Commission Regulation (EC) No 401/2006Show full title

F. METHOD OF SAMPLING FOR MILK AND MILK PRODUCTS; INFANT FORMULAE AND FOLLOW-ON FORMULAE, INCLUDING INFANT MILK AND FOLLOW-ON MILK

This method of sampling is of application for the official control of the maximum levels established for aflatoxin M1 in milk and milk products and infant formulae and follow-on formulae, including infant milk and follow-on milk and dietary foods (milk and milk products) for special medical purposes intended specifically for infants.

F.1. Method of sampling for milk, milk products, infant formulae and follow-on formulae, including infant milk and follow-on milk.

The aggregate sample shall be at least 1 kg or 1 litre except where it is not possible e.g. when the sample consists of one bottle.

The minimum number of incremental samples to be taken from the lot shall be as given in Table 1. The number of incremental samples determined is function of the usual form in which the products concerned are commercialised. In the case of bulk liquid products the lot shall be thoroughly mixed insofar as possible and insofar it does not affect the quality of the product, by either manual or mechanical means immediately prior to sampling. In this case, a homogeneous distribution of aflatoxin M1 is assumed within a given lot. It is therefore sufficient to take three incremental samples from a lot to form the aggregate sample.

The incremental samples, which might frequently be a bottle or a package, shall be of similar weight. The weight of an incremental sample shall be at least 100 grams, resulting in an aggregate sample of at least about 1 kg or 1 litre. Departure from this method shall be recorded in the record provided for under part A.3.8 of Annex I.

Table 1

Minimum number of incremental samples to be taken from the lot

Form of commercialisation	Volume or weight of lot (in litre or kg)	Minimum number of incremental samples to be taken	Minimum volume or weight of aggregate sample (in litre or kg)
Bulk	—	3-5	1
Bottles/packages	≤ 50	3	1
Bottles/packages	50 to 500	5	1
Bottles/packages	> 500	10	1

F.2. Sampling at retail stage

Sampling of foodstuffs at the retail stage shall be done where possible in accordance with the provisions set out in this part of Annex I.

Where that is not possible, an alternative method of sampling at retail stage may be used provided that it ensures that the aggregate sample is sufficiently representative of the sampled lot and is fully described and documented(2).

F.3. Acceptance of a lot or sublot

• acceptance if the laboratory sample conforms to the maximum limit, taking into account the correction for recovery and measurement uncertainty (or decision limit — see Annex II, point 4.4.),

• rejection if the laboratory sample exceeds the maximum limit beyond reasonable doubt taking into account the correction for recovery and measurement uncertainty (or decision limit — see Annex II, point 4.4.).

(1)

A guidance document for competent authorities for the control of compliance with EU legislation on aflatoxins is available at http://europa.eu.int/comm/food/food/chemicalsafety/contaminants/aflatoxin_guidance_en.pdf The guidance document provides additional practical information but the information contained in the guidance document is subordinate to the provisions in this Regulation.

(2)

In case the portion to be sampled is so small that it is impossible to obtain an aggregate sample of 1 kg, the aggregate sample weight might be less than 1 kg.