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About The Requirements For The National Reference Laboratories

Original Language Title: o požadavcích na národní referenční laboratoře

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73/2014 Sb.



DECREE



of 3 July 2003. April 2014



about the requirements for the national reference laboratories and reference laboratories

in the area of activities defined by the law on the central control and

test Institute of agricultural



The Ministry of agriculture establishes, pursuant to § 5 para. 9 of Act No 147/2002

Coll., on Central control and testing Institute of agriculture and amending

some related laws (Act on the central control and

test Institute of agriculture), as amended by Act No. 279/2013 Coll. (hereinafter referred to

"the Act"):



§ 1



The subject of the edit



This Decree in the wake of the directly applicable provisions of the European

Union ^ 1) sets out additional requirements for the material and human resources and facilities

on focus, organization and methods of work of the national reference

the laboratories of the central control and testing Institute of agricultural

(hereinafter referred to as "the Institute") and reference laboratories.



§ 2



Material and staffing requirements for the laboratory equipment



(1) For the national reference laboratories of the Institute are the requirements laid down

directly applicable European Union regulations ^ 1).



(2) a natural or legal person entrusted by the Department pursuant to § 5 para.

4 and 5 of the Act the activities of reference laboratories for the performance of professional activities

According to § 5 para. 1 of the Act, must have in addition to the requirements laid down directly

the applicable provisions of the European Union ^ 1)



and) equipment, instructions and procedures for the use, storage, maintenance and other

handling of equipment and material in a range of professional activities, for

that is to be commissioned,



(b) procedure for transport), receipt, storage and disposal of samples

and dealing with them, including measures against contamination and

depreciation and system clear identification of the samples for the activity for

to be responsible for, and



(c)) the conditions for awarding credentials according to the feed or

the law about fertilizers ^ 2).



§ 3



Requirements on focus, organization and methods of operation of the laboratories



(1) the national reference laboratories of the Institute, in addition to the obligations arising

from the directly applicable European Union legislation ^ 1) further provide



and implementation of laboratory tests,)



(b)) the development of authentication and validation of new laboratory procedures and

cooperation on research, development, verification and validation of new

laboratory procedures,



(c) the development and cooperation) the validation of technical standards at the national,

European and international level and other international procedures



(d) publication of the uniform) working procedures under § 3 para. 1 (b). and)

the law and their continuous replenishment,



(e) Organization of interlaboratory comparative trials) according to § 3 (2). 1

(a). (c)) of the Act,



(f)) in the case of analyses of disputes relating to the accuracy of the results

laboratory tests,



g) supporting documents for the grant, amendment, withdrawal or cancellation of the credentials

awarded by the Institute pursuant to § 5 para. 1 of the law, proving the eligibility

Laboratory of the natural or legal persons,



h) performance of professional activities in accordance with § 5 para. 1 of the Act,



even the activities of bodies and assessment) reference laboratories referred to in point (a)

(f)), and



j) supporting documents for the publication of the list of reference laboratories in charge of

the Institute referred to in § 5 para. 4 and 5 of the Act in the Central control

and test Institute of agricultural.



(2) the national reference laboratories of the Institute and reference laboratories in addition to the

the obligations arising from the directly applicable European Union legislation ^ 1)



and apply in their actions) the current procedures and methods,



(b)) to ensure that the mutual exchange of information on national and international level

and



(c)) are carried out in the scope of its activities, the number of laboratory tests

corresponding to a given method, which will allow the creation of a functional system

quality control.



§ 4



Regulation (EEC)



Shall be repealed:



1. Decree No. 528/2004 Coll., on the requirements of the national reference

laboratories and reference laboratories in the field of activities covered by

the law on the central control and testing Institute of agriculture.



2. Decree No 204/2012 Coll., on technical requirements for the credential

reference laboratory.



§ 5



The effectiveness of the



This Decree shall enter into force on the fifteenth day following the day on

its publication.



Minister:



Ing. Abdoul in r.



1) European Parliament and Council Regulation (EC) No 1829/2003 of 22 July 2003.

September 2003 on genetically modified food and feed, as

the text of the.



European Parliament and Council Regulation (EC) no 1831/2003 of 22 July 2003. September

2003 on additives used in animal nutrition, as amended

the text of the.



European Parliament and Council Regulation No 2003/2003 of 13 October 2003. October

fertilizers, as amended.



European Parliament and Council Regulation (EC) No 882/2004 of 29 April 2004. April

2004 on official controls performed to ensure the verification of compliance with the legal

provisions relating to feed and food law and animal health rules and

animal welfare, as amended.



Commission Regulation (EC) No 378/2005 of 4 October 2005. March 2005 on the detailed

detailed rules for the regulation of the European Parliament and of the Council (EC) No.

1831/2003 as regards the duties and tasks of the reference laboratory

Community in connection with applications for authorisation of feed additives

feedingstuffs, as amended.



Commission Regulation (EC) no 1981/2006 of 22 March. December 2006 on the

the rules for implementing article 32 of regulation of the European Parliament and

Council Regulation (EC) No 1829/2003 concerning the Community reference laboratory

for genetically modified organisms, as amended.



Commission Regulation (EU) No 283/2013 from day 1. March 2013 in

accordance with regulation of the EP and of the Council (EC) No 1107/2009 concerning the placing of

plant protection products on the market provides the data requirements for the active substances.



Commission Regulation (EU) no 284/2013 from day 1. March 2013 in

accordance with regulation of the EP and of the Council (EC) No 1107/2009 concerning the placing of

plant protection products on the market provides the data requirements for plant

plant protection products.



2) Act No. 91/1996 Coll., on feedstuffs, as amended.



Act No. 157/1998 Coll., on fertilisers, excipients, auxiliary

herbal medicines and substrates and agrochemical testing

agricultural soils (fertilisers), as amended.