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

ANNEX I(1) U.K. METHODS OF SAMPLING FOR OFFICIAL CONTROL OF THE LEVELS OF MYCOTOXINS IN FOODSTUFFS

A. GENERAL PROVISIONS U.K.

Official controls shall be performed in accordance with the provisions of Regulation (EC) No 882/2004. The following general provisions shall apply without prejudice to the provisions in Regulation (EC) No 882/2004.

A.1. Purpose and scope U.K.

Samples intended for official control of the levels of mycotoxins content in foodstuffs shall be taken according to the methods set out in this Annex. Aggregate samples thus obtained shall be considered as representative of the lots. Compliance with maximum limits laid down in Regulation (EC) No 466/2001 shall be established on the basis of the levels determined in the laboratory samples.

A.2. Definitions U.K.

For the purpose of this Annex, the following definitions shall apply:

A.2.1.

‘lot’ means an identifiable quantity of a food commodity delivered at one time and determined by the official to have common characteristics, such as origin, variety, type of packing, packer, consignor or markings;

A.2.2.

‘sublot’ means a designated part of a large lot in order to apply the sampling method on that designated part; each sublot must be physically separate and identifiable;

A.2.3.

‘incremental sample’ means a quantity of material taken from a single place in the lot or sublot;

A.2.4.

‘aggregate sample’ means the combined total of all the incremental samples taken from the lot or sublot;

A.2.5.

‘laboratory sample’ means a sample intended for the laboratory.

A.3. General provisions U.K.

A.3.1. Personnel U.K.

Sampling shall be performed by an authorised person F1 ....

Textual Amendments

F1 Words in Annex 1 para. A.3.1 omitted (31.12.2020) by virtue of The Contaminants in Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/639), regs. 1, 13; 2020 c. 1, Sch. 5 para. 1(1)

A.3.2. Material to be sampled U.K.

Each lot which is to be examined shall be sampled separately. In accordance with the specific sampling provisions for the different mycotoxins, large lots shall be subdivided into sublots to be sampled separately.

A.3.3. Precautions to be taken U.K.

In the course of sampling and preparation of the samples, precautions shall be taken to avoid any changes, which would affect:

• the mycotoxin content, adversely affect the analytical determination or make the aggregate samples unrepresentative;

• the food safety of the lots to be sampled.

Also, all measures necessary to ensure the safety of the persons taking the samples shall be taken.

A.3.4. Incremental samples U.K.

As far as possible incremental samples shall be taken at various places distributed throughout the lot or sublot. Departure from such procedure shall be recorded in the record provided for under part A.3.8. of this Annex I.

A.3.5. Preparation of the aggregate sample U.K.

The aggregate sample shall be made up by combining the incremental samples.

A.3.6. Replicate samples U.K.

The replicate samples for enforcement, trade (defence) and reference (referee) purposes shall be taken from the homogenised aggregate sample, unless such procedure conflicts with [F2 the rules applicable in each constituent territory of Great Britain] as regards the rights of the food business operator.

Textual Amendments

F2 Words in Annex 1 para. A.3.6 substituted (31.12.2020) by The Contaminants in Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/639), regs. 1, 14 (as substituted by S.I. 2020/1504, regs. 1(2), 8(4)); 2020 c. 1, Sch. 5 para. 1(1)

A.3.7. Packaging and transmission of samples U.K.

Each sample shall be placed in a clean, inert container offering adequate protection from contamination and against damage in transit. All necessary precautions shall be taken to avoid any change in composition of the sample, which might arise during transportation or storage.

A.3.8. Sealing and labelling of samples U.K.

Each sample taken for official use shall be sealed at the place of sampling and identified following the rules [F3 applicable in each constituent territory of Great Britain].

Textual Amendments

F3 Words in Annex 1 para. A.3.8 substituted (31.12.2020) by The Contaminants in Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/639), regs. 1, 15 (as substituted by S.I. 2020/1504, regs. 1(2), 8(5)); 2020 c. 1, Sch. 5 para. 1(1)

A record shall be kept of each sampling, permitting each lot to be identified unambiguously and giving the date and place of sampling together with any additional information likely to be of assistance to the analyst.

A.4. Different types of lots U.K.

Food commodities may be traded in bulk, containers, or individual packings, such as sacks, bags, retail packings. The method of sampling may be applied to all the different forms in which the commodities are put on the market.

Without prejudice to the specific provisions set out in other parts of this Annex, the following formula may be used as a guide for the sampling of lots traded in individual packs, such as sacks, bags, retail packings.

• weight: in kg

• sampling frequency (SF): every n^th sack or bag from which an incremental sample must be taken (decimal figures should be rounded to the nearest whole number).

B. METHOD OF SAMPLING FOR CEREALS AND CEREAL PRODUCTS U.K.

This method of sampling is of application for the official control of the maximum levels established for aflatoxin B1, total aflatoxins, ochratoxin A and Fusarium-toxins in cereals and cereal products.

B.1. Weight of the incremental sample U.K.

The weight of the incremental sample shall be about 100 grams, unless otherwise defined in this part B of Annex I.

In the case of lots in retail packings, the weight of the incremental sample shall depend on the weight of the retail pack.

In the case of retail packs of more than 100 grams, this will result in aggregate samples weighing more than 10 kg. If the weight of a single retail pack is much more than 100 grams, then 100 grams shall be taken from each individual retail pack as an incremental sample. This can be done either when the sample is taken or in the laboratory. However, in cases where such method of sampling would lead to unacceptable commercial consequences resulting from damage to the lot (because of packaging forms, means of transport, etc.), then an alternative method of sampling can be applied. For example, in case where a valuable product is marketed in retail packs of 500 grams or 1 kg, the aggregate sample can be obtained by the aggregation of a number of incremental samples that is smaller than the number indicated in Tables 1 and 2, on the condition that the weight of the aggregate sample is equal to the required weight of the aggregate sample mentioned in Tables 1 and 2.

Where the retail pack is less than 100 grams and if the difference is not very large, one retail pack is to be considered as one incremental sample, resulting in an aggregate sample of less than 10 kg. If the weight of the retail pack is much less than 100 grams, one incremental sample consists of two or more retail packs, whereby the 100 grams are approximated as closely as possible.

B.2. General survey of the method of sampling for cereals and cereal products U.K.

[F4 Table 1

Subdivision of lots into sublots depending on product and lot weight

a Depending on the lot weight — see Table 2.]
Commodity	Lot weight (tonne)	Weight or number of sublots	No incremental samples	Aggregate sample Weight (kg)
Cereals and cereal products	> 300 and < 1 500	3 sublots	100	10
	≥ 50 and ≤ 300	100 tonnes	100	10
	< 50	—	3-100 a	1-10

Textual Amendments

F4 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).

B.3. Method of sampling for cereals and cereal products for lots ≥ 50 tonnes U.K.

• On condition that the sublot can be separated physically, each lot shall be subdivided into sublots following Table 1. Taking into account that the weight of the lot is not always an exact multiple of the weight of the sublots, the weight of the sublot may exceed the mentioned weight by a maximum of 20 %. In case the lot is not or cannot be physically separated into sublots, a minimum of 100 incremental samples is taken from the lot. [F5 For lots > 500 tonnes, the number of incremental samples is provided for in part L.2 of Annex I.]

