ECHA announced in its June 2013 newsletter that the agency is working on a set of new biocides guidance documents to support applicants preparing for the Biocidal Products Regulation.
The following guidance documents will be published by September 1, 2013, according to ECHA:
- The Guidance on information requirements, which will describe what information the dossier for active substance approval or biocidal products authorization must include according to the Biocidal Products Regulation.
- The Guidance on technical equivalence, which will inform the potential applicants on their obligations under Article 54. This article explains when the applicants need to apply for an assessment of technical equivalence and what the related procedural steps are.
- The Guidance on active substance suppliers, which will explain what obligations active substance suppliers have under Article 95. It will also provide direction on the procedural aspects and regulatory consequences of the submission.
The new guidance for Biocidal Products Regulation will have a different structure than guidance under the Biocidal Products Directive. This will however be implemented in full only at a later stage, ECHA says.
In addition, ECHA announced that almost 300 participants took part in ECHA’s first Biocides Stakeholders’ Day on June 25, 2013. Representatives from most EU Member States, Turkey, India, China, Canada and the U.S. participated.
During the conference, ECHA explained the new processes and application opportunities for companies under the Biocidal Products Regulation. ECHA also presented the review program of active substances and practical implications of Union authorization. ECHA demonstrated to participants how to use IUCLID version 5.5 to prepare biocides dossiers and the upcoming new release of the Register for Biocidal Products (R4BP), which is the tool for submitting these dossiers.
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