DIRECTIVES  
COMMISSION DIRECTIVE 2010/50/EU  
of 10 August 2010  
amending Directive 98/8/EC of the European Parliament and of the Council to include dazomet 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 dazomet.  
(2) Pursuant to Regulation (EC) No 1451/2007, dazomet has 
been evaluated in accordance with Article 11(2) of 
Directive 98/8/EC for use in product-type 8, wood 
preservatives, as defined in Annex V to that Directive.  
(3) Belgium was designated as Rapporteur Member State and 
submitted the competent authority report, together with 
a recommendation, to the Commission by 16 April 
2007 in accordance with Article 14(4) and (6) of Regu ­
lation (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 wood preservatives and containing 
dazomet may be expected to satisfy the requirements 
laid down in Article 5 of Directive 98/8/EC. It is 
therefore appropriate to include dazomet in Annex I to 
that Directive.  
(6) Not all potential uses have been evaluated at EU level. 
The EU level risk assessment addresses only professional 
use outdoors for the remedial treatment of wooden 
poles, such as transmission poles, by insertion of 
granules. It is therefore appropriate that Member States 
assess those uses or exposure scenarios and those risks to 
the compartments and populations that have not been 
representatively addressed in the EU level risk assessment 
and, when granting product authorisations, ensure that 
appropriate measures are taken or specific conditions 
imposed in order to reduce the identified risks to 
acceptable levels.  
(7) 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 dazomet and used as wood preservatives to 
ensure that risks are reduced to an acceptable level in 
accordance with Article 5 of Directive 98/8/EC and 
Annex VI thereto.  
(8) In particular, it is appropriate to require that products 
intended for industrial or professional use be used with 
appropriate personal protective equipment, unless it can 
be demonstrated that risks for industrial or professional 
users can be reduced by other means.  
(9) 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 dazomet and 
also to facilitate the proper operation of the biocidal 
products market in general.EN L 210/30 Official Journal of the European Union 11.8.2010  
( 1 ) OJ L 123, 24.4.1998, p. 1.  
( 2 ) OJ L 325, 11.12.2007, p. 3.(10) 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.  
(11) After inclusion, Member States should be allowed a 
reasonable period to implement Article 16(3) of 
Directive 98/8/EC.  
(12) Directive 98/8/EC should therefore be amended 
accordingly.  
(13) 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, 10 August 2010.  
For the Commission  
The President  
José Manuel BARROSOEN 11.8.2010 Official Journal of the European Union L 210/31ANNEX  
In Annex I to Directive 98/8/EC, the following entry for the substance dazomet 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 (*)  
‘34 Dazomet  Tetrahydro-3,5-dimethyl- 
1,3,5-thiadiazine-2-thione 
EC No: 208-576-7 
CAS No: 533-74-4  960 g/kg  1 August 2012  31 July 2014  31 July 2022  8  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, those uses or exposure scenarios and 
those risks to compartments and populations that have 
not been representatively addressed in the EU level risk 
assessment. In particular, where relevant, Member States 
shall assess any other use than professional use outdoors 
for the remedial treatment of wooden poles by insertion 
of granules. 
Member States shall ensure that authorisations are subject 
to the following condition: 
Products authorised for industrial and/or professional use 
shall be used with appropriate personal protective 
equipment, unless it can be demonstrated in the appli ­
cation for product authorisation that risks to industrial 
and/or professional users can be reduced to an acceptable 
level by others means.’  
(*) 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 210/32 Official Journal of the European Union 11.8.2010