• Each sublot shall be sampled separately.

• Number of incremental samples: 100. Weight of the aggregate sample = 10 kg.

• If it is not possible to carry out the method of sampling set out in this point because of the unacceptable commercial consequences resulting from damage to the lot (because of packaging forms, means of transport, etc.) an alternative method of sampling may be applied provided that it is as representative as possible and is fully described and documented. An alternative method of sampling may also be applied in cases where it is practically impossible to apply the abovementioned method of sampling. This is e.g. the case where large lots of cereals are stored in warehouses or where cereals are stored in silos (2).

Textual Amendments

F5 Inserted 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).

B.4. Method of sampling for cereals and cereal products for lots < 50 tonnes U.K.

For lots of cereals and cereal products less than 50 tonnes, the sampling plan shall be used with 10 to 100 incremental samples, depending on the lot weight, resulting in an aggregate sample of 1 to 10 kg. For very small lots (≤ 0,5 tonnes) a lower number of incremental samples may be taken, but the aggregate sample combining all incremental samples shall be also in that case at least 1 kg.

The figures in Table 2 may be used to determine the number of incremental samples to be taken.

Table 2

Number of incremental samples to be taken depending on the weight of the lot of cereals and cereal products

Lot weight (tonnes)	Number of incremental samples	Aggregate sample weight(kg)
≤ 0,05	3	1
> 0,05-≤ 0,5	5	1
> 0,5-≤ 1	10	1
> 1-≤ 3	20	2
> 3-≤ 10	40	4
> 10-≤ 20	60	6
> 20-≤ 50	100	10

B.5. Sampling at retail stage U.K.

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

Where that is not possible, an alternative method of sampling at retail stage may be applied provided that it ensures that the aggregate sample is sufficiently representative of the sampled lot and is fully described and documented. In any case, the aggregate sample shall be at least 1 kg(3).

B.6. Acceptance of a lot or sublot U.K.

• acceptance if the laboratory sample conforms to the maximum limit, taking into account the correction for recovery and measurement uncertainty;

• rejection if the laboratory sample exceeds the maximum limit beyond reasonable doubt taking into account the correction for recovery and measurement uncertainty.

C. METHOD OF SAMPLING FOR DRIED FRUIT, INCLUDING DRIED VINE FRUIT AND DERIVED PRODUCTS BUT WITH THE EXCEPTION OF DRIED FIGS U.K.

This method of sampling is of application for the official control of the maximum levels established for:

• aflatoxin B1 and total aflatoxins in dried fruit but with the exception of dried figs and

• ochratoxin A in dried vine fruit (currants, raisins and sultanas).

C.1. Weight of the incremental sample U.K.

The weight of the incremental sample shall be about 100 grams, unless otherwise defined in this part C of Annex I.

In the case of lots in retail packings, the weight of the incremental sample depends on the weight of the retail packing.

In the case of retail packs of more than 100 grams, this will result in aggregate samples weighing more than 10 kg. If the weight of a single retail pack is much more than 100 grams, then 100 grams shall be taken from each individual retail pack as an incremental sample. This can be done either when the sample is taken or in the laboratory. However, in cases where such method of sampling would lead to unacceptable commercial consequences resulting from damage to the lot (because of packaging forms, means of transport, etc.) then an alternative method of sampling can be applied. For example, in case where a valuable product is marketed in retail packs of 500 grams or 1 kg, the aggregate sample can be obtained by the aggregation of a number of incremental samples that is smaller than the number indicated in Tables 1 and 2, on the condition that the weight of the aggregate sample corresponds to the required weight of the aggregate sample mentioned in Tables 1 and 2.

Where the retail pack is less than 100 grams and if the difference is not very large, one retail pack shall be considered as one incremental sample, resulting in an aggregate sample of less than 10 kg. If the weight of the retail pack is much less than 100 grams, one incremental sample shall consist of two or more retail packs, whereby the 100 grams are approximated as closely as possible.

C.2. General survey of the method of sampling dried fruit, with the exception of figs U.K.

Table 1

Subdivision of lots into sublots depending on product and lot weight

a Depending on the lot weight — see Table 2 of this part of this Annex.
Commodity	Lot weight (tonnes)	Weight or number of sublots	Number of incremental samples	Aggregate sample weight (kg)
Dried fruit	≥ 15	15-30 tonnes	100	10
	< 15	—	10-100a	1-10

C.3. Method of sampling for dried fruit (lots ≥ 15 tonnes), with the exception of figs U.K.

• On condition that the sublot can be separated physically, each lot shall be subdivided into sublots following Table 1. Taking into account that the weight of the lot is not always an exact multiple of the weight of the sublots, the weight of the sublot may exceed the mentioned weight by a maximum of 20 %.

• Each sublot shall be sampled separately.

• Number of incremental samples: 100. Weight of the aggregate sample = 10 kg.

• If it is not possible to carry out the method of sampling described above because of the commercial consequences resulting from damage to the lot (because of packaging forms, means of transport, etc.) an alternative method of sampling may be applied provided that it is as representative as possible and is fully described and documented.

C.4. Method of sampling for dried fruit (lots < 15 tonnes), with the exception of figs U.K.

For dried fruit lots, with the exception of figs, under 15 tonnes the sampling plan shall be used with 10 to 100 incremental samples, depending on the lot weight, resulting in an aggregate sample of 1 to 10 kg.

The figures in the following table can be used to determine the number of incremental samples to be taken.

Table 2

Number of incremental samples to be taken depending on the weight of the lot of dried fruit

Lot weight (tonnes)	Number of incremental samples	Aggregate sample weight (kg)
≤ 0,1	10	1
> 0,1-≤ 0,2	15	1,5
> 0,2-≤ 0,5	20	2
> 0,5-≤ 1,0	30	3
> 1,0-≤ 2,0	40	4
> 2,0-≤ 5,0	60	6
> 5,0-≤ 10,0	80	8
> 10,0-≤ 15,0	100	10

C.5. Sampling at retail stage U.K.

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, another 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. In any case, the aggregate sample shall be at least 1 kg(4).

C.6. Specific sampling provisions for dried fruit with the exception of dried figs traded in vacuum packs U.K.

For lots equal to or more than 15 tonnes at least 25 incremental samples resulting in a 10 kg aggregate sample shall be taken and for lots less than 15 tonnes, 25 % of the number of incremental samples mentioned in Table 2 shall be taken resulting in an aggregate sample of which the weight corresponds to the weight of the sampled lot (see Table 2).

C.7. Acceptance of a lot or sublot U.K.

• acceptance if the laboratory sample conforms to the maximum limit, taking into account the correction for recovery and measurement uncertainty;

• rejection if the laboratory sample exceeds the maximum limit beyond reasonable doubt taking into account the correction for recovery and measurement uncertainty.

D. METHOD OF SAMPLING FOR DRIED FIGS, GROUNDNUTS AND NUTS U.K.

This method of sampling is of application for the official control of the maximum levels established for aflatoxin B1 and total aflatoxins in dried figs, groundnuts and nuts.

[F6 D.1. Method of sampling for dried figs U.K.

This method of sampling is of application for the official control of the maximum levels established for aflatoxin B1 and total aflatoxins in dried figs.

D.1.1. Weight of the incremental sample U.K.

