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-type 18 Text with EEA relevance

• CELEX: Implementing Regulation (EU) No 408/2014
• Articles: 3

Article 1

Synthetic amorphous silicon dioxide shall be approved as an active substance for use in biocidal products for product-type 18, subject to the specifications and conditions set out in the Annex.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Schedules & Appendices

ANNEX

ANNEX

Common Name

IUPAC Name

Identification Numbers

Minimum degree of purity of the active substance  ( 1 )

Reference structural characteristics  ( 2 )

Date of approval

Expiry date of approval

Product type

Specific conditions  ( 3 )

Synthetic amorphous silicon dioxide (nano)

IUPAC Name:

Silicon dioxide

EC No: 231-545-4

CAS No: 112926-00-8

This approval covers synthetic amorphous silicon dioxide as a nanomaterial in the form of stable aggregated particles of particle size > 1 μm, with primary particles of nanosize.

800 g/kg

—

Size of stable aggregated particles > 1 μm

—

Primary particle size < 25 nm

—

Volume specific surface area > 600 m 2 /cm 3

1 November 2015

31 October 2025

18

The product assessment 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.

( 1 )   The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 8 of Regulation (EU) No 528/2012. The active substance in the product placed on the market can be of equal or different purity if it has been proven technically equivalent with the evaluated active substance.

( 2 )   The structural characteristics indicated in this column were the ones of the active substance used for the evaluation made in accordance with Article 8 of Regulation (EU) No 528/2012.

( 3 )   For the implementation of the common principles of Annex VI to Regulation (EU) No 528/2012, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm