DIRECTIVES  
COMMISSION DIRECTIVE 2010/74/EU  
of 9 November 2010  
amending Directive 98/8/EC of the European Parliament and of the Council to extend the inclusion 
in Annex I thereto of the active 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 Council 
concerning the placing 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 Directive 98/8/EC. That list 
includes carbon dioxide.  
(2) Commission Directive 2008/75/EC of 24 July 2008 
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 (  3 ) included carbon dioxide 
as an active substance in Annex I to Directive 98/8/EC 
for use in product type 14, rodenticides, as defined in 
Annex V to Directive 98/8/EC.  
(3) Pursuant to Regulation (EC) No 1451/2007, carbon 
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, together with 
a recommendation, to the Commission on 19 February 
2008 in accordance with Article 14(4) and (6) of Regu ­
lation (EC) No 1451/2007.  (5) The competent authority report was reviewed 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 used as insecticides, acaricides and products to 
control 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 dioxide in Annex I to 
that Directive to such products.  
(7) Not all potential uses have been evaluated at the 
European level. It is therefore appropriate that Member 
States assess those 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 authorisations, 
ensure that appropriate measures are taken or specific 
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 authorisation level to products 
containing carbon dioxide and used as insecticides, 
acaricides 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 thereto. In particular, it is appropriate to 
require that products are only sold to and used by 
trained professionals, that appropriate measures to 
protect operators are taken to ensure minimum risk, 
including the availability of personal protective 
equipment if necessary, and that appropriate measures 
are taken to protect bystanders, such 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 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.EN L 292/36 Official Journal of the European Union 10.11.2010  
( 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.(10) A reasonable period should 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 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) 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.  
Article 2  
Transposition  
1. Member States shall adopt and publish, by 31 October 
2011 at the latest, the laws, regulations and administrative 
provisions necessary to comply with this Directive.  They shall apply those provisions 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 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, 9 November 2010.  
For the Commission  
The President  
José Manuel BARROSOEN 10.11.2010 Official Journal of the European Union L 292/37ANNEX  
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 and Annex VI, Member States shall 
assess, when relevant for the particular product, those uses or 
exposure scenarios and those risks to compartments and popu ­
lations that have not been representatively addressed in the 
European 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 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 protect operators shall be taken to 
ensure minimum risk, including the availability of personal 
protective equipment if necessary. 
(3) Appropriate measures shall be taken to protect bystanders, 
such as exclusion 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.htmEN L 292/38 Official Journal of the European Union 10.11.2010