EN    EN  
 EUROPEAN COMMISSION 
Brussels, XXX 
[…] 
[…](2011) XXX draft 
  
COMMISSION DIRECTIVE ../…/EU 
of XXX 
amending Directive 98/8/EC of the European Parliament and of the Council to include 
DDACarbonate as an active substance in Annex I thereto 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION DIRECTIVE ../…/EU 
of XXX 
amending Directive 98/8/EC of the European Parliament and of the Council to include 
DDACarbonate 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 Article 11(4) thereof, 
Whereas: (1) The United Kingdom has received on 17 Janua ry 2007 an application from Lonza, in 
accordance with Article 11(1) of Directive 98/8/EC, for the inclusion of the active 
substance DDACarbonate in Annex I to that Directive for use in product-type 8, wood 
preservatives, as defined in Annex V to  Directive 98/8/EC. DDACarbonate was not on 
the market on the date referred to in Article 34(1) of Directive 98/8/EC as an active substance of a biocidal product. 
(2) After carrying out an evaluation, the United Kingdom submitted its report, together 
with a recommendation, to the Commission on 11 November 2010. 
(3) The report was reviewed by the Member States and the Commission within the 
Standing Committee on Biocidal Products on  [insert date of Standing Committee 
meeting], and the findings of the review we re incorporated in an assessment report. 
(4) It appears from the evaluations  that biocidal products us ed as wood preservatives and 
containing DDACarbonate may be  expected to satisfy the requirements laid down in 
Article 5 of Directive 98/8/EC. It is th erefore appropriate to  include DDACarbonate 
for use in product type 8 in Annex I to that Directive. 
(5) Not all potential uses have been evaluated at Union level. For example, use by non-
professional users was not assessed. It is th erefore appropriate to require that Member 
States assess those uses or  exposure scenarios and thos e risks to human populations 
and to environmental compartments that have not been representatively addressed in the Union level risk assessment and, when gr anting product authorisations, ensure that 
                                                
 
1 OJ L 123, 24.4.1998, p. 1.   
EN 3   EN appropriate measures are taken or specific conditions imposed in order to reduce the 
identified risks to acceptable levels. 
(6) In view of the risks identified for human hea lth, it is appropriate to require that safe 
operational procedures are established, and th at products are used  with appropriate 
personal protective equipment, unless it can be demonstrated in the application for 
product authorisation that risk s to industrial users can be  reduced to an acceptable 
level by other means.  
(7) In view of the risks identified for the aquatic and terrestial compartments, it is 
appropriate to require that industrial applic ation is conducted within a contained area 
or on impermeable hard standing with bundi ng, that freshly treated timber is stored 
after treatment under sh elter or on impermeable hard standing, or both, and that any 
losses from the application of products us ed as wood preservatives and containing 
DDACarbonate are collected for reuse or disposal. 
(8) Unacceptable risks for the environment were identified for situations where wood 
treated by dipping with DDACarbonate was c ontinually exposed to the weather or 
subject to frequent wetting (u se class 3 as defined by OEDC2), and where wood 
treated with DDACarbonate was used for out door constructions near or above water 
(the 'bridge' scenario in use class 3, as defined by OECD3) or was 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. 
(9) The provisions of this Directive should be  applied simultaneously in all Member 
States in order to ensure equal treatment on the Union market of biocidal products of 
product-type 8 containing the active substa nce DDACarbonate and also to facilitate 
the proper operation of the biocid al products market in general. 
(10) 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 to bring into force 
the laws, regulations and administrative prov isions necessary to comply with this 
Directive. 
(11) Directive 98/8/EC should therefore be amended accordingly. 
(12) The measures provided for in this Directiv e are in accordance with the opinion of the 
Standing Committee on Biocidal Products, 
                                                
 
2 OECD series on emission scenario documents, Nu mber 2, Emission Scenario Document for Wood 
Preservatives, part 2, p. 64. 
3 Ibid. 
4 Ibid.  
EN 4   EN 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 2013 at the latest, the laws, 
regulations and administrative provisions nece ssary to comply with this Directive.  
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] DDACar
bonate Reaction mass of N,N-Didecyl-N,N-
dimethylammonium Carbonate and N,N-
Didecyl-N,N-dimethylammonium Bicarbonate 
EC No: 451-900-9 
CAS No: 894406-76-9 450 g/kg 
1 February 
2013 Not applicable 31 January 
2023 8 The Union level risk assessment did not 
address all potential uses, but excluded, for 
example, use by non-professionals. When 
assessing the application for authorisation 
of a product in accord ance 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) safe operational procedures shall 
be established, and products shall be used with appropriate personal  
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 (*) 
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 industrial 
application shall be conducted 
within a contained area or on impermeable hard standing with 
bunding, that freshly treated 
timber shall be stored after treatment under shelter or on 
impermeable hard standing, 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; 
(3) products shall not be authorised 
for treatment of wood that will be  
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 (*) 
in contact with fresh water or used 
for outdoor constructions near or 
above water, or for treatment by dipping of wood that will be 
continually exposed to the weather 
or subject to frequent wetting, 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."
 
(*) 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