The DOSSIER Unit of ChemService manages the drafting and filing of registration Dossiers to Authorities for:
ChemService provides the following consulting services, besides drafting of full or partial Dossiers:
Scientific literature research and test on existing data.
Testing and registration strategy development.
Performing of studies and/or their monitoring.
Task Force management for the development and preparation of registration Dossiers. on active ingredients and/or formulated products.
Filing of registration documents and Dossiers to Authorities.
Contacts and follow-up with Authorities.
Specific TECHNICAL SKILLS
Our services comprise:
Scientific litterature research and regular review of available scientific literature.
Assessment of human risk: operator’s risk (UK POEM, German model, CHESAR), residents and employees, consumers (EFSA Primo model, CONSEXPO).
Environmental risk assessment for all units (aquatic and terrestrial) on all organisms (mammals, birds, insects, non-target, bees, soil organisms, etc.).
Models for environmental destination of surface and fail water (FOCUS, etc.).
Data gap analysis, and focus of registration strategies with indications of studies to be developed, as well as possible scientific grounds for non-filing of certain studies.
In-depth insight and knowledge of in silico (Q)SAR more commonly used methods, such as OECD Toolbox, CAESAR, VEGA, ToxTree, DEREK and of in vitro tests (OECD 437, OECD 438; OECD 439, OECD 431, etc.).
Knowledge of the modalities related to the use of "weight of evidence" and "read-across" in regulatory process allows us to optimize the available information and make our services highly competitive as well as ethically sustainable by minimizing the use of in vivo test on vertebrate animals.
Scientific monitoring of complex studies like operator’s exposure, determination of leaf residues (DFR), studies with radio-marked elements.
Usage of specific software packages for the preparation and the electonic filing of registration Dossiers: CADDY, IUCLID.
Since 1994, ChemService is cerified by the Ministry of Health for the execution of a wide range of samplings, in compliance with Good Laboratory Practices, in accordance to D.L. 120/92 (now D.Lvo 50/2007).
ChemService is part of the official list of Certified Laboratories by the Ministry of Health that can make Fodd Self-monitoring Analyses in compliance with the HACCP (Hazard Analysis Critical Control Points), to certify processing, sanitation and control procedures, prevent risks to consumers’ health and define procedures to be adopted in the event of non-conformity as well as monitoring the impact of this programme.
Ministry of Health website on food satefy in Italy
Permit for tests on fish
ChemService holds the official permit by the Ministry of Health to act as a user of fish for experimental purposes and any other scientific purpose in compliance D.L. 116/92.
The accreditation certifies the quality of testing laboratory activities, verifying the compliance of its management system and its expertise with internationally recognized regulatory requirements, as well as with mandatory legislative requirements, but Accredia does not guarantee on single analysis provided by the Laboratory.
The list of the accredited tests is available starting from this page
ChemService ensures that collected and processed data will be protected and not disclosed to third parties. ChemService only processes data that this website visitors voluntarily decide to provide. ChemService is not responsible for the processing of data from sites accessible through our links.
Holder of the data processing is: ChemService S.r.l. Controlli e Ricerche, via f.lli Beltrami 15, 20026, Novate Milanese (MI) - Italy. Pursuant to art. 7 of the italian Legislative Decree n. 196, dated 30.06.2003, the parties to whom the personal data refer have the right to obtain confirmation or disconfirmation of the existence of such data, to know the content and origin, to verify its accuracy or to ask for an update. These parties also have the right to request cancellation at any time, and to oppose to their treatment.