EN    EN  COMMISSION OF THE EUROPEAN COMMUNITIES  
Brussels,  
COM(2007) XXX  
  
Draft  
COMMISSION DIRECTIVE .../…/EC  
of […]  
amending Directive 98/8/EC of the European Parliament and of the Council to include 
carbon dioxide as an ac tive 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 
carbon dioxide as an active substance in Annex I thereto  
(Text with EEA relevance)  
THE COMM ISSION OF THE EUROPEAN COMMUNITIES,  
Having regard to the Treaty establishing 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 mar ket1, and in 
particular the second subparagraph of Article 16(2) thereof,  
Whereas:  
(1) Commission Regulation (EC) No 2032/2003 of 4 November 2003 on the second phase 
of the 10 -year work programme referred to in Article 16(2) of Directive 98/8/EC of 
the Europea n Parliament and of the Council concerning the placing of biocidal 
products on the market and amending Regulation (EC) No 1896/20002 establishes a 
list of active substances to be assessed, with a view to their possible inclusion in 
Annex I, IA or IB to Dir ective 98/8/EC. That list includes carbon dioxide.  
(2) Pursuant to Regulation (EC) No 2032/2003, carbon dioxide has been evaluated in 
accordance with Article 11(2) of Directive 98/8/EC for use in product -type 14, 
rodenticides, as defined in Annex V to Directiv e 98/8/EC.  
(3) France was designated as Rapporteur Member State and submitted the competent 
authority report, together with a recommendation, to the Commission on 15 May 2006 
in accordance with Article 10(5) and (7) of Regulation (EC) No 2032/2003.  
(4) The compete nt authority report was reviewed by the Member States and the 
Commission. In accordance with Article 11(4) of Regulation (EC) No 2032/2003, the 
findings of the review were incorporated, within the Standing Committee on Biocidal 
Products on 21 June 2007, in  an assessment report, with a proposal to include carbon 
dioxide in Annex IA to Directive 98/8/EC, only for use in ready -for-use gas canisters 
functioning  together with a trapping device.  
                                                
1 OJ L 123, 24.4.1998, p. 1. Directive as last amended by Directive 2007 /20/EC (OJ L 94, 04.04.2007, p. 
23). 
2 OJ L 307, 24.11.2003, p. 1. Regulation as last amended by Regulation (EC) No 1849/2006 (OJ L 355, 
15.12.2006, p. 63.   
EN 3   EN (5) An active substance listed in Annex IA should normally also be liste d in Annex I. 
Inclusion in Annex I would cover those uses for which products may be expected to 
satisfy the requirements of Article 5 of Directive 98/8/EC, but not those of low-risk 
products. Such is the case of certain biocidal products used as rodenticid es and 
containing carbon dioxide . It is therefore appropriate to include carbon dioxide in 
Annex I  for product -type 14 , in order to ensure that in all Member States 
authorisations for biocidal products used as rodenticides  and containing carbon 
dioxide can  be granted, modified, or cancelled in accordance with Article 16(3) of 
Directive 98/8/EC.  
(6) The assessment report was modified accordingly, and was reviewed by the Standing 
Committee on Biocidal Products on 29 November  2007.  
(7) The review of carbon dioxide di d not reveal any open questions or concerns to be 
addressed by the Scientific Committee on Health and Environmental Risks.  
(8) The evaluation at the  Community level was carried out  for one specific use. In 
addition, in accordance with Article 8(5) of the Direc tive, some information was not 
submitted, and thus not assessed. It is therefore appropriate that Member States assess 
those risks to the compartments and populations that have not been representatively 
addressed in the Community level risk assessment and,  when granting product 
authorisations, ensure that appropriate measures are taken or specific conditions 
imposed in order to mitigate the identified risks to acceptable levels.  
(9) It is important that the provisions of this Directive be applied simultaneously  in all the 
Member States in order to ensure equal treatment of biocidal products on the market 
containing the active substance carbon dioxide and also to facilitate the proper 
operation of the biocidal products market in general.  
(10) A reasonable period shoul d be allowed to elapse before an active substance is included 
in Annex I in order to permit Member States and the interested parties to prepare 
themselves to meet the new requirements entailed and to ensure that applicants who 
have prepared dossiers can be nefit 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, and in particular, to grant, modify or cancel 
authorisations of biocidal products in product -type 14 containing carbon dioxide to 
ensure that they comply with Directive 98/8/EC.  
(12) Directive 98/8/EC should therefore be amended accordingl y. 
(13) The measures provided for in this Directive 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 accordance with the Annex to this Directive.   
EN 4   EN Article 2  
Transposition  
1. Member States shall adopt and publish, by 31 March 2009  at the latest, the laws, 
regulations and administrative provisions necessary to comply with this Directive. 
They shall forthwith communicate to the Commission the text of th ose provisions 
and a correlation table between those provisions and this Directive.  
They shall apply those provisions from 1 November 2009 . 
When Member States adopt those provisions, they shall contain a reference to this 
Directive or be accompanied by suc h a reference on the occasion of their official 
publication. Member States shall determine 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 twentieth 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. 7’ is inserted in Annex I to Directive 98/8/EC:  
  
No Common 
Name  
 IUPAC Name  
Identification 
Numbers  Minimum purity 
of the active 
substance in the 
biocidal prod uct 
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 inclusi on decisions 
relating to its active substances)  Expiry 
date of 
inclusion  Product 
type Specific provisions  (*) 
"7 carbon 
dioxide  carbon dioxide  
EC No: 204 -
696-9 
CAS No: 124 -
38-9 990 ml/l  1 
November 
2009  31 October 2011  31 
October 
2019  14 When assessing th e application for 
authorisation of a product in accordance with 
Article 5 and Annex VI, Member States shall 
assess, when relevant for the particular 
product, the populations that may be exposed 
to the product and the use or exposure 
scenarios that have not  been representatively 
addressed at the Community level risk 
assessment.  
When granting product authorisation, Member 
States shall assess the risks and subsequently 
ensure that appropriate measures are taken or 
specific conditions imposed in order to 
mitig ate the identified risks.  
Product authorisation can only be granted 
where the application demonstrates that risks 
can be reduced to acceptable levels. " 
(*) For the implementation of the common principles of Annex VI, the content and conclusions of assess ment reports are available on the Commission website: 
http://ec.europa.eu/comm/environment/biocides/index.htm