EN    EN  
 EUROPEAN COMMISSION 
Brussels, XXX 
D0xxxx/01-CA-Sept11-Doc. 4.4 
[…](2011) XXX draft 
  
COMMISSION DECISION 
of XXX 
concerning the non-inclusion of naled for product type 18 in Annex I, IA or IB to 
Directive 98/8/EC of the European Parliament and of the Council concernin g the placin g
of biocidal products on the market 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION DECISION 
of XXX 
concerning the non-inclusion of naled for pr oduct type 18 in Annex I, IA or IB to 
Directive 98/8/EC of the European Parliament  and of the Council concerning the placing 
of biocidal products on the market 
(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 naled. 
(2) Pursuant to Regulation (EC) No  1451/2007, naled (CAS Nr 300-76-5; 
EC Nr 206-098-3) has been evaluated in  accordance with Article 11(2) of 
Directive 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) France was designated as Rapporteur Member State and submitted the competent 
authority report, togeth er with a recommendation, to the Commission on 
17 February 2010 in accordance with Article 14(4) and (6) 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 SC 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) The assessment has demonstrated that biocia l products used as in secticides, acaricides 
and products to control other arthropods a nd containing naled cannot  be expected to 
satisfy the requirements laid down in Artic le 5 of Directive 98/8/EC. The scenarios 
evaluated in the human health risk assessmen t as well as in the environmantal risk 
assessment showed a potential and unacceptabl e risk. Furthermore, the evaluation has 
not demonstrated sufficient efficacy. It is th erefore not appropriate to include naled for 
use in product-type 18 in Annexes I, IA or IB to Directive 98/8/EC. 
(6) In the interest of legal certainty, the date as of which biocidal products of product-type 
18 containing naled should no longer be placed on the market should be specified, taking into account both the unacceptable effects of thos e products and the legitimate 
expectations of manufact urers of those products. 
(7) The measures provided for in this Decision are in accordance with the opinion of the 
Standing Committee on Biocidal Products, 
HAS ADOPTED THIS DECISION: 
Article 1 
Naled shall not be included in Annexes I, IA or IB to Directive 98/8/ EC for product type 18.  
Article 2 
For the purposes of Article 4(2) of Regula tion (EC) No 1451/2007, bioc idal products of 
product type 18 containing nale d (CAS Nr 300-76-5; EC Nr  206-098-3) shall no longer be 
placed on the market with effect from 1 November 2012. 
Article 3 
This Decision is addressed to the Member States. 
Done at Brussels, […] 
 For the Commission 
 Janez POTO ČNIK 
 Member of the Commission