EN    EN  
 
 
 
EN  
EN 1   EN  
 
 
 
Draft 
COMMISSION DIRECTIVE .../…/EC 
of […] 
amending Directive 98/8/EC of the European Parliament and of the Council to include 
alphachloralose 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 alphachloralose. 
(2) Pursuant to Regulation (EC) No 1451/2007, alphachloralose has been evaluated in 
accordance with Article 11(2)  of Directive 98/8/EC for use in product-type 14, 
rodenticides, as defined in Annex V to Directive 98/8/EC. 
(3) Portugal was designated as Rapporteur Me mber State and submitted the competent 
authority report, together with a reco mmendation, to the Commission on 14 November 
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 
                                                 
1 OJ L 123, 24.4.1998, p. 1. Directive as last amended by Commission Directive 2007/70/EC (OJ L 312, 
30.11.2007, p. 26). 
2 OJ L 325, 11.12.2007, p. 3.  
EN 2   EN findings of the review were incorporated, within the Standing Committee on Biocidal 
Products on 30 May 2008, in an assessment report. 
(5) It appears from the examinations made that biocidal products used as rodenticides and 
containing alphachloralose may be expected to satisfy the requirements laid down in 
Article 5 of Directive 98/8/EC. It is theref ore appropriate to include alphachloralose in 
Annex I, in order to ensure that in all Member States authorisations for biocidal 
products used as rodenticid es and containing alphach loralose can be granted, 
modified, or cancelled in accordance with Article 16(3) of Directive 98/8/EC.  
(6) 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. 
(7) In the light of the conclusions of the assessmen t report, it is approp riate to require that 
specific risk mitigation measures are applie d at product authorisation level to products 
containing alphachloralose and used as rode nticides. Such measures should be aimed 
at limiting the risk of primary and s econdary exposure of humans and non-target 
animals as well as the long term effect s of the substance on the environment. 
(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 alphachloralo se 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 bi ocidal products in pr oduct-type 14 containing  alphachloralose 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 3   EN Article 2  
1. Member States shall adopt and publish, by 30 September 2009 at the 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 pr ovisions from 1 October 2010. 
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 4   EN ANNEX  
The following entry ‘No. 15’ 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 dead line 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
* 
 
 
"15 alphachloralose (R)-1,2-O-(2,2,2-
Trichloroethylidene)-
α-D-glucofuranose 
EC No: 240-016-7 CAS No: 15879-93-3 
 825 g/kg 1 October 
2010 30 September 2012 30 
September 
2020 14 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.  
When granting product authorisation, Member States shall 
assess the risks and subsequen tly ensure that appropriate 
measures are taken or specific conditions imposed in order to mitigate the id entified risks.  
Product authorisation can only be granted where the 
application demonstrates that risks can be reduced to acceptable levels. 
In particular, products cannot be authorised for outdoor use 
unless data is submitted to demonstrate that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of  appropriate risk mitigation 
measures. 
Member States shall ensure that  authorisations are subject to 
the following conditions: 
(1) The nominal concentration of the active substance in the 
                                                 
  
EN 5   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 dead line 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
* 
 
 
products shall not exceed 40 g/kg. 
(2) Products shall contain an aversive agent and a dye. 
(3) Products formulated as powde r shall not be authorised. 
(4) Only products formulated as solid blocks and for use in 
tamper resistant and securely closed bait boxes shall be 
authorised." 
 
* 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/envir onment/biocides/index.htm