Commission Implementing Regulation (EU) No 438/2014 of 29 April 2014 approving cyproconazole as an existing active substance for use in biocidal products for product-type 8 Text with EEA relevance — Full Text

Article 1

Cyproconazole shall be approved as an active substance for use in biocidal products for product-type 8, 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 .

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 ) Cyproconazole IUPAC Name: (2RS,3RS;2RS,3SR)-2-(4-chlorophenyl)-3-cyclopropyl-1-(1H-1,2,4-triazol-1-yl)butan-2-ol EC No: N/A CAS No: 94361-06-5 Cyproconazole has two diastereomers. Diastereomer A: enantiomeric pair, where the 2-hydroxy group and the 3-hydrogen are located on the same side (2S, 3S and 2R, 3R). Diastereomer B: enantiomeric pair, where the 2-hydroxy group and 3-hydrogen are located on opposite sides (2R, 3S and 2S, 3R). Technical cyproconazole is ca 1:1 mixture of the two diasteriomers, each of which is exactly a 1:1 mixture of the enantiomers. 940 g/kg Cyproconazole has two diastereomers (Diastereoisomer A: 430-500 g/kg, Diastereoisomer B: 470-550 g/kg). 1 November 2015 31 October 2020 8 Cyproconazole is considered a candidate for substitution in accordance with Article 10(1)(a) and (d) of Regulation (EU) No 528/2012. 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. Authorisations are subject to the following conditions: (1) For industrial 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) Products shall not be authorised for industrial use by double vacuum impregnation, unless data is submitted to demonstrate that the product will not present unacceptable risks, if necessary by the application of appropriate mitigation measures. (3) Appropriate risk mitigation measures shall be taken to protect the soil and aquatic compartments. In particular: a. Labels and, where provided, safety data sheets of products authorised shall indicate that industrial application shall be conducted within a contained area or on impermeable hard standing with bunding, that freshly treated timber shall be stored after treatment under shelter or on impermeable hard standing, or both, to prevent direct losses to soil or water, and that any losses from the application of the product shall be collected for reuse or disposal. b. Products shall not be authorised for industrial treatment of wood that will be exposed to weathering, or for treatment of wood that will be used for outdoor constructions, unless data is submitted to demonstrate that the product will not present unacceptable risks, if necessary by the application of appropriate mitigation measures. ( 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.

Article 1

Article 2

Supplementary provisions

ANNEXSupplementary provisions

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