HGO1004/2010

ID internal unique:  336566 Fiche of the legal act

Russian version

Republic of Moldova

GOVERNMENT

DECISION No. 1004

from  25.10.2010

on the approval of methods of sampling for the official control of pesticide residues in
and on plants and plant origin products

Published: 05.11.2010 in the Official Gazette no. 214-220     Art. no.: 1125     Date of
entering into force: 05.02.2011

    Grounding on Law no.119-XV from April 22, 2004 on plant protection products and
fertilizers (Official Gazette of Republic of Moldova, 2004, no. 100-103, Art.510), with
further amendments and completions, Law no. 105-XV from March 13, 2003 on consumer
protection (Official Gazette of Republic of Moldova, 2003, no. 126-131, Art.507), with
further amendments and completions, Law no.78-XV from March 18, 2004 on food products
(Official Gazette of Republic of Moldova, 2004, no. 83-87, Art.431), as well as in the view of
checking the harmlessness of plant products, the Government DECIDES:
    1. To approve the Methods of sampling for the official control of pesticide residues in and
on plants and plant origin products (attached).
    2. To establish that the Methods for sampling, foreseen in the annex to hereby decision,
shall be applied for the official control of pesticide residues in and on plants and plant origin
products, products and/or traded in by agricultural land owners and economic agents,
regardless of their type of ownership and legal organisational form.
    3. The hereby Decision shall enter into force in 3 months since the publication in the
Official Gazette of Republic of Moldova.
    4. The Ministry of Agriculture and Food Industry and the Ministry of Health shall be held
responsible for the control over the fulfilment of hereby Decision.

    PRIME-MINISTER                                                             Vladimir  FILAT

    No. 1004. Chisinau, October 25, 2010.

  Approved
through Government Decision
no. 1004 from October 25, 2010

METHODS
for sampling for the official control of pesticide residues
in and on plants and plant origin products
    The hereby Methods lay down the necessary framework for applying provisions of Art. 3
paragraph (2) letter c) and d) and annex I to the Regulation (EC) no. 396/2005 of the
European Parliament and of the Council of 23 February 2005 on maximum residue levels of
pesticides in and on food and feed of plant and animal origin and amending Council Directive
91/414/EEC (published in the Official Journal of the European Union (OJ) L 70 from 16
March 2005, pag. 1-16), as well as provisions of Art. 1 points 1 - 5   from tables 1 and 4 from
Annex to Commission Directive 2002/63/EC from 11 July 2002 establishing Community
methods of sampling for the official control of pesticide residues in and on products of plant
and animal origin and repealing Directive 79/700/EEC (published in the Official Journal of
the European Union (OJ) L 187 from 16 July 2002, pag. 30-43).

