ICC Validation and Publication of Standard Methods

For over 50 years ICC has validated and published analytical standard methods applied in safety and quality assessment of cereals and crops, cereal based products, foods and feeds. Validated methods are published in the ICC Standards Collection and can be purchased via ICC Services. ICC Standard Methods serve international trade, national and international legislation, industry standards such as ISO and CEN, and as guidelines for food manufacturers and control laboratories.

Interested in validating your own method?
Please fill out the APPLICATION FORM and/or contact sabine.gratzer[at]icc.or.at 

Basic Requirements of ICC Validation Studies

1. Principle

In principle ICC validation studies / ring trials follow the requirements of the IUPAC / AOAC / ISO international harmonised protocol for collaborative trials (W. Horwitz, Pure and Applied Chemistry, 67 (1995): 331-343). However, the ICC protocol also accounts for several issues that have been discussed at Codex Alimentarius level more recently (e.g. recovery, recovery correction, measurement uncertainty, etc.). The requirements for any ICC validation study are given below and may serve as guideline for organisers and evaluators of ring trials within the ICC standardisation programme. A practical guide for the preparation of an international ring trial and spreadsheets for the statistical analysis are in preparation.

2. Requirements

  1. A minimum of 8 useful results from min. 8 laboratories, respectively (after elimination of outliers and non-compliant laboratories). ICC recommends to include at least 12 laboratories.
  2. The submitting organisation / institution and the coordinating institution / laboratory must be from an ICC Member Country.
  3. Participating laboratories from ICC Member Countries will be preferentially selected, however trial participants from non-member countries may be invited upon the request of the organiser.
  4. To be counted as an international ring trial, a minimum of 3 countries needs to be involved. Regionally used methods may have their justified place in the ICC Standards Collection, however, ring trials not meeting the international scope need to highlight this limitation in the scope. 
  5. No more than a maximum of 50% of the participating laboratories may show an organisational relationship (e.g. laboratories in various locations, but belonging to the same company or distribution network).
  6. A detailed description of the ring trial setup and a full report including a copy of all original data and statistical calculations must be provided to ICC for review by the ICC Technical Director and final discussion and approval by the ICC Technical Committee.
  7. It is advisable to discuss the planned trial with the ICC Technical Director, before undertaking the study. If a study was not planned with the ICC Technical Director it can be submitted to ICC Headquarters for approval / acceptance, but ICC reserves the right to turn the certification as ICC Standard Method down based on non-compliance to ICC rules.
  8. Joint validation and/or joint submission/publication of Standards in collaboration with related SODs (Standardisation Organisations) are recommended.
  9. If a method / appliance /test kit or reference material is jointly validated with other SODs a mutual recognition / equivalence needs to be stated in the published methods, respectively.
  10. For final analysis of the results the statistical methods used must be clearly described. Statistical evaluation of the method must include the following parameters:
    1. Description of the method / appliance /test kit / reference material used.
    2. Description of the "analyte".
    3. Description of the "sample" / reference material.
    4. Homogeneity test results of the sample material (usually performed by the organising laboratory and / or confirmed by 1-2 additional laboratories, e.g. F-test, ANOVA on 10 replicate samples tested taken from the same lot).
    5. Detailed protocol.
    6. Details of participating laboratories including name of operator, operator's function.
    7. Copy of original results / data including lot number, serial number, etc.
    8. Repeatability.
    9. Reproducibility.
    10. Limit of Detection (LOD) and Limit of Quantitation (LOQ), where applicable.
    11. Measurement uncertainty.
    12. Traceability to SI units, if applicable.

3. Samples

  • Any material used as a sample needs to be well described (origin, ingredients, concentration, etc.).
  • Homogeneity and stability needs to be tested, documented and monitored throughout the ring trial.
  • According to the IUPAC / AOAC / ISO international harmonised protocol for collaborative trials at least 5 different samples or 2 different matrix samples at 4 different concentration levels (including a zero / blank sample) shall be used.
  • The samples must be representative of the range of variation of the analyte in the matrix. The samples shall be selected to cover the relevant range of application of the method with concentrations distributed across the whole application range.

4. Costs for proprietary methods

  • Handling and publication fee, includes preparation and handling for publication / validation, a final editorial check and formatting, promotion and announcement via ICC print media
    € 2,000.--
  • Final statistical evaluation after all calculations are completed and all data is generated by the submitting party. Statistics will be reviewed by the ICC Technical Director and finally by the ICC Technical Committee
    € 3,000.--
  • Optional: If raw data is received by ICC and statistical evaluation is done by ICC
    € 6,000.--
  • Optional: If ICC is to organise and manage the ring trial
    € 10,000.--
  • Any additional costs such as shipping of materials, appliances, training of personnel, production of samples are covered by the method provider or added to the basic fee.

5. Publication

  • After approval of an analytical method or a reference material, it is published as ICC Draft Standard Method, until a second review after 2 years of first issue.
  • ICC Draft Standards may become regular ICC Standard Methods by approval after trial period of two years as Draft Standard.
  • ICC Standard Methods can be purchased either as single method standard or as part of the ICC Standard Method Collection. The method provider and organiser of the ring trial shall receive on free copy of the ICC Standard.
  • ICC requires the publication of the obtained results of the validation study in a peer-reviewed journal. The report shall be written and submitted for publication by the organiser of the ring trial or the method provider. Publication in the official ICC Journal "QAS - Quality Assurance and Safety of Crops & Feeds" is recommended.

6. Ownership

ICC Standard Methods are owned by ICC and thus are protected by ICC copyright. ICC Standard Methods are sold by ICC Services GmbH and authorised distributors contracted by ICC. Any submission of ICC Standards to CEN, ISO, Codex Alimentarius by any national / regional government or other institution needs to be approved by ICC and the authorship of ICC needs to be referred to in the publication / submission form.

7. Liability

ICC is only liable for the content and the performance data at the time of evaluation and publication. ICC is not responsible for deviations of performance quality due to manufacturing or non-compliant method application.

Any changes and/or additions to ICC validated methods need to be communicated to the ICC Headquarters at the earliest.

8. Revisions

  • ICC will revise its ICC Standard Methods at a minimum of 10 year intervals. ICC reserves the right to request method revisions in certain intervals, if the advancements and method developments in a certain field of analysis demand a more rapid turn over.
  • ICC reserves the right to ask for revision or a withdrawal of an ICC Standard Method in ease of doubt.
  • The method provider is obliged to inform ICC, if changes or additions have been made to a published method. When changes have been made to an existing ICC Standard, ICC reserves the right to request a new ring trial for the modified / improved method for continued use and circulation as ICC Standard. Failure to provide updating information for a modified method / appliance will result in the withdrawal of the method as ICC Standard and informing its users and collaborating SDOs about the withdrawal.
  • When an ICC Standard Method is changed by international committees, such as ISO, CEN, Codex Alimentarius, ICC requests to be informed about the proposed changes by the submitting agency.

9. Application for Standardisation

  • Applications to have a method validated/standardised by ICC must be submitted to the ICC Headquarters.
  • The application must include a short description of the principle of the method, its application, its current significance and potential future use. The ownership of the method must be clearly stated (generic or proprietory).
  • Contact details of the method provider and the organiser of the ring trial must be provided to ICC Headquarters.
  • Once the submitted method is considered for ICC standardisation, the payment for handling and publication must be received prior to validation/standardisation and is non-refundable irrespective of the results of the validation study.

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