CEN/TC 275/WG 6 - Microbiological contamination

This document specifies a method for the detection of Anisakidae L3 larvae commonly found in marine and anadromous fishes. The method is applicable to fresh fish and/or frozen fish, as well as lightly processed fish products, such as marinated, salted or cold smoked.
This method is applicable to quantifying parasitic infections by estimating the number of parasites in the fish musculature.
This method does not apply to determining the species or genotype of detected parasites. Final identification is made by morphological and/or molecular methods.

This document specifies a method for the detection of Anisakidae L3 larvae commonly found in marine and anadromous fishes. The method is applicable to fresh fish and/or frozen fish, as well as lightly processed fish products, such as marinated, salted or smoked. It is also suitable for visceral organs as a confirmatory method for a visual inspection scheme.
The artificial digestion method[4][5][6] is applicable to quantifying parasitic infections by estimating the number of parasites in the fish musculature and, when applied to fresh fish or lightly processed fish products (never frozen before processing), determining the viability of Anisakidae L3, which can be present.
This method does not apply to determining the species or genotype of detected parasites. Final identification is made by morphological and/or molecular methods.

This document specifies the general principles and the technical protocols (based on orthogonal, factorial studies) for the validation of non-proprietary methods for microbiology of the food chain.
This document is applicable to the validation of methods used for the analysis (detection or quantification) of microorganisms in:
—     products intended for human consumption;
—     products intended for animal feeding;
—     environmental samples in the area of food and feed production, handling;
—     samples from the primary production stage.
This document is, in particular, applicable to bacteria and fungi. Some clauses can be applicable to other (micro)organisms or their metabolites, to be determined on a case-by-case basis.
This document specifies protocols for the validation against a reference method for both quantitative and qualitative methods. This document also provides a protocol for the validation of quantitative methods without a reference method. Qualitative methods cannot be validated without a reference method in accordance with this document.
NOTE    ISO 16140-2 specifies the general principle and the technical protocol for the validation of alternative, mostly proprietary, methods against a reference method.
This document is only applicable to the validation of methods that are fully specified with regard to all relevant parameters (including tolerances on temperatures and specifications on culture media) and that have already been optimized.
Methods that have been validated in accordance with this document can be used by the laboratories of the specified population of laboratories.

This document specifies the general principles and the technical protocols for single-laboratory validation of methods for microbiology in the food chain. The protocols in this document only validate the method for the laboratory conducting the study.
This document is applicable to single-laboratory validation of:
—     methods used in the analysis (detection or quantification) of microorganisms in:
—     products intended for human consumption;
—     products intended for animal feeding;
—     environmental samples in the area of food and feed production, handling;
—     samples from the primary production stage;
—     methods for the confirmation or typing of microorganisms. This validation will replace only the confirmation or typing procedure of a specified method (see Annex G).
This document is, in particular, applicable to bacteria and fungi. Some clauses can be applicable to other (micro)organisms or their metabolites, to be determined on a case-by-case basis.
Single-laboratory validation is required if an interlaboratory validation in accordance with ISO 16140-2 is not appropriate. Possible applications are:
—     validation of an in-house method;
—     method evaluation study in the validation process of a reference method in accordance with ISO 17468;
—     extension of the scope of an ISO 16140-2 validated method, e.g. category extension or test portion size;
—     modifications of existing methods.
Single-laboratory validation is the second step in the standardization of a reference method (see ISO 17468). It is only applicable to methods that are fully specified with regard to all relevant parameters (including tolerances on temperatures and specifications on culture media) and that have already been optimized.

This document specifies the general principle and the technical protocol for the validation of alternative confirmation methods for microbiology in the food chain. This document compares the result of the alternative confirmation method against the confirmation procedure of a reference method or, if needed, a reference confirmation method (e.g. whole genome sequencing).
This document is applicable to the validation of alternative confirmation methods used for the analysis (detection or quantification) of isolated microorganisms in:
—          products intended for human consumption;
—          products intended for animal feeding;
—          environmental samples in the area of food and feed production, handling;
—          samples from the primary production stage.
Validated alternative confirmation methods can be used to replace (partly or completely) the confirmation procedure described in:
—          the reference method;
—          an alternative method validated in accordance with ISO 16140-2 only if one of the isolation agars specified in the validation study of the alternative confirmation method is used.
This document is also applicable to the validation of alternative typing methods, where the reference method can be, for example, a serological method (e.g. serotyping of Salmonella) or a molecular method (e.g. typing of Shiga toxin-producing E. coli).
This document is, in particular, applicable to bacteria and fungi. Some clauses can be applicable to other (micro)organisms, to be determined on a case-by-case basis.
Validation studies in accordance with this document are primarily intended to be performed by organizations or expert laboratories involved in method validation, but can also be used by a single laboratory, especially when performing in-house validation under certain conditions (see ISO 16140-4).

