In Europe, a market authorization is required for biocides by the Biocidal Products Directive 98/8/EC (BPD) which will be repealed and replaced by the Biocidal Products Regulation (BPR), Regulation (EU) No 528/2012, on 1 September 2013. Upon Annex I inclusion of the active substance(s), re-registration of biocidal products is required. Registration dossiers according to the Technical Notes for Guidance need to be submitted for biocidal products within 2 years after the date of entry into force of the Directive on the active substance(s), before the data of Annex I inclusion. The BPD/BPR sets stringent requirements for data on physical-chemical characteristics, efficacy, target organism safety, human risk assessment and environmental risk assessment of biocides and represents a big challenge for all stakeholders in the near future.
Exposure and therefore both human and environmental risk assessments for biocidal products present a unique set of challenges and need to be assembled with great care. The diversity of potential usage scenarios and routes of human exposure and entry into the environment imply that a wide range of exposure assessment techniques may be required. Our experienced environmental modelers are familiar with models relevant to the prediction of biocide concentrations in the environment (e.g. EUSES, ESDs) and for humans (e.g. CONSEXPO, BEAT).
ARCHE services for biocidal products and active substances are:
- Strategic advice on biocide regulatory processes under national transitional registration schemes, BPD and BPR;
- Alert client of new or changed national and European legislation concerning biocides
- Advice on composition of your biocidal product at R&D phase to enhance regulatory acceptance: selection of active ingredients and co-formulants, formulation screening or selection based upon phys/chem, efficacy and (eco)toxicological characteristics;
- Evaluation of existing products and proposals for modification of composition necessary for BPD/BPR compliance;
- Data gap analysis and advice for filling of data gaps or data waivers;
- Risk assessments for human and environmental exposure to active substances and biocidal products;
- Dossier preparation for biocidal active substances and biocidal products. Frame formulation / Biocidal Product Family dossiers.
- Procedures followed: national and mutual recognition procedures, Union Authorisation
- Other services: classification and labeling of biocides, submission and follow-up of dossiers till approval, re-formatting of existing of dossiers, variations, renewals, …
- Customized training
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.