Decree No 528 / 2004 Coll.
Ordinance on requirements for national reference laboratories and reference laboratories in the field of activities covered by the Act on the Central Audit and Examination Institute of the Agricultural
Valid
Order
Effective from 01.11.2004
Text versions:
01.11.2004
15.10.2004
528
DECLARATION
of 30 September 2004
on requirements for national reference laboratories and reference laboratories in the field of activities covered by the Law on the Central Audit and Examination Institute of the Agricultural
The Ministry of Agriculture (hereinafter referred to as "the Ministry") provides, pursuant to Article 5 (7) of Act No. 147 / 2002 Coll., on the Central Audit and Examination Institute of Agriculture and on the amendment of certain related laws (Act on the Central Audit and Examination Institute of Agriculture), as amended by Act No. 21 / 2004 Coll., (hereinafter referred to as "the Act"):
Subject matter
This decree (1) incorporates the relevant European Communityrules (2) and regulates the requirements for material and personnel equipment and the focus, organisation and methods of operation of the national reference laboratory of the Central Control and Testing Institute of Agriculture (hereinafter referred to as the Institute), other national reference laboratories and reference laboratories.
Requirements for laboratory material and personnel equipment
(1) The following requirements shall be laid down for the national reference laboratory of the Institute:
(a) spatial, instrumentation and material equipment, corresponding to technical standard (3);
(b) qualified staff (3) and trained (3) for carrying out and evaluating laboratory tests;
(c) technical and personnel conditions for dealing with expert issues and for cooperation with the European Community Reference Laboratory;
(d) the conditions for ensuring communication at national and international level, corresponding to technical standard (3);
(e) data processing, security and sharing equipment, corresponding to technical standard (3);
(f) in the case of experiments on animals, spatial and material equipment and qualified personnel under specific legislation4).
(2) A further national reference laboratory approved by the Ministry under Section 5 (4) of the Act for professional and test activities not carried out by the Institute shall have the requirements laid down in paragraph 1 (a), (d), (e) and (f) and shall have:
(a) qualified staff (3) and trained (3) for carrying out and evaluating tests within the scope of the approval;
(b) technical and personnel conditions for dealing with expert issues and for cooperation with the Institute and the European Community Reference Laboratory.
(3) A natural or legal person appointed by the Ministry pursuant to Article 5 (5) of the Act by a reference laboratory to carry out professional activities under Article 5 (1) of the Act must comply with the requirements laid down in points (a), (e) and (f) of paragraph 1 and must also have:
(a) qualified staff (3) and trained (3) for carrying out and evaluating tests within the scope of appointment;
(b) administrative, technical and personnel conditions for cooperation with the Institute and other national reference laboratories;
(c) the conditions for granting authorisations under the specific legislation5).
Requirements for laboratory targeting, organisation and methods of operation
(1) The national reference laboratory of the Institute shall ensure:
(a) cooperation with the European Community Reference Laboratory, including staff training;
(b) cooperation on the development, verification and validation of new laboratory procedures;
(c) publication of the uniform working procedures referred to in Article 3 (1) (a) of the Act and their ongoing addition;
(d) the organisation of inter-laboratory comparative tests pursuant to Article 3 (1) (c) of the Act;
(e) carrying out analyses in the case of disputes concerning the accuracy of the results of laboratory tests;
(f) supporting documents for the granting, modification, withdrawal or revocation of an authorisation granted by the Institute pursuant to Article 5 (1) of the Act, demonstrating the competence of laboratories of a natural or legal person to carry out professional activities under Article 5 (1) of the Act, under the conditions laid down in specific legislation5),
(g) supporting documents for the activities of the Institute pursuant to Article 5 (4) of the Act,
(h) supporting documents for the activities of the Institute pursuant to Article 5 (5) of the Act;
(i) an assessment of the activities of the bodies referred to in (f), other national reference laboratories and reference laboratories;
(j) the processing and transmission of expert information, obtained from the reference laboratories of the European Communities and, where appropriate, from other sources, the Constitution;
(k) documents for the publication of the list of reference laboratories appointed by the Ministry pursuant to Article 5 (5) of the Act in the Bulletin of the Central Audit and Examination Institute of the Agricultural Institute.
(2) Other national reference laboratories under Section 5 (4) of the Act provide in coordination with the Institute
(a) the activities referred to in paragraph 1 (a), (b) and (e);
(b) carrying out the laboratory tests required by the authority or person requesting the tests within the specified time limits;
(c) the transmission of documents for the publication of uniform working procedures by the Institute pursuant to Article 3 (1) (a) of the Act;
(d) the processing and transmission of expert information obtained from the European Community reference laboratory, where appropriate from other sources, the Constitution.
