EN    EN EN EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels,  
  
  
Draft 
COMMISSION DIRECTIVE ../…/EC 
of […] 
amending Directive 98/8/EC of the European Parliament and of the Council to include 
fenpropimorph as an active substance in Annex I thereto 
EN EN 2   EN Draft 
COMMISSION DIRECTIVE ../…/EC 
of  
amending Directive 98/8/EC of the European Parliament and of the Council to include 
fenpropimorph as an active substance in Annex I thereto 
(Text with EEA relevance) 
THE COMMISSION OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty esta blishing the European Community, 
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 market1, 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 fenpropimorph. 
(2) Pursuant to Regulation (EC) No 1451/ 2007, fenpropimorph 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 Directive 98/8/EC. 
(3) Spain was designated as Rapporteur Memb er State and submitted the competent 
authority report, together with a reco mmendation, to the Commission on 4 December 
2006 in accordance with Article 14(4) a nd (6) of Regulati on (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 19 September 2008, in an assessment report. 
(5) It appears from the examinations made  that biocidal products used as wood 
preservatives and containing fenpropimor ph may be expected to satisfy the 
requirements laid down in Articl e 5 of Directive 98/8/EC. It is therefore appropriate to 
                                                 
1 OJ L 123, 24.4.1998, p. 1. Directive as last amended by Directive 2008/31/EC of the European 
Parliament and of the Council (OJ L 81, 20.03.2008, p. 57). 
2 OJ L 325, 11.12.2007, p. 3. EN 3   EN include fenpropimorph in Annex I, in order to ensure that in all Member States 
authorisations for biocidal products used  as wood preservati ves and containing 
fenpropimorph can be granted, modified, or cancelled in accordance with Article 16(3) 
of Directive 98/8/EC.  
(6) In the light of the findings of the assessment report, it is appropriate to require that risk 
mitigation measures are applied at product au thorisation level to products containing 
fenpropimorph and used as wood preservatives to ensure that risks are reduced to an 
acceptable level in accordance with Article  5 of Directive 98/8/EC and Annex VI 
thereto. In particular, appropr iate measures should be ta ken to protec t the soil and 
aquatic compartments since unacceptable risks to these compartments have been identified during the evaluation. Products inte nded for industrial use should be used 
with appropriate protective equipment if th e risk identified for industrial users cannot 
be reduced by other means. 
(7) Not all potential uses have been evaluated at the Community level. It is therefore 
appropriate that Member States assess thos e risks to the compartments and populations 
that have not been representatively addre ssed in the Community level risk assessment 
and, when granting product authorisations, ensu re that appropriate measures are taken 
or specific conditions imposed in order to mitigate the id entified risks to acceptable 
levels. 
(8) It is important that the provisions of this Directive be applied simultaneously in all the 
Member States in order to ensure equal tr eatment of biocidal products on the market 
containing the active substance fenpropimorph and also to facilitate the proper operation of the biocidal pr oducts market in general. 
(9) A reasonable period should be allowed to elap se before an active substance is included 
in Annex I in order to permit Member Stat es and the interested parties to prepare 
themselves to meet the new requirements enta iled and to ensure that applicants who 
have prepared dossiers can benefit fully fr om the 10-year period of data protection, 
which, in accordance with Artic le 12(1)(c)(ii) of Directive 98/8/EC, starts from the 
date of inclusion. 
(10) After inclusion, Member States should be allowed a reasonable period to implement 
Article 16(3) of Directive 98/8/EC, and in  particular, to grant, modify or cancel 
authorisations of biocidal  products in product-type 8 containing fenpropimorph to 
ensure that they comply with Directive 98/8/EC. 
(11) Directive 98/8/EC should therefore be amended accordingly. 
(12) 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. EN 4   EN Article 2  
1. Member States shall adopt and publish, by  31 January 2010 at th e 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 and a correlation table between thos e provisions and this Directive. 
They shall apply those provi sions from 1 February 2011. 
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 
 Stavros Dimas  Member of the Commission EN 5   EN ANNEX  
The following entry ‘No. 21’ is insert ed in Annex I to Directive 98/8/EC:  
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 (*) 
 
"21 fenpropimorph Cis-4-[3-(p-tert-
butylphenyl)-2-methylpropyl]-2,6-
dimethylmorpholine 
EC No: 266-719-9 CAS No: 67564-91-
4 
 930 g/kg 1 February 
2011 31 January 2013 31 
January 
2021 8 When assessing the application for 
authorisation of a product in accordance with Article 5 and Annex VI, Member 
States shall assess, when relevant for the 
particular product, the populations that may be exposed to the product and the use 
or exposure scenarios that have not been 
representatively addressed at the Community level risk assessment. 
Member States shall ensure that 
authorisations are subject to the following conditions: 
(1) In view of the assumptions made 
during the risk assessment, 
products authorised for industrial 
use must be used with appropriate personal protective 
equipment, unless it can be 
demonstrated in the application for product authorisation that 
risks to industrial users can be 
reduced to an acceptable level by other means. EN 6   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) In view of the risks identified for 
the soil and aquatic compartments, appropriate risk 
mitigation measures must be 
taken to protect those compartments. In particular, 
labels and/or safety-data sheets 
of products authorised for industrial use shall indicate that 
freshly treated timber must be 
stored after treatment under shelter and on impermeable hard 
standing to prevent direct losses 
to soil or water and that any losses must be collected for reuse 
or disposal."
 
(*) 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