The weight of the incremental sample shall be about 300 grams, unless otherwise defined in part D.1 of Annex I.

In the case of lots in retail packings, the weight of the incremental sample depends on the weight of the retail packing.

In the case of retail packs of more than 300 grams, this will result in aggregate samples weighing more than 30 kg. If the weight of a single retail pack is much more than 300 grams, then 300 grams shall be taken from each individual retail pack as an incremental sample. This can be done either when the sample is taken or in the laboratory. However, in cases where such method of sampling would lead to unacceptable commercial consequences resulting from damage to the lot (because of packaging forms, means of transport, etc.), then an alternative method of sampling can be applied. For example, in case where a valuable product is marketed in retail packs of 500 grams or 1 kg, the aggregate sample can be obtained by the aggregation of a number of incremental samples that is smaller than the number indicated in tables 1, 2 and 3, on the condition that the weight of the aggregate sample corresponds to the required weight of the aggregate sample mentioned in tables 1, 2 and 3.

Where the retail pack is less than 300 grams and if the difference is not very large, one retail pack shall be considered as one incremental sample, resulting in an aggregate sample of less than 30 kg. If the weight of the retail pack is much less than 300 grams, one incremental sample shall consist of two or more retail packs, whereby the 300 grams are approximated as closely as possible.

D.1.2. General survey of the method of sampling for dried figs U.K.

Table 1

Subdivision of lots into sublots depending on product and lot weight

a Depending on the lot weight — see table 2 of this part D.1 of this Annex.
Commodity	Lot weight (tonne)	Weight or number of sublots	No incremental samples	Aggregate sample weight (kg)
Dried figs	≥ 15	15-30 tonnes	100	30
	< 15	—	10-100 a	≤ 30

D.1.3. Method of sampling for dried figs (lots ≥ 15 tonnes) U.K.

• On condition that the sublot can be separated physically, each lot shall be subdivided into sublots following table 1. Taking into account that the weight of the lot is not always an exact multiple of the weight of the sublots, the weight of the sublot may exceed the mentioned weight by a maximum of 20 %.

• Each sublot shall be sampled separately,

• Number of incremental samples: 100,

• Weight of the aggregate sample = 30 kg which shall be mixed and to be divided into three equal laboratory samples of 10 kg before grinding (this division into three laboratory samples is not necessary in case of dried figs subjected to further sorting or other physical treatment and of the availability of equipment which is able to homogenise a 30 kg sample).

• Each laboratory sample of 10 kg shall be separately ground finely and mixed thoroughly to achieve complete homogenisation, in accordance with the provisions laid down in Annex II.

• If it is not possible to carry out the method of sampling described above because of the unacceptable commercial consequences resulting from damage to the lot (because of packaging forms, means of transport, etc.) an alternative method of sampling may be applied provided that it is as representative as possible and is fully described and documented.

D.1.4. Method of sampling for dried figs (lots < 15 tonnes) U.K.

The number of incremental samples to be taken depends on the weight of the lot, with a minimum of 10 and a maximum of 100.

The figures in the following table 2 may be used to determine the number of incremental samples to be taken and the subsequent division of the aggregate sample.

Table 2

Number of incremental samples to be taken depending on the weight of the lot and number of subdivisions of the aggregate sample

Lot weight (tonnes)	No of incremental samples	Aggregate sample Weight (kg) (in case of retail packings, weight of aggregate sample can diverge — see point D.1.1)	No of laboratory samples from aggregate sample
≤ 0,1	10	3	1 (no division)
> 0,1 – ≤ 0,2	15	4,5	1 (no division)
> 0,2 – ≤ 0,5	20	6	1 (no division)
> 0,5 – ≤ 1,0	30	9 (- < 12 kg)	1 (no division)
> 1,0 – ≤ 2,0	40	12	2
> 2,0 – ≤ 5,0	60	18 (- < 24 kg)	2
> 5,0 – ≤ 10,0	80	24	3
> 10,0 – ≤ 15,0	100	30	3

• Weight of the aggregate sample ≤ 30 kg which shall be mixed and divided into two or three equal laboratory samples of ≤ 10 kg before grinding (this division into two or three laboratory samples is not necessary in case of dried figs, subjected to further sorting or other physical treatment and of the availability of equipment which is able to homogenise up to 30 kg samples).

  In cases where the aggregate sample weights are less than 30 kg, the aggregate sample shall be divided into laboratory samples according to following guidance:

  • < 12 kg: no division into laboratory samples;

  • ≥ 12 – < 24 kg: division into two laboratory samples;

  • ≥ 24 kg: division into three laboratory samples.

• Each laboratory sample shall be separately ground finely and mixed thoroughly to achieve complete homogenisation, in accordance with the provisions laid down in Annex II,

• If it is not possible to carry out the method of sampling described above because of the unacceptable commercial consequences resulting from damage to the lot (because of packaging forms, means of transport, etc.) an alternative method of sampling may be applied provided that it is as representative as possible and is fully described and documented.

D.1.5. Method of sampling for derived products and compound foods U.K.

D.1.5.1. Derived products with very small particle weight (homogeneous distribution of aflatoxin contamination) U.K.

• Number of incremental samples: 100; for lots of under 50 tons the number of incremental samples shall be 10 to 100, depending on the lot weight (see table 3),

  Table 3
  Number of incremental samples to be taken depending on the weight of the lot
  Lot weight (tonnes)	No of incremental samples	Aggregate sample weight (kg)
  ≤ 1	10	1
  > 1 – ≤ 3	20	2
  > 3 – ≤ 10	40	4
  > 10 – ≤ 20	60	6
  > 20 – ≤ 50	100	10

• The weight of the incremental sample shall be about 100 grams. In the case of lots in retail packing, the weight of the incremental sample depends on the weight of the retail packing,

• Weight of aggregate sample = 1-10 kg sufficiently mixed,

D.1.5.2. Other derived products with a relatively large particle size (heterogeneous distribution of aflatoxin contamination) U.K.

Method of sampling and acceptance as for dried figs (D.1.3 and D.1.4).

D.1.6. Sampling at retail stage U.K.

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, other effective methods of sampling at retail stage may be used provided that they ensure that the aggregate sample is sufficiently representative of the sampled lot and is fully described and documented. In any case, the aggregate sample shall be at least 1 kg (5) .

D.1.7. Specific method of sampling of dried figs and derived products traded in vacuum packs U.K.

D.1.7.1. Dried figs U.K.

For lots equal to or more than 15 tonnes at least 50 incremental samples resulting in a 30 kg aggregate sample shall be taken and for lots of less than 15 tonnes, 50 % of the number of incremental samples mentioned in table 2 shall be taken resulting in an aggregate sample of which the weight corresponds to the weight of the sampled lot (see table 2).

D.1.7.2. Products derived from dried figs with small particle size U.K.

For lots equal to or more than 50 tonnes at least 25 incremental samples resulting in a 10 kg aggregate sample shall be taken and for lots less than 50 tonnes, 25 % of the number of incremental samples mentioned in table 3 shall be taken resulting in an aggregate sample of which the weight corresponds to the weight of the sampled lot (see table 3).

D.1.8. Acceptance of a lot or sublot U.K.

For dried figs subjected to a sorting or other physical treatment:

• acceptance if the aggregate sample or the average of the laboratory samples conforms to the maximum limit, taking into account the correction for recovery and measurement uncertainty,

• rejection if the aggregate sample or the average of the laboratory samples exceeds the maximum limit beyond reasonable doubt taking into account the correction for recovery and measurement uncertainty,

For dried figs intended for direct human consumption:

• acceptance if none of the laboratory samples exceeds the maximum limit, taking into account the correction for recovery and measurement uncertainty,

• rejection if one or more of the laboratory samples exceeds the maximum limit beyond reasonable doubt taking into account the correction for recovery and measurement uncertainty,

In cases where the aggregate sample is 12 kg or less:

• acceptance if the laboratory sample conforms to the maximum limit, taking into account the correction for recovery and measurement uncertainty,

• rejection if the laboratory sample exceeds the maximum limit beyond reasonable doubt taking into account the correction for recovery and measurement uncertainty,

Textual Amendments

F6 Substituted by Commission Regulation (EU) No 178/2010 of 2 March 2010 amending Regulation (EC) No 401/2006 as regards groundnuts (peanuts), other oilseeds, tree nuts, apricot kernels, liquorice and vegetable oil (Text with EEA relevance).

D.2. Method of sampling for groundnuts (peanuts), other oilseeds, apricot kernels and tree nuts U.K.

This method of sampling is of application for the official control of the maximum levels established for aflatoxin B1 and total aflatoxins in groundnuts (peanuts), other oilseeds, apricot kernels and tree nuts. [F5 This method of sampling is of also of application for the official control of the maximum levels established for ochratoxin A, aflatoxin B1 and total aflatoxins in spices with a relatively large particle size (particle size comparable with peanuts or larger e.g. nutmeg).]

D.2.1. Weight of the incremental sample U.K.

The weight of the incremental sample shall be about 200 grams, unless otherwise defined in part D.2 of Annex I.

In the case of lots in retail packings, the weight of the incremental sample depends on the weight of the retail packing.

In the case of retail packs of more than 200 grams, this will result in aggregate samples weighing more than 20 kg. If the weight of a single retail pack is much more than 200 grams, then 200 grams shall be taken from each individual retail pack as an incremental sample. This can be done either when the sample is taken or in the laboratory. However, in cases where such method of sampling would lead to unacceptable commercial consequences resulting from damage to the lot (because of packaging forms, means of transport, etc.), then an alternative method of sampling can be applied. For example, in case where a valuable product is marketed in retail packs of 500 grams or 1 kg, the aggregate sample can be obtained by the aggregation of a number of incremental samples that is smaller than the number indicated in tables 1, 2 and 3, on the condition that the weight of the aggregate sample corresponds to the required weight of the aggregate sample mentioned in tables 1, 2 and 3.

Where the retail pack is less than 200 grams and if the difference is not very large, one retail pack shall be considered as one incremental sample, resulting in an aggregate sample of less than 20 kg. If the weight of the retail pack is much less than 200 grams, one incremental sample shall consist of two or more retail packs, whereby the 200 grams are approximated as closely as possible.

D.2.2. General survey of the method of sampling for groundnuts (peanuts), other oilseeds, apricot kernels and tree nuts U.K.

Table 1

Subdivision of lots into sublots depending on product and lot weight

a Depending on the lot weight — see table 2 of this part D.2 of this Annex.
Commodity	Lot weight (tonne)	Weight or number of sublots	No incremental samples	Aggregate sample weight (kg)
Groundnuts (peanuts), other oilseeds, apricot kernels and tree nuts	≥ 500	100 tonnes	100	20
	> 125 and < 500	5 sublots	100	20
	≥ 15 and ≤ 125	25 tonnes	100	20
	< 15	—	10-100 a	≤ 20

D.2.3. Method of sampling for groundnuts (peanuts), other oilseeds, apricot kernels and tree nuts (lots ≥ 15 tonnes) U.K.

• On condition that the sublot can be separated physically, each lot shall be subdivided into sublots following table 1. Taking into account that the weight of the lot is not always an exact multiple of the weight of the sublots, the weight of the sublot may exceed the mentioned weight by a maximum of 20 %.

• Each sublot shall be sampled separately,

• Number of incremental samples: 100,

• Weight of the aggregate sample = 20 kg which shall be mixed and to be divided into two equal laboratory samples of 10 kg before grinding (this division into two laboratory samples is not necessary in case of groundnuts (peanuts), other oilseeds, apricot kernels and tree nuts subjected to further sorting or other physical treatment and of the availability of equipment which is able to homogenise a 20 kg sample).

• Each laboratory sample of 10 kg shall be separately ground finely and mixed thoroughly to achieve complete homogenisation, in accordance with the provisions laid down in Annex II.

• If it is not possible to carry out the method of sampling described above because of the commercial consequences resulting from damage to the lot (because of packaging forms, means of transport, etc.) an alternative method of sampling may be applied provided that it is as representative as possible and is fully described and documented.

D.2.4. Method of sampling for groundnuts (peanuts), other oilseeds, apricot kernels and tree nuts (lots < 15 tonnes) U.K.

The number of incremental samples to be taken depends on the weight of the lot, with a minimum of 10 and a maximum of 100.

The figures in the following table 2 may be used to determine the number of incremental samples to be taken and the subsequent division of the aggregate sample.

Table 2

Number of incremental samples to be taken depending on the weight of the lot and number of subdivisions of the aggregate sample

Lot weight (tonnes)	No of incremental samples	Aggregate sample Weight (kg) (in case of retail packings, weight of aggregate sample can diverge — see point D.2.1)	No of laboratory samples from aggregate sample
≤ 0,1	10	2	1 (no division)
> 0,1 – ≤ 0,2	15	3	1 (no division)
> 0,2 – ≤ 0,5	20	4	1 (no division)
> 0,5 – ≤ 1,0	30	6	1 (no division)
> 1,0 – ≤ 2,0	40	8 (- < 12 kg)	1 (no division)
> 2,0 – ≤ 5,0	60	12	2
> 5,0 – ≤ 10,0	80	16	2
> 10,0 – ≤ 15,0	100	20	2

• Weight of the aggregate sample ≤ 20 kg which shall be mixed and if necessary divided into two equal laboratory samples of ≤ 10 kg before grinding (this division into two laboratory samples is not necessary in case of, groundnuts (peanuts), other oilseeds, apricot kernels and tree nuts subjected to further sorting or other physical treatment and of the availability of equipment which is able to homogenise up to 20 kg samples).

  In cases where the aggregate sample weights are less than 20 kg, the aggregate sample shall be divided into laboratory samples according to following guidance:

  • < 12 kg: no division into laboratory samples;

  • ≥ 12 kg division into two laboratory samples.

• Each laboratory sample shall be separately ground finely and mixed thoroughly to achieve complete homogenisation, in accordance with the provisions laid down in Annex II,

• If it is not possible to carry out the method of sampling described above because of the unacceptable commercial consequences resulting from damage to the lot (because of packaging forms, means of transport, etc.) an alternative method of sampling may be applied provided that it is as representative as possible and is fully described and documented.

D.2.5. Method of sampling for derived products, with the exception of vegetable oil, and compound foods U.K.

D.2.5.1. Derived products (other than vegetable oil) with small particle size, i.e. flour, peanut butter (homogeneous distribution of aflatoxin contamination) U.K.