Chapter I. General provisions

    1. The objective of the sampling procedure relies in obtaining a representative sample from
a lot intended for analysis, in order to check the observance of pesticide maximum residue
levels. Where the maximum residue level (hereinafter referred to as – MRL) for a certain
product is missing, the levels set by Codex Alimentarius Commission shall apply.
    2. The defined methods and procedures include methods and procedures recommended by
Codex Alimentarius Commission.
    3. The samples shall be collected by an officer appointed, if necessary, by the phytosanitary
control and supervision body and/or the authority responsible for public health supervision.
    4. The producers and sellers of agricultural products, natural persons or legal entities, shall
allow the appointed officer to collect samples of plants and plant origin products in the
following forms: fresh, dried, processed or included in a complex food product, intended for
import, export or domestic consumption.
    5. The MRL for a plant or a plant product takes into consideration the maximum level
which can exist in a composite sample, obtained from several units of treated product, and
which is deemed to represent the average level of residues from the lot. MRL for plant
products applies to a composite sample from bulk production, obtained from a number of
primary samples ranging between 1 and 10.
Chapter II. Terminology
    6. In the context of hereby Methods, the main notions employed signify the following:
    sampling officer (officer) – person trained in performing sampling procedures. The officer
is responsible for observing the sampling procedure, including: preparation, packaging and
submission of laboratory sample/samples, furnishing the complete package of information
with regard to samples, collaborating with laboratory specialists who perform the
investigations;
     sample size – the number of units, or quantity of material, constituting the sample;
     sampling device – a tool such as a scoop, dipper, borer, knife or spear, used to remove a
unit from bulk material, from packages which are too large to be taken as primary samples, or
a tool such as a riffle box (sample segregator), used to prepare a laboratory sample from a
bulk sample, or to prepare an analytical portion from an analytical sample.
Specific sampling devices are described in the national standards included in the List of
annexes associated to the hereby Decision, approved through the order of Minister of
Agriculture and Food Industry, coordinated with the National Standardization Body.
    For certain bulk material (leaves etc.), the officer’s hand shall be used as sampling tool;
    maximum residue level (MRL) – maximum concentration of pesticide residues, authorized
in and on food and feed for animals, established by the legislation in force, grounding on
good agricultural practices and the lowest level of exposure, allowing for the protection of all
vulnerable consumers;
    lot – quantity of a food material delivered at one time and known, or presumed, by the
sampling officer to have uniform characteristics such as origin, producer, variety, packer, type
of packing, markings, consignor, etc.;
   suspect lot – one which, for any reason, is suspected to contain an excessive residue;
    non-suspect lot – one for which there is no reason to suspect that it may contain an
excessive residue.
   Where a consignment is comprised of lots which can be identified as originating from
different growers, etc., each lot should be considered separately. A consignment may consist
of one or more lots.
   Where the size or boundary of each lot in a large consignment is not readily established,
each one of a series of wagons, lorries, ships bays, etc., may be considered to be a separate
lot.
   A lot may be mixed by grading or manufacturing processes, for example;
    sampling – procedure used to draw and constitute a sample;
    analytical portion – a representative quantity of material removed from the analytical
sample, of proper size for measurement of the residue concentration. A sampling device
should be used to extract the analytical portion;
    analytical sample – The material prepared for analysis from the laboratory sample, by
separation of the portion of the product to be analysed, according to Annex 1 to hereby
Methods, which is subject then to mixing, grinding, fine chopping, etc., for the removal of
analytical portions with minimal sampling error.
   Preparation of the analytical sample must reflect the procedure used in setting MRLs and
thus the portion of the product to be analysed may include parts that are not normally
consumed;
    bulk material – re-united, well mixed and homogeneous sample, obtained from primary
samples collected from a lot.
   The primary samples must contribute sufficient material to enable all laboratory samples to
be withdrawn from the bulk sample.
   Where separate laboratory samples are prepared during collection of the primary sample(s),
the bulk sample is the conceptual sum of the laboratory samples, at the time of taking the
samples from the lot;
   laboratory sample – the sample sent to, or received by, the laboratory, which stands for a
representative quantity of material removed from the bulk sample. The laboratory sample
may be the whole or a part of the bulk sample. Units should not be cut or broken to produce
the laboratory sample(s). Replicate laboratory samples may be prepared.
    primary sample – one or more units taken from one position in a lot. The position from
which a primary sample is taken in the lot should preferably be chosen randomly but, where
this is
physically impractical, it should be from a random position in the accessible parts of the lot.
   The number of units required for a primary sample should be determined by the minimum
size and number of laboratory samples required. Where more than one primary sample is
taken from a lot, each should contribute an approximately similar proportion to the bulk
sample.
   Units may be allocated randomly to replicate laboratory samples at the time of collecting
the primary sample(s), in cases where the units are of medium or large size and mixing the
bulk sample would not make the laboratory sample(s) more representative, or where the units
(e.g. eggs, soft fruit) could be damaged by mixing.
   Where primary samples are taken at intervals during loading or unloading of a lot, the
sampling ‘position’ is a point in time. Units should not be cut or broken to produce the
laboratory sample(s);
    sample – One or more units selected from a population of units, or a portion of material
selected from a larger quantity of material. A representative sample is intended to be
representative of the lot, the bulk sample, in respect of its pesticide residue content and not
necessarily in respect of other attributes.;
   pesticide residues – residues, including active substances, metabolic substances and/or
products obtained as a result of degrading or reaction of active substances used at present or
in the past in plant protection products, in and on products listed in Annex no.1 to hereby
Methods, especially residues likely to be obtained from using active substances for
phytosanitary or veterinary purposes, or as biocides;
    unit – the smallest discrete portion in a lot, which should be withdrawn to form the whole
or part of a primary sample. Units should be identified as follows:
    a) For fresh fruit and vegetables. Each whole fruit, vegetable or natural bunch of them (e.g.
grapes) should form a unit, except where these are small. Units of packaged small products
may be identified as in (b). Where a sampling device may be used without damaging the
material, units may be created by this means. Fresh fruit or vegetables must not be cut or
broken to produce units;
    b) packaged material: The smallest discrete packages should be taken as units. Where the
smallest packages are very large, they should be sampled as bulk, as in (c). Where the
smallest packages are very small, a pack of packages may form the unit;
    c) Bulk materials and large packages – materials which are individually too large to be
taken as primary samples. In such a case, the units are created with a sampling device.

