# 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), Annex

Extent: E+W+S+N.I.

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.
Common Name
IUPAC NameIdentification Numbers
Minimum degree of purity of the active substance
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.

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Source: https://www.legislation.gov.uk/eur/2017/2003/annex (the official version)
Page: https://openlegislation.uk/eu-regulation-2017-2003/annex
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.