EN    EN  
 EUROPEAN 
COMMISSION  
Brussels, XXX   
CA-Sept13-Doc.4.1 
[…](2013) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX  
approving cyproconazole 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 cyproconazole as an existing active  substance 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 
cyproconazole. 
(2) Cyproconazole has been evaluated in accordance with Article 11(2) of Directive 
98/8/EC for use in product-type 8, wood pres ervatives, as defined in Annex V to that 
Directive, which corresponds to  product-type 8 as define d in Annex V to Regulation 
(EU) No 528/2012. 
(3) Ireland was designated as Rapporteur Member State and submitted the competent 
authority report, together with a reco mmendation, to the Commission on 30 May 2012 
in accordance with Article 14(4) a nd (6) of Regulation (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 in  an assessment report reviewed within the 
Standing Committee on Biocidal  Products on [date SCB]. 
(5) According to  that assessment report, bioc idal products used for product-type 8 and 
containing cyproconazole may be expected to satisfy the requirements laid down in 
Article 5 of Directive 98/8/EC provided that certain specifications and conditions relating to its use are satisfied. 
(6) It is therefore appropriate to approve cyproconazole for use in biocidal products for 
product-type 8 subject to co mpliance with such specifications and conditions.  
                                                
 
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 (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. 
(8) The report concludes that cyproconazole meets the criteria for being classified as toxic 
for reproduction category 1B in accordance w ith Regulation (EC) No 1272/2008 of the 
European Parliament and of the Council4, and for being (vP) and toxic (T) according 
to Annex XIII to Regulation (EC) No 1907/2006. 
(9) Since the conditions of the first subparagraph of Article  90(2) of Regulation (EU) 
No 528/2012 are not met, the current pract ice under Directive 98/8/EC should be 
followed. The period of approval sh ould therefore be three years. 
(10) However, for the purpose of authorising products in accordance with Article 23 of 
Regulation (EU) No 528/2012, cyproconazole sh all be considered as a candidate for 
substitution pursuant to Article 10( 1)(a) and (d) of that Regulation. 
(11) A reasonable period should be allowed to elapse before an active substance is 
approved, in order to permit interested pa rties to take the preparatory measures 
necessary to meet the ne w requirements laid down.  
(12) 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 
Cyproconazole shall be approved as an active substance for use in biocidal products for 
product-type 8, subject to th e specifications and conditi ons 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
                                                
 
4 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on 
classification, labelling and packaging of substances and mixtures, amending and repealing Directives 
67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 
1).  
EN 4   EN ANNEX  
Common 
Name IUPAC Name 
Identification Numbers Minimum 
degree of 
purity of 
the active substance
5  Date of 
approval Expiry date 
of approval Product 
type Specific conditions6 
Cyproconaz
ole  IUPAC Name :  
(2RS,3RS;2RS,3SR)-2-(4-chlorophenyl)-3-
cyclopropyl-1-(1H-1,2,4-triazol-1-yl)butan-2-ol  
EC n° : N/A  
CAS n° : 94361-06-5 
 
Cyproconazole has two diastereomers. Diastereomer A: enantiomeric pair, where 
the 3-hydroxy group and the 2-hydrogen 
are located on the same side (2S, 3S and 2R, 3R). 
 
Diastereomer B: enantiomeric pair, where 
the 3-hydroxy group and 2-hydrogens are 
located on opposite sides (2R, 3S and 2S, 
3R). 
 940 g/kg 
 
Cyproconaz
ole has two diastereome
rs. 
(Diastereois
omer A: 
430 – 500 g/kg,  
Diastereois
omer B: 470 – 550 
g/kg). 
 1 
November 
2015 31 October 
2018
 18 Cyproconazole is considered a candidate 
for substitution in accordance with Article 10(1)(a) and (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. 
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. 
                                                 
5 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. 
6 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
5  Date of 
approval Expiry date 
of approval Product 
type Specific conditions6 
Technical cyproconazole is ca. 1:1 mixture 
of the two diasteriomers, each of which is exactly a 1:1 mixture of the enantiomers.  
 (2) Products shall not be authorised 
for industrial use by double vaccum impregnation, unless data 
is submitted to demonstrate that 
the product will not present unacceptable risks, if necessary by 
the application of appropriate 
mitigation measures. 
(3) Appropriate risk mitigation 
measures shall be taken to protect the soil and aquatic compartments. 
In particular: 
a. Labels and, where 
provided, 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  
EN 6   EN Common 
Name IUPAC Name 
Identification Numbers Minimum 
degree of 
purity of 
the active substance
5  Date of 
approval Expiry date 
of approval Product 
type Specific conditions6 
shall be collected for 
reuse or disposal. 
b. Products shall not be 
authorised for industrial 
treatment of wood that will be exposed to 
weathering, or for 
treatment of wood that 
will be used for outdoor 
construction, unless data is submitted to 
demonstrate that the 
product will not present unacceptable risks, if 
necessary, by the 
application of appropriate mitigation measures.