Commission Implementing Regulation (EU) 2015/1726 of 28 September 2015 approving 2-methylisothiazol-3(2H)-one as an existing active substance for use in biocidal products for product-type 13 (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2015/1726
• Articles: 3

Article 1

2-methylisothiazol-3(2H)-one is approved as an active substance for use in biocidal products for product-type 13, 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 .

Schedules & Appendices

ANNEX

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-methylisothiazol-3(2H)-one

IUPAC Name:

2-methylisothiazol-3(2H)-one

EC No: 220-239-6

CAS No: 2682-20-4

95 % w/w

1 October 2016

30 September 2026

13

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.

The authorisations of biocidal products are subject to the following conditions:

(1)

For professional users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means.

(2)

In view of the risks to the professional users, loading of the products into metalworking fluids shall be semi-automated or automated unless it can be demonstrated that risks can be reduced to an acceptable level by other means.

(3)

In view of the risks to the professional users, labels and, where provided, safety data sheets of products shall indicate that preserved metalworking fluids shall be used in semi-automated or automated machines unless it can be demonstrated that risks can be reduced to an acceptable level by other means.

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 2-methylisothiazol-3(2H)-one shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of the 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 16(2) of Directive 98/8/EC. 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.