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 
pyriproxyfen as an active s ubstance 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 
pyriproxyfen 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 pyriproxyfen. 
(2) Pursuant to Regulation (EC) No 1451/2007, pyriproxyfen 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) The Netherlands were designated as Ra pporteur Member State and submitted the 
competent authority report, together with a recommendation, to the Commission on 
2 October 2009 in accordance with Artic le 10(5) and (7) 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 [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) It appears from the evaluations that biocidal products used  as insecticides, acaricides 
and products to control other arthropods a nd containing pyriproxyfen may be expected 
to satisfy the requirements laid down in Artic le 5 of Directive 98/8/ EC. It is therefore 
appropriate to include pyriproxyfen for us e in product type 18 in Annex I to that 
Directive. 
(6) Not all potential uses  and exposure scenarios have b een evaluated at Union level, 
which, in particular, included only professiona l use. 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 a ssessment and, when granting 
product authorisations, ensure that appropr iate measures are taken or specific 
conditions imposed in order to reduce th e 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
3 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/EEC4. 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 products authorised for professi onals are used with appropriate personal 
protective equipment, unless it can be dem onstrated in the a pplication for product 
authorisation that risks to wo rkers and operators can be redu ced 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 for direct use on surface water, unless it can be demonstrated in the application for product au thorisation that risks to the aquatic and 
terrestrial ecosystems and groundwater can be reduced to an acceptable level, and that 
and that any authorisation of products intended  to be used in waste treatment facilities 
is subject to appropriate risk mitigation measures to avoid contamination of the area outside the waste treatment site. 
(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 act ive substance pyriproxyfen a nd also to facilitate the 
proper operation of the biocidal products market in general. 
                                                
 
3  OJ L 152, 16.6.2009, p. 11. 
4  OJ L 70, 16.3.2005, p. 1.  
EN 4   EN (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 20115, 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. 
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 . 
                                                
 
5 OJ C 369, 17.12.2011, p. 14.  
EN 5   EN 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] pyriprox
yfen 4-phenoxyphenyl (RS)-2-(2-
pyridyloxy)propyl ether 
EC No: 429-800-1 
CAS No: 95737-68-1 970 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 use by non-
professionals, were excluded. 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. 
For products containing pyriproxyfen that 
may lead to residues in food or feed, 
Member States shall verify the need to set new or to amend existing maximum 
residue levels (MRLs) in accordance with  
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 (*) 
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. 
Member States shall ensure that 
authorisations are subject to the following 
conditions: 
1) products authorised for 
professionals shall be used with 
appropriate personal protective equipment, unless it can be 
demonstrated in the application 
for product authorisation that risks can be reduced to an acceptable 
level by other means; 
2) products shall not be authorised 
for direct use on surface water, 
unless it can be demonstrated in 
the application for product authorisation that risks 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 (*) 
3) products intended to be used in 
waste treatment facilities shall be 
subject to appropriate risk mitigation measures to avoid 
contamination of the area outside 
the waste treatment site." 
(*) 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