This document specifies requirements and gives guidance for the estimation and expression of measurement uncertainty (MU) associated with quantitative results in microbiology of the food chain.
It is applicable to the quantitative analysis of:
—          products intended for human consumption or the feeding of animals;
—          environmental samples in the area of food production and food handling;
—          samples at the stage of primary production.
The quantitative analysis is typically carried out by enumeration of microorganisms using a colony-count technique. This document is also generally applicable to other quantitative analyses, including:
—           most probable number (MPN) techniques;
—          instrumental methods, such as impediometry, adenosine triphosphate (ATP) and flow cytometry;
—          molecular methods, such as methods based on quantitative polymerase chain reaction (qPCR).
The uncertainty estimated by this document does not include systematic effects (bias).

ISO/TS 15216-2:2013 describes a method for qualitative detection of HAV and NoV genogroups I (GI) and II (GII), from test samples of foodstuffs or food surfaces. Following liberation of viruses from the test sample, viral RNA is then extracted by lysis with guanidine thiocyanate and adsorption on silica. Target sequences within the viral RNA are amplified and detected by real-time RT-PCR.
This approach is also relevant for detection of the target viruses on fomites, or of other human viruses in foodstuffs, on food surfaces or on fomites following appropriate validation and using target-specific primer and probe sets.

ISO/TS 22117:2010 gives requirements and guidance for the organization of proficiency testing schemes for microbiological examinations of: a) food and beverages; b) animal feeding stuffs; c) food production environments and food handling; d) primary production stages.
ISO/TS 22117:2010 is also potentially applicable to the microbiological examination of water where water is either used in food production or is regarded as a food in national legislation.
ISO/TS 22117:2010 relates to the technical organization and the implementation of proficiency testing schemes, as well as the statistical treatment of the results of microbiological examinations.
ISO/TS 22117:2010 is designed for use with ISO/IEC 17043 and ISO 13528, and deals only with areas where specific or additional details are necessary for proficiency testing schemes dealing with microbiological analyses for the areas specified in the first paragraph.

ISO 10272-1:2006 describes a horizontal method for the detection of Campylobacter spp.
It is applicable to products intended for human consumption or for the feeding of animals, and to environmental samples in the area of food production and food handling, subject to the limitations stated in the Introduction.

Migrated from Progress Sheet (TC Comment) (2000-07-10): Should be put on the VA list (see resolution TC 275/WG 6 - but wait for official ++ request from TC Secretary) - (NT/961023)

Specifies a horizontal method for the detection of Listeria monocytogenes. Applicable to products intended for human consumption or as animal feeding stuffs.

ISO 10273:2003 specifies a horizontal method for the detection of Yersinia enterocolitica presumed to be pathogenic to human subjects. It is applicable to products intended for human consumption and the feeding of animals, and environmental samples in the area of food production and food handling.

2011-02-24 EMA: // final draft received in ISO/CS (see notifcation from 2011-02-24 in dataservice.

ISO - Taking over of an ISO Technical Corrigendum

ISO 6887-3:2003 specifies rules for the preparation of fish and fishery product samples and their suspension for microbiological examination when the samples require a different preparation from the method described in ISO 6887-1. ISO 6887-1 defines the general rules for the preparation of the initial suspension and decimal dilutions for microbiological examination.
ISO 6887-3:2003 only describes methods of preparation that are applicable to several microorganisms simultaneously. It excludes the preparations that only apply to the detection and/or enumeration of a single microorganism where the methods of preparation are described in the relevant standard concerning that microorganism, for example Vibrio parahaemolyticus.
ISO 6887-3:2003 is applicable to the following raw, processed, cooked or frozen fish and shellfish and their products: raw fish, crustaceans, molluscs and others; processed fish, crustaceans, molluscs and others; frozen fish, crustaceans, molluscs and others, in blocks or otherwise.

ISO 6887-4:2003 specifies rules for the preparation of samples and decimal dilutions for the microbiological examination of food products other than those covered in other parts of ISO 6887. ISO 6887-1 defines the general rules for the preparation of the initial suspension and decimal dilutions for microbiological examination.
ISO 6887-4:2003 only describes methods of preparation that are applicable to several microorganisms simultaneously. It excludes the preparations that only apply to the detection and/or enumeration of a single microorganism where the methods of preparation are described in the relevant International Standard concerning that microorganism.
ISO 6887-4:2003 is applicable to the following products: general case for acidic products; foods with a high fat content, excluding margarine and spreads; flours, whole cereal grains, cereal by-products, animal feeds and cattle cake; very hard products; gelatine; margarine and spreads; dehydrated products and freeze-dried products (except dairy products and egg products); egg and egg products; fermented products (products containing live microorganisms); pastries and cakes.