Chapter III. Sampling procedures and schematic representation

Section 1. Precautions to be taken

    7. Each lot to be checked for compliance with pesticide residue provisions must be sampled
separately.
    8. Contamination and deterioration of samples must be prevented at all stages, because they
may affect the analytical results.

Section 2. Collection of primary samples

    9. The minimum number of primary samples to be taken from a lot is set in Table 1.
    10. Each primary sample should be taken from a randomly chosen position in the lot.
    11. The schematic representation of sampling procedures is exposed in Annex no.2 to
hereby Methods.
    12. The primary samples must consist of sufficient material to provide the laboratory
sample(s)
required from the lot.

Section 3. Preparation of bulk sample

    13. The procedures for preparing the bulk sample are described in Table 2. The primary
samples should be combined and mixed well, if practicable, to form the bulk sample..
    14. Where mixing to form the bulk sample is inappropriate or impractical, the following
alternative procedure may be followed. Where units may be damaged (and thus residues may
be affected) by the processes of mixing or subdivision of the bulk sample, or where large
units cannot be mixed to produce a more uniform residue distribution, the units should be
allocated randomly to replicate laboratory samples at the time of taking the primary samples.
In this case, the result to be used should be the mean of valid results obtained from the
laboratory samples
analysed.
 Section 4. Preparation of laboratory sample
    15. Where the bulk sample is larger than is required for a laboratory sample, it should be
divided to provide a representative portion. A sampling device, quartering, or other
appropriate size reduction process may be used but units of fresh plant products should not be
cut or broken.
    16. Where required, replicate laboratory samples should be collected at this stage or they
may be prepared using the alternative procedure described above.
    17. The minimum sizes required for laboratory samples are given in Table 2.

Section 5. Sampling record (protocol)

    18. The sampling officer must record the nature and origin of the lot; the owner, supplier or
carrier of it; the date and place of sampling; and any other relevant information.
    19. Any deviation from the recommended sampling method must be recorded.
    20. For each collected sample, the sampling officer shall record and sign a protocol in 3
identical copies, according to Annex no. 3 to hereby Methods. The first copy of the record
(protocol) must accompany the sample transmitted to the laboratory, the second copy shall be
given to the owner of the lot or its representative, regardless of the fact whether the owner or
its representative received or not the laboratory sample, and a third copy should be retained
by the sampling officer.
    21. If sampling records (protocols) are produced in computerised form, these should be
distributed to the same recipients as mentioned in p.20 to hereby Methods, observing a similar
verifiable audit trail.

Chapter IV. Packaging and transmission of laboratory samples

    22. The laboratory sample must be placed in a clean and chemically inert container which
provides secure protection from contamination, damage and leakage.
    23. The container should be sealed and securely labelled, making it impossible to open it or
remove the label without deteriorating the seal.
    24. Where a bar code is utilised, it is recommended that alphanumeric information is also
provided.
    25. The sample must be delivered to the laboratory as soon as practicable. Spoilage in
transit must be avoided. Fresh fruit and vegetables should be kept cool at a temperature
ensuring their good preservation and frozen samples must remain frozen.
    26. The respective sample/samples shall be accompanied by the record (protocol) and, if
necessary, by the Certificate for observing the norms for using plant protection products and
fertilizers, in accordance with Annex no.3 to the Regulation on the import, storage, sale and
use of plant protection products and fertilizers, approved through Government Decision no.
1045 from October 5, 2005, issued by the phytosanitary control and supervision body.
    27. In the laboratory, the competent person will receive the sample and register the
accompanying documents in the Record Register.

