EN    EN EN EN    EN  EUROPEAN COMMISSION 
Brussels, xxx 
C(2011) yyy final D012213/01 
CA-Dec10-Doc.3.4 
  
Draft 
COMMISSION DIRECTIVE ../…/EU 
of […] 
amending Directive 98/8/EC of the European Parliament and of the Council to include 
4,5-Dichloro-2-octyl-2H-isothiazol-3-one as an active substance in Annex I thereto EN 2   EN Draft 
COMMISSION DIRECTIVE ../…/EU 
of  
amending Directive 98/8/EC of the European Parliament and of the Council to include 
4,5-Dichloro-2-octyl-2H-isothiazol-3-one as an active substance in Annex I thereto 
(Text with EEA relevance) 
THE EUROPEAN COMMISSION, 
Having regard to the Treaty on the Functioning of the European Union, 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 market
1, 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 4,5-Dichloro-2-octy l-2H-isothiazol-3-one. 
(2) Pursuant to Regulation (E C) No 1451/2007, 4,5-Dichloro-2 -octyl-2H-isothiazol-3-one 
has been evaluated in accordance with Artic le 11(2) of Directive 98/8/EC for use in 
product-type 8, wood preservatives, as de fined in Annex V to that Directive. 
(3) Norway was designated as Rapporteur and submitted the competent authority report, 
together with a recommendation, to the Commission on 8 September 2008 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 16 December 2010, in an assessment report. 
(5) It appears from the evaluations  that biocidal products us ed as wood preservatives and 
containing 4,5-Dichloro-2-octyl-2H-isothiazol- 3-one may be expected to satisfy the 
                                                
 
1 OJ L 123, 24.4.1998, p. 1.  
2 OJ L 325, 11.12.2007, p. 3. EN 3   EN requirements laid down in Articl e 5 of Directive 98/8/EC. It is therefore appropriate to 
include 4,5-Dichloro-2-octyl- 2H-isothiazol-3-one in Annex I to that Directive. 
(6) Not all potential uses have been evaluated at  Union level. It is therefore appropriate 
that Member States assess those uses or exposure scenarios and those risks to the 
environmental compartments and populations that have not been  representatively 
addressed in the Union level risk a ssessment and, when granting product 
authorisations, ensure that appropriate measures are ta ken or specific conditions 
imposed in order to reduce the iden tified risks to acceptable levels. 
(7) In view of the risks identified for human hea lth, it is appropriate to require that safe 
operational procedures are es tablished for products auth orised for industrial or 
professional use, and that thos e products are used with a ppropriate persona l protective 
equipment unless it can be demonstrated in  the application for product authorisation 
that risks to industrial or professional user s can be reduced to an acceptable level by 
others means. 
(8) In view of the risks identified for the a quatic and terrestrial compartments, it is 
appropriate to require that fr eshly treated timber is stored  after treatment under shelter 
or on impermeable hard standing, or both, and that any losses from the application of 
products used as wood preservatives a nd containing 4,5-Di chloro-2-octyl-2H-
isothiazol-3-one are collected  for reuse or disposal.  
(9) Unacceptable risks for the environment were identified in various scenarios for in-
service use of treated wood not covered and not in contact with the ground, which is 
either continually exposed to the weather or  protected from the weather but subject to 
frequent wetting (use class 3 as defined by OECD3) and wood in contact with fresh 
water (use class 4b as defined by OEDC4). It is therefore appropriate to require that 
products are not authorised for the treatment  of wood intended fo r those uses, unless 
data is submitted demonstrating that the product will meet the requirements of both 
Article 5 of and Annex VI to Directive 98/ 8/EC, if necessary by the application of 
appropriate risk mitigation measures. 
(10) It is important that the provisions of this  Directive be applied simultaneously in all 
Member States in order to ensure equal tr eatment of biocidal products on the market 
containing the active substance 4,5-Dichloro-2 -octyl-2H-isothiazol- 3-one and also to 
facilitate the proper operation of the bi ocidal products market in general. 
(11) A reasonable period should be allowed to elap se before an active substance is included 
in Annex I to Directive 98/8/EC in order to permit Member States and interested 
parties to prepare themselves to meet the ne w requirements entailed and to ensure that 
applicants who have prepared  dossiers can benefit fully from the 10-year period of 
data protection, which, in accordance with Article 12(1)(c)(ii) of Directive 98/8/EC, 
starts from the date of inclusion. 
(12) After inclusion, Member States should be allowed a reasonable period to implement 
Article 16(3) of Directive 98/8/EC. 
                                                 
3 OECD series on emission scenario documents, Nu mber 2, Emission Scenario Document for Wood 
Preservatives, part 2, p. 64. 
4 Ibid. EN 4   EN (13) Directive 98/8/EC should therefore be amended accordingly. 
(14) 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 
 
Transposition 
1. Member States shall adopt and publish, by 30 April 2012 at th e latest, the laws, 
regulations and administrative provisions nece ssary to comply with this Directive.  
They shall apply those provisions from 1 May 2013. 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 
 The President  José Manuel BARROSO  
EN 5   EN ANNEX  
In Annex I to Directive 98/8/EC , the following entry is added:  
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 (*) 
"(**) 
[OPOC
E: please 
insert 
substance 
number] 4,5-
Dichloro
-2-octyl-2H-
isothiazo
l-3-one 4,5-Dichloro-2-octyl-3(2H)isothiazolone 
EC No: 264-843-8 
CAS No: 64359-81-5 950 g/kg 
1 May 2013 30 April 2015 30 April 2023 8 When assessing the application for 
authorisation of a product in accordance 
with Article 5 and Annex VI, Member States shall assess, when relevant for the 
particular product, those uses or exposure 
scenarios and those risks to environmental compartments and populations that have 
not been representatively addressed in the 
Union level risk assessment.  
Products shall not be authorised for 
treatment of wood that will be continually exposed to the weather, protected from the 
weather but subject to frequent wetting or 
in contact with fresh water, unless data have been submitted demonstrating that the 
product will meet the requirements of 
Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation 
measures.  
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 (*) 
Member States shall ensure that 
authorisations are subject to the following 
conditions: 
(1) For products authorised for 
industrial or professional use, 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 to industrial or professional users 
can be reduced to an acceptable 
level by other means. 
(2) Labels and, where provided, 
safety data sheets of products 
authorised shall indicate that 
freshly treated timber shall be 
stored after treatment under 
shelter or on impermeable hard standing under roof, or both, to 
prevent direct losses to soil or  
EN 7   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 (*) 
water, and that any losses from 
the application of the product 
shall be collected for reuse or 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/environment/biocides/index.htm