• Number of incremental samples: 100; for lots of under 50 tons the number of incremental samples shall be 10 to 100, depending on the lot weight (see table 3),

  Table 3
  Number of incremental samples to be taken depending on the weight of the lot
  Lot weight (tonnes)	No of incremental samples	Aggregate sample weight (kg)
  ≤ 1	10	1
  > 1 – ≤ 3	20	2
  > 3 – ≤ 10	40	4
  > 10 – ≤ 20	60	6
  > 20 – ≤ 50	100	10

• The weight of the incremental sample shall be about 100 grams. In the case of lots in retail packing, the weight of the incremental sample depends on the weight of the retail packing,

• Weight of aggregate sample = 1-10 kg sufficiently mixed,

D.2.5.2. Derived products with a relatively large particle size (heterogeneous distribution of aflatoxin contamination) U.K.

Method of sampling and acceptance as for groundnuts (peanuts), other oilseeds, apricot kernels and tree nuts (D.2.3 and D.2.4).

D.2.6. Sampling at retail stage U.K.

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, other effective methods of sampling at retail stage may be used provided that they ensure that the aggregate sample is sufficiently representative of the sampled lot and is fully described and documented. In any case, the aggregate sample shall be at least 1 kg (6) .

D.2.7. Specific method of sampling for groundnuts (peanuts), other oilseeds, apricot kernels, tree nuts and derived products traded in vacuum packs U.K.

D.2.7.1. Pistachios, groundnuts (peanuts), Brazil nuts U.K.

For lots equal to or more than 15 tonnes at least 50 incremental samples resulting in a 20 kg aggregate sample shall be taken and for lots of less than 15 tonnes, 50 % of the number of incremental samples mentioned in table 2 shall bé taken resulting in an aggregate sample of which the weight corresponds to the weight of the sampled lot (see table 2).

D.2.7.2. Apricot kernels, tree nuts other than pistachios and Brazil nuts, other oilseeds U.K.

For lots equal to or more than 15 tonnes at least 25 incremental samples resulting in a 20 kg aggregate sample shall be taken and for lots less than 15 tonnes, 25 % of the number of incremental samples mentioned in table 2 shall be taken resulting in an aggregate sample of which the weight corresponds to the weight of the sampled lot (see table 2).

D.2.7.3. Products derived from tree nuts, apricot kernels and groundnuts (peanuts) with small particle size U.K.

For lots equal to or more than 50 tonnes at least 25 incremental samples resulting in a 10 kg aggregate sample shall be taken and for lots less than 50 tonnes, 25 % of the number of incremental samples mentioned in table 3 shall be taken resulting in an aggregate sample of which the weight corresponds to the weight of the sampled lot (see table 3).

D.2.8. Acceptance of a lot or sublot U.K.

For groundnuts (peanuts), other oilseeds, apricot kernels and tree nuts subjected to a sorting or other physical treatment:

• acceptance if the aggregate sample or the average of the laboratory samples conforms to the maximum limit, taking into account the correction for recovery and measurement uncertainty,

• rejection if the aggregate sample or the average of the laboratory samples exceeds the maximum limit beyond reasonable doubt taking into account the correction for recovery and measurement uncertainty,

For groundnuts (peanuts), other oilseeds, apricot kernels and tree nuts intended for direct human consumption:

• acceptance if none of the laboratory samples exceeds the maximum limit, taking into account the correction for recovery and measurement uncertainty,

• rejection if one or both of the laboratory samples exceeds the maximum limit beyond reasonable doubt taking into account the correction for recovery and measurement uncertainty,

In cases where the aggregate sample is 12 kg or less:

• acceptance if the laboratory sample conforms to the maximum limit, taking into account the correction for recovery and measurement uncertainty,

• rejection if the laboratory sample exceeds the maximum limit beyond reasonable doubt taking into account the correction for recovery and measurement uncertainty.]

E. METHOD OF SAMPLING FOR SPICES U.K.

[F4 This method of sampling is of application for the official control of the maximum levels established for ochratoxin A, aflatoxin B1 and total aflatoxins in spices except in cases of spices with a relatively large particle size (heterogeneous distribution of mycotoxin contamination).]

E.1. Weight of the incremental sample U.K.

The weight of the incremental sample shall be about 100 grams, unless otherwise defined in this part E of Annex I.

In the case of lots in retail packings, the weight of the incremental sample depends on the weight of the retail packing.

In the case of retail packs of >100 grams, this will result in aggregate samples weighing more than 10 kg. If the weight of a single retail pack is >> 100 grams, then 100 grams shall be taken from each individual retail pack as an incremental sample. This can be done either when the sample is taken or in the laboratory. However, in cases where such method of sampling would lead to unacceptable commercial consequences resulting from damage to the lot (because of packaging forms, means of transport, etc.), then an alternative method of sampling can be applied. For example, in case where a valuable product is marketed in retail packs of 500 grams or 1 kg, the aggregate sample can be obtained by the aggregation of a number of incremental samples that is smaller than the number indicated in Tables 1 and 2, on the condition that the weight of the aggregate sample corresponds to the required weight of the aggregate sample mentioned in Tables 1 and 2.

Where the retail pack is less than 100 grams and if the difference is not very large, one retail pack shall be considered as one incremental sample, resulting in an aggregate sample of less than 10 kg. If the weight of the retail pack is much less than 100 grams, one incremental sample shall consist of two or more retail packs, whereby the 100 grams are approximated as closely as possible.

E.2. General survey of the method of sampling for spices U.K.

Table 1

Subdivision of lots into sublots depending on product and lot weight

a Depending on the lot weight — see Table 2 of this part of this Annex.
Commodity	Lot weight (tonnes)	Weight or number of sublots	Number of incremental samples	Aggregate sample Weight (kg)
Spices	≥ 15	25 tonnes	100	10
	< 15	—	5-100a	0,5-10

E.3. Method of sampling for spices (lots ≥ 15 tonnes) U.K.

• On condition that the sublot can be separated physically, each lot shall be subdivided into sublots following Table 1. Taking into account that the weight of the lot is not always an exact multiple of the weight of the sublots, the weight of the sublot may exceed the mentioned weight by a maximum of 20 %.

• Each sublot shall be sampled separately.

• Number of incremental samples: 100. Weight of the aggregate sample = 10 kg.

• If it is not possible to carry out the method of sampling described above because of the unacceptable commercial consequences resulting from damage to the lot (because of packaging forms, means of transport, etc.) an alternative method of sampling may be applied provided that it is as representative as possible and is fully described and documented.

E.4. Method of sampling for spices (lots < 15 tonnes) U.K.

For lots of spices less than 15 tonnes the sampling plan shall be used with 5 to 100 incremental samples, depending on the lot weight, resulting in an aggregate sample of 0,5 to 10 kg.

The figures in the following Table can be used to determine the number of incremental samples to be taken.

Table 2

Number of incremental samples to be taken depending on the weight of the lot of spices

Lot weight (tonnes)	Number of incremental samples	Aggregate sample weight (kg)
≤ 0,01	5	0,5
> 0,01-≤ 0,1	10	1
> 0,1-≤ 0,2	15	1,5
> 0,2-≤ 0,5	20	2
> 0,5-≤ 1,0	30	3
> 1,0-≤ 2,0	40	4
> 2,0-≤ 5,0	60	6
> 5,0-≤ 10,0	80	8
> 10,0-≤ 15,0	100	10

E.5. Sampling at retail stage U.K.

