EN    EN EN  
EN    EN  EUROPEAN COMMISSION 
Brussels, xxx 
C(2011) yyy final  
CA-Feb11-Doc.3.2  
  
Draft 
COMMISSION DIRECTIVE ../…/EU 
of […] 
amending Directive 98/8/EC of the European Parliament and of the Council to include 
copper (II) oxide, copper (II) hydroxide and ba sic copper carbonate as active substances 
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 
copper (II) oxide, copper (II) hydroxide and ba sic copper carbonate as active substances 
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 copper (II) oxide, copper (II) hydroxi de and basic copper carbonate for use in 
product-type 8, wood preservati ves, as defined in Annex V to that Directive.  
(2) Pursuant to Regulation (E C) No 1451/2007, copper (II) oxide, copper (II) hydroxide 
and basic copper carbonate have been eval uated in accordance with Article 11(2) of 
Directive 98/8/EC for use in product-type 8. 
(3) France was designated as Rapporteur Member State and submitted the competent 
authority reports, together with recommendations, to the Commission in accordance with Article 14(4) and (6) of Regul ation (EC) No 1451/2007 on 10 May 2007 for 
copper (II) oxide, on 19 February 2008 for copper (II) hydroxide, and on 10 May 2007 and 19 February 2008 for ba sic copper carbonate. 
(4) The competent authority reports were 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 reviews were incorporate d, within the Standing Committee on Biocidal 
Products on 6 May 2011, in an assessment report. 
                                                
 
1 OJ L 123, 24.4.1998, p. 1.  
2 OJ L 325, 11.12.2007, p. 3.  
EN 3   EN (5) It appears from the evaluations  that biocidal products us ed as wood preservatives and 
containing copper (II) oxide, copper (II) hydr oxide or basic copper carbonate may be 
expected to satisfy the requirements laid dow n in Article 5 of Dir ective 98/8/EC. It is 
therefore appropriate to include copper (II) oxide, copper (II) hydroxide and basic 
copper carbonate in Annex I to that Directive. 
(6) Not all potential uses have been  evaluated at Union level. It  is therefore appropriate to 
require that Member States assess those uses or exposure scenarios and those risks to 
human populations and to environmental compartments that have not been representatively addressed in the Union level risk a ssessment and, when granting 
product authorisations, ensure that appropr iate measures are taken or specific 
conditions imposed in order to reduce th e identified 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 established fo r products containing copper (II) oxide, 
copper (II) hydroxide or basic copper carbonat e and authorised for industrial use, and 
that those products are used with appropria te personal protective equipment, unless it 
can be demonstrated in the application for product authorisation that risks to industrial 
users can be reduced to an accep table level by other means.  
(8) Copper (II) hydroxide and basic copper carbonate were also evaluated for application 
by dipping, and should, in view of the risk s identified for human health, not be 
authorised for that use, unless data is s ubmitted to demonstrate that the product will 
meet the requirements of Article 5 and Anne x VI, if necessary by the application of 
appropriate mitigation measures. For coppe r (II) oxide, application by dipping was not 
assessed, and it follows from the requirement referred to in recital 6 that products cannot be authorised for such applica tion unless the authorising Member State 
assesses it. 
(9) Unacceptable risks for the environment were identified in the case of wood treated 
with copper (II) oxide, copper (II) hydroxide or basic copper carbonate and used for 
outdoor constructions near or above water (t he 'bridge' scenario in use class 3, as 
defined by OECD
3). For basic copper carbonate and copper (II) oxide, unacceptable 
risks were also found for in-service use of treated wood in contact with fresh water 
(use class 4b as defined by OEDC4). It is therefore appropria te to require that products 
are not authorised for the tr eatment of wood intended for 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. For copper (II) hyd roxide, wood in contact with fresh water 
was not assessed, and it follows from the require ment referred to in recital 6 above that 
products cannot be authorised for that use unless the author ising Member State 
assesses it. 
(10) In view of the risks identified for the aquatic and soil compartments, it is appropriate 
to require that freshly treated timber is stored after treatmen t under shelter or on 
impermeable hard standing, or both, and th at any losses from the application of 
                                                 
