EN EN
EUROPEAN
COMMISSION
Brussels, XXX
CA-July13-Doc.3.2
[…](2013) XXX draft
COMMISSION IMPLEMENTING REGULATION (EU) No …/..
of XXX
to approve tebuconazole as an existing active substance for use in biocidal products for 
product -types 7 and 10
(Tex t with EEA relevance)EN 2 ENCOMMISSION IMPLEMENTING REGULATION (EU) No …/..
of XXX
to approve tebuconazole as an existing active substance for use in biocidal products for 
product -types 7 and 10
(Text with EEA relevance)
THE EUROPEAN COMMI SSION,
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 
Counc il of 22 May 2012 concerning the making available on the market and use of biocidal 
products1, and in particular the third subparagra ph of Article 89(1) thereof ,
Whereas:
(1) 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 Council concerning th e placing of biocidal 
products on the market2establishes a list of active substances to be assessed, with a 
view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC. That list 
includes tebuconazole .
(2) Pursuant to Regulation (EC) No 1451/20 07, tebuconazole has been evaluated in 
accordance with Article 11(2) of Directive 98/8/EC for use in product -type 7, film 
preservatives ,and product -type 10, masonry preservatives , as defin ed in Annex V to 
that Directive, which correspond respectivel y to product -types7 and 10 as defined in 
Annex V to Regulation (EU) No 528/2012.
(3) Denmark was designated as Rapporteur Member State and submitted the competent 
authority report s, together with recomm endation s, to the Commission on 16 April 
2012 in accordance wit h Article 14(4) and (6) of Regulation (EC) No 1451/2007.
(4) The competent authority report swerereviewed by the Member States and the 
Commission. I n 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 27 September 2013 , intwoassessment report s.
(5) It appears from the evaluations that biocidal products used for product -types 7 and10 
and tebuconazole maybe expected to satisfy the requirements laid dow n in Article 5 
of Directive 98/8/EC . It also appears from the report sthat such biocidal products may 
be expected to satisfy the requirements laid down in Article 19 of Regulation (EU) No 
528/2012, provided that the conditions specified in the Annex to thi s Regulation are 
satisfied.
(6) In addition, in view of its characteristics which render it very persistent ( vP)and toxic 
(T), in accordance with the criteria laid down in Annex XIII to Regulation (EC) No 
  
1OJ L 167, 27. 6.2012, p. 1.
2OJ L 325, 11.12.2007, p. 3.EN 3 EN1907/2006 of the European Parliament and of the Counci l of 18 December 2006 
concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals 
(REACH), establishing a European Chemicals Agency, amending 
Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and 
Commission Regul ation (EC) No 1488/94 as well as Council Directive 76/769/EEC 
and Commission Directives 91/155/EEC, 93/6 7/EEC, 93/105/EC and 2000/21/EC3, 
tebuconazole should be considered a candidate for substitution in accordance with 
Article 10(1) of Regulation (EU) No 528/2012. 
(7) It is therefore appropriate to approve tebuconazole for use in biocidal products for 
product -type 7 and 10. These approvals should be limited to seven years only in 
accordance with Article 10(4) of Regulation (EU) No 528/2012.
(8) Since the evaluati onsdid not a ddress nanomaterials, the approval sshould 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 Stat es, interested parties , and the Commission 
where appropriate, to prepare themselves to meet the new requirements entailed .
(10) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Biocidal Products ,
HAS ADOPTED THIS REGULATION:
Article 1
Tebuconazole shall be approved as an active substance for use in biocidal produ cts for 
product -types7 and 10, subject to the specifications and conditions set out in the Annex to 
this Regulation.
Article 2
This Regulatio n 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 Commis sion
The President
José Manuel BARROSO
  
3OJ L 396, 30.12.2006, p. 1.EN 4 ENANNEX 
Common 
Nam eIUPAC Name
Identification NumbersMinimum 
degree of 
purity of 
the active 
substance4Date of 
approvalExpiry date 
of approvalProduct 
typeSpecific condit ions5
Tebuconazole IUPAC Name : 
1-(4-chlorophenyl) -4,4-dimethyl-3-
(1,2,4 -triazol -1-ylmethyl)pentan -3-ol
EC No: 403-640-2
CAS No: 107534 -96-3950 g/kg 1 July 
2015 30 June 
20227Tebuconazole is considered a candidate for 
substitution in accordance with Article 
10(1) 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 .
Authoris ations are subject to the following 
condition :
For industrial users, safe operational 
procedures and appropriate organizational 
measures shall be established. Only where 
exposure cannot be reduced to an 
acceptable level by other means, products 
shall be us ed with appropriate personal 
protective equipment.
10Tebuconazole is considered a candidate for 
substitution in accordance with Article 
  
4The purity indicated in this column was the minimum degree of purity of the active sub stance used for the evaluation made in 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 different purity if it has been proven technica lly equivalent with the evaluated 
active substance.
5For 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.htmEN 5 ENCommon 
Nam eIUPAC Name
Identification NumbersMinimum 
degree of 
purity of 
the active 
substance4Date of 
approvalExpiry date 
of approvalProduct 
typeSpecific condit ions5
10(1) 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 
condition s:
1)For industrial or professional 
users, safe operational procedures 
and appropriate organizational 
measures shall be established. 
Only where exposure cannot be 
reduced to an acceptable level by 
other means, products shall be 
used with appropriate personal 
protective equipment. .
2)In the view o f the risk for the soil 
compartment, tebuconazole shall 
not be used to treat a sealant that 
will be used to seal vertical joints 
fillers outside residential facades
(e.g. betw een two houses) , unless 
it can be demonstrated in the 
application for product 
authorisation that risks can be 
reduced to an acceptable level by 
other means. EN 6 EN