Commission Decision
of 12 August 2002
implementing 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)
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 live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC(1), and in particular the second subparagraph of Article 15(1) thereof,
Whereas:
(1) The presence of residues in products of animal origin is a matter of concern for public health.
(2) Commission Decision 98/179/EC 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(2) provides that the analysis of samples is to be carried out exclusively by laboratories approved for official residue control by the competent national authority.
(3) It is necessary to ensure the quality and comparability of the analytical results generated by laboratories approved for official residue control. This should be achieved by using quality assurance systems and specifically by applying of methods validated according to common procedures and performance criteria and by ensuring traceability to common standards or standards commonly agreed upon.
(4) Council Directive 93/99/EEC of 29 October 1993 on the subject of additional measures concerning the official control of foodstuffs and Decision 98/179/EC(3) require official control laboratories to be accredited according to ISO 17025 (1) from January 2002 onwards. Pursuant to Decision 98/179/EC, participation in an internationally recognised external quality control assessment and accreditation scheme is required for approved laboratories. Moreover, approved laboratories must prove their competence by regular and successful participation in adequate proficiency testing schemes recognised or organised by the national or Community reference laboratories.
(5) A network of Community reference laboratories, national reference laboratories and national control laboratories operates under Directive 96/23/EC to enhance coordination.
(6) As a result of advances in analytical chemistry since the adoption of Directive 96/23/EC the concept of routine methods and reference methods has been superseded by criteria approach, in which performance criteria and procedures for the validation of screening and confirmatory methods are established.
(7) It is necessary to determine common criteria for the interpretation of test results of official control laboratories in order to ensure a harmonised implementation of Directive 96/23/EC.
(8) It is necessary to provide for the progressive establishment of minimum required performance limits (MRPL) of analytical method for substances for which no permitted limit has been established and in particular for those substances whose use is not authorised, or is specifically prohibited in the Community, in order to ensure harmonised implementation of Directive 96/23/EC.
(9) Commission Decision 90/515/EEC of 26 September 1990 laying down the reference methods for detecting residues of heavy metals and arsenic(4), Commission Decision 93/256/EEC of 14 May 1993 laying down the methods to be used for detecting residues of substances having a hormonal or a thyrostatic action(5), and of Commission Decision 93/257/EEC of 15 April 1993 laying down the reference methods and the list of the national reference laboratories for detecting residues(6), as last amended by Decision 98/536/EC(7) have been re-examined before in order to take account of developments in scientific and technical knowledge, have been found outdated in their scope and provisions and should accordingly be repealed with this Decision.
(10) In order to allow methods for the analysis of official samples to be adapted to the provisions of this Decision, a transitional period should be laid down.
(11) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS DECISION:
Article 1
Subject matter and scope
This Decision provides rules for the analytical methods to be used in the testing of official samples taken pursuant to Article 15(1), second sentence, of Directive 96/23/EC 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 Community legislation.
Article 2
Definitions
For the purpose of this Decision the definitions in Directive 96/23/EC and in the Annex to this decision shall apply.
Article 3
Analytical methods
The Member States shall ensure that official samples taken pursuant to Directive 96/23/EC 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 Annex to this Decision;
(c) have been validated according to the procedures described in Part 3 of the Annex;
(d) comply with the relevant minimum required performance limits (MRPL) to be established in accordance with Article 4.
Article 4
Minimum required performance limits
The present Decision shall be reviewed to progressively establish the minimum required performance limits (MRPL) of analytical methods to be used for substances for which no permitted limit has been established.
Article 5
Quality control
The Member States shall ensure the quality of the results of the analysis of samples taken pursuant to Directive 96/23/EC, in particular by monitoring tests and/or calibration results according to Chapter 5.9 of ISO 17025 (1).
Article 6
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 - α 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 - α that the particular analyte is present.
4. For substances listed in Group A of Annex I to Directive 96/23/EC, the α error shall be 1 % or lower. For all other substances, the α error shall be 5 % or lower.
Article 7
Repeal
Decisions 90/515/EEC, 93/256/EEC and 93/257/EEC are repealed.
Article 8
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
Date of application
This Decision shall apply from 1 September 2002.
Article 10
Addressees
This Decision is addressed to the Member States.
Done at Brussels, 12 August 2002.