Plant Protection Products
Plant protection products (PPPs) are regulated in the EU by Regulation (EC) No 1107/2009. This Regulation lays down the approval procedure and approval criteria for active substances and products containing these substances. Active substances are assessed at EU level for approval for use in PPPs. When proven safe, an active substance is included on the Approved List of active substances. Products containing these active substances must be assessed and registered by Member States in order to be approved for marketing and use. A product approval can be obtained through zonal authorisation or by mutual recognition.
ARCHE can support you in the preparation and submission of active substance and product dossiers for EU-wide, zonal and national registrations as applicable. We can also assist you in the third phase of the renewal program (AIR3), which covers substances whose current approvals will expire between 2013 and 2018. We can prepare all or part of a dossier, depending on client needs. ARCHE has a profound knowledge of the current legislation and relevant guidance documents (SANCO, OECD, EFSA, etc.). Moreover, we stay up-to-date with the national and European legislation concerning PPPs by actively participating in national and international conferences and by our broad professional network of regulators.
- Provide strategic advice
- Customized training
- Preparation of active substance dossiers in accordance with OECD guidelines
- Preparation of core draft Registration Reports (dRRs) and where applicable National Addenda, hereby implementing the risk envelope approach
- Classification according to CLP regulation (EC) No 1272/2008.
- Submission of dossiers to the competent authorities
- Follow-up of submitted dossiers with the Competent Authorities till approval
- Data gap analysis
- Monitoring and coordination of required tests
- Compilation of Exposure and Risk assessments, (including higher-tier approaches)
- Preparation of single dossier sections (Physical chemical properties, analytical methods, toxicology and human exposure and risk assessment, residues, environmental fate, ecotoxicology and biological assessment dossier)
Keep track of our latest news
New Soil PNEC calculator is available!
A new updated version of the soil PNEC calculator is available for download on our website. Apart from a new layout, this new version now also includes data for Co and Mo. All calculations are now based on the data and methods selected for the EU REACH dossiers (Registration, Evaluation, Authorisation and Restriction of Chemicals; Regulation EC No 1907/2006) for Cu, Ni, Zn, Pb, Cd, Mo and Co, as available in August 2012."
From Soil screening values to Metal Clean-up values
Dr. Koen Oorts (ARCHE) is invited by the North American Metals Council (NAMC) to actively participate in a workshop on "Ecological Soil Levels-Next Steps in the Development of Metal Clean-up Values" scheduled for September 17-20, 2012 in Utah. The workshop's main goal is to provide regulators with the methods and processes developed over the last ten years to move from soil screening values to clean-up values.
SPERC tool for metals is updated!
The first version of the metal SPERCs was published in 2010 for the purpose of the 2010 REACH registration deadline and underwent a review process conducted by Lüskow et al. (2011) on behalf of the Federal Environment Agency of Germany (UBA). The second version of the metal SPERCs were improved based on the recommendations by Lüskow et al. (2011) and Tolls et al. (in press) and were further updated with new data for the purpose of the 2013 REACH registration deadline. This second version is currently undergoing a scientific review process but can already been find on this website.
Our QSARCHE model is released
Vertebrate testing under REACH is discouraged by promoting use of alternative non-testing approaches such as QSARs (Quantitative Structure Activity Relationships). Many QSARs are available, however, robust REACH compliant QSARs predicting chronic ecotoxicity to fish are largely lacking. ARCHE filled this data gap by the release of its QSARCHE fish toxicity model. Click to the right to read on.
Meet us at these upcoming events
4th Symposium on Biocidal Product Authorisation Vienna 23-24 May 2013
Symposium on authorisation/registration of biocidal products according to existing schemes(especially BPD) and the arising issues and interaction with the forthcoming Biocidal ProductRegulation (BPR)
65th International Symposium on crop protection- 21-05-2013 Ghent
This Symposium will be held at the Faculty of Bioscience Engineering of the Ghent University, Coupure links 653, BE-9000 Ghent, Belgium.