Independent · non-commercial · publishes on a quarterly cycle|Current cycle 2026 Q3
Compound Evidence InstituteEvidence synthesis · established 2023Graded assessments of compounds, trials, methods and supply
Document set current to 30 July 2026
Public comment period · §3

Draft standard CEI-MS-11: Determination of aggregate content… — disposition

The disposition of every submission and the amendments that resulted.

Document identifier
CEI-CP-091/3
Series
Public comment period
Version
1.0
Published
26 Feb 2026
Last reviewed
26 Feb 2026
Next review
26 Feb 2027
Identifier
10.71829/cei.cp.91
Certainty
Not rated
Cycle
2026 Q1
Window
13 Jan 2026 – 12 Feb 2026
Status
Closed
Submissions
12

§3Disposition and amendments

§3.1Disposition table

Table 1. Every submission with its disposition. Each row links to the submission in full.

ReferenceRespondentPoint raisedDisposition
DRAFT-AGGREGATES-S/001Professor Bartolomeu Nkosi-LindegaardThe standard does not require retention of the primary dataNoted, no amendment
DRAFT-AGGREGATES-S/002Ivo MountstephenA determination does not record the version of the standard it was made underAccepted
DRAFT-AGGREGATES-S/003Dr Lorcan UttridgeThe matrix interferes with the determination and no control is requiredAccepted
DRAFT-AGGREGATES-S/004Dr Yehudit YorkstoneThe standard assumes a reference standard of known assigned contentAccepted
DRAFT-AGGREGATES-S/005Dr Kolawole Isaksen-BalogunPoint estimates are given without an intervalAccepted in part
DRAFT-AGGREGATES-S/006Bertrand Ollerenshaw industryThe additional determinations required would materially increase release testing costAccepted in part
DRAFT-AGGREGATES-S/007Dr Abimbola Sotomayor-EkwuemeThe standard does not state that a determination on one unit says nothing about the batchAccepted
DRAFT-AGGREGATES-S/008Dr Quentin ZimmerthalNothing in the standard addresses transfer of the method between laboratoriesAccepted in part
DRAFT-AGGREGATES-S/009Dr Oisín RautavaaraRounding conventions are not stated and change the reported resultAccepted
DRAFT-AGGREGATES-S/010Dr Liesbeth AchterbergNothing requires a laboratory to demonstrate ongoing performanceAccepted in part
DRAFT-AGGREGATES-S/011Dr Ivo QuintanilhaAbsence of evidence is presented in a form a reader will take as negative evidenceAccepted
DRAFT-AGGREGATES-S/012Dr Xenia Nyquist-ObioraNothing addresses the container the material was held inAccepted in part
12 submissions in total.

§3.2Summary by disposition

Table 2. Counts by disposition, with the meaning of each.

DispositionCountMeaning
Accepted6The submission is accepted and the draft is amended as proposed. The amendment is recorded in the amendment log of the document it changed and is traceable to the numbered submission.
Accepted in part5Part of the submission is accepted and part is not. The secretariat response states which part is which and on what ground the remainder was declined.
Noted, no amendment1The submission raises a point the Institute accepts but that does not require a change to the draft, most often because the draft already states it elsewhere. The location is given in the response.
Not accepted0The submission is not accepted. The secretariat response gives the reason. A submission that is not accepted remains published in full; the Institute does not remove a submission because it disagrees with it.

§3.3Resulting amendments

  1. A determination does not record the version of the standard it was made under — arising from DRAFT-AGGREGATES-S/002. Every determination reported under this standard now carries the standard identifier and version on its face, and a claim of conformance that does not identify the version is recorded by the Institute as not conformant.
  2. The matrix interferes with the determination and no control is required — arising from DRAFT-AGGREGATES-S/003. An inhibition and enhancement control is now required for every determination under this standard, with stated recovery limits, and a determination reported without it is recorded as not conformant rather than as a low result.
  3. The standard assumes a reference standard of known assigned content — arising from DRAFT-AGGREGATES-S/004. The standard now states which determinations remain available without a reference standard of assigned content, requires that such determinations be labelled as relative rather than absolute, and requires the assumption used in place of an assigned content to…
  4. Point estimates are given without an interval — arising from DRAFT-AGGREGATES-S/005. Every estimate now carries its interval where the source reported one, and where it did not, the estimate is annotated as reported without an interval rather than left to appear as a precise figure.
  5. The additional determinations required would materially increase release testing cost — arising from DRAFT-AGGREGATES-S/006. One of the two determinations is now required only where the stated risk factor is present, with the factor defined in the scope, and the other is retained as a universal requirement with the reasoning stated. The submission is identified as an industry…
  6. The standard does not state that a determination on one unit says nothing about the batch — arising from DRAFT-AGGREGATES-S/007. Every determination made under this standard now carries a sampling statement recording how many units were sampled, from what population and by what plan, and the standard states that a determination on a single unit supports no inference about any other…
  7. Nothing in the standard addresses transfer of the method between laboratories — arising from DRAFT-AGGREGATES-S/008. The standard now states the maximum difference between laboratories analysing the same sample at which results are treated as agreeing, and requires that a comparison across laboratories state whether that criterion was met.
  8. Rounding conventions are not stated and change the reported result — arising from DRAFT-AGGREGATES-S/009. The standard now requires that no rounding be applied before the reporting step, states the reporting precision for each quantity, and states the rounding convention used at that step.
  9. Nothing requires a laboratory to demonstrate ongoing performance — arising from DRAFT-AGGREGATES-S/010. The standard now requires that system suitability results be trended across runs and that a determination report whether the trend was within the laboratory's stated limits, which places the demonstration inside the document the Institute can read.
  10. Absence of evidence is presented in a form a reader will take as negative evidence — arising from DRAFT-AGGREGATES-S/011. A standing formulation has been adopted and is applied wherever an evidence gap is recorded, distinguishing an outcome assessed and not demonstrated from an outcome not assessed. The formulation is identical at every occurrence so that it can be recognised at…
  11. Nothing addresses the container the material was held in — arising from DRAFT-AGGREGATES-S/012. Container type and headspace atmosphere are now reported where known, and recorded as not held where they are not, rather than omitted.

References cited on this page

References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.

  1. International Organization for Standardization. ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories. ISO/IEC Standard 2017;3rd edition. identifier not held by the Institute

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