Annex

IUPAC Name:

4,5-Dichloro-2-octylisothiazol-3(2H)-one

EC No: 264-843-8

CAS No: 64359-81-5

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. (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. (2)

   Labels and, where provided, instructions for use shall indicate that children shall be kept away until treated surfaces are dry.

3. (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. (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^f3 or Regulation (EC) No 396/2005 of the European Parliament and of the Council^f4 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.