COMMISSION DIRECTIVE 2009/89/EC  
of 30 July 2009  
amending Directive 98/8/EC of the European Parliament and of the Council to include nitrogen as 
an active substance in Annex I thereto  
(Text with EEA relevance)  
THE COMMISSION 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 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 nitrogen.  
(2) Pursuant to Regulation (EC) No 1451/2007, nitrogen has 
been evaluated in accordance with Article 11(2) of 
Directive 98/8/EC for use in product-type 18, insec ­
ticides, as defined in Annex V to Directive 98/8/EC.  
(3) Ireland was designated as Rapporteur Member State and 
submitted the competent authority report, together with 
a recommendation, to the Commission on 13 November 
2007 in accordance with Article 14(4) and (6) of 
Regulation (EC) No 1451/2007.  
(4) 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 
28 November 2008, in an assessment report.  
(5) It appears from the examinations made that biocidal 
products used as insecticides and containing nitrogen 
may be expected to satisfy the requirements laid down 
in Article 5 of Directive 98/8/EC. It is therefore appro ­
priate to include nitrogen in Annex I, in order to ensure that in all Member States authorisations for biocidal 
products used as insecticides and containing nitrogen 
can be granted, modified, or cancelled in accordance 
with Article 16(3) of Directive 98/8/EC.  
(6) Not all potential uses have been evaluated at the 
Community level. 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 appro ­
priate measures are taken or specific conditions imposed 
in order to mitigate the identified risks to acceptable 
levels.  
(7) In the light of the findings of the assessment report, it is 
appropriate to require that specific risk mitigation 
measures are applied at product authorisation level to 
products containing nitrogen and used as insecticides. 
In particular, products should only be sold to and used 
by trained professionals with safe working practices and 
safe systems of work in place to ensure minimum risk.  
(8) 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 nitrogen and 
also to facilitate the proper operation of the biocidal 
products market in general.  
(9) 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.  
(10) 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 18 containing nitrogen to ensure that 
they comply with Directive 98/8/EC.  
(11) Directive 98/8/EC should therefore be amended 
accordingly.EN 31.7.2009 Official Journal of the European Union L 199/19  
( 1 ) OJ L 123, 24.4.1998, p. 1.  
( 2 ) OJ L 325, 11.12.2007, p. 3.(12) 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  
1. Member States shall adopt and publish, by 31 August 
2010 at the latest, the laws, regulations and administrative 
provisions necessary to comply with this Directive.  
They shall apply those provisions from 1 September 2011.  
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 20th day following 
its publication in the  Official Journal of the European Union . 
Article 4  
This Directive is addressed to the Member States.  
Done at Brussels, 30 July 2009.  
For the Commission  
Stavros DIMAS  
Member of the CommissionEN L 199/20 Official Journal of the European Union 31.7.2009ANNEX  
The following entry ‘No 27’ 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 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 (*)  
‘27 Nitrogen  Nitrogen 
EC No: 231-783-9 
CAS No: 7727-37-9  999 g/kg  1 September 2011  31 August 2013  31 August 2021  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, 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 mitigate 
the identified risks. 
Product authorisation can only be granted where the 
application demonstrates that risks can be reduced 
to acceptable levels. 
Member States shall ensure that authorisations are 
subject to the following conditions: 
1. Products may only be sold to and used by 
professionals trained to use them. 
2. Safe working practices and safe systems of work 
must be in place to ensure minimum risk, 
including the availability of personal protective 
equipment if necessary.’  
(*) 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 31.7.2009 Official Journal of the European Union L 199/21