Federal Agency
for the Safety
of the Food Chain
ID
Procedure
HANDLING APPROVAL APPLICATIONS OF EXTERNAL LABORATORIES
Version / 02Date of coming into force / 2011/01/01
Competent administration / Laboratories Administration
Responsible service / Central administration
Receivers / Staff members of the central administration of DG Laboratories
External laboratories
Name – function / service / Date / Signature
Written by: / ir. Brigitte Pochet / 2010/12/21 / sgd
Checked by: / Marina Naccarato / 2010/12/22 / sgd
Approved of by: / Geert De Poorter / 2010/12/22 / sgd
List of revisions
B. Pochet
06/02/2009 / Fees due for issuing approvals as from 1 March 2009
When the procedures were under review, it was decided that a new numbering would be applied and that the version numbers would start again from "01".
Former number of this procedure : 2007-34-LAB-agrement-P10-v01
B.Pochet
2010/12/21 / Adaptation as a consequence of the implementation of LABNET, module "approval"
Key words
Approval – laboratory - analyses
APPLICATION FOR THE APPROVAL OF EXTERNAL LABORATORIES
Table of contents
1. Aim 4
2. Scope 4
3. References 4
4. Definitions et abbreviations 4
5. Procedure 5
6. Annexes 9
KONINKRIJK BELGIE 13
1. Aim
The aim of this procedure is to describe how an approval application sent to the Agency should be handled in the context of the Royal Decree of 15 April 2005 on the designation of official laboratories, laying down the procedure and requirements for the approval of laboratories performing analyses within the framework of the control mission of the Federal Agency for the Safety of the Food Chain and implementing the Act of 15 July 1985 on the use in animals of substances with hormonal, anti-hormonal, beta-adrenergic or production stimulating effects.
2. Scope
This procedure shall apply to all external laboratories seeking approval of the FASFC.
3. References
Arrêté royal du 15 avril 2005 relatif à la désignation des laboratoires officiels, fixant la procédure et les conditions d’agrément des laboratoires qui effectuent des analyses dans le cadre des missions de contrôle de l’Agence fédérale pour la Sécurité de la Chaîne alimentaire et portant exécution de la loi du 15 juillet 1985 relative à l’utilisation de substances à effet hormonal, à effet anti-hormonal, effet bêta-adrénergique ou à effet stimulateur de production chez les animaux
Loi du 9 décembre 2004 portant financement de l’Agence fédérale pour la Sécurité de la Chaîne alimentaire
Arrêté royal du 10 novembre 2005 relatif aux rétributions visées à l’article 5 de la loi du 9 décembre 2004 portant financement de l’Agence fédérale pour la Sécurité de la Chaîne alimentaire
4. Definitions et abbreviations
· Officer in charge: the person of DG Laboratories who is in charge of the «laboratories approval cell»
· Co-ordinator(= Business Account Manager) : the person of DG Laboratories who has been appointed to examine a particular approval application.
· Administrative office: the administrative staff of DG Laboratories that is in charge of the administrative management of approval files
· Laboratory: the (Belgian or foreign) external laboratory that submitted the application for approval
· Operator : a physical or a legal person with an activity that is subject to control by the Agency
· BELAC: the Belgian accreditation body
· Analysis: an analysis performed in the context of the control mission of the Agency
· LABO-LIB: Access databank containing the data of laboratories
· LOD : limit of detection
· LOQ : limit of quantification
· CCa : limit of decision
· CCb : detection capability
5. Procedure
5.1 Taking receipt of an application for approval of an external laboratory
The external laboratory seeking approval submits an application for approval in accordance with the procedure laid down in P09 “ Application for the approval of external laboratories”.
DG laboratories receives the application for approval in duplicate by mail The application for approval must also be sent by Email to
mentioning as subject : « application for approval: <name of the laboratory>, accreditation number XXX)».
