Article 1Subject matter and scope
This Decision provides rules for the analytical methods to be used in the testing of official samples taken pursuant to F1relevant F2assimilated law and specifies common criteria for the interpretation of analytical results of official control laboratories for such samples.
This Decision shall not apply to substances for which more specific rules have been laid down in other F3... legislation.
Article 2Definitions
For the purpose of this Decision the definitions in Directive 96/23/EC and in the F4Annex I to this decision shall apply.
F5In this Decision—
“appropriate authority” means—
(a)
as regards England, the Secretary of State;
(b)
as regards Scotland, the Scottish Ministers;
(c)
as regards Wales, the Welsh Ministers;
“relevant F6assimilated law” means—
(a)
as regards England and Scotland, the Animals and Animal Products (Examination for Residues and Maximum Residue Limits) (England and Scotland) Regulations 2015;
(b)
as regards Wales, the Animals and Animal Products (Examination for Residues and Maximum Residue Limits) (Wales) Regulations 2019.
Article 3Analytical methods
The F7appropriate authority shall ensure that official samples taken pursuant to F8relevant F9assimilated law are analysed using methods that:
(a)
are documented in test instructions, preferably according to ISO 78-2 (6);
(b)
comply with Part 2 of the F10Annex I to this Decision;
(c)
have been validated according to the procedures described in Part 3 of the F10Annex I;
(d)
comply with the relevant minimum required performance limits (MRPL) to be established in accordance with Article 4.
F11Article 4Minimum required performance limits
F12The appropriate authority shall ensure that the analytical methods used for detecting the following substances meet the minimum required performance limits (MRPLs) set out in Annex II, against the matrixes referred to in that Annex:
(a)
chloramphenicol;
(b)
nitrofuran metabolites;
(c)
medroxyprogesterone.
(d)
malachite green.
Article 5Quality control
The F13appropriate authority shall ensure the quality of the results of the analysis of samples taken pursuant to F14relevant F15assimilated law, in particular by monitoring tests and/or calibration results according to Chapter 5.9 of ISO 17025 (1).
Article 6Interpretation of results
1.
The result of an analysis shall be considered non-compliant if the decision limit of the confirmatory method for the analyte is exceeded.
2.
If a permitted limit has been established for a substance, the decision limit is the concentration above which it can be decided with a statistical certainty of 1 - ɑ that the permitted limit has been truly exceeded.
3.
If no permitted limit has been established for a substance, the decision limit is the lowest concentration level at which a method can discriminate with a statistical certainty of 1 - ɑ that the particular analyte is present.
4.
For substances listed in Group A of Annex I to Directive 96/23/EC, the ɑ error shall be 1 % or lower. For all other substances, the ɑ error shall be 5 % or lower.
F16Article 7Repeal
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Article 8Transitional provisions
The methods for the analysis of official samples of substances listed in Group A of Annex I to Directive 96/23/EC, which satisfy the criteria set out in Decisions 90/515/EEC, 93/256/EEC and 93/257/EEC may be used for up to two years after this Decision enters into force. Methods currently applied for substances listed in Group B of Annex I to Directive 96/23/EC shall comply with this Decision at the latest five years after the date of application of this Decision.
Article 9Date of application
This Decision shall apply from 1 September 2002.
F17Article 10Addressees
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Done at Brussels, 12 August 2002.
For the Commission