EN    EN  
 EUROPEAN 
COMMISSION  
Brussels, XXX   
CA-May13-Doc.3.2 
[…](2013) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX  
to approve propiconazole as an existin g active substance for use in biocidal products for 
product-type 9 
(Text with EEA relevance) 
 
Ref. Ares(2013)512110 - 27/03/2013EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX 
to approve propiconazole as an existing active  substance for use in biocidal products for 
product-type 9 
(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 Article 89(1) thereof, 
Whereas: (1) Pursuant to Article 89(1) of Regula tion (EU) No 528/2012, the Commission shall 
carry on with the work programme for the systematic examination of all existing active substances commenced in accordance with Article 16(2) of Directive 98/8/EC of the European Parliament and of the C ouncil concerning the placing of biocidal 
products on the market
2. 
(2) Commission Regulation (EC)  No 1451/2007 of 4 December 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 Counc il concerning the pl acing of biocidal 
products on the market3 establishes a list of active substances to be assessed, with a 
view to their possible inclusion in Annex I, IA or IB to Directiv e 98/8/EC. That list 
includes propiconazole. 
(3) Pursuant to Regulation (EC) No 1451/2007, propiconazole has be en evaluated in 
accordance with Article 11(2) of  Directive 98/8/EC for use in product-type 9, fibre, 
leather, rubber and polymerised  materials preservatives, as defined in Annex V to that 
Directive, which corresponds to  product-type 9 as define d in Annex V to Regulation 
(EU) No 528/2012. 
(4) Finland was designated as Rapporteur Member State and submitted the competent 
authority report, togeth er with a recommendation, to the Commission on 
11 February 2011 in accordance with Ar ticle 14(4) and (6) of Commission 
Regulation (EC) No 1451/2007. 
(5) 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 17 May 2013, in an assessment report. 
                                                 
1 OJ L 167, 27.6.2012, p. 1. 
2 OJ L 123, 24.4.1998, p. 1. 
3 OJ L 325, 11.12.2007, p. 3. EN 3   EN (6) It appears from the assessment report that biocidal produc ts used for product-type 9 
and containing propiconazole may be expect ed to satisfy the requirements laid down 
in Article 5 of Directive 98/8/EC. It also appears from the report that such biocidal 
products may be expected to satisfy the requirements laid down in Article 19 of Regulation (EU) 528/2012, provided that the cond itions specified in the Annex to this 
Regulation are satisfied. 
(7) It is therefore appropriate to approve propi conazole for use in biocidal products for 
product-type 9. 
(8) Since the evaluation did not adress nanomater ials, the approval should not cover such 
materials pursuant to Article 4( 4) of Regulation (EU) No 528/2012. 
(9) 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.  
(10) 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 
Propiconazole shall be approved as an active substance for use in biocidal products for 
product-type 9, subject to the sp ecifications and conditions in the Annex to this Regulation. 
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 . 
It shall apply from 1 September 2013. 
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 
(*) Date of 
approval Expiry date 
of approval Product 
type Specific conditions (**) 
Propicon
azole 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-
dioxolan-2-yl]methyl]-1H-1,2,4-triazole 
EC No: 262-104-4 
CAS No: 60207-90-1 930 g/kg 1 October 
2015  30 
September 
2025  9 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 
adressed in the Union level risk assessment 
of the active substance. 
Authorisations are subject to the following 
condition: 
For industrial or professional users, safe 
operational procedures shall be established, 
and products shall be used with appropriate 
personal protective equipment, unless it can be demonstrated in  the application for 
product authorisation that risks can be 
reduced to an acceptable level by other means. 
(*) The purity indicated in this column wa s the minimum degree of purity of the active substance used for the evaluation made i n accordance with Article 8 of Regulation (EU) No 
528/2012. The active substance in the product placed on the market can be of equal or di fferent purity if it has been proven te chnically equivalent with the evaluated active substance. 
(**) For the implementation of the common principles of Annex VI of Regulation (EU) No 528/2012, the content and conclusions of  assessment reports are available on the 
Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm