The registration of plant protection products in the European Union follows the process laid down in the Regulation (EC) No.1107/2009 (which replaced Directive 91/414/EEC) and entered into force on the 14th June 2011. The directives aim is to harmonise the registration of plant protection products across the EU, as well as introducing some new requirements. Many important changes were introduced in this new regulation, with perhaps the most important one being the introduction of the zonal system with mutual recognition, hazard based criteria, assessment of cumulative and synergistic effects, comparative assessment and endocrine disruption.
Providing services to clients wishing to gain authorization for PPP and yield enhancing products, BIOTEK Agriculture staff acts on behalf of the applicants and authorization holders, during and after the whole authorization process, by following the registration process and remaining in constant contact with authorities at a national level. In addition they will conduct all the administration work required for national and zonal registration of PPP including application and any amendments.
Preparing Annex III authorization dossiers in accordance to the rules and requirements necessary for registration or the re-registration (Step 2) of PPP. Submission of the complete and summary dossier for each point of the data requirements of products.
A product registration dossier should include:
– Physical chemical properties,
– Validated methods of analysis,
– Acute toxicology studies and human risk assessment,
– Environmental fate and behaviour data with predicted environmental concentrations,
– Ecotoxicology studies and environmental risk assessment,
– Efficacy and selectivity trials,
– Classification and labelling.
Long term co-operation and relationships with respected as well as well known laboratories and institutions allows the organization of the necessary tests and studies for registration of PPP. These are monitored closely until the end of the studies.
In particular these include efficacy and residue studies throughout Europe, which are conducted within the BIOTEK Agriculture group.
A speciality of ours is the agri-food processing capability, which offers the client a complete range of food, wine, bread and beer processing studies.
Conducting the assessment of tests and studies to ensure they are in accordance to EU regulatory evaluation procedures and assessment methods, including relevant guidelines and EC Directives in the field of: identification of the PPP, identity of the manufacturer and applicant for authorization, physical-chemical properties, analytical methods, toxicology, residue in plant, fate and behaviour in the environment, ecotoxicology and efficacy.
BIOTEK Agriculture Hungary Kft.
Széchenyi u. 132/a, 2141 Csömör, Hungary
Contact : Nóra EL HALLOF
Registration ManagerTel/fax: +36 28 739 672
Mobile: +36 20 341 1881