Press Release MicroVal
New MicroVal Certification Body
MicroVal is a European organization for the validation and certification of alternative methods for the microbiological analysis of food and beverages. The EN-ISO 16140 - Protocol for the validation of the alternative methods forms the basis for the European certification of alternative methods, thus fulfilling European legislation.
Recently Det Norske Veritas (DNV) Certification has been accepted as MicroVal Certification Body in addition to Lloyd's Register QA. By signing a Multilateral Recognition Agreement both Certification Bodies will officially form the MicroVal Certification Body (MCB)-group.
For more information, contact MicroVal secretariat. Tel. +31 (0)15 269
0112, http://www.microval.org and
e-mail: microval@nen.nl.
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.
New documents online
The latest version of the MicroVal Rules and Certification Scheme has been made available. They can be found under Rules & Standards.
A new subject has been added to the website. An indication of the Certification costs can be found under Fees.
Official start of MicroVal validation and certification
PRESS RELEASE MicroVal dd. 2005-09-27
MicroVal is a European organization for the validation and certification of EN-ISO 16140 - Protocol for the validation of the alternative methods forms the basis of the European certification of alternative methods in accordance with the new European legislation.
Recently MicroVal has started the validatation and certification process for several test kits. The MicroVal Certification Body responsible for the entire certification process is Lloyd's Register Quality Assurance (LRQA), The Netherlands. The validation process will be carried out by the MicroVal Expert Laboratory Campden & Chorleywood Food Research Association (CCFRA), UK.
If the studies progress successfully MicroVal will present the first certificates in the spring of 2006.
For more information, contact MicroVal secretariat. tel. +31 15 269 01 12, www.microval.org and email microval@nen.nl.
MicroVal: new MicroVal Certification Bodies-Group
PRESS RELEASE MicroVal
dd. 2005-09-12
MicroVal is a European organization for the validation and approval of alternative methods for the microbiological analysis of food and beverages. The EN-ISO 16140 - Protocol for the validation of the alternative methods forms the basis of European certification of alternative methods.
Formerly we announced that two new Certification Bodies had entered the MicroVal organisation. Recently they have officially become the MicroVal Certification Bodies-group (MCB-group) by signing a Multilateral Recognition Agreement. The MCB-group now consists of AFAQ AFNOR CERTIFICATION, Lloyd's Register Q.A. and TNO Certification B.V.
MICROVAL CERTIFICATION BULLETIN NR.3
Validation of alternative methods in vital phase
2005 is an important, vital year for the MicroVal organization! We expect to start the first certifications in the spring of this year. The certification procedure has been made less time-consuming and the support of public authorities, manufacturers and industry has been enlarged.
MicroVal consisted of two MicroVal Certification Bodies (MCBs) until mid 2003, AFNOR Certification and DIN Certco. The latter one withdrew as MCB due to lack of financial support for active participation. With one MCB the organization was not very viable. Therefore the MV secretariat initiated several actions.
Market need
Market research has been conducted to further evaluate the market need, as noted in MV Bulletin nr. 2. Several European manufactures were asked to participate in this research. The responses indicated a strong market need for validation/certification on a European level.
MicroVal Certification Bodies (MCBs)
Following this research the MV secretariat carried out discussions with possible Certification Bodies, which resulted in membership of two new MCBs, TNO Certification B.V. and Lloyd's Register Quality Assurance next to AFAQ AFNOR CERTIFICATION.
Mid 2004 the MCB-group met for the first time in their new composition at a meeting in Rotterdam. They decided to revise MicroVal documents amongst which 'MV Rules and Certification Scheme' (General Rules of MV organisation). It is the intention of the MCBs to simplify the Rules and make the procedure faster and less expensive.
