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11 50

MDL: How should a method developer estimate this parameter? By using blank matrices or blank 

matrices spiked with reference materials/peptides? How many replicates? We have very clear 

guidelines for allergen determination by ELISA‐why not for “Reference methods for cGMP 

compliance”?

Discuss in the working group maybe follow ELISA guidelines

Reference to Appendix M:  Validation Procedures for 

Quantitative Food Allergen ELISA Methods added to SMPR.  

SMPR will also refer to FDA and/or EPA definition for MDL. 

12 46

LoQ: How should a method developer determine or even estimate this parameter? By using 

reference materials or peptide solutions or blank matrices or blank matrices spiked with reference 

materials/peptides? How many replicates? We have very clear guidelines for allergen 

determination by ELISA‐why not for “Reference methods for cGMP compliance”?

Discuss in the working group maybe follow ELISA guidelines

Reference to Appendix M:  Validation Procedures for 

Quantitative Food Allergen ELISA Methods added to SMPR.

13 46‐69

LoQ, MDL, recovery and precision data need to be determined for every claimed matrix

include a sentence for each parameter that explains the parameter‐

specific validation

Line 108 of version  revised 

to recommend "LOQ, MDL, recovery 

and precision" data for every claimed matrix.

14

116 (table 

1)

By taking the latest published VITAL reference doses C18(Food Chem. Toxicol. 63: 9‐17, 2014) it is 

obvious that the MDLs/LoQs in table 1 are not sufficient when a food is analyzed that is consumed 

in a service size of more than 50 g.  Lower MDL/LoQ appropriately to the following table. Note: C19

Hazelnut: Reference dose as protein: 0.1 mg; Reference dose as allergenic food: 0.64 mg; 

Minimum concentration to be quantified when consuming 50 g food: 12.8 mg/kg and for 200 g 3.2 

mg/kg.

Milk: Reference dose as protein: 0.1 mg; Reference dose as allergenic food: 3.03 mg; Minimum 

concentration to be quantified when consuming 50 g food: 60.6 mg/kg and for 200 g 15.2 mg/kg.

Peanut: Reference dose as protein: 0.2 mg; Reference dose as allergenic food: 0.8 mg; Minimum 

concentration to be quantified when consuming 50 g food: 16 mg/kg and for 200 g 4 mg/kg.

Whole egg: Reference dose as protein: 0.03 mg; Reference dose as allergenic food: 0.25 mg; 

Minimum concentration to be quantified when consuming 50 g food: 4.8 mg/kg and for 200 g 1.2 

mg/kg.

Change MDLs/LoQ in table 1 according to the VITAL values and 

calculations given under comments. Discuss in the working group

No change.  

Working Group discussed on 3/3/2016. There are 

multiple VITALs with different maximum permissiable 

concentrations.  The Working Group consensus is that none of 

the VITALs are international concensusn standards, and declined 

to reset the LOQs or MDLs  based on VITALmaximum 

permissiable concentrations.  

15

How should a method developer prove that the selected peptides are not “too” specific e.g. a 

sequence is used that is not present in every commercially available peanut or hazelnut variety. On 

the opposite, if the selected peptides are not specific enough, near botanical relatives are detected 

which are maybe not allergenic or regulated (see prunus mahaleb example).

At minimum a chapter describing the known specificities/selectivities 

should be provided. (Note: Unknown occurrence of peptides that are 

not from a allergenic source will always occur in the future, see also 

prunus mahaleb)

No change.

  The working group did not agree.

16

What are the minimum performance criteria for peptide selection?

Include criteria for peptide selection or give reference

No change.

  The working group did not agree.

17

VITAL values are based on amount of protein per service size. Therefore, the definition of the food 

allergens as “food commodities” without mentioning the protein content will establish a non‐

comparability between results obtained by an LC‐MS/MS method and VITAL values.

Include some guidance for the user or let the method developer 

describe his way of establishing traceability to VITAL values

No change.

Working Group discussed on 3/3/2016. There are 

multiple VITALs with different maximum permissiable 

concentrations.  The Working Group consensus is that none of 

the VITALs are international concensusn standards, and declined 

to reset the LOQs or MDLs  based on VITALmaximum 

permissiable concentrations.  AND E25

18 9

collaborative test: It should be critically checked if Appendix D is sufficient in the case where LESS 

than 8 participants (and/or LC‐MS/MS machines) are available. Is this still collaborative or 

forbidden at all?

discuss in the working group

No change.  

AOAC policy not a working group decision.

19 3

The title is unclear

change to “…selected food allergens”

Change title to “…selected food allergens."

20 9

This means a method comparison between the original method (checked by an ERP) and this 

method transferred to another lab. Are there any guidelines for this case? What is the minimum 

required number of measurements to be sure that both methods are comparable?

Include minimum requirements for verification

No change.  

Method comparision is not a verification 

requirement.