ANNEX V

 

 

Chapter 1

 

The following laboratories shall be designated Community reference laboratories for the detection of residues of certain substances:

(a) For the residues listed in Annex I, Group A 1, 2, 3, 4, Group B 2 (d) and Group B 3 (d)

Rijksinstituut voor Volksgezondheid en MilieuhygiÎne (RIVM)
A. van Leeuwenhoeklaan, 9
NL-3720 BA Bilthoven

(b) For the residues listed in Annex I, Group B 1 and B 3 (e) and carbadox residues and olaquindox residues

Laboratories des médicaments vétérinaires (CNEVA-LMV)
La Haute Marche, Javene
F-35135-Fougères

(c) For the residues listed in Annex I, Group A 5 and Group B 2 (a), (b), (e)

Bundesinstitut fuer Gesundheitlichen Verbraucherschutz und Veterinärmedizin (BGVV)
Diedersdorfer Weg, 1
D-12277-Berlin

(d) For the residues listed in Annex I, Group B 2 (c) and Group B 3 (a), (b), (c):

Istituto Superiore di Sanità
Viale Regina Elena, 299
I-00161-Roma

The compounds included in Group A 6, B 2 (f) and B 3 (f) are allocated to the designated Community reference laboratories, according to their pharmacological action.

 

 

Chapter 2

 

The powers and operating conditions of the Community reference laboratories for the detection of residues in live animals, their excrement and body fluids and in tissue, animal products, animal feed and drinking water shall be as follows:

1. The functions of Community reference laboratories shall be:

(a) to promote and coordinate research into new analytical methods and to inform national reference laboratories of advances in analytical methods and equipment;

(b) to help the national reference laboratories (NRLs) for residues to implement an appropriate quality assurance scheme system based on good laboratory practice (GLP) principles and EN 45 000 criteria;

(c) to approve validated methods as reference methods, to be integrated into a collection of methods;

(d) to provide the national reference laboratories with the routine analytical methods accepted during the MRL procedure;

(e) to provide national reference laboratories with details of analytical methods and the comparative tests to be conducted, and to inform them of the results of the tests;

(f) to provide national reference laboratories, at their request, with technical advice on the analysis of the substances for which they have been designated the Community reference laboratory;

(g) to organize comparative tests for the benefit of the national reference laboratories, the frequency of which shall be determined in agreement with the Commission. Consequently, the Community reference laboratories shall distribute blank samples and samples containing known amounts of analyte to be analysed;

(h) to identify residues and determine their concentration in cases where the results of an analysis give rise to a disagreement between Member States;

(i) to conduct initial and further training courses for the benefit of analysts from national laboratories;

(j) to provide the Commission services, including the standards, measurements and testing programme, with technical and scientific assistance;

(k) to compile a report on each year's work and transmit it to the Commission;

(l) to liaise, in the field of analytical methods and equipment, with the national reference laboratories designated by third countries in the plans to be submitted in accordance with Article 11 of this Directive.

2. In order to perform the functions specified in paragraph 1, Community reference laboratories must satisfy the following minimum requirements:

(a) have been designated as a national reference laboratory in a Member State;

(b) have suitable qualified staff who are adequately trained in analytical methods used for the residues for which they have been designated the Community reference laboratory;

(c) possess the equipment and substances needed to carry out the analysis for which they are responsible;

(d) have an adequate administrative infrastructure;

(e) have sufficient data-processing capacity to produce statistics based on their findings and to enable rapid communication of those statistics and other information to national reference laboratories and the Commission;

(f) ensure that their staff respect the confidential nature of certain issues, results or communications;

(g) have sufficient knowledge of international standards and practices;

(h) have available an up-to-date list of certified reference material and reference material held by the Institute for Reference Material and Methods, and an up-to-date list of manufacturers and vendors of that material.


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