EU
To strengthen our position we had discussions with several interested parties amongst which the food industry, European Commission (EC) and the FLEP (Food Law Enforcement Practioners). All these parties express their support to MicroVal. The draft Commission Regulation on microbiological criteria for foodstuffs in its present form lays down certain conditions for the use of alternative methods. Both validation and certification have to be in accordance with the protocol set in EN/ISO 16140 or other internationally accepted similar protocols. The MicroVal procedures follow these requirements. The FLEP forwarded a letter in which they recognize and support MicroVal. A letter of support is currently being prepared by the food industry (Nestlé/ Danône/ Kraft/ Unilever).
MGC meeting
At the 5th MGC meeting, which took place in October 2004 in Brussels, several procedures were been considered. Representatives of Nestlé, Masterfoods and Bioline (see composition MGC) were appointed. The MGC has agreed to a number of changes proposed by the certifying organisations (the MCB group).
For example, 'laboratory reviewers' have been removed from the system. The reviewers were meant to ascertain whether or not the Expert laboratory, which is responsible for the testkit validation, conformed to the required qualifications. This is superfluous, as one of the requirements that MicroVal places on Expert laboratories is that they are accredited according to ISO 17025.
Also, instead of both a 'technical' and a 'quality' auditor, a choice has been made to select a single auditor who has both technical experience and experience auditing quality systems. All these changes means for the manufacturer a reduction of time spent on the procedure (on the order of several weeks) in addition to lower costs.
Representatives of AOAC and NordVal attended the MGC meeting in October as observers. At this meeting AOAC indicated that they are starting a project with the FDA to find the best method for international microbiological validation. They have asked MicroVal to join one of their working groups and will shortly communicate the role MicroVal is to play in this group.
MicroVal: Again a new Certification Body
PRESS RELEASE MicroVal
dd. 2004-03-17
MicroVal is a European organization for the validation and approval of alternative methods for the microbiological analysis of food and beverages.
With the publication of EN/ISO 16140 - Protocol for the validation of the alternative methods the last hurdle has been removed for the implementation of the validation and certification procedures as outlined by their document 'MicroVal Rules and Certification Scheme'. The EN/ISO standard forms the basis of European certification of alternative methods.
The developments at the end of last year included discussions with representatives of the EC that led to MicroVal being recognized as a valid third-party certification body, support of the Food Law Enforcement Practitioners (FLEP) and a number of parties from the food industry.
In addition to the information in the previous press release, we can now announce that TNO Certification officially has entered the MCB-group as a MicroVal Certification Body (MCB). TNO certification was involved in the early stages of MicroVal development and recent progress means that the current status of MicroVal meets TNO standards. TNO Certification will start the process of validation and certification of alternative methods.
TNO Certification is an independent Dutch institution certifying and delivering quality certificates for both products and systems. It relies on the expertise of the entire TNO organisation in implementing system tests and assessing products. TNO has been active in the nutrition and food research market for over 60 years. Its research and consulting services have provided invaluable support to the business community and the government alike. The assessment by TNO Certification supports the wish of many clients to be certified by experts who can connect 'seamlessly', whilst maintaining strict independence to meet the requirements of separation between consultancy and certification.
Information
For more information about TNO Certification see http://www.tno-certification.nl and for MV
information, contact MicroVal secretariat, tel. +31 (015) 269 01 12,
http://www.microval.org and email microval@nen.nl.
MicroVal to start certification with new standard
PRESS RELEASE MicroVal
dd. 2003-12-01
MicroVal is a European organization for the validation and approval of alternative methods for the microbiological analysis of food and beverages.
With the publication of EN/ISO 16140 - Protocol for the validation of the alternative methods the last hurdle has been removed for the implementation of the validation and certification procedures as outlined by their document 'MicroVal Rules and Certification Scheme'. The EN/ISO standard forms the basis of European certification of alternative methods.
Recent developments include discussions with representatives of the EC that led to MicroVal being recognized as a valid third-party certification body, support of the Food Law Enforcement Practitioners (FLEP) and a number of parties from the food industry.
Another important development is that Lloyd's Register Quality Assurance has become a MicroVal Certification Body that will also start the process of validation and certification of alternative methods.
For more information, contact MicroVal secretariat. Tel. +31 (0)15 269 01 12, http://www.microval.org and email microval@nen.nl.