4 New MicroVal Certificates!
Last year the first MicroVal certificate has been granted. Today we can announce that recently four new MicroVal certificates have been granted. The following validations according to EN ISO 16140 have been approved by MicroVal:
- Compact Dry ETB for enumeration of Enterobacteriaceae
- Compact Dry CF for enumeration of Coliforms
- Compact Dry EC for enumeration of Coliforms
- Compact Dry EC for enumeration of E.coli
Details:
- Supplier for these test kits is Hyserve GmbH & Co
- Manufacturer: Nissui Pharmaceutical Co. Ltd
- MicroVal Expert Laboratory: CCFRA (UK)
- MicroVal Certification Body: Lloyd's Register QA (NL)
- MicroVal method reviewers: Prof. Basil Jarvis (UK) and Henk Stegeman (NL)
Status of other MicroVal Validations
The next 6 MicroVal validations are being performed; 3 validations are in progress with the MicroVal Expert Laboratory CCFRA (UK) and 3 by MicroVal Expert Laboratory RIKILT, Institute of Food Safety (WUR) (NL). Two contracts are nearly closing and we are in discussion with several other manufacturers.
Report Validation Studies
The validation reports can be downloaded see Validated methods.
Belgium Approval of MicroVal Certificate
The supplier of the Compact Dry TC, the first MicroVal certificate, has been forwarded to the Belgium authorities for approval. By the end of 2007 the MicroVal approved testkit was approved and added to the list of approved FAVV methods.
Information and Application form
If you need more information you can contact the MicroVal secretariat (microval@nen.nl) or in case of a MicroVal application please download the MicroVal application form.
FOODMICRO 2008
Beginning of September 2008 the 21st International ICFMH Symposium 'Evoling Microbial Food Quality and Safety' will be held in Aberdeen. NordVal is chairing a parallel session 'Validation of alternative methods – why and how'. The purpose is to give an update of the present situation on validation, legislation, etc. in Europe. The session will be held 2 September 2008.
NordVal invited the MicroVal secretariat to give a presentation about the status of MicroVal.
Furthermore MicroVal will also be represented with an exhibition stand which is shared by the MicroVal Certification Body, Lloyd's QA, the MicroVal Expert Laboratories CCFRA and RIKILT, Institute of Food Safety (WUR) and the MicroVal Secretariat (NEN).
Observations from the MicroVal Symposium
On March the 20th 2007 a MicroVal symposium was held in Amsterdam. At this symposium the first MicroVal certificate was presented by Chairman Peter McClure to Stephen Speidel (HyServe GmbH. & Co.) for the Compact Dry TC method. At this milestone the opportunity was taken to reflect on recent experiences, suggest improvements and discuss a wide variety of issues surrounding the validation of rapid methods. The symposium was attended by representatives from all areas of the food sector. Users, manufacturers, certification bodies and legislators provided a background with plenty of feedback.
The focus of the presentations and subsequent discussions was the EN/ISO 16140 standard (Protocol for the validation of alternative methods). This standard establishes the general principle and the technical protocol for the validation of alternative methods in the field of microbiological analysis of food, animal feeding stuff and environmental and veterinary samples. Its use is required by the EU.
Experience with the first certificate
An overview of 16140 from a technical perspective was provided first by Lloyds Register QA, the procedural aspects were discussed. This was followed by a presentation Campden & Chorleywood (CCFRA) in which the intricacies of the statistical data analysis were discussed as well as the obstacles encountered.
Point of view users
Nestlé presented issues encountered by users when selecting rapid methods. Nestlé's structure for evaluating traditional and alternative methods (NesVal) were outlined and the requirements it places on testkits as users. 3M Deutschland discussed their selection procedures and echoed the concerns of Nestlé regarding the variety and lack of clarity companies have when selecting rapid methods.
Regulatory perspectives
The regulatory view was provided by the EC DG SANCO (EC Regulation 2073/2005), the Belgian Federal Food Safety (national perspective), FLEP Denmark (MicroVal position) and the UK Health Protection Agency (national perspective).
