Key Benefits:
The President of the Republic,
On the report of the Prime Minister and the Minister for Agriculture and Fisheries,
In view of Regulation (EC) No 882/2004 of the European Parliament and of the European Parliament Council of 29 April 2004 on official controls carried out to ensure compliance with the legislation on feed and food and with the animal health and welfare provisions of the Animals;
In view of Directive 2003 /99/EC of the European Parliament and of the Council of 17 November 2003 on the monitoring of zoonoses and zoonotic agents, amending Council Decision 90 /424/EEC and repealing Council Directive 92 /117/EEC ;
In view of the Rural Code, in particular Articles L. 202-1 to L. 202-5;
In view of Decree No. 97-1202 of 19 December 1997 amended for the application to the Minister of Agriculture and Fisheries of the 1 ° of Article 2 of Decree No. 97-34 of 15 January 1997 Concerning the deconcentration of individual administrative decisions;
In view of the opinions of the French Food Safety Agency dated 23 September 2003 and 6 June 2005;
Conseil d' Etat (section des travaux publics) Heard;
The Council of Ministers heard,
Describes:
In Book II of the Rural Code (regulatory part), a preliminary title is created:
"PRELIMINARY TITLE
" COMMON PROVISIONS
"Chapter I
" Epidemiology
" This chapter does not contain any provisions Regulatory.
"Chapter II
" Laboratories
"Section 1
" General
" Art. R. 202-1. -For the purposes of this chapter and the texts taken for its application, "
" means: 1 ° Official control: any audit, inspection, verification, collection, examination, or any other form of control by the services of the competent State or their Delegates, with a view to ensuring compliance with the provisions of Titles II, III and V of Book II of this Code and the texts taken for their application;
" 2 ° Formal analysis: any laboratory analysis of a sample taken from the Framework for official control;
" 3 ° Autocontrol: any examination, verification, collection, or any other form of control under the responsibility of an owner or holder of animals, a company in the food sector, of food To ensure that the provisions of Titles II, III and V of Book II of this Code and the texts taken for their application are complied with by themselves;
4 ° Self-control analysis: Any laboratory analysis of a sample taken under self-control;
" 5 ° Official method: any method chosen by the Minister responsible for agriculture to carry out an official analysis;
" 6 ° Method Recognized: any method chosen by the Minister responsible for agriculture to conduct a self-monitoring analysis.
"Section 2
" National Laboratories Reference
" Art. R. 202-2. -National reference laboratories referred to in Article L. 202-2 shall be designated for one or more areas of competence by order of the Minister responsible for agriculture
Art. R. 202-3. -Only laboratories that:
can be designated as national reference laboratories 1 Dispose of personnel, premises, equipment and means enabling them to carry out their tasks at any time;
" 2 ° Provide appropriate guarantees of confidentiality, impartiality and independence vis-a-vis any natural or legal person engaged in the production, importation or marketing of goods or goods in relation to Their domain of competence;
" 3 ° Satisfy the general operating criteria of the testing laboratories set out in the international standards in force and are accredited in the fields corresponding to their missions by the Committee French accreditation (COFRAC) or any European body equivalent to the multilateral agreement made in the framework of the European coordination of accreditation
. Art. R. 202-4. -National reference laboratories designated for the first time in a given field of competence shall have twenty-four months to obtain the accreditation necessary for the exercise of their
. Art. R. 202-5. -National reference laboratories are responsible in their field of competence:
" 1 ° Development, optimization and validation of analytical methods and participation in their standardization;
" 2 ° From the animation Network of approved laboratories;
" 3. Where applicable, the conduct of official analyses and, in particular, the confirmation of results of analyses carried out by recognised or recognised laboratories;
" 4 ° Ensure a watch Scientific and technical;
" 5 ° To answer any request for scientific or technical expertise from the Ministry responsible for agriculture and other interested
. An agreement between the Minister responsible for agriculture and Each national reference laboratory shall specify the conditions for carrying out these tasks and any specific tasks which may be entrusted to it according to its field of
. Art. R * 202-6. -National reference laboratories transmit an activity report to the Minister responsible for agriculture each
. The scientific activity of each national reference laboratory is submitted every four years to an evaluation by Experts appointed by the Minister responsible for agriculture
Art. R. 202-7. -The Minister responsible for agriculture may remove the quality of a national reference laboratory from a laboratory that does not respect one or more of its missions or obligations or no longer meets the requirements referred to in Article R. 202-3.
" If a national reference laboratory wishes to terminate the exercise of its tasks, it shall inform the Minister responsible for agriculture at least six months before the end of its activities.
" Section 3
"Approved Laboratories
" Subsection 1
" Performing Formal Analysis
" Art. R * 202-8. -Only national reference laboratories and laboratories approved for that purpose by the Minister responsible for agriculture under the conditions laid down in sub-section 2 may carry out official
. In case of emergency, when Laboratories mentioned in the preceding paragraph may not carry out certain official analyses, the Minister responsible for agriculture may temporarily authorise a laboratory not meeting the conditions laid down in Article R. 202-10.