Chapter V. Preparation of analytical sample and storage of analytical portion

    28. The laboratory sample should be given a unique identification code which, together
with the date of receipt and the sample weight, should be added to the sample record
(protocol).
    29. The part of the commodity to be analysed, according to Annex no. 1 to hereby
Methods, i.e. the analytical sample, should be separated as soon as practicable.
    30. Where the residue level must be calculated to include parts which are not analysed, the
weights of the separated parts must be recorded. The stones of stone fruits shall not be
analyzed, but the level of residues shall be calculated assuming that these have been included
in the analytical sample, but do not contain any residues.
    31. The analytical sample should be comminuted, if appropriate, and mixed well, to enable
representative analytical portions to be withdrawn. The size of the analytical portion should
be determined by the analytical method and the efficiency of mixing.
    32. The methods for comminution and mixing should be recorded and should not affect the
residues present in the analytical sample. Where appropriate, the analytical sample should be
processed under special conditions, e.g. at sub-zero temperature, to minimise adverse effects.
    33. Where processing could affect residues and where practical alternative procedures are
not available, the analytical portion may consist of whole units, or segments removed from
whole units.
    34. If the analytical portion thus consists of few units or segments, it is unlikely to
be representative of the analytical sample and sufficient replicate portions must be analysed,
to indicate the uncertainty of the mean value.
    35. If analytical portions are to be stored before analysis, the method and length of time
of storage should be such that they do not affect the level of residues present. Additional
portions must be withdrawn for replicate and confirmatory analyses, as required.

Chapter VI. Criteria for determining compliance

    36. Analytical results must be derived from one or more laboratory samples taken from the
lot and received in a fit state for analysis.
    37. The results must be supported by accessible quality control data.
    38. Where a residue is found to exceed an MRL, its identity should be confirmed and its
concentration must be verified by analysis of one or more additional analytical portions
derived from the original laboratory sample(s).
    39. The MRL applies to the bulk sample.
    40. The lot complies with an MRL where the MRL is not exceeded by the analytical
result(s).
    41. Where results for the bulk sample exceed the MRL, a decision that the lot is non-
compliant must take into account the results obtained from one or more laboratory samples,
as applicable, and the accuracy and precision of analysis, as indicated by the supporting
quality control data.
    42. The officer shall provide each supplier of plant or plant origin product samples with the
results of laboratory tests in order to use them while filling in the documents required for
placing the products on the market.
Table 1

Minimum number of primary samples to be collected from a lot

  Minimum number of primary samples to be

collected from a lot

Products, packaged or in bulk, which can be 1 (A lot may be mixed by grading or

assumed to be well mixed or homogeneous manufacturing processes)

Products, packaged or in bulk, which may not be For plant origin products comprised of large
well mixed or homogeneous units, being primary food commodities of plant
origin only, the minimum number of primary
 samples should comply with the minimum
number of units required for the laboratory
sample (See table 2)
or  
Weight of lot (in kg):  
< 50 3
50-500 5
> 500 10
or  
Number of bottles, boxes or other recipients  
from the lot
1-25 1
26-100 5
> 100 10
   The table assumes random sampling.
   Where a single primary sample is taken, the probability of detecting a non-compliance is
similar to the incidence of non-compliant residues.
   For exact or alternative probabilities, or for a different incidence of non-compliance, the
number of samples to be taken may be calculated from:
1-p = (1 - i)n, where:
    p – is the probability,
    i – is the incidence of non-compliant residues in the lot (both expressed as fractions, not
percentages),
    n – is the number of samples.

    table 2 –

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    annex no.1 –

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    annex no.2 –

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    annex no.3 –

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