Brně,

— Státní zemědělská a potravinářská inspekce (SZPI),

— Vysoká škola chemicko-technologická v Praze (VŠCHT),

— Výzkumný ústav rostlinné výroby (VÚRV), Praha;

Danmark
— Danmarks Fødevareforskning (DFVF),

— Ministeriet for Fødevarer, Landbrug og Fiskeri, Plantedirektoratet, Laboratorium for Diagnostik i Planter, Frø og Foder;

Deutschland
— Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit (LGL),

— Berliner Betrieb für Zentrale Gesundheitliche Aufgaben (BBGes) — Institut für Lebensmittel, Arzneimittel und Tier-

seuchen (ILAT),

— Bundesinstitut für Risikobewertung,

— Chemisches und Veterinäruntersuchungsamt (CVUA) Freiburg,

— Chemisches und Veterinäruntersuchungsamt Ostwestfalen-Lippe,

— Institut für Hygiene und Umwelt der Hansestadt Hamburg,

— Landesamt für Landwirtschaft, Lebensmittelsicherheit und Fischerei — Mecklenburg-Vorpommern (LALLF MV),

— Landesamt für Soziales, Gesundheits- und Verbraucherschutz — Abteilung F: Verbraucherschutz, Veterinärmedizin,

Lebensmittelhygiene und Molekularbiologie,

— Landesamt für Umweltschutz Sachsen-Anhalt,

— Landesamt für Verbraucherschutz Sachsen-Anhalt — Fachbereich Lebensmittelsicherheit,

— Landesbetrieb Hessisches Landeslabor — Standort Kassel,

— Landeslabor Brandenburg,

— Landeslabor Schleswig-Holstein,

— Landesuntersuchungsamt Rheinland-Pfalz — Institut für Lebensmittelchemie Trier,

— Landesuntersuchungsanstalt für das Gesundheits- und Veterinärwesen Sachsen (LUA),

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— Landwirtschaftliche Untersuchungs- und Forschungsanstalt Rostock der LMS Mecklenburg-Vorpommern,

— Niedersächsisches Landesamt für Verbraucherschutz und Lebensmittelsicherheit (LAVES) — Lebensmittelinstitut (LI)

Braunschweig,

— Sächsische Landesanstalt für Landwirtschaft — Fachbereich Landwirtschaftliches Untersuchungswesen,

— Staatliche Landwirtschaftliche Untersuchungs- und Forschungsanstalt Augustenberg (Baden-Württemberg),

— Thüringer Landesamt für Lebensmittelsicherheit und Verbraucherschutz (TLLV);

Eesti
— DNA analüüsi laboratoorium, Geenitehnoloogia Instituut (GTI), Tallinna Tehnikaülikool (TTÜ),

— Keemilise ja Bioloogilise Füüsika Instituut (KBFI), Molekulaargeneetika laboratoorium (MG),

— Veterinaar-ja Toidulaboratoorium (VTL);

Elláda
— Εθνικό Ίδρυμα Αγροτικής Έρευνας Εργαστήριο Γενετικής Ταυτοποίησης Γεωργικών Προϊόντων, Μικροοργανισμών και

Ελέγχου Σπόρων Σποράς για την Ανίχνευση, Γενετικών Τροποποιήσεων,

— Υπουργείο Οικονομίας και Οικονομικών, Γενική Διεύθυνση Γενικού Χημείου του Κράτους (ΓΧΚ), Διεύθυνση Τροφίμων —

Αθήνα;

España
— Centro Nacional de Alimentación, Agencia Española de Seguridad Alimentartia (CNA-AESA),

— Laboratorio Arbitral Agroalimentario del Ministerio de Agricultura, Pesca y Alimentación (LAA-MAPA);

France
— Groupement d’Intérêt Public — Groupe d’Etude et de contrôle des Variétés et des Semences (GIP-GEVES),

— Laboratoire de Phytopathologie et de méthodologies de la détection (INRA Versailles),

— Laboratoire Direction Générale de la Consommation, de la Concurrence et de la Répression des Fraudes de Strasbourg

(Laboratoire de la DGCCRF de Strasbourg),

— Laboratoire National de la Protection des Végétaux d'Orléans (LNPV Orléans);

Ireland
— The State Laboratory (SL), Celbridge;

Italia
— Ente Nazionale Sementi Elette (E.N.S.E.), Laboratorio Analisi Sementi,

— Istituto Superiore di Sanità, Centro Nazionale per la Qualità degli Alimenti e per i Rischi Alimentari (CNQARA),

— Istituto Zooprofilattico Sperimentale delle Regioni Lazio e Toscana, Centro di Referenza Nazionale per la Ricerca di

