Division 4.3.2.8 Validation reportF1

United Kingdom

The validation report shall contain:

A statement on the STC
A statement on the obtained cut-off.

A statement on calculated false suspected rate
A statement on how the false suspected rate was generated.

Table A

Commodity groups for the validation of screening methods

Commodity groups	Commodity categories	Typical representative commodities included in the category
If a buffer is used to stabilise the pH changes in the extraction step, then this commodity group can be merged into one commodity group ‘ High water content ’ .
‘ Difficult or unique commodities ’ should only be fully validated if they are frequently analysed. If they are only analysed occasionally, validation may be reduced to just checking the reporting levels using spiked blank extracts.
High water content	Fruit Juices	Apple juice, grape juice
	Alcoholic beverages	Wine, beer, cider
	Root and tuber vegetables	Fresh ginger
	Cereal or fruit based purees	Purees intended for infants and small children
High oil content	Tree nuts	Walnut, hazelnut, chestnut
	Oil seeds and products thereof	Oilseed rape, sunflower, cotton-seed, soybeans, peanuts, sesame etc.
	Oily fruits and products thereof	Oils and pastes (e.g. peanut butter, tahina)
High starch and/or protein content and low water and fat content	Cereal grain and products thereof	Wheat, rye, barley, maize, rice, oats Wholemeal bread, white bread, crackers, breakfast cereals, pasta
	Dietary products	Dried powders for the preparation of food for infants and small children
High acid content and high water content ^f1	Citrus products
‘Difficult or unique commodities’^f2		Cocoa beans and products thereof, copra and products thereof, coffee, tea Spices, liquorice
High sugar low water content	Dried fruits	Figs, raisins, currants, sultanas
Milk and milk products	Milk	Cow, goat and buffalo milk
	Cheese	Cow, goat cheese
	Dairy products (e.g. milk powder)	Yogurt, cream

Table B

One tailed t-value for a false negative rate of 5 %

Degrees of Freedom	Number of replicates	t-value (5 %)
10	11	1,812
11	12	1,796
12	13	1,782
13	14	1,771
14	15	1,761
15	16	1,753
16	17	1,746
17	18	1,74
18	19	1,734
19	20	1,729
20	21	1,725
21	22	1,721
22	23	1,717
23	24	1,714
24	25	1,711
25	26	1,708
26	27	1,706
27	28	1,703
28	29	1,701
29	30	1,699
30	31	1,697
40	41	1,684
60	61	1,671
120	121	1,658
∞	∞	1,645

Annotations

Textual amendments

F1: Substituted by Commission Regulation (EU) No 519/2014 of 16 May 2014 amending Regulation (EC) No 401/2006 as regards methods of sampling of large lots, spices and food supplements, performance criteria for T-2, HT-2 toxin and citrinin and screening methods of analysis (Text with EEA relevance).

Footnotes

f1: If a buffer is used to stabilise the pH changes in the extraction step, then this commodity group can be merged into one commodity group ‘ High water content ’ .
f2: ‘ Difficult or unique commodities ’ should only be fully validated if they are frequently analysed. If they are only analysed occasionally, validation may be reduced to just checking the reporting levels using spiked blank extracts.