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Commission Implementing Regulation (EU) 2017/2003 of 8 November 2017 approving fludioxonil as an active substance for use in biocidal products of product-types 7, 9 and 10 (Text with EEA relevance. )

Commission Implementing Regulation (EU) 2017/2003 of 8 November 2017 approving fludioxonil as an active substance for use in biocidal products of product-types 7, 9 and 10 (Text with EEA relevance. )

Implementing Regulation (EU) 2017/2003 · Regulation · 3 articles

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 1

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Fludioxonil is approved as an active substance for use in biocidal products of product-types 7, 9 and 10, subject to the specifications and conditions set out in the Annex.

Article 2

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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

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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 Fludioxonil IUPAC Name: 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile EC No: Not available CAS No: 131341-86-1 950 g/kg 1 April 2018 31 March 2028 7 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 industrial and professional users. The placing on the market of treated articles is subject to the following condition: The person responsible for the placing on the market of a treated article treated with or incorporating fludioxonil shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012. 9 The authorisations of biocidal products are subject to the following condition: 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. The placing on the market of treated articles is subject to the following condition: The person responsible for the placing on the market of a treated article treated with or incorporating fludioxonil shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012. 10 The authorisations of biocidal products are subject to the following condition: 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. The placing on the market of treated articles is subject to the following condition: The person responsible for the placing on the market of a treated article treated with or incorporating fludioxonil shall ensure that the label of that treated article provides the information listed 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 evaluated. 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.

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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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