1998D0179 — EN — 01.05.2004 — 001.001 — 1
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►B COMMISSION DECISION
of 23 February 1998
laying down detailed rules on official sampling for the monitoring of certain substances and resi-
dues thereof in live animals and animal products
(Text with EEA relevance)
(98/179/EC)
(OJ L 65, 5.3.1998, p. 31)
Amended by:
Official Journal
No page date
►A1 Act concerning the conditions of accession of the Czech Republic, the
Republic of Estonia, the Republic of Cyprus, the Republic of Latvia,the Republic of Lithuania, the Republic of Hungary, the Republic ofMalta, the Republic of Poland, the Republic of Slovenia and the SlovakRepublic and the adjustments to the Treaties on which the EuropeanUnion is foundedL 236 33 23.9.2003
▼B
COMMISSION DECISION
of 23 February 1998
laying down detailed rules on official sampling for the monitoring
of certain substances and residues thereof in live animals and
animal products
(Text with EEA relevance)
(98/179/EC)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 96/23/EC of 29 April 1996 on
measures to monitor certain substances and residues thereof in liveanimals and animal products and repealing Directives 85/358/EEC and86/469/EEC and Decisions 89/187/EEC and 91/664/EEC (
1), and in
particular the second subparagraph of Article 15(1) thereof,
Whereas the procedures set up by the competent authorities of the
Member States responsible for sampling and treatment of samples until
they reach the laboratory responsible for analysis have a direct andimmediate bearing on the presence of illegal substances in samplesand the possibilities for detecting the residues of certain substances;whereas such procedures are therefore an important stage in the residue
monitoring plan;
Whereas in order to improve the effectiveness of the monitoring plans
implemented each year by the Member States for the detection ofcertain substances and residues thereof in live animals and animalproducts, and in order to ensure the comparability of the resultsobtained, detailed rules for sampling should be laid down and harmo-nised;
Whereas samples must be taken in accordance with Annexes III and IV
to the abovementioned Directive; whereas, in this respect, the targeting
criteria for sampling must also be specified;
Whereas the measures provided for in this Decision are in accordance
with the opinion of the Standing Veterinary Committee,
HAS ADOPTED THIS DECISION:
Article 1
The detailed rules for official sampling, including the targeting criteria,
are set out in the Annex to this Decision.
Article 2
This Decision is addressed to the Member States.1998D0179 — EN — 01.05.2004 — 001.001 — 2
(1) OJ L 125, 23. 5. 1996, p. 10.
▼B
ANNEX
Rules for official sampling procedures and official sample treatment
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 the samples shall be carried out exclusively by the
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 labora-
tories. The accreditations must be obtained before 1 January 2002.
►A1 For the Czech Republic, Estonia, Cyprus, Latvia, Lithuania,
Hungary, Malta, Poland, Slovenia and Slovakia the accreditation must
be obtained by the date of accession. ◄
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 labora-
tories.
2. Sampling
2.1. Fundamental aspects
Whenever official samples are taken, sampling must be unforeseen,
unexpected and effected at no fixed time and on 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 main-
tained.
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 (1). In this context it has to be consid-
ered 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 activ-
ities etc.
2.2. Sampling strategy
The residue control plan is aimed at:
(a) detecting all illegal treatment, as defined in Article 2(b) of Direc-
tive 96/23/EC;
(b) controlling the compliance with the MRLs for residues of veter-
inary drugs fixed in Annex I and III of Council Regulation (EEC)
No 2377/90 (2) and the maximum levels of pesticides fixed in in
Annex II of Council Directive 86/363/EEC (3) or national regula-
tions on environmental contaminants;
(c) surveying and revealing the reasons for residue in food of animal
origin;
2.3. Collection of the samples
2.3.1. Definitions1998D0179 — EN — 01.05.2004 — 001.001 — 3
(1) OJ L 125, 23. 5. 1996, p. 10.
(2) OJ L 224, 18. 8. 1990, p. 1.
(3) OJ L 221, 7. 8. 1989, p. 43.
▼B
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:
— as a consequence of positive results of sample taken in accordance
with the requirements of Article 5 of Directive 96/23/EC,
— as a consequence of Article 11,— as the requirements of Article 24.
2.3.1.3. Random sample
A random sample is a sample which is taken under statistical considera-
tion 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:
— indication of use of pharmacological active substances,
— secondary sexual characteristics,— behavioural changes,— the same level of development in a group of animals of different
breed/categories,
— animals with good conformation and little fat.
2.3.2.2. Type of targeted sample to be collected
For the detection of pharmacological active substances the corre-
sponding 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 carcases and/or the animal
products to be sampled the inspector should apply the following criteria
inter alia:
— sex, age, species, and farming system,
— information about the producer,
— indication of use of pharmacological active substances,— common practice with regards to the administration of particular
pharmacological active substances in the respective farm production
system.
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 corre-
sponding 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.1998D0179 — EN — 01.05.2004 — 001.001 — 4
▼B
2.6. Samples containers
Samples must be collected in suitable containers to maintain sample
integrity and traceability. In particular, containers must prevent substitu-
tion, 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:
— address of the competent authorities,
— name of the inspector or identification code,— official code number of the sample,— sampling date,— name and address of the owner or the person having charge of the
animals or the animal products,
— name and address of the animal's farm of origin (when sampling on
farm),
— registration number of the establishment-slaughterhouse number,— animal or product identification,
— animal species,
— sample matrix,— medication within the last four weeks before sampling (when
sampling on farm),
— substance or substance groups for examination,— particular remarks.
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:
— address of the competent authorities,
— name of inspector of identification code,— official code number of the sample,— sampling date,
— animal species,
— sample matrix,— substances or substance groups for examination,— particular remarks.
This report is handed over to the routine laboratory together with the
samples.
2.9. Transport and storage
Residue control plans shall specify the suitable storage and transport
conditions for each analyte/matrix combination to ensure analyte stabi-
lity 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.1998D0179 — EN — 01.05.2004 — 001.001 — 5