Commission Regulation (EC) No 378/2005Show full title

ANNEX I Requirements for laboratories participating, as referred to in Article 8

Laboratories participating in the consortium must satisfy the following minimum requirements:

(a)

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;

(b)

have suitable qualified staff that are adequately trained in analytical methods used for the feed additives on which they are involved;

(c)

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;

(d)

have an adequate administrative infrastructure;

(e)

have sufficient data-processing capacity to produce technical reports and to enable rapid communication with the other laboratories participating in the consortium;

(f)

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;

(g)

have sufficient knowledge of international standards and practices in laboratory work;

(h)

must be accredited, or being in the process of accreditation according to international standards such as ISO 17025.

ANNEX II Community reference laboratory and consortium of national reference laboratories, as referred to in Article 6(2)

COMMUNITY REFERENCE LABORATORY

Joint Research Centre of the European Commission. Institute for Reference Materials and Measurements, Geel, Belgium.

NATIONAL REFERENCE LABORATORIES OF THE MEMBER STATES

Belgique/België

• Federaal Voedingslabo Tervuren (FAVV), Tervuren,

• Vlaamse Instelling voor Technogisch Onderzoek (VITO), Mol;

Česká republika

• Central Inst. Superv. Test. Agriculture, Ústřední kontrolní a zkušební ústav zemědělský (ÚKZÚZ), Praha;

Danmark

• Plantedirektoratets Laboratorium, Lyngby;

Deutschland

• Schwerpunktlabor Futtermittel des Bayerischen Landesamtes für Gesundheit und Lebensmittelsicherheit (LGL). Oberschleißheim;

• Landwirtschaftliche Untersuchungs- und Forschungsanstalt (LUFA) Speyer. Speyer;

• Sächsische Landesanstalt für Landwirtschaft. Fachbereich 8 — Landwirtschaftliches Untersuchungswesen. Leipzig;

• Thüringer Landesanstalt für Landwirtschaft (TLL). Abteilung Untersuchungswesen. Jena;

Eesti

• Põllumajandusuuringute Keskus (PMK), Jääkide ja saasteainete labor, Saku, Harjumaa,

• Põllumajandusuuringute Keskus (PMK), Taimse materjali analüüsi labor, Saku, Harjumaa;

España

• Laboratorio Arbitral Agroalimentario, Ministerio de Agricultura, Pesca y Alimentación, Madrid.

• Laboratori Agroalimentari, Departament d’Agricultura, Ramaderia i Pesca, Generalitat de Catalunya, Cabrils.

France

• Laboratoire de Rennes, direction générale de la concurrence, de la consommation et de la répression des fraudes (DGCCRF), Rennes;

Ireland

• The State Laboratory, Dublin;

Italia

• Istituto Superiore di Sanità. Dipartimento di Sanità alimentare ed animale, Roma.

• Centro di referenza nazionale per la sorveglianza ed il controllo degli alimenti per gli animali (CReAA), Torino.

Κύπρος

• Feedingstuffs Analytical Laboratory, Department of Agriculture, Nicosia;

Latvija

• Valsts veterinārmedicīnas diagnostikas centrs (VVMDC), Rīga;

Lietuvos

• Nacionalinė veterinarijos laboratorija, Vilnius,

• Klaipėdos apskrities VMVT laboratorija, Klaipėda;

Luxembourg

• Laboratoire de contrôle et d'essais — ASTA, Ettelbrück;

Magyarország

• Országos Mezőgazdasági Minősítő Intézet (OMMI) Központi Laboratórium, Budapest;

Nederland

• RIKILT- Instituut voor Voedselveiligheid, Wageningen,

• Rijkinstituut voor Volksgezondheid en Milieu (RIVM), Bilthoven;

Österreich

• Österreichische Agentur für Gesundheit und Ernährungssicherheit (AGES), Wien;

Polska

• Instytut Zootechniki w Krakowie, Krajowe Laboratorium Pasz, Lublin,

• Państwowy Instytut Weterynaryjny, Puławy;

Portugal

• Laboratório Nacional de Investigação Veterinária, Lisboa.

Slovenija

• Univerza v Ljubljani. Veterinarska fakulteta, Nacionalni veterinarski inštitut, Enota za patologijo prehrane in higieno okolja, Ljubljana,

• Kmetijski inštitut Slovenije, Ljubljana;

Slovensko

• Skúšobné laboratórium – oddelenie analýzy krmív, Ústredný kontrolný a skúšobný ústav poľnohospodársky, Bratislava.

Suomi/Finland

• Kasvintuotannon tarkastuskeskus/Kontrollcentralen för växtproduktion (KTTK). Vantaa/Vanda;

Sverige

• Foderavdelningen, Statens veterinärmedicinska anstalt (SVA), Uppsala.

United Kingdom

• The Laboratory of the Government Chemist, Teddington.

NATIONAL REFERENCE LABORATORIES OF EFTA COUNTRIES

Norway

• LabNett AS, Agricultural Chemistry Laboratory, Stjørdal.

ANNEX III Text replacing paragraphs 2 and 3 of Annex II to Regulation (EC) No 1831/2003

‘2. For the duties and tasks set out in this Annex, the CRL may be assisted by a consortium of national reference laboratories.

The CRL shall be responsible for:

2.1.

the reception, storage and maintenance of the samples of the feed additive sent by the applicant as provided for in Article 7(3)(f);

2.2.

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);

2.3.

submitting a full evaluation report to the Authority on the results of the duties and tasks referred to in this Annex;

2.4.

where necessary, the testing of the method(s) of analysis.

3. The CRL shall be responsible for coordination of the validation of the method(s) of analysis of the additive, in accordance with the procedure provided for in Article 10 of Regulation (EC) No 378/2005(1). This task may involve the preparation of food or feed test material.

4. The CRL shall provide scientific and technical assistance to the Commission, especially in cases where Member States contest the results of analyses related to the duties and tasks referred to in this Annex, without prejudice to any role defined for it under Articles 11 and 32 of Regulation (EC) No 882/2004 of the European Parliament and of the Council(2).

5. On request by the Commission, the CRL may also be responsible for conducting special analytical or other related studies in a manner similar to the duties and tasks referred to in point 2. This may be the case, in particular, for existing products notified under Article 10 and included in the Register and for the period until an application for authorisation under Article 10(2) is submitted in accordance with Article 10(2).

6. The CRL shall be responsible for the overall coordination of the consortium of national reference laboratories. The CRL shall ensure that the relevant data concerning the applications are made available to the laboratories.

7. Without prejudice to the responsibilities of the Community reference laboratories laid down in Article 32 of Regulation (EC) No 882/2004, the CRL may create and maintain a database of methods of analysis available for control of feed additives and make it available to official control laboratories from Member States and other interested parties.’

(1)

OJ L 59, 5.3.2005, p. 8.

(2)

OJ L 165, 30.4.2004, p. 1. Corrigendum OJ L 191, 28.5.2004, p. 1.