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Analytical ServicesGLP Physico-Chemical Properties Studies5-Batch AnalysisGLP Residue Studies

www.renolab-glp.com

Contacts and Test Facility Manager

Rita Rescae-mail: [email protected]@renolab-glp.comPhone: +39 051 0800110Mobile: +39 347 6301674

Departments

Luisa MaccaferriResidue Studies Responsiblee-mail: [email protected] GazzottiPhysico-Chemical Studies Responsiblee-mail: [email protected]

RENOLAB S.r.l. Head Office and Test FacilityVia XXV Aprile 1945, 19 40016 - S. Giorgio di Piano (BO) - Italy Phone: +39 051 0800110Fax: +39 051 0800114e-mail: [email protected]

Legal Head OfficeVia Verdi, 1124121 Bergamo - Italy www.renolab-glp.com

VAT 03521490163

Reliability

High Quality Service

Flexibility

The requirements of physico-chemical properties of the products are defined by:

• Regulation (EC) no. 1107/2009 of the European Parliament and of the Council of 21 October 2009, concerning the placing of plant protection products on the market;

• Commission Regulation (EU) no. 283/2013 of 1 March 2013, setting out the data requirements for active substances, in accordance with Regulation (EC) no. 1107/2009;

• Commission Regulation (EU) no. 284/2013 of 1 March 2013, setting out the data requirements for plant protection products, in accordance with Regulation (EC) No. 1107/2009;

• Regulation (EU) no. 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products;

• FAO Guideline, Manual on Development and Use of FAO Specifications for Plant Protection Products;

• CropLife, Technical Monograph no. 17, Guidance for Specifying the Shelf life of Plant Protection Products;

• SANCO/3030/99 rev. 4 Guidance for generating and reporting methods of analysis for technical material and preparation.

The physico-chemical characteristics are performed following standardized methods and guidelines as reported in EC methods, CIPAC Handbook Series, OECD guidelines and OPPTS Series.

In order to support products registration dossier, Renolab can act as Study Director in collaboration with other Field Test Facilities and/or as Principal Investigator in Ecotox and in Environmental fate studies, in compliance to data requirements and guidelines:

• Regulation (EC) no. 1107/2009; Concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC;

• EC working document, 1607/VI/97, rev. 2; Guidelines for the generation of data concerning residues;

• OECD 509 – Guideline for the testing of chemicals: crop field trial;

• OECD 506 – Guideline for the testing of chemical: stability of pesticide residues in stored commodities;

• SANCO/3029/99 rev. 4 – Residues: Guidance for generating and reporting methods of analysis in support of pre-registration data requirements;

• SANCO/825/00 rev. 8.1 – Guidance document on pesticide residue analytical methods.

• OECD series on testing and assessment no. 72 and series on pesticides no. 39; Guidance document on pesticide residue analytical methods, ENV/JM/MONO (2007)17, 13/08/2007.

In the Residue laboratory department the residues of the active ingredient and their metabolites are analysed in vegetable and animal matrices, processed products, soil and water.

GLP Physico-Chemical Properties Studies 5 Batch Analysis

GLP Residue Studies

Renolab is an Italian laboratory certified by the Ministry of Health for the Good Laboratory Practices (GLP). Renolab follows up with the “GLP Certification” for the physico-chemical characterization and the residue studies of pesticides, biocides, cosmetics, drugs, additives and other industrial chemical products, in compliance with the GLP principles of the OECD and according to the European Directives implemented by the Italian laws.Good Laboratory Practice are accepted by regulatory authorities throughout the European Community, the United States of America (FDA and EPA) and Japan (MHW, MAFF and METI) on the basis of intergovernmental agreements.

Analytical Service

• GLP Study Direction;• Development and validation of analytical methods for active

ingredient residues and metabolites in crops, processed products, soil and water;

• Field samples residue analysis;• Inter Laboratory Validation (ILV) studies;• Storage stability studies of residues in different kinds of

commodities or specimens;• Effectiveness of cleaning procedure;• Purities/impurities profile of the active substance/technical

material;• 5 Batch analysis;• Development and validation of analytical methods for active

substance and impurities determination;• Formulation analysis;• Physico-chemical characterization of the active substances;• Physico-chemical characterization required for chemical,

agrochemical, biocidal products, drugs, cosmetics…;• Emission of certificate of analysis (CoA);• Studies for general risk of transport and storage;• Studies on storage stability (cold, accelerated and 2 years

shelf life) by monitoring the physico-chemical parameters and integrity of packaging;

• Packaging and migration studies;• Chemical and physical compatibility of tank mix;• Study plans and reports can be individually tailored, as

requested by the client/sponsor;• Studies or analysis without GLP compliance, when requested.

Renolab Equipment

• Liquid chromatographs equipped with MS, MS/MS, Q-TOF, DAD, UV and Coulometric detector;

• Ion chromatograph;• Gas chromatographs equipped with MS, ECD, NPD, FID

detectors and Head Space autosampler; • Atomic Absorption Spectrometer for elements (Cu, Zn, Fe,

P, etc.) analysis;• Other apparatus necessary to perform specific

characterizations.

In Renolab there are special skills that can support the R&D activity in the area of formulation and in new products experimentation both “in vitro” and “in vivo”.

Renolab means:reliability, flexibility, high quality service