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M/352 - analysis for foodstuffs

Supplement n°2 to the CEN's standardisation Mandate concerning methods of analysis for materials and articles intended to come into contact with foodstuffs

Mandate M/352, Supplement No. 2, addresses the standardisation of methods of analysis for materials and articles intended to come into contact with foodstuffs. This mandate supplements the original CEN mandate by specifying additional requirements or revisions for analytical methods to ensure the safety and compliance of food contact materials. The decision involved approval or disapproval actions by the relevant committee under resolution CEN/BT C62/2004. The mandate aims to harmonize testing procedures across European standards organizations to support food safety and regulatory consistency within the EU.

Purpose

This mandate serves as a supplement (n°2) to a previous CEN standardisation mandate focused on methods of analysis for materials and articles intended to come into contact with foodstuffs. Its purpose is to update or extend the scope of standardisation work related to testing and analytical methods that ensure the safety and compliance of such materials in contact with food.

Standardisation request

The mandate requests CEN (European Committee for Standardization) to develop or revise European standards specifying analytical methods for the assessment of materials and articles designed to be in contact with foodstuffs. This may include chemical, physical, or microbiological testing methods that guarantee that materials do not release harmful substances or otherwise compromise food safety.

Expected deliverables

The expected deliverables under this mandate are standardized testing methods or protocols that provide harmonized procedures across the EU. These standards will enable manufacturers, regulators, and testing laboratories to uniformly assess compliance of food contact materials with relevant safety and quality requirements.

Context

This supplement follows the original mandate addressed to CEN concerning analytical methods for food contact materials. It reflects ongoing efforts by the EU to maintain and update harmonised standards in line with evolving scientific knowledge and regulatory needs. The decision linked to this mandate (referenced as CEN/BT C62/2004) indicates formal approval or disapproval proceedings related to the mandate. The standardisation activities contribute to ensuring consumer protection and facilitating free movement of compliant products within the EU internal market.

This mandate covers the development of standardized methods of analysis for materials and articles intended to come into contact with foodstuffs, ensuring safety and compliance in the food contact materials sector.

General Information

Organization
CEN - CEN European Committee for Standardization
Status
Confirmed
Resolution Reference
CEN/BT C62/2004
Resolution Date
11-Aug-2004
Type Of Decision
(Dis-)Approval of mandate
Standardization Organization
ICS
Technical Committee
Directive
50
SIST
SIST EN ISO 20776-1:2020(Main)
Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases (ISO 20776-1:2019, including Corrected version 2019-12)
EN ISO 20776-1:2020

This document describes one reference method, broth micro-dilution, for determination of MICs. The MIC can be a guide for the clinician, and reflects the activity of the drug under the described test conditions, by taking into account other factors, such as drug pharmacology, pharmacokinetics, or bacterial resistance mechanisms. This allows categorisation of bacteria as "susceptible" (S), "intermediate" (I), or "resistant" (R). In addition, MIC distributions can be used to define wild type or non-wild type bacterial populations. Although clinical interpretation of the MIC value is beyond the scope of this document, modifications of the basic method are required for certain antimicrobial agent - bacteria combinations to facilitate clinical interpretation. These modifications are included in a separate annex of this document. It is necessary to compare other susceptibility testing methods (e.g. disc diffusion or diagnostic test devices) with this reference method for validation, in order to ensure comparable and reliable results.

  • Standard
    27 pages
    English language
    e-Library read for
    1 day
CEN
EN ISO 20776-1:2020(Main)
Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases (ISO 20776-1:2019, including Corrected version 2019-12)
SIST EN ISO 20776-1:2020

This document describes one reference method, broth micro-dilution, for determination of MICs. The MIC can be a guide for the clinician, and reflects the activity of the drug under the described test conditions, by taking into account other factors, such as drug pharmacology, pharmacokinetics, or bacterial resistance mechanisms. This allows categorisation of bacteria as "susceptible" (S), "intermediate" (I), or "resistant" (R). In addition, MIC distributions can be used to define wild type or non-wild type bacterial populations. Although clinical interpretation of the MIC value is beyond the scope of this document, modifications of the basic method are required for certain antimicrobial agent - bacteria combinations to facilitate clinical interpretation. These modifications are included in a separate annex of this document. It is necessary to compare other susceptibility testing methods (e.g. disc diffusion or diagnostic test devices) with this reference method for validation, in order to ensure comparable and reliable results.

  • Standard
    27 pages
    English language
    e-Library read for
    1 day
CEN
EN ISO 20776-1:2006(Main)
Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases (ISO 20776-1:2006)
SIST EN ISO 20776-1:2007

ISO 20776-1:2006 describes one reference method, broth microdilution, for determination of MICs. The MIC reflects the activity of the drug under the described test conditions, and can be interpreted for clinical management purposes by taking into account other factors, such as drug pharmacology or bacterial resistance mechanisms. This allows categorization of bacteria as susceptible (S), intermediate (I), or resistant (R). In addition, MIC distributions can be used to define wild type or non-wild type bacterial populations. Although clinical interpretation of the MIC value is beyond the scope of ISO 20776-1:2006, modifications of the basic method are required for certain antimicrobial agent - bacteria combinations to facilitate clinical interpretation. These modifications are included in a separate table. It is advisable to compare other susceptibility testing methods (e.g. routine methods or diagnostic test devices) with this reference method for validation, in order to ensure comparable and reliable results.

  • Standard
    27 pages
    English language
    e-Library read for
    1 day
SIST
SIST EN ISO 20776-1:2007(Main)
Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases (ISO 20776-1:2006)
EN ISO 20776-1:2006

ISO 20776-1:2006 describes one reference method, broth microdilution, for determination of MICs. The MIC reflects the activity of the drug under the described test conditions, and can be interpreted for clinical management purposes by taking into account other factors, such as drug pharmacology or bacterial resistance mechanisms. This allows categorization of bacteria as susceptible (S), intermediate (I), or resistant (R). In addition, MIC distributions can be used to define wild type or non-wild type bacterial populations. Although clinical interpretation of the MIC value is beyond the scope of ISO 20776-1:2006, modifications of the basic method are required for certain antimicrobial agent - bacteria combinations to facilitate clinical interpretation. These modifications are included in a separate table. It is advisable to compare other susceptibility testing methods (e.g. routine methods or diagnostic test devices) with this reference method for validation, in order to ensure comparable and reliable results.

  • Standard
    27 pages
    English language
    e-Library read for
    1 day
50

Frequently Asked Questions

A European Standardization Mandate is a formal request from the European Commission to the European Standardization Organizations (CEN, CENELEC, and ETSI) to develop European standards (ENs) in support of EU legislation and policies. Mandates are issued under Regulation (EU) No 1025/2012 and help ensure that products and services meet the essential requirements set out in EU directives and regulations.

M/352 is a European Standardization Mandate titled "Supplement n°2 to the CEN's standardisation Mandate concerning methods of analysis for materials and articles intended to come into contact with foodstuffs". Supplement n°2 to the CEN's standardisation Mandate concerning methods of analysis for materials and articles intended to come into contact with foodstuffs There are 4 standards developed under this mandate.

Standards developed in response to a mandate and cited in the Official Journal of the European Union become "harmonized standards". Products manufactured in compliance with harmonized standards benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation, facilitating CE marking and market access across the European Economic Area.