Biocidal products
A market authorization is required for biocides by the European Biocidal Products Directive 98/8/EC (BPD). In 2009, a proposal for a new Regulation concerning the placing on the market and use of biocidal products was adopted by the European Commission. This new Biocidal Products Regulation (BPR) will repeal and replace the current BPD in 2013. The review procedures of biocidal active substances will be finalized by the new deadline of 14 May 2014, upon which the re-registration of biocidal products is required. Complete registration dossiers will 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). 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, USES) and in the human (e.g. CONSEXPO, EASE).
We can assist you with dossier preparation under the Biocidal Products Directive in the following areas:
- Preparation of complete biocidal product dossiers.
- Data gap analysis and advice for filling of data gaps (study planning, monitoring).
- Justification for non-submission of data / data waivers.
- Risk assessment for human and environmental exposure for active substances and biocidal products.
- Both national and mutual recognition procedures
- Frame formulations and read-across
- Other services: CLP of biocides, submission and follow-up of dossiers till approval, revision of dossiers, variations, renewals, communication with authorities…
brochure
Download our biocides brochure
Keep track of our latest news
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BIOCIDES 2011 conference in Vienna
ARCHE attended the 14th International annual conference in Vienna (Austria) (28-30th November 2011). The conference is organized by Feierl-Herzele GmbH, that also operates the European Biocides Information Network (https://www.europeanbiocides.net). This fully booked conference is greatly appreciated by participants by its interactive nature and the presence of both industry and government representatives. Click to the right to read on.
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EQSPAE conference in Hong-Kong
ARCHE presented at the International EQSPAE Conference 2011. With this conference, Hong Kong University and SETAC aim to provide an international platform for sharing knowledge on the advancement in the scientific derivation of EQ benchmarks for the protection for aquatic ecosystems and human health. Click to the right to read on.
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The launch of our new website
As you may have noticed by now, we have a new website. And we're quite happy about it too! Click on the arrow on the right for more information.
Meet us at these upcoming events
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VLARIP EVENT REACH: de uitdagingen voor 2012
ARCHE is exhibiting at the yearly VLARIP networking event to be held on 2 February 2012 in Zwijnaarde
Topic: REACH: de uitdagingen voor 2012/the challenges for 2012
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QSAR Workshop
ARCHE invites you to join us at a QSAR workshop to be held 16 February 2012 in Ghent.
Topic: Save resources using QSARs in fulfilling your 2013 registration testing obligations under REACH.
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6th SETAC World Congres
ARCHE is exhibiting at the 6th SETAC World Congress to be held 20-24 May 2012 in Berlin. In addition we are co-chairing a session on "Collection and use of monitoring data for environmental risk assessment of chemicals" scheduled on wednessday 23 May in the morning.
Topic: Securing a sustainable future: integrating science, policy and people
