EN    EN EN  
EN    EN  EUROPEAN COMMISSION 
Brussels, xxx 
C(2011) yyy final D 
CA-Feb11-Doc.4.4  
  
Draft 
COMMISSION DIRECTIVE ../…/EU 
of […] 
amending Directive 98/8/EC of the European Parliament and of the Council to include 
Bacillus thuringiensis subsp.  Israelensis Serotype H14, Strain AM65-52 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 
Bacillus thuringiensis subsp.  Israelensis Serotype H14, Strain AM65-52 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 Bacillus thuringiensis subsp.  Israelensis Serotype H14. 
(2) Pursuant to Regulation (EC) No 1451/2007, Strain AM65-52 of Bacillus thuringiensis 
subsp. Israelensis Serotype H14, has been evaluated in accordance with Article 11(2) 
of Directive 98/8/EC for use in product-t ype 18, insecticides, acaricides and products 
to control other arthropods, as defined in A nnex V to that Directive. Strain SA3A of 
Bacillus thuringiensis subsp. Israelensis Serotype H14  is still under evaluation for use 
in that product-type. 
(3) Italy was designated as Rapporteur Memb er State and submitted the competent 
authority report, together with a reco mmendation, to the Commission on 11 July 2008 
in accordance with Article 14(4) a nd (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 othe r arthropods and containing Bacillus thuringiensis subsp.  
Israelensis Serotype H14, Strain AM65-52, ma y be expected to satisfy the 
requirements laid down in Articl e 5 of Directive 98/8/EC. It is therefore appropriate to 
include Bacillus thuringiensis subsp.  Israelensis Serotype H14, Strain AM65-52 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) 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 Bacillus thuringiensis subsp. Israelensis Serotype H14, 
Strain AM65-52  and also to facilitate the proper ope ration of the market for biocidal 
products in general. 
(8) 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 
data protection, which, in accordance with Article 12(1)(c)(ii) of Directive 98/8/EC, 
starts from the date of inclusion. 
(9) After inclusion, Member States should be allowed a reasonable period to implement 
Article 16(3) of Directive 98/8/EC. 
(10) Directive 98/8/EC should therefore be amended accordingly. 
(11) 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.  
EN 4   EN 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] Bacillus 
thuringien
sis subsp.  
Israelensis 
Serotype 
H14, Strain 
AM65-52 Not appliccabl The 
technical 
grade of 
Bacillus 
thuringiensis subsp.  
Israelensis 
Serotype 
H14, Strain 
AM65-52 shall 
contain 
high and low limits 
of 20% and 
8%, respectively 
of Bacillus 
thuringsiensis subsp. 
israelensis 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. 
Member States shall ensure that 
authorisations are subject to the following 
condition: 
If products are applied directly 
around plants, 1 month time interval 
shall pass between the last treatment 
and crop harvest."  
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 (*) 
solids, 
spores and 
insecticidal toxins. 
(*) 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