# Commission Regulation (EC) No 401/2006 of 23 February 2006 laying down the methods of sampling and analysis for the official control of the levels of mycotoxins in foodstuffs (Text with EEA relevance), Division 4.3.2.2: Terminology

Extent: E+W+S+N.I.

Screening target concentration (STC): the concentration of interest for detection of the mycotoxin in a sample. When the aim is to test compliance with regulatory limits, the STC is equal to the applicable maximum level. For other purposes or in case no maximum level has been established, the STC is predefined by the laboratory.
Screening method: means method used for selection of those samples with levels of mycotoxins that exceed the screening target concentration (STC), with a given certainty. For the purpose of mycotoxin screening, a certainty of 95 % is considered fit-for-purpose. The result of the screening analysis is either ‘ negative ’ or ‘ suspect ’ . Screening methods shall allow a cost-effective high sample-throughput, thus increasing the chance to discover new incidents with high exposure and health risks to consumers. These methods shall be based on bio-analytical, LC-MS or HPLC methods. Results from samples exceeding the cut-off value shall be verified by a full re-analysis from the original sample by a confirmatory method.
‘ Negative sample ’ means the mycotoxin content in the sample is < STC with a certainty of 95 % (i.e. there is a 5 % chance that samples will be incorrectly reported as negative).
‘ False negative sample ’ means the mycotoxin content in the sample is > STC but it has been identified as negative.
‘ Suspect sample ’ (screen positive) means the sample exceeds the cut-off level (see below) and may contain the mycotoxin at a level higher than the STC. Any suspect result triggers a confirmatory analysis for unambiguous identification and quantification of the mycotoxin.
‘ False suspect sample ’ is a negative sample that has been identified as suspect.
‘ Confirmatory methods ’ means methods that provide full or complementary information enabling the mycotoxin to be identified and quantified unequivocally at the level of interest.
Cut-off level: the response, signal, or concentration, obtained with the screening method, above which the sample is classified as ‘ suspect ’ . The cut-off is determined during the validation and takes the variability of the measurement into account.
Negative control (blank matrix) sample: a sample known to be free of the mycotoxin to be screened for, e.g. by previous determination using a confirmatory method of sufficient sensitivity. If no blank samples can be obtained, then material with the lowest obtainable level might be used as long as the level allows the conclusion that the screening method is fit for purpose.
Positive control sample: sample containing the mycotoxin at the screening target concentration, e.g. a certified reference material, a material of known content (e.g. test material of proficiency tests) or otherwise sufficiently characterised by a confirmatory method. In the absence of any of the above, a blend of samples with different levels of contamination or a spiked sample prepared within laboratory and sufficiently characterised can be used, provided it can be proven that the contamination level has been verified.

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Source: https://www.legislation.gov.uk/eur/2006/401/annex/II/division/4/division/4.3/division/4.3.2/division/4.3.2.2 (the official version)
Page: https://openlegislation.uk/eu-regulation-2006-401/annex-II/division-4/division-4.3/division-4.3.2/division-4.3.2.2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.