Residue analytical methods

Nature of residue in plants, Hvestock Residue analytical method (plants, animals)... 

Gros M, Petrovic M, Barcelo D (2006) Development of a multi-residue analytical method based on liquid chromatography-tandem mass spectrometry (LC-MS-MS) for screening and trace level determination of pharmaceuticals in surface and wastewaters. Talanta 70 (4) 678-690... 

Handbook of Residue Analytical Methods for Agrochemicals. 2003 John Wiley Sons Ltd. 

Regulatory guidance and scientific consideration for residue analytical method development and validation... 

Assessment of residue analytical methods for crops, food, feed, and environmental samples the approach of the European Union... 

Residue analytical methods are needed to enforce these legally based limits or guidance values and to perform monitoring projects. For existing a.i., validated analytical procedures for only a few selected compounds have been published in journals or... 

The purpose of this article is to clarify the assessment of residue analytical methods in the context of Directive 91/414/EEC. After discussing the legal and historical background, requirements for enforcement methods as well as data generation methods are reviewed. Finally, an outlook over further developments in the assessment and validation of analytical methods is provided. 

The first step to define data requirements and criteria for decision making for residue analytical methods was attempted in Council Directive 94/43/EC, establishing... 

Annex VI to Directive 91/414/EEC concerning the placing of plant protection products on the market. The section concerning residue analytical methods was not fully finalized when the Directive was first adopted. There were no provisions for methods to determine residues from a.i. and relevant metabolites in soil, water, and air. The criteria for foodstuffs partly proved to be not helpful for the practice of assessment (e.g., with regard to reproducibility, ISO 5725 requires validation in at least eight independent laboratories). 

Commission Directive 96/46/EC of 16 July 1996, amending Annex II to the Directive 91/414/EEC, is the basis for the assessment of residue analytical methods for crops, food, feed, and environmental samples." Provisions of this Directive cover methods required for post-registration control and monitoring purposes but not data generation methods. Because it is necessary to provide applicants as precisely as possible with details on the required information, the guidance document S ANCO/825/00 rev. 6 dated 20 June 2000 (formerly 8064/VI/97 rev. 4, dated 5 December 1998)" was elaborated by the Commission Services in cooperation with the Member States. 

Moreover, this document provides guidance to Member States on the interpretation of the provisions of Directive 96/46/EC concerning minimum validation requirements for residue analytical methods. 

Reliable residue data are generated during the development of an a.i. to support the assessment of the consumer risk (residue data and toxicological data) and the impact on the environment (fate and behavior, efficacy and ecotoxicological data). It is critical that these analytical methods are reliably validated. In the guidance document SANCO/3029/99 rev. 4 (11/07/00), harmonized requirements for the residue analytical method are described. Validated analytical methods are required for the following studies ... 

European Commission, Guidance Document on Residue Analytical Methods, SANCO/ 825/00/rev. 6, 20.06.00. European Commission, Bmssels (2000). This guidance document and also the following ones are available on the World Wide Web http //europa.eu.int/comm/ food/fs/ph ps/pro/wrkdoc/index en.htm. 

The MHLW recognizes the official analytical methods for inspection and survey of MRLs for crops in the market 112 residue analytical methods have already been established and authorized. MHLW also approves the use of the original analytical methods for the official surveillance by which methods local governments analyze residues as they inspect local commercial farm commodities. In such a case, the reliability of the original analytical methods should be guaranteed as being equivalent to that of the official analytical methods. 

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