The application for approval consists of a file that shall contain the following pieces:
1. An approval application form (Annex 1) available on the website of the Agency: www.afsca.be, secteurs professionnels, Administration des laboratoires ;
2. A copy of the accreditation certificate (issued by the Belgian accreditation system BELAC or by a body with which the Belgian accreditation system concluded an agreement of mutual recognition) as well as a copy of the relevant technical annex ;
3. A copy of the most recent audit report drawn up by the accreditation body and, in the case of an extension, also a copy of the intermediate or renewal audit report;
4. A list of the analyses and matrices for which the laboratory seeks approval;
5. For the analyses/parameters that are not included explicitly in the technical annex of the accreditation certificate (e.g. analyses under flexible scope) : the lab shall supply documents of the quality system which show evidence that the analysis of the parameters/matrices combinations is done under accreditation.
6. A list of the analyses and matrices the laboratory is capable of performing apart from the approval (if any).
7. A copy of the statutes of the laboratory
5.2. Handling the approval application
Upon receipt of the approval application sent by mail, the administrative office shall check if the file submitted contains all the pieces mentioned under 4.1. in duplicate.
If the application is complete, the officer in charge shall feed the data of the laboratory into the databank for laboratories approvals.LABNET system
If the application is not complete, a letter shall be sent to the laboratory to inform it of the incompleteness of the application for approval and of the pieces that are missing. Thereupon, the handling of the file is suspended until the arrival of the pieces.
A file is made for the laboratory which shall contain all the pieces related to the laboratory (approval application, a copy of the valid accreditation certificate, a copy of the audit report, a list of analyses, correspondence …) and which shall be available at the secretariat of DG Laboratories.
The officer in charge shall send by Email to the laboratory an acknowledgement of receipt (Annex 2) within 10 working days from the application for approval as well as the tables retrieved from the LABO-LIB databank that must be corrected and/or completed and that mention the analyses and the matrices for which the laboratory seeks approval or that it is capable of performing apart from the approval (if any)an access to LABNET so that the laboratory can enter the analyses for which it seeks approval, according to LAB P510 – DO1.
Once the application for approval is submitted by the laboratory, DG Laboratories receives a mail reporting that laboratory X has submitted one or several files.
The following fields shall be accurately filled out in the distinct tables :
1. Parameters
2. Matrices
3. Technical performance level for each sector of analyses (LOD, LOQ, CCa and CCb)
4. Delivery time for analysis results, as from the receipt of the sample
5. Maximum testing capacity per month
6. Unit price (VAT not included)
7. Accreditation
The tables shall be returned by Email to .
The officer in charge shall appoint aone or several co-ordinator(s) for the laboratory, in agreement with the director general and according to document LAB P 511 – D01 «Handling approval in LABNET».
Upon receipt of the tables by Email, the officer in charge shall forward these to the co-ordinator that was appointed so that the further administrative and technical inquiry may be carried out.
The technical inquiry shall be carried out by the appointed co-ordinator(s), together with the administrative office. Within this context, an assessment shall be made of the analyses for which approval is sought and compliance with all relevant requirements shall be examined.:
1. has the application form been filled out correctly and signed?
2. is the laboratory willing to take part in the dispatching?
3. has the independency and impartiality clause been met ?
4. have the tableshas LABNET been filled out correctly?
5. has the laboratory been accredited for the analyses for which an application approval is being made?
6. is the technical performance satisfactory?
7. are the analysis times acceptable when compared with the times that have been set ?
The co-ordinator decides within a period of no more than 2 months if the approval may be granted and, if such is the case, if it may be granted entirely or partially. That term can be extended by one extra month if a technical audit has been performed on the spot.
He shall notify his decision to the officer in charge.
The tables supplied shall be updated in LABO-LIB by the officer in charge.
The officer in charge and the co-ordinator calculate the time required to process the file and indicate it in LABNET. The invoice is made by the 'financing cell' of the FASFCThe officer in charge shall then make in invoice, in accordance with Annex 6 regarding the estimate of the fee charged for issuing an approval
5.3 Granting approval
5.3.1. Following a favourable inquiry
If the inquiry appears to be favourable for all analyses for which the approval application is made, the approval shall be granted for a indefinite period of 3 years provided if the laboratory has paid the fee due to the Agency.
