EN    EN EN EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels,  
  
  
Draft 
COMMISSION DIRECTIVE ../…/EC 
of […] 
amending Directive 98/8/EC of the European Parliament and of the Council to include 
disodium octaborate tetrahydrate as an active substance in Annex I thereto 
EN EN 2   EN Draft 
COMMISSION DIRECTIVE ../…/EC 
of  
amending Directive 98/8/EC of the European Parliament and of the Council to include 
disodium octaborate tetrahydrate as an  active substance in Annex I thereto 
(Text with EEA relevance) 
THE COMMISSION OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty esta blishing the European Community, 
Having regard to Directive 98/8/EC of the European Parliament and of the Council of 
16 February 1998 concerning the placing of  biocidal products on the market1, and in 
particular the second subparagraph of Article 16(2) 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 Counc il concerning the pl acing of biocidal 
products on the market
2 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 disodium octaborate tetrahydrate. 
(2) Pursuant to Regulation (EC)  No 1451/2007, disodium octabor ate tetrahydrate has been 
evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-
type 8, wood preservatives, as define d in Annex V to Directive 98/8/EC. 
(3) The Netherlands was designated as Rapporteur Member State and submitted the 
competent authority report, together w ith a recommendation, to the Commission on 7 
July 2006 in accordance with Article 14(4)  and (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, within the Standing Committee on Biocidal 
Products on 19 September 2008, in an assessment report. 
(5) It appears from the examinations made  that biocidal products used as wood 
preservatives and containing disodium octa borate tetrahydrate may be expected to 
                                                 
1 OJ L 123, 24.4.1998, p. 1. Directive as last amended by Directive 2008/31/EC of the European 
Parliament and of the Council (OJ L 81, 20.03.2008, p. 57). 
2 OJ L 325, 11.12.2007, p. 3. EN 3   EN satisfy the requirements laid down in Articl e 5 of Directive 98/8/ EC. It is therefore 
appropriate to include disodium octaborate te trahydrate in Annex I, in order to ensure 
that in all Member States authorisati ons for biocidal products used as wood 
preservatives and containing disodium octaborate tetrahydrate can be granted, 
modified, or cancelled in accordance with Article 16(3) of Directive 98/8/EC.  
(6) In the light of the findings of the assessmen t report, it is appropriate to require that 
specific risk mitigation measures are applie d at product authorisation level to products 
containing disodium octaborate tetrahydrate.  In particular, appropriate measures 
should be taken to protect th e soil and aquatic compartmen ts since unacceptable risks 
to these compartments have  been identified during th e evaluation. Products should 
also be used with appropriate protective equipment if the risk identified for professional and industrial users can not be reduced by other means.  
(7) It is important that the provisions of this Directive be applied simultaneously in all the 
Member States in order to ensure equal tr eatment of biocidal products on the market 
containing the active substance disodium octa borate tetrahydrate and also to facilitate 
the proper operation of the biocid al products market in general. 
(8) A reasonable period should be allowed to elap se before an active substance is included 
in Annex I in order to permit Member Stat es and the interested parties to prepare 
themselves to meet the new requirements enta iled and to ensure that applicants who 
have prepared dossiers can benefit fully fr om the 10-year period of data protection, 
which, in accordance with Artic le 12(1)(c)(ii) of Directive 98/8/EC, starts from the 
date of inclusion. 
(9) After inclusion, Member States should be allowed a reasonable period to implement 
Article 16(3) of Directive 98/8/EC, and in  particular, to grant, modify or cancel 
authorisations of biocidal products in product-type 8 c ontaining disodium octaborate 
tetrahydrate to ensure that they comply with Directive 98/8/EC. 
(10) Directive 98/8/EC should therefore be amended accordingly. 
(11) The measures provided for in this Directiv e are in accordance with the opinion of the 
Standing Committee on Biocidal Products, 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
Annex I to Directive 98/8/EC is amended in a ccordance with the Annex to this Directive. 
Article 2  
1. Member States shall adopt and publish, by  31 January 2010 at th e latest, the laws, 
regulations and administrative provisions necessary to comply with this Directive. 
They shall forthwith communicate to the Commission the text of those provisions and a correlation table between thos e provisions and this Directive. 
They shall apply those provi sions from 1 February 2011. EN 4   EN When Member States adopt those provisions,  they shall contain a reference to this 
Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determin e how such reference is to be made. 
2. Member States shall communicate to the Commission the text of the main provisions 
of national law which they adopt in the field covered by this Directive. 
Article 3 
This Directive shall enter into force on the tw entieth day following that of its publication in 
the Official Journal of  the European Union . 
Article 4 
This Directive is addressed to the Member States. 
Done at Brussels, […] 
 For the Commission 
 Stavros Dimas  Member of the Commission  
EN 5   EN ANNEX  
The following entry ‘No. 25’ is insert ed in Annex I to Directive 98/8/EC:  
  
No Common 
Name 
 IUPAC Name 
Identification 
Numbers Minimum purity 
of the active 
substance in the 
biocidal product as placed on the 
market Date of 
inclusion Deadline for compliance with Article 16(3) 
(except for products containing more than 
one active substance, for which the deadline 
to comply with Article 16(3) shall be the one 
set out in the last of the inclusion decisions 
relating to its active substances) Expiry 
date of 
inclusion Product 
type Specific provisions(*) 
"25 disodium 
octaborate tetrahydrate  disodium 
octaborate tetrahydrate 
EC No: 234-
541-0 
CAS No: 
12280-03-4 
  975 g/kg 1 February 
2011 31 January 2013 31 
January 
2021 8 Member States shall ensure that 
authorisations are subject to the following conditions: 
(1) Products authorised for industrial and 
professional use must be used with appropriate personal protective equipment, 
unless it can be demonstrated in the 
application for product authorisation that risks to industrial and/or professional users 
can be reduced to an acceptable level by 
other means. 
(2) In view of the risks identified for the soil 
and aquatic compartments, appropriate risk mitigation measures must be taken to 
protect those compartments. In particular, 
labels and/or safety-data sheets of products authorised for industrial use shall indicate 
that freshly treated timber must be stored 
after treatment under shelter and on impermeable hard standing to prevent 
direct losses to soil or water and that any 
losses must be collected for reuse or  
EN 6   EN No Common 
Name 
 IUPAC Name 
Identification 
Numbers Minimum purity 
of the active 
substance in the 
biocidal product as placed on the 
market Date of 
inclusion Deadline for compliance with Article 16(3) 
(except for products containing more than 
one active substance, for which the deadline 
to comply with Article 16(3) shall be the one 
set out in the last of the inclusion decisions 
relating to its active substances) Expiry 
date of 
inclusion Product 
type Specific provisions(*) 
disposal." 
(*) For the implementation of the common principles of Annex VI , the content and conclusions of assessment reports are availabl e on the Commission website: http://ec.europa.eu/comm/envi ronment/biocides/index.htm