EN    EN EN EN    EN  EUROPEAN COMMISSION 
Brussels, xxx 
C(2010) yyy final D 
CA-May10-Doc.3.1  
  
Draft 
COMMISSION DIRECTIVE ../…/EU 
of […] 
amending Directive 98/8/EC of the European Parliament and of the Council to extend 
the inclusion in Annex I thereto of the acti ve substance carbon dioxide to product 
type 18  EN 2   EN Draft 
COMMISSION DIRECTIVE ../…/EU 
of  
amending Directive 98/8/EC of the European Parliament and of the Council to extend 
the inclusion in Annex I thereto of the acti ve substance carbon dioxide to product 
type 18 
(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 carbon dioxide. 
(2) Commission Directive 2008/75/EC of 24 Ju ly 2008 amending Directive 98/8/EC of 
the European Parliament and of the Counc il to include carbon di oxide as an active 
substance in Annex I thereto3 included carbon dioxide as an active substance in 
Annex I to directive 98/8/EC for use in pr oduct type 14, rodenticides, as defined in 
Annex V to Directive 98/8/EC. 
(3) Pursuant to Regulation (EC) No 1451/2007, ca rbon dioxide has now been evaluated in 
accordance with Article 11(2)  of Directive 98/8/EC for use in product-type 18, 
insecticides, acaricides and products to control other arthropods, as defined in 
Annex V to that Directive. 
(4) France was designated as Rapporteur Member State and submitted the competent 
authority report, togeth er with a recommendation, to the Commission on 
                                                 
1 OJ L 123, 24.4.1998, p. 1.  
2 OJ L 325, 11.12.2007, p. 3. 
3 OJ L 197, 25.7.2008, p. 54. EN 3   EN 19 February 2008 in accordance with Article 14(4) and (6) of Regulation (EC) 
No 1451/2007. 
(5) 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 27 May 2010, in an assessment report. 
(6) It appears from the examinations made that  biocidal products us ed as insecticides, 
acaricides and products to cont rol other arthropods and containing carbon dioxide may 
be expected to satisfy the requirements laid  down in Article 5 of Directive 98/8/EC. It 
is therefore appropriate to extend the inclusion of carbon di oxide in Annex I to that 
Directive to such products. 
(7) Not all potential uses have b een evaluated at the European level. It is therefore 
appropriate that Member States assess thos e uses or exposure scenarios and those risks 
to the compartments and populations that have  not been representatively addressed in 
the European level risk assessment and, when  granting product aut horisations, ensure 
that appropriate measures are taken or sp ecific conditions imposed in order to reduce 
the identified risks to acceptable levels. 
(8) In the light of the findings of the assessment report, it is appropriate to require that risk 
mitigation measures are applied at product au thorisation level to products containing 
carbon dioxide and used as insecticides, a caricides and products to control other 
arthropods to ensure that risks are reduced  to an acceptable level in accordance with 
Article 5 of Directive 98/8/EC and Annex VI th ereto. In particular, it is appropriate to 
require that products are only sold to and used by trained professionals, that 
appropriate measures to prot ect operators are taken to en sure minimum risk, including 
the availability of personal protective e quipment if necessary, and that appropriate 
measures are taken to protect bystanders, su ch as exclusion from the treatment area 
during fumigation. 
(9) It is important that the provisions of this Directive be applied simultaneously in all the 
Member States in order to ensure equal tr eatment of biocidal products on the market 
containing the active substanc e carbon dioxide and also to facilitate the proper 
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 in order to permit Member Stat es and the interested parties to prepare 
themselves to meet the new requirements enta iled and to ensure that applicants who 
have prepared dossiers can benefit fully fr om the 10-year period of data protection, 
which, in accordance with Artic le 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) The measures provided for in this Directiv e are in accordance with the opinion of the 
Standing Committee on Biocidal Products, 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 
 
Transposition 
1. Member States shall adopt and publish, by 31 October 2011 at the latest, the laws, 
regulations and administrative provisions nece ssary to comply with this Directive.  
They shall apply those provi sions from 1 November 2012. 
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. 
1. 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  
The following is added to entry 'No. 7'  in Annex I to Directive 98/8/EC:  
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 (*) 
   "990 ml/l 1 November 
2012 31 October 2014 31 October 
2022 18 When assessing the application for authorisation of a product 
in accordance with Article 5 a nd Annex VI, Member States 
shall assess, when relevant fo r the particular product, those 
uses or exposure scenarios and those risks to compartments 
and populations that have not been representatively addressed in the European level risk assessment. 
When granting product authoris ation, Member States shall 
assess the risks and subsequen tly ensure that appropriate 
measures are taken or specific conditions imposed in order to 
mitigate the identified risks. 
Member States shall ensure that  authorisations are subject to 
the following conditions: 
(1) Product shall only be sold to and used by 
professionals trained to use them. 
(2) Appropriate measures to pr otect operators shall be 
taken to ensure minimum risk, including the availability of personal protective equipment if 
necessary.
  
EN 6   EN (3) Appropriate measures shall be taken to protect 
bystanders, such as excl usion from the treatment 
area during fumigation."  
(*) 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