LegalizeCommission Regulation (EC) No 401/2006 of 23 February 2006 laying down the methods of sampling and analysis for the official control of the levels of mycotoxins in foodstuffs (Text with EEA relevance)
Article 1
Sampling for the official control of the levels of mycotoxins in foodstuffs shall be carried out in accordance with the methods set out in Annex I.
Article 2
Sample preparation and methods of analysis used for the official control of the levels of mycotoxins in foodstuffs shall comply with the criteria set out in Annex II.
Article 3
Directives 98/53/EC, 2002/26/EC, 2003/78/EC and 2005/38/EC are repealed.
References to the repealed Directives shall be construed as references to this Regulation.
Article 4
This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
It shall apply from 1 July 2006.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX I (1)
METHODS OF SAMPLING FOR OFFICIAL CONTROL OF THE LEVELS OF MYCOTOXINS IN FOODSTUFFS
A. GENERAL PROVISIONS
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.
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.
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.
Sampling shall be performed by an authorised person as designated by the Member State.
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.
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.
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.
The aggregate sample shall be made up by combining the incremental samples.
The replicate samples for enforcement, trade (defence) and reference (referee) purposes shall be taken from the homogenised aggregate sample, unless such procedure conflicts with Member States’ rules as regards the rights of the food business operator.
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.
Each sample taken for official use shall be sealed at the place of sampling and identified following the rules of the Member State.
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.
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 nth 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
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.
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.
| 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 (*1) | 1-10 | |
| (*1) Depending on the lot weight — see Table 2. |
— 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. 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) .
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.
| 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 |
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).
— 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
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).
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.
| 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 | — | 10-100 (*1) | 1-10 | |
| (*1) Depending on the lot weight — see Table 2 of this part of this Annex. |
— 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.
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.
| 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 |
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).
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).
— 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
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.
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.
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.
| 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 (*1) | ≤ 30 | |
| (*1) Depending on the lot weight — see table 2 of this part D.1 of this Annex. |
— 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.
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