(3) The reference laboratories provided for in Article 5 (5) of the Act provide for the Institute in coordination with the national reference laboratory
(a) the activity referred to in paragraph 1 (b);
(b) carrying out the laboratory tests required by the authority or person requesting the tests within the specified time limits;
(c) their participation in inter-laboratory comparative tests pursuant to Article 3 (1) (c) of the Act, organised or approved by the Institute.
Where a national reference laboratory of the Institute or another national reference laboratory is appointed by a European Community reference laboratory (6), it shall comply with the requirements for material and personnel equipment and with the requirements for targeting, organisation and methods of action laid down by directly applicable European Community6).
National reference laboratory of the Institute, other national reference laboratories and reference laboratories
(a) apply for testing methods established directly by the European Communities (7) and specific legislation8); where neither the directly applicable provisions of the European Communities nor the specific legislation provide for such methods, they shall apply the methods set out in the relevant technical standards (CEN, ISO, CSN); if the methods laid down or the relevant technical standards are not, they shall use a method sufficiently scientifically supported and validated in practice;
(b) use up-to-date knowledge and methods in their activities as well as exchange of information at national and international level;
(c) comply with the rules on the protection of personal data and commercial secrecy (9) in accordance with specific legislation10);
(d) carry out a sufficient number of laboratory tests in their field of competence to enable the establishment of a functional quality control system;
(e) have a certified quality control system as required by the competent reference laboratory of the European Communities; if these requirements are not specified, they shall operate in accordance with the relevant technical standard (3). This shall not apply to methods which are validated, developed and validated, and to methods which by their nature do not allow compliance with all the requirements laid down in the relevant technical standard (3).
Efficacy
This Decree shall take effect on 1 November 2004.
Minister:
Ing. Palas v. r.
1) It is issued on the basis and within the limits of the law, the content of which allows the relevant provisions of the European Communities to be incorporated by decree.
2) Article 18 (3) of Council Directive 95 / 53 / EC of 25 October 1995 laying down the principles governing the organisation of official controls on animal nutrition.
3) ČSN EN ISO / IEC 17025 General requirements for the competence of test and calibration laboratories.
4) Act No. 246 / 1992 Coll., on the protection of animals against abuse, as amended by Act No. 162 / 1993 Coll., Act No. 193 / 1994 Coll., Act No. 243 / 1997 Coll., Act No. 30 / 1998 Coll. and Act No. 77 / 2004 Coll. Decree No. 207 / 2004 Coll., on the protection, breeding and use of experimental animals.
5) For example, § 17 of Act No. 91 / 1996 Coll., on Feed, as amended by Act No. 244 / 2000 Coll. and Act No. 147 / 2002 Coll., § 10 of Act No. 156 / 1998 Coll., on Fertilizers, Auxiliary Products and Substance and on Agrochemical Testing of Agricultural Soils (Fertilizers Act), as amended by Act No. 308 / 2000 Coll., Act No. 147 / 2002 Coll. and Act No. 317 / 2004 Coll.
6) Article 32 of Regulation (EC) No 1829 / 2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified organisms. Article 21 of Regulation (EC) No 1831 / 2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition.
7) For example, Annexes III and IV to Regulation No 2003 / 2003 of the European Parliament and of the Council.
8) For example, Decree No. 124 / 2001 Coll., laying down the sampling requirements and principles for methods of analysis of feed, additives and premixtures and the method of storage of samples, as amended by Decree No. 497 / 2004 Coll., Decree No. 206 / 2004 Coll., laying down the sampling requirements, the procedures and methods for testing seed and seed.
9) Article 17 of the Commercial Code.
10) For example Act No. 101 / 2000 Coll., on the Protection of Personal Data and on the Amendment of Certain Acts, as amended by Act No. 227 / 2000 Coll., Act No. 177 / 2001 Coll., Act No. 450 / 2001 Coll., Act No. 107 / 2002 Coll., Act No. 309 / 2002 Coll., Act No. 310 / 2002 Coll., Act No. 517 / 2002 Coll., Act No. 439 / 2004 Coll. and Act No. 480 / 2004 Coll.
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Regulation Information
| Citation | Decree No 528 / 2004 Coll., on requirements for national reference laboratories and reference laboratories in the field of activities covered by the Act on the Central Audit and Testing Institute of Agricultural |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 15.10.2004 |
|---|---|
| Effective from | 01.11.2004 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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