Sampling of foodstuffs at the retail stage shall be done where possible in accordance with the sampling 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. In any case, the aggregate sample shall be at least 0,5 kg(7).

E.6. Specific method of sampling for spices traded in vacuum packs U.K.

For lots equal to or more than 15 tonnes at least 25 incremental samples resulting in a 10 kg aggregate sample shall be taken and for lots less than 15 tonnes, 25 % of the number of incremental samples mentioned in Table 2 shall be taken resulting in an aggregate sample of which the weight corresponds to the weight of the sampled lot (see Table 2).

E.7. Acceptance of a lot or sublot U.K.

• acceptance if the laboratory sample conforms to the maximum limit, taking into account the correction for recovery and measurement uncertainty;

• rejection if the laboratory sample exceeds the maximum limit beyond reasonable doubt taking into account the correction for recovery and measurement uncertainty.

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

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. U.K.

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 U.K.

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(8).

F.3. Acceptance of a lot or sublot U.K.

• 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.).

[F6 G. METHOD OF SAMPLING FOR COFFEE, COFFEE PRODUCTS, LIQUORICE ROOT AND LIQUORICE EXTRACT U.K.

This method of sampling is of application for the official control of the maximum levels established for ochratoxin A in roasted coffee beans, ground roasted coffee, soluble coffee, liquorice root and liquorice extract.

G.1. Weight of the incremental sample U.K.

The weight of the incremental sample shall be about 100 grams, unless otherwise defined in this part G of Annex I.

In the case of lots in retail packings, the weight of the incremental sample shall depend on the weight of the retail packing.

In the case of retail packs of more than 100 grams, this will result in aggregate samples weighing more than 10 kg. If the weight of a single retail pack is much more than 100 grams, then 100 grams shall be taken from each individual retail pack as an incremental sample. This can be done either when the sample is taken or in the laboratory. However, in cases where such method of sampling would lead to unacceptable commercial consequences resulting from damage to the lot (because of packaging forms, means of transport, etc.), then an alternative method of sampling can be applied. For example, in case where a valuable product is marketed in retail packs of 500 grams or 1 kg, the aggregate sample can be obtained by the aggregation of a number of incremental samples that is smaller than the number indicated in tables 1 and 2, on the condition that the weight of the aggregate sample corresponds to the required weight of the aggregate sample mentioned in tables 1 and 2.

Where the retail pack is less than 100 grams and if the difference is not very large, one retail pack shall be considered as one incremental sample, resulting in an aggregate sample of less than 10 kg. If the weight of the retail pack is much less than 100 grams, one incremental sample shall consist of two or more retail packs, whereby the 100 grams are approximated as closely as possible.

G.2. General survey of the method of sampling for roasted coffee, ground roasted coffee, soluble coffee, liquorice root and liquorice extract U.K.

Table 1

Subdivision of lots into sublots depending on product and lot weight

a Depending on the lot weight — see table 2 of this part of this Annex.
Commodity	Lot weight (ton)	Weight or number of sublots	No incremental samples	Aggregate sample Weight (kg)
Roasted coffee beans, ground roasted coffee, soluble coffee, liquorice root and liquorice extract	≥ 15	15-30 tonnes	100	10
	< 15	—	10-100 a	1-10

G.3. Method of sampling for roasted coffee beans, ground roasted coffee, soluble coffee liquorice root and liquorice extract (lots ≥ 15 tonnes) U.K.

• On condition that the sublot can be separated physically, each lot shall be subdivided into sublots following table 1. Taking into account that the weight of the lot is not always an exact multiple of the weight of the sublots, the weight of the sublot may vary from the mentioned weight by a maximum of 20 %.

• Each sublot shall be sampled separately,

• Number of incremental samples: 100,

• Weight of the aggregate sample = 10 kg,

• If it is not possible to carry out the method of sampling described above because of the unacceptable commercial consequences resulting from damage to the lot (because of packaging forms, means of transport, etc.) an alternative method of sampling may be applied provided that it is as representative as possible and is fully described and documented.

G.4. Method of sampling for roasted coffee beans, ground roasted coffee, soluble coffee liquorice root and liquorice extract (lots < 15 tonnes) U.K.

For roasted coffee beans, ground roasted coffee, soluble coffee, liquorice root and liquorice extract under 15 tonnes the sampling plan shall be used with 10 to 100 incremental samples, depending on the lot weight, resulting in an aggregate sample of 1 to 10 kg.

The figures in the following table can be used to determine the number of incremental samples to be taken.

Table 2

Number of incremental samples to be taken depending on the weight of the lot of roasted coffee beans, ground roasted coffee, soluble coffee, liquorice root and liquorice extract

Lot weight (tonnes)	No of incremental samples	Aggregate sample weight (kg)
≤ 0,1	10	1
> 0,1 – ≤ 0,2	15	1,5
> 0,2 – ≤ 0,5	20	2
> 0,5 – ≤ 1,0	30	3
> 1,0 – ≤ 2,0	40	4
> 2,0 – ≤ 5,0	60	6
> 5,0 – ≤ 10,0	80	8
> 10,0 – ≤ 15,0	100	10

G.5. Method of sampling for roasted coffee beans, ground roasted coffee, soluble coffee, liquorice root and liquorice extract traded in vacuum packs U.K.

For lots equal to or more than 15 tonnes at least 25 incremental samples resulting in a 10 kg aggregate sample shall be taken and for lots less than 15 tonnes, 25 % of the number of incremental samples mentioned in table 2 shall be taken resulting in an aggregate sample of which the weight corresponds to the weight of the sampled lot (see table 2).

G.6. Sampling at retail stage U.K.

Sampling of foodstuffs at the retail stage shall be done where possible in accordance with the sampling 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. In any case, the aggregate sample shall be at least 1 kg (9) .

G.7. Acceptance of a lot or sublot U.K.

• acceptance if the laboratory sample conforms to the maximum limit, taking into account the correction for recovery and measurement uncertainty,

• rejection if the laboratory sample exceeds the maximum limit beyond reasonable doubt taking into account the correction for recovery and measurement uncertainty.]

H. METHOD OF SAMPLING FOR FRUIT JUICES INCLUDING GRAPE JUICE, GRAPE MUST, CIDER AND WINE U.K.

This method of sampling is of application for the official control of the maximum levels established for

• ochratoxin A in wine, grape juice and grape must and

• patulin in fruit juices, fruit nectar, spirit drinks, cider and other fermented drinks derived from apples or containing apple juice.

H.1. Method of sampling U.K.

The aggregate sample shall be at least one 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 ochratoxin A and patulin can be 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 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 of lot (in litres)	Minimum number of incremental samples to be taken	Minimum volume of the aggregate sample (in litres)
Bulk (fruit juice, spirit drinks, cider, wine)	—	3	1
Bottles/packages (fruit juice, spirit drinks, cider)	≤ 50	3	1
Bottles/packages (fruit juice, spirit drinks, cider)	50 to 500	5	1
Bottles/packages (fruit juice, spirit drinks, cider)	> 500	10	1
Bottles/packages wine	≤ 50	1	1
Bottles/packages wine	50 to 500	2	1
Bottles/packages wine	> 500	3	1

H.2. Sampling at retail stage U.K.

