OpenLegislation

Annex

United Kingdom

Original text. Later amendments are not shown.

The purity indicated in this column was the minimum degree of purity of the active substance evaluated in accordance with Article 89(1) 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 to be technically equivalent to the evaluated active substance.

The structural characteristics indicated in this column were the ones of the active substance used for the evaluation made in accordance with Article 89(1) of Regulation (EU) No 528/2012.

Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11).

Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).

Common NameIUPAC NameIdentification NumbersMinimum degree of purity of the active substancef1 Reference structural characteristicsf2 Date of approvalExpiry date of approvalProduct typeSpecific conditions
Pyrogenic, synthetic amorphous, nano, surface treated silicon dioxide

IUPAC Name:

Silanamine, 1,1,1-trimethyl-N-(trimethylsilyl)-, hydrolysis products with silica

EC No: 272-697-1

CAS No: 68909-20-6

998 g/kg (purity of core measured after ignition).
  • Carbon content: 3,0-4,0 %;

  • Primary particle size: 6,9-8,6 nm;

  • Specific surface area: 217-225 m2/g;

  • Size of stable aggregated particles: > 70 nm;

  • Surface treatment: with > 90 % of the surface surface-treated with hexamethylsilazane (CAS 999-97-3)

1 November 201831 October 202818

The authorisations of biocidal products are subject to the following conditions:

  1. (1)

    the product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any use covered by an application for authorisation, but not addressed in the Union-level risk assessment of the active substance;

  2. (2)

    in view of the risks identified for the uses assessed, the product assessment shall pay particular attention to professional users;

  3. (3)

    for products that may lead to residues in food or feed, the need to set new or to amend existing maximum residue levels (MRLs) in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Councilf3 or Regulation (EC) No 396/2005 of the European Parliament and of the Councilf4 shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded.

Annotations

Footnotes

f1

The purity indicated in this column was the minimum degree of purity of the active substance evaluated in accordance with Article 89(1) 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 to be technically equivalent to the evaluated active substance.

f2

The structural characteristics indicated in this column were the ones of the active substance used for the evaluation made in accordance with Article 89(1) of Regulation (EU) No 528/2012.

f3

Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11).

f4

Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).