EN    EN EN  
EN    EN  EUROPEAN COMMISSION 
Brussels, xxx 
C(2010) yyy final D008215/01 
CA-Mar10-Doc.3.1  
  
Draft 
COMMISSION DIRECTIVE ../…/EU 
of […] 
amending Directive 98/8/EC of the European Parliament and of the Council to include 
N,N-Diethyl-meta-toluamide as an active substance in Annex I thereto  
EN 2   EN Draft 
COMMISSION DIRECTIVE ../…/EU 
of  
amending Directive 98/8/EC of the European Parliament and of the Council to include 
N,N-Diethyl-meta-toluamide as an active substance in Annex I thereto 
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 N,N-Diethyl-meta-tolu amide (hereinafter "DEET").  
(2) Pursuant to Regulation (EC) No 1451/2007, DEET has been evaluated in accordance 
with Article 11(2) of Directive 98/8/EC for use in product-type 19, repellents and 
attractants, as defined in Annex V to that Directive. 
(3) Sweden was designated as Rapporteur Member State and submitted the competent 
authority report, togeth er with a recommendation, to the Commission on 
30 November 2007 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 12 March 2010, in an assessment report. 
(5) It appears from the examinations made that biocidal products used  as repellents or 
attractants and containing DEET may be exp ected to satisfy the requirements laid 
                                                 
1 OJ L 123, 24.4.1998, p. 1.  
2 OJ L 325, 11.12.2007, p. 3.  
EN 3   EN down in Article 5 of Directive 98/8/EC. It is  therefore appropriate to include DEET in 
Annex I to that Directive. 
(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 
DEET and used as repellents or attractants. Products intended for direct application to 
human skin should be labelled with in structions for use including amount and 
frequency of application in order to minimize primary exposure of humans. Concerns 
were identified during the risk assessment for human health, espe cially for children. 
Therefore, products containing DEET should not  be used on children less than three 
years old, and use should be restricted for ch ildren between three and twelve years old, 
except where motivated by the risk for human health through e.g. ou tbreaks of insect-
borne diseases. Furthermore, products s hould contain deterrents for ingestion. 
(7) 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 DEET and also to facilitate the pr oper operation of the 
biocidal products market in general. 
(8) 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. 
(9) After inclusion, Member States should be allowed a reasonable period to implement 
Article 16(3) of Directive 98/8/EC. 
(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 
 
Transposition 
1. Member States shall adopt and publish, by 31 July 2011 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 provisions from 1 August 2012.  
EN 4   EN 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 
 The President  José Manuel BARROSO  
EN 5   EN ANNEX  
In Annex I to Directive 98/8/EC, the following entry fo r the substance N,N-Diethyl-meta-toluamide is added:  
No Comm
on 
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 (*) 
 
"(**) 
[OPOCE: 
please insert 
substance 
number] N,N-
Diethyl-
meta-toluamid
e  N,N-diethyl-m-
toluamide 
EC No: 205-149-7 
CAS No: 134-62-3 970 g/kg 1 August 2012 31 July 2014 31 July 2022 19 Member States shall ensure that 
authorisations are subject to the 
following conditions:  
(1) Primary exposure of humans 
shall be minimized by 
considering and applying appropriate risk mitigation 
measures, including, where 
applicable, instructions for the amount and frequency of 
application of the product on 
human skin. 
(2) Labels and/or safety data 
sheets of products intended for 
application on human skin, hair or clothing shall indicate that the product is not 
intended for use on children 
less than three years old, and is intended only for restricted 
use on children between three 
and twelve years old.  
(3) Products must contain 
deterrents for ingestion."  
(*) 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