ANNEX IRequirements 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:

  1. (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;

  2. (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.

ANNEX IINational 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 Tierseuchen (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),

  • 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);

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);

Suomi/Finland

  • Tullilaboratorio

Sverige

  • Livsmedelsverket (SLV)

United Kingdom

  • Central Science Laboratory (CSL),

  • LGC Limited (LGC),

  • Scottish Agricultural Science Agency (SASA).

ANNEX IIIAmendments to the Annex to Regulation (EC) No 1829/2003

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

  1. 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”.

  2. 3.

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

    1. (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;

    2. (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 Council6, 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;

    3. (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;

    4. (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;

    5. (e)

      submitting full evaluation reports to the Authority.

  3. 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.