Commission Implementing Regulation (EU) 2015/1731 of 28 September 2015 approving medetomidine as an active substance for use in biocidal products for product-type 21 (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2015/1731
• Articles: 3

Article 1

Medetomidine is approved as an active substance for use in biocidal products for product-type 21, 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

Medetomidine

IUPAC name:

(RS)-4-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole

EC No: not available

CAS No: 86347-14-0

99,5 % w/w.

Medetomidine is manufactured as a racemic mixture of R and S enantiomers: dexmedetomidine and levomedetomidine.

1 January 2016

31 December 2022

21

Medetomidine is considered a candidate for substitution in accordance with Article 10(1)(d) and (f) 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)

Persons making products containing medetomidine available on the market for non-professional users shall make sure that the products are supplied with appropriate gloves. Labels and, where provided, instructions for use shall indicate whether other personal protective equipment shall be used.

(3)

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

(4)

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 an impermeable hard standing with bunding or on soil covered with an impermeable material to prevent direct losses and minimise emissions to the environment, and that any losses or waste containing medetomidine shall be collected for reuse or disposal.

(5)

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.

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 medetomidine 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 8(1) of Regulation (EU) No 528/2012. 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 ).