DIRECTIVES  
COMMISSION DIRECTIVE 2010/51/EU  
of 11 August 2010  
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  
(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 Council 
concerning the placing 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 Directive 98/8/EC. That list 
includes N,N-diethyl-meta-toluamide (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, together 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 reviewed 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 
11 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 expected to satisfy the requirements laid 
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 authorisation level to products 
containing DEET and used as repellents or attractants. 
Products intended for direct application to human skin 
should be labelled with instructions 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, 
especially for children. Therefore, unless data is submitted 
to demonstrate that the product will meet the 
requirements of Article 5 and Annex VI when used on 
children, products containing DEET should not be used 
on children less than two years old, and use should be 
restricted for children between two and twelve years old, 
except where motivated by the risk for human health 
through e.g. outbreaks of insect-borne diseases. 
Furthermore, products should 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 treatment of biocidal products on the 
market containing the active substance DEET and also 
to facilitate the proper operation of the biocidal 
products market in general.  
(8) A reasonable period should be allowed to elapse before 
an active substance is included in Annex I in order to 
permit Member States and the interested parties to 
prepare themselves to meet the new requirements 
entailed and to ensure that applicants who have 
prepared dossiers can benefit fully from the 10-year 
period of data protection, which, in accordance with 
Article 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.EN L 211/14 Official Journal of the European Union 12.8.2010  
( 1 ) OJ L 123, 24.4.1998, p. 1.  
( 2 ) OJ L 325, 11.12.2007, p. 3.(10) Directive 98/8/EC should therefore be amended 
accordingly.  
(11) The measures provided for in this Directive 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 accordance 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 apply those provisions from 1 August 2012.  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 determine 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 20th day following 
its publication in the  Official Journal of the European Union . 
Article 4  
This Directive is addressed to the Member States.  
Done at Brussels, 11 August 2010.  
For the Commission  
The President  
José Manuel BARROSOEN 12.8.2010 Official Journal of the European Union L 211/15ANNEX  
In Annex I to Directive 98/8/EC, the following entry for the substance N,N-diethyl-meta-toluamide is added:  
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 (*)  
‘35 N,N-diethyl- 
meta-toluamide  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 on products intended for application on human skin, 
hair or clothing shall indicate that the product is intended 
only for restricted use on children between two and twelve 
years old, and that it is not intended for use on children less 
than two years old, unless it can be demonstrated in the 
application for product authorisation that the product will 
meet the requirements of Article 5 and Annex VI without 
such measures; 
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.htmEN L 211/16 Official Journal of the European Union 12.8.2010