# Commission Implementing Regulation (EU) 2015/984 of 24 June 2015 approving copper pyrithione as an existing active substance for use in biocidal products for product-type 21 (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 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.
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).
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).
Common Name
IUPAC NameIdentification Numbers
Minimum degree of purity of the active substance
Date of approval
Expiry date of approval
Product type
Specific conditions
Copper pyrithione
IUPAC Name:
bis(1-hydroxy-1H-pyridine-2-thionato-O,S)copper
EC No: 238-984-0
CAS No: 14915-37-8
950 g/kg
1 October 2016
31 December 2025
21
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) Products containing copper pyrithione shall not be authorised for or used by non-professional users.
(2) 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.
(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 and on impermeable hard standing with bunding to prevent direct losses and minimise emissions to the environment, and that any losses or waste containing copper pyrithione 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 or Regulation (EC) No 396/2005 of the European Parliament and of the Council shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded.

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Source: https://www.legislation.gov.uk/eur/2015/984/annex (the official version)
Page: https://openlegislation.uk/eu-regulation-2015-984/annex
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.