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.
Textual Amendments
F1Words in Art. 1 substituted (31.12.2020) by The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(b), 6(2)(a)
F2Word in Art. 1 substituted (27.2.2025) by The Retained EU Law (Revocation and Reform) Act 2023 (Consequential Amendments) Regulations 2025 (S.I. 2025/82), reg. 1(2), Sch. 15 para. 62(2)(a)
F3Word in Art. 1 omitted (31.12.2020) by virtue of The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(b), 6(2)(b)
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—
as regards England, the Secretary of State;
as regards Scotland, the Scottish Ministers;
as regards Wales, the Welsh Ministers;
“relevant [F6assimilated] law” means—
as regards England and Scotland, the Animals and Animal Products (Examination for Residues and Maximum Residue Limits) (England and Scotland) Regulations 2015;
as regards Wales, the Animals and Animal Products (Examination for Residues and Maximum Residue Limits) (Wales) Regulations 2019.]
Textual Amendments
F4Replaced by 2003/181/EC: Commission Decision of 13 March 2003 amending Decision 2002/657/EC as regards the setting of minimum required performance limits (MRPLs) for certain residues in food of animal origin (Text with EEA relevance) (notified under document number C(2003) 764)
F5Words in Art. 2 inserted (31.12.2020) by The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(b), 6(3)
F6Word in Art. 2 substituted (27.2.2025) by The Retained EU Law (Revocation and Reform) Act 2023 (Consequential Amendments) Regulations 2025 (S.I. 2025/82), reg. 1(2), Sch. 15 para. 62(2)(b)
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.
Textual Amendments
F7Words in Art. 3 substituted (31.12.2020) by The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(b), 6(4)(a)
F8Words in Art. 3 substituted (31.12.2020) by The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(b), 6(4)(b)
F9Word in Art. 3 substituted (27.2.2025) by The Retained EU Law (Revocation and Reform) Act 2023 (Consequential Amendments) Regulations 2025 (S.I. 2025/82), reg. 1(2), Sch. 15 para. 62(2)(c)
[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.]
Textual Amendments
F11Replaced by 2004/25/EC: Commission Decision of 22 December 2003 amending Decision 2002/657/EC as regards the setting of minimum required performance limits (MRPLs) for certain residues in food of animal origin (Text with EEA relevance) (notified under document number C(2003) 4961)
F12Words in Art. 4 substituted (31.12.2020) by The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(b), 6(5)
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).
Textual Amendments
F13Words in Art. 5 substituted (31.12.2020) by The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(b), 6(6)(a)
F14Words in Art. 5 substituted (31.12.2020) by The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(b), 6(6)(b)
F15Word in Art. 5 substituted (27.2.2025) by The Retained EU Law (Revocation and Reform) Act 2023 (Consequential Amendments) Regulations 2025 (S.I. 2025/82), reg. 1(2), Sch. 15 para. 62(2)(d)
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.
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Textual Amendments
F16Art. 7 omitted (31.12.2020) by virtue of The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(b), 6(7)
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.
This Decision shall apply from 1 September 2002.
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Textual Amendments
F17Art. 10 omitted (31.12.2020) by virtue of The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(b), 6(7)
Done at Brussels, 12 August 2002.
For the Commission
David BYRNE
Member of the Commission