EN    EN   
 EUROPEAN COMMISSION   
Brussels, XXX  
DXXX/01 - CA-Sept11 -Doc.3   
[…](2011) XXX draft   
  
COMMISSION DIRECTIVE ../…/EU  
of XXX  
amending Directive 98/8/EC of the European Parliament and of the Council to include 
bendiocarb as an active substance in Annex I the reto  
(Text with EEA relevance)   
EN 2   EN COMMISSION DIRECTIVE ../…/EU 
of XXX 
amending Directive 98/8/EC of the European Parliament and of the Council to include 
bendiocarb 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 bendiocarb. 
(2) Pursuant to Regulation (EC) No 1451/ 2007, bendiocarb 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) The United Kingdom was designated as Rappor teur Member State and submitted the 
competent authority report, together with a recommendation, to the Commission on 1 April 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 23 September 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 a nd containing bendiocarb may be expected 
to satisfy the requirements laid down in Artic le 5 of Directive 98/8/ EC. It is therefore 
appropriate to include bendiocarb 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 view of the risks identified for the a quatic environment when products were used 
for the treatment of rooms that were subj ect to regular wet cl eaning, resulting in 
emissions of a certain scale to  surface waters, it is appropria te to require that products 
not be authorised for uses resulting in such emissions, 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 application of appropriate risk 
mitigation measures. 
(8) In view of the risks identified for the aquati c environment, it is a ppropriate to require 
that losses to drains are avoided as  far as is reasonably practicable. 
(9) 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 bendiocarb an d also to facilitat e the proper operation 
of the biocidal products market in general. 
(10) 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. 
(11) After inclusion, Member States should be allowed a reasonable period to implement 
Article 16(3) of Directive 98/8/EC. 
(12) Directive 98/8/EC should therefore be amended accordingly. 
(13) 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 January 2013 at the latest, the laws, 
regulations and administrative provisions nece ssary to comply with this Directive.  
They shall apply those provi sions from 1 February 2014. 
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] bendiocar
b 2,2-dimethyl-1, 3-benzodioxol-4-yl 
methylcarbamate 
CAS-No: 22781-23-3 
EC No: 245-216-8 970 g/kg 
1 February 
2014 31 January 2016 31 January 
2024 18 Only professional use has been addressed 
in the Union level risk assessment. When 
assessing the application for authorisation of a product in accord ance 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 shall not be authorised for the 
treatment of areas subject to, and accessible 
to, regular wet cleaning, 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 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 (*) 
Member States shall ensure that 
authorisations are subject to the following 
condition: 
Labels and, where provided, safety 
data sheets of authorised products 
shall indicate that losses to drains shall be avoided as far as is 
reasonably practicable." 
(*) 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