EN    EN  
 EUROPEAN 
COMMISSION  
Brussels, XXX   
CA-Sept13-Doc.3.1 
[…](2013) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX  
approving Cu-HDO as an existing active substance for use in biocidal products for 
product-type 8 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX  
approving Cu-HDO as an existing active s ubstance for use in biocidal products for 
product-type 8 
(Text with EEA relevance) 
THE EUROPEAN COMMISSION, 
Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the 
Council of 22 May 2012 concerning the making av ailable on the market and use of biocidal 
products
1, and in particular the third subpa ragraph of Article 89(1) thereof, 
Whereas: (1) Commission Regulati on (EC) No 1451/2007
2 establishes a list of active substances to 
be assessed, with a view to their possible in clusion in Annex I, IA or IB to Directive 
98/8/EC of the European Parliament and of the Council3. That list includes Cu-HDO. 
(2) Cu-HDO has been evaluated in accordance with  Article 11(2) of Directive 98/8/EC for 
use in product-type 8, wood preservatives, as  defined in Annex V to that Directive, 
which corresponds to product-type 8 as defi ned in Annex V to Regulation (EU) No 
528/2012. 
(3) Austria was designated as Rapporteur Me mber State and submitted the competent 
authority report, together with a recommendation, to the Commission on 25 February 
2008 in accordance with Article 14(4) a nd (6) of Regulati on (EC) No 1451/2007. 
(4) The competent authority report was re viewed by the Member States and the 
Commission. In accordance with Article 15 (4) of Regulation (EC) No 1451/2007, the 
findings of the review were incorporated, within the Standing Committee on Biocidal 
Products on [date SCB], in an assessment report. 
(5) It appears from that report that biocid al products used for product-type 8 and 
containing Cu-HDO may be expect ed to satisfy the requirements laid down in Article 
5 of Directive 98/8/EC. 
(6) It is therefore appropriate  to approve Cu-HDO for use in biocidal products for 
product-type 8. 
(7) Since the evaluation did not a ddress nanomaterials, the appr oval should not cover such 
materials pursuant to Article 4( 4) of Regulation (EU) No 528/2012. 
                                                 
1 OJ L 167, 27.6.2012, p. 1. 
2 Commission Regulation (EC) No 1451/2007 of 4 Decem ber 2007 on the second phase of the 10-year 
work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (OJ L 325, 11.12.2007, p. 3). 
3 Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the 
placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1) .  
EN 3   EN (8) A reasonable period should be allowed to elapse before an active substance is 
approved, in order to permit Member States, interested parties, and the Commission 
where appropriate, to prepare themselves to meet the new requirements entailed.  
(9) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on Biocidal Products,  
HAS ADOPTED THIS REGULATION: 
Article 1 
Cu-HDO shall be approved as an active substa nce for use in biocidal products for product-
type 8, 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 . 
This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels, 
 For the Commission 
 The President  José Manuel BARROSO   
EN 4   EN ANNEX  
Common 
Name IUPAC Name 
Identification Numbers Minimum 
degree of 
purity of 
the active substance
4  Date of 
approval Expiry date 
of approval Product 
type Specific conditions5 
Cu-HDO 
 IUPAC Name :  
bis(N-cyclohexyl-diazenium-dioxy)-copper EC n° : N/A CAS n° : 312600-89-8 
 981 g/kg 1 
September 
2015  31 August 
2025
 8 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. 
Authorisations are subject to the following 
conditions: 
(1) For industrial 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) Appropriate risk mitigation 
measures shall be taken to protect the terrestrial 
compartment. In particular, 
labels and, where provided, 
                                                 
4 The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in a ccordance with Article 8 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 
5 For the implementation of the common principles of Annex VI to Regulation (EU) No 528/2012, the content and conclusions of ass essment reports are available on the 
Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm   
EN 5   EN Common 
Name IUPAC Name 
Identification Numbers Minimum 
degree of 
purity of 
the active substance
4  Date of 
approval Expiry date 
of approval Product 
type Specific conditions5 
safety data sheets of products 
authorised shall indicate that industrial application shall be 
conducted within a contained 
area or on impermeable hard standing with bunding, that 
freshly treated timber shall be 
stored after treatment under 
shelter or on impermeable hard 
standing, or both, to prevent direct losses to soil or water, and 
that any losses from the 
application of the product shall be collected for reuse or 
disposal.