About Plant Protection Products (PPPs)
Having significant experience in the registration / licensing of plant protection products and specialization, ranging from providing up-to-date information on your regulatory obligations, to the preparation and submission of complete files on the active substance and product approval in accordance with Regulation (EC) No 1107/2009 and in accordance with national regulations, Sustchem S.A. is able to meet your every need and provide you with the following services:
- Constant monitoring of the regulatory affairs developments assuring an exhaustive fulfilment of your obligations. Learn More
- Preparation of dossiers for agrochemical active substances and products
- Project Coordination: Identification and evaluation of data gaps in the data package according to current EU requirements (Check of Completeness) for agrochemicals and preliminary risk assessments (human & environmental exposure, risk characterisation human health & environment)
- Cost analysis for completion of the data package (including statements) and preparation of a registration dossier
- Time schedule for study conduction and dossier preparation
- Zonal system dossier submissions
- RENEWALS (procedure under Art. 43 of REG. 1107/2009) for both Existing Registrations of PPP’s and active substances
- Mutal Recognition procedure support
- Label extension and amendments
- Communication with authorities and evaluators
New Type Fertilizer Authorization
Registration and authorization of all New Types Fertilizers, from the Ministry of Rural Development and Food, are necessary before their release on the market. For this reason, submitting a technical dossier with all the required forms, both in printed and electronic form is a prerequisite. SustChem S.A. can fully undertake theauthorization process and in particular:
- Classification and labeling of the product in accordance with applicable national and European legislation
- Issue Security Data Sheets of products in Greek language.
- Determine the content of the label for the Greek market.
- Registration of the product in the National Register of Chemical Products if the product is classified as dangerous.
- Help collect data if not available from Manufacturers.
- To monitor the entire licensing process until the final approval is granted and to appear before the authorities in case this is required.
Labeling correctness check for biostimulants / soil improvers
Biostimulantsand soil improvers, may be placed on the market, for the purpose of marketing and their use in agriculture, provided that they will be characterized, marked and indicate the identity of the product as follows: Type, composition, appropriate (correct) use depending on soil and plant type, dosage as well as season/period of use.
SustChem SA can fully undertake the process of checking the suitability and correctness of labeling procedures in general for such products. Finally, we can undertake the issuance of Safety Data Sheets (based on the Regulations (EC) 830/2015 for SDS, 1907/2006 REACH, 1272/2008 CLP) in the Greek language for each final product in case they are not available.