EN    EN  
 EUROPEAN COMMISSION 
Brussels, XXX   
D022716/01 CA-Sept12-Doc.3.3 
[…](2012) XXX  draft 
  
COMMISSION DIRECTIVE ../…/EU 
of XXX  
amending Directive 98/8/EC of the European Parliament and of the Council to include 
powdered corn cob as an active substance in Annexes I and IA thereto 
(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 
powdered corn cob as an active substance in Annexes I and IA 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 powdered corn cob. 
(2) Pursuant to Regulation (EC)  No 1451/2007, powdered corn cob has been evaluated in 
accordance with Article 11(2) of Directiv e 98/8/EC for use in product-type 14, 
rodenticides, as defined in Annex V to that Directive. 
(3) Greece was designated as Rapporteur Member State and submitted the competent 
authority report, togeth er with a recommendation, to the Commission on 
22 October 2009 in accordance with Artic le 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 with the involvement of the a pplicant. 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 [date of Standing Committee 
meeting to be inserted], 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) The assessment report concludes that bioc idal products used as rodenticides and 
containing powdered corn cob may be expect ed to satisfy the requirements laid down 
in Article 5 of Directive 98/8/EC, a nd therefore recommends the inclusion of 
powdered corn cob for use in product type 14 in Annex I to that Directive. It is appropriate to follow that recommendation.  
(6) The assessment report also concludes that bi ocidal products used as rodenticides and 
containing powdered corn cob may be expect ed to present only low risk to humans, 
animals and the environment, in particular with regard to the use which was examined 
and detailed in the assessment report, that is, the use in dry loca tions of powdered corn 
cob in the form of pellets. The report ther efore recommends the inclusion of powdered 
corn cob for that use in Annex IA to Directiv e 98/8/EC. It is appropriate to follow that 
recommendation. 
(7) In accordance with current practice, and in compliance with Article 10(1) of 
Directive 98/8/EC, it is appropriate to limit the duration of the inclusion to ten years. 
(8) Not all potential uses and expos ure scenarios have been evalua ted at Union level. It is 
therefore appropriate to requi re that Member States asse ss those uses or exposure 
scenarios and those risks to  human populations and to environmental compartments 
that have not been represen tatively addressed in the Union level risk assessment and, 
when granting product authorisations, ensure that appropriate meas ures are taken or 
specific conditions imposed in order to reduce the identified risks to acceptable levels. 
(9) The provisions adopted pursuant to this Dir ective should be applie d simultaneously in 
all Member States in order to ensure equa l treatment on the Union market of biocidal 
products of product-type 14 containing the active substance powdered corn cob and 
also to facilitate the prop er 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 and Annex IA 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 accordan ce 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) In accordance with the Joint Political De claration of Member States and the 
Commission of 28 September 2011on explanatory documents
3, Member States have 
undertaken to accompany, in justified cases, the notification of their transposition 
measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition 
instruments. 
                                                
 
3 OJ C 369, 17.12.2011, p. 14.  
EN 4   EN (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 
Annexes I and IA to Directive 98/8/EC are am ended in accordance with the Annex to this 
Directive. 
Article 2 
1. Member States shall adopt and publish, by 31 January 2014 at the latest, the laws, 
regulations and administrative provisions necessary to comply with this Directive. 
They shall forthwith communicate to the Co mmission the text of those provisions. 
They shall apply those provi sions from 1 February 2015. 
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  
(1) 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] Powdere
d corn 
cob Not allocated 1 000 g/kg 
1 February 
2015 31 January 2017 31 January 
2025 14 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." 
(*) 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   
EN 6   EN (2) In Annex IA 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] Powdere
d corn 
cob Not allocated 1 000 g/kg 
1 February 
2015 31 January 2017 31 January 
2025 14 Member States shall ensure that 
registrations are subject to the following 
condition: 
– Only for use in dry locations of 
powdered corn cob in the form of 
pellets." 
(*) 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