The decision regarding one or more laboratories shall be drafted in accordance with the model added as Annex 3 and be submitted to the Chief Executive Officer.
At the same time, an individual notification signed by the Chief Executive Officer shall be sent to each laboratory, in accordance with the model given in Annex 4 and accompanied by a letter in accordance with the model given in Annex 5.
The decision shall then be published in the “Moniteur belge/Belgisch Staatsblad” and on the website of the Agency, within 2 months, and 3 months if a technical audit has been performed on the spot .
Immediately after publication, the decision shall be sent to the laboratory.
An Excel file containing the list of analyses for which the laboratory is approved, shall be published on the internet and on the intranet.
5.3.2. Following an entirely or partially unfavourable inquiry
If the inquiry appears to be entirely of partially unfavourable for all or part of the analyses for which the approval application is made, the officer in charge makes a draft of a motivated letter informing the laboratory of the decision made by the Agency. This letter may be signed by the director general of the Administration of laboratories and shall be sent by registered mail.
The laboratory is given the possibility to contest the decision of the Agency within 15 days and by means of a registered letter.
Option one: The laboratory does not contest the decision made by the Agency:
DG Laboratories must confirm its decision within 30 days by means of a registered letter. This letter must be signed by the Chief Executive Officer.
If the inquiry appears to be partially unfavourable, the decision is drafted in accordance with the model added as Annex 3 and shall be submitted to the Chief Executive Officer for signature. The decision shall then be published in the “Moniteur belge/Belgisch Staatsblad” and on the website of the Agency. Immediately after the publication, the decision shall be sent to the laboratory.
If the inquiry appears to be unfavourable (e.g. when there is a problem related to the status of the laboratory) a registered letter bearing the signature of the Chief Executive Officer confirming the impossibility of approval under the RD of 15 April 2005 shall be sent to the laboratory.
Option two: the laboratory contests the decision of the Agency within 15 days.
When a partial approval has been granted or when approval has been denied, the file shall be thoroughly examined by the Directorate general of Laboratories, on the basis of the documents and/or a visit to the premises of the laboratory. The DG of Laboratories must notify its final decision by means of a registered letter within 60 days. This letter must bear the signature of the Chief Executive Officer.
5.4 Renewal of the approval
The application in view of the renewal of an approval shall be submitted 3 months before the date of expiry of the approval in force. The same procedure shall be followed as when applying for an approval.
5.54 Withdrawal, suspension of the approval
The Agency may withdraw or suspend the approval entirely or partially when it suspects certain non compliances and deems that it is no longer possible to meet the requirements laid down in the provisions regarding approvals (see procedure P09: «Application for the approval of external laboratories»).
The DG of Laboratories shall conduct a thorough investigation on the legitimacy of the suspicion of non compliances. This, in co-operation with BELAC, if BELAC has supplied the accreditation certificate of the laboratory in question.
When the non compliances are confirmed, a registered letter shall be sent to the laboratory to inform it of the decision made (withdrawal, suspension until the situation is put right).
As soon as the laboratory receives this information, it is no longer authorised to conduct any analysis or counter-analysis within the context of the missions of the Agency.
The laboratory may contest the decision made by the Agency by means of a registered letter within 15 days.
Option one: The laboratory does not contest the decision of the Agency
DG laboratories shall confirm its decision within 30 days.
Option two: The laboratory contests the decision of the Agency within 15 days.
The file is thoroughly examined by DG Laboratories on the basis of documents and/or a visit on the spot to decide whether the decision must be maintained or adjusted. DG Laboratories must then notify its decision by means of a registered letter within 60 days.
When the approval of a laboratory has been withdrawn, this laboratory may only start a new application procedure if the guarantees offered are sufficient to admit that the non compliances or defaults that led to the withdrawal of the approval, will not occur anymore.