COMMISSION DIRECTIVE 2011/69/EU  
of 1 July 2011  
amending Directive 98/8/EC of the European Parliament and of the Council to include imidacloprid 
as an active substance in Annex I thereto  
(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 imidacloprid.  
(2) Pursuant to Regulation (EC) No 1451/2007, imidacloprid 
has been evaluated in accordance with Article 11(2) of 
Directive 98/8/EC for use in product-type 18, insec ­
ticides, acaricides and products to control other 
arthropods, as defined in Annex V to that Directive.  
(3) Germany was designated as rapporteur Member State and 
submitted the competent authority report, together with 
a recommendation, to the Commission on 15 September 
2008 in accordance with Article 14(4) and (6) of Regu ­
lation (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 
16 December 2010, in an assessment report.  
(5) It appears from the evaluations that biocidal products 
used as insecticides, acaricides and products to control 
other arthropods and containing imidacloprid may be expected to satisfy the requirements laid down in 
Article 5 of Directive 98/8/EC. It is therefore appropriate 
to include imidacloprid in Annex I to that Directive.  
(6) Not all potential uses have been evaluated at Union level. 
It is therefore appropriate that Member States assess 
those uses or exposure scenarios and those risks to 
human populations and to environmental compartments 
that have not been representatively addressed in the 
Union 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.  
(7) In view of the risks identified for the aquatic 
compartment, it is appropriate to require that products 
are not authorised for uses in animal housings where 
emission to a sewage treatment plant or direct 
emission to surface water cannot be prevented, unless 
data is submitted demonstrating that the product will 
meet the requirements of both Article 5 of and Annex 
VI to Directive 98/8/EC, if necessary by the application of 
appropriate risk mitigation measures.  
(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. In particular, in 
the light of the possible risk for non-professionals, 
appropriate risk mitigation measures should be taken 
to minimise the potential exposure of infants and 
children.  
(9) In the light of the findings relating to possible indirect 
human exposure via consumption of food, it is appro ­
priate to require, where relevant, verification of the need 
to set new or amended existing maximum residue levels 
(MRLs) according to Regulation (EC) No 470/2009 of the 
European Parliament and of the Council of 6 May 2009 
laying down Community procedures for the estab ­
lishment of residue limits of pharmacologically active 
substances in foodstuffs of animal origin, repealing 
Council Regulation (EEC) No 2377/90 and amending 
Directive 2001/82/EC of the European Parliament and 
of the Council and Regulation (EC) No 726/2004 of 
the European Parliament and of the Council (  3 ) or Regu ­
lation (EC) No 396/2005 of the European Parliament and 
of the Council of 23 February 2005 on maximum 
residue levels of pesticides in or on food and feed of 
plant and animal origin and amending Council 
Directive 91/414/EEC (  4 ). Measures should be adopted 
ensuring that the applicable MRLs are not exceeded.EN L 175/24 Official Journal of the European Union 2.7.2011  
( 1 ) OJ L 123, 24.4.1998, p. 1.  
( 2 ) OJ L 325, 11.12.2007, p. 3.  ( 3 ) OJ L 152, 16.6.2009, p. 11.  
( 4 ) OJ L 70, 16.3.2005, p. 1.(10) It is important that the provisions of this Directive be 
applied simultaneously in all Member States in order to 
ensure equal treatment of biocidal products on the 
market containing the active substance imidacloprid 
and also to facilitate the proper operation of the 
biocidal products market in general.  
(11) A reasonable period should be allowed to elapse before 
an active substance is included in Annex I to Directive 
98/8/EC in order to permit Member States and 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.  
(12) After inclusion, Member States should be allowed a 
reasonable period to implement Article 16(3) of 
Directive 98/8/EC.  
(13) Directive 98/8/EC should therefore be amended 
accordingly.  
(14) 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 30 June 2012 
at the latest, the laws, regulations and administrative provisions 
necessary to comply with this Directive.  
They shall apply those provisions from 1 July 2013.  
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, 1 July 2011.  
For the Commission  
The President  
José Manuel BARROSOEN 2.7.2011 Official Journal of the European Union L 175/25ANNEX  
In Annex I to Directive 98/8/EC, the following entry is added:  
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 (*)  
‘42 imidacloprid  (2E)-1-[(6-chloropyridin-3-yl) 
methyl]-N-nitroimidazolidin-2- 
imine 
EC No: 428-040-8 
CAS No: 138261-41-3  970 g/kg  1 July 2013  30 June 2015  30 June 2023  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 human populations and to envi ­
ronmental compartments that have not been repre ­
sentatively addressed in the Union level risk 
assessment. 
Products shall not be authorised for uses in animal 
housings where emission to a sewage treatment plant 
or direct emission to surface water cannot be 
prevented, unless data is submitted demonstrating 
that the product will meet the requirements of 
Article 5 and Annex VI, if necessary by the appli ­
cation of appropriate risk mitigation measures. 
Authorisations shall be subject to appropriate risk 
mitigation measures. In particular, appropriate risk 
mitigation measures shall be taken to minimise the 
potential exposure of infants and children. 
For products containing imidacloprid that may lead 
to residues in food or feed, Member States shall verify 
the need to set new or amended existing maximum 
residue levels (MRLs) according to Regulation (EC) No 
470/2009 or Regulation (EC) No 396/2005, and take 
any appropriate risk mitigation measures ensuring 
that the applicable MRLs are not exceeded.’  
(*) 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 175/26 Official Journal of the European Union 2.7.2011