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(10).

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.

H.3. Acceptance of a lot or sublot U.K.

• acceptance if the laboratory sample conforms to the maximum limit, taking into account the correction for recovery and measurement uncertainty,

• rejection if the laboratory sample exceeds the maximum limit beyond reasonable doubt taking into account the correction for recovery and measurement uncertainty.

[F4 I. METHOD OF SAMPLING FOR SOLID APPLE PRODUCTS U.K.

This method of sampling is of application for the official control of the maximum levels established for patulin in solid apple products, including solid apple products for infants and young children.]

I.1. Method of sampling U.K.

The aggregate sample shall be at least 1 kg, except where it is not possible e.g. when sampling a single package.

The minimum number of incremental samples to be taken from the lot shall be as given in Table 1. [F7 In the case of liquid products the lot shall be thoroughly mixed insofar as possible by either manual or mechanical means immediately prior to sampling. In this case, a homogeneous distribution of patulin can be assumed within a given lot. It is therefore sufficient to take three incremental samples from a lot to form the aggregate sample.]

Textual Amendments

F7 Deleted 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).

The incremental samples 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 1 kg. 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

Weight of lot (in kg)	Minimum number of incremental samples to be taken	Aggregate sample weight(kg)
< 50	3	1
50 to 500	5	1
> 500	10	1

If the lot consists of individual packages, then the number of packages, which shall be taken to form the aggregate sample, is given in Table 2.

Table 2

Number of packages (incremental samples) which shall be taken to form the aggregate sample if the lot consists of individual packages

Number of packages or units in the lot	Number of packages or units to be taken	Aggregate sample weight(kg)
1 to 25	1 package or unit	1
26 to 100	about 5 %, at least two packages or units	1
> 100	about 5 %, at maximum 10 packages or units	1

I.2. Sampling at retail stage U.K.

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

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(11).

I.3. Acceptance of a lot or sublot U.K.

• acceptance if the laboratory sample conforms to the maximum limit, taking into account the measurement uncertainty and correction for recovery,

• rejection if the laboratory sample exceeds the maximum limit beyond reasonable doubt taking into account the measurement uncertainty and correction for recovery.

J. METHOD OF SAMPLING FOR BABY FOODS AND PROCESSED CEREAL BASED FOODS FOR INFANTS AND YOUNG CHILDREN U.K.

This method of sampling is of application for the official control of the maximum levels established:

• for aflatoxins, ochratoxin A and Fusarium-toxins in baby foods and processed cereal-based foods for infants and young children,

• for aflatoxins and ochratoxin A in dietary foods for special medical purposes (other than milk and milk products) intended specifically for infants and

• for patulin in baby foods other than processed cereal based foods for infants and young children. For the control of the maximum levels established for patulin in apple juice and solid apple products for infants and young children the method of sampling as described under part I of Annex I shall apply.

J.1. Method of sampling U.K.

• The method of sampling for cereals and cereal products as set out in point B.4 of Annex I shall apply to food intended for infants and young children. Accordingly the number of incremental samples to be taken shall depend on the weight of the lot, with a minimum of 10 and a maximum of 100, in accordance with Table 2 at point B.4 of Annex I. For very small lots (≤ 0,5 tonnes) a lower number of incremental samples may be taken, but the aggregate sample uniting all incremental samples shall be also in that case at least 1 kg.

• weight of the incremental sample shall be about 100 grams. In the case of lots in retail packing, the weight of the incremental sample shall depend on the weight of the retail packing and in case of very small lots (≤ 0,5 tonnes) the incremental samples shall have a weight as such that uniting the incremental samples results in an aggregate sample of at least 1 kg. Departure from this method shall be recorded in the record provided for under A.3.8.

• weight of aggregate sampling = 1-10 kg sufficiently mixed.

J.2. Sampling at retail stage U.K.

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(12).

J.3. Acceptance of a lot or sublot U.K.

• acceptance if the laboratory sample conforms to the maximum limit, taking into account the correction for recovery and measurement uncertainty;

• rejection if the laboratory sample exceeds the maximum limit beyond reasonable doubt taking into account the correction for recovery and measurement uncertainty.

[F8 K. METHOD OF SAMPLING FOR VEGETABLE OILS U.K.

This method of sampling is of application for the official control of the maximum levels established for mycotoxins, in particular aflatoxin B1, aflatoxin total and zearalenone, in vegetable oils.

K.1. Method of sampling for vegetable oils U.K.

• The weight of the incremental sample shall be at least about 100 grams (ml) (depending of the nature of the consignment e.g. vegetable oil in bulk, at least 3 incremental samples of about 350 ml have to be taken), resulting in an aggregate sample of at least 1 kg (litre),

• The minimum number of incremental samples to be taken from the lot shall be as given in Table 1. The lot shall be thoroughly mixed insofar possible by either manual or mechanical means immediately prior to sampling. In this case, a homogeneous distribution of aflatoxin can be assumed within a given lot, it is therefore sufficient to take three incremental samples from a lot to form the aggregate sample.

  Table 1
  Minimum number of incremental samples to be taken from the lot
  a On condition that the sublot can be separated physically, large bulk consignments/lots of vegetable oils shall be subdivided into sublots as foreseen in table 2 of this part.
  Form of commercialisation	Weight of lot (in kg) Volume of lot (in litres)	Minimum number of incremental samples to be taken
  Bulk a	—	3
  packages	≤ 50	3
  packages	> 50 to 500	5
  packages	> 500	10

  Table 2
  Subdivision of lots into sublots depending on lot weight
  Commodity	Lot weight (tonne)	Weight or number of sublots	Minimum N o incremental samples	Minimum aggregate sample weight (kg)
  Vegetable oils	≥ 1 500	500 tonnes	3	1
  	> 300 and < 1 500	3 sublots	3	1
  	≥ 50 and ≤ 300	100 tonnes	3	1
  	< 50	—	3	1

K.2. Method of sampling for vegetable oils at retail stage U.K.

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, other effective methods of sampling at retail stage may be used provided that they ensure that the aggregate sample is sufficiently representative of the sampled lot and is fully described and documented. In any case, the aggregate sample shall be at least 1 kg (13) .

K.3. Acceptance of a lot or sublot U.K.

• acceptance if the laboratory sample conforms to the maximum limit, taking into account the correction for recovery and measurement uncertainty,

• rejection if the laboratory sample exceeds the maximum limit beyond reasonable doubt taking into account the correction for recovery and measurement uncertainty.]

Textual Amendments

F8 Inserted by Commission Regulation (EU) No 178/2010 of 2 March 2010 amending Regulation (EC) No 401/2006 as regards groundnuts (peanuts), other oilseeds, tree nuts, apricot kernels, liquorice and vegetable oil (Text with EEA relevance).

[F5 L. METHOD OF SAMPLING FOR VERY LARGE LOTS OR LOTS STORED OR TRANSPORTED IN A WAY WHEREBY SAMPLING THROUGHOUT THE LOT IS NOT FEASIBLE U.K.

L.1. General principles U.K.

In case the way of transport or storage of a lot does not enable to take incremental samples throughout the whole lot, sampling of such lots should preferably be done when the lot is in flow (dynamic sampling).

