Article 1
Pyrogenic, synthetic amorphous, nano, surface treated silicon dioxide is approved as an active substance for use in biocidal products of product-type 18, subject to the specifications and conditions set out in the Annex.
Commission Implementing Regulation (EU) 2017/795 of 10 May 2017 approving pyrogenic, synthetic amorphous, nano, surface treated silicon dioxide as an existing active substance for use in biocidal products of product-type 18 (Text with EEA relevance. )
Commission Implementing Regulation (EU) 2017/795 of 10 May 2017 approving pyrogenic, synthetic amorphous, nano, surface treated silicon dioxide as an existing active substance for use in biocidal products of product-type 18 (Text with EEA relevance. )
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
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 .
Supplementary provisions
ANNEXSupplementary provisions
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 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 m 2 /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 2018 31 October 2028 18 The authorisations of biocidal products are subject to the following conditions: (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) in view of the risks identified for the uses assessed, the product assessment shall pay particular attention to professional users; (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 Council ( 3 ) or Regulation (EC) No 396/2005 of the European Parliament and of the Council ( 4 ) shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded. ( 1 ) 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. ( 2 ) 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. ( 3 ) 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 ). ( 4 ) 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 ).
Other acts of the same type
Commission Implementing Regulation (EU) 2023/247 of 1 February 2023 approving non-minor amendments to the specification for a name entered in the register of protected designations of origin and protected geographical indications (‘Estepa’ (PDO))Commission Implementing Regulation (EU) 2023/248 of 1 February 2023 concerning the classification of certain goods in the Combined NomenclatureCommission Implementing Regulation (EU) 2023/335 of 1 February 2023 approving non-minor amendments to the specification for a name entered in the register of protected designations of origin and protected geographical indications (‘Robiola di Roccaverano’ (PDO))Commission Delegated Regulation (EU) 2023/960 of 1 February 2023 amending the regulatory technical standards laid down in Delegated Regulation (EU) 2017/588 as regards the annual application date of the calculations of the average daily number of transactions for shares, depository receipts and exchange-traded funds for the purposes of the tick sizes (Text with EEA relevance)Council Implementing Regulation (EU) 2023/192 of 30 January 2023 implementing Regulation (EU) No 269/2014 concerning restrictive measures in respect of actions undermining or threatening the territorial integrity, sovereignty and independence of UkraineCommission Regulation (EU) 2023/198 of 30 January 2023 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for abamectin in or on certain products (Text with EEA relevance)Commission Implementing Regulation (EU) 2023/199 of 30 January 2023 approving the low-risk active substance Trichoderma atroviride AT10 in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)Commission Implementing Regulation (EU) 2023/200 of 30 January 2023 concerning the non-approval of lemon essential oil (Citrus limon essential oil) as a basic substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (Text with EEA relevance)Council Regulation (EU) 2023/246 of 30 January 2023 amending Regulation (EU) No 389/2012 as regards the exchange of information maintained in the electronic registers concerning economic operators who move excise goods between Member States for commercial purposesCommission Delegated Regulation (EU) 2023/735 of 30 January 2023 amending Delegated Regulation (EU) 2020/760 with regard to the requirement to submit invoices to establish the reference quantity and clarifying some issues concerning the Licence Operator Registration and Identification (LORI) electronic systemCommission Delegated Regulation (EU) 2023/751 of 30 January 2023 amending Delegated Regulation (EU) 2020/687 supplementing Regulation (EU) 2016/429 of the European Parliament and the Council as regards rules for the prevention and control of certain listed diseases (Text with EEA relevance)Council Implementing Regulation (EU) 2023/180 of 27 January 2023 implementing Regulation (EU) 2022/2474 amending Regulation (EU) No 833/2014 concerning restrictive measures in view of Russia’s actions destabilising the situation in Ukraine
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
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