"Subsection 2
" Application for approval, renewal, suspension, and indentation
" Art. R * 202-9. -The authorisation provided for in Article L. 202-1 shall be issued by the Minister responsible for agriculture to a laboratory for one or more types of analyses, for a renewable period of five
. Minister responsible for agriculture may make Ability to perform several types of analyses within the same domain of jurisdiction.
" Art. R. 202-10. -To be approved, laboratories must:
" 1 ° Dispose of personnel, premises, equipment and means necessary to carry out their missions;
" 2 ° Present guarantees of confidentiality, impartiality and independence Vis-vis any natural or legal person engaged in the production, importation or marketing of goods or goods in relation to the analytical domain concerned;
" 3 ° Meeting the general criteria of Operation of the testing laboratories set out in the international standards in force and accredited by the French Accreditation Committee (COFRAC) or any European body that is a signatory to the multilateral agreement reached in the framework of the The European Coordination of Accreditation Bodies, for the carrying out of the analyses which are the subject of accreditation and carry out these analyses under accreditation;
" 4 ° Commit to continuously maintain their competence for the type of analysis Being approved.
" Art. R * 202-11. -By way of derogation from Article R. 202-10, the Minister responsible for agriculture may grant an unaccredited laboratory a provisional licence for a period of eighteen months
Provisional approval may not be granted Once for a type of analysis.
" Art. R. 202-12. -Applications for approval are sent to the Minister responsible for agriculture. The list of documents in the application package is fixed by order of the Minister responsible for agriculture
Where a laboratory has several establishments, each institution must submit an application for approval.
" Art. R. 202-13. -Any modification of the conditions for the exercise of the activities of the laboratory as set out in the application for approval must be made without delay to the knowledge of the Minister responsible for agriculture
If the importance or nature of the The Minister may request the Laboratory Manager to file a new application for approval within six months.
" Art. R * 202-14. -At any time, in the event of a breach of the obligations arising from this section and the acts adopted for its application, the Minister responsible for agriculture may suspend the authorisation of a laboratory or withdraw it.
" Art. R. 202-15. -Any laboratory wishing to obtain the renewal of its approval must make the request to the Minister responsible for agriculture six months at the earliest and no later than three months before the deadline. The administrative silence for three months on this request is accepted.
"Subsection 3
" Obligations of Approved Laboratories
" Art. R * 202-16. -The Minister responsible for agriculture may designate any person who is qualified to control, on rooms or on the spot, compliance with the provisions of this section by approved laboratories. They are required to participate in any technical evaluation process requested by the Minister responsible for agriculture
Art. R * 202-17. -The analyses referred to in Article R. 202-8 shall be carried out by the laboratories approved in accordance with the official methods published in the Official Bulletin of the Ministry responsible for agriculture
However, the Minister responsible for agriculture may Allow an approved laboratory to use other methods provided that the evidence is provided of their equivalency with the official
. When a new formal method is published for a given type of analysis, the Accredited laboratories for this type of analysis have 18 months from the date of publication to obtain accreditation for this new official method.
" Art. R. 202-18. -Approved laboratories shall carry out the official analyses as soon as possible compatible with the techniques and methods used
Art. R. 202-19. -An approved laboratory may, on an exceptional basis, subcontract the official analyses requested to it, provided that it is entrusted to another accredited laboratory for the same type of analysis and to inform the service of the requesting State Analysis.
" These obligations also apply when an official analysis is to be completed or confirmed by another laboratory.
" Where an official analysis is entrusted to another laboratory under the conditions laid down in the Above, it is the responsibility of the first laboratory to which the samples were entrusted to transmit the results to the service of the State which requested the analysis in accordance with the procedure laid down by the Minister responsible for agriculture
The Subcontracting of samples received in connection with the implementation of the provisions of Article R. 202-16 is prohibited.
" Art. R. 202-20. -An order of the Minister responsible for agriculture shall lay down the cases and conditions in which the samples or analysts isolated in the samples and the documents relating to them shall be kept by the approved laboratories and, Transmitted to another laboratory or research organization.
" Approved laboratories may be required to submit an annual activity report to the Minister responsible for
. Art. R. 202-21. -It is forbidden for an accredited laboratory to refer to its approval without specifying for which types of analyses it is approved.
"Section 4
" Laboratories Discovered
"Subsection 1
" Performing self-control scans
" Art. R. 202-22. -Only recognised laboratories may carry out the analysis of self-control, the list of which shall be fixed by order of the Minister responsible for agriculture, within the limits of the analytical domain for which they are
. This list is established at Looking at, among other things, the risk associated with the object of the self-control analysis considered.