ISO 6887-2:2003 specifies rules for the preparation of meat and meat product samples and their suspension for microbiological examination when the samples require a different preparation from the method described in ISO 6887-1. ISO 6887-1 defines the general rules for the preparation of the initial suspension and decimal dilutions for microbiological examination. ISO 6887-2:2003 only describes methods of preparation that are applicable to several microorganisms simultaneously. It excludes the preparations that only apply to the detection and/or enumeration of a single microorganism where the method of preparation is described in the relevant International Standard concerning that microorganism.
ISO 6887-2:2003 is applicable to the following fresh, raw and processed meats and poultry and their products: refrigerated or frozen; cured or fermented; minced or comminuted; delicatessen meats; pre-cooked meals or poultry-based meals; dried and smoked meats at various degrees of dehydration; concentrated meat extracts.
ISO 6887-2:2003 is not applicable to the following products whose microbiological examination is described in other International Standards: canned products; other products (see ISO 6887-4).

This standard gives general guidance for the preparation of dilutions for microbiological examination.

ISO/TS 15216-1:2013 describes a method for quantification of levels of HAV and NoV genogroup I (GI) and II (GII) RNA, from test samples of foodstuffs or food surfaces. Following liberation of viruses from the test sample, viral RNA is then extracted by lysis with guanidine thiocyanate and adsorption on silica. Target sequences within the viral RNA are amplified and detected by real-time RT-PCR.
This approach is also relevant for detection of the target viruses on fomites, or of other human viruses in foodstuffs, on food surfaces or on fomites following appropriate validation and using target-specific primer and probe sets.

20060207 - ISO DIS running from 2005-09-20 to 2006-02-20.  TC decision to opt for PQ followed by FV/VA ISO lead.  ISO confirmation received that they will wait for PQ closure before embarking on parallel FDIS

ISO - Taking over of an ISO Technical Corrigendum

ISO 6579:2002 specifies a horizontal method for the detection of Salmonella, including Salmonella Typhi and Salmonella Paratyphi.
It is applicable to products intended for human consumption and the feeding of animals, and to environmental samples in the area of food production and food handling.

2011-01-07 EMA: // final draft provided to ISO/CS according to notification received in dataservice on 2010-12-22.

ISO 16140:2003 defines the general principle and the technical protocol for the validation of alternative methods in the field of microbiological analysis of food, animal feeding stuffs and environmental and veterinary samples for the validation of alternative methods which can be used in particular in the framework of the official control, and the international acceptance of the results obtained by the alternative method.
It also establishes the general principles of certification of these alternative methods, based on the validation protocol defined in ISO 16140:2003.
Where an alternative method is used on a routine basis for internal laboratory use without the requirement to meet (higher) external criteria of quality assurance, a less stringent comparative validation of the alternative method than that set in ISO 16140:2003 may be appropriate.

This Technical Specification sets criteria and methods for the performance testing of culture media. This Technical Specification applies to: - commercial bodies producing and/or distributing ready-to-use or semi-finished reconstituted or dehydrated media to microbiological laboratories; - non-commercial bodies supplying media to third parties; - microbiological laboratories preparing culture media for their own use and evaluating the performance of these media.

ISO/TS 11133-1:2009 provides the general terminology related to quality assurance and specifies the minimum requirements for the preparation of culture media to be used for the microbiological analysis of products intended for human consumption or animal feeding.
It is also applicable to culture media to be used for the microbiological analysis of all kinds of water.
These requirements are applicable to four categories of culture media used in laboratories that prepare and/or use culture media for performing microbiological analyses: commercially manufactured ready-to-use media; media to be remelted, supplemented and distributed; media prepared from commercially available dehydrated formulations; and media prepared from their individual components.

This part of ISO 10272 describes a horizontal method for the semi-quantitative determination of
Campylobacter spp. It is applicable to products intended for human consumption or for the feeding of animals, and to environmental samples in the area of food production and food handling. However, it is possible that this part of ISO 10272 is not appropriate in every detail for certain products, deviations from it being made necessary for technical reasons. It is possible that this part of ISO 10272 is not applicable at all to some other products.

ISO/TS 10272-3:2010 describes a horizontal method for the semi-quantitative determination of Campylobacter spp.
It is applicable to products intended for human consumption or for the feeding of animals, and to environmental samples in the area of food production and food handling. However, it is possible that ISO/TS 10272-3:2010 is not appropriate in every detail for certain products, deviations from it being made necessary for technical reasons. It is possible that ISO/TS 10272-3:2010 is not applicable at all to some other products.

This European Standard provides the general terminology related to quality assurance, culture media and specifies the minimum requirements for the quality assurance of culture media to be used for the microbiological analysis of products intended for human consumption or animal feeding.

This European Standard describes a horizontal method for the enumeration of viable Clostridium perfringens in products intended for human consumption or the feeding of animals.

ISO/TS 11133-2:2003 sets criteria and methods for the performance testing of culture media. It applies to:
commercial bodies producing and/or distributing ready-to-use or semi-finished reconstituted or dehydrated media to microbiological laboratories;
non-commercial bodies supplying media to third parties;
microbiological laboratories preparing culture media for their own use and evaluating the performance of these media.

This European Standard specifies a horizontal method for the detection of Salmonella. Subject to the limitations discussed in the introduction, this European Standard is applicable to products intended for human consumption or feeding of animals. The incubation temperature (35°C or 37°C) is subject to agreement by the parties concerned and is specified in the test report.