Proposal for a COUNCIL DIRECTIVE amending Directive 98/8/EC of the European Parliament and of the Council to include flufenoxuron as an active substance for product-type 8 in Annex I thereto
Date: 2011-11-14
Institutions: European Commission
Subjects: environmental impact, health risk, market approval, marketing standard, plant health control, plant health product

EUROPEAN COMMISSION 

Brussels, 14.11.2011 
COM(2011) 708 final 

2011/0311 (NLE) 

Proposal for a 

COUNCIL DIRECTIVE 

amending Directive 98/8/EC of the European Parliament and of the Council to include 
flufenoxuron as an active substance for product-type 8 in Annex I 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).  Flufenoxuron 
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  flufenoxuron  are  that  the 
conditions  for  the  inclusion  of  the  substance  in  Annex  I  for  use  in  product-type  8,  wood 
preservatives,  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 22 September 2011. 

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 

EN 

2 

   EN 

                                                 
2011/0311 (NLE) 

Proposal for a 

COUNCIL DIRECTIVE 

amending Directive 98/8/EC of the European Parliament and of the Council to include 
flufenoxuron as an active substance for product-type 8 in Annex I 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) 

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 flufenoxuron. 

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

France  was  designated  as  Rapporteur  Member  State  and  submitted  the  competent 
authority  report, 
the  Commission  on 
17 March 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. 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 22 September 2011, in an assessment report. 

2 
3 

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

EN 

3 

   EN 

                                                 
(5) 

(6) 

(7) 

(8) 

4 

5 
6 

7 

It appears from the evaluations that biocidal products used as wood preservatives and 
containing  flufenoxuron  may  be  expected  to  satisfy  the  requirements  laid  down  in 
Article  5  of  Directive  98/8/EC.  Therefore,  and  notwithstanding  the  fact  that 
flufenoxuron has not been approved in  certain other areas for which the use specific 
risk assessments gave a different result4, it is appropriate to include flufenoxuron for 
use in product type 8 in Annex I to that Directive. 

laid  down 

the  criteria 

in  Annex XIII 

In  view  of  its  characteristics,  which  render  it  persistent,  liable  to  bioaccumulate  and 
toxic  (PBT),  as  well  as  very  persistent  and  very  liable  to  bioaccumulate  (vPvB),  in 
accordance  with 
to  Regulation (EC) 
No 1907/2006  of  the  European  Parliament  and  of  the  Council  of  18  December  2006 
concerning  the  Registration,  Evaluation,  Authorisation  and  Restriction  of  Chemicals 
(REACH),  establishing  a  European  Chemicals  Agency,  amending  Directive 
1999/45/EC  and  repealing  Council  Regulation  (EEC)  No  793/93  and  Commission 
Regulation  (EC)  No  1488/94  as  well  as  Council  Directive  76/769/EEC  and 
Commission  Directives  91/155/EEC,  93/67/EEC,  93/105/EC  and  2000/21/EC5, 
flufenoxuron should be included in Annex I for three years only and should be made 
subject to a comparative risk assessment in accordance with the second subparagraph 
of Article 10(5)(i) of Directive 98/8/EC before its inclusion in Annex I is renewed. 

The  Union  level  risk  assessment  of  flufenoxuron  used  in  wood  preservatives  only 
addressed  treatment  of  wood  intended  to  be  used  indoors  (use  classes  1  and  2  as 
defined  by  OECD6)  or  outdoors  not  covered  and  not  in  contact  with  the  ground  and 
continually exposed to the weather, protected from the weather but subject to frequent 
wetting or in contact with fresh water (use class 3 as defined by OECD7), which will 
not be used in animal housing or come into contact with food or feed. Unacceptable 
risks for the environment were identified for the in situ treatment of wood outdoors, as 
well  as  in  various  scenarios  for  outdoor  use  of  treated  wood.  In  view  of  the 
characteristics  of  flufenoxuron,  it  is  appropriate  to  authorise  only  those  uses  and 
exposure  scenarios  that  have  been  representatively  addressed  in  the  Union  level  risk 
assessment, and for which no unacceptable risk was found. 

In view of the risks identified for human health for industrial and professional use it is 
appropriate  to  require  that  safe  operational  procedures  be  established  for  products 
authorised  for  such  use,  and  that  those  products  be  used  with  appropriate  personal 
protective  equipment  unless  it  can  be  demonstrated  in  the  application  for  product 
authorisation  that  risks  to  industrial  or  professional  users  can  be  reduced  to  an 
acceptable level by other means. 

Commission Implementing Regulation (EU) No 942/2011 of 22 September 2011 concerning the non-
approval of the active substance flufenoxuron, in accordance with Regulation (EC) No 1107/2009 of the 
European  Parliament  and  of  the  Council  concerning  the  placing  of  plant  protection  products  on  the 
market,  and  amending  Commission  Decision  2008/934/EC,  OJ L 246  of  23.9.2011,  p. 13.  See  also 
Draft  Commission  Decision  concerning  the  non-inclusion  of  flufenoxuron  for  product  type  18  in 
Annex I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council concerning the 
placing  of  biocidal  products  on  the  market,  to  which  the  Standing  Committee  for  Biocidal  Products 
gave a favourable opinion on 22 September 2011. 
OJ L 396, 30.12.2006, p. 1. 
OECD  series  on  emission  scenario  documents,  Number  2,  Emission  Scenario  Document  for  Wood 
Preservatives, part 2, p. 64. 
Ibid. 

EN 

4 

   EN 

                                                 
(9) 

In  view  of  the  risks  identified  for  the  aquatic  and  terrestrial  compartments,  it  is 
appropriate  to  require  that  appropriate  risk  mitigation  measures  be  taken  to  protect 
those compartments, in particular that freshly treated timber be stored after treatment 
under shelter or on impermeable hard standing, or both, and that any losses from the 
application  of  products  used  as  wood  preservatives  and  containing  flufenoxuron  be 
collected for reuse or disposal.  

(10)  The  provisions  of  this  Directive  should  be  applied  at  the  same  time  in  all  Member 
States in order to ensure equal treatment on the Union market of biocidal products of 
product-type 8 containing the active substance flufenoxuron and also to facilitate the 
proper operation of the biocidal products market in general. 

(11)  A reasonable period should be allowed to elapse 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 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. 

(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 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 to Directive 98/8/EC is amended in accordance with the Annex to this Directive. 

Article 1 

Article 2 

Transposition 

1. 

Member  States  shall  adopt  and  publish,  by  31 January 2013  at  the  latest,  the  laws, 
regulations and administrative provisions necessary to comply with this Directive.  

They shall apply those provisions 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 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. 

EN 

5 

   EN 

 
This Directive shall enter into force on the twentieth 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 

EN 

6 

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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 

flufenox
uron 

1-[4-(2-chloro-alpha, 
para-tolyloxy)-2-fluorophenyl]-3-(2,6-
difluorobenzoyl)urea 

alpha,alpha-trifluoro-

960 g/kg 

1  February 
2014 

EC No: 417-680-3 

CAS No: 101463-69-8 

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

(except 

for 
Deadline 
compliance with Article 
16(3) 
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 
inclusion 
the 
last  of 
decisions  relating  to  its 
active substances) 
31 January 2016 

Expiry  date 
of inclusion 

Product 
type 

Specific provisions (*) 

31 
2017 

January 

8 

the 

subject 

Flufenoxuron 
to  a 
shall  be 
comparative risk assessment in accordance 
with 
of 
Article 10(5)(i)  of  Directive  98/8/EC 
before  its  inclusion  in  this  Annex  is 
renewed. 

subparagraph 

second 

The Union level risk assessment addressed 
treatment  of  wood  which  will  not  be  used 
in  animal  housing  or  come  into  contact 
with  food  or  feed.  Products  shall  not  be 
authorised  for  uses  or  exposure  scenarios 
representatively 
that  have  not  been 
addressed 
risk 
level 
in 
assessment. 

the  Union 

EN 

7 

(1) 

Products  shall  only  be 

EN 

States 

Member 
that 
authorisations  are  subject  to  the  following 
conditions: 

ensure 

shall 

 
  
for 

used 
intended for indoor use. 

treatment  of  wood 

(2) 

(3) 

For  products  authorised 
for  industrial  or  professional  use 
safe  operational  procedures  shall 
be  established,  and  products  shall 
be used with appropriate personal 
protective equipment unless it can 
be demonstrated in the application 
for product authorisation that risks 
to  industrial  or  professional  users 
can  be  reduced  to  an  acceptable 
level by other means. 

soil 

and 
In 

Appropriate 
risk  mitigation 
measures shall be taken to protect 
the 
aquatic 
particular, 
compartments. 
labels and, where provided, safety 
data sheets of authorised products 
shall  indicate  that  freshly  treated 
stored  after 
timber 
treatment  under  shelter  or  on 
impermeable  hard  standing,  or 
both,  to  prevent  direct  losses  to 
soil  or  water,  and  that  any  losses 
from 
the 
the  application  of 
product  shall  be  collected  for 
reuse or disposal." 

shall  be 

(*)  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 

8 

EN