Say you produce product in Latin America and you export to Europe and the USA. What methods should be used to test your product to meet requirements – both within the country of origin, and to meet requirements for the country of import? How many methods must be used? BOTH the standard method of the country of origin - AND the standard method of the importing country?

This is an important struggle that can impact industry and trade. Each country may have a preferred standard method, and even within a country different regulatory agencies may use different methods to test for the SAME analyte, based on the commodities they regulate. For example: methods used by the US Food and Drug Administration for the detection of Listeria monocytogenes are different than the methods used by the US Department of Agriculture Food Safety Inspection Service to detect this SAME organism.

Two globally recognized analytical standards developing organizations (SDOs) are: AOAC INTERNATIONAL and the International Standards Organization (ISO). Both organizations have expert volunteers working together to develop and validate standards.

Several years ago, AOAC INTERNATIONAL began using a Stakeholder Panel model to create Standard Method Performance Requirements (SMPRs) – which are then used to validate standard methods. Stakeholder panels are made up of both users and creators of methods and standards. Stakeholders are global volunteers from industry, academia, government agencies, technology providers and other SDOs all with a common goal: to define method criteria (SMPRs) and to evaluate methods against these agreed-upon criteria to become useful, harmonized, standard methods.

Today, there are many active Stakeholder panels within AOAC INTERNATIONAL, working on a variety of topics in need of methods and standards development and validation.

Recently, members of the AOAC INTERNATIONAL Stakeholder Panel on Analytical Methods (ISPAM) worked to come to agreement concerning a number of key method validation criteria in order to bring the microbiology method validation requirements for ISO and AOAC INTERNATIONAL closer towards harmonization. Technical agreements from these ISPAM meetings were included in the recently published document: ISO 16140-2:2016 – Microbiology of the Food Chain – Method Validation, Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method.

Members of the AOAC Stakeholder Panel on Infant Formula and Adult Nutritionals (SPIFAN) created SMPRs for nutrients in Infant formula. Eight of these methods have been validated against their respective SMPR criteria and have achieved AOAC Official Methods of AnalysisSM (OMA) status. To ensure global harmonization, these methods were jointly developed and published with ISO and the International Dairy Federation (IDF) also as their standards. Members of the SPIFAN stakeholder panel, who also participate as members of the Codex Committee on Methods of Analysis and Sampling (CCMAS), brought these methods to CCMAS for recommended adoption of these eight AOAC OMA methods to the CODEX Alimentarius Commission (CAC). They were successful in achieving recognition of a first set of these methods as Type II (dispute resolution) methods, and recently submitted a second set, approved to move forward to the CAC. Codex recognition increases the chance these methods will be used by Codex member countries.

3M Food Safety and other members of GFSI participate in organizations that continue to work together towards harmonization in many areas - harmonization of standards, methods, certifications, audits, etc. Someday (soon?) we’ll be living the dream!

This post was written and contributed by: DeAnn Benesh
DeAnn Benesh is a regulatory affairs manager with 3M Food Safety in St. Paul, Minn. She can be reached at This email address is being protected from spambots. You need JavaScript enabled to view it..


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