OGM (CROGM);

Kypros
— Γενικό χημείο του κράτους (γχκ);

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Latvija
— Pārtikas un veterinārā dienesta Nacionālais diagnostikas centrs (PVD NDC);

Lietuva
— Nacionalinė Veterinarijos Laboratorija, GMO Tyrimų Skyrius;

Luxembourg
— Laboratoire National de Santé (LNS), Division du contrôle des denrées alimentaires;

Magyarország
— Országos Élelmiszerbiztonsági és Táplálkozástudományi Intézet (OÉTI),

— Országos Mezőgazdasági Minősítő Intézet, Központi Laboratórium (OMMI);

Nederland
— RIKILT Instituut voor Voedselveiligheid,

— Voedsel en Waren Autoriteit (VWA);

Österreich
— Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH — Kompetenzzentrum Biochemie (AGES -

CC BIOC),

— Umweltbundesamt GmbH;

Polska
— Instytut Biochemii

i Biofizyki Polskiej Akademii Nauk, Laboratorium Analiz Modyfikacji Genetycznych Instytutu

Biochemii i Biofizyki Polskiej Akademii Nauk (GMOIBB), Warszawa,

— Instytut Hodowli i Aklimatyzacji Roślin (IHAR); Laboratorium Kontroli Genetycznie Modyfikowanych Organizmów,

Błonie,

— Instytut Zootechniki (National Feed Laboratory – NFL), Lublin,

— Państwowego Instytutu Weterynaryjnego – Państwowego Instytutu Badawczego w Puławach, Puławy,

— Regionalne Laboratorium Badań Żywności Genetycznie Modyfikowanej (RLG);

Portugal
— Direcção-Geral de Protecção das Culturas (DGPC), Laboratório de Caracterização de Materiais de Multiplicação de

Plantas (LCMMP),

— Instituto Nacional de Engenharia Tecnologia e Inovação (INETI), Laboratório para a Indústria Alimentar (LIA);

Slovenija
— Kmetijski inštitut Slovenije (KIS), Ljubljana,

— Nacionalni inštitut za biologijo (National institute of Biology, NIB), Ljubljana;

Slovensko
— Štátny veterinárny a potravinový ústav, Dolný Kubín (State Veterinary and Food Institute Dolný Kubín),

— Ústav molekulárnej biológie SAV (Molecular Biology Institute of the Slovak Academy of Slovakia),

— Ústredný kontrolný a skúšobný ústav poľnohospodársky, Oddelenie molekulárnej biológie Bratislava, (Central Control

and Testing Institute of Agriculture);

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Suomi/Finland
— Tullilaboratorio

Sverige
— Livsmedelsverket (SLV)

United Kingdom
— Central Science Laboratory (CSL),

— LGC Limited (LGC),

— Scottish Agricultural Science Agency (SASA).

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ANNEX III

Amendments to the Annex to Regulation (EC) No 1829/2003

Points 2, 3 and 4 are replaced by the following:

‘2. For the duties and tasks outlined in this Annex, the Community reference laboratory shall be assisted by the
national reference laboratories referred to in Article 32, which shall consequently be considered as members of
the consortium referred to as the “European Network of GMO laboratories”.

3. The Community reference laboratory shall be responsible, in particular, for:

(a) the reception, preparation, storage, maintenance and distribution to the members of the European Network
of GMO laboratories of the appropriate positive and negative control samples, subject to assurance given by
such members of the respect of the confidential nature of the data received where applicable;

(b) without prejudice to the responsibilities of the Community reference laboratories laid down in Article 32 of
Regulation (EC) No 882/2004 of the European Parliament and of the Council (*), the distribution to national
reference laboratories within the meaning of Article 33 of that Regulation of the appropriate positive and
negative control samples, subject to assurance given by such laboratories of the respect of the confidential
nature of the data received where applicable;

(c) evaluating the data provided by the applicant for authorisation for placing the food or feed on the market,

for the purpose of testing and validation of the method for sampling and detection;

(d) testing and validating the method for detection, including sampling and identification of the transformation
event and, where applicable, for the detection and identification of the transformation event in the food or
feed;

(e) submitting full evaluation reports to the Authority.

4. The Community reference laboratory shall play a role in dispute settlements concerning the results of the tasks
outlined in this Annex, without prejudice to the responsibilities of the Community reference laboratories laid
down in Article 32 of Regulation (EC) No 882/2004.

___________
(*) OJ L 165, 30.4.2004, p. 1, as corrected by OJ L 191, 28.5.2004, p. 1.’