Proposal for a COUNCIL DIRECTIVE 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
Date: 2013-02-05
Institutions: European Commission
Subjects: maize, market approval, pesticide, plant health control

EUROPEAN 
COMMISSION 

Brussels, 5.2.2013  
COM(2013) 46 final 

2013/0026 (NLE) 

Proposal for a 

COUNCIL DIRECTIVE 

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 

   EN 

 
 
 
  
 
EXPLANATORY MEMORANDUM 

According  to  Directive  98/8/EC  of  the  European  Parliament  and  the  Council  of 
16 February 19981 concerning the placing of biocidal products on the market, a programme of 
work shall be carried out concerning the review of all active substances contained in biocidal 
products already on the market on 14 May 2000 (existing active substances). Powdered corn 
cob was identified as an existing active substance and evaluated in the context of that work 
programme. 

In accordance with the second subparagraph of Article 16(2) of Directive 98/8/EC, it may be 
decided  through  the  regulatory  procedure  with  scrutiny  referred  to  in  Article 28(4)  of  the 
Directive that an existing active substance shall be included in Annex I to the Directive. In the 
view of the Commission, the conclusions of the evaluation of powdered corn cob are that the 
conditions  for  the  inclusion  of  the  substance  into  both  Annex  I  and  Annex  IA  for  use  in 
product-type 14, rodenticides, as defined in Annex V to the Directive, are met under certain 
conditions.  Accordingly,  the  Commission  submitted  a  draft  Directive  for  vote  in  the 
Committee  established  under  Article 28(1)  of  Directive 98/8/EC.  The  Committee  did  not 
deliver  a  favourable  opinion  on  the  draft  Directive  in  its  meeting  on  21 September 2012.  In 
particular, some Member States had reservations regarding the level of efficacy of this active 
substance.  The  Commission  considers  that  sufficient  information  has  been  submitted  to 
demonstrate a certain efficacy to justify an inclusion into the annex I and IA of the directive, 
in particular in light of the fact that additional efficacy data will have to be submitted in the 
applications for product authorisation.  

Thus,  in  accordance  with  the  procedure  set  out  in  Article  5(a)  of  Decision  1999/468/EC,  a 
Proposal for a Council Directive is submitted to the Council and forwarded to the European 
Parliament. 

1 

OJ L 123, 24.4.1998, p. 1 

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2013/0026 (NLE) 

Proposal for a 

COUNCIL DIRECTIVE 

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 COUNCIL OF THE EUROPEAN UNION, 

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  market2,  and  in 
particular the second subparagraph of Article 16(2) thereof, 

Whereas: 

(1) 

(2) 

(3) 

(4) 

(5) 

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  Council  concerning  the  placing  of  biocidal 
products  on  the  market3  establishes  a  list  of  active  substances  to  be  assessed,  with  a 
view  to  their  possible  inclusion  in  Annex  I,  IA  or  IB  to  Directive  98/8/EC.  That  list 
includes powdered corn cob. 

Pursuant to Regulation (EC) No 1451/2007, powdered corn cob has been evaluated in 
accordance  with  Article 11(2)  of  Directive  98/8/EC  for  use  in  product-type  14, 
rodenticides, as defined in Annex V to that Directive. 

Greece  was  designated  as  Rapporteur  Member  State  and  submitted  the  competent 
authority  report, 
the  Commission  on 
22 October 2009  in  accordance  with  Article  14(4)  and  (6)  of  Regulation (EC) 
No 1451/2007. 

together  with  a  recommendation, 

to 

The  competent  authority  report  was  reviewed  by  the  Member  States  and  the 
Commission with the involvement of the applicant. 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  21  September  2012,  in  an 
assessment report. 

The  assessment  report  concludes  that  biocidal  products  used  as  rodenticides  and 
containing powdered corn cob may be expected to satisfy the requirements laid down 
in  Article  5  of  Directive 98/8/EC,  and  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 biocidal products used as rodenticides and 
containing  powdered  corn  cob  may  be  expected  to  present  only  low  risk  to  humans, 

2 
3 

OJ L 123, 24.4.1998, p. 1.  
OJ L 325, 11.12.2007, p. 3. 