Hereafter the current status and future changes of EN/ISO 16140 were presented. It is expected that at least 2- 3 years will be needed before all parts of the revised standard will be available for comments by ISO and CEN. The final presentations concerned the state of the global harmonization efforts, by AOAC International. This presentation focused on the harmonization of international validation for analytical methods, followed by AOAC Research Institute that detailed the ongoing harmonization efforts between MicroVal and AOAC.
After the presentations, there followed a lively debate concerning the road ahead. The diversity of the participants was again obvious, as theoretical questions would quickly be illustrated with real-world examples. The general feeling was that it had been a productive day for all concerned. (For more information download the summary of the symposium).
Press Release MicroVal
First MicroVal Certificate granted
At the MicroVal symposium on 20 March 2007 the first MicroVal certificate was granted for the COMPACT DRY TC, supplied by HYSERVE GmbH & Co, Germany and manufactured by Nissui Pharmaceutical Co.Ltd. in Japan.
The MicroVal Certification Body responsible for the certification process was Lloyd's Register Quality Assurance (LRQA), The Netherlands. The validation process according to the EN ISO 16140 was performed by the MicroVal Expert Laboratory Campden & Chorleywood Food Research Association (CCFRA), UK
Five more certification and validations are underway and scheduled for later this year.
MicroVal's organisation of validation and certification is based on an independent European structure.
MicroVal offers:
- an open platform for all European Certification Bodies
- aiming at a harmonized interpretation of the EN ISO 16140
- working towards a harmonized international market for all test kits
- is headed by one European platform with all European stakeholders involved
- a neutral MicroVal secretariat not part of a certification organisation
For more information, contact the MicroVal secretariat. Tel. +31 15 2690 112, http://www.microval.org and email microval@nen.nl.
Press Release MicroVal
AFAQ AFNOR Certification to follow separate path
AFAQ AFNOR Certification (AAC) has notified that it is withdrawing from the Multilateral Recognition Agreement relating to the MicroVal system.
It is with regret that we received this letter. Throughout the years since our founding, AAC has made significant contributions to the development of the MicroVal organization and the MicroVal Rules and Certification scheme.
The MicroVal Eureka project was started to create a unified organization for validation and certification within Europe. The aim was, and remains, the harmonization of the market, the facilitation of cross-border acceptance and to allow all parties concerned to cooperate. We regret that AAC no longer shares this vision.
MicroVal will naturally continue to operate according to its stated goals.
For more information, contact MicroVal secretariat. Tel. +31 15 269 01 12, http://www.microval.org and email microval@nen.nl.
Final Symposium program available
The program for the MicroVal Symposium is now final, with all speakers confirmed. It is available for download on the Symposium website or directly via this download link.
Registration for attendees is still open.
MicroVal symposium 20 March 2007
Updates to our symposium website include:
- A more detailed program (e.g. name of FLEP speaker)
- Extra details for exhibitors
Registration has already started and can be done by filling in the registration form. If you intend to book a stand please contact the secretariat for your booth preference as several have already been booked.
Press release MicroVal - New contract
In December 2006 a new contract was signed for MicroVal validation and certification. The MicroVal Certification Body responsible for the overall certification process is Lloyd's Register Quality Assurance (LRQA), The Netherlands. The validation process has started and is being performed by the MicroVal Expert Laboratory RIKILT - Institute of Food Safety in The Netherlands.
If the study progresses successfully MicroVal will present this certificate in the autumn of 2007. At the moment MicroVal is in a final discussion with a few other manufacturers.
For more information, contact MicroVal secretariat. tel. +31 15 269 01 12,
www.microval.org and email microval@nen.nl.
Registration MicroVal Symposium started
Registration for the MicroVal Symposium 2007 the First Certificate has started. Visit the Symposium website for details.
MicroVal Symposium
MicroVal is organising a symposium. This symposium MicroVal, the first Certificate will be held on Tuesday 20 March 2007 in Amsterdam. Please keep this date in your dairy, more details will follow soon. If you need more information please contact the MicroVal secretariat: tel. +31 15 2690 112 or extension 366.
Update Rules
The MicroVal Rules and Certification Scheme is recently modified and published. The new version is version 5, August 2006. In this new version an update has been made to annex K indicating the quality requirements for the validation of the alternative methods.
The latest updates to the MicroVal Rules and Certification Scheme have been made available. They can be found under Rules & Standards or downloaded directly, here.
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