New report generator plug-in available for IUCLID 5.5

In a recent news alert (ECHA/NA/13/27), ECHA announced the release of a new IUCLID report generator plug-in to help applicants prepare summaries of product characteristics (SPCs) for biocidal product authorisation applications. This plug-in can also be used to generate chemical safety reports (CSRs) for REACH purposes, and replaces the existing CSR plug-in.



New biocides regime under BPR

The Biocidal Products Regulation (BPR; Regulation (EU) 528/2012) heralds a new regime for the control of biocidal products on the EU market. The regulation – applicable from 1 September 2013 – aims to improve the functioning of the biocides market, whilst ensuring a high level of protection for humans and the environment. It also promotes a reduction in the use of laboratory animals by introducing mandatory data-sharing obligations and encouraging the use of alternative methods for testing. It will repeal the former legislation, the Biocidal Products Directive (Directive 98/8/EC).

If you need support with preparing your dossiers and product submissions, turn to the team at bibra for proficient and cost-effective help. We can assist with any aspect of the job   be it large or small.

We have many years of experience in: searching for information; summarising chemical hazard data; risk assessment; data-gap analysis and Integrated Testing Strategies; data waiving, read-across and weight-of-evidence approaches to minimise the need for additional testing; and drafting (robust) study summaries and endpoint summaries in IUCLID.

Over the years, bibra scientists have helped a number of companies with their submissions on active substances and formulations under the Biocidal Products Directive. We aim to continue that support, unfazed by the new regulatory regime, and look forward to hearing from you.

If you think we can be of assistance, or would like more information, give us a call on
+44 (0)20 8544 4150, or visit our biocides page


The above items were taken from the September 2013 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here for more details).

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