Commission Decisionof 12 August 2002implementing Council Directive 96/23/EC concerning the performance of analytical methods and the interpretation of results(notified under document number C(2002) 3044)(Text with EEA relevance)(2002/657/EC)

Article 1 U.K. Subject matter and scope

This Decision provides rules for the analytical methods to be used in the testing of official samples taken pursuant to [F1 relevant [F2 assimilated] 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

F1 Words 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)

F2 Word 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)

F3 Word 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)

Article 2 U.K. Definitions

For the purpose of this Decision the definitions in Directive 96/23/EC and in the [F4 Annex I] to this decision shall apply.

[F5 In 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 [F6 assimilated] 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.]

Textual Amendments

F4 Replaced 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)

F5 Words 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)

F6 Word 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)

Article 3 U.K. Analytical methods

The [F7 appropriate authority] shall ensure that official samples taken pursuant to [F8 relevant [F9 assimilated] 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 [F10 Annex I] to this Decision;

(c) have been validated according to the procedures described in Part 3 of the [F10 Annex I];

(d) comply with the relevant minimum required performance limits (MRPL) to be established in accordance with Article 4.

Textual Amendments

F7 Words 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)

F8 Words 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)

F9 Word 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)

F10 Replaced 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)

[F11 Article 4 U.K. Minimum required performance limits

[F12 The 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

F11 Replaced 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)

F12 Words 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)

Article 5 U.K. Quality control

The [F13 appropriate authority] shall ensure the quality of the results of the analysis of samples taken pursuant to [F14 relevant [F15 assimilated] law], in particular by monitoring tests and/or calibration results according to Chapter 5.9 of ISO 17025 (1).

Textual Amendments

F13 Words 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)

F14 Words 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)

F15 Word 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)

Article 6 U.K. Interpretation 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.

F16 Article 7 U.K. Repeal

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F16 Art. 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)

Article 8 U.K. Transitional 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 9 U.K. Date of application

This Decision shall apply from 1 September 2002.

F17 Article 10 U.K. Addressees

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F17 Art. 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