EN    EN  
 EUROPEAN COMMISSION 
Brussels, XXX   
CA-Sept12-Doc. 
[…](2011) XXX  draft 
  
COMMISSION DIRECTIVE ../…/EU 
of XXX  
amending Directive 98/8/EC of the European Parliament and of the Council to include 
Didecyldimethylammonium Chloride 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 
Didecyldimethylammonium Chloride 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 Didecyldimethyl ammonium Chloride. 
(2) Pursuant to Regulation (EC) No 1451/2007, Didecyldimethylammonium Chloride has 
been evaluated in accordance with Article  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) Italy was designated as Rapporteur Memb er State and submitted the competent 
authority report, togeth er with a recommendation, to the Commission on 
14 August 2007 in accordance with Article  10(5) and (7) 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 [date of Standing Committee meeting to be inserted], 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 Didecyldimethylammonium Chlori de may be expected to satisfy the 
requirements laid down in Article 5 of Direc tive 98/8/EC. It is therefore appropriate to 
include Didecyldimethylammonium Chloride fo r use in product type 8 in Annex I to 
that Directive. 
(6) Not all potential uses and exposure scenarios have been evaluated at Union level. For 
example, exposure of food or feeding stuff were not assessed. It is therefore appropriate to require that Me mber States assess those us es or exposure scenarios and 
those risks to human populations and to e nvironmental compartments that have not 
been representatively addre ssed in the Union le vel risk assessment 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, th at products are used with appropriate 
personal protective equipment, and that pr oducts are not applie d on wood that may 
enter in direct contact with children unless it can be demo nstrated in the application 
for product authorisation that risks can be reduced to an acceptable level. 
(8) In view of the risks identified for the envir onment, it is appropriate to restrict dipping 
and vacuum pressure treatment to those plants where significant losses can be 
contained and appropriately r ecycled or disposed, and to require that freshly treated 
timber is stored after treatment on impermeable  hard standing to pr event direct losses 
to soil or water and that any losses from the application of products used as wood preservatives and containing Didecyldimet hylammonium Chloride are collected for 
reuse or disposal. 
(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 subs tance Didecyldimethylammonium Chloride 
and also to facilitate the pr oper operation of the biocidal pr oducts 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 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. 
(11) After inclusion, Member States should be allowed a reasonable period to implement 
Article 16(3) of Directive 98/8/EC. 
(12) Directive 98/8/EC should therefore be amended accordingly. 
(13) In accordance with the Joint Political De claration of Member States and the 
Commission on explanatory documents of 28 September 2011
3, Member States have 
undertaken to accompany, in justified cases, the notification of their transposition 
measures with one or more documents explaining the relationship between the 
                                                 
3 OJ C 369, 17.12.2011, p. 14.  
EN 4   EN components of a directive and the corresponding parts of national transposition 
instruments. 
(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 
1. Member States shall adopt and publish, by 31 January 2014 at the latest, the laws, 
regulations and administrative provisions nece ssary to comply with this Directive.  
They shall apply those provi sions from 1 February 2015. 
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] Didecyld
imethyla
mmonium 
Chloride
;  
DDAC N,N-Didecyl-N,N-dimethylammonium 
Chloride 
EC No: 230-525-2 CAS No: 7173-51-5 Dry weight: 
870 g/kg 
1 February 
2015 31 January 2017 31 January 
2025 8 The Union level risk assessment did not 
address all potential uses and exposure 
scenarios; certain uses and exposure scenarios, such as exposure of food or feed, 
were excluded. 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) for industrial users safe  
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 (*) 
operational procedures shall be 
established, and products shall be 
used with appropriate personal protective equipment; 
(2) products shall not be used for 
treatment of wood that may enter in direct contact with children, 
unless it can be demonstrated in 
the application for product 
authorisation that risks can be 
reduced to an acceptable level; 
(3) dipping and vacuum pressure 
treatment shall be restricted to 
plants where significant losses can be contained and appropriately 
recycled or disposed; 
(4) labels and, where provided, safety 
data sheets of products authorised 
shall indicate that freshly treated 
timber shall be stored after treatment on impermeable hard 
standing to prevent direct losses to  
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 (*) 
soil or 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