# L_2014121EN.01001701.xml

| 24.4.2014 | EN | Official Journal of the European Union | L 121/17 |
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24.4.2014

EN

Official Journal of the European Union

L 121/17

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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)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular the third subparagraph of Article 89(1) thereof,

Whereas:

| (1) | Commission Regulation (EC) No 1451/2007 (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council (3). That list includes silicon dioxide. |
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(1)

Commission Regulation (EC) No 1451/2007 (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council (3). That list includes silicon dioxide.

| (2) | Silicon dioxide has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 18, insecticides, acaricides and products to control other arthropods, as defined in Annex V to that Directive, which corresponds to product-type 18 as defined in Annex V to Regulation (EU) No 528/2012. |
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(2)

Silicon dioxide has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 18, insecticides, acaricides and products to control other arthropods, as defined in Annex V to that Directive, which corresponds to product-type 18 as defined in Annex V to Regulation (EU) No 528/2012.

| (3) | The data submitted for the purpose of the evaluation allowed conclusions to be drawn only regarding a certain form of silicon dioxide, i.e. synthetic amorphous silicon dioxide described as wet silica CAS No 112926-00-8. The evaluation did not allow conclusions to be drawn regarding any other substance complying with the definition of silicon dioxide CAS No 7631-86-9 in the abovementioned list of active substances in Regulation (EC) No 1451/2007. Therefore, only synthetic amorphous silicon dioxide should be covered by the approval. |
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(3)

The data submitted for the purpose of the evaluation allowed conclusions to be drawn only regarding a certain form of silicon dioxide, i.e. synthetic amorphous silicon dioxide described as wet silica CAS No 112926-00-8. The evaluation did not allow conclusions to be drawn regarding any other substance complying with the definition of silicon dioxide CAS No 7631-86-9 in the abovementioned list of active substances in Regulation (EC) No 1451/2007. Therefore, only synthetic amorphous silicon dioxide should be covered by the approval.

| (4) | France was designated as rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 16 April 2009 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007. |
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(4)

France was designated as rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 16 April 2009 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.

| (5) | The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated in an assessment report reviewed within the Standing Committee on Biocidal Products on 13 March 2014. |
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(5)

The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated in an assessment report reviewed within the Standing Committee on Biocidal Products on 13 March 2014.

| (6) | According to that assessment report, biocidal products used for product-type 18 and containing synthetic amorphous silicon dioxide may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC, provided that certain specifications and conditions relating to its use are satisfied. |
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(6)

According to that assessment report, biocidal products used for product-type 18 and containing synthetic amorphous silicon dioxide may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC, provided that certain specifications and conditions relating to its use are satisfied.

| (7) | It is therefore appropriate to approve synthetic amorphous silicon dioxide for use in biocidal products for product-type 18 subject to compliance with such specifications and conditions. |
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(7)

It is therefore appropriate to approve synthetic amorphous silicon dioxide for use in biocidal products for product-type 18 subject to compliance with such specifications and conditions.

| (8) | Since synthetic amorphous silicon dioxide as evaluated is a nanomaterial, the approval should cover such nanomaterials pursuant to Article 4(4) of Regulation (EU) No 528/2012 provided that certain specifications and conditions relating to their use are satisfied. |
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(8)

Since synthetic amorphous silicon dioxide as evaluated is a nanomaterial, the approval should cover such nanomaterials pursuant to Article 4(4) of Regulation (EU) No 528/2012 provided that certain specifications and conditions relating to their use are satisfied.

| (9) | A reasonable period should be allowed to elapse before an active substance is approved, in order to permit interested parties to take the preparatory measures necessary to meet the new requirements laid down. |
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(9)

A reasonable period should be allowed to elapse before an active substance is approved, in order to permit interested parties to take the preparatory measures necessary to meet the new requirements laid down.

| (10) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, |
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(10)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,

HAS ADOPTED THIS REGULATION:

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.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 23 April 2014.

For the Commission

The President

José Manuel BARROSO

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(1)  
  OJ L 167, 27.6.2012, p. 1.

1

(2)  Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (OJ L 325, 11.12.2007, p. 3).

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(3)  Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1).

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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) |
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| 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 |

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 |
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—

Primary particle size < 25 nm

| — | Volume specific surface area > 600 m2/cm3 |
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—

Volume specific surface area > 600 m2/cm3

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.

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(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

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