Article 1
4,5-Dichloro-2-octyl-2H-isothiazol-3-one shall be approved as an active substance for use in biocidal products for product-type 21, subject to the specifications and conditions set out in the Annex.
Commission Implementing Regulation (EU) No 437/2014 of 29 April 2014 approving 4,5-Dichloro-2-octyl-2H-isothiazol-3-one as an existing active substance for use in biocidal products for product-type 21 Text with EEA relevance
Commission Implementing Regulation (EU) No 437/2014 of 29 April 2014 approving 4,5-Dichloro-2-octyl-2H-isothiazol-3-one as an existing active substance for use in biocidal products for product-type 21 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 ) Date of approval Expiry date of approval Product type Specific conditions ( 2 ) 4,5-Dichloro-2-octyl-2H-isothiazol-3-one IUPAC Name: 4,5-Dichloro-2-octylisothiazol-3(2H)-one EC No: 264-843-8 CAS No: 64359-81-5 950 g/kg 1 January 2016 31 December 2025 21 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. Persons making products containing 4,5-Dichloro-2-octyl-2H-isothiazol-3-one available on the market for non-professional users shall make sure that the products are supplied with appropriate gloves. Authorisations are subject to the following conditions: (1) For industrial or professional users, safe operational procedures and appropriate organizational measures shall be established. Where exposure cannot be reduced to an acceptable level by other means, products shall be used with appropriate personal protective equipment. (2) Labels and, where provided, instructions for use shall indicate that children shall be kept away until treated surfaces are dry. (3) Labels and, where provided, safety data sheets of products authorised shall indicate that application, maintenance and repair activities shall be conducted within a contained area, on impermeable hard standing with bunding or on soil covered with an impermeable material to prevent losses and minimize emissions to the environment, and that any losses or waste containing 4,5-Dichloro-2-octyl-2H-isothiazol-3-one shall be collected for reuse or disposal. (4) 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. Where an article has been treated with or intentionally incorporates one or more biocidal products containing 4,5-Dichloro-2-octyl-2H-isothiazol-3-one and where necessary due to the possibility of skin contact as well as the release of 4,5-Dichloro-2-octyl-2H-isothiazol-3-one under normal conditions of use of the article, the person responsible for placing the article on the market shall ensure that the label provides information on the risk of skin sensitisation, as well as the information referred to in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012. ( 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 ) 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 ( 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 ).
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
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