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 products used as wood preservatives and c ontaining copper (II) oxide, copper (II) 
hydroxide or basic copper carbonate ar e collected for reuse or disposal. 
(11) The provisions of this Direct ive should be applied at the same time in all Member 
States in order to ensure equal treatmen t on the Union market of biocidal products 
containing the active substances copper ( II) oxide, copper (II ) hydroxide and basic 
copper carbonate, and also to facilitate th e proper operation of the biocidal products 
market in general. 
(12) 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. 
(13) After inclusion, Member States should be allowed a reasonable period to implement 
Article 16(3) of Directive 98/8/EC. 
(14) Directive 98/8/EC should therefore be amended accordingly. 
(15) 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 30 September 2012 at the latest, the laws, 
regulations and administrative provisions nece ssary to comply with this Directive.  
They shall apply those pr ovisions from 1 October 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 .  
EN 5   EN Article 4 
This Directive is addressed to the Member States. 
Done at Brussels,  
 For the Commission 
 The President  José Manuel BARROSO  
EN 6   EN ANNEX  
In Annex I to Directive 98/8/EC , the following entries are 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] copper 
hydroxid
e Copper (II) hydroxide 
EC No: 243-815-9 
CAS No: 20427-59-2 965 g/kg 
1 October 
2013 30 September 2015 30 September 
2023 8 When assessing the application for 
authorisation of a product in accordance 
with Article 5 and Annex VI, Member States shall assess, where relevant for the 
particular product, those uses or exposure 
scenarios and those risks to human populations and to environmental 
compartments that have not been 
representatively addressed in the Union 
level risk assessment. 
Member States shall ensure that 
authorisations are subject to the following 
conditions: 
(1) Products shall not be authorised 
for application by dipping, unless 
data have been submitted in the 
application for product authorisation demonstrating that  
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 (*) 
that application meets the 
requirements of Article 5 and 
Annex VI, if necessary by the application of appropriate risk 
mitigation measures. 
(2) For products authorised for 
industrial 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 users can be reduced to an acceptable level by other 
means. 
(3) 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  
EN 8   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 (*) 
prevent direct losses to soil or 
water, and that any losses from the 
application of the product shall be collected for reuse or disposal. 
(4) Products shall not be authorised 
for treatment of wood that will be used in outdoor constructions near 
or above water, unless data is 
submitted to demonstrate that the product will meet the 
requirements of Article 5 and 
Annex VI, if necessary by the application of appropriate 
mitigation measures.
 
(**) 
[OPOCE: 
please 
insert substan
ce 
number] copper 
(II) oxide Copper (II) oxide 
EC No: 215-269-1 
CAS No: 1317-38-0 976 g/kg 
1 October 
2013 30 September 2015 30 September 
2023 8 When assessing the application for 
authorisation of a product in accordance with Article 5 and Annex VI, Member 
States shall assess, where relevant for the 
particular product, those uses or exposure scenarios and those risks to human 
populations and to environmental 
compartments that have not been representatively addressed in the Union  
EN 9   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 (*) 
level risk assessment. 
Member States shall ensure that 
authorisations are subject to the following conditions: 
(1) For products authorised for 
industrial 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 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  
EN 10   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 (*) 
prevent direct losses to soil or 
water, and that any losses from the 
application of the product shall be collected for reuse or disposal. 
(3) Products shall not be authorised 
for treatment of wood that will be used in outdoor constructions near 
or above water or for the treatment 
of wood in contact with fresh 
water, unless data is submitted to 
demonstrate that the product will meet the requirements of Article 5 
and Annex VI, if necessary by the 
application of appropriate mitigation measures. 
(**) [OPOC
E: 
please 
insert 
substance 
number] basic 
copper 
carbonat
e Copper (II) ca rbonate, basic 
EC No: 235-113-6 
CAS No: 12069-69-1 957 g/kg 
1 October 
2013 30 September 2015 30 September 
2023 8 When assessing the application for 
authorisation of a product in accordance 
with Article 5 and Annex VI, Member 
States shall assess, where relevant for the 
particular product, those uses or exposure 
scenarios and those risks to human populations and to environmental 
compartments that have not been  
EN 11   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 (*) 
representatively addressed in the Union 
level risk assessment. 
Member States shall ensure that 
authorisations are subject to the following 
conditions: 
(1) Products shall not be authorised 
for application by dipping, unless 
data have been submitted in the 
application for product 
authorisation demonstrating that 
that application meets the requirements of Article 5 and 
Annex VI, if necessary by the 
application of appropriate risk mitigation measures. 
(2) 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  
EN 12   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 (*) 
for product authorisation that risks 
to industrial users can be reduced 
to an acceptable level by other means. 
(3) 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 
water, and that any losses from the 
application of the product shall be collected for reuse or disposal. 
(4) Products shall not be authorised 
for treatment of wood that will be used in outdoor constructions near 
or above water, or for the 
treatment of wood in direct contact with fresh water, unless 
data is submitted to demonstrate 
that the product will meet the  
EN 13   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 (*) 
requirements of Article 5 and 
Annex VI, if necessary by the 
application of appropriate mitigation measures."
 
(*) 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