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Commission Regulation (EC) No 378/2005 of 4 March 2005 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the duties and tasks of the Community Reference Laboratory concerning applications for authorisations of feed additives (Text with EEA relevance)
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There are outstanding changes not yet made to Commission Regulation (EC) No 378/2005. Any changes that have already been made to the legislation appear in the content and are referenced with annotations.
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Laboratories participating in the consortium must satisfy the following minimum requirements:
have been proposed as a national reference laboratory by a Member State for the purpose of taking part in the consortium referred to in Annex II to Regulation (EC) No 1831/2003;
have suitable qualified staff that are adequately trained in analytical methods used for the feed additives on which they are involved;
possess the equipment needed to carry out the analysis of feed additives, in particular the ones on which they are carrying tasks under this Regulation;
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 consortium;
provide assurance that their staff respect the confidential aspects of issues, results or communications involved in the handling of applications for authorisation submitted in accordance with Regulation (EC) No 1831/2003 and in particular the information referred to in Article 18 of that Regulation;
have sufficient knowledge of international standards and practices in laboratory work;
must be accredited, or being in the process of accreditation according to international standards such as ISO 17025.
Textual Amendments
Joint Research Centre of the European Commission. Institute for Reference Materials and Measurements. Geel, Belgium.
Federaal Laboratorium voor de Voedselveiligheid Tervuren (FLVVT –FAVV);
Vlaamse Instelling voor Technologisch Onderzoek (VITO), Mol;
Centre wallon de Recherches agronomiques (CRA-W), Gembloux.
Ústřední kontrolní a zkušební ústav zemědělský (ÚKZÚZ), Praha.
Fødevarestyrelsens Laboratorie Aarhus (kemisk);
Fødevarestyrelsens Laboratorie Ringsted (kemisk og mikrobiologisk).
Sachgebiet Futtermittel des Bayrischen Landesamtes für Gesundheit und Lebensmittelsicherheit (LGL), Oberschleißheim;
Landwirtschaftliche Untersuchungs- und Forschungsanstalt (LUFA), Speyer;
Staatliche Betriebsgesellschaft für Umwelt und Landwirtschaft. Geschäftsbereich 6 — Labore Landwirtschaft, Nossen;
Thüringer Landesanstalt für Landwirtschaft (TLL). Abteilung Untersuchungswesen. Jena.
Põllumajandusuuringute Keskus (PMK). Jääkide ja saasteainete labor, Saku, Harjumaa;
Põllumajandusuuringute Keskus (PMK), Taimse materjali labor, Saku, Harjumaa.
Laboratorio Arbitral Agroalimentario. Ministerio de Agricultura, Alimentación y Medio Ambiente, Madrid;
Laboratori Agroalimentari, Departament d'Agricultura, Ramaderia, PESCA, Alimentació i Medi Natural. Generalitat de Catalunya, Cabrils.
Laboratoire de Rennes (SCL L35), Service Commun des Laboratoires DGCCRF et DGDDI, Rennes.
The State Laboratory, Kildare.
Εργαστήριο Ελέγχου Κυκλοφορίας Ζωοτροφών Θεσσαλονίκης.
Istituto Superiore di Sanità. Dipartimento di Sanità Pubblica Veterinaria e Sicurezza Alimentare, Roma;
Centro di referenza nazionale per la sorveglienza ed il controllo degli alimenti per gli animali (CReAA), Torino.
Feedingstuffs Analytical Laboratory, Department of Agriculture, Nicosia.
Pārtikas drošības, dzīvnieku veselības un vides zinātniskais institūts BIOR, Rīga.
Nacionalinis maisto ir veterinarijos rizikos vertinimo institutas, Vilnius.
Laboratoire de Contrôle et d'essais — ASTA, Ettelbruck.
Nemzeti Élelmiszerlánc-biztonsági Hivatal, Élelmiszer- és Takarmánybiztonsági Igazgatóság, Takarmányvizsgáló Nemzeti Referencia Laboratórium, Budapest.
RIKILT Wageningen UR, Wageningen.
