Commission Implementing Regulation (EU) 2015/985 of 24 June 2015 approving clothianidin as an existing active substance for use in biocidal products for product-type 18 (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2015/985
• Articles: 3

Article 1

Clothianidin is approved as an active substance for use in biocidal products for product-type 18, 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

Clothianidin

IUPAC Name:

(E)-1-(2-Chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2- Nitroguanidine

EC No: 433-460-1

CAS No: 210880-92-5

93 % w/w

1 October 2016

30 September 2026

18

Clothianidin is considered a candidate for substitution in accordance with Article 10(1)(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.

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

(1)

For industrial or 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)

Products shall not be authorised for uses in animal housings where emission to a sewage treatment plant or direct emission to surface water cannot be prevented, unless it can be demonstrated that risks to the environment can be reduced to an acceptable level by other means.

(3)

Due to the risks identified for the soil compartment, products shall not be authorised for uses in animal housings others than for beef cattle, unless it can be demonstrated that risks to the environment can be reduced to an acceptable level.

(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  ( 2 ) or Regulation (EC) No 396/2005 of the European Parliament and of the Council  ( 3 ) shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded.

( 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.

( 2 )   Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council ( OJ L 152, 16.6.2009, p. 11 ).

( 3 )   Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC ( OJ L 70, 16.3.2005, p. 1 ).