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3 

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non-target animals and the environment, in particular with regard to the use which was 
examined  and  detailed  in  the  assessment  report,  that  is,  when  used  in  the  form  of 
pellets  in  dry  locations.  The  report  therefore  recommends  the  inclusion  of  powdered 
corn cob for that use in Annex IA to Directive 98/8/EC. It is appropriate to follow that 
recommendation. 

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. 

Not all potential uses and exposure scenarios have been evaluated at Union level. It is 
therefore  appropriate  to  require  that  Member  States  assess  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 and, 
when  granting  product  authorisations,  ensure  that  appropriate  measures  are  taken  or 
specific conditions imposed in order to reduce the identified risks to acceptable levels. 

The provisions adopted pursuant to this Directive should be applied simultaneously in 
all Member States in order to ensure equal treatment on the Union market of biocidal 
products  of  product-type  14  containing  the  active  substance  powdered  corn  cob  and 
also to facilitate the proper operation of the biocidal products market in general. 

(7) 

(8) 

(9) 

(10)  A reasonable period should be allowed to elapse 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  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) 

In  accordance  with  the  Joint  Political  Declaration  of  Member  States  and  the 
Commission  of  28  September  2011on  explanatory  documents4,  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. 

(14)  The Committee established by Article 28(1) of Directive 98/8/EC has not delivered an 
opinion on the measures provided for in this Directive, and the Commission therefore 
submitted  to  the  Council  a  proposal  relating to  the  measures  and  forwarded  it  to  the 
European Parliament, 

HAS ADOPTED THIS DIRECTIVE: 

Annex  I  and  IA  to  Directive  98/8/EC  are  amended  in  accordance  with  the  Annex  to  this 
Directive. 

Article 1 

4 

OJ C 369, 17.12.2011, p. 14. 

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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 Commission the text of those provisions. 

They shall apply those provisions 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 determine 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. 

This Directive shall enter into force on the day following that of its publication in the Official 
Journal of the European Union. 

Article 3 

Article 4 

This Directive is addressed to the Member States. 

Done at Brussels,  

For the Council 
The President 

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(1) In Annex I to Directive 98/8/EC, the following entry is added: 

ANNEX  

No 

Common 
Name 

IUPAC Name 
Identification Numbers 

Date 
inclusion 

of 

Minimum 
of 
purity 
the 
active 
substance in 
the  biocidal 
product  as 
placed 
on 
the market 

Powdered 
corn cob 

Not allocated 

1 000 g/kg 

1  February 
2015 

"(**) 
[OPOC
E: 
please 
insert 
substan
ce 
number] 

Deadline 
for 
compliance with Article 
16(3) 
for 
(except 
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 
inclusion 
the 
decisions  relating  to  its 
active substances) 
31 January 2017 

Expiry  date 
of inclusion 

Product 
type 

Specific provisions (*) 

31 
2025 

January 

14 

assessing 

application 

for 
the 
When 
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 
to  human 
scenarios  and 
environmental 
populations 
compartments 
been 
representatively  addressed  in  the  Union 
level risk assessment." 

to 
have 

those 

risks 

that 

and 

not 

(*)  For  the  implementation  of  the  common  principles  of  Annex  VI,  the  content  and  conclusions  of  assessment  reports  are  available  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 

Date 
inclusion 

of 

Minimum 
of 
purity 
the 
active 
substance in 
the  biocidal 
product  as 
placed 
on 
the market 

Powdered 
corn cob 

Not allocated 

1 000 g/kg 

1  February 
2015 

"(**) 
[OPOC
E: 
please 
insert 
substan
ce 
number] 

Deadline 
for 
compliance with Article 
16(3) 
for 
(except 
containing 
products 
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 
inclusion 
the 
decisions  relating  to  its 
active substances) 
31 January 2017 

Expiry  date 
of inclusion 

Product 
type 

Specific provisions (*) 

31 
2025 

January 

14 

States 

Member 
that 
registrations  are  subject  to  the  following 
condition: 

ensure 

shall 

–  Only  for  use  in  the  form  of  pellets  in 

dry locations." 

(*)  For  the  implementation  of  the  common  principles  of  Annex  VI,  the  content  and  conclusions  of  assessment  reports  are  available  on  the  Commission  website: 
http://ec.europa.eu/comm/environment/biocides/index.htm 

EN 

7 

EN