Österreichische Agentur für Gesundheit und Ernährungssicherheit (AGES), Wien.
Instytut Zootechniki — Państwowy Instytut Badawczy, Krajowe Laboratorium Pasz, Lublin;
Państwowy Instytut Weterynaryjny, Pulawy.
Instituto Nacional de Investigação Agrária e Veterinária, I.P. (INIAV,IP), Lisboa.
Univerza v Ljubljani. Veterinarska fakulteta. Nacionalni veterinarski inštitut. Enota za patologijo prehrane in higieno okolja, Ljubljana;
Kmetijski inštitut Slovenije, Ljubljana.
Skúšobné laboratórium analýzy krmív, Ústredný kontrolný a skúšobný ústav poľnohospodársky, Bratislava.
Elintarviketurvallisuusvirasto/Livsmedelssäkerhetsverket (Evira), Helsinki/Helsingfors.
Avdelningen för kemi, miljö och fodersäkerhet, Statens Veterinärmedicinska Anstalt (SVA), Uppsala.
LGC Ltd, Teddington.
The National Institute of Nutrition and Seafood Research (NIFES), Bergen.]
The CRL shall be responsible for:
the reception, storage and maintenance of the samples of the feed additive sent by the applicant as provided for in Article 7(3)(f);
evaluating the method of analysis of the feed additive, and of other relevant methods of analysis related to it, on the basis of the data provided in the application for authorisation of the feed additive as regards its suitability for official control in accordance with the requirements of the implementing rules referred to in Article 7(4) and (5) and the guidance of the Authority referred to in Article 7(6);
submitting a full evaluation report to the Authority on the results of the duties and tasks referred to in this Annex;
where necessary, the testing of the method(s) of analysis.
Textual Amendments
For the purpose of the calculation of the fee, the fee is composed of the following two components:
The first component is intended to support the CRL administrative costs and the costs related to the handling of the reference samples. This first component amounts to EUR 2 000 .
The second component is intended to support the costs of the Rapporteur Laboratory for the scientific evaluation and preparation of the evaluation report. This second component amounts to EUR 4 000 .
The two components are applied as detailed below to calculate the fee rates.
Fee = Component 1 + Component 2 = EUR 6 000
when Article 3 (4)(a) and Article 5(4)(a) apply:
Fee = EUR 0
when only Article 3 (4)(a) applies, only Component 2 is applicable:
Fee = EUR 4 000
Fee = Component 1 + Component 2 = EUR 6 000
For groups of applications concerning more than one feed additive submitted simultaneously belonging to the same category of feed additives, functional group and sub classification, if applicable, and other than chemically defined flavourings, zootechnical additives, coccidiostats and histomonostats, and when the methods of analysis used for these feed additives are of the multi-analyte type of methods of analysis, the fee shall be calculated as follows:
The first component is multiplied by the number (n) of feed additives in the group:
Component 1 = (EUR 2 000 × n) = N
The second component is multiplied by the number (m) of methods of analysis to be evaluated by the CRL:
Component 2 = (EUR 4 000 × m) = M
The fee shall be the sum of the two components:
Fee = N + M
For groups of applications concerning more than one chemically defined flavouring submitted simultaneously and when the methods of analysis used for these feed additives are of the multi-analyte type of methods of analysis, the fee shall be calculated as follows:
The first component is multiplied by the number (n) of reference samples, as specified in Article 3 paragraph 1, submitted to the CRL:
Component 1 = (EUR 2 000 × n) = N
The second component is multiplied by the number (m) of methods of analysis to be evaluated by the CRL:
Component 2 = (EUR 4 000 × m) = M
The fee shall be the sum of the two components:
Fee = N + M
when Article 3(4)(b) and Article 5(4)(b) apply:
Fee = EUR 0
when only Article 3(4)(b) applies, only Component 2 applies:
Fee = EUR 4 000
Fee = component 2 = EUR 4 000
when Article 5(4)(c) applies: Fee = EUR 0.] ]
OJ L 165, 30.4.2004, p. 1. Corrigendum OJ L 191, 28.5.2004, p. 1.’
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