In the case of large warehouses destined to store food, operators should be encouraged to install equipment in the warehouse enabling (automatic) sampling across the whole stored lot.

When the sampling procedures as provided for in this part L are applied, the food business operator or his representative should be informed of the sampling procedure. If the sampling procedure is questioned by the food business operator or his representative, the food business operator or his representative shall enable the competent authority to sample throughout the whole lot at his/her own cost.

Sampling of a part of the lot is allowed, on the condition that the quantity of the sampled part is at least 10 % of the lot to be sampled. If a part of a lot of food of the same class or description has been sampled and identified as not satisfying [F9 legal] requirements, it shall be presumed that the entire lot is also affected, unless further detailed assessment shows no evidence that the rest of the lot is unsatisfactory.

Textual Amendments

F9 Word in Annex 1 para. L1 substituted (31.12.2020) by The Contaminants in Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/639), regs. 1, 16; 2020 c. 1, Sch. 5 para. 1(1)

The relevant provisions, such as weight of the incremental sample, provided for in the other parts of this Annex are applicable for the sampling for very large lots or lots stored or transported in a way whereby sampling throughout the lot is not feasible.

L.2. Number of incremental samples to be taken in the case of very large lots U.K.

In the case of large sampled portions (sampled portions > 500 tonnes), the number of incremental samples to be taken = 100 incremental samples + √tonnes. However in case the lot is less than 1 500 tonnes and can be subdivided into sublots in accordance with the table 1 of part B and on the condition that the sublots can be separated physically, the number of incremental samples as provided for in part B have to be taken.

L.3. Large lots transported by ship U.K.

L.3.1. Dynamic sampling of large lots transported by ship U.K.

The sampling of large lots in ships is preferably carried out while the product is in flow (dynamic sampling).

The sampling is to be done per hold (entity that can physically be separated). Holds are however emptied partly one after the other so that the initial physical separation no longer exists after transfer into storage facilities. Sampling can therefore be performed based on initial physical separation or based on the separation after transfer into the storage facilities.

The unloading of a ship can last for several days. Normally, sampling has to be performed at regular intervals during the whole duration of unloading. It is however not always feasible or appropriate for an official inspector to be present for sampling during the whole operation of unloading. Therefore sampling of part of the lot is allowed to be undertaken (sampled portion). The number of incremental samples is determined by taking into account the size of the sampled portion.

Even if the official sample is taken automatically, the presence of an inspector is necessary. However if the automatic sampling is done with pre-set parameters which cannot be changed during the sampling and the incremental samples are collected in a sealed receptacle, preventing any possible fraud, then the presence of an inspector is only required at the beginning of the sampling, every time the receptacle of the samples needs to be changed and at the end of the sampling.

L.3.2. Sampling of lots transported by ship by static sampling U.K.

In cases where the sampling is done in a static way the same procedure as foreseen for storage facilities (silos) accessible from above has to be applied (see point L.5.1).

The sampling has to be performed on the accessible part (from above) of the lot/hold. The number of incremental samples is determined by taking into account the size of the sampled portion.

L.4. Sampling of large lots stored in warehouses U.K.

The sampling has to be performed on the accessible part of the lot. The number of incremental samples is determined by taking into account the size of the sampled portion.

L.5. Sampling of storage facilities (silos) U.K.

L.5.1. Sampling of silos (easily) accessible from above U.K.

The sampling has to be performed on the accessible part of the lot. The number of incremental samples is determined by taking into account the size of the sampled portion.

L.5.2. Sampling of silos not accessible from above (closed silos) U.K.

L.5.2.1. Silos not accessible from above (closed silos) with individual sizes > 100 tonnes U.K.

Food stored in such silos cannot be sampled in a static way. Therefore when the food in the silo has to be sampled and there is no possibility to move the consignment, the agreement has to be made with the operator that he or she has to inform the inspector about when the silo will be unloaded, partially or completely, in order to enable sampling when the food is in flow.

L.5.2.2. Silos not accessible from above (closed silos) with individual sizes < 100 tonnes U.K.

Contrary to the provision in part point L.1 (sampled part at least 10 %), the sampling procedure involves the release into a receptacle of a quantity of 50 to 100 kg and taking the sample from it. The size of the aggregate sample corresponds to the whole lot and the number of incremental samples relate to the quantity of the food from the silo released into the receptacle for sampling.

L.6. Sampling of loose food in large closed containers U.K.

Such lots can often only be sampled when unloaded. In certain cases it is not possible to unload at the point of import or control and therefore the sampling should take place when such containers are unloaded. The operator has to inform the inspector about the place and time of unloading the containers.

M. METHOD OF SAMPLING OF FOOD SUPPLEMENTS BASED ON RICE FERMENTED WITH RED YEAST MONASCUS PURPUREUS U.K.

This method of sampling is applicable to the official control of the maximum level established for citrinin in food supplements based on rice fermented with red yeast Monascus purpureus.

Sampling procedure and sample size U.K.

The sampling procedure is on the supposition that the food supplements based on rice fermented with red yeast Monascus purpureus are marketed in retail packages containing usually 30 to 120 capsules per retail package.

Lot size (number of retail packages)	Number of retail packages to be taken for sample	Sample size
1-50	1	All capsules
51-250	2	All capsules
251- 1 000	4	From each retail package taken for sample, half of the capsules
> 1 000	4 + 1 retail package per 1 000 retail packages with a maximum of 25 retail packages	≤ 10 retail packages: from each retail package, half of the capsules > 10 retail packages: from each retail package, an equal number of capsules is taken to result in a sample with the equivalent of the content of retail 5 packages]

(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)

[F4 The sampling of such lots shall be performed in accordance with the rules set out in part L. Guidance for sampling large lots shall be provided in a guidance document available on the following website: http://ec.europa.eu/food/food/chemicalsafety/contaminants/guidance-sampling-final.pdf

The application of sampling rules in accordance with EN ISO 24333:2009 or GAFTA Sampling Rules 124, applied by food business operators to ensure compliance with provisions in legislation is equivalent to the sampling rules set out in part L.

For the sampling of lots for Fusarium -toxins, the application of sampling rules in accordance with EN ISO 24333:2009 or GAFTA Sampling Rules 124, applied by food business operators to ensure compliance with provisions in legislation is equivalent to the sampling rules set out in part B]

(3)

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.

(4)

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.

(5)

[F6 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.]

(6)

[F6 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.]

(7)

In case the portion to be sampled is so small that it is impossible to obtain an aggregate sample of 0,5 kg, the aggregate sample weight might be less than 0,5 kg.

(8)

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.

(9)

[F6 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.]

(10)

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

(11)

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.

(12)

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.

(13)

[F8 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.]

Textual Amendments

F4 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).

F6 Substituted by Commission Regulation (EU) No 178/2010 of 2 March 2010 amending Regulation (EC) No 401/2006 as regards groundnuts (peanuts), other oilseeds, tree nuts, apricot kernels, liquorice and vegetable oil (Text with EEA relevance).

F8 Inserted by Commission Regulation (EU) No 178/2010 of 2 March 2010 amending Regulation (EC) No 401/2006 as regards groundnuts (peanuts), other oilseeds, tree nuts, apricot kernels, liquorice and vegetable oil (Text with EEA relevance).