EN    EN EN 
 COMMISSION OF THE E UROPEAN COMMUNITIES 
 
 
Brussels,  
C(2009) XXX final D003725/01 
  
Draft 
COMMISSION DIRECTIVE .../…/EC 
of […] 
amending Directive 98/8/EC of the European Parliament and of the Council to include 
nitrogen as an active 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 
nitrogen as an active subs tance in Annex I thereto 
(Text with EEA relevance) 
THE COMMISSION OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty esta blishing 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 market1, 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 C ouncil 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 inclusio n in Annex I, IA or  IB to Directive 98/8/EC. That list 
includes nitrogen. 
(2) Pursuant to Regulation (EC) No 1451/2007, n itrogen has been evaluated in accordance 
with Article 11(2) of Directive 98/8/EC fo r use in product-type 18, insecticides, as 
defined in Annex V to Directive 98/8/EC. 
(3) Ireland was designated as Rapporteur Memb er State and submitted the competent 
authority report, together with a reco mmendation, to the Commission on 13 November 
2007 in accordance with Article 14(4) a nd (6) of Regulati on (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 28 November 2008, 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 examinations made that biocidal products used as insecticides and 
containing nitrogen may be expected to sati sfy the requirements laid down in Article 5 
of Directive 98/8/EC. It is therefore appropr iate 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 Stat es assess those risks to the compartments and populations 
that have not been representatively addre ssed in the Community level risk assessment 
and, when granting product authorisations, en sure that appropriate 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 applie d at product authorisation level to products 
containing nitrogen and used as insecticid es. In particular, products should only be 
sold to and used by trained professionals w ith safe working practi ces 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 tr eatment of biocidal products on the market 
containing the active substance nitrogen and al so to facilitate th e proper operation of 
the biocidal products market in general. 
(9) 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 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 gran t, modify or cancel 
authorisations of biocidal products in product-type 18 cont aining nitrogen to ensure 
that they comply with Directive 98/8/EC. 
(11) Directive 98/8/EC should therefore be amended accordingly. 
(12) 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.  
EN 4   EN Article 2 
1. Member States shall adopt and publish, by 31 August 2010 at th e latest, the laws, 
regulations and administrative provisions nece ssary to comply with this Directive. 
They shall apply those provi sions 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 determin e how such reference is to be made. 
2. Member States shall communicate to the Co mmission 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 
 Stavros DIMAS  Member of the Commission 
EN 5   EN ANNEX  
 
The following entry ‘No. 27’ is insert ed 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 dead line 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  
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 dead line 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 (*) 
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/e nvironment/biocides/index.htm