EN    EN EN  
EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels,  
C(2009)XXX final  
Draft 
COMMISSION DIRECTIVE ../…/EC 
of […] 
amending Directive 98/8/EC of the European Parliament and of the Council to include 
acrolein as an active su bstance in Annex I thereto  
EN 2   EN Draft 
COMMISSION DIRECTIVE ../…/EC 
of  
amending Directive 98/8/EC of the European Parliament and of the Council to include 
acrolein as an active su bstance 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 Article 11(4) thereof, 
Whereas: (1) The United Kingdom has received on 18 Au gust 2006 an application from Baker 
Petrolite, in accordance with Article 11(1) of  Directive 98/8/EC, for the inclusion of 
the active substance acrolein in its Annex I for use in product-type 12, slimicides, as 
defined in Annex V to Directive 98/8/EC. Ac rolein was not on the market on the date 
referred to in Article 34(1) of Directive 98/8/EC as an active substance of a biocidal product. 
(2) After carrying out an evaluation, the Unite d Kingdom submitted its report, together 
with a recommendation, to the Commission on 16 March 2009. 
(3) The competent authority report was re viewed by the Member States and the 
Commission. In accordance with Article 15( 4) of Commission Re gulation (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 Eur opean Parliament and of the 
Council concerning the pl acing of biocidal products on the market
2, the findings of the 
review were incorporated, within the Standing Committee on Biocidal Products on 18 
September 2009, in an assessment report. 
(4) It appears from the examinations made that  biocidal products used as slimicides and 
containing acrolein may be expected to sati sfy the requirements la id down in Article 5 
of Directive 98/8/EC. It is therefore appropriate to incl ude acrolein in Annex I. 
                                                 
1 OJ L 123, 24.4.1998, p. 1. 
2 OJ L 325, 11.12.2007, p. 3.  
EN 3   EN (5) Not all potential uses have been evaluated at the Community level. It is therefore 
appropriate that Member States assess thos e uses or exposure scen arios and those risks 
to compartments and populations that have no t been representatively addressed in the 
Community level risk assessment and, when granting product auth orisations, ensure 
that appropriate measures are taken or sp ecific conditions imposed in order to reduce 
the identified risks to acceptable levels.  
(6) In the light of the findings of the assessment re port, it is appropriate to require that risk 
mitigation measures are applied at product authorisation level to products containing 
acrolein used as slimicides.  
(7) In particular, it is appropriate to require  that products intended for industrial or 
professional use be used with appropria te protective equipment and that safe 
operational procedures are established such as the use of air monitoring and exclusion 
zones, unless it can be demonstrated that ri sks for industrial or professional users can 
be reduced by other means.  
(8) Appropriate measures should be  taken to limit the risks to  the marine environment, 
since unacceptable risks to this compar tment have been identified during the 
evaluation. To this end, certain conditi ons should be imposed by the competent 
authorities when authorising the biocidal pr oduct, namely ensuring that waste water is 
monitored and, if necessary, treated before discharge. 
(9) A reasonable period should be allowed to elap se before an active substance is included 
in Annex I in order to permit Member States  to bring into force the laws, regulations 
and administrative provisions necessary to comply with this Directive. 
(10) Directive 98/8/EC should therefore be amended accordingly. 
(11) 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 the laws, regulations and administrative 
provisions necessary to comply with this  Directive by 31 August 2010 at the latest. 
 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 Co mmission the text of the main provisions 
of national law which they adopt in the field covered by this Directive.  
EN 4   EN 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 for the substance acrolein is added 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 d
a
"(**) [OPOCE: 
please insert substance 
number] Acrolein Acrylaldehyde 
EC No: 203-453-4 
CAS No: 107-02-8  963 g/kg 1 September 
2010 Not applicable 31 Augu
s
(*) For the implementation of the common principles of Annex VI, the content and conclusions of asse ssment reports are available on  the 
Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm