EN    EN  
 EUROPEAN COMMISSION 
Brussels, XXX   
CA-Sept12-Doc. 
[…](2011) XXX  draft 
  
COMMISSION DIRECTIVE ../…/EU 
of XXX  
amending Directive 98/8/EC of the European Parliament and of the Council to include 
diflubenzuron as an active substance in Annex I 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 
diflubenzuron 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 N-[[(4-chlorophenyl)amino]carbonyl ]-2,6-difluorobenzamide, which is a 
synonym for diflubenzuron. 
(2) Pursuant to Regulation (EC) No 1451/2007, diflubenzuron has been evaluated in 
accordance with Article 11(2) of Directiv e 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) Sweden was designated as Rapporteur Member State and submitted the competent 
authority report, togeth er with a recommendation, to the Commission on 
19 November 2007 in accordance with Article 10(5) and (7) of Commission Regulation (EC) No 2032/2003 of 4 Nove mber 2003 on the second phase of the 10-
year work programme referred to in Artic le 16(2) of Directive 98/8/EC of the 
European Parliament and of the Council c oncerning the placing of biocidal products 
on the market, and amending Regulation (EC) No 1896/2000
3. 
                                                 
1 OJ L 123, 24.4.1998, p. 1.  
2 OJ L 325, 11.12.2007, p. 3. 
3  OJ L 307, 24.11.2003, p.1.  
EN 3   EN (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 [date of Standing Committee meeting to be inserted], in an assessment 
report. 
(5) It appears from the evaluations that biocidal products used  as insecticides, acaricides 
and products to control ot her arthropods and containi ng diflubenzuron may be 
expected to satisfy the requirements laid dow n in Article 5 of Dir ective 98/8/EC. It is 
therefore appropriate to include  diflubenzuron for use in product type 18 in Annex I to 
that Directive. 
(6) Not all potential uses and exposure scenarios have been evaluated at Union level. For 
example, outdoor use, use by non-professiona ls, and exposure of livestock were not 
assessed. It is therefore appropr iate 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 aut horisations, ensure that appropriate 
measures are taken or specific conditions im posed in order to re duce the identified 
risks to acceptable levels. 
(7) In the light of the findings in the assessmen t report that there is  a possible indirect 
human exposure via consumption of food as a result of those uses represented in the 
assessment, it is appropriate to require, where relevant, verification of the need to set new or to amend existing maximum residue levels in accordance with Regulation (EC) 
No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying 
down Community procedures for the es tablishment of residue limits of 
pharmacologically active substan ces in foodstuffs of animal  origin, repealing Council 
Regulation (EEC) No 2377/90 and amending Di rective 2001/82/EC of the European 
Parliament and of the Council and Regulat ion (EC) No 726/2004 of the European 
Parliament and of the Council
4 or with Regulation (EC) No 396/2005 of the European 
Parliament and of the Council of 23 Febr uary 2005 on maximum residue levels of 
pesticides in or on food a nd feed of plant and animal  origin and amending Council 
Directive 91/414/EEC5. Measures should be adopted ensuring that th e applicable 
maximum residue levels are not exceeded. 
(8) In view of the assumptions made during th e risk assessment, it is appropriate to 
require that professional users of products containing diflubenzur on wear appropriate 
personal protective equipment, unless it can be demonstrated in the application for 
product authorization that risks to worker s and operators can be reduced to an 
acceptable level. 
(9) In view of the risks identifie d for the environment, it is appropriate to require that 
products are not authorised in water systems, unless it can be demonstrated in the application for product authoris ation that risks to the aqua tic and terrestrial ecosystems 
can be reduced to an  acceptable level, and that produc ts authorised for use on manure 
                                                
 
4  OJ L 152, 16.6.2009, p. 11. 
5  OJ L 70, 16.3.2005, p. 1.  
EN 4   EN are only used on dry manure, which has to  undergo complete aerobic composting prior 
to application of the manure on arable land. 
(10) The provisions of 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 18 containing the ac tive substance diflubenzuron a nd also to facilitate the 
proper operation of the biocidal products market in general. 
(11) 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. 
(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) In accordance with the Joint Political De claration of Member States and the 
Commission on explanatory documents of 28 September 20116, 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. 
(15) 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 31 January 2014 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 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. 
                                                
 
6 OJ C 369, 17.12.2011, p. 14.  
EN 5   EN 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 6   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] difluben
zuron 1-(4-chlorophenyl)-3-(2,6-
difluorobenzoyl)urea 
EC No: 252-529-3 
CAS No: 35367-38-5 960 g/kg 
1 February 
2015 31 January 2017 31 January 
2025 18 The Union level risk assessment did not 
address all potential uses and exposure 
scenarios; certain uses and exposure scenarios, such as outdoor use, use by non-
professionals, and exposure of livestock 
have not been assessed. 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 products containing diflubenzuron that 
may lead to residues in food or feed, 
Member States shall verify the need to set 
new or to amend existing maximum  
EN 7   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 (*) 
residue levels (MRLs) in accordance with 
Regulation (EC) No 470/2009 or 
Regulation (EC) No 396/2005, and take any appropriate risk mitigation measures 
ensuring that the app licable MRLs are not 
exceeded. 
Products shall not be authorised in water 
systems, unless it can be demonstrated in 
the application for product authorisation 
that risks to the aquatic and terrestrial 
ecosystems can be reduced to an acceptable level. 
Member States shall ensure that 
authorisations are subject to the following conditions: 
(1) professional users shall wear 
appropriate personal protective equipment, unless it can be 
demonstrated in the application 
for product authorization that risks to workers and operators can be 
reduced to an acceptable level.  
EN 8   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 (*) 
(2) Products authorised for use on 
manure shall only be used on dry 
manure, and the manure shall undergo complete aerobic 
composting prior to application on 
arable land." 
(*) 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