EN    EN EN  
EN    EN  EUROPEAN COMMISSION 
Brussels, xxx 
C(2010) yyy final D012210/01 
CA-Dec10-Doc.3.3  
  
Draft 
COMMISSION DIRECTIVE ../…/EU 
of […] 
amending Directive 98/8/EC of the European Parliament and of the Council to include 
imidacloprid as an active substance in Annex I thereto  
EN 2   EN Draft 
COMMISSION DIRECTIVE ../…/EU 
of  
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 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 imidacloprid. 
(2) Pursuant to Regulation (EC) No 1451/2007, imidacloprid has b een 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. 
(3) Germany was designated as Rapporteur Me mber State and submitted the competent 
authority report, togeth er with a recommendation, to the Commission on 
15 September 2008 in accordance with Article  14(4) and (6) of Regulation (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 16 December 2010, 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 evaluations that biocidal products used  as insecticides, acaricides 
and products to control other arthropods a nd containing imidacloprid may be expected 
to satisfy the requirements laid down in Artic le 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 the 
environmental compartments and populations that have not been  representatively 
addressed in the Union level risk a ssessment and, when granting product 
authorisations, ensure that appropriate measures are ta ken or specific conditions 
imposed in order to reduce the iden tified risks to acceptable levels. 
(7) In view of the risks identified for the aquati c compartment, it is appropriate to require 
that products are not authorised for uses  in animal housings where exposure 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 au thorisation level. In particular, in the 
light of the possible risk for non-professiona ls, appropriate risk mitigation measures 
should be taken to minimise the potentia l exposure of infants and children.  
(9) In the light of the findings relating to  possible indirect human exposure via 
consumption of food, it is appr opriate to require,  where relevant, verification of the 
need to set new or amended existing maxi mum residue levels (MRLs) according to 
Regulation (EC) No 470/2009 of the Europ ean Parliament and of the Council of 
6 May 2009 laying down Community procedur es for the establishment of residue 
limits of pharmacologically activ e substances in foodstuffs of  animal origin, repealing 
Council Regulation (EEC) No 2377/90 and am ending 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 Regulation (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. 
(10) It is important that the provisions of this  Directive be applied simultaneously in all 
Member States in order to ensure equal tr eatment of biocidal products on the market 
containing the active substance imidacloprid an d also to facilitate the proper operation 
of the biocidal products market in general. 
(11) A reasonable period should be allowed to elap se 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 ne w requirements entailed and to ensure that 
applicants who have prepared  dossiers can benefit fully from the 10-year period of 
                                                 
3 OJ L 152, 16.6.2009, p. 11. 
4 OJ L 70, 16.3.2005, p. 1.  
EN 4   EN 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 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. 
Article 2 
 
Transposition 
1. Member States shall adopt and publish, by 30 April 2012 at th e latest, the laws, 
regulations and administrative provisions nece ssary to comply with this Directive.  
They shall apply those provisions from 1 May 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 determin e 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 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  
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 (*) 
"(**) 
[OPOC
E: please 
insert 
substance 
number] imidaclo
prid (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 May 2013 30 April 2015 30 April 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 environmental compartments and populations that have 
not been representatively addressed in the 
Union level risk assessment. 
Products shall not be authorised for uses in 
animal housings where exposure 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 
application of appropriate risk mitigation measures.  
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 
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 (*) 
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 app licable 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.htm