"Subsection 2
" Request for recognition, renewal, suspension, and Removing
" Art. R. 202-23. -I.-Recognition shall be granted to a laboratory for one or more types of analyses, for a renewable period of five years, by the prefect of the laboratory's location
. II. -To be recognized, laboratories must:
" 1 ° Dispose of personnel, premises, equipment and means necessary to carry out their missions;
" 2 ° Present appropriate guarantees of impartiality towards any person Physical or legal entity engaged in the production, importation or marketing of goods or goods in connection with the analytical domain for which recognition is sought;
" 3 ° Meeting the general criteria of Operation of testing laboratories set out in existing international standards;
" 4 ° In certain analytical fields, where an order of the Minister of Agriculture finds that the health risk justifies it, be accredited by the French Accreditation Committee (COFRAC) or any European body equivalent to the multilateral agreement adopted in the framework of the European Coordination of Accreditation Bodies, for the carrying out of the analyses which are the subject of their Discovery and perform these scans under trust.
" III. -By way of derogation from the provisions of 4 ° of II, recognition may be granted provisionally to an unaccredited laboratory for a period of 18 months. Provisional recognition can only be granted once for a type of analysis.
" Art. R. 202-24. -Applications for recognition shall be addressed to the prefect of the department of the place of establishment of the laboratory accompanied by a file whose composition is fixed by order of the Minister responsible for agriculture
When a laboratory includes Multiple institutions, each institution must request its discovery.
" Art. R. 202-25. -Any change in the conditions for the exercise of the activities of the laboratory as set out in the application for recognition must be made without delay to the knowledge of the prefect
If the importance or nature of the changes The prefect may ask the head of the laboratory to file a new application for recognition within six months.
" Art. R. 202-26. -At any time, in the event of a breach of the obligations resulting from this section and the texts taken for its application, the Prefect who granted the recognition may suspend or withdraw it.
" Art. R. 202-27. -Any laboratory wishing to obtain the renewal of its recognition must make the request to the prefect six months at the earliest and no later than three months before the deadline. The administrative silence for three months on this request is accepted.
"Subsection 3
" Obligations of Recognized Laboratories
" Art. R. 202-28. -The Prefect may designate any person who is qualified to control, on rooms or on the spot, compliance with the provisions of this section by recognized laboratories. They are required to participate in any technical evaluation process, requested by the Minister responsible for agriculture or by the Prefect
Art. R. 202-29. -The reports of self-control tests carried out by recognized laboratories must allow identification:
" -the requester;
" -sample: nature, state, date received;
" -analysis date;
" -of the Analysis method used;
" -the result of the analysis, with, if applicable, the units of measurement;
" -if applicable, criteria for interpreting the results.
" Art. R. 202-30. -The analyses referred to in Article R. 202-22 shall be carried out by laboratories recognised in accordance with accepted methods which shall be published in the Official Bulletin of the Ministry responsible for agriculture
Art. R. 202-31. -A recognized laboratory may sub-process the self-testing analyses requested, subject to a recognized laboratory for the same type of analysis. Subcontracting for the analysis of samples received as part of the implementation of the provisions of Article R. 202-28 is prohibited.
" Art. R. 202-32. -An order of the Minister responsible for agriculture shall lay down the cases and conditions in which the samples or analysts isolated in the samples and the documents relating to them shall be kept by the recognised laboratories and, the If applicable, passed to another laboratory or research organization.
"Section 5
" Final Provisions
" Art. R. 202-33. -Orders of the Minister responsible for agriculture shall lay down, as appropriate, the arrangements for the application of this
. Art. R. 202-34. -The provisions of this Chapter may be amended by decree in the Council of State with the exception of those contained in articles R. * 202-6, R. * 202-8, R. * 202-9, R. * 202-11, R. * 202-14, R. * 202-16 and R. * 202-17, which will be amended in the Conditions laid down in Article 2 of Decree 97-34 of 15 January 1997.
"Chapter III
" Reagents
" There are no provisions in this chapter Regulations. "
Paragraph " Quality and safety of plant and animal production " The table in Section 2 of Title II of the Annex to Decree No. 97-1202 of 19 December 1997 is supplemented by the The following entries:
You can view the table in OJ
No 4 of 05/01/2006 text number 16
This provision can be modified in accordance with Article 2 of the Decree of 15 January 1997 referred to above.
The Prime Minister, the Minister of Economy, Finance and Industry, the Minister of Agriculture and Fisheries and the Minister Delegate to the Budget and State Reform, Government Spokesperson, Are responsible, as far as it is concerned, for the application of this Decree, which shall be published in the Official Journal of the French Republic.
Done at Paris, January 4, 2006.
Jacques Chirac
By the President of the Republic:
The Prime Minister,
Dominique de Villepin
Minister of Agriculture and Fisheries,
Dominique Bussereau
Minister of Economy,
Finance and Industry,
Thierry Breton
Associate Minister
budget and state reform,
Government Spokesperson,
Jean-François Copé
