The detailed rules for official sampling, including the targeting criteria, are set out in the Annex to this Decision.
This Decision is addressed to the Member States.
1. RESPONSIBILITIES
1.1. Inspector
Official inspectors shall be designated by the competent authority for taking, registering, preparing and organising the transport of the official control samples under appropriate condition.
1.2. Approved laboratories
The analysis of samples shall be carried out exclusively by laboratories approved for official residue control by the competent authority.
Participation in an internationally recognised external quality control assessment and accreditation scheme is required for authorised laboratories. The accreditations must be obtained before 1 January 2002.
These laboratories must prove their competence by regularly and successfully participating in adequate proficiency testing schemes recognised or organised by the national or community reference laboratories.
2. SAMPLING
2.1. Fundamental aspects
Whenever official samples are taken, sampling must be unforeseen, unexpected and effected at no fixed time and no particular day of the week - the Member States must take all the precautions necessary to ensure that the element of surprise in the checks is constantly maintained.
Sampling shall be carried out in variable intervals spread over the whole year at the establishments mentioned in paragraph 1 of Annex III of Council Directive 96/23/EC. In this context it has to be considered that a number of substances is administered only in particular seasons.
Without prejudice of the regulations of the residue control plan, other available information shall be taken into consideration when choosing the samples, e.g. the use of presently unknown substances, diseases suddenly appearing in particular regions, indications of fraudulent activities, etc.
2.2. Sampling strategy
The residue control plan is aimed at:
2.3. Collection of the samples
2.3.1. Definitions
2.3.1.1. Targeted sample
Targeted sample is a sample which is taken in accordance with the sampling strategy as defined in 2.2. above.
2.3.1.2. Suspect sample
Suspect sample is a sample which is taken:
2.3.1.3. Random sample
A random sample is a sample which is taken under statistical consideration to provide representative data.
2.3.2. On farm targeted sampling
2.3.2.1. Criteria for the selection of targeted sample
Farms for on farm sampling can be chosen using local knowledge or any other relevant information such as type of fattening system, breed and sex of animal. The inspector then makes an assessment of all the stock on the farm to select those animals to be sampled. In making this assessment the following criteria should be applied inter alia:
2.3.2.2. Type of targeted sample to be collected
For the detection of pharmacological active substances the corresponding suitable samples are taken according to the provisions in the residue control plan.
2.3.3. Targeted sampling at primary processing establishments
2.3.3.1. Criteria for the selection
In making their assessment on the animal carcasses and/or the animal products to be sampled the inspector should apply the following criteria inter alia:
When taking the samples, efforts should be made to avoid multiple sampling from one producer.
2.3.3.2. Type of samples collected
For the detection of pharmacological active substances the corresponding suitable samples are taken according to the provisions in the residue control plan.
2.4. SAMPLE QUANTITY
The minimum sample quantities must be defined in the national
residue control plan. It must be sufficient to enable the approved
laboratories to carry out the analytical procedures necessary to
complete the screening and the confirmatory analyses.
2.5. DIVISION INTO SUB-SAMPLES
Unless technically impossible or not required by national
legislation, each sample must be divided into at least two equivalent
sub-samples each allowing the complete analytical procedure. The
subdivision can take place at the sampling location or in the
laboratory.
2.6. SAMPLES CONTAINERS
Samples must be collected in suitable containers to maintain sample integrity and traceability. In particular, containers must prevent substitution, cross-contamination and degradation. The containers must be officially sealed.
2.7. SAMPLING REPORT
A report shall be produced after each sampling procedure.
The inspector collects at least the following data in the sampling report:
Copies of the report are to be foreseen depending on the sampling procedure. The sampling report and its copies shall be signed at least by the inspector: in case of on-farm sampling, the farmer or his deputy may be invited to sign the original sampling report.
The original of the sampling report remains at the competent authority, which has to guarantee that unauthorised persons cannot access this original report.
If necessary, the farmer or the owner of the establishment may be
informed of the sampling undertaken.
2.8. LABORATORY REPORT
The laboratory report established by the competent authorities contains at least the following information:
2.9. TRANSPORT AND STORAGE
Residue control plans shall specify the suitable storage and transport conditions for each analyte/matrix combination to ensure analyte stability and sample integrity. Specific attention must be paid to transport boxes, temperature and delivery times to the responsible laboratory.
In case of any non-compliance with the requirements of the control plan the laboratory shall inform the competent authority without delay.