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Commission Implementing Regulation (EU) No 408/2014

Synthetic amorphous silicon dioxide in its nano-form has been officially approved by the European Commission (EC) for use as an active substance in biocidal products for product-type 18 through Commission Implementing Regulation (EU) No 408/2014. It comes into force following the publication of the decree in the Official Journal of the European Union on 23 April 2014.


The substance has been approved 'as a nanomaterial in the form of stable aggregated particles of particle size > 1 micrometre, with primary particles of nanosize'. Furthermore any assessment of products containing the material 'shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance'.


The EC's Biocides Competent Authorities began discussing the approval of the substance in October 2013; a request for an opinion on a biocidal product containing nano-form amorphous silicon dioxide, HeiQ AGS-20, was made by the EC to the European Chemicals Agency (ECHA) on 26 November 2013, which in turn asked its Biocidal Products Committee to answer it. This opinion provided the basis for the approval of the substance.


Here the direct link to the Document:

COMMISSION IMPLEMENTING REGULATION (EU) No.408/2014 of 23 April 2014 approving synthetic amorphous silicon dioxide as an existing active substance for use in biocidal products for product-type18. (PDF, 300 KB).


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The chapters on release, exposure, uptake and behavior of nanomaterials in the human body and in the environment as well as the risk assessment will give you a first overview.



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