EN    EN EN  
EN    EN  EUROPEAN COMMISSION 
Brussels, xxx 
C(2011) yyy final D 
CA-Feb11-Doc.4.1  
  
Draft 
COMMISSION DIRECTIVE ../…/EU 
of […] 
amending Directive 98/8/EC of the European Parliament and of the Council to include 
lambda -cyhalothrin 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 
lambda -cyhalothrin 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 lambda -cyhalothrin. 
(2) Pursuant to Regula tion (EC) No 1451/2007, lambda -cyhalothrin has 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. 
(3) Sweden was designated as Rapporteur Member State and submitted the competent 
authority report, togeth er with a recommendation, to the Commission on 
8 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 6 May 2011, 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 and containing lambda -cyhalothrin may be 
expected to satisfy the requirements laid dow n in Article 5 of Dir ective 98/8/EC. It is 
therefore appropriate to include lambda -cyhalothrin 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 compartmen ts 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 the light of the risks identified for th e aquatic and terrestrial ecosystems when 
products were emitted to a sewage treatment plant, it is appropria te to require that 
products are not authorised for such uses, unless data are 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 a pplication of appropriate risk mitigation 
measures. 
(8) In the light of the risks identified for pr ofessional use without personal protective 
equipment, it is appropriate to require that product author isations for professional use 
are granted only for use with appropriate pe rsonal protective equipment, unless it can 
be demonstrated in the application for produc t authorisation that risks to professional 
users can be reduced to an accep table level by others means. 
(9) In the light of the possible indirect huma n exposure via consumption of food as a 
result of those uses represented in the a ssessment, it is appropriate to require, where 
relevant, verification of the need to se t new or amended existing maximum residue 
levels according to Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 la ying down Community procedures for the establishment 
of residue limits of pharmacol ogically 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 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 maximum residue levels are not exceeded. 
(10) The provisions of this Direct ive should be applied at the same time in all Member 
States in order to ensure equal treatmen t on the Union market of biocidal products 
containing the active substance lambda -cyhalothrin and also to facilitate the proper 
operation of the biocidal pr oducts 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 
                                                 
3 OJ L 152, 16.6.2009, p. 11. 
4 OJ L 70, 16.3.2005, p. 1.  
EN 4   EN 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 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 
1. Member States shall adopt and publish, by 30 September 2012 at the latest, the laws, 
regulations and administrative provisions nece ssary to comply with this Directive.  
They shall apply those pr ovisions from 1 October 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] lambda -
cyhalothri
n A mixture of: α-cyano-3-phenoxybenzyl (Z)-
(1R,3R)-[(S)-3-(2-chloro-3,3,3-trifluoro-
prop-1-enyl)]-2,2-
dimethylcyclopropanecarboxylate α-cyano-
3-phenoxybenzyl (Z)-(1S,3S)-[(R)-3-(2-
chloro-3,3,3-trifluoro-prop-1-enyl)]-2,2-
dimethylcyclopropanecarboxylate 
CAS-No: 91465-08-6 
EC No: 415-130-7 900 g/kg 
1 October 
2013 30 September 2015 30 September 
2023 18 When assessing the application for 
authorisation of a product in accordance 
with Article 5 and Annex VI, Member States shall assess, where relevant for the 
particular product, 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. 
Products applied in such a way that 
emission to a sewage treatment plant 
cannot be prevented shall not be 
authorised, unless data are submitted demonstrating that the product will meet 
the requirements of Article 5 and Annex 
VI, if necessary by the application of appropriate risk mi tigation 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 (*) 
Products authorised for professional use 
shall be used with appropriate personal 
protective equipment, unless it can be demonstrated in the application for product 
authorisation that risks to professional 
users can be reduced to an acceptable level by others means. 
For products containing lambda -
cyhalothrin 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